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

One year ago, in this journal, I predicted the FDA’s concerns disseminated in recent monthsregarding a rapidly growing field of device-based treatment for women’s genitourinary (GU) disorders. In that article entitled, “Devices in Women’s Health” (JDD November 2017), I put forth the status of FDA clearance Lasers and Energy-Based Devices for Women’s Genitourinary Health: Scientific and Clinical Evidence and FDA Clearance for devices in the women’s GU health domain and warned of marketing preceding appropriate clearances.¹ Current FDA clearances are only for general use such as “incision, excision, vaporization, and coagulation of body soft tissues including gynecology and GU surgery,” or “electrocoagulation and hemostasis and to create lesions in nervous tissue in dermatological and general surgical procedures.”¹ On July 31, 2018, the FDA warned against the use of energy-based devices to perform vaginal “rejuvenation” or vaginal cosmetic procedures (https://www.fda.gov/MedicalDevice/Safety/AlertsandNotices/ucm615013.htm) followed by a statement from FDA Commissioner Scott Gottlieb MD on efforts to safeguard women’s health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for “vaginal rejuvenation” (https://www.fda.gov/NewsEvents/Newsroom/Press Announcements/ucm615130.htm). As I forewarned a year ago, the proper testing and clearances for GU applications are imperative to ensuring these potential treatments are safe and effective for women’s GU disorders; marketing of women’s health technologies should not get ahead of clearances.Lasers have a long over 40-year history of use in women’s GU disorders among gynecologists, urologists, dermatologists, and plastic surgeons. Carbon dioxide (CO2) laser has been used for incision and ablation of GU tissue, endometriosis, and genital warts, and defocused CO2 for tissue contraction. Diode laser has been used for myomectomy. Photodynamic therapy has been performed with various lasers and light sources for lichen sclerosus, including those published in this journal.² Radiofrequency has been used in the lower genital tract for endometrial ablation. Over the past 15 years, fractional lasers and radiofrequency technologies have been increasingly reported for the treatment of atrophic vaginitis, stress urinary incontinence,