Senate Concludes that Medtronic Improperly Influenced Infuse® Bone Graft Studies
According to a report based on an investigation launched in June 2011, the Senate Financial Committee has concluded that medical device maker, Medtronic, improperly influenced studies on its Infuse® bone grafts. Specifically, it is alleged that Medtronic participated in writing and editing these studies that appeared in journal articles – without disclosing its role in shaping these studies. These thirteen key studies as summarized in these articles, and financed by Medtronic, failed to mention serious risks associated with Infuse®, including male sterility, infection, and increased back and leg pain. It is also alleged that Medtronic paid study authors $210 million in consulting fees for unrelated work over the span of fifteen years.
The committee’s report is the latest in a series of federal inquiries into Medtronic’s promotion of Infuse®. The FDA originally approved Infuse® in 2002 for use in spinal, oral, and dental graft procedures. However, the product is generally used in other surgical procedures, such as neck surgery, which can result in the patient experiencing difficulty swallowing, breathing, and speaking, as well as the need for additional surgeries. To date, Infuse® has been used in nearly 500,000 patients, generating hundreds of millions of dollars in revenue annually for Medtronic.
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