PD36-12 CHARACTERIZATION OF SAFETY EVENTS FOR ENERGY-BASED DEVICES FOR TREATMENT OF VAGINAL SYMPTOMS: AN ANALYSIS OF THE FOOD AND DRUG ADMINISTRATION MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE) DATABASE FROM 2013 TO 2016

Abstract

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Female Incontinence: Therapy III (PD36)1 Apr 2019PD36-12 CHARACTERIZATION OF SAFETY EVENTS FOR ENERGY-BASED DEVICES FOR TREATMENT OF VAGINAL SYMPTOMS: AN ANALYSIS OF THE FOOD AND DRUG ADMINISTRATION MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE) DATABASE FROM 2013 TO 2016 Shannon Wallace* and Ekene Enemchukwu Shannon Wallace*Shannon Wallace* More articles by this author and Ekene EnemchukwuEkene Enemchukwu More articles by this author View All Author Informationhttps://doi.org/10.1097/01.JU.0000556356.54361.ecAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: Energy-based devices have gained momentum as minimally invasive procedures to stimulate collagen regeneration in the female lower genital tract and treat vaginal symptoms related to menopause, urinary incontinence or sexual dysfunction. However, the FDA recently issued a statement cautioning patients and providers that the safety and efficacy of energy-based devices for the treatment of vaginal symptoms has not been well established. The existing data on side effects is insufficient and limited to observation studies. We sought to characterize the safety events of vaginal energy devices by analysis of surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: The MAUDE database was queried between September 30, 2013 and September 30, 2018 for all energy-based vaginal devices. The incidence of safety events was reported for these devices and the most common complaints were described and characterized. RESULTS: Twenty-seven unique and relevant medical device reports were retrieved for vaginal energy based devices including Mona Lisa Touch (Cynosure, Westford, MA) (13/27; 48.1%), diVa (Sciton, Palo Alto, CA) (3/27; 11.1%), ThermiVa (ThermiGen, Irving, TX) (5/27; 18.5%), FotonaSmooth (Fotona, Dallas, TX) (1/27; 3.7%) and FemTouch (Lumenis, San Jose, CA) (5/27; 18.5%). Five reports were filed in 2016 (18.5%), six in 2017 (22.2%) and sixteen in 2018 (59.3%). Within the reports there were 53 different complaints. The most common complaints were vaginal pain (15/27; 55.6%), dyspareunia (6/27; 22.2%), bladder pain (4/27; 14.8%) and urinary frequency (3/27; 33.3%). (Table 1) CONCLUSIONS: MAUDE-reported data shows these patients who receive treatment with energy-based vaginal devices are still at risk for vaginal pain, bladder pain and urinary symptoms. Additional studies are needed to understand the risk profile and complication rates of the available energy-based therapies. This data will better help guide providers to promote effective and safe treatments of pelvic floor conditions. Source of Funding: None Stanford, CA© 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 201Issue Supplement 4April 2019Page: e660-e661 Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.MetricsAuthor Information Shannon Wallace* More articles by this author Ekene Enemchukwu More articles by this author Expand All Advertisement PDF downloadLoading ...