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Tissue Transplant Investigation

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Authorities are investigating the use of tissue and bone transplants from improperly screened donors. The FDA issued an alert to physicians, hospitals and tissue processing plants that tissue received from Biomedical Tissue Services, Ltd. (BTS) in Ft. Lee, New Jersey may not have met FDA donor requirements and may contain infectious diseases such as HIV, Hepatitis B, Hepatitis C, and Syphilis.

Transplants can involve any part of the body; common transplants (allografts) involve tissue, bone/ bone marrow, tendons, organs, and even corneas. These transplants, taken from a deceased (or sometimes a live donor) and implanted into a needy recipient, require the written approval from the family or prior approval from the donor. Transplants also require a medical history review, physical assessment, and disease screening test to meet FDA donor requirements.

It is alleged that tissue may have been taken without proper authorization and without donor screening. In this case, tissue processors in New Jersey, Georgia, Texas, and Florida received tissue from BTS. The potentially diseased tissue may have been involved in bone marrow transplants, bone transplants, heart valve transplants, or skin grafts from 1/2004 to 9/2005.

Unfortunately, this is not the first case of transplanted organs, bones, or tissue obtained without the donor's permission and without proper screening. The demand for these transplants is high and those involved will often take illegal measures to deliver the parts for a high price. These actions can pose serious health threats to the transplant recipient and emotional trauma to the deceased donor's loved ones.

The FDA has provided information on this investigation into human tissue transplantation: [FDA WEB SITE] website.-->

If you have received a letter or notification related to bone or tissue transplants or have had any type of bone or tissue transplant in 2004 or 2005 you may be at risk.



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