Characterizing Adverse Events Reporting for an Over-the-Counter Disposable Intravaginal Support Device for Stress Urinary Incontinence.
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 05 2022
01 05 2022
Historique:
pubmed:
18
9
2021
medline:
14
5
2022
entrez:
17
9
2021
Statut:
ppublish
Résumé
In recent years, new intravaginal support devices for stress urinary incontinence have been introduced to the market. Although studies have demonstrated their safety and efficacy, few studies have examined adverse events attributed to their use. The objective of this study was to characterize reported adverse events for an over-the-counter intravaginal support device and determine whether further medical treatment was necessary to manage the adverse event. We searched the Manufacturer and User Device Experience database from January 2015 to September 2020 for pertinent reported adverse events, which included the unique report key, event date, report date, event text descriptions, and resulting course of treatment. Per Manufacturer and User Device Experience database mandatory requirements, all reports were submitted by the manufacturer within 30 days of receiving the consumer's voluntary submission. A total of 257 reports were included for analysis. The most common reported adverse event was related to the string of the device, which broke with either removal or insertion of the device (230 of 257 [89.5%]). The majority of patients who required medical attention (133 of 257 [51.8%]) were evaluated and managed in the office setting (85 of 133 [63.9%]), whereas 37% (95 of 257) of patients were able to self-treat. Most complications attributed to device use were self-managed or managed in the outpatient setting. No emergent hospitalizations or deaths were attributed to their use, supporting their generally low-risk profile and high tolerability. Limitations of this review include the inability to decipher a denominator for these reported adverse events and the potential bias attributed to voluntary consumer reporting.
Identifiants
pubmed: 34534195
doi: 10.1097/SPV.0000000000001109
pii: 01436319-202205000-00005
doi:
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
300-303Subventions
Organisme : FDA HHS
ID : U01 FD006936
Pays : United States
Informations de copyright
Copyright © 2021 American Urogynecologic Society. All rights reserved.
Déclaration de conflit d'intérêts
The authors have declared they have no conflicts of interest.
Références
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