tissue transplant
tissue transplant
tissue transplant



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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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