No Longer Accepting Cases

January 23, 2015 — A recent warning from the FDA highlights serious safety risks when bioengineered bone-graft substitutes like Infuse are used in children under 18.

The FDA has received reports of serious injuries, such as excess bone growth, fluid accumulation, inhibited bone healing, and swelling in adults who were treated with bone-graft substitutes containing recombinant proteins or synthetic peptides.

These side effects in children could be much more serious due to their smaller size and growing bones. Long-term complications could include nerve damage, chronic pain, weakness, abnormal skeletal development, and more.

Medtronic Infuse is one of the most popular bone-graft substitutes. It contains recombinant human bone morphogenic protein (rhBMP-2), which is soaked in a collagen sponge.

When the product is implanted during spinal fusion surgery, it acts like a scaffold to encourage new bone growth and fuse the gaps between vertebrae.

The FDA has approved Infuse for specific spinal surgeries in the lower back in adults. However, it is widely used “off-label” for uses that have never been evaluated in clinical trials.

In 2012, a study published in JAMA found that nearly 10% of spinal fusion surgeries in children used BMP, a bone-growth product.

The FDA has also issued a Safety Warning about the risk of life-threatening complications when rhBMP-2 products, such as Infuse, are used in the cervical spine.

Between 2004-2008, the FDA received at least 38 reports of swelling in the patient’s neck and throat, which constricted their airway and nerves. Some patients had problems swallowing, breathing, or speaking.