The FDA approved the Medtronic Infuse Bone Graft strictly only for a small number of conditions, such as severe scoliosis, spinal instability, or spinal fractures. The Infuse Bone Graft simplified spinal cord injury surgery and revolutionized treatment. However, the dangerous side effects of the bone morphogenetic protein-2 was not reported in the study published in 2004 and was downplayed in subsequent papers by doctors who had financial ties with Medtronic. Patients who have been severely injured by the side effects of Infuse Bone Graft may be entitled to recover compensation for their financial losses, pain and suffering. Having a professional Medtronic bone graft lawyers can help you protect your rights.
Infuse Bone Graft Side Effects
When Medtronic first initiated studies in 1999 on the bone morphogenetic protein, researchers discovered 70 percent of patients developed unnatural bone growth called ectopic bone growth. When the study was finally published in 2004, researchers deemphasized the dangers. Other studies found several patients suffered from male sterility after being treated with the Infuse Bone Graft treatment. The ectopic bone growth can cause other complications such as:
- Respiratory problems
- Nerve damage
- Chronic pain
- Speaking difficulty
- Bone dissolution
- Wrongful death
Medtronic’s Paid Researchers
Over 290 cases of adverse events has been filed with the FDA, and many are raising questions about the safety of the Infuse Bone Graft and the credibility of the dozens of papers promoting the widespread and even off-label use of the product. In June 2011, a study published in The Spine Journal reported that researchers paid by Medtronic failed to disclose the severe complications that Infuse can cause. According to news reports, five surgeons had been paid $7 million over the course of nine months, only a fraction of the millions Medtronic had paid its researchers, doctors, and medical professionals. Several patients have already filed lawsuits against Medtronic, claiming the billion-dollar medical technology company promoted the product for off-label use and purposefully downplayed its dangers.
Filing a Product Liability Claim
Patients who suffer from defective medical devices are protected under product liability law that holds the manufacturer responsible for the damages incurred from the bone graft side effects. Numerous spinal surgeons have raised concerns over the safety of the Infuse and have stressed the necessity to restrict its use to particular cases approved by the FDA. If you or a loved one has been wrongly injured from the illegal promotion or the unreported safety hazards of the Infuse Bone Graft, please schedule a free consultation with our qualified Medtronic bone graft lawyers. Our defective medical device lawyers are currently screening patients for potential cases and are offering free consultations. For the sake of your future health and optimal recovery, please schedule an appointment today and let our attorneys help you secure your rightful compensation.