Sales at Medtronic Inc.’s spinal division are still struggling, thanks to the ongoing controversy surrounding its Infuse Bone Graft. According to a report from, worse could be coming, following the release of a U.S. Senate report that found the company manipulated research to spur sales of the Medtronic Infuse Bone Graft.

Medtronic Infuse Bone Graft is a bone growth protein used in certain spinal fusion surgeries. According to the report, Infuse constitutes a key product for Medtronic’s spinal division. Medtronic’s market share in the spinal division has declined from near 40% in 2008 to 35% in 2011. At the same time, Infuse has been at the center of one controversy after another. “While we already expect Medtronic’s market share to decline to below 30% mainly on these issues, the continuance of such news may result in a further loss of revenue and market share,” the report warns.

Medtronic Infuse Bone Graft was brought to market in 2008, and was expected to revolutionize spinal fusion surgery. However, even though Infuse is only approved for one particular type of spinal fusion called anterior approach lumbar fusion and a couple of dental procedures, it quickly became apparent that many doctors were using Infuse in cervical spinal fusions and other off-label procedures. In 2008, the U.S. Food & Drug Administration (FDA) issued a safety alert in 2008 warning that Medtronic Infuse Bone Graft had been associated with serious complications when used in cervical spine fusions, including excessive swelling in the neck, compressed airways, difficulty breathing, problems swallowing and nerve damage.

Since the FDA alert, the controversy surrounding Medtronic Infuse bone graft has only grown. During the summer of 2011, an investigation published in The Spine Journal raised serious concerns that research used to garner regulatory approval for Infuse was biased, as many of the doctors involved in those studies had significant financial relationships with Medtronic. According to one analysis published by the Journal, more than 13 Infuse clinical trials that were submitted to the FDA prior to its approval failed to report serious complications, including cancer, in patients treated with Infuse.

The Spine Journal expose sparked an investigation by the U.S. Senate Finance Committee, which released the results of its 16-month probe earlier this month. That investigation, which examined thousands of Medtronic-provided documents, concluded that the company manipulated studies for Infuse in order to downplay its serious side effects and to promote off-label use of the bone protein.

“Medtronic’s actions violate the trust patients have in their medical care. Medical journal articles should convey an accurate picture of the risks and benefits of drugs and medical devices, but patients are at serious risk when companies distort the facts the way Medtronic has,” Senator Max Baucus (D-Mont.), chair of the Senate Finance Committee, said in a statement announcing the investigation’s findings.

A number of Medtronic Infuse Bone Graft lawsuits allege patients sustained serious injuries in off-label procedures. If you or a loved one were injured by Infuse, you may be entitled to compensation for your pain and suffering. To learn more about Medtronic Infuse lawsuits, please contact one of the attorneys at Bernstein Liebhard LLP today at 1-877-779-1414.

Published November 7, 2012 by