Evidence Mounts against Medtronic Infuse Graft

March 12, 2012, 1:30PM. By Jane Mundy

Minneapolis, MNAlthough it is not illegal to use an off-label (not FDA approved) medical device in surgical procedures, it is illegal to promote off-label use, and that is why Medtronic, the manufacturer of the Medtronic Infuse Bone Graft is in trouble financially. About 85 percent of Infuse procedures were used off-label, allegedly attributable to Medtronic’s aggressive off-label promotional campaign.

Now the world's largest medical device company appears to be back-pedaling by funding Yale University to conduct reviews of its Infuse safety and effectiveness.

Medtronic announced in August 2011 that it would provide Yale with a $2.5 million grant to conduct the reviews on the Infuse bone graft, which was approved by the FDA in 2002 for use only in the lumbar spine in patients with degenerative disc disease; for treatment of acute, open tibial shaft fractures; and for certain oral and maxillofacial uses.

The Yale reviews are expected to take six months and will be available in 18 months. According to Medtronic, it will help Yale make the data available to researchers through an online registry and it will also make all of the Infuse clinical trial data available on ClinicalTrials.gov.

Meanwhile, with increasing Infuse adverse side effects, both from patients and experts, Medtronic lawsuits are mounting.

A study published in The Spine Journal (May 2011) linked the Medtronic Infuse Graft to a condition that can result in infertility in men. And again in June, the same journal, which is the official publication of the North American Spine Society, published an article that suggested some researchers did not disclose all serious side effects in patients who were involved in previous studies.

Then there was the case of the 15 surgeons who were paid about $62 million by Medtronic to skew the Infuse Graft research, according to The Wall Street Journal.

Meanwhile, Medtronic gets about $800 million in annual revenue from Infuse, one industry analyst said. But the company reports that Infuse sales are down, mainly because the economy "has pressured governments to cut healthcare spending and kept patients out of the doctor's office," said Chief Executive Officer Omar Ishrak.

Currently, three US Senators are demanding answers and the Senate Finance Committee is looking into Infuse. According to Fierce Medical Devices, the Senators want to know about the "financial relationships" between paid researchers who glossed over the side effects of Infuse—side effects that include incapacitating swelling in the throat that have caused permanent injury and even death in some patients—and researchers paid by Medtronic.