Vaginal energy-based devices: characterization of adverse events based on the last decade of MAUDE safety reports. Issue 2 (February 2021)

• Record Type: Journal Article
• Authors: Wallace, Shannon L.; Sokol, Eric R.; Enemchukwu, Ekene A.
• Is Part Of: Menopause. Volume 28:Issue 2(2021)
• Publication Date: 2021-02
• Subjects: Adverse events -- Dyspareunia energy-based devices -- Erbium: YAG vaginal laser -- Fractional CO2 vaginal laser therapy -- Genitourinary syndrome of menopause -- MAUDE database -- Radiofrequency therapy -- Vaginal rejuvenation; Menopause -- Periodicals; 618.175005
• DOI: 10.1097/GME.0000000000001661
• Languages: English
• ISSNs: 1072-3714

Abstract

Abstract: Objectives: Energy-based devices have gained momentum as minimally invasive procedures to treat both medical and cosmetic pelvic floor disorders including genitourinary syndrome of menopause, vaginal laxity, stress urinary incontinence, dyspareunia, and vulvar disorders such as lichen diseases and vestibulitis. 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. Additionally, the FDA sent letters to the manufactures of energy-based devices with notifications that they could be violating the marketing standards of the FDA. The existing data on side effects is insufficient and limited to observational studies. We sought to characterize the safety events of vaginal energy-based devices by analysis of surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database and specifically look at those events that occurred prior to the July 30, 2018 warning. Methods: The MAUDE database was queried between September 30, 2013 and October 31, 2019 for all vaginal energy-based devices. The incidence of safety events was reported for these devices and the most common complaints were described and characterized. Event reporting was analyzed before and after July 30, 2018. Results: Forty-two unique and relevant medical device reports (MDRs) were retrieved. The Mona Lisa Touch had the highest number of MDRs (40.5%) followed by ThermiVa (16.7%) and Viveve (14.2%). Each medical device report was associated with a single patient experience and within the 42 medical device reports, there were 85 complaints. A majority of the MDR complaints (52.9%) were also indications for energy-based devices procedures, which include vaginal pain, dyspareunia, lichen sclerosis, and urinary frequency. Two-thirds of the complaints (68.2%) were related to pain, but serious adverse events such as third-degree burns (3.5%) were rare. Most of the reportable events occurred before July 30, 2018 (83.3%), but most were reported after July 30, 2018 (78.6%). 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. N/A: Video Summary: http://links.lww.com/MENO/A650 . Abstract : Supplemental Digital Content is available in the text