Published September 1, 2019 | Version v1
Journal article

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

  • 1. Unidad Ginecoestetica, Instituto Médico Laser (Spain)
  • 2. Hospital Universitario San Jorge, División de Uroginecología y Cirugía Mínimamente Invasiva, Liga contra el Cáncer (Colombia)
  • 3. Clinica de GinecoEndocrino, Complejo Hospitalario Metropolitano Caja Seguro Social (Panama)
  • 4. "Alexandra" Hospital, National and Kapodistrian University of Athens, Urogynaecology Unit, 1st Department of Obstetrics and Gynecology (Greece)
  • 5. University of Insubria, Department of Dermatology, School of Medicine (Italy)
  • 6. Cosmetic Gynecology, General Secretary of the World Society of Cosmetic Gynecology (United States)
  • 7. Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Obstetrics and Gynecology Unit (Italy)
  • 8. DIATROS, Clínica de Atención a la Mujer (Spain)

Description

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.

Additional details

Identifiers

Publishing Information

Journal Title
Lasers in Medical Science (Online)
Journal Volume
34
Journal Issue
7
Journal Page Range
p. 1509-1511
ISSN
1435-604X

INIS

Country of Publication
United Kingdom
Country of Input or Organization
International Atomic Energy Agency (IAEA)
INIS RN
51106042
Subject category
S60: APPLIED LIFE SCIENCES;
Descriptors DEI
EQUIPMENT; GYNECOLOGY; LASERS; MENOPAUSE; PATIENTS; RADIOWAVE RADIATION; SIDE EFFECTS; SURGERY; TRAINING; US FDA
Descriptors DEC
EDUCATION; ELECTROMAGNETIC RADIATION; MEDICINE; NATIONAL ORGANIZATIONS; RADIATIONS; US HEW; US ORGANIZATIONS

Optional Information

Copyright
Copyright (c) 2019 Springer-Verlag London Ltd., part of Springer Nature