2019-04-01 Allure

(Nora) #1

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 tighten-
ing, better lubrication, 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 sensa-
tion—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 actu-
ally 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 under-
estimate 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: eye-
brow microblading), according to the American Med Spa
Association. But studies on these technologies have been lim-
ited 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, gynecol-
ogy, and urology at Georgetown University School of
Medicine and a leading researcher on energy-based devices.
Now the FDA is finally speaking up, recently issuing a
harsh warning: “The deceptive marketing of a dangerous pro-


cedure 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 associ-
ated with vaginal rejuvenation and other unapproved treat-
ment.” The agency added that it continues to “monitor a
specific set of energy-based devices in which certain manu-
facturers 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
manufacturers 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.” We
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 exces-
sive thermal damage.” This and a lack of downtime, he adds,
differentiate Goddess from other CO 2 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 treat-
ments. You can still walk into med-spas and doctors’ offices
(including gynecologists, but also dermatologists and plas-
tic surgeons) across the country to get your vagina “rejuve-
nated.” “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 repro-
ductive 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 asso-
ciations are countering with.
But let’s back up for a second: How did these devices
become available in the first place? The answer has nothing to
do with multiple orgasms, and everything to do with tattoos

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