Medtronic, the world’s largest medical technology company, is currently under scrutiny due to an increased cancer risk associated with its Infuse Bone Graft Device. Infuse, which accounts for an estimated $900 million of the company’s annual profits, contains a controversial ingredient called recombinant bone morphogenetic protein-2 (rhBMP-2). Medtronic claims that Infuse does not pose any risk of harm to patients; however, other experts believe that between 10% and 50% of Infuse patients suffer complications ranging from infections and leg pain to unwanted bone growth, and even cancer. Previously existing studies regarding Medtronic Infuse are believed to be biased and misleading due to undisclosed financial ties between the doctors leading the studies and Medtronic. In addition to the Infuse cancer controversy, Medtronic has also been accused of promoting off-market uses for Infuse, for uses that are not FDA approved.
Medtronic Infuse Cancer Risk Higher Than Previously Believed
A new research study reveals that the already controversial Medtronic bone graft product Infuse may carry with it a higher risk of cancer than previously suggested. Dr. Eugene Carragee, a professor at the Stanford University School of Medicine, believes that patients who received treatment with Infuse increase their cancer risk by more than two times as much within one year of treatment. In the three years following treatment, this risk is increased by nearly 5x. Carragee, who is also the editor of Spine Journal, dedicated an entire issue of the journal to exposing issues with Infuse and its use of synthetic growth proteins.
Medtronic Amplify Failed to Obtain FDA Approval Due to Cancer Risk
In July of 2010, an advisory panel of the United States Food and Drug Administration failed to approve Medtronic’s Amplify product because a vote determined that the product’s harm outweighed any potential benefits. Interestingly, Amplify contained the same active ingredient as Medtronic Infuse: rhBMP-2. This genetically engineered growth protein has been linked to the increased risks of cancer present in Infuse treatment, but in a higher dose.