title: Transvaginal mesh: a historical review and update of the current state of affairs in the United States.
abstract: BACKGROUND
  Transvaginal mesh usage has been at the forefront of popular media and academic debate for the past 10 years. Several US Food and Drug Administration (FDA) communications, society statements, and research articles have been written in an attempt to define and articulate the classification system, safety data, and efficacy of this approach to transvaginal surgery. In this review, we explore the history of transvaginal mesh surgery for pelvic organ prolapse (POP), review FDA and society statements, and research current practice in the United States.
  
  
  METHODS
  We searched the English language literature using PubMed for articles related to safety and monitoring of transvaginal mesh and reviewed all FDA publication and notices and gynecology and urogynecology society statements on its use in the United States. We then reviewed 22 articles and grouped them into several sections.
  
  
  RESULTS
  Mesh used to augment transvaginal repair of POP was introduced in the United States in 2005 without clinical safety and efficacy data. In the subsequent years of use, both major and minor complications were increasingly reported, leading to several FDA notifications and warnings. The type of mesh used, reporting and classifications systems, and provider usage has varied widely over time.
  
  
  CONCLUSIONS
  We present a historical review of transvaginal mesh use for pelvic organ prolapse in the United States from 2005 to 2016. There continues to be heated debate among practitioners about balancing the efficacy of mesh use to decrease recurrent prolapse and complications. Research into safety and efficacy, along with tighter FDA regulations, is ongoing.
authors.affiliation: Department of Urogynecology, North Shore University Health Systems, 3950 Gross Point Road, Suite 3900, Skokie, IL, 60076, USA. SIyer@northshore.org.
authors.forename: Shilpa
authors.identifier: http://orcid.org/0000-0001-9133-6594
authors.initials: S
authors.lastname: Iyer
authors.affiliation: Department of Urogynecology, North Shore University Health Systems, 3950 Gross Point Road, Suite 3900, Skokie, IL, 60076, USA.
authors.forename: Sylvia M
authors.initials: SM
authors.lastname: Botros
mesh_terms: D005260:Female; D013509:Gynecologic Surgical Procedures / Q000266:history*; D049674:History, 21st Century; D006801:Humans; D056887:Pelvic Organ Prolapse / Q000601:surgery*; D013526:Surgical Mesh / Q000266:history*; D014481:United States
keywords: Pelvic organ prolapse; Review; Transvaginal mesh