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.
Medtronic Infuse Bone Graft Studies Publicly Refuted
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.