FDA Warns Some Transplanted Tissue Unsafe

New Jersey company did not properly screen human bone, skin and tendons before transplant

THURSDAY, Oct. 27 (HealthDay News) -- The U.S. Food and Drug Administration (FDA) warned Wednesday that human tissue recovered by a New Jersey company and implanted into patients from early 2004 to September 2005 came from donors who may not have been thoroughly screened for infectious diseases.

The tissue includes human bone, skin and tendons recovered by Biomedical Tissue Services, Ltd. (BTS) of Fort Lee, N.J., and sent to five tissue processors in New Jersey, Georgia, Texas and Florida.

While the risk of infection is low and no adverse reactions have been reported, the agency is advising recipients of this transplanted tissue to get tested for HIV-1 and 2, hepatitis B virus, hepatitis C virus and syphilis. The FDA requires tissue donors to have a review of their medical history, a physical check-up and communicable disease testing.

The five tissue processing companies have voluntarily recalled unused tissue and are working with the FDA to notify physicians whose patients received the tissue, according to the FDA statement.

Meanwhile, the FDA wants physicians to inform their patients and direct them to "appropriate infectious disease testing." The agency also requests that infectious diseases be reported to the FDA's MedWatch program.

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