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Medicolegal Issues Surrounding Devices and Mesh for Surgical Treatment of Prolapse and Incontinence

NOSTI, PATRICK A. MD; IGLESIA, CHERYL B. MD

Clinical Obstetrics & Gynecology: June 2013 - Volume 56 - Issue 2 - p 221–228
doi: 10.1097/GRF.0b013e31828e63d4
Devices and Meshes for the Surgical Treatment of Prolapse and Incontinence

Legal issues related to vaginal mesh devices for prolapse and incontinence include abnormal injury and inadequate informed consent. Although vaginal mesh devices are currently cleared through the 510(k) process, new developments at the US Food and Drug Administration requiring additional postmarket studies (522 studies) for transvaginal mesh for prolapse and mini-suburethral synthetic slings have been issued to ensure product safety and effectiveness. New initiatives including unique device identification numbers and the Pelvic Floor Disorders Registry have been developed to improve surveillance throughout the total product/device life cycle.

Section of Female Pelvic Medicine and Reconstructive Surgery, Department of ObGyn and Urology, MedStar Washington Hospital Center, Georgetown University School of Medicine, Washington, District of Columbia

The authors declare that they have nothing to disclose.

Correspondence: Cheryl B. Iglesia, MD, Section of Female Pelvic Medicine and Reconstructive Surgery, Department of ObGyn and Urology, MedStar Washington Hospital Center, Georgetown University School of Medicine, Washington, DC. E-mail: cheryl.iglesia@medstar.net

© 2013 by Lippincott Williams & Wilkins.