Negative Side Effects of Infuse Bone Graft Continue

 Posted on January 11, 2014 in Defective Medical Devices

Medtronic Inc. devised a bone graft device known as Infuse Bone Graft, which hit the market in 2011. As of mid-2013, the Infuse had been used in millions of surgeries across the nation, touted as a safer alternative to a bone graft after spinal surgery. According to Bloomberg News, however, the Infuse “works no better than a graft and carries side effects including an increased risk of cancer, two independent reviews found.” These studies were originally published in the Annals of Internal Medicine, Bloomberg reports, and were commissioned by Medtronic Inc. “after the product's risk-benefit profile was called to question by research linking it to male sterility, infections, and cancer,” Bloomberg News reports.

In mid-2013, shares for Medtronic, “the world's biggest maker of spinal treatments,” fell 1.1 percent after having gained 39 percent since 2012, reports Bloomberg. Part of the controversy stemmed from the fact that, according to Medscape, “several harmful side effects of using [Infuse] in spinal fusion surgery went unreported in the published articles supporting the safety and efficacy of that product.” Data presented by Medtronic as to the safety of Infuse were at complete odds with data compiled from similar studies by the FDA. According to Medscape, “the FDA data show there was increased radiculitis, an increased number of leg pain events, increased infection rates, and an increased chance of sterility.”

In 2011, spine specialists publically repudiated Medtronic research, according to The New York Times, an unprecedented move by the healthcare industry. The repudiation “represents a watershed in the long-running debate over conflicts of interest for the sponsorship of scientific studies by makers of drugs and medical devices,” the Times reports. Yet even then the Infuse was not completely removed from the operating room. According to Bloomberg, Infuse accounted for 3 percent of Medtronic's total business in FY 2012.

If the Infuse Bone Graft or any other defective medical device has negatively affected you, you are likely eligible for compensation. The most important step is to seek legal counsel in the Chicagoland area. Contact Newland & Newland, LLP today.