In response to the FDA warning about the use of photomedicine in gynecology
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To alert patients and health care providers about the use of energy-based devices to perform a vaginal “rejuvenation,” cosmetic vaginal procedures, or nonsurgical vaginal procedures to treat symptoms related to menopause, urinary incontinence, or sexual function, the US Food and Drug Administration (FDA) has issued a warning about the effectiveness and safety of such devices. We agree with the FDA that certain devices (laser, radiofrequency, etc.) have been marketed inappropriately for uses that are outside of their cleared or approved intended uses. We want to position ourselves in the strict training of professionals so that the indications and techniques are used in the best possible way, knowing that, similar to any medical or surgical technique, the side effects can appear in the short and long term, and should be recognized and remedied.
KeywordsFDA safety communication Energy-based devices Vaginal ‘rejuvenation’ Vaginal cosmetic procedures
All authors contributed equally to writing this editorial.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
- 1.FDA Warns Against Use of Energy-Based Devices to Perform Vaginal “Rejuvenation” or Vaginal Cosmetic Procedures: FDA safety communication. Date Issued: July 30, 2018Google Scholar
- 2.The American College of Obstetricians and Gynecologists. Fractional laser treatment of vulvovaginal atrophy and US Food and Drug Administration clearance: position statement. May 2016Google Scholar
- 3.Portman DJ, Gass ML (2014) Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women’s Sexual Health and the North American Menopause Society. J Sex Med 11(12):2865–2872CrossRefGoogle Scholar
- 4.Bachmann G, Santen RJ (2018) Treatment of genitourinary syndrome of menopause (vulvovaginal atrophy). UpToDateGoogle Scholar
- 5.Salvatore S, Athanasiou S, Candiani M (2015) The use of pulsed CO2 lasers for the treatment of vulvovaginal atrophy. Curr Opin Obstet Gynecol 27(6):504–508Google Scholar