Characterizing Adverse Events Reporting for an Over-the-Counter Disposable Intravaginal Support Device for Stress Urinary Incontinence.

Abstract

Objectives: 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.

Methods: 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.

Results: 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.

Conclusions: 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.