Tissue Implant: Lawyer and Lost Mountain Tissue Bank Information

According to the Food and Drug Administration (FDA), Lost Mountain Tissue Bank of Kennesaw, Georgia, may have processed and distributed tissue implant materials to hospitals and other medical facilities that were not adequately tested. The tissue in question would have been purchased by Lost Mountain Tissue Bank from Biomedical Tissue Services (BTS) of Fort Lee, New Jersey. BTS has been charged with illegally harvesting human tissue, bones and tendons.

FDA Warning Letter to Lost Mountain Tissue Bank
This is not the first time Lost Mountain Tissue Bank has had issues regarding the safety of the tissues it was selling for implantation. In 2003, during an inspection of Lost Mountain Tissue Bank of Kennesaw, Georgia, the FDA documented significant deviations of the federal regulations for human tissue intended for transplantation, as set forth in Title 21, Code of Federal Regulations (21 CFR) Part 1270. According to an FDA warning letter, the deviations included:

Failure to prepare, validate, and follow written procedures for prevention of infectious disease contamination or cross-contamination by tissue during processing [21 CFR 1270.31(d)], in that:
a. Your firm does not have any documentation of validation of your firm's human tissue processing procedures . . . .
b. Your firm routinely reworks tissue products in order to extend the expiration date without validated written procedures for the reworking of human tissue products.

The records indicate the company corrected the 2003 problems to the agency's satisfaction.

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