The Food and Drug Administration is cracking down on devices marketed for use in “vaginal rejuvenation.”
In a statement issued Monday, FDA Commissioner Scott Gottlieb said a growing number of manufacturers are marketing “vaginal rejuvenation” devices. Some manufacturers claim the devices can treat symptoms of menopause, problems with sexual function, and urinary incontinence. The FDA said those claims aren’t supported by scientific evidence — and warns the products could pose serious risks to women’s health.
“We are deeply concerned women are being harmed,” Gottlieb said.
The devices work by using lasers or other energy sources to destroy or reshape vaginal tissue. The FDA has cleared or approved such devices in the past, but to kill pre-cancerous tissue and genital warts. The agency hasn’t evaluated the safety or effectiveness of the devices for “vaginal rejuvenation.”
The FDA said it had reviewed adverse event reports and medical literature and catalogued “numerous cases” in which use of the devices resulted in vaginal burns, scarring, pain during intercourse, and chronic pain.
In some cases, the FDA said, the devices are being marketed specifically to women who have gone through treatment for breast cancer and are experiencing early menopause.
“The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious,” Gottlieb said. And, he added, the misleading marketing of unproven treatments might keep some women from receiving appropriate, evidence-based care for their conditions.
The FDA recently issued warning letters to seven device manufacturers — Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and Thermigen — detailing its concerns about inappropriate marketing of “vaginal rejuvenation” procedures. The agency is encouraging patients to talk about the risks and benefits of any treatment for vaginal symptoms with their health care providers.
Gottlieb said the FDA will continue to closely monitor adverse event reports linked to “vaginal rejuvenation” procedures and is asking patients who have experienced adverse events to report them through Medwatch, the adverse event reporting system.
About the Author Reprints
I would consider Intrarosa Rx, the new topical (vaginal) DHEA preparation,for the vaginal conditions cited.
Isn’t that the one that converts to estrogen?
Mavis,
You are obviously a young woman. To think that women seeking this treatment has anything to do with body dysmorphia is ignorant and unfair. I am well aware of the dangers of pseudoscience and an active member of our local skeptics community so you are preaching to the choir. But women who have had cancer and now suffer from pain and dryness after menopause are in a very real and life altering dilemma. Sex becomes almost impossible. Relationships are threatened. The pain is ever present as well as other uncomfortable problems like dryness, itching, and leakage.
The ONLY medicine available is hormone based and is not a good idea for women with a history of cancer. In my case I was told it was such a small dose it was safe but it caused my endometrial wall to thicken and I had to stop.
The laser treatments done by a legitimate doctor have had amazing positive effects. For heavens sake…do the research before having a knee jerk reaction about pseudoscience. “alternative” treatments for cancer do not even belong on this thread. It is as Isobel said, apples and oranges.
For many this is the last resort that could change their lives. And it would not be the first time the FDA made a finding to protect big pharma. My guess is that these treatments are cutting into pharmaceutical profits and that is why 14 years after finding these treatments safe they are suddenly suspect with only vague anecdotal evidence to back it up.
Unfortunately the FDA is a Mad Hatter’s Tea Party. we can’t expect them to make any decisions based on Science and Facts. This response by the FDA might be in response to a recent Documentary on Netflix, The Bleeding Edge, about the deceptive practices of the FDA, and the device industry. It looks like they are going after the devices that won’t effect their industry friends. This will make it appear they are going after the industry, while they protect their insiders. Besides they never cared about any of this before. For these types, female parts are a mysterious dark continent. Perhaps they think that only “loose women” will use these devices, or they could lead to furious sexual activity.
The FDA has failed to regualte dangerous implants and devices, they failed to keep the public informed on adverse events. They allow Pharma to change the laws, even as the death rates rise. The public has no way to evaluate the safety of any of this, because the FDA and their industry cronies, decided that could cut into profits.
Ms Johnson, have you any actual science to back up your claims that laser treatments fall into the same category as actual pseudoscience? I did not hear about this treatment from any weird source but from a very credible and well respected gynecologist who has had excellent results using this treatment. She is a Mount Sinai doctor in a well respected practice. The article says that the FDA has not actually done the research yet and so is suggesting caution. But there are hundreds of reviews from several practices on line from women who have had remarkable results. It is not a magic bullet but it does seem to promote collagen growth and help with some of the very real issues women face after menopause. I am still trying to decide whether to go forward but these irrational rants do not really help. I was hoping to hear from doctors and women who have actually used this procedure.
