FDA Bone Graft Warning Issued for Minors

A new FDA bone graft warning has been issued, advising doctors to avoid off-label use of certain bone graft substitutes in patients with bone disorders, who are younger than 18 years old ─ this includes Medtronic’s Infuse bone graft.

The FDA noted that these bone graft substitutes could cause serious injury to young patients.

These specific bone graft substitutes contain recombinant proteins or synthetic peptides that mimic natural bone-growth substances. When joined with a carrier or scaffold, these elements are embedded in the body to replace or heal an existing bone or to encourage new bone growth.

FDA bone graft warning

The FDA has approved bone graft substitutes for both orthopedic and dental use in patients who are at least 18 years of age, as their bones have stopped growing. Conversely, they have not been approved for younger patients, as their bones are still growing and the extra stimulation can cause serious injuries.

“In a body that is still growing, vital organs and tissues are closer together than in a body that is done growing,” stated the FDA. “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.”

While bone graft substitutes have never been FDA approved for patients under 18 years of age, the Agency says physicians continue to use them on an off-label basis for younger patients. Consequently, the FDA has received reports of fluid accumulation, excess bone growth, swelling, inhibited bone healing and more in minors.

It’s possible for these bone graft complications to occur in older patients, but much more likely in younger people because they’re both smaller in size and their bones are still growing. This puts minor patients at a greater risk for injuries such as spinal cord damage and other injuries that can cause harm to vital organs and tissues.

FDA categorizes bone graft substitutes as “high risk”

“The FDA considers bone graft substitutes containing recombinant proteins or synthetic peptides high-risk (Class III) medical devices,” stated the Agency. “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.”

The Agency recommended three other treatments physicians should try before resorting to the use of bone graft substitutes in patients under 18 years of age, including:

• Autograft bone: garnered from another part of the body
• Allograft bone: transplanted from a donor’s body
• FDA-Approved bone graft substitutes that do not contain recombinant proteins or synthetic peptides

If a physician does decide to use bone graft substitutes containing recombinant proteins or synthetic peptides in a patient under 18 years of age, the FDA advises them to closely monitor their progress and report any adverse agents to the Agency.

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