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The use of transvaginal surgical mesh has been linked to reports of severe and debilitating complications, and new research suggests that even women who undergo surgery to remove of the vaginal mesh often continue to experience problems.
More than 50,000 women nationwide are now pursuing a vaginal mesh lawsuit against the manufacturers of these products, which have been used in recent years for repair of pelvic organ prolapse (POP) and female stress urinary incontinence (SUI).
These women allege that they have suffered various problems following vaginal mesh surgery, including erosion of the mesh through the vagina, infections and other complications. In many cases, plaintiffs indicate that they have required vaginal mesh removal surgery and continue to pursue claims for permanent injuries.
The findings of a new study presented at the American Urological Association’s annual meeting seems to provide further support for these claims, indicating that women who undergo surgery to remove vaginal mesh often continue to suffer from pain and symptoms of urinary incontinence.
Researchers from the University of California – Los Angeles reviewed data on 214 women who had their vagina mesh explanted due to complications, surveying the women three years later to evaluate the outcomes. The findings suggest that about a third of women continue to suffer severe or moderate pain three years later, with half of the women reporting pain during sexual intercourse. About 28% of women continue to suffer urinary leakage at least once every day, according to the findings.
The study has not yet been peer-reviewed or published, and the researchers note that they sent out almost 700 surveys and it is possible that women experiencing problems may be more likely to respond.
Vaginal Mesh Concerns
The findings come about three weeks after the FDA announced plans to reclassify vaginal mesh products from a moderate risk health device to a class III high risk device. The change will result in a new premarket approval process that should be far more stringent and will require proof that the devices are safe and effective.
Transvaginal mesh products have been introduced by a number of different companies over the past decade. The mesh is surgically implanted to help prevent a woman’s internal organs from descending due to age or childbirth, which can place pressure on the bladder and cause incontinence and other urinary problems.
The FDA first issued a warning about transvaginal mesh risks in October 2008, indicating that hundreds of women had reported experiencing problems after surgery.
In July 2011, the FDA reported that it had received thousands of adverse event reports and noted that it saw no benefit from transvaginal mesh when used to treat POP.
Manufacturers were ordered by the FDA to start planning new studies into the transvaginal mesh complication rates in January 2012, which the agency indicated were needed to examine the benefits and risks of the devices. However, many companies opted to stop making the products instead of conducting the required research.
Thousands of women are now pursuing product liability lawsuits against the manufacturers of vaginal mesh products, alleging that the devices are defective and unreasonably dangerous. The first cases are just now starting to go to trial, with several lawsuits resulting in multi-million dollar damage awards.