SPIEGEL ONLINE - News - International ~~ August 28 2009
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Inside a Creepy Global Body Parts Business By Martina Keller and Markus Grill
The German company Tutogen's business in body parts is as secretive as it is lucrative. It extracts bones from corpses in Ukraine to manufacture medical products, as part of a global market worth billions that is centered in the United States.
Anatoly Korzhak, a pensioner and former engineer, died in Kiev on August 5, 2004. His body was picked up at 2 a.m. and taken to the forensic medicine institute in the Ukrainian capital. That same night, Korzhak's daughter, Lena Krat, received a telephone call and was asked to come to the institute immediately in the morning, where she was told she would receive further information.
It was the first time Krat was confronted with the death of a close relative. "I was so upset that I couldn't think clearly," she recalls. When she arrived at the institute in the morning, a man there said something to her about skin transplants. He was an employee of a Ukrainian company that works hand-in-hand with forensic medicine experts. She said to the man: "Leave me alone. I don't understand what you're talking about, and I don't want to listen to you."
But the employee was persistent and eventually gave her a form to sign. He told her that if she consented to skin removal, she would be helping pediatric burn victims who needed transplants. Krat signed the form. "It was as if I had been hypnotized," she says.
But now Krat, a mother of two young girls, has learned from SPIEGEL that the Ukrainian company in question sends the body parts to a German company, Tutogen Medical GmbH, which in turn apparently supplies large numbers of such parts to the American tissue market.
In addition to strips of skin, tendons, bones and cartilage are removed from the bodies. "This shocks me," says Krat. "If I had known that so much is cut out, I would never have given my consent."
A Lucrative Industry The incident in the Ukrainian capital is part of the secretive daily routine of a little-known but highly lucrative branch of the medical industry, in which companies use corpses to make medical spare parts. In doing so, they reuse almost everything the human body has to offer: bones, cartilage, tendons, muscle fascia, skin, corneas, pericardial sacs and heart valves. In the jargon of the profession, all of this is referred to as tissue.
Bones and tendons, the parts that interest Tutogen the most, are subjected to complex processing. The company degreases and cleans bones, cuts, saws or mills them into the desired shapes, then sterilizes, packages and sells the finished product in more than 40 countries around the world. With a prescription, it is even possible to order Tutogen's products through online pharmacies.
Photo Gallery: Tutogen's Global Business in Body Parts 1. HQ: Tutogen headquarters in Neunkirchen am Brand, a town of 8,000 people in northern Bavaria. Body parts extracted in Ukraine are shipped by are to Frankfurt or Nuremberg before being taken here. 2. A photo of the rundown pathology department where autopsies are conducted in the Ukrainian city Dnipropetrovsk. 3. Assistant District Attorney Josh Hanshaft holds a photograph of an X-ray showing the pelvic area of a deceased person with PVC plumbing pipe inserted where bones should have been at a Feb. 23, 2006 press conference in New York. Prosecutors allege four individuals including the head of Biomedical Tissue Services illegally extracted body parts of the deceased and sold them for profit. The case is still pending.
The market for tissue products is still small in Germany. When it comes to bones, for example, experts estimate that only about 30,000 transplants a year are used in hospitals nationwide, mainly for use in bone reconstruction for hip surgery and in spinal column surgery.
It's a completely different story in the United States. According to the American Academy of Orthopedic Surgeons, more than a million bone parts are used in transplants every year. In no other country is it possible to make so much money with body parts. If a body were disassembled into its individual parts, then processed and sold, the total proceeds could amount to $250,000 (€176,000). For a single corpse! The US tissue industry generates total revenues of about $1 billion a year, says journalist Martina Keller, a co-author of this article and the author of the German book, "Cannibalized: The Human Corpse as a Resource."
Legal and Ethical Questions
This raises the question of just how legal the process of obtaining raw materials is. And are bone products made from corpses even medically necessary? According to Klaus-Peter Günther, president of the German Society of Orthopedics and Orthopedic Surgery, they are often "not the first choice" in operations. "For us, the gold standard is still tissue taken directly from the patient in question."
Alternatives are only an option, says Günther, when the material from the patient's body is insufficient. Those alternatives include animal bones and artificial replacement parts made of ceramic material, for example -- or human donor bones.
Many hospitals collect and reuse bone fragments removed from patients who have received artificial hips. "For this reason," says Günther, "we have not had to resort to dead donors so far."
In the United States, doctors have far fewer qualms about using body parts from corpses than their German counterparts -- in such areas as spinal surgery, sports injuries and cosmetic surgery. For instance, doctors used pulverized skin particles to enhance lips and smooth out wrinkles.
Should corpses be butchered to make cosmetic procedures possible? Ingrid Schneider is decidedly opposed to the practice. For the past 15 years the Hamburg political scientist, a former member of the Investigative Commission on Law and Ethics in Modern Medicine in the German parliament, has been involved in the subject of recycling body substances. Schneider argues that the body is not a source of raw materials that can be sold at will. Given such concerns, it is not surprising that many people are deeply opposed to allowing the body of a family member to be reused, even for medical purposes.
Even if it is unrealistic to expect that all commercialization of the body could be ruled out in modern medicine, says Schneider, it is important to set boundaries. For that reason, she insists that human tissue ought to be used sparingly -- that is, only when such use is medically necessary and clearly superior to other forms of treatment.
The conviction that the body is much more than an object has also shaped the policies of the World Health Organization (WHO), the European Parliament and the European Council, the EU's body representing the leaders and ministers of the 27-member bloc. All of these bodies condemn the practice of trading in human body parts to turn a profit.
In Germany, the country's organ transplant act regulates the removal of tissue. Only those who have consented to organ and tissue harvesting are considered as donors. If a person dies and is not already a donor, his or her closest relatives can consent to donation. Paragraph 17 of the transplant act explicitly states: "Trading in organs or tissue intended for use in the medical treatment of others is prohibited." Physicians who remove tissue can only be paid suitable compensation for their efforts. The law calls for prison sentences of up to five years for violation of the trading prohibition.
Part 2: A Booming Tissue Market Tutogen paid its Ukrainian partners a fixed price for each body part. In January 2002, the company paid €42.90 for a complete femur, €42.90 for a humerus and €13.30 to €16.40 for a pericardial sac, depending on its size. Graduated prices were also arranged with the Ukrainians. Take, for example, the removal of patellar tendons with bone segments, known as "bond-tendon-bone," or BTB. When coroners supplied less than 40 BTBs on-site, Tutogen paid €14.30 apiece. For larger numbers of BTBs, the price went up: to €23 apiece for 40 or more BTBs and to €26.10 for 60 or more. For a coroner, who makes about €200 ($287) a month in Ukraine, such graduated prices must have been an incentive to remove as much body material as possible.
Thousands of pages of internal memos, faxes, supply lists and documents from the years 2000 to 2004, which SPIEGEL has obtained, suggest that not only did Tutogen process the Ukrainian body parts itself, but it also supplied the US tissue market.
Florida-based RTI Biologics, one of the US market leaders in the industry, generated $147 million in sales in 2008. The company describes itself as the "leading provider of sterile biological implants for surgeries around the world."
To that end, RTI acquired Tutogen Medical, Inc., the American parent company of the German company Tutogen Medical GmbH, last year. The acquisition was good news for RTI shareholders, because of Tutogen's large international donor network, says CEO Brian Hutchison. Put differently, Tutogen is a company that knows the ins and outs of gaining access to as many body parts as possible.
The body parts from Ukraine are shipped by air to Frankfurt or Nuremberg. From there, they are taken to Tutogen headquarters in Neunkirchen am Brand, a town of 8,000 people in northern Bavaria.
Tutogen's facilities in Neunkirchen, just a few kilometers north of Nuremberg, comprise several low, warehouse-like buildings, where about 140 employees work. All in all, it is an inconspicuous place for visitors who fly in regularly from Ukraine and the United States.
Company President Karl Koschatzky refused to respond to requests for an interview, and the company declined to answer a list of questions sent to its offices.
The Middleman Tutogen uses a middleman to organize its deliveries from Ukraine. Dr. Igor Aleshenko, a coroner by training, manages the company's relationships with the various local forensic medicine institutes. He has been working for Tutogen in Ukraine for about 10 years.
In that time, Aleshenko has become a wealthy man, and he now divides his time between his two residences, one in Kiev and one in Moscow. In 2002, Tutogen described Aleshenko as a "cost-intensive person." He too was unavailable for an interview in Kiev, nor did he respond to written questions.
In Ukraine, Aleshenko is far more than Tutogen's local contact. He is the director of Bioimplant, a company that manages tissue removal. Because of its close ties to the Ukrainian Health Ministry, Bioimplant is practically immune to overly probing government inspections of bone shipments crossing the border.
Ukrainians are kept somewhat in the dark when it comes to Bioimplant's true business dealings. According to the company's Web site, its "primary activity" is the "production of bio-implants" for use in Ukrainian patients. But what does Bioimplant really do?
Kiev, on a summer's day in 2009. Anyone seeking to pay a visit to Bioimplant's headquarters would be inclined to head to the company's official address at Patrice Lumumba Street 4/6, an office building with a number of tenants -- where Bioimplant doesn't even have its own mailbox.
A guard and a doorman greet visitors and send them to the fourth floor, where Bioimplant's offices are supposedly located. Room 305 is in a long hallway of closed doors. There is not even a sign to identify the room as being associated with Bioimplant. A young man in a pinstriped suit opens the door. He says that he hasn't been working for Bioimplant for very long, and that most of his work consists of photocopying.
According to the young man, the company leases three rooms in the office complex, but Dr. Aleshenko is not in today. Tutogen brochures and packets of sterilized corpse bones are stacked in the next room. Instead of the expected production facility, the offices are nothing but a distribution site.
Tutogen developed its business relationship with Aleshenko about 10 years ago. During a trip to Tutogen headquarters in the Bavarian countryside in November 2001, Aleshenko met with Koschatzky at the Bayerischer Hof Hotel in Erlangen, near Nuremberg. The minutes of the meeting contain a list of "new pathologies" working for Tutogen in the eastern Ukrainian cities of Dnipropetrovsk, Poltava and Zhytomyr.
Aleshenko had apparently brought along a wish list to the meeting, and his German business partners were eager to comply. According to the minutes, "TTG (Tutogen) agreed to provide 5,000 deutsche marks for investment costs in Dnipropetrovsk (Ukraine). Dr. Aleshenko will send us the necessary payment instructions."
Unkosher Discussions Some of the issues discussed at the meeting were less than kosher. For instance, the minutes state, "TTG is testing whether depilation of the corpse prior to skin removal could alleviate the hair problem (perhaps using the hot wax or cold wax method)."
A list of "pathologies currently providing (parts)," dated November 2001, already included abbreviations for 15 facilities in Ukraine. In the 2000-2001 fiscal year alone, 1,152 bodies in Ukraine were used to provide tissue for Tutogen.
But it still wasn't enough for the company, which needed more cooperating institutions, more donors and more bone parts to supply a booming tissue market.
According to an internal planning document dated June 17, 2002 (the file is titled "Raw Tissue Requirements"), Tutogen needed the following parts for the coming fiscal year:
* 2,920 shafts of the femur,
* 3,000 iliac crests,
* 1,190 patellar tendons,
* 3,750 kneecaps,
* 10,200 femoral muscle fascia (or fascia lata),
* 50 cranial bones,
* 70 Achilles tendons.
Aleshenko, who Tutogen apparently paid directly for the tissue parts, is believed to have funneled part of the money to coroners in Dnipropetrovsk, Kiev, Kharkiv and other Ukrainian cities. According to an internal list of "paid incoming goods," Tutogen's Ukrainian partner received roughly €350,000 between January and August 2001.
The investment must have paid off. Online pharmacies charge between €367 and €854, depending on the size, for a Tutoplast Spongiosa Block (Bone Substance). According to the price lists used at the time, the Ukrainians received between €23 and €26.10 for the original body part, again depending on the size. Even if Tutogen were paying twice as much for the raw material today, it would still be a bargain.
Part 3: Tissue and Organ Harvesting
Not surprisingly, Tutogen could afford to be generous to its Ukrainian partners. That generosity included large quantities of equipment the company routinely sent to its hardworking coroners.
According to the internal documents, in the 2000-2001 fiscal year Tutogen shipped 6,000 scalpels, 2,600 pairs of sterile gloves, 500 surgical gowns, 15 hacksaw blades for autopsies and many other items to Ukraine -- at a total cost of €40,000 in "donor expenses without tissue," as the Tutogen bookkeepers noted fastidiously. Tutogen paid its Ukrainian partners roughly €500,000 for the body parts during the same period.
The US Food and Drug Administration (FDA) currently lists 20 facilities in Ukraine that are authorized to supply body parts for the US market. But no matter which of these facilities one clicks on in the FDA database, all share the same contact information: the telephone number of Tutogen Medical GmbH in northern Bavaria.
One of the facilities on the list is the forensic medicine institute in Krivoy Rog, an industrial city in southeastern Ukraine, with a population of about 700,000. According to the FDA database, the Krivoy Rog site is authorized to supply bones, cartilage, fascia, ligaments, pericardial sacs, sclera (the white of the eye), skin and tendons.
Tissue and Organ Harvesting The whitewashed, Spartan structure housing the forensic medicine institute is on the edge of the hospital grounds. Frosted glass windowpanes behind latticed windows discourage prying eyes. Visitors immediately notice the cloying odor of corpses upon entering the building. The director of the institute is unavailable, even though his car is parked on the hospital grounds. A doctor wearing a denim jacket assumes the task of getting rid of anyone inquiring about the institute's collaboration with the German company.
Instead, he tells the reporters to contact the district attorney's office and points to a sign above the door, which reads: "No Admittance without Authorization." Does that include Tutogen, the reporters ask? "No, Tutogen is not unauthorized here," the man says, indicating that the conversation is over.
The former director of the city's forensic medicine department, Vladimir Bondarenko, is slightly more forthcoming. A retiree, he meets with visitors at a street café. Tissue harvesting began at his department about 10 years ago, says Bondarenko.
"It was illegal," he says. "The family members should have been told about what was happening with the bodies," but they had no idea. "When the deceased is lying in the coffin, the family members see nothing but the face. What they don't see is that the bones of the legs or arms have been removed."
The Ukrainian tissue transplant act includes a provision stating that family members must consent to tissue donation if the deceased did not already do so while still alive. However, there are indications that this was often not the case. Ukrainian authorities in Krivoy Rog and several other cities are conducting investigations into suspected illegal tissue and organ harvesting.
The case of the deceased father of Kiev resident Lena Krat, for example, was examined in connection with an investigation identified by the file number 50-3793, begun on Jan. 4, 2005. The investigation included all incidents that took place between May and September 2004. The names of 10 deceased persons are listed in the files. Their family members stated that they "did not consent to the removal of anatomical material."
According to the court order authorizing the proceedings, "family members were deceived, in that they were told that only a small part of the deceased would be removed, such as a bone or tissue fragment. In actual fact, almost all bones and tissue were removed. ... All of the material is taken to Germany."
A Legal Twist Despite the evidence, the Kiev district attorney's office closed the proceedings in July 2005, "for lack of a statutory offense." Curiously, the document states, as grounds for dropping the case, that the Bioimplant employees had not violated the transplant act, because they had not transplanted material from corpses, but had merely removed it so that it could be processed into "bio-implants." As a result of this legal twist, the recycling of corpses has been allowed to continue to this day.
Kiev, the forensic medicine institute on Orangery Street: A long, brick building, from which doctors wearing light-green aprons occasionally emerge to smoke cigarettes outside the front door. Family members stand next to the entrance, waiting for the release of their dead relatives. There is a display of coffins and wreaths in front of a funeral parlor across the street.
Vladimir Yurchenko is the director of the institute. He points to the room where bodies are processed for Tutogen. It is on the ground floor and sealed off to outsiders. Why? "Because that's what the US health authorities require," says Yurchenko.
Kiev's senior forensic pathologist explains the process. Bioimplant obtains the relatives' consent, and company employees also come to the institute to harvest the body parts. Yurchenko's staff members assist in the process, for which they receive additional compensation. Once bones and other parts have been removed, wooden sticks are inserted into the body so that it retains its shape until the funeral.
The harvested bones, tendons and pieces of cartilage are stored in zinc-plated metal boxes in a refrigerated room in the basement. "The tissue parts are brought up once every few weeks, when a truck comes and takes them away," says Yurchenko. Karl Koschatzky, the secretive Tutogen executive from Bavarian, also turns up occasionally.
Part 4: 'A Source of Raw Materials' According to Yurchenko, about 8,000 corpses a year are delivered to the forensic medicine department. Of that number, more than 5,000 are potential bone donors, but family members only consent to harvesting from about 150 bodies. If the two facilities in the capital already provide parts from about 150 bodies each, as Yurchenko says, and if a total of 20 facilities in Ukraine are registered with the FDA -- and, therefore, are collaborating with Tutogen -- it can be assumed that the German company obtains its body parts from large numbers of Ukrainian corpses. "All we are for the rich countries is a source of raw materials," says Yurchenko.
In May 2004, Tutogen signed a five-year contract with Bioimplant, which describes the process as follows: The Ukrainians transfer harvested tissue to Tutogen in Germany to have it processed into products. But this processing is costly. How does the Ukrainian company pay for the expensive processing? The answer is deceptively simple: with the bones, from Ukrainian corpses, that have been processed into products in Germany. This is the currency accepted by both parties to the arrangement.
What the agreement does not state is that the Germans were not producing products for Bioimplant, but were ordering substantial amounts of raw material from the Ukrainians every month.
At times, much larger numbers of body parts from Ukraine and other countries were arriving in Neunkirchen than Tutogen could even process. A document titled "Inventory, Raw Material Storage 1," dated March 2000, reveals the scope of this excess material. According to this inventory document, Tutogen warehouses already contained 688 patellar tendons, 1,831 kneecaps, 1,848 fibula, 2,114 fascia and 1,196 foot bones, or a total of more than 20,000 body parts.
In June 2002, Tutogen employees wrote the following comments in the minutes of a meeting: "Warehouse problems. More tissue than necessary continues to be delivered. Solutions are needed to address this problem."
The company documents also include references to the kinds of solutions Tutogen had in mind. According to an internal memo dated April 2002, a Ms. R. noted "that there is no longer any storage capacity in the deep freezers. Efforts must be stepped up to ship tissue to the USA."
According to a document dated June 2002, which lists the "Raw Tissue Requirements for USA Needs," the US partners required the following monthly supply:
* 119 iliac crests,
* 667 pieces of fascia lata,
* 267 kneecaps,
* 243 shafts of the femur.
Did Tutogen Break the Law? Apparently, the deliveries to the United States were not only sent to the parent company in Florida, Tutogen Medical Inc., which could have been explained as a way of shifting the problem within the company, but also to RTI, the company's US competitor at the time.
In a table detailing a shipment from Lugansk in Ukraine, delivered on Dec. 7, 2001, a sum of €62,000 is quoted, but the recipient is identified as "TM/RTI."
If Tutogen was indeed shipping unprocessed tissue to the United States, this could constitute an act of engaging in illegal tissue trade, provided a profit was generated as a result.
In a memo dated April 4, 2002, a Tutogen employee issued the following cautionary statement: "We should avoid shipping unprocessed raw material to TMUS (Tutogen USA), so as not to create the impression of engaging in the tissue trade."
The German Institute for Cell and Tissue Replacement, another major bone producer, categorically rejects such practices. Director Hans-Joachim Mönig insists that "obtaining raw tissue from one country and passing it on to third parties is against the law. In our view, this constitutes the crime of trading in tissue."
To date, its collaboration with Aleshenko and the Kiev Health Ministry has worked exceedingly well for Tutogen. All investigations against Tutogen's Ukrainian partners in Krivoy Rog, Kiev and Dnipropetrovsk have been suspended.
But that could change. Last year, the public prosecutor's office in Krivoy Rog launched a new investigation.
Once again, forensic medicine employees, as the public prosecutor's office states in response to SPIEGEL's inquiry, are suspected of "having used coercion and fraud to obtain the consent of family members for the removal of tissue and other anatomical material for purposes of transplantation." Seventeen family members of the deceased have already testified.
On Jan. 9, 2009, the district attorney's office submitted the case to the relevant district court, where the case is still underway.
