Medtronic, researchers failed to report known link to complication

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates AHCJ's social media efforts and edits and manages production of association guides, programs and newsletters.

Medtronic, a medical device maker, and researchers with financial ties to the company have known for years that a “biological agent used in back surgery was linked to sterility in men,” reports John Fauber of the Milwaukee Journal Sentinel.

The doctors, who have received millions in royalties from Medtronic, failed to include the information in journal articles and instead claimed the sterility was caused by surgical technique, not the product. Information linking the product to the complication was included in what the company sent to the FDA as part of the approval process in 2002. But the doctors linked to Medtronic claimed there was “no relationship” as recently as last year.

Several independent doctors contacted by the Journal Sentinel say that while the surgical technique may be a factor in the development of the complication, the Medtronic authors should have stated Infuse also was linked to the condition.

The Journal Sentinel uses Document Cloud to share the documents – journal articles, letters of concern and commentaries – that explain the history of the product, Infuse. The documents are annotated, with key points highlighted and comments explaining the conflicts.

A study done by independent researchers, published today, links Infuse to retrograde ejaculation, a condition that causes sterility in men. Fauber reports the study was prompted in part by the Journal Sentinel‘s earlier articles about Medtronic.

“To have such strong evidence that a life-changing complication of sterility exists and then cover it up in my opinion is obscene,” said Charles Rosen, an orthopedic surgeon and president of the Association for Medical Ethics who has read the Stanford study.

Update

Read about the little -known Croatian doctor who pursued concerns about Infuse. Medical journals dismissed his concerns, including one reviewer who told him “as a Croatian he did not have the standing to make comments about Infuse.”

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