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According to 2 new medical studies, Medtronic Inc.'s Infuse, used to help bones heal after spinal surgery, works no better than a bone graft and carries side effects including an increased risk of cancer.

The studies was published today in the Annals of Internal Medicine. Infuse is used in more than 1 million patients and Medtronic paid for the $2.5 million review of Infuse in 2011 after research linked it to male sterility, infections and cancer.
Infuse is less invasive than a bone graft, which can require a separate surgery, but the researchers said the rise in cancer rates and other potential risk are worrisome.

According to Harlan Krumholz, the Yale University professor who was in charge of the project, “I remain concerned that products like these are approved with too little study before they reach the market and too little afterward. There is a tremendous amount of uncertainty about the benefit it provides and how safe it is.”

Previous Studies Tainted

Older studies that said Infuse was risk-free were tainted by reports of financial ties between the researchers and the company. One of the new reviews found those publications misrepresented the risks and benefits.

Infuse Treatment Risks and Benefits

Infuse is a treatment for some fusions in the lower spine, wrote Daniel Resnick from the University of Wisconsin and Kevin Bozic, from the University of California, San Francisco, in an editorial.

It shouldn’t be used at the top of the spine, where it isn’t approved, without a compelling reason because of higher complication rates, they said.

The role of Infuse “in spinal surgery is still being defined,” according to the editorial. “Clinicians should carefully weigh the demonstrated and potential benefits and harms as well as the costs when considering the adoption and use of new health care technologies.”

The Yale review analyzed findings from two research groups, one at the Oregon Health & Sciences University in Portland and the University of York in the U.K. The two groups were given detailed data from 17 spinal studies using Infuse on more than 2,000 patients, as well as safety reports given to U.S. regulators and other publications about the product.

The Oregon review found that Infuse was similar to bone grafts in overall success, fusion rates and risks when used in lumbar spine fusion, though some published studies incorrectly said Infuse performed better.

No Advantage for Infuse Use

“We couldn’t find a clear advantage in terms of benefits, and when you take into account there could be potential risks that should be more carefully evaluated, it tips the scales toward not using it,” said senior author Mark Helfand, an internal medicine specialist at OHSU.

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