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From: TSS ()
Greetings BSE-L et al; Biomedical Tissue Services (BTS) THE BODY SNATCHERS and mad cow disease i.e. CJD and other dangerous pathogens Body snatchers tied to allograft firms? 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 FDA News 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 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. Recall of Human Tissue October 13, 2005 PRODUCT: Human Tissue for Transplantation MANUFACTURER: Biomedical Tissue Services, Ltd 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. http://www.fda.gov/cber/recalls/btstis101305.htm 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. 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 October 14, 2005 PRODUCT: Human Tissue For Transplantation MANUFACTURER: Regeneration Technologies, Inc 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. FDA News FDA Provides Information on Investigation into Human Tissue for Transplantation 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 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 October 11, 2005 PRODUCT: Human Tissue for Transplantation MANUFACTURER: The Blood and Tissue Center of Central 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. Recall of Human Tissue Products October 12, 2005 PRODUCT: Human Tissue for Transplantation MANUFACTURER: Tutogen Medical, Inc. 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. Withdrawal of Human Tissue Products October 10, 2005 PRODUCT: Human Tissue for Transplantation MANUFACTURER: Lost Mountain Tissue Bank 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. DATE RECALL INITIATED: September 30, 2005 PRODUCT: AlloDerm, Repliform, and GraftJacket MANUFACTURER: LifeCell Corporation 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. From: TSS () WASHINGTON http://www.chron.com/cs/CDA/ssistory.mpl/nation/3419112 FDA Provides Information on Investigation into Human Tissue for Transplantation 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 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. #### a bit of history; ############ Creutzfeldt-Jakob Disease Greetings list members, I was impressed that someone is listening, transmit infectivity this way. Makes me wonder about blood? Vol. 282 No. 23, December 15, 1999 Houston, Texas channel 11 news 28 Nov 99 http://mad-cow.org/~tom/dec99_news.html#bbb Preventing Prion Transmission in Corneal Transplants To the Editor: We agree with the Council on Scientific Affairs' recommendation that "physicians become knowledgeable about BSE [bovine spongiform encephalopathy] so they can appropriately advise their patients about routes and rates of BSE transmission."1 Unfortunately, there is only passing mention of prion transmission by corneal transplantation, which is performed on 40,000 to 50,000 patients each year in the United States.2 In addition to the 1974 US case,3 2 additional cases of probable and possible transmission, respectively, have been reported in Germany and Japan,3 but the major new concern relative to prion transmission via corneas occurred recently in Great Britain. In February 1997, the corneal transplant and sclera from a 53-year-old woman who had died of presumed metastatic lung cancer were transplanted to 3 recipients.4 In November 1997, the donor's brain revealed sporadic Creutzfeldt-Jakob disease (CJD), confirmed by the United Kingdom CJD Surveillance Unit.4 . . . [Full Text of this Article] http://www.vegsource.com/talk/madcow/messages/7643.html http://www.vegsource.com/talk/madcow/messages/7708.html http://mad-cow.org/~tom/dec99_news.html#bbb TSS Submission to the same Committee; http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_13.pdf
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