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.
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The letter to Medtronic was one of five individual letters sent to different medical device producers whose equipment has malfunctioned after being placed on the market. Grassley, Kohl and Blumenthal also have introduced legislation to require device makers to do clinical studies after their products are offered for sale to the public if those products are approved under a streamlined process that lets them avoid extensive pre-market testing. "A researcher at Stanford University School of Medicine found a higher risk of cancer associated with Infuse, and there have been allegations that researchers who received funds from Medtronic, sometimes millions of dollars, did not report negative findings from clinical trials," the letter states.
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The letter to Medtronic was one of five individual letters sent to different medical device producers whose equipment has malfunctioned after being placed on the market. Grassley, Kohl and Blumenthal also have introduced legislation to require device makers to do clinical studies after their products are offered for sale to the public if those products are approved under a streamlined process that lets them avoid extensive pre-market testing. “A researcher at Stanford University School of Medicine found a higher risk of cancer associated with Infuse, and there have been allegations that researchers who received funds from Medtronic, sometimes millions of dollars, did not report negative findings from clinical trials,” the letter states.
Doctors use Infuse to help bones fuse in spine surgery. In 13 premarket studies, researchers reported no adverse effects from the use of Infuse. But in June, a medical publication, Spine Journal, said another review revealed adverse affects in 10 to 50 percent of the cases studied, including cancer, inflammation and male sterility. The journal charged that Medtronic researchers had downplayed those problems.
Additional information from the FDA
File a Medtronic Infuse Bone Graft Lawsuit: Speak to an Attorney
If you or a loved one suffered Medtronic Infuse Bone Graft complication, call the Willis Law Firm today. You may have a potential Medtronic Infuse Bone Graft claim that could result in financial compensation. All lawsuits are taken on a contingency fee basis. This means that you will be charged no legal fees unless a successful recovery is made. Call us today.