Vaginal Tightening and Rejuvenating Devices Can Be Dangerous, the FDA Warns

“We are deeply concerned women are being harmed."

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Let’s get on the same page: Lasers for your vagina exist, and the Food and Drug Administration wants you to think very, very carefully before using them. I’m not talking about lasers for laser hair removal, though, but the lasers some doctors and spas are using off label to “tighten” and “rejuvenate” your literal vagina, which can apparently result in severe burns and scarring, says the FDA.

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The Background

“We are aware that certain device manufacturers may be marketing their energy-based medical device for vaginal 'rejuvenation' and/or cosmetic vaginal procedures,” reads a statement issued by the FDA on Monday. “The safety and effectiveness of energy-based medical devices to perform these procedures has not been established.”

Although these devices in question have been approved by the FDA to safely treat both genital warts and cancerous cervical tissue, they haven’t been approved for their new off-label use: vaginal “rejuvenation,” which can include tightening a lax vagina or increasing sexual sensations.

“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,” reads the statement.

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According to the New York Times, the FDA also sent warning letters to manufacturers of devices like the MonaLisa Touch and Femilift telling them to stop promoting the lasers as a tool for vaginal rejuvenation.

The Issue

The process of lasering your vagina involves creating microscopic incisions in the vaginal tissue to stimulate collagen and thicken vaginal skin. As you might guess, there are risks that come with the off-label treatment, including incidents of vaginal burns, scarring, and significant lasting pain.

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“These products have serious risks and don’t have adequate evidence to support their use for these purposes,” said FDA commissioner Dr. Scott Gottlieb in a statement. “We are deeply concerned women are being harmed.” Currently, the American College of Obstetricians and Gynecologists does not support the use of laser devices for vaginal rejuvenation, though it appears that some doctors are offering the service anyways.

If your physician has used or suggests using a device on you for tightening or “rejuvenating,” the FDA recommends stopping treatment immediately and reporting any issues to MedWatch, FDA’s adverse event reporting program.

Update: Another version of this article misidentified the name of the device made by the company Venus Concept Ltd. The device is the Venus Fiore System, not the Venus Fiore RF Ablation System. The FDA posted a copy of a letter dated August 1 to Venus Concept on its website requesting information about the marketing of the device. In a statement issued to MarieClaire.com, Venus Concept said it is not selling or marketing the Venus Fiore System in the United States. “We have regulatory clearances/approvals in several countries outside the US and we are beyond any doubt following all of the proper regulatory pathways to secure clearances/approvals in each and every country before commercialization,” the company wrote in the statement.

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