Surgeons Never Reported Infuse Trial Failures

Surgeons who were paid handsomely to test Medtronic’s Infuse bone graft medical device system never reported failures and complications in their research results, according to a new study published in the Spine Journal.
According to the Wall St. Journal breaking news report, Over the past decade, 15 of those surgeons have collectively received at least $62 million from the medical-device giant for unrelated work, according to a Wall Street Journal analysis of Medtronic documents and of recent disclosures made on the company’s website.
Last week, the Senate Finance Committee began investigating whether Medtronic’s large payments to the surgeons played a role in the fact they didn’t report the complications, after seeing an advance copy of the study. The product, called Infuse Bone Graft, has already been the subject of a series of inquiries by the Senate committee, as well as of an ongoing investigation by the Justice Department into its use beyond its official Food and Drug Administration indication. Infuse represents about $700 million in annual sales for Medtronic.”
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The failed results are serious according to the study-cancer, sterility, infections, bone dissolution and worsened back and leg pain, occurred in 10% to 50% of patients who were administered Infuse or a sister product in 13 clinical trials funded by Medtronic and conducted by the surgeons between 2000 and 2010.