Medtronic Infuse Bone Graft Injury Lawsuit
The Medtronic Infuse Bone Graft was approved by the Food and Drug Administration as a sanctioned medical device designed to stimulate spinal bone growth in patients suffering from lower spine degenerative diseases. According to Medtronic, Infuse has been used to treat more than 500,000 patients and generated sales of about $800 million in fiscal 2011.
The Medtronic Infuse Bone Graft contains recombinant human Bone Morphogenetic Protein (rhBMP- 2), a protein released naturally by the body. According to the company’s website, the bone graft provides the scaffolding where new bone can grow,. The Infuse is approved by the United States Food and Drug Administration (FDA) to treat a condition of the lumbar spine known as Degenerative Disc Disease, as well as open fractures of the tibia. The FDA has also approved the device for use in two dental bone graft procedures, known as sinus augmentation and localized alveolar ridge augmentation.
The FDA has not approved the Medtronic Infuse Bone Graft for any other procedure, thus any other use of the device would be considered off-label. In July of 2008, the FDA reported that the device had caused serious problems when used off-label in procedures of the cervical spine (neck). The FDA said at that time it had received 38 reports in 4 years of serious side effects in these cases which involved swelling of the neck and throat tissue, causing compression of the airway and other structures in the neck. Patients reported difficulty swallowing, breathing and speaking, and some more serious cases required emergency treatment, including tracheotomies and insertion of feeding tubes, as well as revision surgeries to repair the problems caused by the off-label use of the Infuse.
A U.S. Senate report stated that Medical device maker Medtronic, Inc. edited health journal articles and paid doctors millions of dollars for company-sponsored studies of its Infuse bone-grafting product used in spinal surgery. Claims of Medtronic promoting the Infuse Bone Graft for off-label use, which is illegal, began to surface. While it is illegal for the manufacturer of a medical device to promote its use for off-label situations, a physician or surgeon may use the device in any manner he or she sees fit.
If you or someone you love were injured due to a surgical procedure involving a lumbar or cervical bone graft, you owe it to yourself to contact the attorneys at Loncar & Associates. Contact our office at 800-285-4878, or use the link to the right for a free case evaluation.
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