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In 2002, the FDA approved the Medtronic Infuse Bone Graft for limited use in lumbar, oral, and dental procedures, such as treating degenerative disc disease, open fractures on the tibia, sinus augmentation, and localized alveolar ridge augmentation, but since that point, the bone morphogenetic protein (rhBMP-2) product has been associated with several health complications:
- Swelling of airways, leading to difficulty breathing, speaking, or swallowing
- Retrograde ejaculation, leading to male sterility
- Ectopic, excessive, or unwanted bone growth
- Neurological impairment
- Chronic radiating pain in legs or arms
- Cauda Equina Syndrome (CES)
- Cyst formation
- Nerve impingement
Complications start to show two to 14 days after surgery. Recipients have required respiratory support, a feeding tube, anti-inflammatory medications, tracheotomies, or additional surgery.
Although the product stimulates bone growth to replace damaged spinal discs and originally was thought to be an improvement over standard grafts from the hip, Medtronic allegedly marketed the product for off-label procedures, including for cervical fusion, thoracic fusion, posterior fusion, and multi-level fusions.
Risks and Studies
In July 2008, the FDA put out a warning regarding off-label uses for Infuse Bone Grafts. Particularly, use of the bone graft in the cervical spine poses risks, has not proven to be effective, and was not FDA-approved. Other reports around this time revealed Medtronic may have paid doctors involved in studies to deliver positive results.
At the same time, the U.S. Department of Justice began looking into the product’s off-label uses, as 280 reports of side effects had been filed with the FDA.
By 2011, the U.S. Senate Finance Committee began investigating the surgeons Medtronic allegedly paid. The investigation involved determining whether the surgeons did not report complications, including swelling in neck and throat, abnormal bone growth, and sterility.
The Spine Journal, in July 2011, issued a series of articles about risks associated with the Infuse Bone Graft: Medtronic’s reticence to report the product’s effects from its clinical trials and lack of disclosure about the authors’ financial ties to the company; how the Infuse Bone Graft can cause nerve and spinal cord problems; and the side effects associated with off-label usage.
Following these reports, Medtronic announced Yale University would be conducting an independent study on the Infuse Bone Graft. The results same out in June 2013 in Annals of Internal Medicine, revealing Medtronic’s Infuse works as well as a traditional bone graft but may not be safe. The product, according to the findings, is associated with a minimal but still increased risk of cancer and may be of little to no benefit compared with traditional treatments. As well, the article found early published data underreported side effects, instead emphasizing favorable results.
According to statements from Medtronic, more than 1 million patients have received an Infuse Bone Graft, either for standard or off-label treatments. Even before the Yale University study results were published, recipients and employees already filed lawsuits concerning incentives paid to doctors, wrongful death, emergency surgery, fraudulent promotion, and off-label uses.
Lawyers have primarily focused on off-label uses with lawsuits. While it’s not illegal for a doctor to use a product for off-brand uses, it is for a manufacturer to market its products as such.