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.

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

Zerbinati N.;
2019-01-01

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.
2019
2019
link.springer.de/link/service/journals/10103/index.htm
Energy-based devices; FDA safety communication; Vaginal cosmetic procedures; Vaginal ‘rejuvenation’
Escribano, J. J.; Gonzalez-Isaza, P.; Tserotas, K.; Athanasiou, S.; Zerbinati, N.; Leibaschoff, G.; Salvatore, S.; Sanchez-Borrego, R.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11383/2133073
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