Bladder Slings Improve Stress Urinary Incontinence: Study
The findings of new research suggest that transvaginal mesh implants may help women suffering from stress urinary incontinence more than physiotherapy, finally giving some indication that the beleagured bladder sling design may have at least some limited use.
In a study published in the New England Journal of Medicine on September 19, Dutch researchers indicate that women suffering from moderate to severe stress urinary incontinence (SUI) may show more improvement if the first line of treatment is midurethral-sling surgery, as compared to undergoing physiotherapy as the first line of treatment.
Researchers looked at 230 women who underwent bladder sling surgery for female stress urinary incontinence and compared them to 230 women who went to a physiotherapy group, where women go through a form of physical therapy and perform exercises meant to strengthen the pelvic floor. Nearly 91% of the women who received a vaginal mesh sling reported improvement, compared to just over 64% of women who underwent physiotherapy.
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In some cases, women changed their form of treatment during the study, with nearly half of the women who initially underwent physiotherapy eventually getting a vaginal mesh sling, compared to only 11.2% of the women who started out with a vaginal mesh and then switched to physical therapy. The researchers found that women who decided to have the mesh later showed better outcomes than those who did not.
The findings are one of the few that show some possible benefit to vaginal mesh surgery. However, the study did not compare the effectiveness of bladder slings to other, more traditional, surgical options. The study also comes just days after another study found no benefit to using vaginal mesh implants to treat pelvic organ prolapse (POP).
Bladder Sling Health Concerns
Questions about whether vaginal mesh products should stay on the market arose in July 2011, when the FDA announced that it had received nearly 3,000 reports of vaginal mesh complications between January 2008 and December 2010, including cases where the mesh eroded through the vagina, causing infections and other debilitating injuries.
FDA investigators said they could see no clear benefit to using vaginal mesh to treat pelvic organ prolapse (POP), as opposed to use for treatment of stress urinary incontinence (SUI). Serious questions have been raised about whether the risk of vaginal mesh complications justify the potential health benefits.
In early 2012, the FDA sent a letter to several manufacturers of these products, ordering that they conduct additional studies and trials to evaluate the safety of transvaginal mesh products, looking for additional information to establish whether they pose an unreasonable risk of injury for women.
As concerns have surfaced over the safety and effectiveness of vaginal mesh, many of the manufacturers have elected to cease marketing their products in an effort to avoid conducting the required studies.
Vaginal Mesh Litigation
More than 25,000 women nationwide are now pursuing vaginal mesh lawsuits against the manufacturers of the products, alleging that the companies did not properly research or design the products, and failed to adequately warn about the risk of complications.
In the federal court system, six different multidistrict litigation (MDLs) have been established in the Southern District of West Virginia for lawsuits filed against different manufacturers of the surgical mesh, including Johnson & Johnson’s Ethicon unit, C.R. Bard, American Medical Systems (AMS), Boston Scientific, Coloplast Corp., and Cook Medical.
All of the complaints involve similar allegations that women experienced complications from vaginal mesh products implanted for repair of POP or SUI, including claims where the surgical mesh eroded through the vagina, caused infections and other painful and debilitating injuries.
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