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From: TSS ()
Subject: Re: THE LEGAL TRADING AND SELLING OF BODY PARTS AND HUMAN TSEs IN THE USA
Date: January 18, 2006 at 1:37 pm PST
----- Original Message ----- From: "Terry S. Singeltary Sr." To: "Bovine Spongiform Encephalopathy" Sent: Wednesday, January 18, 2006 3:54 PM Subject: Re: THE LEGAL TRADING AND SELLING OF BODY PARTS AND HUMAN TSEs IN THE USA > ENFORCE -- January 18, 2006 > > 06-03 > > > > PRODUCT > Human Tissue for Transplantation, Recall # B-0322-6 > a) 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, and 18+mm); > f) Tibialis Tendon > CODE > a) Code: BS30-4008, BS30-4009, BS30-4010; > b) Code: LATM; > c) Code: LCISM & LCIPM; > d) Code: LTTM; > e) Code: LIWXLM, LIWLM, LIWMM, LIWSM; > f) Code: LTTM > RECALLING FIRM/MANUFACTURER > Recalling Firm: Lost Mountain Tissue Bank, Kennesaw, GA, by letters dated > October 12, and October 21, 2005. > Manufacturer: Biomedical Tissue Services, Ltd., Fort Lee, NJ. Firm initiated > recall is ongoing. > REASON > Human tissues, procured from donors without adequate donor eligibility > determinations, were distributed. > VOLUME OF PRODUCT IN COMMERCE > 283 tissues > DISTRIBUTION > Nationwide and Turkey > > _______________________________ > PRODUCT > PUROS Allograft Bone; > Suspend Tutoplast Processed Fascia Lata, > Recall # B-0375-6 > CODE > a) U00000000045293 U00000000045294 U00000000045295 U00000000045296 > U00000000045297 U00000000045298 U00000000045299 U00000000045300 > U00000000045301 U00000000045302 U00000000045303 U00000000045368 > U00000000045369 U00000000045370 U00000000045371 U00000000045372 > U00000000045373 U00000000045374 U00000000045375 U00000000045425 > U00000000045426 U00000000045427 U00000000045428 U00000000045429 > U00000000045430 U00000000045532 U00000000045533 U00000000045534 > U00000000045535 U00000000045536 U00000000045537 U00000000045618 > U00000000045619 U00000000045620 U00000000045621 U00000000045622 > U00000000045623 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U00000000045977 U00000000045978 U00000000045979 > U00000000045980 U00000000045981 U00000000045982 U00000000045983 > U00000000045984 U00000000046043 U00000000046044 U00000000046051 > U00000000046052 U00000000046053 U00000000046054 U00000000046055 > U00000000046056 U00000000046057 U00000000083301 U00000000083302 > U00000000083310 U00000000083313 U00000000083317 U00000000083324 > U00000000083325 U00000000083326 U00000000083327 U00000000083331 > U00000000083336 U00000000083337 U00000000083338 U00000000083339 > U00000000083296 U00000000083300 U00000000083303 U00000000083304 > U00000000083305 U00000000083306 U00000000083307 U00000000083308 > U00000000083309 U00000000083311 U00000000083312 U00000000083314 > U00000000083315 U00000000083316 U00000000083318 U00000000083319 > U00000000083320 U00000000083321 U00000000083322 U00000000083323 > U00000000083328 U00000000083329 U00000000083330 U00000000083332 > U00000000083333 U00000000083334 U00000000083335 U00000000083297; > b) BM03L11421A012031504 BM03L11821A012031504 BM04A11421A012041204 > BM03K10421A017031504 BM03K10421B017031504 BM03K10421C017031504 > BM03L11221A017020904 BM03L11421A017031504 BM03L11421B017031504 > BM03L12121A017031504 BM03L12221A017031504 BM04B10421A017051704 > BM03K10421A018031504 BM03K10421B018031504 BM03K11021A018031504 > BM03K11021B018031504 BM03K11021C018031504 BM03K11021D018031504 > BM03L10421A018020904 BM03L10421B018020904 BM03L11621A018031504 > BM03L11621B018031504 BM03L12121A018031504 