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Surgeons, Medtronic Under Investigation Over Infuse Complications

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Washington, DCFurther to concerns about financial conflict of interest stemming from reports of physicians with financial ties to the medical device company, Medtronic, a senate committee has been established to investigate whether or not those physicians were aware of the serious complications associated with Medtronic's spinal device, Medtronic Infuse, and if so, why they failed to disclose those adverse events in journal papers.

Infuse, a bone morphogenetic protein-2, is used in spinal fusion surgery. It works by stimulating growth of the bone, thereby eliminating the need to harvest bone from the patient to create a fusion between two vertebrae. It has proven to be very popular. However, Infuse carries an FDA warning on the label because it is associated with ectopic bone formation; retrograde ejaculation, which causes male sterility; and cervical complications including swelling in the throat or neck.

According to a report in the MedPageToday.com more than 500,000 patients have received an Infuse implant, which converts to several hundred million dollars a year of revenue to Medtronic.

This isn't the first time Medtronic has been investigated. Earlier, it was the subject of an investigation for off-label marketing of Infuse, by the U.S. Department of Justice.

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