Lena Krat, the Kiev woman who was persuaded to release her father's body for tissue harvesting in 2004, would be pleased to see those responsible finally brought to justice. "Those people are truly guilty," she says, "and I am outraged that these terrible things are still taking place."
http://www.spiegel.de/international/europe/0,1518,645375,00.html
DER SPIEGEL (9/2001) - 24.02.2001 (9397 Zeichen)USA: Loch in der MauerDie BSE-Angst erreicht Amerika: Trotz strikter Auflagen gelangte in Texasverbotenes Tiermehl ins Rinderfutter - die Kontrollen der Aufsichtsbehördensind lax. Link auf diesen Artikel im Archiv: http://service.spiegel.de/digas/find?DID=18578755"
Its as full of holes as Swiss Cheese" says Terry Singeltary of the FDA regulations. ...
http://service.spiegel.de/digas/servlet/find/DID=18578755
http://usdameatexport.blogspot.com/2008_01_01_archive.html
2001
Last, but not least. The illegal/legal harvesting of body parts and tissues will come back to haunt you. Maybe not morally, but due to NO background checks and human TSEs, again it will continue to spread.
http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf
Tutogen Medid,U.S.,Inc.
December 9, 2002
Dockets Management Branch (HFA-305)
Food and Drug Administration5630 Fishers Lane,Rm. 1061Rockville, MD 20852
RE: Docket No. 02D-0266, CBER 150. Draft Guidance for Industry: Preventive Measures toReduce the Possible Risk of Transmission of Creutzfeldt-Jakob disease (CID) andVariant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular andTissue-Based Products (HCT/Ps); Availability. Pages 42789--42790 FR Dot. 02-158981
Tutogen Medical Inc. (“Tutogen”) appreciates the opportunity to comment on the draft documentissued by the FDA in June 2002 entitled: “Preventive Measures to Reduce the Possible Risk ofTransmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease(vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) ” Inparticular, we wish to use this venue to respond to your request for data assessing the impact ofthe recommendations contained therein to reduce the risk of CJD and vCJD on the availability ofHCT/P.
snip...
1. # of Tissue Banks reporting 63
2. # of tissue donors recovered (HCT/P domw population) 18,021
3. # of Bone allografts dlstributed in U.S. 675,370
4. Volume of Skin grafts distributed in U.S. 11,222 ft2
1Excerpt Corn “Background” statement contained in the American Association of Tissue Banks MembershipDirectory 2001-2002.
snip...
II. Impact of donor deferral upon the availability of HCT/ps: During the year 2001, Tutogenprocessed 3,500 donors recovered by our contract recovery agencies from various locationsincluding Europe. In the 12 months from July 1, 200l to June 30, 2002, Tutogen distributed atotal of 21,639 musculoskeletal allograft products to patients in the U.S. Based upon the dataabove, this represents approximately 3% of the total number of bone allograft productsdistributed by AATB accredited Banks in the United States.
The implementation of the FDA’s proposed guidance would immediately reduce the number ofavailable HCT/P donors by approximately 10% in the U.S. due to country of origin exclusion.The direct impact to Tutogen would be an approximate 50% reduction in our donor base orapproximately 10,820 musculoskeletal allograft products. Therefore, the impact of this proposalfrom the FDA upon Tutogen would be greater than upon any other U.S. based tissue bank.Among the remaining 16,271 HCT/P donors (approximately) recovered by other AATBaccredited organizations annually, a large percentage would be eliminated under the proposedFDA rule that would disqualify any donor who has visited a listed country for a cumulativeperiod of 6-months or more. Not only would frequent travelers be considered deferred donors,but a large share of military veterans and their immediate family members due to being stationedoverseas. Tutogen does not have verifiable data concerning these figures, however, it is notinconceivable that this would adversely impact the donor pool by at least an additional 6% ormore, based on the blood bank industry experience, this would translated to a 976 HCT/P donors.The combination of Tutogen’s and the rest of the tissue banks would total approximately 2,726HCT/P donors. .
III. Musculoskeletal allografl tissue has been scientijiiaUy classified as low risk forCVZWCJD transmission. As with other AATB certified organizations, Tutogen allograftproducts are used across a multitude of medical applications. Currently, none of TutogenHCT/Ps in the United States are so-called high-risk tissue such as dura mater or corneas (refer toAppendix 1).
Not all tissue has the same infectivity risk. The HCT/Ps utilized by Tutogen in allografiproducts, distributed in the US, are classified as Category IV tissue (i.e., “No detectible @Jo-)infectivity”) by the World Health Organization in its March 19972 study.Tutogen has not processed or distributed in the United States high-risk Category II tissue such asdura mater since June 2000. Tutogen has never processed or distributed comeal tissue.Therefore the effect of any donor deferral ruling by the FDA on HCT/Ps limited to high-riskCategory II tissue, will not have any effect upon Tutogen’s ability to continue providing HCT/Psin the United States as shown in the table above.
2 World Health Organization, Emerging and other Communicable Diseases Report of a WHO consultation onmedicinal and other products in relation to human and animal transmissible Spongiform Encephalophathies.
2
IK Tutoplast safe@ claims are supported by a long-hktory (25 consecutive years) ofsuccessful allograft implants:
Tutogen HCT/Ps are recovered following a very stringent donor selection criterion in accordancewith AATB standards and FDA regulations. The current industry standard concerning CJDsignificantly reduces the risk of harvesting tissue from a potentially infected HCT/P donor.All Tutogen HCT/Ps are processed using a proprietary system known as the Tutophst 8 process.Tutogen’s single donor tissue processing methods (no pooling of donors) have been shown toensure viral/bacterial inactivation in controlled studies. The Tutopht 8 process has beenvalidated, specifically for the inactivation of prions and other transmissible agents. Twoindependent studies have confirmed that the Tutophst 8 process is capable of removinginfectious Prion agents from sol? tissue as a result of treating soft tissue with sodiumhydroxide. ‘4
Recommendations:
Tutogen recognizest hat the spread of bovine spongiform encephalopathy, or mad cow disease,has prompted debate concerning the possible modification of recent deferral criteria Tutogenurges the FDA to continue inviting scientists, physicians and patient groups to participate in thispolicy discussion. Physicians must be given accurate information about the benefits and risks,both real and theoretical associatedw ith HCT/P transplantations o that they can effectivelyeducate every patient when an HCT/P transplant is needed.
While Tutogen also recognizes that studies about the potential for transmission of TSEs inanimal models continue, however, evidence is still lacking of such transmission among patientswho have received human tissues, blood transfusions and clotting factor concentrates. Tutogenrespectfully requests that the Food and Drug Administration, before any final ruling, addressissues sited herein, by limiting its definition of deferred donor to those cases where high-riskCategory II tissue is being implanted (e.g., dura mater, corneas), and/or to those cases wheretissue recovery and processing methods being used pose additional risks.
Conclusion:
The very low incidence of human CJDMXD and our current screening criterion already poses alow risk that an infected donor may enter the process. The Centers for Disease Control andPrevention reports that the incidence of CJD is one case per million people each year.3Robert Koch Institut in Berlin (Department of the German FederalI nstitute of Health) Diringer H, Braig H,Infectivity of unconventional viruses in duramater,The Lancet, February 25, 19894L aboratorieso f RBM, Ivrea, Italy and expert opinion by Dr. Masullo (NurosurgeonM) asullo, 1994, Estimate ofthe theoretical risk of transmission of Creutzfeld-Jacob Disease by human duramater grafts manufactured by theTutoplast process.R MB, Studienbericht1, 994, Determination of the clearance factor for unconventional slowviruses during the processing of duramater.
3
Based upon the track record of safety, quality, and clinical effkacy of
mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000055/!x-usc:mailto:TutopZast@%20and theproduct approval protocols adhered to by Tutogen, and already audited by the FDA, relating tothe import of HCT/Ps into the U.S. from Europe, we do not believe that there is any additionalrisk associated with HCT/Ps recovered and processed by Tutogen. Given the scientific dataavailable today, Tutogen does not believe that a blanket ruling to defer HCT/P donors fromspecific counties would reduce CJD and vCJD risk in cases where a validated recovery andprocessing procedure is being used. Indeed, the impact of a deferred donor ruling as presentlyproposed would significantly reduce the availability of HCT/Ps in the United States (up to 20%or more based upon the data contained herein) without a commensurate and measurable riskreduction in CJD and vCJD transmission.
Very truly yours,
Wade S, Tetsuka
Tutogen Medical U.S., Inc.General Manager
P.J. PardoTutogen Medical U.S., Inc.Director,Regulatory Affairs/ Quality Management
Appendix 1:
mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000055/!x-usc:mailto:Tutoplast@P rocessedA llografks Distributed
Spinal / TraumaSulzer SpineTech,Minneapolis MNOphthalmologyIOP, Inc., Costa Mesa, CAENTUrologyMentor Corp., SantaBarbara, CADentalSulzer Dental, Carlsbad, CASpinal Fusion, ACL,Rotator Cuff repairGlaucoma patch, eyebrowslings, enucleationwraps, poterior segment,eyelid spacersTymp~oplasty,CholesteomaR esectionPelvic Floor repair,urinary incontinencePeridontal implantsFemur, Ulna, Radius,Humurous with cuff,anterior cruciateligament.Sclera, Pericardium,Fascia LataSclera, Pericardium,Fascia TemporalisFascia Lata,Pericardium,D ermisCancellousb onec hipsfrom femur, ulna, radius4,000 grafh8,000 grafts2,000 grafls9,000 grafts17,000 grafts
http://www.fda.gov/ohrms/DOCKETS/dailys/02/Dec02/121002/02d-0266.pdf
From: TSS
Subject: Possible body parts theft ring uncovered (spreading TSEs from stolen body parts perfectly legal in Texas after 4 hours)Date: December 24, 2005 at 7:36 am PST
Dec. 23, 2005, 11:44PMPossible body parts theft ring uncoveredSkin and bones are alleged to have been sold secretly
By TOM HAYSAssociated Press
NEW YORK - Michael Bruno's life had been uncomplicated: He was an immigrant who worked hard, spoke his mind and succumbed to kidney cancer two years ago at 75.
"Typical Italian cab driver," recalled his son, Vito. "He had an opinion about everything."
It's only after death that his story became ghoulish.
Authorities believe his body and those of hundreds of other people — including famed British broadcaster Alistair Cooke — were secretly carved up in the back rooms of several funeral parlors citywide to remove bone, skin and tendons, without the required permission from their families. Authorities allege the body parts were then sold for a profit.
Worse, health officials fear some of the stolen body parts were diseased, and could infect patients who received them in skin grafts, dental implants or other orthopedic procedures — a risk concealed by paperwork doctored with forged signatures and false information.
"It's not just disrespectful to my father," said Vito Bruno, who has sued one of the funeral homes. "It's an absolutely hideous crime against other people."
In the Cooke case, authorities confirmed this week that investigators contacted the late broadcaster's family after finding paperwork indicating his bones had been removed and sold by a Fort Lee, N.J.,
tissue bank, Biomedical Tissue Services, before he was cremated. Cooke, best known as the host of PBS's Masterpiece Theatre, died from cancer last year at 95 in Manhattan.
Violation of FDA rulesThe family insists it never signed off on the procedure, and that someone had falsified documents by changing his cause of death to heart attack, and by lowering his age to 85. Harvesting bones from cancer patients violates rules by the Food and Drug Administration.
A state grand jury in Brooklyn has been hearing evidence against at least a half dozen funeral homes in the borough and against Biomedical Tissue Services. Authorities allege that they illegally profited by conspiring to sell stolen body parts, and say indictments could be handed up early next year.
The scandal's reach extends beyond the New York City area. In the fall, the FDA ordered a recall of products produced by tissue processors in Texas, New Jersey, Florida and Georgia, all customers of Biomedical Tissue Services.
Health officials advised physicians that patients who were implanted with the tissue should be tested for HIV, hepatitis and other infectious diseases. The officials said they believed the health hazards were minimal, and no infections have been reported since the FDA warning.
But past cases have demonstrated dire risks. In 2001, a Minnesota man died after a knee surgery from an infection traced to cartilage from an infected donor. A year later, health officials in Oregon announced that several patients were infected with hepatitis C after receiving donated organs and tissue from a single corpse.
Authorities say the Brooklyn case stems from a deal struck between a dentist who started Biomedical Tissue Services, Michael Mastromarino, 42, of Fort Lee, and Joseph Nicelli, 49, an embalmer and funeral parlor operator from Staten Island.
Alleged harvesting schemeInvestigators suspect Nicelli helped secure access to tissue and bones from funeral directors for $500 to $1,000 a body. Mastromarino allegedly would remove the body parts, then ship them to processors paying thousands of dollars per order.
Attorneys for Nicelli and Mastromarino did not respond to numerous phone messages left by the Associated Press, but have previously denied that their clients did anything wrong. A
phone number listed for Biomedical Tissue Services was disconnected.
http://www.chron.com/disp/story.mpl/nation/3545690.
html
Dec. 23, 2005, 11:05AM
Authorities Probe Theft of Body Parts
By TOM HAYS Associated Press Writer© 2005 The Associated Press
NEW YORK — Authorities are investigating allegations that hundreds of bodies were illegally carved up in funeral homes around New York City and sold for parts without the permission of the families of the deceased.
Corpses _ including that of famed British broadcaster Alistair Cooke _ were used to harvest human bone, skin and tendons which were then sold for a profit, authorities allege.
Worse, health officials fear some of the stolen body parts were diseased, and could infect patients who received them in skin grafts, dental implants or other orthopedic procedures _ a risk concealed by paperwork doctored with forged signatures and false information.
"It's not just disrespectful to my father," said Vito Bruno, who has sued one of the funeral homes after his father Michael's corpse was desecrated. "It's an absolutely hideous crime against other people."
In the Cooke case, authorities confirmed this week that investigators contacted the late broadcaster's family after finding paperwork indicating his bones had been removed and sold by a Fort Lee, N.J., tissue bank, Biomedical Tissue Services, before he was cremated. Cooke, best known as the host of "Masterpiece Theatre," died from cancer last year at 95 in Manhattan.
The family insists it never signed off on the procedure, and that someone had falsified documents by changing his cause of death to heart attack, and by lowering his age to 85. Harvesting bones from cancer patients violates rules by the Food and Drug Administration.
A daughter, Susan Cooke Kittredge, said the family was "shocked and saddened" by the news.
"That people in need would have received his body parts, considering his age and the fact he was ill when he died, is appalling to the family, as is that his remains were violated," she said.
The probe _ first reported by the Daily News in October _ has generated other gruesome stories. In one instance, the corpse of a Queens grandmother that investigators exhumed last month had nearly all the bones removed below the waist and replaced with PCV pipes.
A grand jury in Brooklyn has been hearing evidence against at least a half dozen funeral homes in the borough and against Biomedical Tissue Services that they illegally profited by conspiring to sell stolen body parts. Authorities say indictments could be handed up early next year.
The brewing scandal's reach extends far beyond the New York City area.
In the fall, the FDA ordered a recall of products produced by tissue processors in New Jersey, Florida, Georgia and Texas, all customers of Biomedical Tissue Services. Since the announcement, authorities in Canada have determined that about 300 potentially tainted products were imported there, and used for dental surgery on at least two patients.
Health officials advised physicians that patients who were implanted with the tissue should be tested for HIV, hepatitis and other infectious diseases. The officials said they believed the health hazards were minimal, and no infections have been reported since the FDA warning.
But past cases have demonstrated dire risks.
In 2001, a Minnesota man died after a knee surgery from an infection caused by a bacterium traced to cartilage from an infected donor. A year later, health officials in Oregon announced that several patients were infected with hepatitis C after receiving donated organs and tissue from a single corpse.
Authorities say the Brooklyn case stems from a deal struck between a dentist who started Biomedical Tissue Services, Michael Mastromarino, 42, of Fort Lee, and Joseph Nicelli, 49, an embalmer and funeral parlor operator from Staten Island.
Investigators suspect Nicelli helped secure access to tissue and bones from funeral directors for $500 to $1,000 a body. Mastromarino allegedly would remove the body parts, then ship them to processors paying thousands of dollars per order.
Attorneys for both Nicelli and Mastromarino did not respond to numerous phone messages left by The Associated Press. A phone number listed for Biomedical Tissue Services was disconnected.
The Brooklyn case demonstrates the potential pitfalls of allowing funeral homes and tissue banks to do
business without stricter oversight, said Annie Cheney, author of the upcoming book, "Body Brokers: Inside America's Underground
Trade in Human Remains."
"The fact that these people were supposedly able to get away with this for so long is shocking," she said.
http://www.chron.com/disp/story.mpl/ap/nation/3544706.html
Dec. 23, 2005, 10:35AM
Allegations of body part sales investigated
Associated Press
NEW YORK — Authorities are investigating allegations that the body of British broadcaster Alistair Cooke — among hundreds of others — was illegally carved up in the back room of a funeral home and sold so its parts could be used in transplants.
Officials confirmed this week that investigators found paperwork indicating Cooke's bones had been removed and sold by Biomedical Tissue Services, a Fort Lee, N.J., tissue bank, before he was cremated.
Cooke, longtime host of PBS' "Masterpiece Theatre" and known around the world for his "Letter From America" shows on the BBC, died from cancer last year at age 95 in New York.
His family said it never agreed to the bone removal and that someone falsified documents by changing Cooke's cause of death to heart attack and by lowering his age to 85.
A day after his death, Cooke's bones were allegedly sold for about $7,000 to two transplant companies. The family was supplied with what they were told were his ashes, and scattered them in Central Park.
A daughter, Susan Cooke Kittredge, said the family was "shocked and saddened" by the news.
"That people in need would have received his body parts, considering his age and the fact he was ill when he died, is appalling to the family, as is that his remains were violated," she said.
A phone number listed for Biomedical Tissue Services was disconnected.
http://www.chron.com/disp/story.mpl/nation/3544620.html
TSS
----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Tuesday, December 20, 2005 4:25 PM
Subject: Re: THE LEGAL TRADING AND SELLING OF BODY PARTS AND HUMAN TSEs IN THE USA
----- Original Message ----- From: "Terry S. Singeltary Sr." To: Sent: Tuesday, December 20, 2005 4:25 PM Subject: Re: THE LEGAL TRADING AND SELLING OF BODY PARTS AND HUMAN TSEs IN THE USA
##################### Bovine Spongiform Encephalopathy #####################
Subject: Biomedical Tissue Services (BTS) THE BODY SNATCHERS and mad cow disease i.e. CJD and other dangerous pathogens Date: December 20, 2005 at 2:05 pm PST
Greetings BSE-L et al;
well, the 'dear unlucky john recipient' letters are in the mail, while these company's are laughing all the way to the bank. ...TSS
Biomedical Tissue Services (BTS) THE BODY SNATCHERS and mad cow disease i.e. CJD and other dangerous pathogens
Body snatchers tied to allograft firms? Alleged New York-area ring investigated for selling parts to corpse tissue harvesters. October 7, 2005: 2:54 PM EDT By Aaron Smith, CNN/Money staff writer
NEW YORK (CNN/Money) - A Brooklyn funeral home and a New Jersey company that harvests body parts from corpses are being investigated for their alleged roles in a body snatching ring that sold parts to companies specializing in medical grafts, sources close to the investigation said Friday.
The Brooklyn district attorney's office declined to comment on the investigation. But sources close to the investigation acknowledged that it has been going on for about one and a half years, focusing on Michael Mastromarino of Biomedical Tissue Services Ltd. of Fort Lee, N.J., who allegedly harvested body parts illegally from the Daniel George funeral home in Brooklyn.
The firms that bought the allegedly black-market tissue have not been accused of any wrongdoing. Human tissue is usually obtained from non-profit tissue banks. In the U.S., it's illegal to buy and sell human tissue.
Wendy Crites-Wacker, spokeswoman for Regeneration Technologies (down $0.66 to $7.28, Research), a company in Alachua, Fla., said her company has severed all ties with Biomedical Tissue Services, their former source for some of the body parts used to make medical grafts, or allografts.
"We had previously terminated the relationship with Biomedical Tissue Services and we are cooperating with the appropriate authorities on this issue," said Crites-Wacker, who declined to say when the termination took place.
Crites-Wacker also said that her company's BioCleanse process, in which bones and tendons are sterilized through a melange of chemicals, temperature and pressure, ensures that its products are safe.
Two other allograft companies have been identified as customers of Biomedical Tissue Services: LifeCell Corp. (down $2.82 to $17.33, Research), of Branchburg, N.J. and Tutogen Medical Inc. (down $0.15 to $4.06, Research) of West Paterson, N.J.
LifeCell Corp. had issued a Friday statement saying it had voluntarily recalled some human tissue products after questions were raised about Biomedical Tissue Services.
"Specifically, the company recalled all lots of product that were produced using tissue from Biomedical Tissue Services (BTS)," LifeCell said in a release.
LifeCell, which markets products made from human tissues that are used in surgical procedures, said it recalled certain AlloDerm, Repliform and GraftJacket products on Sept. 30.
