Vaginal Energy-based Devices: Characterization of Adverse Events Based on the Last Decade of MAUDE Safety Reports

Shannon L. Wallace, MD; Eric R. Sokol, MD; Ekene A. Enemchukwu, MD, MPH

Disclosures

Menopause. 2021;28(2):135-141. 

In This Article

Methods

The MAUDE database is a publicly available reporting system mandated by the FDA that provides over 5 million records related to medical device safety for post market surveillance. The database is maintained by a division of the FDA and is available for public use under the Freedom of Information Act. This database collects anonymous medical device reports (MDRs) of suspected device-associated deaths, serious injuries, and malfunctions. Voluntary reports are those provided by healthcare professionals, patients, and consumers, while mandatory reports are those provided by manufacturers, importers, and device use facilities. The MAUDE database consists of all voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. Manufacturers are required to report device-related death, serious injury, or malfunction within 30 days of becoming aware of the event. User facilities (hospitals, outpatient diagnostic or treatment facilities, nursing homes, and ambulatory surgical facilities) are also required to submit reports to the FDA within 10 work days.[21]

We performed an IRB-exempt query of the MAUDE database between September 30, 2013 and October 31, 2019 for all energy-based vaginal devices. All downloadable MAUDE files were imported into Excel Version 1910 and consolidated. Data was filtered by brand name using the following search terms: "diVA," "ThermiVa," "FemTouch," "Fotona," "FemiLift," "Fiore," "Geneveve," "Genevieve" "Viveve," "Mona Lisa," "Mona Lisa Touch," "DEKA SMARTXIDE2," and "Exilis."

Each adverse event report lists the device type, brand name and manufacturer, as well as the reporter occupation, report date, and a free text description of the event. Events were included if they documented 1) use of an energy-based device in the vagina or on the vulva, 2) a listed indication for vaginal energy-based device therapy, and 3) one or more specific posttreatment complaints believed to be related to the energy-based device procedure. The incidence of safety events was reported, and the most common complaints were described and characterized. Event reporting was analyzed before and after July 30, 2018.

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