The Food and Drug Administration (FDA) is recommending against the routine use of bone graft substitutes containing recombinant proteins or synthetic peptides in patients <18 years old. The FDA has received reports of serious injuries including excess bone growth, fluid accumulation, inhibited bone healing, and swelling.
These adverse events are similar to those observed in patients >18 years old but they are more concerning in this age group because of their overall smaller size and bones that are still growing. If the bone grafts are implanted near open growth plates, there is potential for negative bone formation and growth. Manufacturers are required to submit premarket approval application (PMA) with clinical data supporting the safety and efficacy of these Class III high-risk medical devices. However, the FDA has not reviewed or approved the safety and efficacy in patients <18 years old.
The FDA recommends first considering the use of alternatives such as autograft bone, allograft bone, and bone graft substitutes that do not contain recombinant proteins or synthetic peptides in patients <18 years old. If bone graft substitutes that contain recombinant proteins or synthetic peptides are considered the best or only option, then parents/guardians and patients should be informed about the risks and benefits of using such products. Patients <18 years old should be monitored closely and be referred for appropriate corrective treatment if necessary.
For more information visit FDA.gov.