At this time, medical technology giant Medtronic is being investigated by the Department of Justice as well as several Senate members due its failure to report associated complications with its Infuse synthetic bone graft product. Medtronic is also being accused of promoting non-FDA approved uses of the same product. Recently, Medtronic’s Amplify failed to be approved by the FDA entirely, due to its association with increased cancer risks. Many lawsuits have been filed against Medtronic in relation to these various problems with their bone graft treatments. Common complications with Medtronic’s Infuse include: cancer, leg pain, infection, sterility (in male patients), unwanted bone growth, as well as bone loss.
A collection of spine experts have gathered to publicly refute the findings of research studies that supported Medtronic’s Infuse Bone graft product. These specialists referred to existing research as both biased and misleading, and an entire issue of The Spine Journal was devoted to repudiating research studies about Infuse (June 2011). Infuse is a bone growth product that contains a genetically engineered version of a natural protein called rhBMP-2(recombinant bone morphogenetic protein-2). This protein is controversial in the medical community due to a link with increased cancer risks in high doses. Medtronic, which made nearly $900 million last year from Infuse alone, still maintains that its product is not related to any complications. However, other experts estimate an adverse event rate between 10-50%, depending on how the product is used.
FDA Rejects Medtronic Amplify Bone Graft
Amplify, a Medtronic bone growth product, failed to be approved by the United States Food and Drug Administration due to studies linking the product with higher number of cancers. Interestingly, the active ingredient in Medtronic’s Amplify bone growth product is the exact same synthetic protein used in its Infuse bone graft product. Cancer risks can be even greater in patients who smoke or with genetically higher cancer risks as well.
Have you experienced complications or adverse effects following treatment with a Medtronic Bone Graft product? If so, you may want to consider a Medtronic Bone Graft Lawsuit. Call the Willis Lawsuit today, and we will gladly help you evaluate your potential Medtronic claim with no charge or further obligation. You may be entitled for considerable financial compensation in relation to the physical, emotional, and financial suffering associated with your injuries. At this time, our firm is accepting Medtronic clients in all 50 states; furthermore, all bone graft cases are handled via Contingency Fee Basis.