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Lasers in Medical Science

, Volume 34, Issue 7, pp 1509–1511 | Cite as

In response to the FDA warning about the use of photomedicine in gynecology

  • Juan José Escribano
  • Pablo González-Isaza
  • Konstantinos Tserotas
  • Stavros Athanasiou
  • Nicola Zerbinati
  • Gustavo Leibaschoff
  • Stefano Salvatore
  • Rafael Sánchez-BorregoEmail author
Letter to the Editor
  • 126 Downloads

Abstract

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.

Keywords

FDA safety communication Energy-based devices Vaginal ‘rejuvenation’ Vaginal cosmetic procedures 

Notes

Authors’ contribution

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.

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Copyright information

© Springer-Verlag London Ltd., part of Springer Nature 2019

Authors and Affiliations

  • Juan José Escribano
    • 1
  • Pablo González-Isaza
    • 2
  • Konstantinos Tserotas
    • 3
  • Stavros Athanasiou
    • 4
  • Nicola Zerbinati
    • 5
  • Gustavo Leibaschoff
    • 6
  • Stefano Salvatore
    • 7
  • Rafael Sánchez-Borrego
    • 8
    Email author
  1. 1.Unidad Ginecoestetica, Instituto Médico LaserMadridSpain
  2. 2.División de Uroginecología y Cirugía Mínimamente Invasiva, Liga contra el CáncerHospital Universitario San JorgePereiraColombia
  3. 3.Clinica de GinecoEndocrino, Complejo Hospitalario Metropolitano Caja Seguro SocialPanamáPanama
  4. 4.Urogynaecology Unit, 1st Department of Obstetrics and Gynecology“Alexandra” Hospital, National and Kapodistrian University of AthensAthensGreece
  5. 5.Department of Dermatology, School of MedicineUniversity of InsubriaVareseItaly
  6. 6.Cosmetic Gynecology, General Secretary of the World Society of Cosmetic GynecologyDallasUSA
  7. 7.Obstetrics and Gynecology UnitVita-Salute San Raffaele University and IRCCS San Raffaele HospitalMilanItaly
  8. 8.DIATROS, Clínica de Atención a la MujerBarcelonaSpain

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