FDA Warnings for Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides

Los Angeles, CA: The FDA is informing healthcare providers, patients, and parents/guardians that bone graft substitutes containing recombinant proteins or synthetic peptides should not be the first treatment considered for patients under age 18 with significant bone defects or rare bone disorders.

The FDA has not approved these products for use in patients under age 18 because their bones may still be growing and using this product may cause serious injuries. The agency recommends that health providers consider other treatment options first.

Through scientific literature and medical device reports (MDRs), the FDA is aware of healthcare providers using bone graft substitutes containing recombinant proteins or synthetic peptides in patients under age 18. Reports of serious injuries, such as excess bone growth, fluid accumulation, inhibited bone healing, and swelling, have increased the FDA' concern. While these types of events are similar to those seen in patients over age 18, they are of more concern in patients under age 18 because of their overall smaller size and because 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 FDA considers bone graft substitutes containing recombinant proteins or synthetic peptides high-risk (Class III) medical devices. Before marketing the products, manufacturers are required to submit a premarket approval application (PMA) that includes clinical data supporting safety and effectiveness. The FDA has not evaluated their safety and effectiveness in patients under age 18.

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Last updated on Jun-7-17