Food and Drug Administration Safety Communication on the Use of Transvaginal Mesh in Pelvic Organ Prolapse Repair Surgery: The Impact of Social Determinants of Health.

ABSTRACT:

Objective

This study was to examine the impact of the July 2011 Food and Drug Administration (FDA) safety communication on the use of transvaginal mesh in pelvic organ prolapse (POP) repair by patients' race and ethnicity.

Methods

We conducted an observational cohort study of women undergoing POP repairs in 2008 to 2015 in New York State. We examined the changes in transvaginal mesh use in POP repairs before and after the FDA communication by patients' race and ethnicity. Piecewise logistic regression models were used to assess the trends of mesh use, adjusting for patient characteristics. We performed a subgroup analysis of the trends of transvaginal mesh use by racial groups, stratifying by patients' neighborhood socioeconomic status.

Results

We included 49,848 wome

SUBMITTER: Mao J 

PROVIDER: S-EPMC7679269 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature