On February 9, 2016, Endo International announced their decision to discontinue operations of its ASTORA Women’s Health division. ASTORA was the manufacturer of what were formerly American Medical Systems (AMS) midurethral sling and pelvic organ prolapse mesh products. ASTORA abruptly shut down production of all mesh products, slings and vaginal prolapse kits. As of March 30th they’re no longer available. It was a purely financial move. The parent company Endo International no longer wanted to manage the liability of the embroiled vaginal mesh controversy. Despite the fact that midurethral slings are the most studied incontinence procedures and the ASTORA slings had excellent safety data, jury settlements over vaginal mesh lawsuits led to the closure decision. For surgeons who regularly used the ASTORA transobturator tape and/or pubovaginal sling, the announcement was a shock. Finding a new brand of midurethral sling can be difficult when looking for the same efficacy and breadth of safety data afforded by those products.
While it will be difficult for individual practitioners to find a replacement sling they like, there are also questions as to whether this move will have implications for existing polypropylene sling manufacturers. Furthermore, will news of this withdrawal weaken patient confidence in the products used? Currently Boston Scientific, Caldera, Coloplast and Gynecare are still providing sling products, and there’s no word of a similar closure. In 2014 the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU), and the American Urogynecologic Society (AUGS) produced a concise "[position statement](. http://sufuorg.com/docs/news/augs-sufu-mus-position-statement-approved-1-3-2014.aspx)." supporting the use of mesh midurethral slings. They plan on publishing an updated version to mitigate recent concerns. Time, and unfortunately market forces, will tell what options remain available for our patients in the future.
Article by the Publications and Communications Committee
Additional Information
Position Statement on Mesh Midurethral Slings for Stress Urinary Incontinence