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Vaginal Rejuvenation Devices

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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.

What are Vaginal Rejuvenation Devices?

Typically, energy-based vaginal rejuvenation devices use laser or radiofrequency waves to treat certain symptoms and conditions, including:

• Vaginal laxity
• Vaginal atrophy
• Dryness or itching
• Pain during sexual intercourse
• Decreased sexual sensation

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.

FDA Warning for Vaginal Rejuvenation Devices

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:

• Severe vaginal burns
• Vaginal scarring
• Pain during sexual intercourse
• Recurring/chronic vaginal pain

Among other things, the agency recommended that patients:

• Be aware that the safety and effectiveness of energy-based devices to perform vaginal “rejuvenation” or cosmetic vaginal procedures has not been established.
• Understand that the FDA has not cleared or approved any energy-based medical device for vaginal “rejuvenation” or vaginal cosmetic procedures, or for the treatment of vaginal symptoms related to menopause, urinary incontinence, or sexual function.

FDA Targets Manufacturers for Inappropriate Marketing of Energy-Based Devices for Vaginal Rejuvenation

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:

• Alma Lasers
• BTL Industries
• Cynosure
• InMode
• Sciton
• ThermiGen
• Venus Concepts

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.