VivaSync

They have names that sound feminine and mysterious — like Goddess and FemTouch — and just hint at the kinds of results some doctors say they may deliver: vaginal tightening, better lubrication, and toe-curling orgasms for the rest of your life. All you have to do is get your vagina prodded with a laser or radio-frequency probe and pay as much as $3,000 for the privilege. Everyone says it doesn’t hurt as much as you’d think, that when you walk out, you’d never even know you’d birthed two children or had your first hot flash five years ago. Peeing when you laugh, dryness, reduced sensation — all things of the past. At least that’s the idea.

"Vaginal rejuvenation" is a catchall term often used to describe noninvasive energy-based devices that aim for a range of clock-rewinding results. “But this isn’t a medical term; it’s a marketing term,” says Lauren Streicher, a clinical professor of obstetrics and gynecology at Northwestern University’s Feinberg School of Medicine and the medical director of the Northwestern Medicine Center for Sexual Health and Menopause. “These devices may promise all these things — they’ll lift and separate and make you happier and save your marriage — but ‘vaginal rejuvenation’ doesn’t actually mean anything, medically speaking.”

Emotionally speaking, though, “vaginal rejuvenation” means a lot. It’s estimated that around 40 percent of women in the U.S. suffer from various forms of sexual dysfunction. “Patients who ask about these devices have dryness or pain during sex, changes in orgasm and arousal. After menopause, patients say what once felt like thunder and lightning is now more of a drizzle,” says Michael Krychman, an obstetrician and gynecologist, sexual therapist, and associate professor of clinical obstetrics and gynecology at the University of California, Irvine, who is also a consultant for Viveve Medical, which makes one of these devices. He says you can’t underestimate how these treatments are starting a dialogue about female sexuality and sexual wellness: “They have been vilified by society for too long.”

And dialogue is great. But what about data? Do these devices, well, work? So far, the science still has to catch up to the sexy marketing. Vaginal rejuvenation was one of the fastest-growing treatments at med-spas in 2017 (another: eyebrow microblading), according to the American Med Spa Association. But studies on these technologies have been limited in scope. “We need larger studies with long-term follow-up and placebo controls before we can come up with best-practice guidelines on how to use these devices in this area,” says Cheryl Iglesia, a professor of obstetrics, gynecology, and urology at Georgetown University School of Medicine and a leading researcher on energy-based devices.

The deceptive marketing of a dangerous procedure with no proven benefit...is egregious

Now the FDA is finally speaking up, recently issuing a harsh warning: “The deceptive marketing of a dangerous procedure with no proven benefit...is egregious.... In reviewing adverse event reports and published literature, we have found numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain.” We asked the FDA whether companies cleaned up their acts after this 2018 statement, and they noted that seven manufacturers “made significant changes to their websites to remove claims associated with vaginal rejuvenation and other unapproved treatment.”

The agency added that it continues to “monitor a specific set of energy-based devices in which certain manufacturers may be inappropriately marketing their devices to women.” But plenty of med-spas still refer to these devices as “vaginal rejuvenation” treatments, regardless of whether the manufacturer's removed claims from their sites. And the North American Menopause Society and the American College of Obstetricians and Gynecologists (ACOG) have both released statements critical of these devices. ACOG asserts that ob-gyns “should be wary of adopting new or innovative approaches on the basis of promotions or marketing.”

Allure asked the makers of Goddess and FemTouch for comment on the FDA and ACOG statements. Allen Howes, the president of Lasering USA, the U.S. distributor of Goddess by V-Lase, tells us, “We have not received a letter from the FDA, and our claims are in line with our 510(k) clearance for coagulation of soft tissue in gynecological procedures.” He says that the kind of “mild, controlled heating” the device uses “stimulates angiogenesis [formation of new blood vessels], fibroblast activity, and collagen production without ablative or excessive thermal damage.” This and a lack of downtime, he adds, differentiate Goddess from other CO2 lasers. The makers of FemTouch declined to comment.

The strong words from the FDA and ACOG have not dimmed the appeal, or the big business, of these treatments. You can still walk into med-spas and doctors’ offices (including gynaecologists, but also dermatologists and plastic surgeons) across the country to get your vagina “rejuvenated.” “My patients hear about these devices from friends and ask me if they should be getting them—it’s a question I’m asked a couple of times a week,” says Mary Jane Minkin, a clinical professor of obstetrics, gynecology, and reproductive sciences at the Yale School of Medicine, who doesn’t offer any type of vaginal rejuvenation treatment in her practice. “It’s a buyer-beware market,” she says. “These manufacturers are marketing their devices vociferously.” And they’re doing so with a lot more slick brochures than the FDA and the country’s preeminent gynecological associations are countering with.

