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Jun 29 2011

Medtronic’s Infuse May Have Unreported Side Effects, Due To Financial Ties To Clinical Investigators

Posted in Community Service, Product Liability

Consumers must be aware that not every medical product on the market has been objectively evaluated and vetted by medical professionals, Alabama product liability attorney Keith T. Belt says

Extremely troubling press reports suggest that doctors conducting clinical trials examining the safety and effectiveness of Infuse on behalf of Medtronic were aware that Infuse, a treatment commonly used in spinal surgery, may cause medical complications, but failed to report this in the medical literature.  This issue is compounded by the fact that some clinical investigators have substantial financial ties to Medtronic.

  • Last year, the Milwaukee Journal Sentinel reported that a Medtronic-funded study published in 2004 found that 75% of bone morphogenetic protein 2 (BMP-2) patients experienced ectopic bone growth, where potentially harmful bone growth occurs outside of the fusion area.   In a  2008 study conducted by physicians without financial ties to Medtronic, “neurological impairment occurred” in five patients who had the same ectopic bone formation.
  • According to the New York Times, a recent study “found that men treated with Infuse developed a condition that causes temporary or permanent sterility at a far higher rate than men who received a bone graft.”  This link to sterility was not reported in the original Medtronic-funded study. In addition, the Milwaukee Sentinel Journal reports that one author of the original study, Thomas A. Zdeblick, an orthopedic surgeon at the University of Wisconsin School of Medicine and Public Health, received “more than $23 million in various royalty payments from Medtronic since 2002.”  In addition, “Zdeblick also is the editor of the journal where two of the Infuse papers that failed to mention the link [to sterility] were published.”

Reports have linked Infuse to potentially fatal swelling in the neck and throat, and radiating leg pain.  Concerns have also been expressed about a potential link to cancer. The main analysis, which was led by editors of the Spine Journal

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