title: The FDA and the Vaginal Mesh Controversy--Further Impetus to Change the 510(k) Pathway for Medical Device Approval.
authors.affiliation: Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.
authors.forename: Vanessa L
authors.initials: VL
authors.lastname: Jacoby
authors.affiliation: Departments of Obstetrics, Gynecology, and Reproductive Sciences; Urology; and Epidemiology & Biostatistics, University of California, San Francisco.
authors.forename: Leslee
authors.initials: L
authors.lastname: Subak
authors.affiliation: Department of Obstetrics and Gynecology, University of California, Davis.
authors.forename: L Elaine
authors.initials: LE
authors.lastname: Waetjen
mesh_terms: D005260:Female; D013509:Gynecologic Surgical Procedures / Q000295:instrumentation*; D006801:Humans; D056887:Pelvic Organ Prolapse / Q000601:surgery*; D013526:Surgical Mesh / Q000706:statistics & numerical data*