The FDA Wants to Remind You That It Has Not Approved Any Devices for 'Vaginal Rejuvenation'

The term “vaginal rejuvenation” has been thrown around for years, but what, exactly, it’s supposed to be is a little murky given that this isn’t an actual medical procedure. At its core, vaginal rejuvenation seems to be a promise that by doing something, your vagina will be restored to its glory days…whatever that means.

Not only do procedures like that reinforce the misguided idea that there's something wrong with your vagina that needs fixing, but they may also be marketed in sneaky ways, the Food and Drug Administration (FDA) said in a statement released Monday.

The FDA is warning patients that, despite marketing to the contrary, no medical procedures are FDA-approved for vaginal rejuvenation.

“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,” FDA commissioner Scott Gottlieb, M.D., said in a statement. The FDA is specifically looking at procedures that use lasers, usually CO2 lasers, and “other energy-based devices” to “destroy or reshape vaginal tissue,” he continued. “These products have serious risks and don’t have adequate evidence to support their use for these purposes,” Gottlieb said. “We are deeply concerned women are being harmed.”

Mary Jane Minkin, M.D., a clinical professor of obstetrics and gynecology and reproductive sciences at Yale Medical School, tells SELF that she was “delighted” by the FDA’s statement. “Until we see prospective randomized trials, we really cannot say what any of these procedures are accomplishing,” she says.

“The idea that a laser is going to tighten your vagina and make you look more youthful is all nonsense and hasn’t been proven in scientific literature,” Lauren Streicher, M.D., an associate professor of clinical obstetrics and gynecology at Northwestern University Feinberg School of Medicine, tells SELF, adding that she’s “thrilled” with the statement. “You also have a lot of people like dermatologists and plastic surgeons offering ‘vaginal rejuvenation’ with these lasers who have no business doing that,” she says.

Jane G. Mazur, vice president of Global Divisional Communications at Hologic which is behind Cynosure (one of the companies called out by the FDA), tells SELF that her company is “aware” of the FDA’s statement. “As a leader in women’s health, Hologic has a strong track record of rooting our products in science and clinical evidence so we take the contents of this letter seriously,” she said. “We are evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements.”

Technically, the devices themselves are FDA approved or cleared to treat certain conditions—but not for vaginal rejuvenation.

Those conditions include things like the destruction of abnormal or pre-cancerous cervical or vaginal tissue, as well as genital warts, Dr. Gottlieb pointed out. “But the safety and effectiveness of these devices hasn’t been evaluated or confirmed by the FDA for ‘vaginal rejuvenation,’” he wrote.

But that doesn't mean providers can't use the device in off-label ways.

There is some data that suggest that CO2 lasers are helpful for vaginal atrophy.

Vulvovaginal atrophy is a medical condition that causes vaginal dryness, irritation, soreness, and pain during sex, the Mayo Clinic explains. It usually occurs after a woman goes through menopause.

Although CO2 lasers aren’t FDA approved or cleared for treating vulvovaginal atrophy, Dr. Streicher points to the existing research as evidence that there may be some benefit for women who are struggling with the condition.

For instance, in a 12-week pilot study published in 2014, 50 postmenopausal women had their vulvovaginal atrophy symptoms measured before and after laser treatment, which consisted of three sessions. All of the women included had been dissatisfied with other treatment options, and 84 percent of them reported that they were satisfied with the laser treatment. However, this is a small study and did not include a control group.

Another study, also published in 2014 from the same group of researchers, looked specifically at sexual function following laser treatment in 77 postmenopausal women with vulvovaginal atrophy (the condition can cause painful sex). Using a similar 12-week treatment program, the researchers found that, of the 20 women in the study who initially reported avoiding sex due to the condition, 17 of them (85 percent) reported regaining a normal sex life after treatment. A 2016 study looking specifically at postmenopausal women who had also survived breast cancer found similar results.

Both a review of the safety of the procedure and the effectiveness of the procedure for this use conclude that there is promising evidence out there for it, but that evidence mainly comes from small prospective studies and needs to be reproduced on a larger scale.

“I applaud that the FDA talked about ‘vaginal rejuvenation’ and appropriate marketing, but I’m disappointed that they lumped that in the same category as experts who are treating vulvovaginal atrophy with the CO2 laser,” she says. “It has been a game-changer for many women.”

The American College of Obstetricians and Gynecologists (ACOG) does acknowledge the potential for using the devices in this way, but notes that the research supporting that use is "preliminary" and that "additional data clearly are needed to further assess the efficacy and safety of this procedure in treating vulvovaginal atrophy, particularly for long-term benefit."

But Dr. Streicher likens using CO2 lasers for vulvovaginal atrophy to using hormonal birth control pills to try to help treat menstrual cramps. Technically it’s not FDA-approved for that use, but because there is some research, doctors may decide that this use is appropriate. She also offers information about this treatment on her website. Dr. Minkin agrees that there's promise in using the devices in this way, but she adds that you need to do the treatments once a month for three months (as in the 12-week studies), which can be costly.

Even if there's research to suggest that CO2 lasers can help with vulvovaginal atrophy, the FDA's statement is aimed at all devices and procedures that promise "vaginal rejuvenation," not just those treating menopause-related vulvovaginal changes.

And it's important to keep in mind that procedures involving these devices may come with real health risks.

The FDA has received reports of some serious side effects associated with vaginal rejuvenating procedures, including "vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain," according to Dr. Gottlieb's statement. But because the devices haven't undergone a full review for this specific use, the FDA doesn't have a complete understanding of the potential risks and can't evaluate whether or not they outweigh the possible benefits. So, whether or not the procedure is worth the financial costs and potential health risks associated with it is currently up to you and your doctor.

If you feel like your vagina has changed and it bothers you, there are a few other options.

If tightness and incontinence is your concern, the first line of defense is typically Kegels, Dr. Minkin says. This is a non-invasive exercise you can do pretty much anywhere (though it's best if you have a gynecologist or pelvic floor physical therapist explain how to do them properly) in which you tighten and release your pelvic floor muscles. Or, if you’re experiencing postmenopausal vaginal dryness, she recommends trying OTC vaginal moisturizers like Replens or Revaree. If that doesn’t do the trick, talk to your doctor about using a vaginal product with estrogen or prasterone, or an oral medication like ospemifene, which is designed to help treat pain during intercourse, she says.

Above all, talk to your doctor—and we mean your ob/gyn, not a plastic surgeon or dermatologist. This is what they do, and they should be able to help steer you toward a treatment that’s right for you.


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