4.4 Letter

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

Journal

LASERS IN MEDICAL SCIENCE
Volume 34, Issue 7, Pages 1509-1511

Publisher

SPRINGER LONDON LTD
DOI: 10.1007/s10103-019-02744-1

Keywords

FDA safety communication; Energy-based devices; Vaginal 'rejuvenation'; Vaginal cosmetic procedures

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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.

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