BM03L12221A018031504 > BM04A11221A018041204 BM04A11321A018041204 BM04B10421A018051704 > BM03L11521A023020904 BM03L11521B023020904 BM03L11521D023020904 > BM03L11821A024031504 BM03L12321A024031504 BM04A11221A024041204 > BM03K10421A045031504 BM03K12121A045020904 BM03L10421A045020904 > BM03L10621A045020904 BM03L11621A045031504 BM03L11621B045031504 > BM03L12121A045031504 BM03J11421A048011904 BM03J11421B048011904 > BM03K12121A048020904 BM03L10621A048020904 BM03L10621B048020904 > BM03L11221A048020904 BM03L11521A048020904 BM03L11521B048020904 > > RECALLING FIRM/MANUFACTURER > > Recalling Firm: Tutogen Medical, Inc., Alachua, FL, by telephone, facsimile > and letter on October 14, 2005 and by letter dated October 24, 2005. > Responsible Firm: Biomedical Tissue Services, Ltd., Fort Lee, NJ. Firm > initiated recall is ongoing. > > REASON > > Human Tissues, procured from donors without adequate donor eligibility > determinations, were distributed. > VOLUME OF PRODUCT IN COMMERCE > a) 5,676 allografts; > b) 48 allografts > DISTRIBUTION > Nationwide, and Canada > > > http://www.fda.gov/bbs/topics/enforce/2006/ENF00935.html > > > Recall of Human Tissue Products > > horizontal rule > > 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. > > horizontal rule > > 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 > > > Greetings, > > amazing isn't it, well disgusting really. the amazing part is the spin they > put on it; > > we go from this; > > REASON > Human tissues, procured from donors without adequate donor eligibility > determinations, were distributed. > > OR > > 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. ... > > > TO the disgusting reality of the true allegations; > > > 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. > > > have not seen much about that at FDA/CDC site. it's been going on for some > time though$ > > > CJD, they eye's have it, and they could be stealing them from your loved one > > > http://www.mad-cow.org/dec99_news.html#bbb > > > > TSS > > > ----- Original Message ----- > From: "Terry S. Singeltary Sr." > To: > Sent: Tuesday, December 27, 2005 8:39 PM > Subject: Re: THE LEGAL TRADING AND SELLING OF BODY PARTS AND HUMAN TSEs IN > THE USA > > > > ##################### Bovine Spongiform Encephalopathy > ##################### > > > > CJD WATCH MESSAGE BOARD > > Anonymous > > Re: Possible body parts theft ring uncovered (spreading TSEs > > Tue Dec 27, 2005 20:34 > > 70.110.84.167 > > > > > > Update on Donor Screening > > for TSEs > > Melissa A. Greenwald, MD > > Division of Human Tissues > > Office of Cellular, Tissue and Gene Therapies > > AATB 29th Annual Meeting > > Hollywood, Florida > > Council of Accredited Tissue Banks > > Tuesday 20 September 2005 > > Today’s talk will focus on: > > • What are Transmissible Spongiform > > Encephalopathies (TSEs)? > > • Background on CJD/vCJD Draft > > Guidance > > • Specific recommended deferral criteria > > • Allow time for discussion and > > questions > > What are TSEs? > > • Human Transmissible Spongiform > > Encephalopathies (TSEs) include > > Creutzfeldt Jakob Disease (CJD) and > > variant Creutzfeldt Jakob Disease > > (vCJD) > > • CJD has been a known agent, but > > vCJD has only been identified in the > > recent past—is a human form of > > Bovine Spongiform Encephalopathy > > (BSE), known as “mad cow disease” > > What are TSEs? (cont.) > > • The TSE agent is a prion–a poorly > > understood agent; is an abnormal > > protein that causes a degenerative > > disease