title: An appraisal of the Food and Drug Administration warning on urogynecologic surgical mesh.
abstract: Currently, there is no consensus on the use of mesh in transvaginal surgical repairs for the treatment of pelvic organ prolapse. This review recapitulates and assesses the recent U. S. Food and Drug Administration (FDA) warnings about the use of surgical mesh in transvaginal pelvic organ prolapse repair and summarizes the responses of the national organizations that represent the health care providers most invested in treating patients with transvaginal surgical mesh. Mesh exposure or extrusion through the vaginal wall, true mesh erosion into viscera, and infection are the major complications that are currently used to define the safety of synthetic mesh use. Other potential adverse postsurgical outcomes that can affect quality of life, sexual function, and patient satisfaction include dyspareunia, "hispareunia" (ie, complaints of a sexual partner), prosthetic contraction or prominence, vaginal shortening, pelvic pain, urinary dysfunction, and failure of the repair. These outcomes are frequently attributed to mesh use, and can result in expense, frustration, and the need for further medical and surgical interventions for patients undergoing treatment for pelvic floor disorders. Information regarding the FDA's reports on the use of surgical mesh in pelvic organ prolapse repair should be made available to patients at the time of surgical planning and should be used as an adjunct in the process of obtaining informed consent.
authors.affiliation: Division of Urology, University of Pennsylvania, Perelman Center for Advanced Medicine, Philadelphia, 19104, USA. lindsey.menchen@uphs.upenn.edu
authors.forename: Lindsey C
authors.initials: LC
authors.lastname: Menchen
authors.forename: Alan J
authors.initials: AJ
authors.lastname: Wein
authors.forename: Ariana L
authors.initials: AL
authors.lastname: Smith
mesh_terms: D003558:Cystoscopy; D004869:Equipment Safety; D006801:Humans; D018579:Patient Selection; D017773:Pelvic Floor / Q000601:surgery; D011358:Product Surveillance, Postmarketing; D019651:Plastic Surgery Procedures; D013526:Surgical Mesh / Q000009:adverse effects*; D014481:United States; D014486:United States Food and Drug Administration