Vaginal Rejuvenation | Why the FDA Says Lasers & Radiofrequency May Not Be Safe

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At the End of July (2018), the FDA issued a warning to women & healthcare providers about energy based devices (like radiofrequency & lasers) for  cosmetic vaginal treatments.

And that's BIG NEWS for lots of people because this treatment is becoming more and more popular. At the very least, vaginal rejuvenation is searched more and more every year:

RealSelf.com says that vaginal rejuvenation, which includes both surgical and nonsurgical treatments, has grown 37% year over year! They had 3.8 million visits in 2016 alone! And about 52% of the women researching vaginal rejuvenation on RealSelf book a consultation.

That's a LOT of women looking for good answers - and lots of healthcare providers treating them - and lots of manufacturers selling vaginal rejuvenation devices!

So Why All the Interest in Vaginal Rejuvenation?

A LOT of women have kids. And I think it's fair to say that most think pregnancy and childbirth were hard on their body. There are noticeable changes to the vulva (the exterior female sex organs). There are also weight changes - and eventually, the hormone changes from menopause. All these things can cause stress incontinence, vaginal atrophy (muscle weakening), vaginal dryness, painful sex, decreased libido, and decreased sensitivity. These changes can create low self esteem and a loss of libido / sex drive. So it's not just that women don't like these changes in their appearance. Women get vaginal rejuvenation for medical reasons as well.

What Does Vaginal Rejuvenation Entail?

Vaginal rejuvenation is an umbrella term. It's used to describe procedures that improve the appearance and / or function of the vagina and surrounding tissue.

Treatments can be noninvasive like hormone replacement therapy, lubricants, or Kegel exercises (to strengthen pelvic floor muscles and improve urinary incontinence). Included in this group are also radiofrequency and laser treatments like ThermiVa, The Mona Lisa Touch, IntimaLase, FemiLift, etc. (ThermiVa is radiofrequency which uses sound waves to create heat; the rest are lasers which use light waves to create heat.)

On the other end of the spectrum lies surgery. Labiaplasty changes the appearance of the labia and folds of skin surrounding the vulva. There's also vaginoplasty - surgery of the pelvic floor.

"When the vagina loosens after childbirth, it's the muscles that have loosened. The skin stretches too, but the distances between the levator muscles (Kegel muscles) and the muscles of perineum is commonly permanently widened. In addition, the attachments of pelvic floor muscles, the bladder, and the rectum can become damaged. Procedures generally known as vaginoplasty and pelvic floor reconstruction are designed to fix the damage, tighten the muscles, and tighten the skin to create a long lasting and effective solution."  - Marco A. Pelosi, III, M.D. Dr. Pelosi is a New Jersey board certified specialist in Obstetrics & Gynecology and a Cosmetic Surgeon.

So Why Is the FDA Concerned About Energy Based Cosmetic Vaginal Treatments?

The problem is this. Although there are many studies that show this technology works well on your face, there are very few that show it works on your vagina. Even so, there are lots of devices being marketed for vaginal rejuvenation.

Here's what the FDA says:

"We are aware that certain device manufacturers may be marketing their energy-based medical device for vaginal 'rejuvenation' and/or cosmetic vaginal procedures. The safety and effectiveness of energy-based medical devices to perform these procedures has not been established.

Vaginal 'rejuvenation' is an ill-defined term; however, it is sometimes used to describe non-surgical procedures intended to treat vaginal symptoms and/or conditions including, but not limited to:

Vaginal laxity (looseness) * Vaginal atrophy (muscle shrinking or wasting), dryness, or itching * Pain during sexual intercourse * Pain during urination * Decreased sexual sensation

To date, we have not cleared or approved for marketing any energy-based devices to treat these symptoms or conditions, or any symptoms related to menopause, urinary incontinence, or sexual function. The treatment of these symptoms or conditions by applying energy-based therapies to the vagina may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain."

And this press release from FDA Commissioner, Scott Gottlieb, M.D., explains even more:

"As part of our efforts to promote women’s health, the FDA has cleared or approved laser and energy-based devices for the treatment of serious conditions like the destruction of abnormal or pre-cancerous cervical or vaginal tissue, as well as condylomas (genital warts). But the safety and effectiveness of these devices hasn’t been evaluated or confirmed by the FDA for 'vaginal rejuvenation.' In addition to the deceptive health claims being made with respect to these uses, the 'vaginal rejuvenation' procedures have serious risks. In some cases, these devices are being marketed for this use to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause. The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, 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 haven’t reviewed or approved these devices for use in such procedures. Thus, the full extent of the risks is unknown. But these reports indicate these procedures can cause serious harm."

Now it doesn't sound good at all!

