Transvaginal & Pelvic Mesh

    AMS Gets FDA Approval for New Mesh Sling Device for SUI


    American Medical Systems Inc., a subsidiary of Endo Health Solutions Inc., gained FDA approval for its RetroArc Retropubic Sling System. The device is used to treat women with stress urinary incontinence (SUI). The sling system uses transvaginal mesh, currently under scrutiny for causing serious complications in thousands of women. In fact, many women now filing mesh sling lawsuits were implanted with the device to treat SUI.

    Risks of Using Pelvic Mesh to Treat SUI Patients

    American Medical Systems said its sling device could cause infection, urethra or vessel perforation and erosion. The most common side effects include urinary tract infections and urinary retention, the company said. However, AMS said its newest device is still effective.

    “FDA Clearance of the RetroArc Retropubic Sling System rounds out the AMS family of slings,” said Steve Blum, AMS general manager, Women’s Health. “It underscores our commitment to physicians and patients for the treatment of female stress urinary incontinence, and builds on our leadership in women’s health.”

    SUI is the most common type of urinary incontinence. The condition results in accidental urine loss during physical activity like heavy lifting or even while coughing or sneezing. More than 13 million women suffer from SUI in the United States alone.

    AMS Faces Mesh Device Lawsuit

    One Pennsylvania woman filed a lawsuit against AMS, alleging the In-Fast Ultra pelvic mesh device caused pain and suffering. Gertrude Moore said the device meant to treat SUI symptoms injured her “catastrophically,” The Pennsylvania Record reported. Moore said she has suffered severe and permanent pain, disability, impairment, loss of life’s enjoyment and economic despair, according to her lawsuit against the Minnesota-based company. Like many other women, Moore experienced mesh erosion, infection, inflammation, organ perforation, blood loss, pelvic floor damage and pelvic pain, the Record reported. She also continues to suffer from SUI.

    Moore said AMS markets its pelvic mesh devices as safe as well as effective, which isn’t accurate. In fact, the device has high failure, complication and injury rates, says Moore. AMS failed to provide safe devices for women with SUI, alleges Moore. She also says it’s impossible to safely or easily remove the device from women already suffering complications.

    “Defendant AMS in particular has consistently underreported and withheld information about the propensity of their pelvic mesh to fail and to cause injury and complications, and have misrepresented the efficacy and safety of their pelvic mesh products through various means and media, actively and intentionally misleading the medical community, patients, and the public at large,” the lawsuit states.

    What You Can Do

    If you have a mesh device implanted that caused severe complications, you may be eligible for compensation. Fill out your free pelvic mesh claim review form today to see if your claim may qualify. An experienced mass tort attorney will contact you to discuss your case.

    Lori Polemenakos is Director of Consumer Content and SEO strategist for LeadingResponse, a legal marketing company. An award-winning journalist, writer and editor based in Dallas, Texas, she's produced articles for major brands such as, Yahoo!, MSN, AOL, Xfinity,, and edited several published books. Since 2016, she's published hundreds of articles about Social Security disability, workers' compensation, veterans' benefits, personal injury, mass tort, auto accident claims, bankruptcy, employment law and other related legal issues.

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