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.
The vaginal mesh controversy highlights a broad and long-unaddressed failure of the U.S. Food and Drug Administration's premarket screening for safety and effectiveness of moderate-risk or high-risk devices.
Division of Urogynecology, the Knowledge and Evaluation Research Unit, and the Division of Endocrinology, Mayo Clinic, Rochester, Minnesota.
Corresponding author: Emanuel C. Trabuco, MD, Mayo Clinic, 200 First Street SW, Rochester, MN 55905; email: firstname.lastname@example.org.
Financial Disclosure The authors did not report any potential conflicts of interest.
Each author has indicated that he has met the journal's requirements for authorship.
Received March 16, 2018
Received in revised form May 11, 2018
Accepted May 24, 2018