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Future of Medtronic Infuse Unclear as Safety Woes Mount

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Medtronic’s headline-making Infuse bone graft product is facing a hazy future. Amid an independent investigation and suppression of evidence, Medtronic Inc. has seen a significant drop in sales.

According to a report from Newsinferno, Medtronic aggressively attempted to contain proof that Infuse (rhBMP-2)—specifically when used in unapproved medical procedures—is the culprit in numerous health issues, including cancer. It seems that prior to its approval in 2002, Medtronic paid surgeons very generously to provide research pointing to the product’s safety and, when research indicated that Infuse was linked to complications, Medtronic suppressed that research.

Although what had long been believed to be medically sound research indicating that Infuse was an effective bone growth product, was, in reality, not. Infuse has proven anything but safe and concern is high among surgeons not paid by Medtronic, that Infuse is, in truth, dangerous. The U.S. Food and Drug Administration (FDA), to date, has received at least 280 reports

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of serious complications linked to Infuse and lawsuits against Medtronic accuse the company of its dangers. The lawsuits allege Infuse has the potetial to cause serious complications, including unwanted bone growth, cancer, and sterility in male patients.

Medtronic has also been accused of pushing Infuse for off-label procedure like neck surgeries, which would be illegal. Patients who undewent such procedures sometimes suffered severe neck and throat swelling, breathing and speaking problems, and airway compression. In 2008, a growing number of such reports prompted the FDA to issue a warning about off-lable use of Infuse.

This past November, Infuse became mired in even more controversy after Standford University spine researcher, Dr. Eugene Carragee, presented a study at the North American Spine Society that raised serious questions about a possible association between rhBMP-2 and an increased risk of cancer. According to Carragee, his analysis of a Medtronic study for its Amplify product, a higher-dose version of Infuse, found that the researches failed to identify a significant cancer risk. While the FDA ultimately refused to approve Infuse, Carregee said his findings have important implications for Infuse, as doctors often administer Infuse off-label at doses equal to or higher than what is found in Amplify.

With Infuse sales dropping due to the controversies, Medtronic commissioned researchers Yale University to independently review Infuse data, said Med City News. And, while outcomes are highly anticipated by Omar Ishrak, Medtronic CEO, in the hopes he will see vindication for his controversial blockbuster product, at least one research analyst does not see increased sales in Infuse’s future, even if Yale reviewers deem it safe.

“Given that we’ve already had the proverbial eyebrow raised about Infuse, will they go back to it, I don’t think so,” said Caroline Corner, an analyst with investment bank MLV & Co. who does not cover Medtronic, wrote Med City News.

Corner holds a PhD in biological and environmental engineering from Cornell University. According to Comer, talks with leading spine surgeons nationwide indicate that Infuse may continue to be used, but in a lesser capacity, for instance, in older people whose risk for cancer is decreased as well as hard-to-treat patients, according to Med City News.

“Someone who is a very poor healer, someone who is in a revisional surgery, someone who is older and not in child-bearing age … some doctors still see an (Infuse) application in treating these hard -to-treat people,” Corner said. “But doctors, in general, are definitely shying away from using Infuse (most of the time),” which increases opportunities for an alternative to Infuse, said Comer, wrote Med City News.

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