LifeCell's stock price slid about 5 percent this morning, and a Piper Jaffray analyst attributed the slump to a New York Daily News story that first reported on the investigation.
"We believe this morning's weakness in LifeCell's shares is related to a news article that alleges LifeCell inadvertently received tissue from an illegal body-snatching ring," said Raj Denhoy of Piper Jaffray, in a written report.
LifeCell said in the statement all other tissues supplied by Biomedical Tissue Services remain "on hold until the discrepancies in the donor documentation can be resolved."
Denhoy said that LifeCell did not appear to do anything illegal and that "LifeCell itself was the victim of fraud," referring to allegations that Biomedical Tissue Services forged death certificates and family consent forms.
Denhoy said that LifeCell receives tissue from 30 sources, "so the loss of one will likely not impact the underlying business," though increased regulatory scrutiny could drive down the stock price.
"While LifeCell and the other tissue companies appear to have done nothing wrong, this event could increase regulatory and media scrutiny of the business," said Denhoy, who rates the company market perform. "We recently downgraded LifeCell shares on competitive concerns and today's revelations may pressure the stock further."
Eric Franz, the attorney representing funeral home owners Debora Johnson and Robert Nelms, said his clients "did not participate in any criminal conduct whatsoever."
Attempts to reach Mastromarino and his company Biomedical Tissue Services were unsuccessful. The Daily News reported that Mastromarino declined to comment.
Regeneration Technologies produces heart valves, bone and tendon implants and bone paste, which is used to plug holes. LifeCell specializes in AlloDerm, a "dermal matrix" made from human skin that is used in grafts. Tutogen focuses on bone and dental implants.
--from staff and wire reports
http://money.cnn.com/2005/10/07/news/midcaps/corpse/?section=money_latest
FDA News FOR IMMEDIATE RELEASE P05-77 October 26, 2005 Media Inquiries: Julie Zawisza, 301-827-6242 Consumer Inquiries: 888-INFO-FDA
FDA Provides Information on Investigation into Human Tissue for Transplantation The Food and Drug Administration (FDA) is notifying the public of its investigation of human tissue recovered by Biomedical Tissue Services, Ltd. (BTS) of Ft. Lee, NJ, and sent to tissue processors. Some of this tissue may have been implanted into patients from early 2004 to September 2005. The tissue was recovered by BTS from human donors who may not have met FDA donor eligibility requirements and who may not have been properly screened for certain infectious diseases. At this time, the implicated tissues from BTS include human bone, skin, and tendons. These products represent only a small percentage of the overall U.S. tissue supply.
While no adverse reactions related to these tissues have been reported to FDA at this time, because of the potential lack of proper screening of the tissue donors, some recipients of the tissues may be at increased risk of infections that could potentially be transmitted through tissues. FDA and the Centers for Disease Control and Prevention (CDC) believe the risks from these tissues are low because the tissues were routinely processed using methods that help to reduce the risk of infectious disease; however, the actual infectious risk is unknown.
FDA's requirements to determine donor eligibility include important steps to ensure that donors do not harbor infections that could be transmitted to recipients. These steps include reviewing the donor's medical history and other factors, physically assessing the donor, and testing for relevant communicable diseases that may place the donor at an increased risk of infections that could then unintentionally be transmitted to recipients through the tissues.
The following tissue processors received tissue from BTS:
LifeCell Corporation of Branchburg, NJ Lost Mountain Tissue Bank of Kennesaw, GA Blood and Tissue Center of Central Texas in Austin, TX Tutogen Medical, Inc., of Alachua, FL Regeneration Technologies, Inc., of Alachua, FL These firms already have voluntarily recalled all unused tissue remaining in inventory and are working cooperatively with FDA to ensure that the implanting physicians whose patients may have received the products are properly notified. Physicians who implanted tissue from BTS should have been contacted at this time by the receiving health care facility.
FDA and CDC recommend that implanting physicians inform their patients that they may have received tissue from a donor for whom an adequate donor eligibility determination was not performed. While the overall infectious risk is likely low, FDA and CDC recommend that physicians offer to provide patients access to appropriate infectious disease testing. The relevant communicable diseases for which a tissue donor is required to be tested are HIV-1 and 2 (the viruses that cause AIDS), hepatitis B virus, hepatitis C virus, and syphilis. Physicians who still have concerns or questions about the source of the tissue should contact the health care facility where the procedure was performed. FDA will continue its investigation into this matter and will issue further public health updates, as needed.
Patients and physicians should report any infectious disease possibly related to a tissue transplant to the processing firms, who then should notify FDA. Patients and physicians who wish to notify FDA directly of such infectious disease should report via FDA’s MedWatch reporting program at
http://www.fda.gov/medwatch.
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01249.html
Recall of Human Tissue
DATE RECALL INITIATED:
October 13, 2005
PRODUCT:
Human Tissue for Transplantation
MANUFACTURER:
Biomedical Tissue Services, Ltd Fort Lee, New Jersey
REASON:
Biomedical Tissue Services (BTS) was recently made aware that there is the possibility that tissue has been procured from donors without proper medical/social histories. BTS is performing a voluntary recall of any unused tissue from its consignees.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.
Updated October 18, 2005
http://www.fda.gov/cber/recalls/btstis101305.htm
Tutogen Medical Tissue Recall
Frequently Asked Questions and Answers
Q: What prompted this recall?
A: Tutogen was unable to verify donor consent for certain tissue provided by one of its recovery agency suppliers (BioMedical Tissue Services of Fort Lee, NJ). Tutogen, along with several other tissue processing companies, received allograft material from BioMedical Tissue Services. One of these other processing companies notified Tutogen that they were having difficulty in reaching persons taking the consent information or next of kin for BioMedical tissue donors. Upon receiving this notification, Tutogen immediately initiated a review and investigation of all donor consents received from BioMedical Tissue Services. Tutogen also experienced problems in contacting consent takers, witnesses and next of kin shown on the documentation provided by BioMedical Tissue Services. We further attempted to contact Dr. Michael Mastromarino, CEO and Executive Director of BioMedical Tissue Services, to assist in this matter, but without success. Although Tutogen does not believe that there are any safety concerns related to this tissue, the company elected to initiate a voluntary recall of products incorporating the BioMedical tissues, on ethical grounds.
Q: What tissue products are being recalled?
A: Specific serial/lot numbers of Tutogen’s Puros® Allograft Cancellous Particles (marketed by Zimmer Dental) and a small quantity of Tutoplast® Fascia Lata (marketed by Mentor Corporation and Innovative Opthalmic Products, Inc.) are involved in this recall.
Q: How much allograft tissue did BioMedical Tissue Services provide to Tutogen?
A: The quantity of tissue received from BioMedical represents a small fraction (about 2%) of all tissue processed by Tutogen.
Q: What did Tutogen do to notify customers of the recall?
A: Upon completion of its donor documentation investigation, Tutogen notified the FDA of our intent to initiate a voluntary recall. We immediately identified all BioMedical tissue, from raw material stock through finished goods and field distribution, and quarantined all material within our control. Customer shipment information was assembled and a recall letter was prepared and approved by the FDA. Initially, Tutogen alerted all customers of record via telephone, describing the reason for the recall, providing serial numbers of product shipped to them and indicating the process for the return and replacement of affected product.
Simultaneously, copies of the recall letter and distribution information for the affected product was sent to each customer by facsimile. This same information was then provided to customer accounts by certified mail. At the request of the FDA, Tutogen sent a recall follow-up letter to affected customers, including FDA mandated language regarding patient notification and access to disease testing.
An additional letter was prepared and mailed to those customers that had not received any of the products manufactured using BioMedical tissue and were not affected by the voluntary recall. In the interim, the company prepared and issued a press release concerning this recall and participated in numerous conference calls, throughout the U.S. and Canada, with surgeon groups, industry organizations (such as the American Association of Tissue Banks) and professional associations (such as the American Association of Oral and Maxillofacial Surgeons and the American Academy of Periodontology).
These prior communications were supplemented by a scientific dissertation mail-out that described the Tutogen Tutoplast® process, which subsequently led to the preparation of a technical monograph detailing this process and its qualification history. The monograph may be accessed on this website by selecting the link entitled, "The Tutoplast® Process: A Review of Efficacy".
Q: How can I tell whether I received any of the affected product?
A: All customers of record, that received products manufactured utilizing tissue provided by BioMedical, were notified and should have received an individualized list of all product serial numbers shipped to them. Affected product may also be quickly identified by visually checking the alpha-numeric designator beneath the product barcode label (see samples, shown below).
The affected product alpha-numeric code begins with the letters "BM" or "BT".
Q: How should I go about returning affected product that may remain in my inventory stock?
A: Once any affected product has been identified, place it in a shipping container and mark the outside of the container with "BMRECALL". Address the package to:
Tutogen Medical
13709 Progress Boulevard
South Wing
Alachua, FL 32615
Biomedical Tissue Services
Biotissue Recovery Services
Call UPS at (800) PICK UPS and request a package pick-up. Forward the package to Tutogen, via UPS ground, using account number Y6X706. This shipping account number is reserved for the return of recalled items and is for one-way service to Tutogen, from U.S. accounts. Only product affected by this recall will be accepted for return.
Canadian customers should contact Zimmer Dental Corporation Customer Service at (800) 265-0968 or (905) 567-2073 for return instructions.
Q: What is the risk to patients that have already received recalled implants?
A: The FDA and CDC have indicated that they believe the overall risk of disease transmission by these products is low, but unknown. Because Tutogen’ s Tutoplast® tissue preservation and sterilization process is extremely rigorous and has passed significant challenge testing, we believe that all tissue distributed by Tutogen, including that from BioMedical Tissue Services, is safe and effective for its intended use. In addition, comprehensive physical examination and serology testing is routinely performed on all donors processed by Tutogen.
Q: What types of evaluations are performed on donors processed by Tutogen Medical?
A: Consent for donation, along with a detailed medical/social history, is obtained from each donor or their next of kin by hospital, medical examiner, funeral home or recovery agency personnel. The recovery team identifies the donor and conducts a detailed physical evaluation of the body. This examination incorporates an extensive assessment checklist for characteristics that would disqualify a donor from further consideration and addresses tissue appearance and condition during the retrieval process. The recovery team also collects a donor blood sample and forwards it to a third-party CLIA certified laboratory for disease testing, using FDA approved test methodology. The serology test results, along with the previously mentioned donor documentation, is examined by Tutogen’s Quality Assurance Department and a staff Medical Director (a licensed physician). Only after these thorough reviews are completed and release is granted by the Medical Director, is donor tissue allowed to enter the Tutoplast® process.
Q: What testing is done on the donor serology sample?
A: Tutogen requires that the following serology testing be performed and found to be "negative" or "non-reactive", prior to accepting any donor tissue for processing:
Hepatitis B surface antigen (HBsAg)
Hepatitis B core antibody (HBcAb – IgG +IgM)
Hepatitis C Virus antibody (HCV Ab)
Hepatitis B and C Nucleic Acid Testing (HBV and HCV NAT)
Human Immunodeficiency Virus I and II antibodies (HIV I and II Ab)
HIV I – p24
Human T-Lymphotropic Virus I and II (HTLV I and II Ab)
Syphilis – Rapid Plasma Reagin (RPR/STS)
Q: Who will pay for the cost of disease testing for my patients?
A: Although Tutogen does not feel that the products manufactured using BioMedical tissue pose a safety concern, out of respect for your patients’ welfare and as a service to you, Tutogen has elected to bear the cost of the appropriate infectious disease testing.
Q: What process has Tutogen put in place to accomplish the disease testing"?
A: We have made arrangements with ViroMed Laboratories (division of LabCorp), a respected, CLIA and FDA certified organization, to conduct this testing. Should you choose to inform those patients who received the affected implants, we suggest that you offer them the opportunity to be tested for the specified infectious diseases. Additionally, we recommend that you maintain a record of notification for each patient, which would indicate their acceptance or rejection of the testing offered and be signed/dated by that individual. For those patients that elect to undergo testing, both U.S. and Canadian customers should follow the process delineated, below.
1. Provide Tutogen Medical with the name and mailing address of the patient. Only patients that received implants utilizing tissue provided by BioMedical Tissue Services are eligible for this pre-paid testing. This information will be verified in our Tissue Utilization Record (TUR) database, or you may provide documentation confirming the patient’s implant, if no TUR was previously forwarded to Tutogen.
2. Let the patient know that a test kit will be sent to him or her by ViroMed Laboratories within the next few days and will include instructions on how to proceed.
3. Instruct the patient to set up an appointment with and take the test kit to their Primary Care physician. Alternatively, the patient may elect to visit a LabCorp service center as indicated in item # 7, below.
4. Following the instructions provided with the kit, the Primary Care physician or professional healthcare office staff member should obtain a blood sample from the patient and forward it to ViroMed Laboratories in the postage-paid mailer that will be included in the kit.
5. ViroMed Laboratories will perform the appropriate disease testing and forward the results to the patient’s Primary Care physician. If a confirmatory test is necessary, ViroMed Laboratories will automatically perform this additional testing and include those results in the final test report.
6. Upon receipt of the ViroMed data, the Primary Care physician should contact the patient and discuss the final results of the testing with him or her.
7. In the event that your patient does not have a Primary Care physician, he or she may go to a "walk-in" clinic to have a blood sample taken or to be referred to a LabCorp service
center near them and have this blood sample drawn and forwarded to ViroMed Laboratories for testing. The attending physician may call ViroMed Client Services, at (800) 582-0077, to arrange for a test kit or to obtain instructions for handling the sample. These patients must have their eligibility verified by Tutogen. LabCorp or ViroMed will provide all associated test kit supplies. A list of service center locations is available on the LabCorp website (
www.labcorp.com ) under the "Patient Service Center Locator" link.
If you have a patient that has already presented for infectious disease testing, a reimbursement request for costs not covered by the individual’s insurance carrier can be made by forwarding the invoice, showing the net responsibility of the patient, or a receipt, marked "Paid" to:
Tutogen Medical, Inc.
Accounts Payable
13709 Progress Blvd., Box 19
Alachua, FL 32615
The invoice should clearly show the name and address of the facility performing the disease testing and be annotated with the name of the patient ’s dentist/oral surgeon and practice name, as well as the identifier, "BMRECALL".
Q: What testing will be performed on each patient’s blood sample?
A: The recommended testing is for HIV I and II, Hepatitis B virus, Hepatitis C virus and syphilis. All test results will remain confidential, between patient and doctor.
Q: Is Tutogen still receiving tissue from BioMedical Tissue Services?
A: No. Upon initiating the voluntary recall, Tutogen suspended the acceptance of any tissues from BioMedical Tissue Services and has officially terminated its relationship with them.
Q: How can a situation such as this be prevented in the future?
A: At this point, there is no simple answer to this question. Tutogen adhered to all of its standard screening, inspection and processing procedures and there was no deviation or departure from its quality assurance systems. All processing companies rely on the FDA registered and state licensed recovery agencies to comply with established regulations and industry guidelines. Tutogen is currently evaluating a number of potential additional safeguards, but no mechanisms have been identified that would provide a foolproof solution. In addition, we are working very closely with the Food and Drug Administration and American Association of Tissue Banks to devise workable options that might preclude recurrence.
http://www.tutogen.com/recallQandA.pdf
Recall of Human Tissue Products
DATE RECALL INITIATED:
October 14, 2005
PRODUCT:
Human Tissue For Transplantation
MANUFACTURER:
Regeneration Technologies, Inc Alachua, Florida
REASON:
Regeneration Technologies, Inc. (RTI) is conducting a voluntary recall of all tissue received from BioMedical Tissue Services (BTS; Ft. Lee, New Jersey) as a result of information regarding the accuracy of donor screening documentation. RTI informed its consignees that a lack of assurance of donor identity as well as the risk of infectious diseases also exists. Consignees are asked to contact the manufacturer to arrange for product return.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.
Updated October 18, 2005
http://www.fda.gov/cber/recalls/rtitis101405.htm
FDA News FOR IMMEDIATE RELEASE P05-77 October 26, 2005 Media Inquiries: Julie Zawisza, 301-827-6242 Consumer Inquiries: 888-INFO-FDA
FDA Provides Information on Investigation into Human Tissue for Transplantation The Food and Drug Administration (FDA) is notifying the public of its investigation of human tissue recovered by Biomedical Tissue Services, Ltd. (BTS) of Ft. Lee, NJ, and sent to tissue processors. Some of this tissue may have been implanted into patients from early 2004 to September 2005. The tissue was recovered by BTS from human donors who may not have met FDA donor eligibility requirements and who may not have been properly screened for certain infectious diseases. At this time, the implicated tissues from BTS include human bone, skin, and tendons. These products represent only a small percentage of the overall U.S. tissue supply.
While no adverse reactions related to these tissues have been reported to FDA at this time, because of the potential lack of proper screening of the tissue donors, some recipients of the tissues may be at increased risk of infections that could potentially be transmitted through tissues. FDA and the Centers for Disease Control and Prevention (CDC) believe the risks from these tissues are low because the tissues were routinely processed using methods that help to reduce the risk of infectious disease; however, the actual infectious risk is unknown.
FDA's requirements to determine donor eligibility include important steps to ensure that donors do not harbor infections that could be transmitted to recipients. These steps include reviewing the donor's medical history and other factors, physically assessing the donor, and testing for relevant communicable diseases that may place the donor at an increased risk of infections that could then unintentionally be transmitted to recipients through the tissues.
The following tissue processors received tissue from BTS:
LifeCell Corporation of Branchburg, NJ Lost Mountain Tissue Bank of Kennesaw, GA Blood and Tissue Center of Central Texas in Austin, TX Tutogen Medical, Inc., of Alachua, FL Regeneration Technologies, Inc., of Alachua, FL These firms already have voluntarily recalled all unused tissue remaining in inventory and are working cooperatively with FDA to ensure that the implanting physicians whose patients may have received the products are properly notified. Physicians who implanted tissue from BTS should have been contacted at this time by the receiving health care facility.
FDA and CDC recommend that implanting physicians inform their patients that they may have received tissue from a donor for whom an adequate donor eligibility determination was not performed. While the overall infectious risk is likely low, FDA and CDC recommend that physicians offer to provide patients access to appropriate infectious disease testing. The relevant communicable diseases for which a tissue donor is required to be tested are HIV-1 and 2 (the viruses that cause AIDS), hepatitis B virus, hepatitis C virus, and syphilis. Physicians who still have concerns or questions about the source of the tissue should contact the health care facility where the procedure was performed. FDA will continue its investigation into this matter and will issue further public health updates, as needed.
Patients and physicians should report any infectious disease possibly related to a tissue transplant to the processing firms, who then should notify FDA. Patients and physicians who wish to notify FDA directly of such infectious disease should report via FDA’s MedWatch reporting program at
http://www.fda.gov/medwatch.
Additional information is available on FDA’s web site at
http://www.fda.gov/cber/recalls.htm and by calling 1-800-835-4709.
####
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01249.html
Recall of Human Tissue Products
DATE RECALL INITIATED:
October 11, 2005
PRODUCT:
Human Tissue for Transplantation
MANUFACTURER:
The Blood and Tissue Center of Central Texas Austin, Texas
REASON:
Central Texas Regional Blood and Tissue Center is voluntarily recalling tissue products as the firm is unable to confirm information provided by BioMedical Tissue Services (BTS; Ft. Lee, New Jersey). Consignees are asked to contact the manufacturer to arrange for product return.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.
Updated October 18, 2005
http://www.fda.gov/cber/recalls/blotis101105.htm
Recall of Human Tissue Products
DATE RECALL INITIATED:
October 12, 2005
PRODUCT:
Human Tissue for Transplantation
MANUFACTURER:
Tutogen Medical, Inc. Alachua, Florida
REASON:
Tutogen Medical is conducting a voluntary recall of all materials that were manufactured utilizing BioMedical Tissue Services (BTS; Ft. Lee, New Jersey) donor tissue. This action is being taken because Tutogen is unable to satisfactorily confirm that donor eligibility had been properly obtained by BTS. Tutogen informed its consignees that there is a lack of assurance that appropriate donor identification, donor screening, and medical history data collection was performed and, therefore, a risk of infectious disease exists. Consignees are asked to contact the manufacturer to arrange for product return.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.
