The rise and fall of mesh in pelvic surgery and the shortcomings of medical device regulation

Emanuel C. Trabuco, Victor Manuel Montori

Research output: Contribution to journalArticle

Abstract

Two U.S. Food and Drug Administration public health warnings regarding the use of mesh in stress incontinence and prolapse repairs have had far-reaching clinical and legal consequences. In this commentary, we explore the drastically distinct results from these mesh-based procedures, which revealed systemic flaws with the medical device approval process across specialties and affected thousands of patients.

Original languageEnglish (US)
Pages (from-to)736-740
Number of pages5
JournalObstetrics and Gynecology
Volume132
Issue number3
DOIs
StatePublished - Jan 1 2018

ASJC Scopus subject areas

  • Obstetrics and Gynecology

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