of the central nervous > > system (CNS) that is not curable and > > invariably leads to the death of the > > person with the disease > > • The agent is very difficult to destroy > > and would not be inactivated by > > current tissue processing technology > > What are TSEs? (cont.) > > • Blood from some animals > > experimentally infected with TSE > > agents, including the BSE agent, > > contains low levels of infectivity > > • Several TSE agents, including BSE, > > have been experimentally > > transmitted by transfusion > > • Agent for vCJD is ingested, so it is > > likely that the agent has a bloodborne > > phase in humans (the > > specifics of the pathology in humans > > is poorly understood) > > What are TSEs? (cont.) > > • There are no published studies > > showing transmission of the BSE > > agent via HCT/Ps; however > > • vCJD agent is present in lymph > > nodes and tonsils of infected > > patients > > • vCJD has been transmitted via blood > > transfusion in the UK > > • Transmission of CJD via cornea and > > dura mater has already been > > demonstrated in humans > > What are TSEs? (cont.) > > • Because of studies showing blood > > infectivity of TSE agents, it is a > > theoretical risk that HCT/Ps have the > > potential to transmit TSEs > > • Because of this theoretical risk, FDA > > is concerned about the potential for > > transmission of TSEs via HCT/Ps > > and therefore considers TSEs a > > RCDAD and requires donor > > screening for these agents > > CJD/vCJD draft guidance > > • Deferral of tissue donors for risk > > factors for “classic” (sporadic) > > CJD—already recommended in the > > 1997 guidance for industry > > • The draft guidance for CJD/vCJD > > incorporated those deferrals, and in > > addition recommends deferrals for > > risk factors for variant CJD—travel or > > residence in BSE-affected countries > > • The draft guidance published June > > 2002 > > • There was a 6 month comment > > CJD/vCJD draft guidance > > • Draft guidance was modeled after the > > guidance for industry for blood > > donors, issued August 2001 > > • Recommends the same countries, > > dates, and lengths of > > travel/residence as does the > > guidance for blood donors > > • Permits an exception for the > > collection and storage of > > hematopoietic stem cells from > > donors who live in or travel to a BSEaffected > > country (for urgent medical > > CJD/vCJD draft guidance > > • Comments reviewed at CBER > > • Final recommendations for > > CJD/vCJD screening will be > > incorporated into the final Donor > > Eligibility guidance when published > > • As of May 25, 2005 Transmissible > > Spongiform Encephalopathy (CJD > > and vCJD) is a relevant > > communicable disease agent or > > disease (RCDAD) and establishments > > must screen for CJD/vCJD > > CJD/vCJD draft guidance > > • Specific deferral criteria in the draft > > guidance are an indication of FDA’s > > current thinking about how to > > adequately and appropriately reduce > > the risk of infectious disease > > transmission by this agent > > • Until a final guidance is issued, > > establishments would not > > necessarily have to “adopt” the > > recommended deferral criteria but > > the regulations do require some > > screening for TSEs (including CJD > > and vCJD) > > CJD/vCJD draft guidance > > • May use alternate screening criteria as long > > as the screening criteria are at least as strict > > as those recommended by FDA (i.e., are as > > effective to adequately and appropriately > > reduce