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The consumer watchdog group, Public Citizen, has placed transvaginal mesh products on its “Do Not Use” list, urging women to seek alternative treatments for pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
While Public Citizen’s “Best Pills, Worst Pills” publication does not typically address medical devices, the group indicated last week that an exception was made because of the serious risk of complications from transvaginal placement of surgical mesh, which has been linked to a risk of eroding through the vaginal tissue, causing pain, infection, bleeding and urinary problems. There is also a risk of organ perforation during the surgical procedure to install a mesh.
Also commonly referred to as a bladder sling, transvaginal mesh was used in more than 75,000 procedures to repair pelvic organ prolapse last year. In recent years, a growing number of doctors have been recommending the surgical mesh products, despite no evidence to suggest it provides any advantages over other available methods of treating pelvic organ prolapse.
The Public Citizen designation came after the FDA issued a press release last week, indicating that side effects of transvaginal mesh for pelvic organ prolapse may outweigh any health benefits. The FDA indicated that between 2008 and 2010, more than 1,500 reports of problems with pelvic organ prolapse transvaginal mesh were received by the agency, representing a five fold increase from the number of adverse event reports received between 2005 and 2007.
Complications from transvaginal mesh have been associated with products made by a number of different manufacturers, including C.R. Bard, American Medical Systems (AMS), Boston Scientific, Johnson & Johnson and others.
The FDA first issued a warning about transvaginal mesh problems in October 2008, indicating that hundreds of people had reported experiencing problems with products made by at least nine different manufacturers. In addition, a study published earlier this year found a high risk of problems with all transvaginal mesh implants.
Many women who have experienced painful and debilitating injuries, are now considering transvaginal mesh lawsuits against the manufacturers for failing to adequately research their products or warn about the risk complications.
Last year, Johnson & Johnson reportedly settled a number of lawsuits over Mentor ObTape vaginal mesh, which had been linked to a complication rate as high as 17% to 18%. The Mentor ObTape bladder sling was removed from the market in 2006, only three years after it was introduced.
Over the past year, a growing number of Bard Avaulta mesh lawsuits have also been filed by women who have experienced problems. All of the complaints involve similar allegations that C.R. Bard’s Avaulta Anterior and Posterior BioSynthetic Support System, which was introduced in 2007, was negligently designed and that the company failed to warn patients of possible complications that can result in severe pain and disfigurement.
Other suits over transvaginal mesh products have been filed by women who received the Ethicon Gynecare Gynemesh, Prolene Mesh, Prolift and TVT sling products, as well as the AMS Sparc, Elevate, Apogee, Perigee and Monarc sling systems.