Enmeshed in Controversy: Use of Vaginal Mesh in the Current Medicolegal Environment

Maggie J. Kuhlmann-Capek, Gokhan Kilic, Akhil B. Shah, Zaid M. Diken, Russell Snyder, John Phelps

Research output: Contribution to journalArticle

12 Citations (Scopus)

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. Objectives 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.

Original languageEnglish (US)
Pages (from-to)241-243
Number of pages3
JournalFemale Pelvic Medicine and Reconstructive Surgery
Volume21
Issue number5
DOIs
StatePublished - Sep 9 2015

Fingerprint

Jurisprudence
United States Food and Drug Administration
Informed Consent
Consent Forms
Physicians
Pelvic Organ Prolapse
Search Engine
Stress Urinary Incontinence
Documentation
Medical Records
Communication
Databases
Safety
Equipment and Supplies
Surgeons
Therapeutics

Keywords

  • learned intermediary doctrine
  • pelvic organ prolapse
  • stress urinary incontinence
  • vaginal mesh

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Surgery
  • Urology

Cite this

Enmeshed in Controversy : Use of Vaginal Mesh in the Current Medicolegal Environment. / Kuhlmann-Capek, Maggie J.; Kilic, Gokhan; Shah, Akhil B.; Diken, Zaid M.; Snyder, Russell; Phelps, John.

In: Female Pelvic Medicine and Reconstructive Surgery, Vol. 21, No. 5, 09.09.2015, p. 241-243.

Research output: Contribution to journalArticle

Kuhlmann-Capek, Maggie J. ; Kilic, Gokhan ; Shah, Akhil B. ; Diken, Zaid M. ; Snyder, Russell ; Phelps, John. / Enmeshed in Controversy : Use of Vaginal Mesh in the Current Medicolegal Environment. In: Female Pelvic Medicine and Reconstructive Surgery. 2015 ; Vol. 21, No. 5. pp. 241-243.
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