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Greg Webb
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More Study Ordered on Implantable Surgical Mesh by FDA

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Earlier this month, the U.S. Food and Drug Administration (FDA) issued an order "requiring makers of implantable surgical mesh used to treat urinary incontinence in women to study its risks."[1] One might say to the FDA that the horse is already out of the barn. The order for more study is coming very late in the game for those who have suffered from the use of surgical mesh as there have been "years of reports of serious injuries linked to the devices, including pain, infections and other complications." [2] Heretofore, "the mesh products… belong to a class of implantable devices that manufacturers do [did] not have to study in patients before they are marketed or closely follow in patients afterward." [3]

As of November 2009, more than 1000 people who had surgical mesh implanted to solve problems such as inguinal hernia, vaginal prolapse and urinary incontinence, had experienced severe problems following those types of surgeries, due to the use of surgical mesh. Approximately 185,000 women underwent procedures in 2010 in which mesh was implanted vaginally to treat urinary incontinence.[4] The same year, it was reported "in a medical journal that about 15 percent of women treated with vaginal mesh experienced potential complications."[5] According to an article that appeared in the Grand Forks Backpage.com, of November 29, 2011,

"At least 35,000 women may have been treated with the OB Tape vaginal sling between 2003 and 2006 to treat female stress urinary incontinence (SUI)."[6] A number of women who suffered deleterious results have filed "Mentor sling" lawsuits.

There are several vaginal mesh products, including those used to treat Pelvic Organ Prolapse (POP) and SUI. The top producers of vaginal mesh now include Boston Scientific, C. R. Bard, Ethicon and W. L. Gore & Associates. In 2008, the FDA issued a warning about the use of vaginal mesh. In the year that followed, there was a five-fold increase in reports of adverse events from the use of vaginal mesh, according to Dr. William Maisel, deputy director of the FDA's Center for Devices and Radiological Health, FDA’s chief scientist who oversees medical devices.

During the past year, the FDA frequently has used its power to require manufacturers of medical devices to conduct critical studies. These after-the-fact studies do little to assuage the suffering of those who already have the devices implanted: "…preventing patient injuries is questionable because by the time the agency acts, a device has been on the market for years and been implanted in hundreds of thousands of patients."[7]