This news investigation (9 May 2012) asks whether the current system in the United States is failing to ensure that mesh devices are safe and effective.
The article reports that more than 350 thousand women undergo surgery for pelvic floor prolapse in the U.S. every year. Thousands of those women say the mesh is causing them severe pain and emotional distress and, for some, even affecting their relationships.
Between 2008 and 2010, the FDA received over 1,500 reports of complications with mesh implants, 5 times the rate reported between 2005 and 2007. The FDA responded in July 2011, ordering the manufacturers to carry out post-market studies and alerting the medical community of the concerns.
According to the news feature, a new Consumer Reports poll shows Americans support stricter safety standards for medical devices with more than eight of 10 people saying it was more important to prevent safety problems than to encourage innovation.
No immediate answer to the problem appears to be on the horizon and mesh products are still being manufactured and marketed. Class action lawsuits are pending but could take years to resolve.
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