The FDA has received at least 280 complaints from patients suffering adverse side effects of Medtronic’s Infuse Bone Graft Device, with as many as 75% of all complaints involving off-label use.regulators received data demonstrating that up to half of all patients implanted with the Infuse Bone Graft suffered some complications. Though Medtronic reported no adverse risks found in thirteen company-sponsored studies involving 700 patients, U.S.Medtronic admitted to paying $800,000 to a surgeon who falsified the results of a study, providing a positive review of Infuse and minimizing its risks.Medtronic, Inc., recently agreed to an $85 million settlement to investors who accused the company of making false claims about Infuse, and who claim that 85% of sales were from off-label use, often by physicians paid by Medtronic.Because of allegations of unethical and illegal marketing practices, Medtronic is the subject of a criminal investigation as well as numerous lawsuits:
Though physicians are not prohibited from using a device off-label, drug companies and medical manufacturers are disallowed from marketing a device as appropriate for off-label use. The FDA has approved the use of the Infuse Bone Graft solely for lumbar spine surgery. Most lawsuits pertaining to BMP and the Infuse implant are related to off-label use of the device, particularly in surgeries of the cervical spine or neck. We can, however, help put you in contact with a qualified Medtronic infuse bone graft lawyer who does handle such cases. Our firm does not handle infuse bone graft defective device cases. If you or a loved one has suffered because of this device, contact a defective medical device lawyer today to see what options are available for you and your family.
is currently under investigation by Congress and the Department of Justice and is the defendant in a number of personal injury, dangerous products, wrongful death, and class action lawsuits. When used off-label, in a manner not condoned by the FDA, the substance BMP-2 has been demonstrated to have a high rate of potentially life-threatening complications.īecause of these risks and Medtronic’s allegedly unethical practices regarding the marketing and sale of Infuse, Medtronic, Inc. Medtronic, Inc., the nation’s leading manufacturer of medical devices, developed an implant used for spinal surgery to help eliminate the need for painful bone graft surgery.įDA-approved for lumbar spine surgery, or surgery of the lower spine, the Infuse Bone Graft device was intended to be implanted in the spine to encourage bone growth after spinal surgery.Įven when used as approved by the FDA, Infuse, like many other medical devices or procedures, carries some risk of adverse side effects. Medical researchers are continually involved in developing new pharmaceuticals, surgical procedures, technologies, and medical devices that are designed to cure illnesses, improve healing, minimize pain and recovery time, and maximize patient outcomes. Medtronic Infuse Bone Graft Implant Device
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