the risk of infectious disease > > transmission) > > • No testing recommendations made—there > > are no FDA approved tests for humans > > CJD/vCJD Risks for Donor > > Screening > > • Persons who have been diagnosed > > with vCJD or any other form of CJD > > • Persons who have been diagnosed > > with dementia or any degenerative or > > demyelinating disease of the CNS or > > other neurological disease of > > unknown etiology [Possible that > > FDA may make a distinction between > > dementia and acute delirium (e.g., > > delirium caused by toxic/metabolic > > disease or recent head trauma)] > > Donor Screening (cont.) > > • Persons who are at increased risk for CJD > > – Receipt of human dura mater transplant > > – Receipt of human pituitary-derived growth > > hormone > > – One or more blood relatives diagnosed with > > CJD > > • Persons who spent three months or more > > cumulatively in the U.K. from the > > beginning of 1980 through the end of 1996 > > Donor Screening (cont.) > > • Persons who are current or former > > U.S. military members, civilian > > military employees, or dependents of > > a military member or civilian > > employee who resided at U.S. > > military bases in Northern Europe for > > 6 months or more from 1980 through > > 1990, or elsewhere in Europe for 6 > > months or more from 1980 through > > 1996 > > Donor Screening (cont.) > > • Persons who lived cumulatively for 5 > > years or more in Europe between > > 1980 and the present > > • Persons who received any > > transfusion of blood or blood > > components in the U.K. between > > 1980 and the present > > • NOTE—If the person being > > interviewed is not familiar with the > > term CJD, you may take that as a > > negative response > > The UK > > • For the guidance, the UK includes > > – England > > – Northern Ireland > > – Scotland > > – Wales > > – Isle of Man > > – Channel Islands > > – Gibraltar > > – the Falkland Islands. > > Military Bases > > • In Northern Europe includes > > – Germany, UK, Belgium, Netherlands > > – Deferral from 1980-1990 > > • In Southern Europe includes > > – Greece, Turkey, Spain, Portugal, Italy > > – Deferral from 1980-1996 > > Family History of CJD > > • Would be ineligible UNLESS: > > – the diagnosis of CJD was subsequently found > > to be an incorrect diagnosis; > > – the CJD was iatrogenic; or > > – laboratory testing (gene sequencing) shows > > that the donor does not have a mutation > > associated with familial CJD > > For further information > > http://www.fda.gov/cber/gdlns/cjdvcjd0602 > > .htm > > Melissa Greenwald > > 301-827-2002 > > melissa.greenwald@fda.hhs.gov > > Vox Sang. 89(2) pp. 63-70. > > > > > > http://www.fda.gov/cber/summaries/aatb092005mg.pdf > > > > > > > > what does this week have in store for recipients of donor tissue; > > > > > > PRODUCT > > Acellular Dermal Matrix Skin Tissue, Recall # B-0276-6 > > CODE > > Alloderm > > B10084-002, B10084-007, B10084-009, B10084-012 thru 014, B10084-017 and > 018, > > B10084-023, B10084-025 thru 029, B10085-001 and 002, B10085-007 thru 012, > > B10085-017, B10085-021 thru 025, B10088-001, B10088-006 thru 009, > B10088-010 > > thru 021, B10088-025 thru 035, B10134-001 thru 004, B10134-010 and 011, > > B10134-017 thru 026, B10192-007 and 008, B10192-012, B10192-016 and 017, > > B10192-019, B10192-024 and 025, B10192-028 thru 035, B10222-001, > B10222-005 > > and 006, B10222-014 and 015, B10222-017 thru 020, B10222-022 thru 024, > > B10222-026, B10222-028, B10721-009 thru 