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FDA releases safety communication on bone graft substitutes
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The FDA has released a safety communication to inform health care providers that bone graft substitutes containing recombinant proteins or synthetic peptides should not be the first treatment considered for patients younger than 18 years of age with significant bone defects or rare bone disorders.
A press release from the FDA reported results of serious injuries, including excess bone growth, fluid accumulation, inhibited bone healing and swelling, with use of bone graft substitutes containing recombinant proteins or synthetic peptides. Although these events are similar to those seen in patients older than 18, the FDA reported a higher concern in patients younger than 18 due to their overall smaller size and because their bones are still growing.
According to the release, the FDA recommends:
- against routine use of bone graft substitutes containing recombinant proteins or synthetic peptides in patients younger than 18 because their safety and effectiveness has not been reviewed or approved for use in this population;
- considering alternatives such as autograft bone, allograft bone and bone graft substitutes that do not contain recombinant proteins or synthetic peptides before using bone graft substitutes containing recombinant proteins and synthetic peptides in patients younger than 18;
- carefully considering the benefits and risks before using these products in any patient; and
- closely monitoring patients younger than 18 for adverse events and, if necessary, referring patients to the appropriate health care provider for corrective treatment.
The FDA also advised health care providers to report any adverse events associated with the use of recombinant proteins or synthetic peptides experienced by patients.
Perspective
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Brandon C. Rocque, MD, MS
The FDA has recently released a statement describing reports of serious injury to patients under the age of 18 years who are exposed to bone graft substitutes containing recombinant proteins. These products have the potential to lead to local complications, such as seroma formation and overgrowth of bone, to adversely affect skeletal development, and have the theoretical potential to increase the likelihood of future malignancy.
Available published literature includes mostly case series and examinations of large, third-party databases. Long-term data about the safety of these products in children is simply not available. Nevertheless, their use appears to be on the rise. Surgeons are cautioned to use these products with great discretion in children, only when suitable alternatives are unavailable.
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