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


Menopause. 2021;28(2):135-141. 

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In conclusion, MAUDE-reported data suggests that the majority of patient complaints after energy-based device treatment for PFDs are not severe and some may be related to progression of the disease. However, as current literature lacks robust efficacy and safety-profile data, the few severe adverse events reported in the MAUDE database may have contributed to the FDA warning regarding energy-based devices. While robust clinical trials of energy-based devices are ongoing, healthcare professionals should continue to review and encourage voluntary reporting to the MAUDE database.