The FDA Is Finally Cracking Down on ‘Vaginal Rejuvenation’

In Health

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On Monday, the FDA issued a warning to seven companies that market products using laser or radio frequencies to help women “rejuvenate” their vaginas. The therapies, often involving probes, are sold to women on the promise that they will tighten and refresh vaginas into what is thought to be their most natural, beautiful state.

The problem? There is almost no proof that these therapies actually work.

“Without long term studies, it’s hard to know what the risks will be,” Scot Glasberg, a past president of the American Society of Plastic Surgeons, told The Daily Beast.

That’s true not only of the vaginal rejuvenation but of other cosmetic and aesthetic products. Glasberg pointed to Botox, whose initial use when it came out was for the upper area of the face. But “off-label” use isn’t uncommon, as doctors and aestheticians experiment. Botox today has been used in various parts of the body even for non-cosmetic uses (look to migraine treatments for its more unusual, promising use).

Likewise, Glasberg said, it’s possible that these therapies could be useful for vaginal rejuvenation. “It’s not uncommon for devices to be used off-label,” Glasberg said. But without scientific studies and proof that off-label use is safe, the FDA is doubling down. “That marketing” of vaginal rejuvenation being safe with lasers “gets [the FDA’s] ire up and gets those companies the warning letter,” he said.

“The deceptive marketing of unproven treatments may not only cause injuries but also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions,” FDA Commissioner Scott Gottlieb said in a press release. “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.”

Indeed, risks include vaginal burns, scarring, painful sex, and recurring and/or chronic pain, the FDA said.

The FDA is further worried because of the unknown safety implications for those who have undergone chemotherapy. Vaginal rejuvenation therapies, after all, have been heavily marketed to women who have completed breast cancer treatments and are experiencing early menopause. The FDA went so far as to describe the marketing of this potentially dangerous set of products as “egregious.”

But the target audience of women who are seeking vaginal rejuvenation is mostly concentrated among those who are looking to revitalize their vaginas into their former “virgin” state. Some women have gone through difficult births or have experienced vaginal tearing that has fundamentally changed how their vagina looks and feels. Others are experiencing sexual difficulty in the aftermath of menopause. None of them are quite happy with how their vagina looks.

Still others are seeking vaginal rejuvenation as they seek to remake their vaginas into what they think is the societal ideal of what a vagina should look like. That’s fed in part by celebrities who have adopted the language of feminism to promote the practice. V Spot Medispa on the Upper East Side in Manhattan, for example, was founded by Cindy Barshop, a Real Housewives of New York alum who declares on its millennial pink homepage that “Feeling good isn’t taboo—it’s a right!The Kardashians are fans. The members of the Real Housewives franchise have practically universally undergone treatments and given the process tons of praise. Jada Pinkett-Smith has gushed that vaginal rejuvenation has given her a “yoni […] like a 16-year-old!”

“The vaginal rejuvenation market has grown in the last five years. It’s especially grown with minimally invasive techniques in the market.”

— Scot Glasberg, past president of the American Society of Plastic Surgeons

Glasberg has seen growing demand in his clinic from healthy patients seeking the procedure for strictly aesthetic reasons. “The vaginal rejuvenation market has grown in the last five years,” he told The Daily Beast (Glasberg himself does not use vaginal rejuvenation methods). “It’s especially grown with minimally invasive techniques in the market.”

That’s what makes the procedure attractive to many people now, said Glasberg—that it doesn’t involve a knife and anesthesia and purports to offer a “more natural” way to achieve a tighter vagina without the side effects of plastic surgery.

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But, says Glasberg, “there’s no such thing as a lunchtime facelift.”

“There’s a clear trend towards minimally invasive techniques that are easier for the patient, with less pain and down time,” he said. “That’s the appeal with a [vaginal rejuvenation] device, because surgical procedures are more extensive and carry presumably more risk.” But perception may not be reality here, given the lack of long range, thorough scientific studies that present data about risk.

Glasberg also pointed out that customers are often trying to cut costs, but minimally invasive techniques can sneakily raise costs due to multiple visits, botched jobs, or less long lasting effects. “You get what you pay for,” Glasberg said.

What complicates the situation is that the claims the seven companies under review make are both confusing and spectacular, with promises that don’t necessarily make sense to the untrained eye but include terminology designed to sound as if it’s better than going under the knife. Cynosure’s MonaLisa Touch, for example, cites “18+ published clinical studies” proving the insertion of a vaginal probe to deliver “gentle, virtually painless laser energy to the vaginal wall.” That “laser energy” is meant to incite cell stimulation and reintroduce fluids and collagen and elastin to revitalize the vagina. Another company’s product, Alma Laser’s Pixel CO2 Laser System, promises to use carbon dioxide lasers to send “light and thermal energy to assist in vaginal mucosa revitalization.”

These claims are backed (somewhat) by the American Society of Plastic Surgeons, which describes them in detail on its website along with the possibility of combining them with labiaplasty to reshape any asymmetry in the labia. And there are a few review articles that have trickled out in recent years as well, such as this one from the September 2016 issue of the International Journal of Women’s Dermatology. “In the hands of well-trained physicians, energy-based devices are likely to benefit millions of women by aiding them in reclaiming, relishing, and reveling in their femininity at full capacity,” the authors of the research wrote.

