FDA Warning for Tainted Tissue Transplants

December 14, 2012 — The U.S. Food and Drug Administration (FDA) has sent a Warning Letter to a company in Florida after investigators found that tissue transplants and body parts were contaminated with bacteria and fungi. The facility, operated by RTI Biologics, sells human tendons for sports injuries and “bone putty” to help heal fractures. According to FDA documents from 2011, RTI has received 758 complaints in one year, including 4 reports of infection.

 

According to the FDA, RTI sold more than 33,000 tendons used to repair knees, ankles, and other joints. The company also sells bones, skin, ligaments, and other tissues obtained in the U.S. and abroad. They sell their products in all 50 states and in some foreign countries, which raises concern about wide-scale infections linked to contaminated body parts.

RTI is currently facing dozens of lawsuits stemming from a scandal in 2005. One of RTI’s biggest suppliers of body parts was was Michael Mastromarino, who was sent to prison for harvesting non-organ body parts from the dead and selling them without donor permission.

FDA investigators detected Pseudomonas bacteria contaminating 70 implants intended for sports medicine between January 1, 2011 and June 30, 2012. The FDA also found Bacillus, Serratia, and Staphylococcus bacteria, fungus, and yeast. The FDA found bacterial contamination in the company’s water supply and in their tissue sterilization process.

According to the warning letter from FDA Florida District Director Emma R. Singleton:

“We remain concerned about the conditions that were identified during the most recent inspection and the ongoing contamination issues that appear to be problematic throughout your facility.”

The FDA warned that RTI must address the contamination problems, or they could potentially face additional regulatory action. The FDA has the authority to recall contaminated products, destroy inventory, and force a company to cease manufacturing of human tissue products.

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