FDA Investigating Infected Tissue

Human tissue used for transplants is under investigation by the Food and Drug Administration (FDA) because it may not have been properly screened for certain infectious diseases. The FDA reports that their donor eligibility requirements may not have been met on the infected tissue used for transplants between sometime in early 2004 and September 2005.

Requirements are maintained by the FDA concerning transplant donor eligibility to limit the risk of infection. They include: reviewing the donor's medical history, physically assessing the donor and testing for communicable diseases.

The actual infection risk is still unknown, however, no adverse reactions related to transplants of the infected tissue have been received by the FDA. Some transplant recipients of the infected tissue may be at a higher infection risk.

The FDA, along with the Centers for Disease Control and Prevention (CDC), say there is low risk of infection from the infected tissue, but recommend any patient who received a transplant of the suspect tissue be screened for HIV-1 and 2 (the viruses that cause AIDS), hepatitis B virus, hepatitis C virus, and syphilis.

Biomedical Tissue Services, Ltd. (BTS) of Ft. Lee, NJ, procured the infected human tissue and sent it on to tissue processors. Receiving the infected tissue are the following processors:

• 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

Any unused tissue has been voluntarily recalled by the processors and they have notified the transplant physicians, said a statement by the FDA. Physicians who transplanted tissue directly from BTS were also contacted, according to an attorney familiar with the issue.