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U.S. Food and Drug Administration (2018) Statement from FDA Commissioner Scott Gottlieb, M.D., 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/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-efforts-safeguard-womens-health-deceptive-health-claims

has been cited by the following article:

• TITLE: Non-Ablative Transvaginal Radiofrequency in the Treatment of Stress Urinary Incontinence: Review of the Literature

  AUTHORS: Haley Calcagnotto, Laura Leite, Vittoria Dreher Longo, Gustavo Messinger Piva, Thais Gasperin, Alexandra Maria Flores Bordignon, Renata Rauber Felkl, Jose Mauro Madi, Gabriela Françoes Rostirolla

  KEYWORDS: Radiofrequency, Urinary Incontinence, Genitourinary Syndrome of Meno-pause, Vaginal Atrophy

  JOURNAL NAME: Open Journal of Obstetrics and Gynecology, Vol.13 No.2, February 13, 2023

  ABSTRACT: Background: Urinary incontinence is defined as the involuntary loss of urine, which can affect up to 45% of women after menopause. Radiofrequency is a non-invasive procedure that involves the application of an electromagnetic wave that through heat generation promotes neocollagenesis and neoeslatinogenesis in the vaginal epithelium. This energy-based technology has been studied as a potential alternative for the treatment of genitourinary syndrome of menopause and urinary incontinence. Objective: To review the recent literature (from 2020 to June 2022) on the use of transvaginal radiofrequency in the treatment of stress urinary incontinence, by searching articles at databases of Capes, PubMed Cochrane and Scielo. Methods: The descriptor terms “Urinary Incontinence/therapy” [Majr] AND “Urinary Incontinence, Stress/therapy” [Majr] AND RADIOFREQUENCY-Search Results-PubMed, [“woman” OR “women”] AND [“urinary incontinence” OR “stress urinary incontinence”] AND Radiofrequency were used, with a filter for the period 2020 to 2022. Conclusion: The studies evaluated in this review demonstrated significant results of radiofrequency in the resolution or reduction of complaints of women with urinary incontinence, especially stress urinary incontinence, but most of these studies presented a low methodological quality. There is, therefore, a lack of studies with longer follow-ups, evaluation of cost-effectiveness, randomized clinical trials with objective outcomes and the use of validated questionnaires with international acceptance.