A medical company in Florida is facing big trouble after it was revealed that the human tissue implants it supplies to hospitals across the country and the world have been contaminated with bacteria, fungi and other potentially deadly organisms.
The Food and Drug Administration posted a warning to their website earlier this week saying they had discovered widespread contamination throughout the plant operated by RTI Biologics in Alachua, Florida.
Among the items that were being warned about are human tendons used to speed recovery time after sports injuries as well as “bone putty” that can help repair fractures. The RTI plant in Florida produces and processes tissue that is used in all 50 states and across more than 30 countries. Records obtained by the FDA indicate that there were 70 incidents of the presence of Pseudomonas species of bacteria in sports implants produced at RTI between January 1, 2011 and June 30, 2012. The letter posted by the FDA also showed that tests detected Bacillus and Serratia bacteria, fungus and yeast on multiple occasions.
The FDA wrote that the problems reveal a troubling problem with RTI’s ability to process and distribute tissue and also to test the tissue in a way that prevents the spread of diseases. Possibly worst of all, the company has failed to remedy the problems despite repeated efforts.
Though the warning is, by itself, big news, the exact harm that the dangerous products have produced remains unknown. So far officials with the FDA have not said whether there have been reports of illness or death linked to any of RTI’s products. Officials with the company vehemently deny their products have caused any patient problems, though this conflicts with reports in a recent FDA inspection. The inspection report form 2011 indicated that the company had gotten 758 reports of adverse events that year, including four reports of infection that were forwarded along to the FDA.
The warning letter is more bad news for a company that is still dealing with fallout from a revelation that in 2005, the president of Biomedical Tissue Services was sent to jail for his involvement in a body-selling scheme (RTI was one of their biggest clients). Beyond that episode, the company has been at the center of several stories about whether it provided improperly obtained tissues for use in U.S. military hospitals.
If you or someone you know have been injured by a defective product and you would like to discuss your case with an attorney, please call contact the Georgia product liability litigation attorneys at Pope McGlamry P.C. today to schedule a free consultation
Source: “Tainted human body parts prompt FDA warning,” by JoNel Aleccia, published at NBCNews.com.
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