FDA Warns on Tainted Tissue Implants
A Florida firm is under scrutiny by federal regulators for providing human tissue implants contaminated with bacteria, fungi, and other potentially dangerous organisms to its roster of U.S. and global clients.
The U.S. Food and Drug Administration (FDA) posted a warning letter sent to RTI Biologics Inc. stating that there was pervasive contamination throughout a facility in Alachua, Florida, operated by the biological implant provider, reports NBC News.
The tainted tissue implants include human tendons used to heal sports injuries and “bone putty” for repairing fractures. The products manufactured at the plant are used in the U.S. and in more than 30 countries across the world.
The FDA has not confirmed any reports of infection, illness, or death linked to RTI products but an FDA inspection document from 2011 indicates that RTI received 758 internal reports of complaints and adverse events in a year, reports NBC News. These complaints included four reports of infections that were sent over to the FDA by the company, which under the law can decide when to pass on complaints to the agency.
The company, however, stated that it hasn’t received reports of injuries from its products and that no contaminated products were distributed to the public. RTI says it is working with the FDA to address the concerns.
If you or a loved one has been harmed by an unsafe medical product, contact Sokolove Law today for a free legal consultation and to find out if a product liability lawyer may be able to help you.