FDA Safety Warning for Bone Growth Products in Children

FDA Safety Warning for Bone Growth Proteins in ChildrenJanuary 21, 2015 — The FDA has issued a Safety Communication to warn against using bioengineered bone growth products instead of traditional bone grafts in children due to an increased risk of complications.

According to a study published in October 2012 by the Journal of the American Medical Association, about 9.2% of spinal surgeries in children use bone-growth proteins, such as rhBMP-2.

The FDA has received reports of serious injuries, including excess bone growth, fluid accumulation, inhibited bone healing, and swelling.

These adverse events have also occurred in adults, but the FDA is more concerned about children because they are smaller. Vital organs and tissues are closer together, which could allow slight excess bone growth to have serious consequences.

Another concern is that the bones of children are still growing. Bone growth products could alter normal skeletal development, especially if implanted near open growth plates.

The FDA warns:

“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.”

Traditional bone graft techniques do not carry these risks. The procedure involves multiple surgeries to harvest bone from the hip, pelvis, or chest, and transplanting it where bone is needed. Another technique uses bone from a cadaver or a donor.

In recent years, synthetic bone graft products have gained popularity as an alternative to using actual bones. The products contain bioengineered bone-growth proteins, recombinant proteins, and synthetic peptides, which mimic natural bone-growth proteins that are normally found in the body.

The bioengineered proteins are often combined with ceramic granules to create a scaffold on which new bone cells can grow. The product is implanted in patients who have had spinal fusion surgery, rare bone disorders, or significant bone defects.

The FDA classifies bone-growth products as Class III (“high risk”) medical devices that are subject to strict pre-marketing requirements. They are not approved for use in children under 18 years old.

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