FDA: Stop the using recombinant proteins and synthetic peptides in patients under 18

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
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