Updated October 18, 2005
http://www.fda.gov/cber/recalls/tutotis101205.htm
Withdrawal of Human Tissue Products
DATE WITHDRAWAL INITIATED:
October 10, 2005
PRODUCT:
Human Tissue for Transplantation
MANUFACTURER:
Lost Mountain Tissue Bank Kennesaw, Georgia
REASON:
Lost Mountain Tissue Bank, Inc. (LMTB) has initiated consignee notifications for all tissue products processed and/or distributed from donors procured in the New York area by Biomedical Tissue Services (BTS; Ft. Lee, New Jersey). LMTB was informed of some discrepant and possibly fraudulent information in donor documentation. LMTB is notifying all relevant hospitals and medical professionals of the market withdrawal of all tissue products beginning with the letters “GL” or “T” in the tissue identification number (ID#).
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.
Updated October 18, 2005
http://www.fda.gov/cber/recalls.htm
DATE RECALL INITIATED:
September 30, 2005
PRODUCT:
AlloDerm, Repliform, and GraftJacket
MANUFACTURER:
LifeCell Corporation Branchburg, New Jersey
REASON:
LifeCell Corporation initiated a voluntary recall of certain AlloDerm, Repliform, and GraftJacket product from the marketplace on September 30, 2005. The recall was prompted when internal quality processes raised questions about the donor documentation received from one tissue recovery organization. Specifically, the company recalled all lots of product that were produced using tissue from Biomedical Tissue Services (BTS). Life Cell promptly notified the FDA and all relevant hospitals and medical professionals. All other BTS inventory remains on hold until the discrepancies in the donor documentation can be resolved. LifeCell works with more than 40 other tissue recovery organizations that are not affected by this recall.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.
Updated October 12, 2005
http://www.fda.gov/cber/recalls/tislife093005.htm
Compliance Program Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 7341.002
http://www.fda.gov/cber/cpg/7341002tis.htm
TSS
----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Thursday, October 27, 2005 9:55 AM Subject: THE LEGAL TRADING AND SELLING OF BODY PARTS AND HUMAN TSEs IN THE USA
##################### Bovine Spongiform Encephalopathy #####################
From: TSS () Subject: THE LEGAL TRADING AND SELLING OF BODY PARTS AND HUMAN TSEs IN THE USA Date: October 27, 2005 at 8:40 am PST
WASHINGTON FDA investigating human tissue sales WASHINGTON - The Food and Drug Administration said Wednesday that it is investigating a New Jersey-based company that sold human tissue to processors for eventual implantation into people, because it may not have been properly screened for infections. The New York Daily News reported earlier this month that the district attorney's office in Brooklyn, N.Y., is investigating the company, Biomedical Tissue Services of Fort Lee, N.J., on allegations that the company illegally bought body parts from funeral homes to sell to tissue processors. An FDA spokeswoman would not comment on those allegations. The tissues include human bones, skin and tendons and constitute only a small portion of the U.S. tissue supply, the FDA said. They were implanted between early 2004 and September 2005. The Blood and Tissue Center of Central Texas in Austin received some.
http://www.chron.com/cs/CDA/ssistory.mpl/nation/3419112
FOR IMMEDIATE RELEASE P05-77 October 26, 2005 Media Inquiries: Julie Zawisza, 301-827-6242 Consumer Inquiries: 888-INFO-FDA
FDA Provides Information on Investigation into Human Tissue for Transplantation The Food and Drug Administration (FDA) is notifying the public of its investigation of human tissue recovered by Biomedical Tissue Services, Ltd. (BTS) of Ft. Lee, NJ, and sent to tissue processors. Some of this tissue may have been implanted into patients from early 2004 to September 2005. The tissue was recovered by BTS from human donors who may not have met FDA donor eligibility requirements and who may not have been properly screened for certain infectious diseases. At this time, the implicated tissues from BTS include human bone, skin, and tendons. These products represent only a small percentage of the overall U.S. tissue supply.
While no adverse reactions related to these tissues have been reported to FDA at this time, because of the potential lack of proper screening of the tissue donors, some recipients of the tissues may be at increased risk of infections that could potentially be transmitted through tissues. FDA and the Centers for Disease Control and Prevention (CDC) believe the risks from these tissues are low because the tissues were routinely processed using methods that help to reduce the risk of infectious disease; however, the actual infectious risk is unknown.
FDA's requirements to determine donor eligibility include important steps to ensure that donors do not harbor infections that could be transmitted to recipients. These steps include reviewing the donor's medical history and other factors, physically assessing the donor, and testing for relevant communicable diseases that may place the donor at an increased risk of infections that could then unintentionally be transmitted to recipients through the tissues.
The following tissue processors received tissue from BTS:
LifeCell Corporation of Branchburg, NJ Lost Mountain Tissue Bank of Kennesaw, GA Blood and Tissue Center of Central Texas in Austin, TX Tutogen Medical, Inc., of Alachua, FL Regeneration Technologies, Inc., of Alachua, FL These firms already have voluntarily recalled all unused tissue remaining in inventory and are working cooperatively with FDA to ensure that the implanting physicians whose patients may have received the products are properly notified. Physicians who implanted tissue from BTS should have been contacted at this time by the receiving health care facility.
FDA and CDC recommend that implanting physicians inform their patients that they may have received tissue from a donor for whom an adequate donor eligibility determination was not performed. While the overall infectious risk is likely low, FDA and CDC recommend that physicians offer to provide patients access to appropriate infectious disease testing. The relevant communicable diseases for which a tissue donor is required to be tested are HIV-1 and 2 (the viruses that cause AIDS), hepatitis B virus, hepatitis C virus, and syphilis. Physicians who still have concerns or questions about the source of the tissue should contact the health care facility where the procedure was performed. FDA will continue its investigation into this matter and will issue further public health updates, as needed.
Patients and physicians should report any infectious disease possibly related to a tissue transplant to the processing firms, who then should notify FDA. Patients and physicians who wish to notify FDA directly of such infectious disease should report via FDA’s MedWatch reporting program at
http://www.fda.gov/medwatch.
Additional information is available on FDA’s web site at
http://www.fda.gov/cber/recalls.htm and by calling 1-800-835-4709.
####
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01249.html
a bit of history;
The Eyes have it/CJD * and they could be stealing them from YOUR loved one, hence the spread of CJD (aka MADCOW DISEASE) will spread...
############ Creutzfeldt-Jakob Disease #############
Greetings list members, I was impressed that someone is listening, considering the timing of when I broke the story in Nov. and this was posted in Dec., what a coincidence. Thanks for listening. I find it rather frightening of the fact sporadic CJD as well as vCJD can
transmit infectivity this way. Makes me wonder about blood? Kind Regards, Terry S. Singeltary Sr., Bacliff, Texas USA
http://mad-cow.org/~tom/dec99_news.html#bbb
Testimony of Bess Believeaux, Lions Eye Bank of Central Texas (Submission to the Jan. 18/19 meeting of the TSE Advisory Committee)
http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_16.pdf
TSS Submission to the same Committee;
http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf
Tissue Banks International (TBI), Gerald J Cole
http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_13.pdf
re-use contact lenses
http://mad-cow.org/~tom/dec99_news.html#bbb
TSS
Link: Reported by Terry S. Singeltary Sr. son of CJD victim 28 Nov 99 THE EYES HAVE IT, CJD...
####################
https://lists.aegee.org/bse-l.html ####################
####################
https://lists.aegee.org/bse-l.html ####################
http://mad-cow.org/~tom/dec99_news.html#bbb
American, 39, dies of dura mater implant
April 19, 2000
By RONALD CAMPBELL The Orange County Register
A tissue implant in 1992 helped cure Karen Bissell of numbness in her hands and legs. Six years later, it probably killed her. Bissell, 39, died Sept. 21, 1998, of Creutzfeldt-Jakob Disease, or CJD, a rare neurological condition. Scientists believe she was one of about 110 people worldwide who acquired the disease since 1987 from contaminated tissue transplants.
After Bissell's death, the company that provided the tissue launched a voluntary recall, while maintaining there was no conclusive proof the implant killed her.
The disease erupted in June 1998. In her last days, Bissell did not even know that she was being moved from a Denver hospital to a hospice. "The doctor told me she did not know what was happening, and she was not in any pain," said her mother, Eleanor Bissell. "I'm thankful for that." A friend memorialized her as "an angel to everyone she touched when she walked on Earth and now an angel to all as she resides in heaven."
Bissell will get a much-longer epitaph in the medical and legal literature. The scientists who investigated her death are preparing an article for a medical journal � at least the fourth such article tying CJD to transplants of dura mater, the outer lining of the brain. Because of the growing medical evidence, the U.S. Food and Drug Administration issued guidelines last October to prevent the spread of CJD through dura mater transplants.
CJD is a rare disease, striking one person in a million. Most victims are 55 or older. When CJD strikes a younger person, "we try to see if we can find some kind of exposure," said Colorado State Epidemiologist Richard Hoffman, who investigated Bissell's death. "In this case, there was a fairly glaring possibility as to where the person acquired it." Hoffman discussed Bissell's case in general terms, without naming her. The Orange County Register independently verified her identity.
In 1992, Eleanor Bissell recalled, her daughter complained of numbness in her hands as well as numbness and a tingling sensation in her legs. A physician diagnosed Arnold-Chiari malformation, an obstruction of nerves entering her brain. He operated to relieve the obstruction and used a package of dura mater from a German processor to patch the dura he had cut. The surgery bought Bissell six years of good health.
She was the youngest of four daughters. Never married, she remained close to her parents, often sharing their house in a Denver suburb. After 15 years of working at Lowry Air Force Base, however, Bissell decided in the fall of 1997 that she wanted a change. She got a job with the U.S. Department of Agriculture in Miami.
In June 1998, home for vacation, Bissell complained of blurry vision and headaches. The next month, the symptoms worsened, and she began a long round of visits to doctors, in search of answers. Finally, on Aug. 26, she flew to Denver.
"First she was using a cane when she got home," her mother recalled. "Then she was using a walker. Then she was using a wheelchair." From cane to walker to wheelchair was a journey of 10 days. "Day by day, she just went down, down," Eleanor Bissell said. "Each day it got a little bit worse."
The doctors in Miami had not been able to figure out what was h
appening. The Denver doctors while conducting a test saw brain cells literally being destroyed as they watched, and made their diagnosis.
While Bissell lay dying, Hoffman and investigators for the Centers for Disease Control and Prevention and the FDA scoured her medical records. They learned of the 1992 dura mater transplant, traced it to the German manufacturer and to a donor who, Hoffman said, died of a neurological illness. An autopsy had been done, but not a microscopic examination of the brain, which might have revealed CJD.
"I don't think we can conclusively say that the donor did or did not have (CJD)," Hoffman said. But he believes the transplant was "the most likely source of exposure."
The investigation of Bissell's death prompted the American parent of the German dura mater processor, New Jersey-based Tutogen Medical Inc., in mid-1999 to voluntarily recall all dura mater processed in Germany before 1994. Little was returned. In addition, Germany imposed new requirements for dura processing that the company said cost it $350,000 in revenue and $210,000 in profit.
Manfred Kreuger, Tutogen's chief executive, expressed "our deepest sympathy to the woman's family." But, he added, "to suggest that the dura mater was the cause of her condition is, frankly, unfounded." Tutogen was denied access to Bissell's medical records, Kreuger said. But a review of the donor's records showed that while "he certainly had some neurology abnormalities" and depression, he died from heart disease.
He said he believes Tutogen's dura mater "is a very safe product." Tutogen recalled its dura anyway, the company said in a May 1999 report to the Securities and Exchange Commission, because it "cannot rule out with absolute certainty" that its dura killed Bissell.
http://www.mad-cow.org/00/may00_news.html#ccc2
TUTOGEN
http://www.tutogen.com/
TutoplastTM
bone, bone-patellar tendon-bone
* alkaline treatment for prions (tissues are treated with 1N sodium hydroxide for 1 hr at room temperature)
-fascia
-pericardium
-dermis
* because this treatment also affects collagen in a time dependent manner it CANNOT BE USED ON BONES, TENDONS, OR LIGAMENTS WITHOUT A SIGNIFICANT REDUCTION IN BIOMATERIAL PROPERTIES.
http://www.clearant.com/latestnews/im47200211271552.PDF
TUTOGEN MEDICAL INC - Annual Report (Small Business Issuers ...
http://sec.edgar-online.com/tutogen-medical-inc/10ksb-annual-report-small-business-issuers/2001/12/20/Section2.aspx
-------- Original Message --------
Subject: Re: A NEW BRUNSWICKER REPORTED DEAD OF CJD AFTER BRAIN SURGERY (7 CJD cases possible in N.B., officials say)
Date: Fri, 26 Sep 2003 17:11:39 -0500
From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy To: BSE-L@uni-karlsruhe.deReferences: <3f71d32b.5000506@wt.net> <3f72fb5f.5030205@wt.net>
3F743CE8.8070804@wt.net
European Journal of Epidemiology 16 (4) p.353-355 April 2000Kluwer
Creutzfeldt–Jakob Disease in health professionals in SlovakiaMitrová Eva1 and Belay Girma1
1.Institute of Preventive and Clinical Medicine, Limbová 14, 833 01Bratislava, Slovakia
Creutzfeldt–Jakob disease (CJD) is the most important humantransmissible spongiform encephalopathy (prion disease), recognised insporadic, genetic but also iatrogenic forms. The identification of 8health care workers in a group of 114 definitive CJD patients inSlovakia suggested the possibility of professionaly acquired CJD andinduced the investigation of potential endo- and exogenous risk factors.In CJD-affected health professionals special attention was paid to adetailed occupational history, including a possible professional contactwith CJD patient and to the findings characteristic for iatrogenic CJD:early cerebellar symptomatology, long duration of the disease, absenceof typical EEG finding and homozygosity of PRNP gene at codon 129.Analysis of epidemiological, clinical and molecular biological data ininvestigated group of CJD-affected health professionals gave no evidenceof an occupational risk for CJD.
Creutzfeldt–Jakob disease, Health professionals, Iatrogenic
PDF(63K)
BibTex
EndNode
Copyright© 2000 Kluwer Academic Publishers All rights reserved
http://reo.nii.ac.jp/journal/HtmlIndicate/Contents/SUP0000001000/JOU0001000164/ISS0000002345/ART0000025322/ART0000025322_abstract.html
comments from Tom about these cases;
Comment (webmaster): 7% of sporadic CJD in health professionals is waytoo high to occur by chance, despite the tone of the abstract. Now thefirst thing Dr. Mitrova would have done is rule out familial CJD of theform E200K, which has a very extensive cluster in Slovakia, though theabstract does not really say what was sequenced besides codon 129 of theprion gene. Little credence can be given to the idea that acharacteristic pattern exists for iatrogenic CJD, which is a totalhodge-podge after the dominant forms,
growth hormone and dura mater, aresubtracted.
One very real possibility in Slovakia is that the high numbers of E200Kcases, prior to diagnosis, has led to a secondary epidemic in healthcare workers. This source would be missed by epidemiology because onlyexposure to clinical E200K (hospice workers) would be considered.
One clear-cut case of a health worker at occupational risk is theorthopedic surgeon who removed dura mater from sheep brain for thecompany in Germany selling dura mater for human transplants.
Until Germany conducts a Prionics-type survey of its sheep, we will haveno real idea of the prevalence of scrapie there. The whole dura matertragedy unfolding in Japan may have resulted from sheep dura mater beingused instead of human cadaver. If so, this unfortunate 'experiment'would prove transmissibility of scrapie to humans (though who woulddoubt this in a scrapie dura mater brain transplant?).
Spinal dura contains elastin and collagen gene products, which wouldallow the species origin of the transplant to be determined even decadeslater (if it is not resorbed). Thus it is still possible to determine iscausing the Japanese dura mater outbreak.
The other related case of a possibly affected caregiver is ahusband-and-wife pair who contracted sporadic CJD within a few years ofeach other:
http://www.mad-cow.org/00/aug00_last_news.html#ddd
i'd say this doctor has seemingly misrepresented
medical informationthat was readily available to him from official Health Canada web sites andprominent previous alerts that he and his hospital would have previouslyreceived.
Tutogen Medical, Inc. was formerly known as Pfrimmer-Viggo GmbH+Co,Erlangen, Germany). Their Canadian distributor is listed as CenterpulseDental Canada (hmmm) where in the US it is Tutogen Medical Inc.[Productlines: Dental, Spine, Membrans, Sports Medicine, Bone (more hmmm) ]
http://www.tutogen.de/pages/kontakt/vertreiberadressen.html
what would you call this Health Canada statement ...
"The April 2001, edition of "Neurology" published details of the first case of classical Creutzfeldt-Jakob Disease (CJD) associated with the use of Tutoplast Dura. Following the publication of this news, Health Canada took action to obtain further information on the current surgical need for the use of Tutoplast Dura in Canada. It wrote to orthopaedic, neurosurgical and otolaryngological professional associations seeking advice on the importance to their members of the continued availability of Tutoplast duramater. The Canadian Neurosurgical Society (CNSS) responded by conducting a survey of their members. Of those who replied, 61% supported discontinuing the use of donor dura mater.
On April 10, 2002, Health Canada suspended the medical device licence for Tutoplast Dura. The suspension means that the importation and sale of this medical device is no longer permitted in Canada. Tutoplast Dura manufactured before 1992 was processed with a less concentrated disinfectant solution than material manufactured after October 1992.
The disinfectant used initially, which was in accordance with what was known regarding prion diseases at the time, was a ten times weaker solution of sodium hydroxide than was used starting in 1992. Tutoplast Dura (manufactured by Tutogen Medical GmbH of Germany) was first sold in Canadain January, 1982."
On the company's website in Germany, it seems they have now gone over to Tutomesh ... from bovine pericardium " that is prepared using theTUTOPLAST® procedure thus eliminating antigenic properties"
http://www.tutogen.de/pages/produkte/indikation/detail/tutomeshhernen.html
Some previous experiences in Japan:
"The most recent recipient of a dura mater graft among the 43 graft-associated CJD patients was a woman aged 65 years at the time ofonset of CJD. She had two neurosurgical procedures in 1991 to repair acerebral arterial aneurysm (one in September and one in October); duramater grafts were used during both operations. In February 1994, 28 months after the second operation, she developed progressive dysphagia, dysarthria, and unsteady gait, followed within a few weeks by dementia. In April 1995, she developed generalized myoclonic jerks and akinetic mutism. An electroencephalograph showed a 6- to 10-Hz background rhythm with the periodic synchronized slow activity complexes typical of CJD. Examination of the cerebrospinal fluid revealed a normal protein level and cell count. A magnetic resonance imaging scan showed marked cerebral and cerebellaratrophy. The patient died in October 1995, and no autopsy was performed.
Neither the brand nor year of processing of the dura mater grafts used inthis patient in 1991 could be determined. However, the hospital in which both neurosurgical procedures were performed opened in 1989 and reported using only two brands of dura mater grafts in 1991, LYODURA{Registered} andTutoplast (Pfrimmer-Viggo GmbH+Co, Erlangen, Germany). The investigation suggested that in this patient, the use of LYODURA{Registered} processed before May 1987 was unlikely but could not be ruled out.
http://www.cdc.gov/mmwr/preview/mmwrhtml/00049829.htm
... Even stringent donor screening and processing of each dura separately to avoid possible cross-contamination may not completely eliminate the potential for an infectious graft. In addition, the treatment of dura with NaOH may not inactivate all of the infectious agent that may be present(6). Therefore, surgeons should be aware of the possibly inherent risk for CJD transmission by dura mater grafts and may want to consider the alternative use of autologous fascia lata, fascia temporalis, or synthetic substitutes (4). "
http://www.hc-sc.gc.ca/english/media/releases/2003/cjdbk.htm
September 2003
Information
Tutoplast Dura mater
Health Canada is the national authority that regulates the safety, efficacyand quality of therapeutic products (such as medical devices) used inCanada. It derives its statutory authority over therapeutic products fromthe Food and Drugs Act and Regulations.
Tutoplast Dura mater is a medical device that was available in Canadabetween January 1982 and April 2002 for use in various surgical treatments,including neurosurgery.
The term "medical device" covers a wide range of products used in thetreatment, mitigation, diagnosis or prevention of a disease or abnormalphysical condition. Some examples include pacemakers, artificial heartvalves, hip implants, synthetic skin, medical laboratory diagnosticinstruments, test kits for diagnosis and
contraceptive devices.
The Medical Devices Bureau of the Therapeutic Products Directorate (TPD) atHealth Canada is the national authority that monitors and evaluates thesafety, effectiveness and quality of diagnostic and therapeutic medicaldevices in Canada. The Medical Devices Bureau enforces the Medical DevicesRegulations, which aim to ensure to the extent possible, the safety,effectiveness and quality of medical devices in Canada. This is donethrough a combination of pre-market review, post-approval surveillance andquality systems in the manufacturing process.
