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Medtronic Faces Allegations of Off-Label Marketing

Posted on in Defective Medical Devices

When industry giant Medtronic Inc. announced that it had come up with an implant known as INFUSE, that could potentially replace the bone graft procedure, it was big news in the medical world. The Food and Drug Administration, which regulates procedures such as these, approved INFUSE for use in spinal surgery, specifically in a lower spine operation known as an anterior lumbar interbody fusion. Medtronic, however, had other ideas for INFUSE. One of these was in dental restoration surgery.

Bone grafts in dental restoration can be dangerous and expensive, and rely on “bone-harvesting from a patient's own body for reliable and safe sinus life procedures,” according to a Medtronic pamphlet. The INFUSE, argued Medtronic, was a safer way to do the same thing. “Most patients grew enough bone to place a dental implant regardless of whether they had autogenous bone or INFUSE Bone Graft,” according to Medtronic. Some didn't, however, and these were the ones for whom the INFUSE would be the most important. According to the pamphlet, “multiple studies were conducted on approximately 312 patients who did not have enough bone in their upper jaw to place implants.” Some of these patients received an INFUSE while others an autogenous bone graft. “Both the INFUSE Bone Graft and autogenous bone graft formed new bone that allowed for the placement of dental implants into patients who otherwise would not have been able to have implants placed,” according to the pamphlet.

Yet in June, according to Bloomberg News, two independent reviews found that the Medtronic Inc. INFUSE, “works no better than a graft and carries side effects including an increased risk of cancer.” These studies were initially published in the Annals of Internal Medicine, and were intended to inform doctors who may use or recommend the product to their patients. Other research called out the INFUSE as responsible for male sterility and other infections. Medtronic is facing allegations of off-label marketing because INFUSE was not approved for the dental restoration procedure for which it was being marketed.

If you or someone you know has been affected by INFUSE, or any other defective medical device, don't go through it alone. Contact a dedicated defective medical device attorney today.

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