Energy-Based Devices for Functional Vaginal Problems: Issues and Answers

Abstract

Vaginal rejuvenation is a marketing term that encompasses surgical and medical treatments for functional vaginal/vulvar problems including but not limited to genitourinary syndrome of menopause (GSM), sexual dysfunction, vaginal laxity, and stress urinary incontinence (SUI) and for esthetic concerns including dissatisfaction with vulvovaginal appearance. Multiple treatment options have become available for indications of functional vaginal problems. Noninvasive management options including the use of more novel treatments such as energy-based devices have gained interest. Previously, studies regarding the efficacy and safety of the energy-based devices for functional vaginal problems were mostly limited to cohort studies without sham treatment, control groups, randomization, or double blinding. As a result of this insufficient data in 2018, the FDA released a statement of warning against the use of energy-based devices in the treatment of functional vaginal problems or vaginal cosmetic procedures (Https://Www.Fda.Gov/Medical-Devices/Safety-Communications/Fda-Warns-Against-Use-Energy-Based-Devices-Perform-Vaginal-Rejuvenation-or-Vaginal-Cosmetic. 1–4, 2018).Purpose of ReviewThis article reviews the most current treatment modalities in the realm of vaginal rejuvenation therapy with an emphasis on the efficacy and safety of the energy-based devices.Recent FindingsIn the most recent literature, there have been studies with improvements in study design that support the efficacy and the short-term safety of the energy-based devices.SummaryMore recent studies with improved study design evidence that the use of energy-based devices results in improvements in functional vaginal problems and that serious adverse events appear to be rare. The availability of these devices as treatment options for functional vaginal problems has the potential to impact patient by improving their symptoms and quality of life. Caution still remains however regarding their safety following a longer period of time after their use.