Medtronic’s bone graft device called Infuse was once hailed as a major advance in spine surgery and is now the subject of investigations by the FDA and the U.S. Senate and the Department of Justice over omissions of safety problems from its clinical trial data and over off-label use. According to investigators many orthopedic surgeons who were paid millions of dollars by Medtronic, failed to report serious complications from Infuse, including cancer, sterility in men, infections, bone dissolution and worsened back and leg pain. The article said complications occurred in 10 to 50 percent of patients who got the product in 13 Medtronic-funded clinical trials between 2000 and 2010.
Infuse, approved by FDA for use in some spinal fusion surgeries and dental procedures, is also used for unapproved purposes, or off-label, at the physician’s discretion.
While off label use of Infuse is not illegal, the company is prohibited by law from marketing the product for off-label purposes. A U.S. Department of Justice investigation is underway to determine whether that was the case for Infuse.
Sens. Charles Grassley, R-Iowa, Herb Kohl, D-Wis., and Richard Blumenthal, D-Conn., have called for specific explanations of how Medtronic monitors products once they are released to the public. The Senators’ letter also seeks specific data about Medtronic’s embattled spine product Infuse.