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Infected Tissue Transplant
Recent reports say the Food
and Drug Administration (FDA) has launched an investigation of certain human
tissue that may not have been properly screened for certain infectious diseases.
The donors of the infected tissue may not have met FDA donor eligibility requirements
and may have been transplanted in patients from early 2004 to September 2005.
The infected human tissue was recovered by Biomedical Tissue Services, Ltd. (BTS)
of Ft. Lee, NJ, and forwarded to tissue processors for transplant. Tissue processors
receiving infected tissue include: 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.
The FDA reports these tissue processor
firms have voluntarily recalled all unused tissue and notified the implanting
physicians of the problem. Physicians who used the transplant tissue directly
from BTS also have been contacted.
Although they say the risk from the infected tissue is low, the FDA and the
Centers for
Disease Control and Prevention (CDC) recommend that anyone
receiving a transplant of the questionable tissue be screened
for certain communicable diseases, including HIV-1 and 2 (the
viruses that cause AIDS), hepatitis B virus, hepatitis
C virus, and syphilis.
No adverse reactions related to a transplant of the infected
tissue have been reported to FDA. However, some recipients of the infected tissue
may have an increased risk of infections. The actual infectious risk is unknown.
The FDA has certain requirements concerning donor eligibility to ensure donors
of transplanted tissue are free of infections that may be
transmitted to recipients. These include a review of the donor's
medical history and other factors, a physical assessment of
the donor, and testing for relevant communicable
diseases.
Law experts recommend that anyone receiving a notice from
the FDA concerning the tissue involved in a recent transplant
seek legal advice.
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