Contaminated Human Tissue Implants May Pose Risk of Infection, Death

Federal health investigators indicate that serious deficiencies and contaminants have been found at a Florida facility that makes biological implants from human tissue and body parts.

Earlier this week, the FDA released a warning letter sent to RTI Biologics in October, stating that the human tissue implant maker failed to store, process, package, and label its products in a way that prevents the spread of communicable diseases.

The findings outlined in the letter raise serious concerns about the safety of the human tissue implants that may have been shipped to medical providers worldwide.

Sports-Betting-Addiction-Lawsuits
Sports-Betting-Addiction-Lawsuits

RTI Biologics is known mainly for the production of human tendons used to treat sport injuries and bone putty products used to treat broken and fractured bones.

Inspectors found bacteria on finished product packaging for RTI’s sports medicine products on 70 separate occasions. The letter states that some finished products contained fungus, yeast and bacteria like Bacillus species and Pseudomonas aeruginosa. Pseudomonas aeruginosa is a pathogen that can cause pneumonia and skin and soft tissue infections.

Bacteria that could cause staph infections was found on one occasion, and Pseudomonas species bacteria was found in the water supply used to clean tissue processing areas and other locations on multiple investigations.

RTI Biologics has attempted to address some of the FDA’s complaints involving their production facility in Alachua, Florida, the letter notes. However, the federal health regulatory agency continues to have serious concerns.

“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 letter warns.

The FDA has warned that if RTI does not properly address the contamination problems it could face further action, including human tissue implant recalls, destruction of inventory or an order to cease operations.


0 Comments


Share Your Comments

This field is hidden when viewing the form
I authorize the above comments be posted on this page
Post Comment
Weekly Digest Opt-In

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

MORE TOP STORIES

Following a Class I recall, more than 100 BioZorb lawsuits have been filed by breast cancer survivors who suffered painful complications after the surgical tissue marker failed to dissolve as intended.