%0 Journal Article
%T The Role of Vaginal Mesh Procedures in Pelvic Organ Prolapse Surgery in View of Complication Risk
%A David R. Ellington
%A Holly E. Richter
%J Obstetrics and Gynecology International
%D 2013
%I Hindawi Publishing Corporation
%R 10.1155/2013/356960
%X Synthetic transvaginal mesh has been employed in the treatment of pelvic organ prolapse for more than a decade. As the use of these devices increased during this period so did adverse event reporting. In 2008, the Food and Drug Administration (FDA) Public Health Notification informed physicians and patients of rising concerns with the use of synthetic transvaginal mesh. Shortly thereafter and in parallel to marked increases in adverse event reporting within the Manufacturer and User Device Experience (MAUDE), the FDA released a Safety Communication regarding urogynecologic surgical mesh use. Following this report and in the wake of increased medical industry product withdrawal, growing medicolegal concerns, patient safety, and clinical practice controversy, many gynecologists and pelvic reconstructive surgeons are left with limited long-term data, clinical guidance, and growing uncertainty regarding the role of synthetic transvaginal mesh use in pelvic organ prolapse. This paper reviews the reported complications of synthetic transvaginal mesh with an evidence-based approach as well as providing suggested guidance for the future role of its use amidst the controversy. 1. Introduction The Food and Drug Administration (FDA) cleared the first surgical mesh product specifically designed for the surgical treatment of pelvic organ prolapse (POP) in 2001. Surgical mesh in absorbable and permanent forms had been employed in vaginal approaches to pelvic floor surgery for several years. In fact, biologic grafts and synthetic mesh prostheses have been utilized in abdominal repairs for POP since the 1970s [1]. Nonetheless, with an estimated 300,000 surgical procedures performed annually for prolapse as well as an effort to address high recurrence rates (6 to 29 percent) requiring women to undergo reoperation for POP, efforts to improve patient outcomes has led to the development and introduction of materials, including synthetic mesh, to augment gynecologic reconstructive surgical repairs [2¨C5]. Despite limited evidence-based data and with the perfect storm of manufacturing company promotion, limitations of the FDA 510(k) process, and with the promise of shorter operative times and minimally invasive techniques, synthetic transvaginal mesh use surged with the development of an estimated 100 synthetic mesh devices. Unfortunately, concomitant to the increased use of vaginal synthetic mesh was an increase in adverse event reporting, specifically medical device reports (MDRs), within the Manufacturer and User Device Experience (MAUDE) database. In October 2008, the FDA
%U http://www.hindawi.com/journals/ogi/2013/356960/