In Canada, certain medical devices must have a Medical Device Licencebefore they can be sold. To determine which ones need a Licence, allmedical devices have been categorized based on the risk associated withtheir use. This approach means that all medical devices are grouped intofour classes with Class I devices presenting the lowest potential risk(e.g. a thermometer) and Class IV devices presenting the greatest potentialrisk (e.g. pacemakers).
Prior to selling a medical device in Canada, manufacturers of Class II, IIIand IV devices must obtain a Medical Device Licence. Although Class Idevices do not require a Licence, they are monitored through EstablishmentLicences.
What is Tutoplast dura mater?
Dura mater is a tissue that covers and protects the brain and spinal cord.Commercially processed dura mater, obtained from human donors, has beenused in the surgical treatment of many conditions in Canada since the 1970s.
Tutoplast Dura manufactured before 1992 was processed with a lessconcentrated disinfectant solution than material manufactured after October1992. The disinfectant used initially, which was in accordance with whatwas known regarding prion diseases at the time, was a ten times weakersolution of sodium hydroxide than was used starting in 1992.
Processed dura mater is regulated as a class IV medical device. TutoplastDura (manufactured by Tutogen Medical GmbH of Germany) was first sold inCanada in January, 1982.
The April 2001, edition of "Neurology" published details of the first caseof classical Creutzfeldt-Jakob Disease (CJD) associated with the use ofTutoplast Dura.
Following the publication of this news, Health Canada took action to obtainfurther information on the current surgical need for the use of TutoplastDura in Canada. It wrote to orthopaedic, neurosurgical andotolaryngological professional associations seeking advice on theimportance to their members of the continued availability of Tutoplast duramater. The Canadian Neurosurgical Society (CNSS) responded by conducting asurvey of their members. Of those who replied, 61% supported discontinuingthe use of donor dura mater.
On April 10, 2002, Health Canada suspended the medical device licence forTutoplast Dura. The suspension means that the importation and sale of thismedical device is no longer permitted in Canada.
Physicians were advised at the time to place any existing Tutoplast productin a secure location and immediately inform the manufacturer or distributor.
This action was based on the following considerations:
Advice received through Health Canada's consultation with the CanadianNeurosurgical Society The recommendations of a leading Canadian expert onprion illness (Dr. Neil Cashman). The availability of adequate alternativematerials that can be used instead of commercially-processed dura materobtained from human donors.
The Canadian distributor of Tutoplast Dura conducted the recall of theproduct as per Health Canada's request.
The day following the suspension of the licence (April 11, 2002), HealthCanada initiated an Import Alert with Canadian Customs.
Health Canada informed international partners of the suspension and recallaction through the National Competent Authority Report system. HealthCanada forwarded copies of the medical device suspension letter and of theSafety Advisory to the German authorities for information pertaining to themanufacturer Tutogen Medical GmbH in their jurisdiction.
Health Canada sent a letter to health care professionals on April 11, 2002,advising them:
Not to use Tutoplast Dura manufactured by Tutogen Medical GmbH in anysurgical procedure, as it is no longer licensed for sale in Canada. Toplace any remaining stocks of Tutoplast Dura in a secure location so thatit can no longer be used and immediately inform the manufacturer ordistributor who sold the product.
Individuals who want more information on the recall may leave a message onthe Medical Devices Hotline at 1-800-267-9675. A Health Canada officialwill return the call.
Last Updated: 2003-09-24
TSS
Terry S. Singeltary Sr. wrote:
I was amazed at the comment the doctor made about this in an article yesterday. i had to send a note to him.....tss
snip...
Dr. Dow said he doubted that the woman had died of an infected brain patch. And while there is a theoretical risk that the disease could be spread through instruments contaminated with prion proteins from a patient with CJD, he added to my knowledge there has been no proven case of a neurosurgical instrument contaminated with protein from a patient with CJD causing infection in another patient.
snip...
end
http://www.theglobeandmail.com/services/site/help.html#webstaff
what do you call this;
1: J Neurol Neurosurg Psychiatry 1994 Jun;57(6):757-8
Transmission of Creutzfeldt-Jakob disease to a chimpanzee by electrodes contaminated during neurosurgery.
Gibbs CJ Jr, Asher DM, Kobrine A, Amyx HL, Sulima MP, Gajdusek DC.
Laboratory of Central Nervous System Studies, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD 20892.
Stereotactic multicontact electrodes used to probe the cerebral cortex of a middle aged woman with progressive dementia were previously implicated in the accidental transmission of Creutzfeldt-Jakob disease (CJD) to two younger patients. The diagnoses of CJD have been confirmed for all three cases. More than two years after their last use in humans, after three cleanings and repeated sterilisation in ethanol and formaldehyde vapour, the electrodes were implanted in the cortex of a chimpanzee. Eighteen months later the animal became ill with CJD. This finding serves to re-emphasise the potential danger posed by reuse of instruments contaminated with the agents of spongiform encephalopathies, even after scrupulous attempts to clean them.
PMID: 8006664 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8006664&dopt=Abstract
7 CJD cases possible in N.B., officials say Brain-wasting ailment confirmed in woman who died in July, after she had neurosurgery
RICHARD FOOT CanWest News Service
Thursday, September 25, 2003 ADVERTISEMENT
Click here to find out more!
New Brunswick health officials have warned seven former hospital patients they may have contracted Creutzfeldt-Jakob disease during neurosurgery in Moncton, N.B., following the death of a woman this summer from the rare but fatal brain-wasting illness.
The woman died on July 31, about six weeks after undergoing neurosurgery at Moncton Hospital, where doctors noticed she was showing symptoms of the disease.
On Monday, autopsy results of her brain tissue confirmed she died of classical Creutzfeldt-Jakob disease, or CJD.
Only about 30 Canadians are diagnosed each year with classical CJD, which is a related but separate illness from the human form of mad cow disease, called variant-CJD.
"I want to make it very clear that this is not a case of mad cow disease,'' Gordon Dow, the hospital's chief of infectious diseases, said yesterday in Moncton.
How the woman contracted classical CJD remains a mystery. It's also unclear what specific type of infection she had.
If she died of sporadic CJD, her death poses no risk to the seven other patients. However, officials cannot rule out the chance she died of a less common form called iatrogenic CJD.
This is contracted when the disease is mistakenly passed from one person to another, through shared surgical instruments or through brain tissue transplants. The woman may have been infected during a brain tissue transplant on her spinal cord in 1992, when doctors implanted a tissue graft taken from the brains of human cadavers.
The type of implant used in 1992, known as Tutoplast dura mater, was banned by Health Canada last year because of concerns that it could transmit CJD.
The woman returned to hospital for a second operation in June this year, and died shortly afterwards. The instruments used in her operation have since been incinerated, but of the seven patients warned in the wake of the woman's death, two may have been exposed to those instruments before they were destroyed. Five others received similar brain tissue transplants in the early 1990s.
© Copyright 2003 Montreal Gazette
http://canada.com/national/story.asp?id=AD81755E-B1B4-4F27-ACCE-E6D809057C60
Terry S. Singeltary Sr. wrote:
Brain-wasting disease confirmed in N.B. woman
By LUMA MUHTADIE Globe and Mail Update
A New Brunswick woman died in hospital from Creutzfeldt-Jakob disease, health officials in Moncton announced on Wednesday.
Officials stressed that the case of so-called “classical” CJD cannot spread from person to person, and is not connected to the variant of the disease, which has been linked to mad cow or bovine spongiform encephalopathy.
“This is not a case of mad cow disease,” Gordon Dow, chief of infectious diseases at Moncton Hospital, told the press conference.
However, health officials said that tests were inconclusive as to whether the disease developed spontaneously in the 55-year-old woman (as it does in about 30 Canadians a year) or whether it was iatrogenic, meaning it resulted from an infection acquired during a medical procedure.
In 1992, doctors in Moncton grafted a patch made from tissue taken from a human corpse onto the woman's brain. She returned to the Moncton Hospital in June for a secondary neurosurgical operation, and in a follow-up consultation on June 18, possible CJD was diagnosed. She died on July 31 and the diagnosis of CJD was confirmed through an autopsy on Monday.
Health Canada banned the use of brain-tissue patches taken from human corpses last year due to CJD fears.
Dr. Dow said he doubted that the woman had died of an infected brain patch. And while there is a theoretical risk that the disease could be spread through instruments contaminated with prion proteins from a patient with CJD, he added “to my knowledge there has been no proven case of a neurosurgical instrument contaminated with protein from a patient with CJD causing infection in another patient.”
He said it would be very useful to know if the patient represented a sporadic form of CJD, in which case there would be “absolutely no risk to anybody else” or if she acquired the disease from the graft she received in 1992, “whereby potentially, other patients could have been exposed to the same graft.”
As a safety measure, the Moncton Hospital quarantined all neurosurgical and spinal instruments in the region, later narrowing the quarantine to only those instruments used in the woman's more recent operation.
The hospital also searched the charts of all patients who received graft surgery within one year on either side of the woman's original surgery -– or from 1991 to 1993 -– to identity all potential recipients of the same graft. Seven individuals were found and informed that they were at a small risk of infection.
CJD is a degenerative disease of the central nervous system that initially alters the personality or makes social interaction difficult, but quickly progresses into problems with speech, memory and vision. It eventually leads to motor problems such as stiffness, paralysis and twitching.
“During this rapid deterioration, patients quickly become confined to bed in a mute, paralyzed state -- probably in a semi-comatose state -- with very little insight or understanding ... or sensation of their illness and subsequently die,” Dr. Dow said.
It generally takes six months from the onset of symptoms until death. There is currently no treatment available for CJD.
http://www.theglobeandmail.com/servlet/story/RTGAM.20030924.wcreu0924/BNStory/Front
spontaneous my @ss..... how can these people continue to believe that 85%+ of all CJDs happen from nothing (a spontaneous happening without route and source). this is total BSeee and they cannot prove this. it is only wishful thinking by scientist and there politicians that advocate this myth $$$
TSS
Terry S. Singeltary Sr. wrote:
######## Bovine Spongiform Encephalopathy #########
New Brunswicker reported dead of Creutzfeldt-Jakob Last Updated Wed, 24 Sep 2003 12:25:17
MONCTON - A New Brunswick resident has died of Creutzfeldt-Jakob disease after brain surgery, CBC has learned.
Sources tell CBC News that this case was not the CJD variant caused by eating tainted beef and is not related to bovine spongiform encephalopathy, or mad cow disease.
Diagnosis of the disease cannot be confirmed until after death.
Public health authorities are expected to hold a news conference later Wednesday to release more details.
* FROM APRIL 13, 2002: Health Canada bans 'brain patch' linked to brain disease
From: TSS (216-119-130-124.ipset10.wt.net)Subject: BRAIN PATCH STILL IN USE $ (re-dura/CJD) $ LESS THAN ONE MONTH TO GO FOR COSMETICS/BSE/BeijingDate: March 27, 2002 at 6:04 pm PST
POSTED AT 2:08 AM EST Tuesday, March 26[space]Brain patch still in use despite risk[space][space] Advertisement[space]
By CAROLYN ABRAHAM From Tuesday's Globe and Mail
Canadian patients still receive brain-tissue patches taken from human corpses, despite a World Health Organization call to ban them because of the risk of transmitting a fatal brain-wasting disease similar to bovine spongiform encephalopathy (mad-cow disease).
The WHO recommended in 1997 that grafts of human dura, tissue harvested from the outer lining of cadaver brains, should be used only if a surgeon has no other means to patch and close an incision.
But based on a recent survey, the Canadian Neurosurgical Society estimates that surgeons stitch these human-tissue patches into the brains of 200 patients a year.
Scientists, meanwhile, fear that the incurable Creutzfeldt-Jakob disease can contaminate these tissue grafts, especially since the infection is known to survive extreme sterilization measures. Grafts are produced by companies that collect the dura from cadavers.
One type, the German-made Lyodura, a brand that is no longer in production, has been linked to 115 CJD deaths worldwide, four of them in Canada over the past decade.
"There are so few things that we know can transmit CJD, why the hell not just eliminate one possibility?" said Neil Cashman, a neurologist at the University of Toronto Centre for Neurodegenerative Disease.
Dr. Cashman, also a member of the CJD National
Surveillance Team, said the benefits of using these tissue grafts in brain operations are not worth the potential risks.
Britain banned their use in 1989. Japan, where more than half the Lyodura-linked deaths have occurred, halted its use in 1997. But in Canada, as in the United States, there have been no similar restrictions.
Health Canada spokesman Ryan Baker said, however, that federal officials are now considering whether there should be.
"Health Canada is currently reviewing the potential risks of human-derived dura substitutes," Mr. Baker said.
No government official would speak about the use of the brain patches because Health Canada is being sued by the family of a 14-year-old boy who died of CJD in 1999 after receiving a Lyodura implant in 1988. Warnings that the product could be tainted with CJD had been published a year earlier.
According to Mr. Baker, there are seven licensed products on the market to patch the tough outer membrane of patients' brains after an operation. Four are synthetic and two are derived from bovine heart tissue. Only one, he said, comes from human cadavers ? a product called Tutoplast that is made by New Jersey-based Tutogen Medical Inc.
Rick Moulton, president of the Canadian Neurosurgical Society, said Health Canada contacted his organization last fall trying to find out how many patients receive the human dura patches and how brain surgeons would react to banning them.
"We actually support a complete ban on all human dura [grafts]," Dr. Moulton said. "In part because there is no way to test the product for CJD and there is no way to test the patient who receives it."
The society represents 130 of the approximately 170 neurosurgeons in Canada.
Dr. Moulton, also head of the division of neurosurgery at St. Michael's Hospital in Toronto, said the "gold standard" is to patch the dura with the patient's own tissue, taken from the skull or thigh.
Paul Brown, a senior investigator with the U.S. National Institute of
Neurological Disorders and an expert on CJD and its related diseases, said some surgeons have felt that "none of the alternatives are as good as human dura."
He also said that manufacturers who have a clean record feel they should not be punished for the cases that have been linked to one company.
Dr. Brown explained certain procedures can reduce risks, such as ensuring that no brain tissue is collected from a donor who suffered neurological problems, that specimens are not pooled in one
container to avoid contaminating others, and that the tissue undergoes special and proper sterilization.
CJD, usually a rare disorder that hits one in a million elderly people, strikes about 26 people a year in Canada. It can develop sporadically, with no explanation, it can be the result of a genetic mutation and it can be spread to the brain through medical procedures, such as tissue implants or contaminated surgical tools.
CJD is also linked to the neurodegenerative BSE, in which misshapen proteins devour the brain, leaving the tissue resembling a sponge after death.
Public Citizen, the national U.S. group founded by consumer advocate Ralph Nader, petitioned the U.S. Food and Drug Administration last August for a complete ban on the use of donated human dura tissue in surgery.
http://www.globeandmail.com/servlet/RTGAMArticleHTMLTemplate/C/20020326/wxlyod?hub=homeBN&tf=tgam%252Frealtime%252Ffullstory.html&cf=tgam/realtime/config-neutral&vg=BigAdVariableGenerator&slug=wxlyod&date=20020326&archive=RTGAM&site=Front&ad_page_name=breakingnewshtml&cf=tgam/realtime/config-neutral&vg=BigAdVariableGenerator&slug=wxlyod&date=20020326&archive=RTGAM&site=Front&ad_page_name=breakingnews
POSTED AT 3:07 AM EST Wednesday, March 27[space]Patients want answers on brain patch
By CAROLYN ABRAHAM
From Wednesday's Globe and Mail
Anxious patients who underwent brain surgery in the past dozen years are trying to find out if they received a brain tissue patch that has since been linked to a lethal, neurodegenerative disease.
Calls to doctors, hospitals and The Globe and Mail indicate that while there is no way to tell whether a patient received a tissue graft contaminated by the brain-wasting Creutzfeldt-Jakob disease, people still want to know if they are at risk.
"I have received calls from families whose members received a Lyodura [brain-tissue] transplant who also want to know what they can do. But the answer is, there is no answer," said Neil Cashman, a neurologist at the University of Toronto's Centre for Neurodegenerative Diseases.
Unless a person has actually begun to develop symptoms of CJD, such as trembling, loss of balance and dementia, no examination can reveal if they may be infected, said Dr. Cashman, who is also a member of the CJD National Surveillance effort.
Still, Health Canada is recommending that "anyone who received Lyodura or anyone who has concerns about their surgery should consult their physician," said Health Canada spokesman Ryan Baker.
But Mr. Baker added, "If we hear about a case of CJD, we will trace it to its origins."
Lyodura, processed from the brain coverings of human cadavers and produced by the German multinational medical supply giant B.
Braun Melsungen until 1996, has been associated with 115 deaths in 11 countries ? including four in Canada.
The caseload has raised questions about the safety and sources of tissues harvested from human corpses for medicinal use, and the abilities of the health system to protect patients.
Hundreds of Canadians received Lyodura patches in the 1980s when surgeons stitched closed the dura, the brain's outer lining. But how many are at risk remains a mystery because no one knows which lots might have been infected with CJD, a condition that can incubate for 30 years.
One man, for example, who read on the weekend about the risks associated with Lyodura, learned from a Montreal hospital this week that he had in fact received this brand of tissue implant in 1988.
The man, who asked not to be identified, said hospital officials are now digging in their archives to determine which lot his Lyodura came from. The man said the hospital had also received the same request from another concerned patient.
Health Canada issued a recall of two lots of Lyodura in 1987 that had been linked to a CJD death in the United States. But U.S. health authorities warned later that year that the risk of CJD was not limited to any particular lot number, but applied to all Lyodura tissue grafts produced before 1987.
This is because the U.S. officials had found that, unlike other companies, B. Braun had been collecting dura brain matter from corpses and pooling all the tissue in one container, increasing the risk that one CJD-tainted specimen could contaminate all the others.
The investigation also learned that the company had no records on individual donors, making it impossible to trace the source of a possible infection.
Then it was reported in 1994 that the company had paid hospital autopsy workers $18 for each brain membrane harvested from a cadaver. German officials were quoted as saying that the tissues were sometimes collected without permission of the donor's families or hospital administrators.
However, Ermias Belay, a medical epidemiologist following the Lyodrua cases for the U.S. Centers for Disease Control, noted, "Not everyone who got Lyodura will get CJD. The risk is not 100 per cent."
In Canada, at least one family has settled out of court after filing a suit against B. Braun and others in connection to Lyodura. The family of Dominique Roy-Regimbald, a 14-year-old who died in 1999 after receiving the tissue graft in 1988, now has a suit before Quebec provincial court.
Other people with relatives who died of CJD after undergoing brain surgery are also haunted by questions.
Marianne Pope, whose 62-year-old mother died of CJD in May, 1991, contacted The Globe this week, saying she and her sister, brother and father were looking for answers.
Their mother, Margaret Sandercott, had undergone surgery at a London, Ont., hospital in November, 1988, to remove a tumour in her inner ear. They are now trying to find out from records whether she received a human tissue graft, or Lyodura, in the process.
"She lost all brain function less than three years after that operation," said Ms. Pope. "We've always been pretty convinced that she somehow contracted it through the operation.
"We feel there is way more of this out there than people realize."
http://www.globeandmail.com/servlet/RTGAMArticleHTMLTemplate/C/20020327/wxlyod?hub=homeBN&tf=tgam%252Frealtime%252Ffullstory.html&cf=tgam/realtime/config-neutral&vg=BigAdVariableGenerator&slug=wxlyod&date=20020327&archive=RTGAM&site=Front&ad_page_name=breakingnewsaca
Last updated at: (Beijing Time) Tuesday, March 26, 2002
BSE-related Cosmetics' Sale BannedChinese establishments that sell imported cosmetics which might spread mad cow disease have less than one month to clear their shelves of the potentially deadly products.
Chinese establishments that sell imported cosmetics which might spread mad cow disease have less than one month to clear their shelves of the potentially deadly products.
The
Ministry of Health and the State General Administration of Quality Supervision and Inspection and Quarantine issued a statement early this month to ban the import and sale of such cosmetics before April 20.
Enterprises urged to withdraw products immediately At present, many shops still stock cosmetics containing cattle or sheep brain tissues, nerve tissue, internal organs, placenta, blood or their extracts from dozens of countries and regions where mad cow disease (bovine spongiform encephalopathy, or BSE) has been found.
Enterprises that have already imported cosmetic products containing such components are urged to immediately report them to the health authorities and withdraw.
Some large department stores claim they have already withdrawn the imported cosmetics.
In North Star Shopping Centre, only Lan Ono, a cosmetic brand from Australia which is famous for its wool oil cosmetics and is free of mad cow disease, is on sale.
Some cosmetics still flourishingHowever, in many small and medium-sized markets in Beijing and other cities, such cosmetics are reportedly still flourishing.
