Medtronic Infuse Bone Graft | Defective Medical Device Lawyers
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Medtronic INFUSE Bone Graft
The Medtronic INFUSE Bone Graft was approved by the U.S. Food & Drug Administration (FDA) to grow synthetic bone for certain spinal fusion procedures. The FDA approved its use for lumbar spinal surgeries; however, the Infuse Bone Graft System has been used in off-label procedures that can cause serious and even fatal side effects. If you have suffered ectopic bone growth, respiratory failure, nerve damage or other severe side effects due to the Medtronic INFUSE Bone Graft, defective medical device lawyers at Burnetti, P.A. may be able to help.
What is INFUSE Bone Graft?
Instead of bone graft procedures that take bone from the hip, the Medtronic INFUSE Bone Graft was designed to use recombinant human bone morphogenetic protein (rhBMP-2) to copy protein in the body and help grow and form bone. The bone graft was approved by the FDA for lumbar spinal surgeries, but many surgeons have used the INFUSE Bone Graft system for unapproved and untested procedures, which have resulted in patients needing respiratory support, feeding tubes, tracheotomies, and many needing additional surgeries.
INFUSE Bone Graft Spine Journal
According to a study by The Spine Journal, there are spinal fusion procedures performed on approximately 80,000 people annually and an estimated half of them were Medtronic bone graft systems. The study stated that over 500,000 patients have had the bone graft procedure and at least one-third of the surgeries were done off-label. The study also reported that Medtronic paid doctors to downplay and conceal the many side effects and complications associated with the bone graft procedure.
INFUSE Bone Graft Side Effects
Medtronic bone grafts have many serious side effects, especially if the bone graft was used in an off-label or non-approved surgery:
Uncontrolled bone growth
Studies have also shown that the INFUSE Bone Graft used in off-label surgeries can also produce a significantly high risk of certain cancers, such as:
Medtronic Spine Lawsuit
An article by the Wall Street Journal reported that about 85% of Medtronic INFUSE Bone Graft procedures were done off-label. If you have suffered the serious side effects associated with the bone graft medical device, INFUSE bone graft lawyers may be able to file a claim on your behalf. For more information, call 1-800-BURNETTI or fill out a free case evaluation here.