Energy-based vaginal rejuvenation devices have been marketed to women as a fix for vaginal discomfort and symptoms associated with menopause, urinary incontinence, or sexual function. However, the benefits of vaginal rejuvenation devices are unproven and their use may result in serious injuries and complications.
Typically, energy-based vaginal rejuvenation devices use laser or radiofrequency waves to treat certain symptoms and conditions, including:
Vaginal rejuvenation devices are often marketed to women who suffer from symptoms of early menopause or who have finished treatment for breast cancer. The non-surgical, cosmetic procedures may be referred to “designer vaginoplasty,” “revirgination” or “G-spot amplification” and are usually not covered by insurance.
Unfortunately, these devices have never been approved by the U.S. Food & Drug Administration (FDA) for vaginal rejuvenation. Rather, they were only cleared for the treatment of abnormal or precancerous cervical or vaginal tissue, as well as condylomas (genital warts) and other serious conditions.
In July 2018, the FDA issued a warning that advised against the use of energy-based devices for vaginal rejuvenation.
“These products have serious risks and don’t have adequate evidence to support their use for these purposes,” the FDA commissioner said in a statement dated July 30th. “We are deeply concerned women are being harmed.”
According to the agency, use of these devices to treat vaginal symptoms can result in serious injuries and complications, including:
Among other things, the agency recommended that patients:
The FDA also notified 7 device manufacturers of its concerns regarding the inappropriate marketing of energy-based devices for vaginal rejuvenation. Those device makers included:
The above companies were given 30 days to address the FDA’s concerns. If they fail to do so, the agency will consider “appropriate actions”, including enforcement actions.
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