The world’s largest medical technology company, Medtronic, has become the center of controversy due to claims regarding its Infuse bone graft product. Many of the recipients of Medtronic Infuse Bone Graft treatment have filed lawsuits against the company after experiencing complications and adverse events related to the device. Medtronic claims that its Infuse bone growth treatment has no risks of complications and cites several research studies, which were conveniently conducted by people with significant financial ties to the company. In each of the Infuse research studies, financial conflicts of interests were either not clear or entirely left unmentioned.
What is Medtronic Infuse Bone Graft?
The Medtronic Infuse Bone Graft is a bone growth treatment used to help repair complex bone fractures, as well as fractures that do not heal correctly or those with increased risks to the patients. Medtronic Infuse bone graft products utilize a synthetic version of a naturally occurring protein, which is supposed to initiate and encourage bone growth in specific areas of the spine. Unfortunately, high doses of this ingredient, called recombinant human bone morphogenetic protein (rhBMP-2), have been linked to various complications, including an increased risk of cancer. Amplify, another Medtronic bone graft product, contained rhBMP-2 as well and failed to obtain FDA approval as a result. Despite these risks, Medtronic continues to claim that its Infuse product carries with it no risks or adverse effects.
Medtronic Infuse Off-Market Promotion
Although doctors have the prerogative to use medical devices as they see fit, medical technology companies are prohibited from promoting their products for uses other than the uses that are approved by the United States Food and Drug Administration. Although Infuse bone grafts are only FDA approved for lumbar spine procedures, Medtronic is suspected of promoting its Infuse products to doctors for non-FDA approved cervical spine procedures as well. As a result of this alleged promotion, Medtronic is under investigation by both the Department of Justice as well as several members of the Senate.
Medtronic Infuse Bone Graft Lawsuit: Speak to an Attorney
If you were treated with a Medtronic Infuse Bone graft and experience complications, contact the Willis Law Firm today for your free lawsuit evaluation. Medtronic infuse bone graft has been linked to all of the following complications:
- Male Sterility
- Unwanted bone growth & bone loss
- Leg pain