FDA warns 'vaginal rejuvenation' treatments may pose safety risks
{{#rendered}} {{/rendered}}The FDA warned against "vaginal rejuventation" treatments. (AP)
The U.S. Food & Drug Administration warned against “vaginal rejuvenation” treatments due to potential health and safety risks, including burns and scarring.
The FDA commissioner Scott Gottlieb released a statement Monday, saying they had “recently became aware” of manufacturers selling “vaginal rejuvenation” treatments and devices to treat “conditions and symptoms related to menopause, urinary incontinence or sexual function.”
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{{#rendered}} {{/rendered}}The administration said some of the procedures use lasers or “energy-based devices” to “destroy or reshape vaginal tissue.”
“To date, we have not cleared or approved for marketing any energy-based devices to treat these symptoms or conditions, or any symptoms related to menopause, urinary incontinence, or sexual function,” the statement explained.
The FDA said it was “deeply concerned” people were being injured with these procedures. The agency has reviewed many cases of women being burned, scarred, injured and having pain during intercourse after undergoing treatments.
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“We haven’t reviewed or approved these devices for use in such procedures. Thus, the full extent of the risks is unknown. But these reports indicate these procedures can cause serious harm,” the FDA said.
The FDA said they issued warnings over "inappropriate marketing” to device manufacturers Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen.