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Home > Archive > Hepatitis disease > December 2005 > FDA Release Re: New York body-snatchers and AIDS hepatitis B virus, hepatitis C virus,
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FDA Release Re: New York body-snatchers and AIDS hepatitis B virus, hepatitis C virus,
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| In article <memo.20051223221557.588J@veloceraptor.free-online.co.uk>,
alan@veloceraptor.free-online.co.uk (Alan) wrote:
> In article <memo.20051223113246.1008A@veloceraptor.free-online.co.uk>,
> alan@veloceraptor.free-online.co.uk (Alan) wrote:
>
>
>
>
>
> FDA Provides Information on Investigation into Human Tissue for
> Transplantation
> FOR IMMEDIATE RELEASE
> P05-77
> October 26, 2005
> http://www.fda.gov/bbs/topics/NEWS/2005/NEW01249.html
>
> --
>
> 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
> http://money.cnn.com/2005/10/07/new...on=money_latest
>
> --
>
> Class-Action Claims Tainted Body Tissue Could Give Patients AIDS
> December 1, 2005
> http://www.courthousenews.com/Jump.Dec.1.htm
>
> EDISON, N.J. (CN) – Medtronic Sofamor Danek and its subsidiary, Spinal
> Graft Technologies, are lead defendants in a racketeering class-action
> claim in Somerset County Court that accuses them of putting people at risk
> of AIDS, hepatitis and other diseases by negligently harvesting,
> processing and selling human tissue and body parts. Plaintiffs,
> represented by Lombardi & Lombardi, claim the multiple defendants did not
> properly screen the material collected for allografts – human implants –
> and that the USFDA in October issued a recall of human tissue transplant
> material manufactured of distributed by defendant Biomedical Tissue
> Services. Also in October, the Centers for Disease Control recommended
> that all physicians who implanted tissue provided by defendants Medtronic,
> RTI, Tutogen, LifeCell, LMTB and BTCCT recommend that the patients be
> tested for HIV, hepatitis B and C and syphilis, the suit states.
> Plaintiffs seek punitive damage, disgorgement, and a fund for the putative
> victims.
>
> The defendants are Medrontic Sofamor Danek; Spinal Graft Technologies,
> L.L.C., a subsidiary of Medrontic Sofamor Danek; Regeneration
> Technologies, Inc.; Biomedical Tissue Services, Ltd.; Tutogen Medical,
> Inc.; Lifecell Corp.; Lost Mountain Tissue Bank; Blood and Tissue Center
> of Central Texas; Michael Mastromarino, D.M.D.; Joseph Nicelli; and Daniel
> George & Son Funeral Home.
>
> --
>
> CNN Sunday
> December 18, 2005
> http://transcripts.cnn.com/TRANSCRI.../18/sun.02.html
> (About half way down, using Find: Feyerick)
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.
Alan
"Can't you see we're still here,
Can't you see we're still here,
Singing loud; Singing clear,
We shall not go under,
We're still here."
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