Adverse Event Reports Associated with Vaginal Mesh: An Interrupted Time Series Analysis.

BACKGROUND: Surgery with vaginal mesh is often used to treat female urinary incontinence. Questions have emerged over the past decade about the safety and efficacy of vaginal mesh devices.

OBJECTIVE: This study examines trends in adverse event reports associated with vaginal mesh devices, testing the hypothesis that Food and Drug Administration (FDA) announcements will result in increased adverse event reports to the FDA.

METHODS: Using interrupted time series regression models, we analyzed adverse event report data collected from the FDA's Manufacturer and User Facility Device Experience reporting system in 1998 through 2015.

RESULTS: FDA announcements had limited effects on the number of adverse event reports, whereas an announcement from a mesh manufacturer that it was withdrawing devices from the market resulted in a large spike in reports.

CONCLUSIONS: These findings raise concerns about the dispersion of risk communications, the FDA's reliance on adverse event reports for postmarket surveillance, and the FDA's clearance of vaginal mesh without safety or efficacy testing.