Transvaginal mesh (also known as pelvic mesh) has been manufactured and marketed by several companies. The United States Food and Drug Administration (FDA) states, “Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material. In urogynecologic procedures, surgical mesh is permanently implanted to reinforce the weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence.” This mesh has been used in gynecological surgery since the 1990’s.
However, on October 20, 2008, the FDA issued a Public Health Notification and Additional Patient Information warning of serious complications associated with surgical mesh. On July 13, 2011, the FDA followed up this notification with a Safety Communication which stated, “The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. This Safety Communication provides updated recommendations for health care providers and patients and updates the FDA’s activities involving surgical mesh for the transvaginal repair of POP.”
Data collected by the FDA shows that between 2008 and 2010, the most frequent complications reported to the FDA for surgical mesh devices for POP repair are the following: mesh erosion through the vagina (exposure, extrusion or protrusion), pain, infection, bleeding, dyspareunia, organ perforation, and urinary problems. As one can imagine these conditions often require additional surgery to fix the physical harms, but no surgery can fix the emotional trauma such conditions cause.
If you live in California and your surgeon used any brand of transvaginal mesh during your surgery, you should know that attorney and physician Paul J. Molinaro is available to answer your legal questions and help you determine whether you are entitled to compensation from the manufacturer of the mesh. You can reach Paul J. Molinaro, M.D. J.D. toll free at (888)MDJDLAW. The initial consultation is also free, and if Paul determines that you have a case, and you decide to hire Paul, he will represent you on a contingent basis.