FDA ISSUE “SAFETY COMMUNICATION” OVER CERTAIN BONE GRAFT SUBSTITUTES (Orthopedics This Week)
Stop the routine use of bone graft substitutes containing recombinant proteins or synthetic peptides high-risk (Class III) medical devices in patients under 18 years of age, warns the Food and Drug Administration (FDA).
On January 21, 2015, the agency issued a “Safety Communication – Reports of Serious Injury,” because reports of serious injuries, “such as excess bone growth, fluid accumulation, inhibited bone healing, and swelling,” have increased the agency’s concern.
Younger Patients – Added Risks
These reports of injuries, says the agency, are of special concern because patients under 18 are typically smaller and their bones are still growing. “Any product that affects bone growth could have the potential to negatively impact skeletal development by altering normal bone formation and growth, especially if implanted near open growth plates.” The agency also said that before marketing such products, companies need to submit a premarket approval application (PMA) with clinical data.
The agency says certain recombinant proteins and synthetic peptides “mimic bone growth substances normally f...
