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NOSTI, PATRICK A. MD; IGLESIA, CHERYL B. MD
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.
© 2013 by Lippincott Williams & Wilkins.
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vaginal mesh, 510(k), medical malpractice, synthetic vaginal mesh, polypropylene
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