Some market managers claim they are waiting for a list of the banned cosmetics before clearing their shelves, as they do not know which ones should be pulled.
Consumers are also waiting for such a list to know which cosmetics to avoid.
The Ministry of Health will distribute a list. However, it will not be until after April 20, according to Zhang Yinfa, a ministry official.
The ministry will also check a list of cosmetics it previously approved to see which of them contain suspected tissues, he added.
"It will be a hard task because there are nearly 10,000 imported cosmetics already approved in China,'' said Zhang.
To some, the ban will not make much difference to consumers and enterprises.
For example, Meng Jun, deputy manager of the cosmetics sale department in Beijing Xidan Plaza, said the majority of marketable cosmetics are made of
plant tissues -- a fashion in the cosmetic industry -- and, therefore, the ban will not have a great influence on the sale of cosmetics.
Consumers should remain cautiousBefore the list comes out, consumers should remain cautious when buying cosmetics, and check products' contents, experts suggest.
In China, cosmetics imported legally and sold have Chinese characters displaying their contents and usage.
Since the first case of mad cow disease was detected in Britain in 1985, BSE cases have cropped up in many European countries, including
Ireland, Switzerland, France, Belgium, Luxembourg, the Netherlands, Germany, Portugal, Denmark, Italy, Spain, the Principality of Liechtenstein, the Slovak Republic, Finland and Austria.
China Bans Cosmetics from Countries Suffering from 'Mad-Cow' DiseaseA bulletin released jointly by the Ministry of Health and the State General Administration for Quality Supervision and Inspection and Quarantine noted that the cosmetics containing the material extracted from brains, nerve cells, inner organs, placentas and blood of cows and sheep which came from countries or regions suffering from "mad-cow" disease will be banned to import and sell.
Cosmetics containing the material extracted from brains, nerve cells, inner organs, placentas and blood of cows and sheep which came from countries or regions suffering from "mad-cow" disease will be banned to import and sell, noted a bulletin released jointly by the Ministry of Health and the State General Administration for Quality Supervision and Inspection and Quarantine. In Detail
http://english.peopledaily.com.cn/200203/26/eng20020326_92835.shtml
TSS
To: Mad Cow USA
madcow@lists.iatp.org
From:
flounder9@verizon.net
Date: 2006-06-01 15:20:59
Subject: Fw: Brief Report: Investigation into Recalled Human Tissue for Transplantation --- United States, 2005--2006
----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Wednesday, May 31, 2006 4:13 PM
Subject: Brief Report: Investigation into Recalled Human Tissue forTransplantation --- United States, 2005--2006
##################### Bovine Spongiform Encephalopathy#####################
MMWR Brief Report: Investigation into Recalled Human Tissue forTransplantation --- United States, 2005--2006Posted: 5/30/2006
Brief Report: Investigation into Recalled Human Tissue forTransplantation --- United States, 2005--2006
On September 29, 2005, a human tissue-processing company discoveredinaccuracies in donor records forwarded from a tissue-recovery firm andnotified the Food and Drug Administration (FDA). An FDA investigationdetermined that the recovery firm, Biomedical Tissue Services, Ltd. (BTS)(Fort Lee, New Jersey), recovered tissues from human donors who might nothave met donor eligibility requirements and who were not screened properlyfor certain infectious diseases. In October 2005, BTS and the fiveprocessors* that had received the tissues, working with FDA, issued a recallfor all tissues recovered by BTS. The continuing FDA investigationdetermined that information for some donors (e.g., cause, place, or time ofdeath) was not consistent with death certificate data obtained from thestates where the deaths occurred. The investigation also determined that BTShad failed to recover tissues in a manner that would prevent contaminationor cross-contamination and failed to control environmental conditionsadequately during tissue recovery. These failures were violations of theCurrent Good Tissue Practice Rules? (effective May 25, 2005), which requiremanufacturers to recover, process, store, label, package, and distributehuman cells, tissue, and cellular and tissue-based products (HCT/Ps) toprevent introduction, transmission, or spread of communicable diseases. InJanuary 2006, FDA ordered BTS to cease manufacturing and to retain allHCT/Ps.
The tissues recovered by BTS had been sent to five processors, whodistributed them through one or more sub-distributors or directly toclinicians and health-care facilities. CDC learned that, during June2002--October 2005, approximately 25,000 BTS-recovered tissue products weredistributed to all 50 states and internationally. Most of these tissueallografts were bone or demineralized bone matrix; others included skin andsoft tissue (e.g., tendons or fascia lata). Before distribution, tissueswere disinfected by tissue processors to reduce or eliminate contaminationwith bacteria, fungi, or viruses.
During September--October 2005, the five tissue processors recalled allproducts that had been produced from BTS tissues. Each of the processors andrelated distributors issued letters to consignees (i.e., health-carefacilities or clinicians) to notify them of the recall and request return ofunused products. The letters included a recommendation by FDA and CDC thattransplant recipients be notified of the recall and offered access totesting for the communicable diseases for which donor screening is required:human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis Cvirus (HCV), and syphilis.
In March 2006, FDA determined that, in some instances, blood samplessubmitted for disease screening had not come from the persons from whom thelinked tissues had been obtained. This finding cast doubt on the bloodsample--screening status of the tissue donors, and FDA and CDC issued anupdate§ that strongly recommended health-care providers offer patientsaccess to or referral for testing for HIV, HBV, HCV, and syphilis. CDCrecommendations¶ for testing persons who received BTS tissues call forpatients whose tissue implants have been in place >6 months to be offeredthe following tests: HIV antibody, antibody to hepatitis B core antigen,antibody to hepatitis C virus, a non-treponemal syphilis test (i.e., rapidplasma reagin [RPR] or Venereal Disease Research Laboratory [VDRL]), and atreponemal syphilis test (i.e., Treponema pallidum particle agglutination[TP-PA] or any enzyme-linked immunosorbent assay [ELISA] test). Patientswhose tissue implants have been in place <6 href="mailto:mmwrq@cdc.gov">mmwrq@cdc.gov.
Date last reviewed: 5/25/2006
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5520a6.htm
Body snatchers tied to allograft firms?
Alleged New York-area ring investigated for selling parts to corpse tissue harvesters.
October 7, 2005: 2:54 PM EDTBy Aaron Smith, CNN/Money staff writer
NEW YORK (CNN/Money) - A Brooklyn funeral home and a New Jersey company that harvests body parts from corpses are being investigated for their alleged roles in a body snatching ring that sold parts to companies specializing inmedical grafts, sources close to the investigation said Friday.
The Brooklyn district attorney's office declined to comment on the investigation. But sources close to the investigation acknowledged that it has been going on for about one and a half years, focusing on Michael Mastromarino of Biomedical Tissue Services Ltd. of Fort Lee, N.J., who allegedly harvested body parts illegally from the Daniel George funeral home in Brooklyn.
The firms that bought the allegedly black-market tissue have not been accused of any wrong doing. Human tissue is usually obtained from non-profittissue banks. In the U.S., it's illegal to buy and sell human tissue.
Wendy Crites-Wacker, spokeswoman for Regeneration Technologies (down $0.66to $7.28, Research), a company in Alachua, Fla., said her company has severed all ties with Biomedical Tissue Services, their former source for some of the body parts used to make medical grafts, or allografts.
"We had previously terminated the relationship with Biomedical Tissue Services and we are cooperating with the appropriate authorities on this issue," said Crites-Wacker, who declined to say when the termination took place.
Crites-Wacker also said that her company's BioCleanse process, in which bones and tendons are sterilized through a melange of chemicals, temperatureand pressure, ensures that its products are safe.
Two other allograft companies have been identified as customers ofBiomedical Tissue Services: LifeCell Corp. (down $2.82 to $17.33, Research),of Branchburg, N.J. and Tutogen Medical Inc. (down $0.15 to $4.06, Research)of West Paterson, N.J.
LifeCell Corp. had issued a Friday statement saying it had voluntarily recalled some human tissue products after questions were raised about Biomedical Tissue Services.
"Specifically, the company recalled all lots of product that were produced using tissue from Biomedical Tissue Services (BTS)," LifeCell said in a release.
LifeCell, which markets products made from human tissues that are used in surgical procedures, said it recalled certain AlloDerm, Repliform and Graft Jacket products on Sept. 30.
LifeCell's stock price slid about 5 percent this morning, and a Piper Jaffray analyst attributed the slump to a New York Daily News story that first reported on the investigation.
"We believe this morning's weakness in LifeCell's shares is related to a news article that alleges LifeCell inadvertently received tissue from an illegal body-snatching ring," said Raj Denhoy of Piper Jaffray, in a written report.
LifeCell said in the statement all other tissues supplied by Biomedical Tissue Services remain "on hold until the discrepancies in the donor documentation can be resolved."
Denhoy said that LifeCell did not appear to do anything illegal and that"LifeCell itself was the victim of fraud," referring to allegations that Biomedical Tissue Services forged death certificates and family consent forms.
Denhoy said that LifeCell receives tissue from 30 sources, "so the loss of one will likely not impact the underlying business," though increased regulatory scrutiny could drive down the stock price.
"While LifeCell and the other tissue companies appear to have done nothing wrong, this event could increase regulatory and media scrutiny of the business," said Denhoy, who rates the company market perform. "We recently downgraded LifeCell shares on competitive concerns and today's revelations may pressure the stock further."
Eric Franz, the attorney representing funeral home owners Debora Johnson and Robert Nelms, said his clients "did not participate in any criminal conduct whatsoever."
Attempts to reach Mastromarino and his company Biomedical Tissue Services were unsuccessful. The Daily News reported that Mastromarino declined to comment.
Regeneration Technologies produces heart valves, bone and tendon implants and bone paste, which is used to plug holes. LifeCell specializes in AlloDerm, a "dermal matrix" made from human skin that is used in grafts. Tutogen focuses on bone and dental implants.
--from staff and wire reports
http://money.cnn.com/2005/10/07/news/midcaps/corpse/?section=money_latest
Order to Cease Manufacturing and to Retain HCT/Ps
January 31, 2006
CERTIFIED MAILRETURN RECEIPT REQUESTED
Michael Mastromarino, D.D.S.CEO & Executive Director of OperationsBiomedical Tissue Services, Ltd.2125 Center Avenue, Suite 300Fort Lee, NJ 07024-5874
Dear Dr. Mastromarino:
The Food and Drug Administration (FDA or the agency) conducted an inspection of your establishment, Biomedical Tissue Services, Ltd. (BTS or Establishment), at 2125 Center Avenue, Suite 300, Fort Lee, New Jersey07024, which manufactures human cells, tissues, and cellular and tissue-based products (HCT/Ps), between October 4 and 27, 2005. At the conclusion of the inspection, the FDA investigators issued you a FormFDA-483, Inspectional Observations. In addition to the inspection, the agency conducted a concurrent investigation of several funeral homes that provided you with potential donors of HCT/Ps for recovery. Our review of the information and records examined and collected during the inspection and investigation reveal that significant violations of Title 21, Code ofFederal Regulations (21 CFR), Part 1271, issued under the authority ofSection 361 of the Public Health Service Act (PHS Act) [42 U.S.C. 264],exist at BTS. The agency has determined that these deviations, because of their serious nature, constitute a danger to health. This Order to Cease Manufacturing and to Retain HCT/Ps relates exclusively to conduct occurring on or after May 25, 2005, the effective date of these regulations. We note that the FDA retains authority to pursue other actions and remedies.
Therefore, pursuant to 21 CFR 1271.440(a)(1) and (3), both you individually, and your Establishment, 1) must immediately cease all manufacturing until compliance with the regulations in 21 CFR Part 1271 has been achieved, and2) must retain all HCT/Ps recovered on or after May 25, 2005 that are inyour possession until they are disposed of as agreed by the agency or until the safety of the HCT/P is confirmed. Pursuant to 21 CFR 1271.3(e),"Manufacture" means, but is not limited to, any or all steps in the recovery, processing, storage, labeling, packaging, or distribution of anyHCT/P, and the screening or testing of the HCT/P donor.
Deficiencies noted include, but are not limited to, the following:
You failed to implement the standard operating procedures (SOP or SOPs) that you have established for all steps that you perform in determining donor eligibility, as required by 21 CFR 1271.47(a), and you failed to review the certificate of death for each donor, a relevant medical record, regarding risk factors for, or clinical evidence of, relevant communicable disease agents and diseases, as required by 21 CFR 1271.75(a). More specifically,your standard operating procedure entitled "Donor Identification" requiresthat, when recovering HCT/Ps at a funeral home, you review the death certificate to confirm the eligibility of the donor. However, you recovered HCT/Ps from at least eight donors, obtained from --- different funeral homes, located in ------ different states, in which you failed to review valid death certificates. The documents purporting to be the certificates of death for these donors were collected from BTS during our inspection, are not authentic death certificates issued by the state, and are inaccurate. For example:
You confirmed the eligibility of donor ------------, who donated HCT/Ps at afuneral home in ----------. The donor is listed on the BTS version of the certificate of death as being 63 years of age, having died of acutemyocardial infarction due to coronary artery disease, at ----pmon ------------, whereas the State of ---------------issued certificate of death lists this donor as being 69 years of age, having died of multi-organ failure, due to liver dysfunction, which in turn was due to thrombosis, at ----pm on ------------------;
You confirmed the eligibility of donor --------------, who donated HCT/Ps ata funeral home in ----------------. The donor is listed on the BTS version of the certificate of death as being 44 years of age, having died of blunt trauma in a motor vehicle accident, at ----am on ----------------, where as the State of -----------------issued certificate of death lists this donoras being 48 years of age, having died of congestive cardiac failure due to atherosclerotic cardiovascular disease, at ----am on ------------------;
You confirmed the eligibility of donor -------------, who donated HCT/Ps at a funeral home in ---------------. The donor is listed on the BTS version of the certificate of death as being 70 years of age, having died of cardio-pulmonary arrest due to acute myocardial infarction, at ---- pmon ------------------, whereas the State of ---------------------issued certificate of death lists this donor as being 74 years of age, having died of complications from the intravenous administration of medication due to aradical resection of a -----------------------------------------------------------------, at ----pm on ---------------------;
You confirmed the eligibility of donor ------------------, who donatedHCT/Ps at a funeral home in ---------------. The donor is listed on the BTS version of the certificate of death as having died of cardio-pulmonaryarrest due to atherosclerotic heart disease, at ----pm on -----------------, whereas the State of -------------issued certificate of death lists this donor as having died of cardio-pulmonary asystole due to sepsis and shock, at ----pm on --------------;
You confirmed the eligibility of donor ---------------, who donated HCT/Psat a funeral home in ----------------------. The donor is listed on the BTS version of the certificate of death as being 45 years of age, having died of blunt trauma due to a motor vehicle accident, at ----pm on ---------------, whereas the State of ----------------------issued certificate of death lists this donor as being 41 years of age, with a cause of death which was undetermined pending additional studies, at ----pm on -------------------;
You confirmed the eligibility of donor -------------, who donated HCT/Ps ata funeral home in -------------. The donor is listed on the BTS version ofthe certificate of death as having died of cardio-pulmonary arrest due toacute myocardial infarction, at ----pm on -----------------, whereas theState of ------------------issued certificate of death lists this donor as dying of probable ventricular fibrillation due to -------------------failure, as a consequence of -------------------- disease, at ----amon ----------------------;
You confirmed the eligibility of donor -------------, who donated HCT/Ps ata funeral home in ------------. The donor is listed on the BTS version ofthe certificate of death as being 58 years of age, having died of acutemyocardial infarction, at ----am on ----------, whereas the State of ---------------------issued certificate of death lists this donor as being 50 years of age, having died of diabetes mellitus and hypertension due to cardio-vascular disease, at ----pm on ---------------------------; and
You confirmed the eligibility of donor --------------, who donated HCT/Ps ata funeral home in ----------------. The donor is listed on the BTS version of the certificate of death as being 63 years of age, having died of acutemyocardial infarction, at ----pm on ------------, whereas the State of -------------issued certificate of death lists this donor as being 79 years of age, having died of pneumonia due to a myocardial infarction, at ----pm on -----------------.
You failed to implement the SOPs that you have established for all steps that you perform in determining donor eligibility, regarding your assessment of risk factors for, or clinical evidence of, relevant communicable disease agents and diseases, as required by 21 CFR 1271.47(a).
Furthermore, you failed to create and maintain accurate records, as required by 21 CFR1271.55(d)(2) and 21 CFR 1271.270(a).More specifically, your "Documenting the Recovery" SOP requires that, if the donor had been admitted to a health care facility immediately prior to death, you were to document the date and reason for admission; check the appropriate boxes regarding availability of donor history, physical, and discharge summary; check the appropriate box regarding surgeries; check the appropriate boxes regarding availability of lab results (including blood cultures, x-rays, and lung biopsies); and check the appropriate boxes regarding documentation of HIV, Hepatitis and Tuberculosis infection. However, your Medical Evaluation forms fordonors -----------------, ---------------, -------------------, -------------, ---------------, and -------------------- (who donated HCT/Psin ---------- different funeral homes located in ---------- different states), do not contain any of this information. Instead, you incorrectly stated that these donors were ? not admitted to a health care facility immediately prior to death?,? which statements are contradicted by the state-issued certificates of death for each of these donors.
You failed to create and maintain accurate records, as required by 21 CFR1271.55(d)(2) and 21 CFR 1271.270(a). More specifically:
The Medical Evaluation forms created and maintained by you for the following six donors are inaccurate in that you state that the donors were ? not admitted to a health care facility immediately prior to death?.? In so doing, you also failed to adhere to the following SOPs:
Documenting theRecovery SOP; Quality Assurance Audit of Donor Records SOP; QualityAssurance Check-Off Form; and Audit Check List. These six donors donated HCT/P at -----different funeral homes, located in -------- different states. More specifically:
the State of --------------issued certificate of death for donor ----------------- states that at the time of her death she was a patient at ------------------- Hospital;the State of ------------issued certificate of death for donor ------------------ states that at the time of his death he was a hospital inpatient at ---------;
the State of --------------issued certificate of death for donor ----------states that at the time of his death he was a patient at --------------------- Hospital;
the State of ----------------issued certificate of death for donor ---------- states that at the time of her death she was a patient at ------------- Hospital;
the State of ---------------------issued certificate of death for donor ---------- states that at the time of his death he was a patientat -------------- Hospital;
and the State of ---------------issued certificate of death for donor --------------- states that at the time of her death she was a patient in the emergency room of ----------------- Hospital.
The records created and maintained by you for donor --------------- are inaccurate in that you state in your Certifying Physician Interview formthat the donor was a 44 year old male who died as a result of a blunt traumato the head region in a motor vehicle accident;
your Circumstances of Death form states that the donor was a 44 year old male who was involved in amotor vehicle accident, sustained blunt trauma, and expired at the scene of the accident prior to medical intervention; and your Donor Physical Assessment form includes an incorrect schematic of the donor, showing fractures to the anterior and posterior portions of the skull, together with bruises or contusions to the anterior and posterior portions of the neck. These records are contradicted by the State of --------------------issued certificate of death, which states that the donor died of natural causes (congestive cardiac failure, resulting from atherosclerotic cardiovasculardisease), at his home, at the age of 48. The only other significant condition which is listed as contributing to the death of the donor in theState of --------------issued certificate of deathis -----------------------. In creating and maintaining these inaccurate records, you have also failed to adhere to your "Documenting the Recovery"SOP, your "Quality Assurance Audit of Donor Records" SOP, your Audit CheckList, and your Quality Assurance Check-Off form.
The records created and maintained by you for donor ---------------- are inaccurate in that you state in your Certifying Physician Interview form that the donor was a 45 year old female who suffered blunt trauma in a motor vehicle accident, and died at the scene of the accident prior to medical intervention; your Circumstances of Death form states that the donor was a 45 year old female who was involved in a motor vehicle accident, sustained blunt trauma to the head region, and expired prior to medical intervention;
and your Donor Physical Assessment form includes an incorrect schematic of the donor, showing fractures to the anterior and posterior portions of the skull, together with bruises or contusions to the anterior and posterior portions of the neck. These records are contradicted by the State of --------------issued certificate of death, which states that the donor died at her home, at the age of 41, was -----, and with an undetermined cause of death, pending additional studies. There were no other significant conditions listed as possibly contributing to the death of the donor in the state-issued certificate of death. In creating and maintaining these inaccurate records, you have also failed to adhere to your "Documenting theRecovery" SOP, your "Quality Assurance Audit of Donor Records" SOP, your Audit Check List, and your Quality Assurance Check-Off form.
