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.
Journal
Female pelvic medicine & reconstructive surgery
ISSN: 2154-4212
Titre abrégé: Female Pelvic Med Reconstr Surg
Pays: United States
ID NLM: 101528690
Informations de publication
Date de publication:
01 01 2021
01 01 2021
Historique:
pubmed:
27
5
2020
medline:
15
12
2021
entrez:
27
5
2020
Statut:
ppublish
Résumé
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. 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. We included 49,848 women (78% white, 7% black, and 15% Hispanic) with an average ± SD age of 60.2 ± 13.0 years. After the safety communication, the use of transvaginal mesh in POP repairs decreased among white women (odds ratio [OR], 0.45; 95% confidence interval [CI], 0.41-0.50) and African Americans (OR, 0.48; 95% CI, 0.35-0.67) but remained stable among Hispanic women (OR, 0.88; 95% CI, 0.70-1.11). Only in the subgroup of patients from high-income areas, there was a trend toward decreasing mesh use among Hispanic patients after 2011 (OR, 0.71; 95% CI, 0.49-1.04). The communications related to the safety of transvaginal mesh did not have an equal impact across racial groups. Mesh use decreased among white and African American women but not among Hispanic women after the 2011 FDA safety communication. Particular attention is warranted for patients from disadvantaged groups, especially low-income minorities, when disseminating medical device safety messages.
Identifiants
pubmed: 32453208
pii: 01436319-202101000-00036
doi: 10.1097/SPV.0000000000000863
pmc: PMC7679269
mid: NIHMS1570372
doi:
Types de publication
Journal Article
Observational Study
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
e133-e138Subventions
Organisme : FDA HHS
ID : U01 FD005478
Pays : United States
Organisme : FDA HHS
ID : U01 FD006936
Pays : United States
Informations de copyright
Copyright © 2020 American Urogynecologic Society. All rights reserved.
Déclaration de conflit d'intérêts
The authors have declared they have no conflicts of interest.
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