A new multidistrict litigation (MDL) proceeding has been formed for transvaginal mesh products manufactured by Coloplast Corporation. This MDL proceeding will take place in the Southern District of West Virginia, with Judge Joseph R. Goodwin presiding. The new Coloplast MDL joins 4 others in that Court involving transvaginal mesh product manufacturers C.R. Bard, Ethicon, Inc. (a division of Johnson & Johnson), American Medical Systems, Inc., and Boston Scientific Corporation. In excess of 1,000 cases have been consolidated into these 5 multidistrict litigation proceedings. Other mesh-related cases are pending in State Courts around the United States.
Coloplast Corporation acquired the urology business division of Mentor Corporation. In doing so, Coloplast entered into the business of selling mesh products intended to treat conditions known as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). These mesh products are surgically implanted through the vagina in women who are suffering from POP and SUI. The 3 Coloplast vaginal mesh products intended to treat POP are Novasilk Synthetic Flat Mesh, Exair Mesh, and Restorelle Smartmesh. Coloplast’s bladder sling products intended to correct SUI include the Omnisure Sling, Minitape Sling, Aris Transobturator Sling, Supris Suprapubic Sling, and the T-Sling with Centrasorb.
Recently, the United States Food and Drug Administration (FDA) issued an updated safety communication in which it warned doctors, healthcare professionals, and patients that the placement of surgical mesh through the vagina to treat POP and SUI may present greater risks for the patient than other procedures which do not involve the use of mesh. The FDA’s investigation of problems associated with the use of transvaginal mesh to treat POP and SUI is ongoing.