title: Implications of the FDA statement on transvaginal placement of mesh: the aftermath.
abstract: The release of the U.S. Food and Drug Administration (FDA) safety communication on the use of transvaginal mesh (TVM) for pelvic organ prolapse (POP) has resulted in changes in the pelvic reconstruction community. This monograph reviews the implications of the FDA statements over the last 18-24 months. Recent findings show that there have been significant developments in the areas of regulatory mandates, media and medico-legal activity, and statements from surgical societies. In summary, well-publicized communications from the FDA and major medical organizations are defining a change in the use of TVM for POP.
authors.affiliation: Department of Urology, Medical University of South Carolina, 96 Jonathan Lucas Street, Charleston, SC, 29451, USA, mkoski82@hotmail.com.
authors.forename: Michelle E
authors.initials: ME
authors.lastname: Koski
authors.forename: Eric S
authors.initials: ES
authors.lastname: Rovner
mesh_terms: D003257:Consumer Product Safety; D005260:Female; D006801:Humans; D056887:Pelvic Organ Prolapse / Q000628:therapy*; D053825:Suburethral Slings; D013526:Surgical Mesh; D014481:United States; D014486:United States Food and Drug Administration; D014549:Urinary Incontinence / Q000628:therapy*