American Medical Systems Faces Thousands of Transvaginal Mesh Lawsuits, But New Transvaginal Mesh Sling System Receives FDA Approval
Although US District Court Judge Joseph R. Goodwin recently scheduled the bellwether trials in the American Medical Systems transvaginal mesh multidistrict litigation (MDL), the medical manufacturer received approval earlier in December for a new transvaginal mesh sling device.
On December 9th, American Medical Systems, which is a subsidiary of Endo Health Solutions, announced that they had received FDA approval through the controversial 510(k) system for their Retropubic Sling System to treat female stress urinary incontinence (SUI). The new transvaginal mesh sling is described as a minimally-invasive device that can treat SUI through an outpatient procedure.
“FDA Clearance of the RetroArc Retropubic Sling System rounds out the AMS family of slings,” says Steve Blum, AMS general manager of 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.”
“At AMS, we are committed to providing world-class medical devices that improve patients’ quality of life,” said Camille Farhat, AMS president. “The RetroArc Retropubic Sling System is another example of how AMS innovates to provide world-class medical devices for patients around the world,” said Farhat. “We support our products with robust physician training and we encourage physician-patient conversations on the risks and benefits of these therapies.”
Manufacturers Develop New Transvaginal Mesh Despite Studies Showing Ineffectiveness
On Monday, September 30th, attorneys for five of the six transvaginal mesh manufacturers with MDLs reportedly began settlement talks. American Medical Systems/Endo Health Solutions was represented in that group.
Part of the reason the transvaginal mesh manufacturers are looking at the settlement option could be due to the potential for more lawsuits – the number could reportedly swell to 50,000 transvaginal mesh personal injury lawsuits.
Both Bard and Endo have already settled some of the personal injury lawsuits. Earlier in the year, Endo officials paid $54.5 million to settle a still-unspecified number of cases involving transvaginal mesh injury. Bard has lost two cases, one stand-alone in California, and one of the bellwether trials in their transvaginal mesh MDL.
The announced settlements came after several bellwether cases in other transvaginal mesh trials were decided in favor of the plaintiffs, and also after medical studies were published, showing that transvaginal mesh is ineffective in prolapse and SUI repair.
The latest study, conducted by Robert E. Gutman, MD, from Georgetown University in Washington, DC, was published in the September 6th online version of Obstetrics & Gynecology. It looked at 65 participants, and found no difference in cure rates for women with or without the use of the mesh devices. The authors are quoted as saying: “There was no difference in three-year cure rates when comparing patients undergoing traditional vaginal prolapse surgery without mesh with those undergoing vaginal colpopexy repair with mesh.”
The Strom Law Firm Fights for Women in Transvaginal Mesh Personal Injury Case
Transvaginal mesh kits were initially produced to help with pelvic organ prolapse and stress urinary incontinence. Several varieties of mesh kits exist, but transvaginal mesh specifically was supposed to produce less scarring and pain, because the procedure was less invasive. However, vaginal mesh slings can cause a host of problems, including organ perforation, infection, internal scarring, continued organ prolapse, and bleeding. If you or a loved one has pelvic organ prolapse or stress urinary incontinence, have had a transvaginal mesh device implanted, and have since experienced detrimental complications, you may be entitled to compensation. The experienced lawyers at Strom Law, LLC can help. We offer free consultations, so please contact us today, and we can help get you on the road to recovery. 803.252.4800