FDA Safety Warning for Bone Graft Products in Patients Under 18

FDA Warning – Bone Graft Products/Patients Under 18

The Food and Drug Administration has issued a safety alert to healthcare providers, patients, and parents and guardians that bone graft devices containing recombinant proteins or synthetic peptides should not be the first treatment considered for patients under age 18.

Certain recombinant proteins and synthetic peptides mimic bone growth substances normally found in the body and may be added to a carrier and then surgically implanted in a patient with a bone defect to promote new bone growth or to replace or heal existing bone. The FDA has approved devices such as Medtronic Infuse for orthopedic and dental use only in patients over the age of 18 who are done growing (skeletal mature). The labeling for each product provides the specific indications for use. The FDA has not evaluated their safety and effectiveness in patients under age 18, who are considered skeletally immature. Any product that affects bone growth has the potential to negatively impact skeletal development by altering normal bone formation and growth, especially if implanted near open growth plates.

The FDA has received reports of serious injuries and adverse effects, including excess bone growth, fluid accumulation, inhibited bone healing, and swelling. While these events are also seen in patients over 18, they are of greater concern in those under age 18 because their bones are still growing and vital organs and tissues are closer together than in a body that is done growing. In a growing body, small changes from one organ/tissue to have serious effects on another, the FDA says. Parents or guardians should contact the physician if a child treated with these products experiences adverse events, such as fever, swelling, rash, pain, or physical changes near the implantation site.

The agency acknowledges that there are limited treatment options for patients under18 with significant bone defects or rare bone disorders and recognizes that healthcare providers may determine these products to be the best or only option. But the FDA advises doctors to consider other options before using bone graft substitutes containing recombinant proteins or synthetic peptides.