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FDA Warning for Infuse Bone Graft Risks in Kids

No Longer Accepting Cases

January 23, 2015 — New warnings from the FDA highlights the increased safety risks children face when they undergo spinal surgery with Infuse and other bone-graft substitutes.

Reported side effects of bone-graft substitutes in adults include excess bone growth, fluid accumulation, inhibited bone healing, and swelling.

In children, these complications could be much more serious due to their smaller size, which could increase the risk of nerve damage, weakness, and chronic pain. If the graft is used on growing bones in a child, it could cause abnormal skeletal development.

The FDA was specifically concerned about bone-graft substitutes containing recombinant proteins or synthetic peptides.

One of the most popular products is Medtronic’s Infuse bone graft, which contains recombinant human bone morphogenic protein (rhBMP-2) soaked in a collagen sponge. Infuse is designed to be implanted between vertebrae, where BMP stimulates bone growth that fuses bones together.

Although Infuse is not FDA-approved for use in children, a study published in JAMA in 2012 found that nearly one in ten children who undergo spinal fusion surgery are treated with BMP.

In fact, Infuse is frequently used “off-label” for surgeries that are not FDA-approved. And this is not the first time the FDA has issued warnings about serious safety risks.

In 2008, the agency issued a warning about life-threatening complications that could occur when it was used in the neck. They received 38 adverse event reports describing swelling in the neck and throat, which could cut off the patient’s airway and cause death

 

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