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Regeneration Technologies, Inc. Body Tissue Parts

On October 14, 2005, Regeneration Technologies, Inc. (RTI) a Florida-based processor of orthopedic, cardiovascular and other biologic implants, announced that the company, along with the Food and Drug Administration (FDA), issued a voluntary recall. The recall includes allograft implants processed from donor tissue received from Biomedical Tissue Services (BTS), due to questions raised with respect to donor documentation received from Biomedical Tissue Services (BTS).

Thousands of patients who underwent tissue, bone and organ transplants are at risk of developing serious diseases due to the use of untested body parts. Recent criminal charges detailed the illegal sale of untested body parts and tissue to hospitals, distributors and medical device manufacturers. The FDA is concerned that the recipients of untested body parts and tissues are potentially at risk of developing HIV, Hepatitis B, Hepatitis C, Syphilis and other infectious diseases.

The untested body parts and tissue scandal centers around Biomedical Tissue Services (BTS), which allegedly acquired body parts without donor permission and sold them for use in transplants performed at hospitals and other medical facilities throughout the United States. The owner and three other employees of Biomedical Tissue Services (BTS) have been indicted in Brooklyn, New York for taking body parts without legal consent and without proper screening. It is believed that funeral home operators accepted money from Biomedical Tissue Services (BTS) in exchange for ignoring obviously forged death certificates and consent forms. The body parts and tissue in question have been distributed throughout the country and used in thousands of operations.

Biomedical Tissue Services (BTS) sold these illegal body parts to several large companies including LifeCell Corporation, Tutogen Medical, Inc.,  Lost Mountain Tissue Bank and Blood & Tissue Center of Central Texas. The FDA and most of the companies involved have not disclosed the number of patients that received the untested parts and tissue.

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