Patients say what once felt like thunder and lightning is now more of a drizzle

Theoretically, lasers “rejuvenate” vaginas much the same way that they make skin look younger: By poking teeny holes in the tissue of the vagina and vulva, they’re supposed to stimulate the tissue’s natural wound-healing process. Radio-frequency devices use heat on deeper tissue to activate fibroblasts. In both cases, collagen production and blood flow to the area increase, making vaginal walls plumper and better lubricated, respectively. "But the lasers work by targeting water in tissue,” says Iglesia. “If you use one to treat vaginal dryness and there’s no water to target, that could cause a burn.”

Iglesia notes that some preliminary small studies have found slight improvements in vaginal dryness and tightness 6 or 12 months after three treatments of laser or radio frequency. In one that she reviewed, researchers found that erbium-YAG lasers may improve dryness slightly more than topical estrogen (a common treatment generally covered by insurance). But Iglesia thinks it’s too early to get excited. She also warns: “You need follow-ups over the course of many years to determine how effective and safe the treatments are, especially as women age.” Iglesia adds, “Your vagina naturally tightens with menopause, so I worry about patients in their 30s. If you’ve had your vagina tightened after kids but before menopause, what happens later? What if you can’t have sex because your vagina is so tight that it becomes painful, or what if the device caused scarring?”

These questions need to be answered. But no one is saying we should write off these technologies completely: In accordance with FDA regulations, some manufacturers are beginning to conduct clinical trials on their claims, and there have been a few promising, slightly larger placebo-controlled studies so far. “I think ultimately we’ll find that the science is good,” says Krychman, who was a leading researcher on a placebo-controlled study that investigated the link between an energy-based device (a radio-frequency therapy called Viveve-1) and sexual satisfaction.

“We found radio frequency may improve the collagen, fibroblasts, and connective tissue of the clitoris after menopause, which could lead to enhanced sensation and arousal,” he says. “I predict that what will come out in the wash is lasers are better for dryness, and radio frequency is better for urinary incontinence and sexual functioning.” But he’s quick to point out that better sex from radio frequency alone is a trumped-up promise: “Sexual functioning is multidimensional and should be treated as such. The brain-body connection is of paramount importance.”

After publishing a review of the available studies on vaginal rejuvenation devices (and surgical procedures), Giussy Barbara, an obstetrician, gynecologist, and researcher in Milan, is less gracious: “The idea that the mere conquest of the ‘perfect vagina’ may lead to sexual satisfaction is a miserable and alarming human perspective. What is the destiny of passion, energy, romantic love, relational happiness? Understanding female sexual functioning requires a non-mechanistic, holistic approach.”

There’s also the very real and very scary possibility that seeking treatment with energy-based devices could lead to a serious medical condition being overlooked: “Say you want a laser to treat painful sex. If you go to a med-spa, they might use a device on you and miss a more serious underlying condition, like ovarian cancer,” says Streicher, who does treat some postmenopausal patients with a CO2 laser to alleviate dryness and pain during sex.

“Only a third of the patients who come to my clinic and ask for a laser get one. At a med-spa, chances are that 100 per- cent of women who ask for a laser will get one. They’re not being properly evaluated or offered other safe, effective options for treating dryness and pain during sex — like topical medications — that are generally covered by insurance.” And Iglesia says the risk of complications, like scarring, means that you really don’t want to get these procedures done by anyone but a board-certified doctor. “One of the biggest questions going forward is who’s equipped to use these devices,” says Krychman.

Plastic surgeons and dermatologists know laser technologies better than gynecologists, but gynecologists know the vaginal area. “Health-care professionals who are familiar with the technology can educate those who are not,” says Krychman. “I believe that collaboration will be key to making the field better.” Neil Sadick, a clinical professor of dermatology at Weill Cornell Medical College in New York City, offers some of these procedures in his practice (and has consulted for some of the companies making these devices) but stresses: “It’s important to get a full evaluation by a gynecologist before seeing a dermatologist or plastic surgeon for any concerns regarding the vaginal area.”

And the basic idea that anyone needs these devices for a “younger” vagina is in itself controversial. “Vaginal tightening isn’t something most people need unless you’ve had pelvic-floor prolapse after giving birth to two or three 10-pound babies,” says Minkin. “But that’s very rare, and it’s a surgery we do not take lightly.” So maybe you don’t have a medical need for these procedures, but won’t a tighter vagina mean better sex? “Not that I know of,” says Minkin. Her prescription: “What’s wrong with Kegels? They’re free, and they work at any age. Please, just do some Kegels.”

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