The records created and maintained by you for donor ------------- are inaccurate and incomplete in that your Certifying Physician Interview form for this donor fails to indicate the cause of death; your Circumstances of Death form for this donor incorrectly states that the donor was a 70 year old female, and fails to indicate the cause of death;
your Medical/Social History Interview form incorrectly states that the donor never received an organ transplant; and your Donor Physical Assessment form for this donor fails to show on the schematic that the donor had a surgical procedure to her ------------------------ immediately prior to her death, and also fails to show that the donor had undergone a ------ transplant. These records are contradicted by the State of ------------issued certificate of death, which states that the immediate cause of death of this donor was due to complications related to the intravenous administration of medication due to a ------------------------------------------------------------------------------------------------------. The donor is also listed on the State of ----------------issued certificate of death as having undergone a status post-cadaver -------- transplant for ------------- disease, and as having died at the age of 74. In creating and maintaining these inaccurate records, you have also failed to adhere to your "Quality Assurance Audit of Donor Records" SOP, your "Documenting the Recovery" SOP, your Audit Check List,and your Quality Assurance Check-Off form.
The records created and maintained by you are inaccurate as concerns the identity of the funeral home from which donors -------, ----------------, and ----------------------were obtained and at which HCT/P recovery procedures were performed for these donors. In your Donor Demographics forms for these donors you state that their recovery location was a funeral home in -----------, -------------, and you also state that the director of the funeral home provided you with a positive identification of these three donors. However, in an affidavit provided to the agency by the director of the funeral home, while he estimates that his funeral homes have provided between --- and ---- donors to BTS, they did not provide BTS with these three donors. In creating and maintaining these inaccurate records, you have also failed to adhere to your "Quality Assurance Audit of Donor Records"SOP, your "Documenting the Recovery" SOP, your Audit Check List, and your Quality Assurance Check-Off form.
You failed to implement the SOPs you established for donor eligibility determinations specifically for documenting and confirming the identity ofthe donors' next of kin, including your Donor Medical Social History Interview SOP, your Quality Control Review of Donor Records SOP, your Quality Assurance Audit of Donor Records SOP, your Audit Check List, and your Quality Assurance Check-Off form, all as required by 21 CFR 1271.47(a), and you failed to create and maintain accurate records, as required by 21CFR 1271.55(d)(2) and 21 CFR 1271.270(a), in that you have inaccurately and incompletely recorded the donors' next of kin information.
Morespecifically:
The records created and maintained by you for donor ------------ are inaccurate and incomplete in that your information on the donor's spouse differs from that found in the State of -------------issued certificate of death. More specifically:
while your Consent for Donation of Anatomical Gifts form for this donor lists the donor's spouse as the consenting next of kin, the donor's spouse is incorrectly listed as another individual, residing at an entirely different address than the donor;
while your Medical/Social History Interview form for this donor lists the interviewee as the donor's spouse, the interview form incorrectly identifies the donor's spouse and residential address;
your Circumstances of Death form for this donor also incorrectly identifies the spouse; and the BTS version of the certificate of death for this donor is incomplete in that it does not list any surviving spouse, and does not indicate whether the donor was married.
The records created and maintained by you for donor ------------- are inaccurate and incomplete in that your information on the donor's spouse differs from that found in the State of --------------issued certificate of death. More specifically:
while your Consent for Donation of Anatomical Gifts form for this donor lists the donor's spouse as the consenting next of kin, the donor's spouseis incorrectly listed as another individual, residing at an entirely different address than the donor;
while your Medical/Social History Interview form for this donor lists the interviewee as the donor's spouse, the interview form incorrectly identifies the donor's spouse and residential address;
your Circumstances of Death form for this donor also incorrectly identifies the spouse;
andthe BTS version of the certificate of death for this donor is incomplete in that it does not list any surviving spouse, and does not indicate whether the donor was married.
You failed to implement the SOPs you established for donor eligibility determinations, as required by 21 CFR 1271.47(a), and to assure the timely refrigeration of donors and recovery of HCT/P, as required by 1271.180(a). You failed to recover HCT/P in a manner that does not cause contamination or cross-contamination during recovery, to adequately control environmental conditions, and to provide proper conditions for operations, all as requiredby 21 CFR 1271.145, 21 CFR 1271.195(a)(1), and 21 CFR 1271.215. Furthermore, you failed to create and maintain accurate records, as required by 21 CFR1271.55(d)(2) and 21 CFR 1271.270(a).Your SOPs require that donors be refrigerated within ----- hours and that HCT/P excision begin within ----- hours post cardiac asystole. However, you did not meet these standards for the following donors:
your Donor Demographics form for donor ------------- states that the donor was "? refrigerated within --- hours and tissue excision began within ----hours post cardiac asystole" and that the donors refrigeration time was at ----am on -----------, which, according to the State of --------------------issued certificate of death's time of death (----pmon ----------------), is more than 33 hours post-cardiac asystole. Also, according to your Tissue Recovery Log form for this donor, HCT/P excision of the donor began at ----pm on --------, almost 48 hours post-cardiacasystole. As a result, your Donor Demographics form is inaccurate; and
your Donor Demographics form for donor ---------------states that the donor was "?refrigerated within ----hours and tissue excision began within ----hours post cardiac asystole" and that the donors refrigeration time was at --------------------------------------------, which, according to theStateof -------------------------------------------------------------------------------------------------issued certificate of death(---------------------------------------------), is almost 48 hours post-cardiac asystole. Also, according to your Tissue Recovery Log form for this donor, HCT/P excision of the donor began at ----pm on -------------, more than 54 hours post-cardiac asystole. As a result, your Donor Demographics form is inaccurate.
You failed to implement SOPs you established to assure that HCT/P recovery takes place in a suitable environment, as required by 21 CFR 1271.180(a). You failed to recover HCT/Ps in a manner that does not cause contamination or cross-contamination during recovery, and you failed to adequately control environmental conditions and to provide proper conditions for operations,all as required by 21 CFR 1271.145, 21 CFR 1271.195(a)(2), and 21 CFR1271.215. Furthermore, you failed to create and maintain accurate records,as required by 21 CFR 1271.55(d)(2) and 21 CFR 1271.270(a). Your SOP requires that the HCT/P recovery site ensure a maintained and controlled,closed airflow system so that there is no direct access to the outside ofthe building. However, you recovered HCT/P from donors ----------and ------------ at a funeral home in ------------, ---------- that is not equipped with any refrigeration units in which to hold the deceased. The embalming room where HCT/P recovery took place was equipped with an exhaust fan that delivered air to the adjacent garage/outside. There was no air filtration system in the room. Moreover, you recorded in your Nonstandard Tissue Recovery Site Assessment form for these donors that the recovery site ensured a maintained and controlled, closed airflow system so that there was no direct access to the outside of the building.
You failed to implement SOPs you established for donor eligibility determinations, specifically to confirm whether an autopsy was performed, as required by 21 CFR 1271.47(a). In particular, your Quality Control Review of Donor Records SOP requires that "[t]he team leader will assure a physical exam was performed and the information documented on the recovery paper work is included in the donor chart?" and your Physical Assessment of a Cadaveric Donor SOP requires that the team leader physically check the donor in their entirety. Furthermore, you failed to create and maintain accurate records,as required by 21 CFR 1271.55(d)(2) and 21 CFR 1271.270(a). Your Donor Demographics forms for donors -------- and ----------------------- stat that no autopsies had been performed on these donors, and the Donor Physical Assessment forms for these donors provide schematics of the donors which fail to show that autopsies had been performed. These documents are contradicted by the State of ----------------issued certificates of death for these donors, which confirm not only that autopsies were performed on these two donors, but also that the autopsy findings were available to complete the cause of death. The fact that an autopsy had been performed should have been obvious to you upon your physical assessment of the donors at the time of HCT/P recovery.The above-identified deficiencies are not intended to be an all-inclusive list of violations by you and your Establishment. Nevertheless, they indicate serious noncompliance with many of the regulations under 21 CFRPart 1271, which are designed to protect against the risks of communicable disease transmission. Of particular concern are the serious deficiencies involving:
1/ your failure to create and maintain accurate records;
2/ your failure to implement SOPs for all steps in determining donor eligibility;
3/ your failure to recover HCT/Ps in a manner that does not cause contamination or cross-contamination during recovery; and
4/ your failure to adequately control environmental conditions. These deficiencies involve donors from numerous funeral homes located in different states. Based on the fore going, the agency finds that there are reasonable grounds to believe that HCT/Ps manufactured by you are violative because they were manufactured in contravention of the regulations under 21CFR Part 1271 and, therefore, the conditions of manufacture of the HCT/Ps do not provide adequate protections against the risks of communicable disease transmission. Moreover, these deficiencies, including your failure to createand maintain accurate records, are so serious and widespread that FDA finds there are reasonable grounds to believe that they present a danger to public health.
This letter confirms the telephone conversation on January 31, 2006, in which notice was given that, pursuant to 21 CFR 1271.440(a)(3), you individually, and your Establishment,
1) must immediately cease all manufacturing, as defined in 21 CFR 1271.3(e), until compliance with the regulations in 21 CFR Part 1271 has been achieved, and
2) must retain allHCT/Ps recovered on or after May 25, 2005 that are in your possession until they are disposed of as agreed by the agency or until the safety of the HCT/P is confirmed. Instructions were given at that time not to recover or ship HCT/Ps. Neither you, nor your Establishment, can resume operations without prior written authorization from FDA. Any shipment of HCT/Ps inviolation of this order constitutes a violation of section 368 of the PHSAct [42 U.S.C. § 271], for which criminal penalties may be imposed.
Within five (5) working days from the receipt of this Order to Cease Manufacturing, you may request a hearing on the matter in accordance with 21CFR Part 16 (copy attached), to Mary A. Malarkey, Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, 1401 Rockville Pike, HFM-600, Rockville, MD 20852 (telephone:301-827-6190). Failure to request a hearing within the specified time period constitutes a waiver of the right to a hearing. You may also wish to inform yourself with respect to the agency's guidelines regarding electronic media coverage of its administrative proceedings, which can be found at 21 CFRPart 10, Subpart C.
Sincerely,
----- signature -----
Jesse L. Goodman, M.D., M.P.H.DirectorCenter for Biologics Evaluation and Research
Effective Date: 31 January Time: 11:25 AM Eastern
Updated February 1, 2006
http://www.fda.gov/cber/compl/bts013106.htm
TSE i.e. CJD and the legal stealing of tainted tissue
http://www.rense.com/general62/don.htm
http://creutzfeldt-jakob-disease.blogspot.com/2008_01_01_archive.html
http://mad-cow.org/~tom/dec99_news.html#bbb
TSS
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https://lists.aegee.org/bse-l.html####################
http://lists.iatp.org/listarchive/archive.cfm?id=119823
From: TSS
Subject: Dubious transplant recipients sue companies
Date: March 4, 2006 at 5:52 pm PST
Dubious transplant recipients sue companies
By PENNY BROWN ROBERTSAdvocate staff writer Published: Mar 4, 2006
Hundreds of Louisianians may have body parts transplanted inside them that were looted from corpses — some riddled with cancer or infected with syphilis or hepatitis.
A class-action lawsuit made public Friday in Baton Rouge federal court alleges that a New York medical supply company sold illegal — and unscreened — tissue and bone to Our Lady of the Lake Regional Medical Center and other unnamed hospitals in the state. Darrel Bourque of Gonzales says surgeons notified him in January that tissue transplanted in his neck during spinal surgery a year ago came from that supply company — Biomedical Tissue Services.
They urged the petrochemical industry supervisor to undergo blood testing to see if the transplanted tissue was infected with syphilis, HIV or hepatitis.
Although the tests haven’t shown anything, Bourque said in an interview Friday that he’s worried that, “There’s still the possibility something could have been there.”
“I have a lot of depression and a lot of anger. I don’t really know what the future holds,” Bourque said. “I’m worried about whether or not I’ll still be able to get insurance coverage for further illnesses that may come about.”
The lawsuit estimates the defective tissue has been implanted in hundreds of Louisiana patients since 2002. In addition to damages, it seeks to establish a comprehensive medical monitoring program and treatment of any future disease or complication related to the implants.
In an advisory issued Friday, the U.S. Food and Drug Administration “strongly” recommends health-care providers inform patients who received tissue implants from Biomedical Tissue Services that they “may be at increased risk for communicable disease transmission and to offer them testing. While FDA believes the risks from these tissues are low … the actual infectious risk is unknown.”
Baton Rouge lawyer Philip Bohrer said Friday the class-action lawsuit is intended to protect Louisiana victims from the potential “long-term consequences of what’s happened to them.”
Several patients outside the state who got transplants of the tissue in question already have tested positive for hepatitis and syphilis, according to news reports.
“I believe unfortunately that many people in our community may be victims of this practice,” Bohrer said. “The people who received this contaminated tissue are at risk for the rest of their lives, and initial blood test or screening cannot rule out future diseases, such as cancer, leukemia or other diseases with long latency periods that may have been in the tissue they received.”
Biomedical Tissue Services owners Michael Mastromarino and Joseph Nicelli and others are accused of secretly carving up bodies from funeral parlors and city morgues in three states and forging death certificates and organ-donor consent forms to make it appear as if the bones, skin, tendons, heart valves and other tissues were removed legally.
Some of the corpses were those of people who had not given consent; others didn’t meet federal donor eligibility requirements because they were infected with syphilis, AIDS or hepatitis or had cancer or heart disease. Among the cadavers they allegedly raided for parts was that of former PBS “Masterpiece Theatre” host Alistair Cook, who died of cancer in 2004 at the age of 95.
Last month, the FDA shut down Biomedical Tissue Services. Those involved have pleaded innocent to charges of enterprise corruption, body stealing and opening graves, unlawful dissection, forgery and other counts.
Staten Island lawyer, Mario Gallucci — who is representing Mastromarino and Biomedical Tissue Services — said Friday he was not aware of the Louisiana lawsuit.
Mastromarino “finds it unfortunate but does sympathize with all of these people who received the tissue,” Gallucci said. “He is just as taken aback as all these people are that he was misled. Hopefully, the distribution companies have done what they were supposed to do in sterilization, processing and release of this tissue. Dr. Mastromarino is traumatized by the prospect that his life’s work may have been tainted by the processing of this tissue.”
According to prosecutors, Mastromarino is a former dentist and oral surgeon who went into the tissue harvesting business after losing his license. He was sued for malpractice by several patients — one of whom claimed he deserted them in the middle of surgery.
Also named as defendants in the Louisiana lawsuit are Florida-based Regeneration Technologies and Memphis-based Medtronic Sofamor Danek USA, which allegedly distributed the millions of dollars worth of tissue, bone and organs. The lawsuit alleges the companies violated industry standards, their own internal safety and testing procedures, and possibly state and federal laws.
The lawsuit does not blame Our Lady of the Lake Regional Medical Center, other hospitals or any local surgeons, saying none of them was aware that the body parts “consisted of the stolen human tissue obtained by BTS, or that RTI failed to follow its own safety protocols.”
Our Lady of the Lake Regional Medical Center spokeswoman Catherine Harrell said Friday that 27 of its patients are known to have gotten such transplants. She said the hospital bought the tissue in question from Tennessee-based SpinalGraft Technologies.
Harrell said that once the hospital was notified of a nationwide recall of the tissue, it “immediately” returned its remaining supply to the manufacturer.
The hospital also notified surgeons of the situation “so that the physicians could communicate with their patients about the situation and really answer any questions the patients had.”
She said the doctors should have notified all their patients by now.
The American Association of Tissue Banks estimates there are more than 1 million tissue transplants annually in the United States. The FDA began regulating the billion-dollar industry in 1993 and now has strict regulations requiring examination of the cadaver, testing for disease-causing agents, interviews with the donor family and reviews of medical records, lab test results, coroner and autopsy reports and other relevant records.
In 2005, the agency added screening for diseases such as syphilis, West Nile, SARS and the neurological condition Creutzfeldt-Jakob to tests already required for HIV and hepatitis.
The Louisiana case has been assigned to U.S. District Judge Frank Polozola. No hearing dates have been set.
http://www.2theadvocate.com/news/2406461.html
25 Apr 2002 :
Column WA58 Bovine Embryos and Live Cattle: Imports from North America
The Earl of Caithness asked her Majesty's Government:
When the ban on the importation of embryos and live cattle from North America will be lifted; and [HL3912] What is the scientific evidence for the imposition of a ban on the importation of embryos and live cattle from North America. [HL3913]
Lord Whitty: Her Majesty's Government have not imposed a ban on imports of bovine embryos and live cattle from North America.
The European Parliament and European Council introduced legislation in May last year laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (TSEs). The legislation was introduced in response to the recommendations of the Office International des Epizooties (OIE—the international animal health organisation) and advice from the Commission's scientific comittees. The legislation (and the transitional measures which came into effect in October last year) includes requirement that imports into the EU of bovine embryos and live cattle must be accompanied by certification confirming that the feeding of ruminants with protein derived from mammals has been banned and that the ban has been effectively enforced. Some exporting countries, such as Canada and the USA, are currently unable to meet these new requirements.
http://www.publications.parliament.uk/pa/ld199900/ldhansrd/pdvn/lds02/text/20425w04.htm
BSE: US Export of Specified Risk Material
Lord Kennet asked Her Majesty's Government:
Whether the United States contends that under the provisions enforceable by the World Trade Organisation the European Union may not ban the import into Europe from the United States of "specified risk material" (that is, material at possible risk of BSE infection).
Lord Donoughue: Yes. But their position on the Specified Risk Material legislation is based on the assumption that the United States can safely be regarded as a "BSE free" country. Their case for such treatment has not been accepted by the EU Commission's Scientific Veterinary Committee.
http://www.publications.parliament.uk/pa/ld199798/ldhansrd/vo971215/text/71215w02.htm
Baroness Masham of Ilton: My Lords, as blood products which infected haemophiliacs with HIV came from the USA, is the Minister confident that something else nasty may not come again from imported blood from the USA? Is he aware that there are ways of cleaning blood to make it safer? I know that that is done in Vienna, in Austria. Will the Minister look into that? Following the question asked by the noble Lord, Lord Clement-Jones, about people using their own blood, I am sure that, when this Statement goes out into the wider community, people will want to know that information.
http://www.publications.parliament.uk/pa/ld199900/ldhansrd/pdvn/lds03/text/31217-09.htm
However, the Bio Products Laboratory who produce plasma products did export surplus products, under the Income Generation Regulations for the NHS, and used the income for the benefit of the health service.[21]
http://www.publications.parliament.uk/pa/cm200001/cmselect/cmpubacc/207/20703.htm#n21
43. Do you sell any of it abroad at all?(Mr Gorham) No. The only circumstances in which we would export blood would be if there was an approach to the British Government and the British Government felt that it was appropriate to support an international emergency or something like that. We do supply the British Forces. We occasionally help out our colleagues in Wales and Scotland and they would reciprocate with us if that was appropriate. At the moment it is more or less totally contained within the United Kingdom.
http://www.publications.parliament.uk/pa/cm200001/cmselect/cmpubacc/207/1012904.htm
Blood and Blood Products
Mr. Hinchliffe: To ask the Secretary of State for Health what estimate he has made of the number of persons who have been inoculated with blood or blood products over the past three years in the United Kingdom. [61681]
Ms Jowell [holding answer 2 December 1998]: It is estimated that about one million people in the United Kingdom receive blood and blood products every year.
