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

Kuhlmann-Capek, Maggie J. MD; Kilic, Gokhan S. MD; Shah, Akhil B. MD; Diken, Zaid M. MD; Snyder, Russell R. MD; Phelps, John Y. III MD, JD, LLM

Female Pelvic Medicine & Reconstructive Surgery: September/October 2015 - Volume 21 - Issue 5 - p 241–243
doi: 10.1097/SPV.0000000000000192
Review Article
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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.

Medico-legal review of a litigation technique often used by attorneys in transvaginal mesh law suits.

From the Department of Obstetrics and Gynecology, The University of Texas Medical Branch at Galveston, Galveston, TX.

Reprints: John Y. Phelps, MD, JD, LLM, The University of Texas Medical Branch at Galveston Department of Obstetrics & Gynecology 301 University Blvd. Galveston, TX 77555-0587. E-mail: jyphelps@utmb.edu; Maggie J. Kuhlmann-Capek, MD, The University of Texas Medical Branch at Galveston Department of Obstetrics & Gynecology 3.120 McCullough Building 301 University Boulevard Galveston, TX 77555-0587. E-mail: makuhlma@utmb.edu.

The authors have declared they have no conflicts of interest.

Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.