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Medtronic Infuse May Pose Significant Cancer Risk

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Medtronic’s controversial Infuse bone growth product may cause a significant cancer risks, even more so than originally believed, according to respected research.

Patients treated with Infuse suffered a more than two-fold risk of developing cancer within the first year of use, according to Stanford University School of Medicine professor and Spine Journal editor of Dr. Eugene Carragee, said MassDevice. Worse, the cancer risk increased to nearly five-fold after three years, said to Dr. Carragee.

Infuse uses the recombinant human bone morphogenetic protein (rhBMP-2)—a synthetic recreation of a protein found in the body. First believed to be a good alternative to traditional spinal fusion, which uses bone from the hip, Infuse was approved in 2002 by the FDA for use in one type of spine surgery—anterior approach lumbar fusion—and two types of dental surgeries, explained NewsInferno. Despite this, estimates reveal that most—upwards of 85%-—Infuse procedures are actually conducted for uses that are not FDA approved (so-called off-label uses).

According to a Spine Journal issue devoted completely to growth proteins such as Infuse, a shocking 13 Medtronic-backed studies either minimized or omitted all evidence of Infuse’s safety risks, said MassDevice. Following the Journal’s findings, federal investigations were initiated over allegations that consultants paid by Medtronic likely concealed Infuse-caused risks.

The protein used in Infuse—described by some experts as a cancer-promoting agent—was reviewed by a July 10 U.S. Food & Drug Administration (FDA) panel that met to look at Amplify, a higher dose version of the same protein, said MassDevice. The panel, which ended up in a 6-to-5 split vote, with tree abstentions, found that the device’s benefits outweigh its risks. Meanwhile, clinical studies conducted prior to the panel hearing revealed 15 cancer incidents in Amplify patients, versus five in the control group, which led the FDA to halt on Amplify last March.

Carragee’s data suggested that cancer risks linked to the lower dose Infuse could be greater than what was noted in earlier clinical studies. Using pooled information released by the FDA, Carragee discovered increased cancer rates in Infuse patients versus those of the control group, said Reuters previously.

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