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. [Read more…]