The FDA issues Statement
In an August 2 statement, the FDA outlined their concerns about marketing claims being made about vaginal rejuvenation by the device manufacturers. According to the agency, “These products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed. We’ve recently become aware of a growing number of manufacturers marketing “vaginal rejuvenation” devices to women and claiming these procedures will treat conditions and symptoms related to menopause, urinary incontinence or sexual function.”
Over the last few years, some laser manufacturers have promoted their products for the off-label treatment of symptoms of vaginal atrophy, urinary incontinence, menopause, and sexual function. The laser vaginal rejuvenation procedures may also be marketed as designer vaginoplasty, revirgination, and G-spot amplification treatments.
The FDA has continued to receive reports of serious burns, scarring and lasting pain due to laser vaginal rejuvenation procedures. This led to the agency issuing letters to seven device manufacturers outlining its concerns about inappropriate marketing of their devices for “vaginal rejuvenation” procedures.
The companies are:
- Alma Lasers
- BTL Industries
- Venus Concept