March 5, 2014 — In a securities filing, Medtronic Inc. stated that about 1,000 people have filed 700 Infuse Bone Graft lawsuits in state and federal courts. They expect that number to grow considerably in the next few years. In addition, several states are investigating sales and marketing practices involving Infuse.
Infuse is a bioengineered bone-growth protein (bone morphogenic protein-2 or BMP-2) that was implanted in the spines or more than 1 million people undergoing spinal fusion surgeries. About 85% of these uses were “off-label,” not approved by the FDA.
Hundreds of lawsuits have been filed by people who experienced excess bone growth that occurred after “off-label” surgery. In 2008, the FDA published a Safety Alert about life-threatening complications that occur when Infuse is used “off-label” in the neck (cervical spine), causing swelling and compression of the airway and nerves.
Problems with the Infuse have been ongoing for over a decade. Medtronic paid $210 million to a group of doctors and two corporations over the course of 15 years, including $34 million to University of Wisconsin surgeon Thomas Zdeblick.
The U.S. Senate Finance Committee investigated and found that Medtronic secretly wrote and edited 13 papers that were attributed to independent scientists and doctors. Investigators also found that Medtronic downplayed risks associated with Infuse — including male sterility, infection, and chronic pain in the back and legs — while promoting the device as safer and less painful than traditional bone-graft devices.
Medtronic marketed Infuse as superior to traditional bone-grafting surgery, which may involve harvesting bone from other areas of the body (usually the hip) or transplanting cadaver bone. In 2013, two independent studies found that Infuse offered little benefit over traditional bone-grafting surgery, but warned it could increase the risk of devastating side effects like cancer, male sterility, growth of unwanted bone, and more.