The Rise and Fall of Mesh in Pelvic Surgery and the Shortcomings of Medical Device Regulation.
editorial · Level V
Where this comes from
- Record sourced from PubMed, PMID 30095770.
- Also identified by DOI 10.1097/AOG.0000000000002776.
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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.
Medical subject headings
- Gynecologic Surgical Procedures
- Medical Device Legislation
- Pelvic Organ Prolapse
- Surgical Mesh
- Urinary Incontinence, Stress