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Medtronic Infuse® Bone Graft Lawsuits Allege Excessive Spinal Bone Growth

Medtronic’s Infuse® Bone Graft 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.

Notwithstanding these criteria issued by the Food and Drug Administration, the Infuse® Bone Graft has been widely used by surgeons for “off-label” purposes, including neck surgeries. According to one report, researchers have alleged that 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 Food and Drug Administration had not approved.

However, off-label usage of Infuse® Bone Grafts during spinal surgery have 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. The first study can be found here and the second study can be found here.

Although the Infuse® Bone Graft was once considered a groundbreaking means of replacing damaged or diseased bone by stimulating bone growth, the Infuse® Bone Graft is now the target of lawsuits alleging that the device causes life-threatening complications when used for such 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. While no formal multidistrict litigation (MDL) has been formed as of yet, it appears to be only a matter of time before some sort of coordinated action is initiated on behalf of persons who have sustained serious and permanent injuries as a result of the Infuse® Bone Graft.


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