The Medtronic Infuse bone graft is a medical device which was approved by the FDA in 2002 to treat specific medical complications involving the lumbar spine, which is the lower spine, and for use in oral and dental procedures. More specifically, the FDA approved the Infuse Bone Graft to treat degenerative disc disease and certain fractures, such as an open fracture, to the tibia, which is the bone that connects the knee to the ankle. Although the FDA approved this device for these limited and not for any other use, the device has been used by some doctors from across the country to treat other medical complications, including off-label cervical spine operations. When a doctor uses a drug off-label to treat medical complications, essentially the physician is using the drug for purposes other than its FDA approved usage. Generally it is a common belief that once the FDA approves a drug or device, the product is safe for consumer use.
The Infuse Bone Graft which is currently being marketed by Medtronic, contains recombinant human Bone Morphogenetic Protein (rhBMP). This protein is a genetically engineered version of protein that is naturally produced in the human body to stimulate growth and healing of the bones, specifically those located in certain areas of the spine. However, due to numerous reports from patients who underwent treatment with this device, the Medtronic Infuse bone graft has been linked to several adverse medical complications.
According to the FDA, most injuries associated with the Medtronic Infuse bone graft normally occur within two to 14 days after a surgical procedure. Some of the most common reported serious side effects patients across the country have experienced include:
If you or a loved one has suffered an adverse side effect that was caused by the Medtronic Infuse Bone Graft, you should consult with an attorney such as those listed on Law Info to discuss your complaint. You may be entitled to receive monetary compensation to recover financial loss due to your medical costs, pain and suffering, and additional damages you have sustained.
Medtronic Attorneys across the country are helping patients injured by the Medtronic Infuse Bone Graft by filing a civil lawsuit against the company and its manufacturers. Far too many individuals have suffered serious complications as a result of using this medical device, and usually when physicians have failed to use the products according to FDA approved purposes. In July 2008, the agency issued a warning concerning the off-label usage of the Medtronic Infuse Bone Graft, and 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”.
Even more alarming are reports that the company, Medtronic, paid a surgeon to release fabricated reports about the positive results of its Infuse Bone Graft. In June 2011, the U.S. Senate and Finance Committee began investigating whether or not the company paid consultants to release these favorable reports on its behalf and failed to release information regarding the adverse risks associated with the use of this device, among which include nerve damage, sterilization, and swelling of the neck and throat.
The attorneys listed on our website are interested in your helping you or a loved one harmed due to the use of this device. If you or your loved one has suffered a serious side effect, or wrongful death, contact one of the attorneys listed here. You could have a potential Medtronic lawsuit and be entitled to recover monetary compensation for your damages.
For assistance with your Medtronic Infuse Bone Graft case, click here to find Medtronic Infuse Bone Graft lawyers near you or find lawyers in a different state.