Complications With The Use of Medtronic Infuse Bone Graft

Comments: I'm Attorney JoAnn Spinks Coleman and I'm here today to discuss the complications arising from the use of the Medtronic Infuse. In 2002, the Food and Drug Administration approved the Medtronic Infuse for one type of spine surgery, the anterior approach lumbar fusion. Infusewas not approved for other types of spine surgeries or surgery on the neck. Despite its limited approved use, many patients have received Infuse during surgeries on the lumbar or cervical spine, even though it wasn't authorized for that procedure. When any drug or device is used by a physician in a way that is not authorized, the surgeon should fully disclose to the patient the risks of the unauthorized substance prior to the surgery. That way the patient can make an informed decision as to whether or not they want to go ahead with the surgery. Infuse bone graft is made of bioengineered liquid bone protein that encourages bone growth. It is put in a small container or cage like device and then is implanted into the spine.Infuse is made by Medtronic, Inc., the nation's largest maker of medical devices. It is estimated that 100,000 patients in the U.S. who have spinal fusion surgery annually are implanted with Infuse. Last year, The Spine Journal, a medical journal, devoted an entire issue to articles about earlier Infuse studies. According to the journal the early studies were biased because they were conducted by physicians with financial ties to Medtronic.The Journal went on to say that none of the 13 trials funded by Medtronic reported adverse events from Infuse. However, data provided to U.S. regulators and other publications showed that up to 50 percent of patients who were implanted with Infuse incurred side effects. Some of those side effects were ectopic bone growth, uncontrolled bone growth, inflammatory cyst formation, and cancer, and infertility in men. If you were implanted with Infuse and suffered side effects it is urgent that you seek legal advice. Don't hesitate to call an experienced law firm and find out how you can receive the help you need.