Rian Maercks, M.D., a plastic surgeon in Miami, has similar concerns that he shares on his blog:

"Cynosure, the manufacturer of the 'MonaLisa touch' system a CO2 fractionated laser that shoots inside the vagina, send me endless emails about how I can make amazing amounts of money by being an early adopter. Before you know it this will be a recommended add on to your annual appointment.

What the public has to understand is that the drives behind these products are not efficacy but rather capitalization on the dreams and desires of most people. Just like there are hundreds of different machines that will 'make you skinny and toned with a painless and noninvasive visit to a practitioners office.' Of course none of them work but it is a billion dollar industry because people will be pay if you tell them what they want is easy and painless.

Laser treatments on a basic level are controlled wounding that incites a healing process to make your body generate healthier tissue. I am very concerned with the widespread use of CO2 based laser technology in amateur hands to women’s vaginas. CO2 technology has been largely abandoned by knowledgeable practitioners because it causes extensive “coagulative” or heat based damage to the tissues that can result in scarring, thinning and destruction of components of the skin. I only use a more advanced erbium laser on the face for example. The long term effects of repeated CO2 laser on the vagina could be devastating and to make things worse, the practitioner is protected from mistakes because they are hidden on the inside and not readily visible.

My advice is for women to stay far away from these interventions for now."

Dr. Maercks adds more in a post on RealSelf.com:

"These lasers claim to promote 'vaginal health' without even qualifying what that statement means.  The most common draw is the concept of 'vaginal tightening.' The thought is that coagulative contraction would cause shrinkage of the vaginal walls making a tighter vagina. This simply doesn't work and if it did would cause big problems. The important thing to understand is that the vagina does not naturally get tightness from its lining. During climax the vagina can open up significantly and there is enough surface area of lining in a young and tight vagina to allow a baby through. Vaginal tightness comes from muscular sling and soft tissue. Laxity can be attributed to both less tone and less soft tissue from atrophy. Attempts to directly tighten the vagina like excisional vaginoplasty almost invariably lead the to pain with intercourse. If we were able to tighten the vagina with a laser the result would be similar. Many techniques toughted to tighten the vagina are simply caustic agents that irritate and inflame the vagina which leads to dryness that can feel like tightening but a dry vagina is not a good thing. I recommend staying away from these technologies."

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Doctors Don't Agree on the Effectiveness of Lasers & Radiofrequency for Vaginal Rejuvenation Either.

Look at the answers to a reader's question about the differences between laser vaginal rejuvenation treatments on RealSelf.com. You'll see LOTS of different answers. Too many. The opinions vary WIDELY.

I think I'll divide them by beliefs then tally the results - just for fun. Here goes!

There are a total of 16 doctor answers to this question as of today, August 20, 2018.

Group #1 - Fractional lasers work for vaginal rejuvenation - Radiofrequency (like ThermiVa) does not (or it isn't as strong). * 5 VOTES

Group #2 - Fractional lasers work best. No mention of radiofrequency (ThermiVa) whatsoever. * 1 VOTE

Group #3 - No mention of whether the devices work or not. Advice is mostly to make sure your provider treats you with the best device for your condition. * 2 VOTES

Group #4 - Emphasizes that lasers & radiofrequency devices are best for those who are looking for nonsurgical, no downtime, less expensive, milder, temporary results. Surgery gives a better, lasting result, but women should have choices. * 3 VOTES

Group #5 - All the devices give the same results. Look for a doctor who does surgical vaginoplasty because the devices won't work for significant laxity / looseness. * 1 VOTE

Group #6 - BEWARE. Devices don't work. Go with vaginoplasty & fat grafting. * 1 VOTE

Group #7 - DiVa erbium laser all the way! * 1 VOTE

Group #8 - All the devices work, but the MonaLisa Touch is best. * 1 VOTE

Group #9 - All the devices work, but the ThermiVa works REALLY well with the O-Shot. See a provider who offers multiple noninvasive options & surgical options. * 1 VOTE

And the Winner Is, Group #1!

5 Out of 16 Doctors Agree (so less than 1/3) That Fractional Lasers Work for Vaginal Rejuvenation & Radiofrequency (like ThermiVa) Does Not (or isn't as strong)

But What About the Women Getting Vaginal Rejuvenation Treatments? Do They Like Them?

But these high ratings are for SURGICAL vaginal rejuvenation. On RealSelf.com the nonsurgical treatments are rated BY THE DEVICE USED. Considering all the mixed reviews I've read so far, the satisfactions levels are very high:

THERMIVA:

DIVA:

FEMILIFT:

MONALISA TOUCH:

INTIMA:

ULTRA FEMME 360:

GENEVEVE:

If that leaves you feeling thoroughly confused, you're not alone. I'm confused too!

