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PubMed

The Rise and Fall of Mesh in Pelvic Surgery and the Shortcomings of Medical Device Regulation.

PMID: 30095770 · 2018

E, m, a, n, u, e, l, , C, , T, r, a, b, u, c, o, ;, , V, i, c, t, o, r, , M, , M, o, n, t, o, r, i

RevistaObstetrics and gynecology
Año2018
PMID30095770

Resumen

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.

Fuente oficial

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