The INFUSE Bone Graft was a revolutionary product that could stimulate bone growth for spinal fusion without having to harvest bone matter from the patient. But when the FDA approved the Medtronic INFUSE Bone Graft in 2002 to be used strictly on patients suffering from spinal fractures, scoliosis, and other injuries in the lumbar region. As it turns out, the Infusion Bone Graft system was used widely off-label in patients with injuries in their neck, the cervical vertebrae. The severe side effects associated with the treatment have caused severe adverse events in patients who had been treated with the bone morphogenetic protein-2. As a result, hundreds of patients have suffered severe complications and several have filed claims against the billion-dollar medical technology company. If you have become injured as a result of your Infusion treatment, a professional Medtronic bone graft lawyers at Estey Bomberger can help you seek justice by securing your rightful compensation.
Cervical Spine Procedures
Approximately 85 percent of Infuse use is for off-label procedures many of were cervical spine procedures. Before the Infusion Bone Graft was approved for sale in the United States, researchers discovered 70 percent of patients had ectopic bone growth that worsened the conditions of their spinal cord injury. Despite this, the researchers who were funded by Medtronic deemphasized the danger of this finding and brought the product to market, even recommending the Infuse Bone Graft for off-label use. Patients whose cervical spine injuries were treated with the genetically engineered product were at a higher risk of fatality and may suffer complications such as:
- Ectopic or uncontrolled bone growth
- Nerve damage
- Respiratory problems
- Chronic pain
- Difficulty speaking
- Severe inflammatory reactions
- Male sterility
A Controversial Treatment
Despite the FDA approval and the research that had been published in 2004, there have been several reports on the dangers of the bone morphogenetic protein-2, side effects of which Medtronic had knowledge of but failed to acknowledge. All of the papers published on the product failed to mention or adequately address the known dangers. And more recently, a number of surgeons have stepped forward, explaining the dangers associated with the Infuse bone graft and how its use should be limited to specific cases that the FDA approved of. As evidence for the dangers of the product accumulates, there is growing concern over the widespread off-label use of the product, allegedly encouraged by Medtronic.
Take Legal Action
Several victims have already filed suit against Medtronic. Having professional representation from a skilled defective medical device lawyer can ensure you recover the damages for the pain and suffering caused by the dangerous treatment. For more information on how our attorneys can help you, please contact our offices to schedule a free consultation today.