An investigation by Milwaukee Journal Sentinel/MedPage Today revealed recently that the medical device company, Medtronic, along with a group of doctors with financial ties to the company, were aware that the company’s new biological agent used in back surgery was linked to sterility in men. Following receipt of this news, a group of independent researchers at Stanford University conducted a retrospective review of outcomes of patients treated at Stanford, finding that the use of the recombinant human bone morphogenetic protein-2, or BMP-2 (marketed as Infuse by Medtronic) in their patients was, indeed, linked to the onset of a condition that causes sterility.

The issue of sterility is the latest in a list of questions raised with regard to the use of BMP-2. Since the drug’s approval, as series of complications, including some that are life threatening, have emerged. Perhaps the most alarming discovery involves the investigation into the alleged “cover-up” by Medtronic and the doctors with whom the company is financially linked regarding the potential for sterility an adverse event.

The investigation went on to reveal that last year alone, Medtronic paid more than $6 million in royalties for various products to the doctors who co-authored the BMP-2 studies. Moreover, the Journal Sentinel/MedPage Today investigation disclosed that doctors who had a financial tie to Medtronic reported better results using BMP-2 in clinical trials than doctors who had no financial link to the company.

In a statement by Charles Rosen, MD, an orthopedic surgeon and president of the Association for Medical Ethics, “To have such strong evidence that a life-changing complication of sterility exists and then to cover it up, in my opinion, is obscene.” Rosen, while not a part of the Stanford study, went on to say that thousands of men have become sterile without knowing that the product even posed such a risk.

Medtronic is currently being investigated by the U.S. Department of Justice for the possible off-label marketing of Infuse, a case that could be settled in the future with civil, as well as criminal penalties. All in all, the emergence of sterility as an adverse event linked to the use of BMP-2 suggests a dim future for the device.

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