Importantly, while they found small instance of women dealing with medical issues—for example, incontinence—seeing improved results with vaginal rejuvenation, the use of the therapy to recreate the ultimate vagina remained something that required more robust research.

In other words: Is it safe to use a laser or other energy-diffusing device to stimulate the vaginal wall into producing collagen, elastin, and mucus while “tightening” it after normal aging effects? The jury is still out.

The deeper problem with the rise in vaginal rejuvenation and other attempts by women to redesign their vaginas is rooted in how society expects females and their vaginas to look, and how women buy into these societal expectations, however misplaced they are, in a desperate attempt to fit in with what has been deemed “normal” and/or “beautiful.”

The pursuit of the perfect vagina has given rise to a slew of treatments meant to help women resculpt their genitals by sidestepping the scalpel and anesthesia normally associated with plastic surgery and using “natural” remedies to help achieve the ideal vaginal aesthetic. As Jen Gunter, an obstetrician and gynecologist based in California, wrote in The New York Times in June, this has taken a variety of forms.

One is douching, which has taken on what Gunter jokes takes on the quality of “a recipe for tzatziki sauce”: lemon juice, yogurt, garlic, cucumber, and oregano oil have been applied to vaginas. Khloe Kardashian has suggested slathering the vagina with Vitamin E oil. Gwyneth Paltrow of faux wellness giant Goop has famously suggested everything from steaming to sticking a jade egg up the vagina to promote a “healthier,” more beautiful vagina.

Vaginal rejuvenation is the tipping point in a centuries-old culture that shames women about their vaginas and aggressively promotes the idea that they are not “good” the way they are. Vaginas must be scrubbed to be considered clean, stripped of hair to be considered beautiful, resculpted to be considered virginal. Women have been taught to be ashamed of their vagina’s unique odor, to think its colors and folds are something that need to be nipped and tucked, that the vagina they are born with is somehow… wrong.

The blatant and sad irony of this widely prevailing misconception of vaginal beauty is that a healthy vagina doesn’t necessarily look like or smell like anything specific. In fact, a vagina that smells like a field of lavender is probably not a healthy one at all. Researchers have repeatedly said that the best way to take care of a vagina is to—drumroll, please—wash it, just like any other part of the body, no special chemicals or tzatziki sauce required. The vagina a woman was born with, that has grown with her through puberty and sex and childbirth and menopause and everything in between, is actually the best vagina a woman can have.

“It turns out women are diverse in their vaginal appearance and measurements due to age, race, sexual activity, and plain old genetics, among other factors. In short: There’s no such thing as the perfect vagina.”

After all, what does a perfect vagina even look like? A review in the British Journal of Obstetrics and Gynecology: An International Journal of Obstetrics and Gynecology recruited women to describe the measurements and appearance of what they thought a vagina should look like, then compared it to the actual vaginal measurements and appearances of real women. It turns out women are diverse in their vaginal appearance and measurements due to age, race, sexual activity, and plain old genetics, among other factors. In short: There’s no such thing as the perfect vagina.

For a more recent BJOG study, published this June, researchers took the genital measurements of 657 white, healthy, not pregnant women between the ages of 15 and 84 in Switzerland. The goal was simple: Find out what normal, healthy female vaginas look like.

Outer labia measurements ranged from half an inch to seven inches long, and labia measurements went from 0.03 inches to three inches. It was a study of fewer than a thousand women—white women only, at that—so that’s something to keep in mind. But even still, it was the largest study of its kind conducted thus far, and even among hundreds of women, no one single model of a healthy, “normal” vagina emerged.

That the FDA is investigating what might appear to be a sham is a critical turning point in women’s health, as the wellness industry has mushroomed in the past decade thanks in large part to Paltrow’s Goop, which went from blog to wellness giant promoting “alternative” health trends in the course of a few years. Paltrow’s company purports to serve American women’s health by questioning science and offering alternative ways to help women achieve their best health.

But Paltrow was right about one thing when she told The New York Times’ Taffy Brodesser-Akner, “It’s a cultural firestorm when it’s about a woman’s vagina.”

This is a rare admission, but Paltrow is capitalizing on something that has long evaded too many women: doctors who believe in them and a medical establishment that understands female concerns and needs. Women make up 50 percent of the population, but their reproductive and sexual health are overwhelmingly ignored or dismissed. The United States has some of the world’s worst maternal health outcomes, fueled in large part by cultural narratives that suggest a woman’s vagina is meant not necessarily to be healthy but to be judged by others. And while Americans have gotten better about talking about reproductive and sexual health, we still are not where we should be, as a whole movement of women who stick laser probes up their vaginas to “virginize” them will attest.

That narrative is one that has to be put to rest for the sake of women’s health. Indeed, Gottlieb said in his note that he hoped the investigation would help ensure women’s health was more regulated going forward, starting with a registry of women’s medical devices reviewed by the agency to ensure their safety.

Whether women want to reshape their vaginas is a personal decision. Perhaps the best thing to do to a vagina is absolutely nothing at all.

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