- Medtronic Infuse Bone Graft is used stimulate bone growth and replace damaged spinal disks
- Approximately 250,000 spinal fusions are performed each year, half on the upper and half on the lower spine
- The Wall Street Journal reported Medtronic paid $800,000 over three years to a surgeon who fabricated a positive study for the Infuse Bone Graft
- In July 2011, The Spine Journal published articles exposing the risks associated with Medtronic’s Infuse Bone Graft
- Risks include inflammatory reactions, adverse back and leg pain events, radiculitis, retrograde ejaculation in men, urinary retention, bone resorption, and implant displacement.
- Howard Nations has been successfully prosecuting cases for over 45 years
Information on Medtronic Infuse®
The Medtronic bone graft contains recombinant human Bone Morphogenetic Protein (rhBMP), which is a genetically engineered version of a protein that is naturally released by the body. Use of the Bone Morphogenetic Protein is intended to initiate bone growth in specific areas of the spine, so surgeons have some control over where the bone re-growth occurs. The Infuse® Bone Graft was approved by the FDA in 2002 for use in lumbar (lower back) spinal repair surgeries. In these surgeries, it is only approved for anterior surgical approaches, that is, through the front (stomach) of the patient. However, Medtronic encouraged physicians to use its Infuse® product off-label in the cervical spine, which helped generate sales of more than $3 billion for the manufacturer.
Medtronic Infuse® and the FDA
In July 2008, the FDA issued a warning concerning the risks of Medtronic Infuse® Bone Graft use on the cervical spine.The agency’s warning stated,” that the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use.” The Wall Street Journal reported by 2008 that FDA records showed approximately 200 adverse events with serious complications after Infuse® was used off-label. According to reports, doctors who wrote favorable reports about the product may have been paid by Medtronic. The Wall Street Journal also said that Medtronic paid approximately $800,000 over three years to a surgeon who was accused of fabricating a study that reported positive results for the Infuse® Bone Graft. In June 2011, the US Congress announced it would investigate surgeons who were paid consultants for Medtronic.
In July 2011 The Spine Journal published a number of articles regarding the risks associated with Medtronic’s Infuse® Bone Graft, including the following: Medtronic’s failure to accurately report the side effects from its clinical trials; Medtronic’s failure to report that many of the authors who studied and promoted its product had significant financial ties to the company; that Infuse® Bone Graft can cause severe problems with nerves and spinal cords; and that off-label use of Infuse® Bone Graft can lead to severe side effects.
Medtronic, the manufacturer of Infuse® BMP, owes a duty to its consumers to provide a safe and effective product, but to also warn of the potential dangers associated with its product’s use. By placing Infuse on the market for all spinal fusion surgeries, Medtronic has actively ignored the dangers associated with its product’s use. Medtronic must now compensate those patients who by merely seeking treatment for their spinal problems are now suffering from much worse complications.
At The Nations Law Firm we have years of experience in pharmaceutical and medical device litigation. It’s what we do. We have the resources, knowledge, and commitment required to stand up to the drug and device companies and fight for your rights. If you or someone you know may have developed complications after spinal fusion surgery using the Infuse product, please contact our offices at (800) 269-3050 for a free case evaluation by one of our experienced attorneys.