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Medtronic Infuse Critic Says Product May Cause Male Sterility

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A critic of Medtronic Infuse says the product may cause male sterility. Long linked to controversy, the spine growth product was the focus of a just-released study conducted by a Stanford University surgeon.

Infuse, which is a bioengineered bone growth protein, utilizes recombinant human bone morphogenetic protein (rhBMP-2), a synthetic version of a naturally occurring protein in the body. Infuse has been broadly used since 2002 in spinal fusions.

According to Dr. Eugene Carragee, said The New York Times, Infuse may pose a risk for male sterility. The product’s label does indicate that sterility complications are a potential side effect, yet Medtronic-backed researchers claim there is no link between sterility and Infuse. Despite what Medtronic’s researchers claimed, Dr. Carragee discovered that men who received Infuse ended up developing temporary or permanent sterility more often than men who received a bone graft to fuse spinal vertebrae, said The Times, which noted that the study appears on The Spine Journal’s website, which is edited by the surgeon.

Dr. Carragee asked physicians to speak with patients about the risks linked with Infuse. “It is important that men who are considering having children have the opportunity to weigh the risks of the various available procedures,” said Dr. Carragee, wrote The Times. The study involved 240 patients Dr. Carragee treated with Infuse or a bone graft; 69 received Infuse. Of the 69, five men developed sterility-related complications versus one patient of 174 who were treated with a bone graft. Of the six, said The Times, the condition has not resolved itself in three of the men.

A commentary accompanying the study, written by Dr. James D. Kang of the University of Pittsburgh, found that industry support was one feasible way in which to explain how Dr. Carragee and the Medtronic-sponsored researchers reached such different conclusions, explained The Times. “There does not seem to be any rational explanation for these observational differences,” Dr. Kang wrote, The Times added.

Infuse has been linked to other side effects, including swelling of the neck, difficulty breathing, infection, increased leg and back pain, and cancer, according to a June 2011 Spine Journal article, also authored by Dr. Carragee, said NewsInferno. Another study authored by the doctor raised serious concerns that high doses of rhBMP-2 could increase cancer risks. “Almost certainly this is cancer promoting and not a carcinogenic,” which means that the risk is greater than with a carcinogenic substance. Dr. Carragee’s data revealed that patients treated with Infuse are 2.5 times likelier to develop cancer in one year and five times likelier after three years.

Dr. Carragee is not the only one to write about how Medtronic-backed research minimized Infuse’s risks in medical journals, said The Times. For instance, since 2006, Dr. Tomislav Smoljanovic, a Croatian orthopedic surgeon, has written over 35 letters to medical journals questioning these claims. As a matter-of-fat, Dr. Carragee said his Infuse research was initiated due to a complaint received from Dr. Smoljanovic about an Infuse-related article that appeared in The Spine Journal, said The Times.

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