Recombinant bone growth proteins and synthetic peptides should not be used routinely in spinal fusion surgery involving children due to the risk of severe bone graft complications, according to a Safety Communication from the U.S. Food and Drug Administration.

One of the most popular products, Medtronic Infuse, contains recombinant proteins that stimulate bone growth. Health officials are concerned that children may be at greater risk of nerve damage, chronic pain, weakness, and other bone graft complications due to their smaller size and growing skeleton.

In 2012, a study found that 10 percent of spinal fusion surgeries in children used bone-growth proteins. The FDA was particularly concerned about spinal surgery, warning:

“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.”

The FDA has already received reports of children who developed excess bone growth, fluid accumulation, inhibited bone healing, and swelling.

Medtronic Infuse Bone Graft Complications

These adverse bone graft complications also occur in adults, but the FDA is more concerned about children due to their smaller size and growing bones.

For example, if the products were implanted near an open growth plate, it could affect normal skeletal development. Vital organs are also closer together in children, which increases the risk of complications from excess bone growth.

Traditional bone graft techniques in children do not have the same risks. These techniques include autograft bone (bone that comes from another part of the patient’s body) and allograft bone (“banked bone” which is transplanted bone from another person).

Despite the lack of FDA approval, bio-engineered bone-growth products have gained popularity for use in children. The products contain synthetic peptides or recombinant proteins (such as rhBMP-2), which mimic the effect of natural bone-growth proteins in the body.

None of these products are FDA-approved for use in children under 18 years old. The FDA classifies them as a high-risk, Class III medical device subject to strict regulation.

Medtronic Bone Graft Lawsuits

Medtronic is facing a growing number of Infuse bone graft lawsuits. The first Infuse lawsuits were whistleblower lawsuits filed by three employees of Medtronic who alleged that the company promoted Infuse by paying doctors millions of dollars to produce favorable studies.

Soon after, the U.S. Department of Justice launched a criminal investigation. Furthermore, many people who were injured have filed Infuse bone graft lawsuits alleging that Medtronic failed to properly disclose the dangers of the Infuse bone graft.