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Certain recombinant proteins and synthetic peptides mimic bone growth substances normally found in the body and may be added to a carrier or scaffold to be used as bone graft substitutes. These products are not approved for any use in patients under the age of 18 who are still growing (skeletally immature).
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’s concern.
In a body that is still growing, vital organs and tissues are closer together than in a body that is done growing. This could potentially allow small changes from one organ/tissue to have serious effects on another. For example, there is less space between the spinal cord and the bones surrounding it. If one of these products is used in the spine of a patient under age 18, who then experiences the same amount of excess bone growth or fluid accumulation as a patient over age 18, it may more easily lead to spinal nerve injury, pain, or weakness.
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.
Contact your healthcare provider if you or your underage child was treated with these products and is experiencing adverse events, such as fever, swelling, rash, pain, or physical changes near the implantation site.