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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_search=&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




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