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Studies point to risks with Infuse


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Following years of research, Yale University earlier this year released its long awaited study on Medtronic's bone growth stimulator - the Infuse.

First developed to help speed healing and reduce pain following spinal fusion surgeries, the medical device, which uses bioengineered materials, has been linked to serious side effects.

According to the Food and Drug Administration, the Medtronic Infuse has been associated with nerve damage, difficulty breathing, swallowing or speaking and even death. And the Yale study found that the effectiveness of the Infuse has been overblown.

Medtronic has also been criticized for paying hundreds of millions of dollars in so-called consulting fees to medical writers and doctors in exchange for underreporting Infuse's adverse events.

To make matters worse, the product has also been linked with an increased cancer risk because of the ingredients used to spur bone growth, which are called BMPs.

Another study, this one conducted by researchers at Duke University, noted that the use of BMPs in bone fusion procedures is associated with tumors that can develop in the brain and nervous system.

The medical giant faces a number of lawsuits from people who claim they have suffered serious side effects following treatment with the Infuse. Some of those treatments were not approved for use by the FDA.

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