title: Enmeshed in Controversy: Use of Vaginal Mesh in the Current Medicolegal Environment.
abstract: Vaginal mesh has been a valuable tool in the treatment of stress urinary incontinence and pelvic organ prolapse. As our knowledge of the long-term outcomes and complications of this product has evolved, however, vaginal mesh has become the subject of legal scrutiny. Therefore, it is imperative that physicians understand pertinent litigation techniques to optimize their informed consent and documentation processes and protect themselves.
  
  
  OBJECTIVE
  Our objective is to familiarize physicians who use vaginal mesh with how law suits involving transvaginal mesh are construed. We also describe the current medicolegal environment surrounding the use of these products.
  
  
  METHODS
  The food and drug administration public safety communications, food and drug administration Manufacturer and User Facility Device Experience database, and LexisNexis legal search engine were used to review data relevant to current vaginal mesh litigation. This information was used to create a medicolegal review.
  
  
  RESULTS
  Litigation involving transvaginal mesh follows 3 paths. The first consists of claims against the manufacture of transvaginal mesh with allegations, such as design defects, failure to warn, and misrepresentation. The second is a defensive legal strategy called the learned intermediary doctrine, used by manufacturers to shift liability from themselves to surgeons. The manufacturers claim that the duty to inform patients of potential complications lies with the surgeon. The third involves claims by patients against surgeons for lack of informed consent, alleging that they were not sufficiently informed of potential complications associated with transvaginal mesh before insertion.
  
  
  CONCLUSIONS
  To lessen the liability, a surgeon using transvaginal mesh should inform patients of potential complications associated with the products and document informed consent in their medical records.
authors: From the Department of Obstetrics and Gynecology, The University of Texas Medical Branch at Galveston, Galveston, TX.
authors: Maggie J
authors: MJ
authors: Kuhlmann-Capek
authors: Gokhan S
authors: GS
authors: Kilic
authors: Akhil B
authors: AB
authors: Shah
authors: Zaid M
authors: ZM
authors: Diken
authors: Russell R
authors: RR
authors: Snyder
authors: John Y
authors: JY
authors: Phelps
mesh_terms: D005260:Female; D013509:Gynecologic Surgical Procedures / Q000331:legislation & jurisprudence / Q000379:methods; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D008318:Malpractice / Q000331:legislation & jurisprudence; D056887:Pelvic Organ Prolapse / Q000601:surgery*; D013526:Surgical Mesh / Q000009:adverse effects* / Q000706:statistics & numerical data; D014481:United States; D014550:Urinary Incontinence, Stress / Q000601:surgery*