It is about time. The FDA has fallen down on the job. Instead of protecting the public their lack of action, has become an endorsement for all kinds of quackery, nonsense and pseudo science. This not only costs American consumers, billions of dollars every year, it has undermined the credibility of real science. The marketing of this junk on social media, is a big profitable business. They use content marketers, advertorials, and celebrities, to peddle it. Now they need to start cracking down on Chiropractors, Acupuncturists, and other Alternative Medicine that only appears harmless. A lot of Medical Doctors are endorsing the nonsense, since they believe it “can’t hurt.” Peddling supplements, wrinkle creams, and other seemingly harmless products on TV and social media appears harmless, but opens the door to magical thinking.
Ms. Johnson, you’re mixing apples and oranges. Acupuncture for instance is recommended by spine specialists because it works. It has been closely studied over many years in several countries and shown to be significantly useful to control arthritis pain (several spine surgeons and spine specialists have prescribed it for me, with life-changing results), migraine headaches, morning sickness in pregnant women, epilepsy, and other conditions. I don’t think you’ve done the research that would let you condemn several forms of therapeutic intervention with one magic wand. The Internet will be a wonderful free library for a while longer, till the end of net neutrality takes root. Why not look up the literature on acupuncture soon, in case you ever need it?
Isobel, I am sorry to say that Acupuncture does not work. I know of surgeons that have recommended even more obscure ‘treatments’ in order to get rid of unprofitable or patients that were previously operated on. They don’t like to work on a previous surgeons mistakes.
A few years ago Acupuncturists tried to get the VA to cover Battlefield Acupuncture, needless to say, it did not go over well. Acupuncturist promoting their profession attempted to go to refugees who had no access to conventional medicine to promote their business, they were laughed at. They tried to use a crisis, to promote Acupuncture, so they could advertise their profession.
I live in a town with an Acupuncture School, the stories I could tell. Any unscrupulous huckster with a few bucks can be an Acupuncturist. The Chinese are having a good laugh, this has been one of their most lucrative exports. In N Korea, the use Acupuncture, because they don’t have the money for conventional medicine, the outcomes speak for themselves.
The “Studies” that you refer to are mostly low quality, qualitative studies.
Here is one where they studied the effectiveness for pain, https://www.bmj.com/content/338/bmj.a3115
There is little evidence that Acupuncture does more than provide a Placebo Response. Any other “benefits’ can be attributed to a human being being nice to the subject, expectation bias and the narrow range of conditions studied.
Here in the US, we have one of the least effective and most expensive healthcare systems or any developed nation. Recently Medicare began discussing removing those Spine Surgery Centers from their pay schedule. Those Surgery Centers, were advertised heavily on TV, yet it was nearly impossible for anyone to find information about outcomes. This is typical of most American healthcare. CMS The Center for Medicare Services, can really only use billing data to determine whether something works or not. A groups of Spine Surgeons, touted limited Data, from a group of 50 Surgical Centers as if it were informational, or gave us any insight into our odds of a good outcome. What they left out was that the only data they had was dependent on the goodwill of the surgical centers. There was no objective or quantitative data. Only the data they felt like providing.
We are all being Gas Lighted. Alternative Medicine is profitable, and it appears harmless, until you start looking at the outcomes. A recent study of cancer patients who used alternative medicine, found that they had a higher death rate. There is no one looking at how this alternative medicine actually postpones care. For a cancer patient that can be deadly. No one ever asks the right questions.
They have been “Studying” Acupuncture since Nixon came back from China in the 70s, and even though some really generous foundations have supplied academic institution with large grants to study it again and again, the evidence remains anecdotal.
P. S. No one is touching my HooHa with any Lazers or Goop. The Internet is full of this nonsense. I know women who were insecure, or had some kind of Body Dismorphic Disorder, who had procedures done on their female parts. They should really make a distinction between women with real issues, like genital warts or cancerous growths, and so called “Vaginal Rejuvenation.” There are women with “Mudflaps” large labia, they feel self conscious about, that might be a different matter.
