June 19, 2013 — Two studies published by the Annals of Internal Medicine have concluded that Medtronic Infuse bone-growth protein is no more effective than traditional bone grafts for spinal fusion surgeries, but it could increase the risk of severe, life-threatening side effects, such as cancer.
Medtronic released data to the researchers after an investigation found that they paid millions of dollars to researchers who produced research that was favorable to Infuse. The company is now facing many lawsuits from people who were injured.
Two studies of the Medtronic Infuse bone-growth protein:
The controversy erupted in 2011, when The Spine Journal published reports showing that researchers who were paid millions of dollars in consulting fees, royalties, and other payments produced research that showed Infuse was better than traditional bone grafts.
Soon afterward, Congress and the Justice Department launched investigations, the U.S. Food and Drug Administration (FDA) issued safety warnings, and numerous lawsuits and class actions were filed. It is estimated that one million people were treated with Infuse between 2002 and 2011.
Medtronic defended the integrity of Infuse by touting its primary advantage. Unlike traditional bone grafts, which require multiple surgeries so a surgeon can harvest bone from a patient’s hip, patients treated with Infuse only require one surgery.