FDA Issues Safety Warning on Use of Bone Graft Devices in Patients Under 18

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FDA Issues Safety Warning on Use of Bone Graft Devices
FDA Issues Safety Warning on Use of Bone Graft Devices

FDA Issues Safety Warning on Use of Bone Graft Devices
FDA Issues Safety Warning on Use of Bone Graft Devices

In a safety communication addressed to healthcare providers, patients, and parents and guardians, the Food and Drug Administration is warning that bone graft devices containing recombinant proteins or synthetic peptides can cause serious injury when used in patients under age 18.

Certain recombinant proteins and synthetic peptides mimic natural bone growth substances and these may be added to a device that is 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 have finished growing (skeletal mature). The labeling for each product provides the specific indications for use. The FDA has not evaluated the safety and effectiveness of these devices in patients under age 18, whose skeletons are considered immature. Any product that affects bone growth could negatively impact skeletal development by altering normal bone formation and growth, especially if implanted near open growth plates, the FDA explains.

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

Because there are limited treatment options for patients under 18 with significant bone defects or rare bone disorders, healthcare providers may determine that these products are the best or only option. But the FDA advises doctors to consider other options—for example, grafting bone from another part of the patient’s body or bone transplanted from another person—before using bone graft substitutes containing recombinant proteins or synthetic peptides.