Lasers and Energy-Based Devices for Women’s Genitourinary Health: Scientific and Clinical Evidence and FDA Clearance

The scientific basis for the application of laser and energybased devices to GU tissue has thus been extensively studied. The vagina is lined by skin externally, directly relating tothe transfer of dermatologic devices to external vaginal applications. The vaginal tract is lined by non-keratinized stratified squamous epithelium, which is estrogen-dependent, glycogen-rich, but which undergoes atrophy following menopause, ovarectomy, breast cancer, radiation, and breast feeding. It is estimated that 50% of post menopausal women suffer from GSM. Treatment of atrophic post-menopausal vaginal epithelium with lasers and energy-based devices has been published in a number of histologic and clinical reports to restore vaginal epithelial thickness, glycogen levels, glycogen-rich shedding and pH, to stimulate fibroblasts and vascularity in the underlying lamina propria to pre-menopausal levels; and to improve the clinical signs and symtoms of GSM.³An accumulating body of evidence, including randomized clinical trials comparing devices to topical estradiol, increasingly support the scientific and clinical basis for this therapeutic approach to a group of disorders for which there is a paucity of highly effective treatment options. From a safety perspective, while 14 adverse events (AE) from devices used on vaginal tissue were reported to the FDA to date, the rate of AE appears to be exceedingly small as the global sales for devices in this arena exceeded $100 million in 2016 and only immediate, shortterm, mild, and the absence of severe AEs have been observed in clinical trials. An over-the-counter LED device has been determined by the FDA to constitute a general wellness product that is “low risk” to be used “to increase sexual pleasure and for personal wellness to improve confidence with sexual intercourse.” ⁵ More randomized, controlled clinical trials comparing laser and energy-based devices to FDA-approved treatments are needed in order for FDA clearances to allow for any marketing of these technologies to treating women’s health conditions.References