There has been a lot of criticism lately of a certain celebrity, who uses weaponized internet marketing, tied to magazines, and celebrity gossip. This marketing was perfected by a certain talk show host, who now owns a huge media business. She promoted a couple of quack Doctors to television, who actively promoted pseudo science and nonsense to millions of Americans. This stuff is profitable so it spreads, it is reinforced with Internet marketing, a lot of it is presented as if it were factual. They use the amplifying effect of Facebook, to spread misinformation, latch on to insecurities, and normalize this stuff. Any time a woman insecure about her body, perhaps one who just gave birth, looks at a site to see if her vagina is normal, Facebook tracks that. That data is then sold to unscrupulous marketers. They use those data points to sell products, and misinform. A trivial curiosity, is amplified by Facebook. That person is then inundated with articles, about vaginal products, procedures, and information designed to create fear, and insecurity, about their body parts. Celebrities, and self described “experts” promote this nonsense, and make it appear sensible. Even Wal Mart has jumped on the bandwagon, they see profit in peddling useless products to the millennials.
The FDA should have stepped in years ago, or the FTC, but they are not allowed to regulate the grey area of health products. They have loosened regulations of marketing of alternative medicine, and failed to keep up with Internet marketing. The same problem is occurring with Pharma advertising. The Ads are non stop on television, radio, and Internet search engines.
We are living in Post Fact America, our Healthcare System is broken. We have no access to facts. A website devoted to challenging, false claims and using Science to evaluate any of this would not get corporate funding. The mass media only perpetuates this nonsense, some of us turn to sites like this for fact based medical information. The comments often turn to the promotion of pseudo science, anecdotal nonsense and stuff they heard on other sites. Now the fact that the FDA does not regualte certain things, is an advertisement for their safety and effectiveness.
Ms. Johnson, this is a ridiculous conversation. Some of the most eminent surgeons and spine specialists in the United States prescribed acupuncture to me, and after years of debilitating pain I was finally afforded some relief and able to move and take up my career again. All you have to do is to read the medical literature on this. It’s been decades since anyone talked about acupuncture as “magical thinking.” The science is against you. You should research it because you might need it. As indeed, depending on your condition, you might need other treatments you have convinced yourself, from a position of ignorance, are “magical thinking.” I don’t know why you are uninterested in medical science–perhaps because you have no illness yourself?–but you should not cut yourself off from proven, long-studied therapies because of a prejudice decades out of date. Nor should you tell people who’ve told you they were helped by a treatment that “it doesn’t work.” It’s rude and uninformed.
As with any procedure— in the wrong hands or in the wrong candidates, the results can be anything from disappointing to disastrous. I have seen instances where vaginal lasers have actually changed women’s lives—for the better—especially in the breast cancer population. It is key that the proper patient evaluations and preparations be done as well as s discussion of risks and benefits. The FDA can and should evaluate individual cases where it seems something went wrong; but don’t blanket all doctors and all procedures as “inappropriate” or “harmful” if that is clearly not the case.
MEGAN – THIS ARTICLE LISTS SEVEN CONCERNS THAT APPEAR TO BE PERFORMING WHAT AMOUNTS TO FEMALE GENITAL MUTILATION ON HAPLESS, POORLY INFORMED WOMEN. THE FDA SAYS IT IS “CONCERNED” BUT HAS NOT “MOVED IN” OR ARRESTED ANYONE AT THESE WTCH-DOCTOR OUTFITS. YET THE FDA SPENDS MILLIONS, WITH TONS OF PAPERWORK, IN EVALUATING THE SAFETY OF A NEW DRUG. WHAT THE HELL IS GOING ON HERE AND WHO IS RESPONSIBLE!!! ???. WHO IN CONGRESS CAN PUT SOME HEAT ON THESE GREEDY AND CRUEL CRIMINALS? PS: I AM A LEADING INVESTMENT THEORIST BUT I ALSO HAVE A SOCIAL CONSCIOUS. YOU CHECK INTO MY BACKGROUND BY GOOGLING: EUGENE HAWKINS AT INVESTMENT ANALYTICS. THANKS – GENE
Eugene,
Why are you YELLING?
Wonderful to imagine that the FDA is still to some extent trying to monitor the safety of Big Pharmam’s industrial expansion. Thank you for the hope this article incidentally provides.
This sounds suspect. My doctor swears by this treatment and the reviews are almost 100% positive. I have not seen a single instance of someone complaining of any of these side effects. Could be negative lobbying.
Your Dr. “swears by endorsing the procedure…” Makes me wonder how greatly he/she benefits from being a significant stakeholder in any of these companies. Follow the $$$$…
Reputable medical journals have long reported complications with vaginal rejuv. procedures, incl., but not limited to: severe IC, vulvodynia, chronic pelvic pain, dysparunia, vaginal shortening due to scarring/ adhesions,
among countless other objective evidence confirming complications and consequences of scope w/ vag. rejuv…