Vaginal energy-based devices: characterization of adverse events based on the last decade of MAUDE safety reports

Conclusions: MAUDE-reported data suggests that the majority of patient complaints after vaginal energy-based device treatment include vaginal pain, bladder pain, and urinary symptoms. This study suggests that the majority of complaints are not severe, and some may be related to progression of the disease. The few severe adverse events reported in the MAUDE database may have contributed to the FDA warning regarding energy-based devices. Recall bias after the FDA warning, as well as the potential for litigation, may have prompted an increase in adverse event reporting after July 30, 2018. Video Summary:http://links.lww.com/MENO/A650.
Source: Menopause - Category: OBGYN Tags: Original Studies Source Type: research