012, B10721-016 thru 024, > B10819-001 > > and 002, B10819-005 thru 007, B10819-009 thru 014, B10819-016 thru 018, > > B10819-031 and 032, B10819-035, B10838-007, B10838-009, B10838-018 thru > 023, > > B10838-026 thru 028, B10850-001 thru 004, B10850-009 thru 016, B11021-001 > > and 002, B11021-008 thru 011, B11022-016 and 017, B11024-011 thru 013, > > B11024-015 thru 019, B11025-001, B11025-011 thru 016, B11025-019 thru 021, > > B11026-001 thru 003, B11026-010 thru 012, B11026-015, B11026-017 thru 023, > > B11052-003 and 004, B11052-012 and 013, B11052-015 and 016, B11054-013, > > B11055-003 and 004, B11055-011 and 012, B11055-017, B11055-019 and 020, > > B11061-002, B11061-015 thru 017, B11064-002 thru 004, B11064-013 thru 017, > > B11064-020, B11064-022, B11065-001 and 002, B11065-004, B11065-006 and > 007, > > B11065-009, B11065-012 thru 018, B11079-004, B11079-013 and 014, > B11079-016, > > B11079-019, B11079-021 thru 024, B11079-029 thru 031, B11080-002, > B11080-009 > > thru 011, B11080-016, B11080-021, B11083-019 thru 022, B11083-024 thru > 027, > > B11087-003 thru 005, B11087-007 thru 013, B11099-012 and 013, B11099-016 > > thru 026, B11103-003, B11103-008, B11103-011 thru 015, B11104-002 thru > 005, > > B11104-009, B11107-002 thru 004, B11107-011, B11107-014 thru 020, > > B11107-025, B11115-003 and 004, B11115-012 and 013, B11115-018 thru 021, > > B11115-025 and 026, B11120-019, B11120-021, B11127-008 thru 010, > B11127-013 > > and 014, B11129-001, B11129-009 and 010, B11129-013 and 014, B11131-011 > thru > > 013, B11131-015 thru 017, B11148-012, B11148-016 thru 023, B11156-009, > > B11156-013 thru 017, B11163-002, B11163-015, B11163-017 thru 021, > > B11180-001, B11180-004, B11180-009 thru 012, B11180-014 and 015, > B11180-017, > > B11181-001, B11181-003, B11181-009, B11181-011 thru 015, B11202-001 thru > > 004, B11202-014 thru 016, B11202-021 and 022, B11213-001, B11213-003 and > > 004, B11213-007, B11213-010 thru 014, B11213-022, B11217-010 thru 013, > > B11217-015, B11239-003, B11239-006, B11239-015, B11239-023 and 024, > > B11239-026, B11239-030, B11244-014, B11244-017, B11244-020, B11244-022, > > B11247-001, B11247-016, B11247-018, B11247-021, B11262-016, B11266-014, > > B11266-016, B11266-018 and 019, B11266-023, B11281-021, B11281-023, > > B11282-015, B11282-019, B11286-013 and 014, B11296-010 thru 013, > B11296-015, > > B11324-027, B11324-030, B11327-014 and 015, B11349-009, B11350-012, > > B11350-017, B11350-019, B11363-012, B11363-015, B11367-018 thru 020, > > B11367-030 and 031, B11410-012 and 013, B11432-012, B11432-014, B11468-013 > > and 014, B7406-001 thru 031, B7406-034 thru 037, B7406-045 thru 047, > > B7406-050 thru 061, B7406-065 thru 067, B7406-069 thru 077, B7417-001 thru > > 013, B7417-015 , B7417-019 thru 023, B7417-037 thru 042, B7417-044 thru > 046, > > B7417-048, B7417-050, B7417-054 thru 058, B7430-001 thru 014, B7430-018, > > B7430-020, B7430-026 and 027, B7430-035 thru 037, B7430-039 thru 079, > > B8410-012 thru 037, B8410-039 thru 052, B8411-002 and 003, B8411-007, > > B8411-014 and 015, B8411-017 thru 056, B8414-001 thru 008, B8414-015 thru > > 029, B8421-001, B8421-003, B8421-005 and 006, B8421-009, B8421-024 thru > 048, > > B8421-051 thru 058, B8422-001 thru 006, B8422-008, B8422-012, B8422-018 > thru > > 028, B8422-030 thru 032, B8422-035 thru 039, B8422-043, B8422-045 thru > 047, > > B8422-050 and 052, B8422-054, B8424-001 thru 004, B8424-008, B8424-010, > > B8424-014 thru 016, B8424-022 thru 032, B8424-034 