Infuse Bone Graft Dangers

Can you imagine how it would feel to have to fight for every breath? How would you feel if swallowing became so difficult and there was no relief in sight? This is the fate of thousands of patients who suffer side-effects after surgical implantation of a Medtronic Infuse Bone Graft placed in the cervical spine. Uncontrolled bone growth may occur which can result in difficulty talking, swallowing or even breathing. Severe neck swelling may also result from bone growth. Using a Medtronic Infuse Bone Graft in this manner is considered off-label, as it was not approved by the Food and Drug Administration. Off label use is the practice of prescribing pharmaceutics for an unapproved indication, an unapproved age group, or an unapproved dose. Contrary to popular notion, it is legal in the United States and other countries to use pharmaceuticals off label as the FDA does not have the legal authority to regulate the practice of medicine. The physicians are authorized to use pharmaceutical devices or prescribe medications off label. The company that manufactures Infuse has been accused of promoting the unapproved use of its product. In addition to above listed complications, many other injuries can develop after Medtronic Infuse Bone Graft implantation via off-label use. Nerve damage and chronic pain, especially in the arms and legs, may result. Bone growth can become uncontrolled and can expand beyond the original cage in which the bone graft was placed in. These nerve injuries can cause chronic or intermittent severe pain. Male sterility and urogenital injuries may also occur. The Medtronic Infuse Bone Graft may be used off-label when it is implanted in the lumbar spine as well. Originally, the FDA approved the graft to be used only in anterior approach lumbar surgery. However, the graft has been implanted by posterior and lateral approach surgeries in the lumbar spine as well. Doctors and researchers with significant financial ties to the manufacturer, Medtronic, have come under scrutiny for reporting no serious side effects from the Bone Graft. These doctors suspiciously wrote glowing reviews of the device while pocketing large fees from Medtronic. After several investigations and a lawsuit brought by Medtronic shareholders, Rudolph F.X. Migliore, P.C. is prepared to investigate claims against Medtronic for off-label use of the Infuse Bone Graft. If you or someone you know has had a bone graft surgery and suffered side effects, call our office at 631-543-3663 for a free case evaluation.