Vaginal Mesh Removal Surgery Often Fails To Correct Problems: Study
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The study has not yet been peer-reviewed or published, and the researchers note that they sent out almost 700 surveys and it is possible that women experiencing problems may be more likely to respond.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.
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NicholeMay 29, 2014 at 3:35 am
It destroyed my life since 2007 these $40,000 settlements are bullshit! I think we should take all the big wigs and attorneys from theses companies and implant this crap into them. You can bet your sweet butt they would change their attitude and thought process on how much we deserve. I had to have a complete hysterectomy before I was 40 anyone who has been through menopause can tell you what k[Show More]It destroyed my life since 2007 these $40,000 settlements are bullshit! I think we should take all the big wigs and attorneys from theses companies and implant this crap into them. You can bet your sweet butt they would change their attitude and thought process on how much we deserve. I had to have a complete hysterectomy before I was 40 anyone who has been through menopause can tell you what kind of havoc that plays on your life it altered everything in mine. And let's not forget the pain I am in every day even now that it has been removed. That itself is a horrific experience! These things are permanent so when they remove them they take cut good tissue as well as the sling. $40,000 won't even cover medical bills. Also why is nobody looking into how this foreign body thing effects a persons auto immune system? Women with these things are having all kinds of problems that should be part of the lawsuit! They not only destroyed my body and my life but my children suffered because I haven't been able to do the things a normal mother can do and enjoy. My husband....well I am grateful he hasn't gone out to find sex elsewhere because he isn't getting it at home because of the pain. Let condemn theses male lawyers and big wigs to a life of celibacy!!!! I wonder if a $40,000 settlement could ease their pain and replace their loss.....
dakeyMay 20, 2014 at 8:18 pm
The FDA should be included in all these lawsuits, no more running, jumping, sitting for long periods of time, standing is out . No more normal activities . These lawsuits should be in the Billions . Future medical problems is what I have forwarded to look for . Normal life is gone. There should be another organization too watch the FDA.
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