and 035, B8424-037 thru > > 044, B8425-010 thru 019, B8425-021 and 022, B8425-025 thru 027, B8684-001 > > thru 005, B8684-007 and 008, B8684-010, B8684-016 thru 030, B8684-032, > > B8684-034 and 035, B8684-037 thru 050, B8685-001 thru 003, B8685-011 thru > > 042, B8695-002 and 003, B8695-005 thru 013, B8695-023 thru 061, B8697-001, > > B8697-006, B8697-014, B8697-017 and 018, B8697-020 and 021, B8697-037 thru > > 039, B8697-041, B8697-043 thru 058, B8706-001 and 002, B8706-006 thru 009, > > B8706-013, B8706-019 thru 023, B8706-025 thru 048, B8707-007 thru 014, > > B8707-016 thru 019, B8708-008 thru 025, B8720-001, B8720-003 thru 005, > > B8720-009, B8720-012, B8720-021 thru 025, B8720-027 thru 033, B8720-035 > and > > 036, B8720-038 and 039, B8720-040 , B8720-042 thru 062, B8722-002, > B8722-010 > > and 011, B8722-017 thru 025, B8722-027 thru 042, B8723-001, B8723-004 thru > > 007, B8723-016, B8723-025 and 026, B8723-028 and 029, B8723-031 thru 33, > > B8731-013 and 014, B8731-017, B8731-021 and 022, B8731-026 thru 045, > > B8732-001, B8732-004 and 005, B8732-005, B8732-016 thru 024, B8732-026 > thru > > 045, B8734-021 thru 023, B8734-027, B8734-029 thru 031, B8734-033, > B8734-037 > > and 038, B8734-041, B8734-043 thru 053, B8734-055 thru 057, B9132-002 thru > > 005, B9132-010, B9132-014 thru 029, B9228-007 thru 018, B9232-004, > B9232-010 > > and 011, B9232-016 thru 023, B9243-001, B9243-003, B9243-005, B9243-011, > > B9243-014, B9243-016, B9243-018 thru 027, B9245-001, B9245-009, B9245-013 > > and 014, B9245-014, B9245-017, B9245-019 thru 028, B9284-001 thru 005, > > B9284-007, B9284-011 thru 020, B9284-023 thru 026, B9284-029 thru 042, > > B9285-001 and 002, B9285-004, B9285-012 and 013, B9285-016, B9285-019 thru > > 027, B9285-029, B9322-002 thru 004, B9322-007, B9322-013 thru 022, > B9322-024 > > thru 026, B9323-001, B9323-006 and 007, B9323-017, B9323-019 thru 030, > > B9331-001, B9331-004 thru 007, B9331-017, B9331-020 thru 028, B9331-031 > thru > > 042, B9333-001 thru 003, B9333-005 and 006, B9333-012, B9333-015 thru 020, > > B9340-002 and 003, B9340-006 and 007, B9340-010 thru 012, B9340-014 thru > > 022, B9491-001 thru 003, B9491-006, B9491-011 thru 013, B9491-017 thru > 023, > > B9509-001, B9509-012, B9509-018 thru 022, B9693-002, B9693-008 thru 015, > > B9725-001, B9725-005 and 006, B9725-012 thru 031, B9725-033 thru 037, > > B9765-002 and 003, B9765-005 thru 007, B9765-015, B9765-018 thru 022, > > B9927-001 thru 004, B9927-007, B9927-009 thru 011, B9927-013 thru 029, > > B9927-031 thru 033, C10602-016 thru 021 > > Repliform > > B10084-019 and 020, B10084-022, B10084-024, B10134-016, B10192-013, > > B10192-015, B10192-018, B10192-020 thru 023, B10819-027, B11120-008 thru > 11, > > B7406-044, B7406-048, B7406-064, B7406-078 thru 83, B7417-031 and 32, > > B7430-038, B8414-014, B8421-020, B8421-022 and 23, B8422-042, B8424-036, > > B8684-015, B8685-005 thru 8, B8697-040, B8697-042, B8706-024, B8723-019, > > B8723-024, B8734-042, B9232-014 and 015, B9243-015, B9245-018, B9284-027 > and > > 028, B9285-015, B9285-017 and 018, B9333-007 and 08, B9333-010 and 011, > > B9509-015, B9725-007, B9765-008, C10602015 > > Graft Jacket > > B10084-016, B10084-021, B10085-014 thru 016, B10088-023 and 024, > B10134-013, > > B10838-015, B11021-006, B11052-010, B11065-011, B11079-009, B11087-006, > > B11131-008, B11148-009, B11163-016, B11163-008 and 009, B11181-010, > > B11266-012, B7406-062, B7417-051 thru 053, B8421-049 and 