The American College of Obstetricians & Gynecologists sheds some light in a statement released May, 2016:

"Preliminary observational data have shown some potential benefits with the use of this technology in treating patients with vulvovaginal atrophy. However, these observational trials do not evaluate the use of concomitant  treatments (different treatments given at the same time), and they lack long-term follow-up (trials assessed follow-up at 12 weeks). No randomized trials or comparative effectiveness studies have been published. Although initial data indicate potential utility, additional data clearly are needed to further assess the efficacy (effectiveness) and safety of this procedure in treating vulvovaginal atrophy, particularly for long-term benefit."

So in layman's terms they're saying that lasers and radiofrequency vaginal rejuvenation treatments might work, BUT studies are needed to prove that they work and they're safe.

Another problem is that these treatments have been presented to women as FDA "approved" or "cleared" on several websites. I myself saw one doctor's website bill his laser as the "only vaginal rejuvenation device approved by the FDA," when in truth, none were ever approved or cleared.

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And that leads me to another recommendation by the American College of Obstetricians & Gynecologists:

"It is critical that patients are provided with accurate information regarding the efficacy and safety of treatment options, particularly when considering emerging technology. One component of this information is an accurate description of the FDA’s clearance or approval terminology. Obstetrician–gynecologists have an ethical responsibility to provide accurate and current information to patients in order for them to be fully engaged in the informed decision-making process."

And I couldn't agree more!

Answers Are Coming!

Dr. Marie Paraiso, a professor of obstetrics and gynecology at the Cleveland Clinic, has been using the MonaLisa Touch to treat women with genitourinary syndrome of menopause (dropping estrogen levels that cause dryness, burning, irritation, pain with sex, painful urination, etc.). Her group has done 300 treatments using the laser with no complaints of persistent vaginal pain or scarring. She says 80 - 90% of her patients respond and 20 - 25% seek retreatment within a year. “I believe for women who have contraindications to hormonal therapy or do not tolerate or cannot afford prolonged hormonal therapy, the COfractional vaginal laser has been effective.”

If nonsurgical vaginal rejuvenation is something you're interested in . . .

Do your homework! Find a doctor who's had some practice. He or she should tell you that lasers and radiofrequency devices are not FDA approved or cleared for vaginal rejuvenation. Your doctor should also talk to you about all of the benefits and risks of ALL available treatment options for vaginal symptoms (like over-the-counter lubricants, vaginal moisturizers, vaginal estrogen, hormone therapy, etc.). There are lots of options. Choose the best one for you!

If you do get a laser or radiofrequency vaginal rejuvenation treatment - and things don't go as planned - you can file a report with the FDA through their adverse event reporting program, MedWatch.

Good luck! Thanks for reading!

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References:

https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm615013.htm

https://www.allure.com/story/fda-warning-vaginal-rejuvenation-procedures

https://www.realself.com/vaginal-rejuvenation

http://www.refinery29.com/2017/06/157624/vagina-whisperer-amir-marashi-profile

https://www.acog.org/Clinical-Guidance-and-Publications/Committee-Opinions/Committee-on-Gynecologic-Practice/Vaginal-Rejuvenation-and-Cosmetic-Vaginal-Procedures

https://www.acog.org/Clinical-Guidance-and-Publications/Position-Statements/Fractional-Laser-Treatment-of-Vulvovaginal-Atrophy-and-US-Food-and-Drug-Administration-Clearance

https://www.realself.com/vaginal-rejuvenation/non-surgical-treatments#.W3GfCc5KjIV

https://en.wikipedia.org/wiki/Vulva

https://www.sciencedirect.com/science/article/pii/S2352647516300107

https://www.realself.com/question/los-angeles-ca-differences-laser-vaginal-rejuvenation-treatments

https://www.mdedge.com/edermatologynews/article/171921/gynecology/fda-warning-shines-light-vaginal-rejuvenation

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm615130.htm

https://themaercksinstitute.com/why-you-shouldvaginal-health/

http://www.issm.info/sexual-health-qa/what-is-genitourinary-syndrome-of-menopause-sgm/

https://www.fda.gov/Safety/MedWatch/HowToReport/ucm085568.htm

Disclaimer:

The Information provided on our website is not medical advice and should not be viewed as such. By law, only a medical doctor can diagnose or give medical advice. As a registered nurse, my goal is to educate, so I provide information on skin care, skin care products, and skin care treatments. If you have any condition that concerns you, please see a medical doctor. While most skin conditions are benign, some - like melanoma - can be deadly. If there is any doubt, please, please consult your physician. Thank you!