In two reviews, two studies and an editorial appearing in a special issue of The Spine Journal today, a group of spinal specialists directly rebuke the research of other spinal surgeons that has supported the widespread use of a Medtronic bone growth product called Infuse. More specifically, the specialists chastise those researchers who received millions of dollars from Medtronic and allegedly failed to report serious complications and side effects that affected patients receiving the Medtronic Infuse bone graft product during clinical trials. Ultimately, the specialists have found the clinical research to be both misleading and biased. Early access to these reports spurred the U.S. Senate Finance Committee to announce last week that it was conducting a formal investigation into whether doctors with financial ties to the Medtronic were aware of but didn’t report potentially serious complications including male sterility, infection, bone loss and unwanted bone growth.
NONE of the 13 clinical trials, involving 780 patients and funded by Minneapolis-based Medtronic, reported ANY adverse events from the product, according to a review led by Eugene Carragee, chief of spinal surgery at Stanford School of Medicine in Palo Alto, California. However, according to his review, approximately 10% to 50% of patients who were part of clinical trials experienced complications including infection, pain, cyst formation and cancer. The reason why these problems failed to appear in a number of studies published by researchers? According to the report, 15 of the researchers who took part in the studies received $62 million from Medtronic over a 10-year period. Despite being peer-reviewed and published, everyone seemed to turn a blind eye to what seemed to be obvious discrepancies… until now.
All Medtronic could muster in response to the news was that they “will continue to investigate questions surrounding researchers’ potential conflicts of interest, refine our policies as warranted, and strive to lead the industry in ethical and transparent business practices.”
Infuse, also known as bone morphogenetic protein-2, is a powerful biological agent used in spinal fusion surgery. The product stimulates bone growth and eliminates the need to harvest a small amount of a patient’s own bone to create a fusion between two vertebrae. As a result, it is highly popular with spinal surgeons. Medtronic has said that Infuse has been implanted into more than 500,000 patients and is used by more than 2,300 surgeons.
Since Medtronic received approval for the product by the FDA in 2002, the Infuse has been the subject of constant controversy and scrutiny for its off label implementation, which encompasses about 85% of Infuse use. In the past, Medtronic has been accused of actively promoting and marketing the Infuse bone stimulator off-label for use in the cervical spine, or neck.
If you or a love one has suffered from male sterility, infection, cyst formation, bone loss, unwanted bone growth, or even cancer following a spinal surgery where Medtronic Infuse was used, you should contact your doctor immediately to discuss your options.