050, B8422-041, > > B8684-036, B8695-019, B8697-032, B8706-014, B8720-016, B8720-019, > B8720-020, > > B8720-034, B8720-037, B8732-025, B8732-013, B9243-013, B9245-015, > B9245-016, > > B9284-022, B9331-029 and 030, B9340-009, B9491-014, B9765-013, B9765-016 > > RECALLING FIRM/MANUFACTURER > > LifeCell Corporation, Branchburg, NJ, by telephone and facsimile > > transmission beginning September 30, 2005, and by follow-up letter dated > > October 12, 2005. Firm initiated recall is ongoing. > > REASON > > Human Tissues, procured from donors without adequate donor eligibility > > determinations, were distributed. > > VOLUME OF PRODUCT IN COMMERCE > > 1,652 allografts from 102 lots > > DISTRIBUTION > > Nationwide, Australia and Korea > > > > http://www.fda.gov/bbs/topics/enforce/2005/ENF00932.html > > > > > > TSS > > > > > > > > ----- Original Message ----- > > From: "Terry S. Singeltary Sr." > > To: > > Sent: Saturday, December 24, 2005 9:57 AM > > Subject: Re: THE LEGAL TRADING AND SELLING OF BODY PARTS AND HUMAN TSEs IN > > THE USA > > > > > > > ##################### Bovine Spongiform Encephalopathy > > ##################### > > > > > > 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, 11:44PM > > > Possible body parts theft ring uncovered > > > Skin and bones are alleged to have been sold secretly > > > > > > By TOM HAYS > > > Associated 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 rules > > > 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 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 scheme > > > 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 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 > > > > > > > > > > ##################### 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 > > > > > > > > Vol. 282 No. 23, December 15, 1999 > > > > Preventing Prion Transmission in Corneal Transplants > > > > > > > > > > > > http://www.vegsource.com/talk/madcow/messages/7242.html > > > > > > > > > > > > Cadaver corneal transplants -- without family permission > > > > > > > > Houston, Texas channel 11 news 28 Nov 99 > > > > Reported by Terry S. Singeltary Sr. son of CJD victim > > > > > > > > http://mad-cow.org/~tom/dec99_news.html#bbb > > > > > > > > > > > > VOL. 282 No. 23, December 15, 1999 > > > > > > > > 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://jama.ama-assn.org/cgi/content/extract/282/23/2211?maxtoshow=&HITS=10& > > > > > > > > > > hits=10&RESULTFORMAT=&fulltext=CJD+EYE&searchid=1130425573446_2695&stored_se > > > > arch=&FIRSTINDEX=0&journalcode=jama > > > > > > > > > > > > http://www.vegsource.com/talk/madcow/messages/7643.html > > > > > > > > > > > > http://www.vegsource.com/talk/madcow/messages/7708.html > > > > > > > > > > > > VVOL > > > > > > > > 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://www.vegsource.com/talk/madcow/messages/7691.html > > > > > > > > > > > > TSS > > > > > > > > > > > > Link: Reported by Terry S. Singeltary Sr. son of CJD victim 28 Nov 99 > > THE > > > > EYES HAVE IT, CJD... > > http://www.mad-cow.org/dec99_news.html#bbb > > > > > > > > > > > > > > #################### https://lists.aegee.org/bse-l.html > > > #################### > > > > > > > > #################### https://lists.aegee.org/bse-l.html > > > #################### > > > > > > #################### https://lists.aegee.org/bse-l.html > > #################### > > > > > > > #################### https://lists.aegee.org/bse-l.html > #################### > > >
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