Medtronic’s Infuse® Bone Graft Associated with Increased Risk of Developing Tumors, Study Finds
A new study suggests that patients undergoing surgery involving Medtronic Infuse® Bone Graft may face an increased risk of developing tumors. Neurosurgery researchers from Duke University, University of Louisville, and the Center for Neurosurgical Outcomes Research investigated whether Medtronic’s Infuse® Bone Graft is associated with an increased risk of cancer or benign tumors. The researchers looked at data for more than 4,600 patients who underwent spinal surgery using Medtronic’s Infuse® Bone Graft, which is used during spinal fusion surgeries and contains a bone morphogenetic protein (BMP). The researchers compared this data to data from other patients who underwent spinal surgery without the Infuse® Bone Graft. The results of the study suggest that the Infuse® Bone Graft is associated with a significantly higher rate of malignant cancer (9.4% of patients using Infuse® Bone Graft compared to 7.9% other patients). Although the difference is not statistically significant, based on the results, the researchers also believe that the Infuse® Bone Graft is associated with a statistically significant higher rate of benign tumors (Infuse® Bone Graft patients were 31% more likely to develop benign tumors than non- Infuse® Bone Graft patients).
Medtronic’s Infuse® is a bio-engineered bone graft product that is promoted as an alternative to traditional spine surgery, which entails harvesting bone from another area of the body or a cadaver. The Food and Drug Administration (FDA) only approved the Infuse® Bone Graft for use during limited spinal fusions, where the lumbar spine is approached frontally and the product is utilized in conjunction with a collagen sponge. FDA approval also mandates that the Infuse® Bone Graft be implanted within an “LT-Cage” to encourage bone growth between vertebrae. Recently, concerns have grown that the Infuse® Bone Graft has been widely used by surgeons for “off-label” purposes, including neck surgeries. In fact, some claim Medtronic may have illegally promoted such off-label use of the Infuse® Bone Graft to encourage doctors to use the product in ways that the FDA had not approved.
Off-label usage of Infuse® Bone Grafts during spinal surgery has been linked to severe and painful complications stemming from excessive bone growth around the spine. The bone overgrowth, in turn, can damage nerves around the spinal cord, causing intense pain, paralysis, spasms, and other serious complications. In fact, two independent studies published in the Annals of Internal Medicine have concluded that the Infuse® Bone Graft provides no benefits over traditional spine surgery and may expose patients to additional risks. Medtronic is now facing lawsuits alleging that their Infuse® Bone Graft device causes life-threatening complications when used for off-label purposes. Lawsuits have been filed against Medtronic seeking recovery for patients who have suffered serious and permanent injuries after undergoing a bone graft procedure involving the Infuse® Bone Graft.
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