http://www.parliament.the-stationeryoffice.co.uk/pa/cm199899/cmhansrd/vo990210/text/90210w02.htmstationeryoffice.co.uk/pa/cm199899/cmhansrd/vo990210/text/90210w02.htm
Human vaccine prepared in animal brains
http://www.mad-cow.org/00/nov00_late_news.html#fff
http://www.whale.to/v/singeltary7.html
http://www.mad-cow.org/00/may00_news.html
http://www.mad-cow.org/00/jul00_dont_eat_sheep.html#hhh
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I_______________________________PRODUCTHuman Tissue for Transplantation, Recall # B-0432-6:a) Tricortical Wedge (R) 1.5 x 2.5 cm,Freeze Dried Irradiated;b) Tricortical Wedge ( L ) 1.7 x 3.0 cm,Fresh Frozen Irradiated;c) Cancellous Crushed 60.0 cc, Freeze Dried,Irradiated;d) Cancellous Crushed 30.0 cc Freeze Dried,Irradiated;e) Achilles Tendon OA ( R ) Fresh FrozenIrradiated;f) Achilles Tendon OA ( L ) Fresh FrozenIrradiated;g) Lumbar;h) Cancellous Crushed 30.0 cc Fresh Frozen,IrradiatedCODEa) Tissue 04091-002;b) Tissue 04113-003;c) Tissues 04091-008, 04101-008, 04103-002,04103-003, 04105-003;d) Tissues 04091-005, 04091-006, 04091-007,04101-006, 04101-007, 04102-004, 04102-005,04104-003, 04104-004, 04104-005, 04105-002,04109-003, 04109-004, 04120-004, 04124-003,04124-004, 04138-002, 04138-003, 04140-002,04143-002, 04143-003, 04146-001, 04152-001;e) Tissues 04101-003, 04123-004;f) Tissues 04101-004, 04123-003;g) Tissues 03049-001, 03051-001, 04091-001,04102-001, 04103-001, 04104-001, 04105-001,04106-001, 04107-001, 04108-001, 04109-001,04113-001, 04120-001, 04122-001, 04123-001,04124-001;h) Tissue 04108-002RECALLING FIRM/MANUFACTURERRecalling Firm: Central Texas Regional Blood & Tissue Center, Austin, TX, bytelephone on October 4, 2005, and by letter dated October 11, 2005.Manufacturer: Biomedical Tissue Services, Fort Lee, NJ, firm initiatedrecall is ongoing.REASONHuman tissues, procured from donors without adequate donor eligibilitydeterminations, were distributed.VOLUME OF PRODUCT IN COMMERCE51 allograftsDISTRIBUTIONTX and COPRODUCTHuman Corneal Tissues for Transplantation, Recall # B-0380-6CODETissues: CI044108 OD and CI044108 OSRECALLING FIRM/MANUFACTURERMichigan Eye Bank, Ann Arbor, MI, by letter dated November 22, 2005, and byfacsimile dated November 28, 2005. Firm initiated recall is complete.REASONHuman Corneas, collected from an ineligible donor, were distributed.VOLUME OF PRODUCT IN COMMERCE2 tissuesDISTRIBUTIONMI, CA and Germany_______________________________PRODUCTa) Red Blood Cells Leukocytes Reduced,Recall # B-0617-6;b) Red Blood Cells (Apheresis) Leukocytes Reduced(distributed as split product), Recall # B-0618-6;c) Platelets Leukocytes Reduced, Recall # B-0619-6;d) Fresh Frozen Plasma, Recall # B-0620-6;e) Cryoprecipitated AHF, Recall # B-0621-6;f) Plasma Cryoprecipitate Reduced, Recall # B-0622-6;g) Recovered Plasma, Recall # B-0623-6CODEa) Unit numbers: 1136792, 1040212, 1011245;b) Unit numbers: 1048247-1, 1048247-2;c) Unit numbers: 1040212, 1011245;d) Unit number: 1136792;e) Unit numbers: 1040212, 1011245;f) Unit number: 1040212;g) Unit number: 1011245RECALLING FIRM/MANUFACTURERHoxworth Blood Center, Cincinnati, OH, by letter dated September 6, 2005.Firm initiated recall is complete.REASONBlood products, collected from a donor considered to be at increased riskfor variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE12 unitsDISTRIBUTIONOH and FL_______________________________END OF ENFORCEMENT REPORT FOR MARCH 1, 2006###http://www.fda.gov/bbs/topics/enforce/2006/ENF00941.htmlPRODUCTRecovered Plasma, Recall # B-0643-6CODEUnit numbers: R170537, R165863, and R158308RECALLING FIRM/MANUFACTURERPuget Sound Blood Center, Seattle, WA, by facsimile on October 7, 2003. Firminitiated recall is complete.REASONBlood products, which were collected from an unsuitable donor based on riskfactors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE3 unitsDISTRIBUTIONAustriaEND OF ENFORCEMENT REPORT FOR FEBRUARY 22, 2006###http://www.fda.gov/bbs/topics/enforce/2006/ENF00940.htmlPRODUCTa) Product is 1.0 cc Regenaform® RT. SINGLE PATIENTUSE ONLY. Recall # Z-0481-06;b) OPTEFORM Allografts of varying sizes. SINGLE PATIENTUSE ONLY. Recall # Z-0482-06;c) Product is OPTEFORM Allograft Paste of varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0483-06;d) OPTEFORM® RT Moldable Allograft of varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0484-06;e) Osteofil + RT Allograft Paste in varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0485-06;f) Osteofil Allograft Paste (Bio) of varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0486-06;g) Osteofil IC Syringeable of varying sizes. SINGLEPATIENT USE ONLY. Recall # 0487-06;h) Osteofil ICM Moldable Strip of varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0488-06;i) Osteofil RT, ICM Allograft Paste of varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0489-06;j) OSTEOFIL® DBM Paste of varying sizes. SINGLEPATIENT USE ONLY. Recall # Z-0490-06;k) OsteoPack 3 FZ 22cc. SINGLE PATIENT USE ONLY.Recall # Z-0491-06;l) Regenafil IC. SINGLE PATIENT USE ONLY.Recall # Z-0492-06;m) REGENAFORM RT Allograft Paste, 1cc. SINGLEPATIENT USE ONLY. Recall # Z-0493-06;n) Product is REGENAFORM® Allograft Moldable Blocks,of varying sizes. SINGLE PATIENT USE ONLY.Recall # Z-0494-06;o) Product is RTI Allograft Paste of varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0495-06;p) Product is REGENAFIL® Allograft Paste, Syringe,0.5cc. SINGLE PATIENT USE ONLY. Recall # 0496-06;q) Product is 1.0cc flowable paste from donorapproved for distribution in Italy. SINGLEPATIENT USE ONLY. Recall # Z-0497-06;r) Product is OPTEFIL Allograft Paste of varyingsizes. SINGLE PATIENT USE ONLY. Recall# Z-0498-06;s) Product is OPTEFIL Allograft Paste, Syringeof varying sizes. SINGLE PATIENT USE ONLY.Recall # Z-0499-06;t) Product is OPTEFORM® Allograft Full Disc,5 x 90mm, 32cc, Frozen. SINGLE PATIENT USEONLY, Recall # Z-0500-06;u) Product is 2.0 cc Opteform® RT. SINGLEPATIENT USE ONLY. Recall # Z-0501-06CODE2879130 2879131 2879132 2879133 2879134 2879135 2879136 2879137 28791382879139 2879350 2879351 2879352 2879353 2879354 2879355 2879440 28794412879442 2879443 2879444 2879445 2879446 2879447 2879448 2879449 28794502879451 2879452 2879453 2879454 2879455 2879456 2879457 2879458 28794592886780 2886781 2886782 2886783 2886784 2886785 2886786 2886787 28867882886789 2886950 2886951 2886952 2886953 2886954 2886955 2886956 28869572886958 2886959 2962280 2962281 2962282 2962283 2962284 2962285 29622862962287 2962288 2962289 2963820 2963821 2963822 2963823 2963824 29638252963826 2963827 2963828 2963829 2963910 2963911 2963912 2963913 29639142963915 2963916 2963917 2963918 2963919 2963990 2963991 2963992 29639932963994 2963995 2963996 2963997 2963998 2963999 2965900 2965901 29659022965903 2965904 2965905 2965906 2965907 2965908 2965909 2965910 29659112965912 2965913 2965914 2965915 2965916 2965917 2965918 2974861 29748622974863 2974864 2974865 2974866 2974867 2974868 2974869 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29979052997906 2997907 2997908 2997909 2997910;3043561 3043562 3043563 3043564 3043565 3043566 3043567 3043568 30435693043570 3047041 3047042 3047043 3051158 3051159 3051160 3051193 30511943051195 3051196 3051197 3051198 3051199 3051491 3051493 3051495 30514973050703 3050705 3050706 3050710 3056760 3060591 3027677 3027678 30276793044581 3044582 3044583 3044584 3044585 3044586 3044587 3044588 30445893044590 3044931 3044932 3044933 3044934 3044935 3044936 3044937 30449383044939 3044940 3044941 3044942 3044943 3044944 3044945 3044946 30449473044948 3044949 3044950 3045571 3045572 3045573 3045574 3045575 30455763045941 3045942 3045943 3045944 3045946 3045947 3045948 3045949 30463413046342 3046343 3046344 3046345 3046346 3046347 3046348 3046349 30463503046531 3046532 3046533 3046534 3046535 3046536 3046537 3046538 30465393046540 3046621 3046622 3046623 3046624 3046625 3046626 3046627 30466283046629 3046630 3046661 3046662 3046663 3046664 3046665 3046666 30466673046668 3046669 3046670 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3035951 3035952 3035953 3035954 3035959;2984056 2984062 2984064 2984065 2984067 2986825 2986827 2986829 29953212995322 2995323 2995324 2995325 2995326 2995327 2995328 2995329 29953302999692 2999693 2999694 2999695 2999696 2999697 2999698 2999699 29997002999924 2999925 2999926 2999927 2999928 2999929 2713387 2718732 27187362718737 2718738 2559751 2559752 2559753 2559754 2559755 2559756 25597572559758 2559759 2559760 2560031 2560032 2560033 2560034 2560035 25600362560037 2560038 2560039 2560040 2560271 2560272 2610521 2610522 26105232610524 2610525 2610526 2610527 2610528 2610529 2610530 2610541 26105422610543 2610544 2610545 2610546 2610547 2610548 2610549 2610550 26105812610582 2610583 2610584 2610585 2610586 2610601 2610602 2610603 26106042610605 2610606 2610607 2610608 2610609 2610610 2610611 2610612 26106132610614 2610615 2610616 2610617 2610618 2610619 2610620 2610761 26107622610763 2610764 2610765 2610766 2610767 2610768 2610769 2610770 26667402666741 2666742 2666743 2666744 2666745 2666746 2666747 2666748;2956993 2956994;2667541 2667542 2667543 2667548 2667981 2667983 2667984 2667985 26679872667988 2667989 2669552 2669553 2669554 2669556 2669559 2669633 26696362669639 2669640 2669965 2669967 2669968 2669969 2669981 2669983 2669985RECALLING FIRM/MANUFACTURERRegeneration Technologies, Inc., Alachua, FL, by letter on October 14, 2005.Firm initiated recall is ongoing.REASONThe tissue was collected from donors for whom there is no verifiableidentity or consent. The medical records and social histories of the donorscannot be ascertained. The devices which incorporate these donor bonetissues undergo processing, including sterilization, which has beenvalidated to inactivate and/or remove all viral diseases for which humantissue donors are tested.VOLUME OF PRODUCT IN COMMERCE5,320DISTRIBUTIONNationwide and InternationallyEND OF ENFORCEMENT REPORT FOR FEBRUARY 15, 2006###http://www.fda.gov/bbs/topics/enforce/2006/ENF00939.html_______________________________PRODUCTSource Plasma, Recall # B-0584-6CODEUnits VL53767, ZZ031076, ZZ030881, ZZ03046, VL151413, VL151144, VL50837RECALLING FIRM/MANUFACTURERBioLife Plasma Services LP, Shreveport, LA, by facsimile dated October 6,2003. Firm initiated recall is complete.REASONSource Plasma, collected from a donor who was at increased risk for variantCreutzfeldt-Jakob Disease (vCJD), was distributed.VOLUME OF PRODUCT IN COMMERCE7 unitsDISTRIBUTIONNCEND OF ENFORCEMENT REPORT FOR FEBRUARY 1, 2006###http://www.fda.gov/bbs/topics/enforce/2006/ENF00937.html_______________________________PRODUCTRed Blood Cells, Recall # B-0552-6CODEUnit number: 4426304RECALLING FIRM/MANUFACTURERFlorida's Blood Center, Inc., St. Petersburg, FL, by facsimile on July 8,2005. Firm initiated recall is complete.REASONBlood product, collected from a donor who may have been at increased riskfor new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.VOLUME OF PRODUCT IN COMMERCE1 unitDISTRIBUTIONFLEND OF ENFORCEMENT REPORT FOR JANUARY 25, 2006###http://www.fda.gov/bbs/topics/enforce/2006/ENF00936.htmlRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I_______________________________PRODUCTHuman Tissue for Transplantation, Recall # B-0322-6a) Alloquent CC Allograft (8, 9 & 10 mm);b) Achilles Tendon;c) Cancellous Bone 4-10 mm (15 & 30 cc);d) Patella Tendon-Hemi;e) Iliac Crest Wedge (14-17mm, 11-13mm,<10mm, href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000055/!x-usc:http://deposit.ddb.de/cgi-bin/dokserv?idn=993774407&dok_var=d1&dok_ext=pdf&filename=993774407.pdf">http://deposit.ddb.de/cgi-bin/dokserv?idn=993774407&dok_var=d1&dok_ext=pdf&filename=993774407.pdf
http://www.gtp.org.tw/Files/Download/2008613134233.pdf
Wednesday, January 02, 2008
Risk factors for sporadic Creutzfeldt-Jakob disease
http://creutzfeldt-jakob-disease.blogspot.com/2008/01/risk-factors-for-sporadic-creutzfeldt.html
Sunday, December 16, 2007
Risk factors for sporadic Creutzfeldt-Jakob disease
http://creutzfeldt-jakob-disease.blogspot.com/2007/12/risk-factors-for-sporadic-creutzfeldt.html
Monday, December 31, 2007
Risk Assessment of Transmission of Sporadic Creutzfeldt-Jakob Disease in Endodontic Practice in Absence of Adequate Prion Inactivation
http://creutzfeldt-jakob-disease.blogspot.com/2007/12/risk-assessment-of-transmission-of.html
New Jersey mayors and rabbis arrested in money laundering probea.. Daniel Nasaw in Washington b.. guardian.co.uk, Thursday 23 July 2009 17.31 BST c..
Two New Jersey mayors and more than two dozen political figures and religious leaders were arrested today as part of a massive international money laundering scheme that includes illegal traffic in human body parts.Among those arrested following a two-year investigation were Hoboken mayor Peter Cammarano III, Secaucus Mayor Dennis Elwell, Jersey City deputy mayor Leona Beldini, officials in the state capital and several rabbis. Federal law enforcement officials this morning also were searching the offices of the New Jersey state department of consumer affairs. Details of the charges were sparse today. The Wall Street Journal reported that the investigation included a probe of an international body-part trafficking ring. One of the people arrested is accused of dealing in human organs. State legislator Daniel Van Pelt was accused of taking $10,000 in bribes from a government informant to facilitate a real estate development, the Asbury Park Press reported. Many of the arrested come from a gritty, urban area of New Jersey directly across the Hudson River from New York City that in recent years has attracted young professionals driven out of New York by high real-estate prices.The detained clergymen came from a enclaves of Syrian Jews in New Jersey and in Brooklyn, New York. Their connection to the politicians was unclear Thursday morning.One northern New Jersey man arrested in the wide-ranging investigation, Levy Izhak Rosenbaum, was charged with conspiring to traffic human organs, the Record newspaper of Bergen County reported.Cammarano, Hoboken mayor, was apparently unaware he was sought in the probe, spending yesterday evening tending bar at a Hoboken festival and celebrating his 32nd birthday. "I would like to thank everyone today for the birthday wishes," he wrote on Twitter about 1am on Wednesday. "Hope everyone had a great time at the opening night for St Ann's feast."
http://www.guardian.co.uk/world/2009/jul/23/new-jersey-corruption-money-laundering
Mayors, rabbis arrested in NJ corruption probeThu Jul 23, 2009 3:17pm EDT
NEW YORK (Reuters) - Two northern New Jersey mayors, several rabbis and other politicians were arrested on Thursday in a federal investigation into public corruption and international money laundering, U.S. authorities said.Among the approximately 30 people arrested were Hoboken Mayor Peter Cammarano, who took office 23 days ago, Secaucus Mayor Dennis Elwell, state Assemblyman Daniel Van Pelt and Jersey City Deputy Mayor Leona Beldini, according to the U.S. Attorney's Office in Newark.Also arrested in the money-laundering investigation were several rabbis in New York and New Jersey, the federal prosecutor's office said.The international money-laundering was "high volume," it said.Local television showed images of rabbis and the two mayors taken into federal custody in Newark, New Jersey.No further details were immediately available from authorities. A news conference was scheduled for later on Thursday.Court appearances for those arrested were to begin in the early afternoon.(Reporting by Ellen Wulfhorst; editing by Mohammad Zargham)
http://www.reuters.com/article/newsOne/idUSTRE56M3QU20090723
Feds Target Politicians and Rabbis in Massive Corruption, Money-Laundering Case in New Jersey and New YorkAtlanta, Ga. 7/23/2009 03:24 PM GMT (TransWorldNews - Top Story) Federal authorities have arrested at least 30 people, including mayors, rabbis and politicians, in New Jersey and New York as part of a corruption and money-laundering investigation.Those arrested included Hoboken Mayor Peter Cammarano and Secaucus Mayor Dennis Elwell.According to federal authorities several rabbis in the two states were also detained.There have been reports that suggest some of those arrested on Thursday were involved in organ trafficking, having accepted cash payments to locate organs for those in need of transplants. ###
http://www.transworldnews.com/NewsStory.aspx?id=104213&cat=5
Saturday, January 26, 2008
CJD HGH BODY SNATCHERS
http://creutzfeldt-jakob-disease.blogspot.com/2008/01/cjd-hgh-body-snatchers.html
THE LEGAL TRADING AND SELLING OF BODY PARTS AND TSEs i.e. THE BODY SNATCHERS
http://disc.server.com/discussion.cgi?disc=167318;article=2864;title=CJD%20WATCH
http://disc.server.com/discussion.cgi?disc=7498;article=2818;title=CJD%20Voice%20Discussion%20Group
http://lists.iatp.org/listarchive/archive.cfm?id=119823
STOLEN BODY PARTS
http://www.google.com/search?hl=en&q=stolen+body+parts&btnG=Search
Friday, August 07, 2009
CJD Human Cornea Tissue, Recall END OF ENFORCEMENT REPORT FOR AUGUST 5, 2009
http://creutzfeldt-jakob-disease.blogspot.com/2009/08/cjd-human-cornea-tissue-recall-end-of.html
Update: Creutzfeldt-Jakob Disease Associated with Cadaveric Dura Mater Grafts --- Japan, 1979--2003
MMWR Weekly December 5, 2003 / 52(48);1179-1181
http://www2.niddk.nih.gov/AboutNIDDK/CommitteesAndWorkingGroups/HGH_CJD_Dec_11_2003_TAB_A.htm
Thursday, October 23, 2008
Creutzfeldt-Jakob Disease Associated with Cadaveric Dura Mater Grafts - Japan, 1979-2008 : UPDATE
http://creutzfeldt-jakob-disease.blogspot.com/2008/10/creutzfeldt-jakob-disease-associated.html
http://www.wellsphere.com/cjd-article/medical-procedures-and-risk-for-sporadic-creutzfeldt-jakob-disease-japan-1999-2008-warning-to-neurosurgeons-and-ophthalmologi/641229
Thursday, January 29, 2009
Medical Procedures and Risk for Sporadic Creutzfeldt-Jakob Disease, Japan, 1999-2008 (WARNING TO Neurosurgeons and Ophthalmologists) Volume 15, Number 2-February 2009 Research
http://creutzfeldt-jakob-disease.blogspot.com/2009/01/medical-procedures-and-risk-for.html
Wednesday, August 12, 2009
Unique clinicopathological features and PrP profiles in the first autopsied case of dura mater graft-associated Creutzfeldt-Jakob disease
http://creutzfeldt-jakob-disease.blogspot.com/2009/08/unique-clinicopathological-features-and.html
Sunday, May 10, 2009
Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009 (Singeltary submission)
http://tseac.blogspot.com/2009/05/meeting-of-transmissible-spongiform.html
Tuesday, August 11, 2009
Characteristics of Established and Proposed Sporadic Creutzfeldt-Jakob Disease Variants
http://creutzfeldt-jakob-disease.blogspot.com/2009/08/characteristics-of-established-and.html
TSS>>>>>>>>>>>> * FROM MAY 9, 2001: Possible Creutzfeldt-Jakob case reported in
>>> Windsor>>>>>> Classical CJD, which occurs naturally in a small number of people, can>>> be transmitted by transplants of human tissue.>>>>>> The disease affects the central nervous system.>>>>>> It occurs in the world population at a rate of about one case per>>> million people per year – about 30 cases are diagnosed each year in>>> Canada. Most cases die within months.>>>>>> Written by CBC News Online staff>>>>>> http://www.cbc.ca/stories/2003/09/24/moncton030924>>>>>> it would be most interesting how this hospital has handled the>>> quarantining>>> of the surgical instruments and the operating/surgical arena after this>>> surgery>>> and the finding of CJD in the patient. were the instruments used on>>> this>>> victim used on any other persons and can they trace all tools ???>>>>>> TSS>>>>>>
########### http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html>>> ############>>>>>>>>>
Labels: atypical CJD, BODY SNATCHERS, CJD, ORGAN DONOR, PRION, tissue
