FDA Alerts and Letters about Tainted Tissue

The Food and Drug Administration alerted the public to potential dangers from tissues provided by Biomedical Tissue Services on October 26, 2005 in a letter that detailed the improprieties of the company. The agency also cited the safety oversight of the tissue banks that were supplied with these potentially tainted tissues. It warned that these tissues were not properly screened for easily communicable diseases such as AIDS, HIV, hepatitis, and syphilis, and recommended that people who received recent tissue transplants consult their doctors immediately.

On January 31, 2006, the FDA issued an Order to Cease Manufacturing and to Retain Human Cells, Tissues and Cellular and Tissue Based Products (HCT/Ps) to BTS after the an investigation of BTS facilities revealed a number of serious health violations regarding screening and record keeping. A number of records appeared to have been forged or faked, and there were a number of incongruities in death certificates on file at BTS and in coroner offices where the deaths were recorded. BTS is also suspected of providing incorrect blood samples along with the tissues they sold, in order to further cover up the health status of the donor.

People who received recent tissue transplants should be aware they may have received tainted samples. The Food and Drug Administration continues to encourage patients to seek testing for communicable diseases in order to rule out potential contamination. Medical giant Medtronic, Inc. reported that at least 8,000 people could have received tainted tissue from their banks, and there are six other tissue banks that have yet to report on the number of patients that could have been the recipients of contaminated specimens.

Thousands of people may be at risk of developing potentially life-threatening diseases such as AIDS, HIV, hepatitis, and syphilis because of the actions of a few shortsighted and reprehensible individuals who put their greed ahead of consumer safety. If you or someone you love received a recent transplant or had another procedure such as a dental implant or skin graft that utilized these tainted tissues, you need to speak to a lawyer immediately. You may be entitled to seek financial compensation for your physical and pain and emotional suffering. Let a dedicated and experienced tainted tissue attorney help you get the justice you deserve today.