The Rise and Fall of Mesh in Pelvic Surgery and the Shortcomings of Medical Device Regulation.
PMID : 30095770 · 2018
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Publicité
RevueObstetrics and gynecology
Année2018
PMID30095770
Résumé
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.
Publicité
Source officielle
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