The Vaginal Laser Controversy

Studies show it doesn't work for menopause, but that hasn't changed a thing

Late last year I was asked by the editors at JAMA Network Open to write a commentary about an upcoming article they would soon be publishing. I jumped at the chance because A) It’s a big honor and B) It was a study about vaginal laser therapy for women with genitourinary syndrome of menopause. I couldn’t pass up the opportunity to read the article before everyone else!  

Some Background on Menopause, the Vagina, and the Laser

In menopause, dropping levels of estrogen cause significant changes in the vagina. Blood flow decreases. The layers of cells in the mucosa (the lining the vagina) thins and becomes fragile, potentially very tender, and can even bleed when touched. The collagen (the tissue that helps things stretch) weakens, which can cause pain and trauma to the tissues with insertion. The cells in the vagina lose their storage sugar (it’s something that helps keep them plump), which is what feeds the good bacteria. When there is nothing to feed the good bacteria, the vaginal microbiome changes, which can cause more symptoms. Production of mucus, which helps to lubricate the vagina and protect the vagina from potentially harmful bacteria, also stops. Typically this is treated with vaginal estrogen or dehydroepiandrosterone (a steroid that is converted by the cells into testosterone and estrogen). Both are available as prescriptions from pharmaceutical companies and are very effective. 

However, some women don’t like using vaginal therapies and a few have difficulty finding ones that work for them. Also, we don’t have the highest quality data regarding the safety of these products for women with estrogen receptor positive breast cancer who are also taking aromatase inhibitors (medications that stop the production of estrogen in every tissue).

One supposed solution…laser therapy, such as the MonaLisa Touch® (a fractional carbon dioxide laser). Laser proponents claim it creates microscopic damage and then the body’s natural healing response increases blood flow, causes collagen to remodel, and even restores the vaginal microbiome. In theory, this would in turn increase vaginal lubrication and increase the thickness and elasticity of the vaginal tissues. Basically, it can reverse all or most of the changes of low estrogen, without estrogen. 

This mechanism of action has alway troubled me, because it is at odds with how we believe things work in the vagina. For example, how does the laser cause glycogen (the storage sugar) to enter the cells? And more importantly, given the cells of the vaginal lining replace themselves every 96 hours, how can laser therapy cause a change that maintains this process? How does it encourage ongoing mucus production?  Biologically, this just doesn’t make sense.  

However, I always remind myself that medicine is filled with undiscovered science. What makes no biological sense today, may, with new technologies, become very clear. But when there are uncertainties about how a therapy, like the laser, might work, we must have studies that prove it is effective, otherwise it’s a massive leap of faith with the women getting the procedure bearing all of the risks, physical and financial. 

Sadly, the laser catapulted into gynecology with very weak supporting data. I wrote in The Vagina Bible in 2019 about how this lack of data regarding vaginal laser treatment like the MonaLisa Touch® infuriated me. Here we had an understudied therapy that was biologically implausible and yet was being offered as if it were safe and effective. There is an awful legacy of understudied gynecological devices being pushed onto women in the United States as the bar for these devices to get FDA approval is so much lower than the bar for medications. This is of course absurd, but here we are. We even had reports to the FDA back in 2018 about injuries from these laser devices, but that didn’t seem to slow anyone down, because there was money to be made. 

The first quality study about the laser was published in 2021, and it compared the laser against a sham procedure (meaning a placebo therapy). This is so important as placebo rates can be very high in these kinds of studies. It was unsurprising to me that the laser performed no better than the sham procedure. You can read what I thought about that study and the quality of the data leading up to that study here in a previous post that I wrote for The Vajenda.

I thought surely this 2021 study would be the end of it and that people would stop doing vaginal laser outside of clinical trials, so we could gather more data. But it seemed that many doctors, hospitals, and medispas were unperturbed and they pivoted to anecdotes and various excuses to downplay the study's findings. A doctor who claimed to know more about an upcoming study assured me my side eye, which had been pushed into super, mega side-eye, was unfounded.  

The Opportunity to Prove Me Wrong About Laser Arrives (or maybe not)

So with that set up you can understand now how eager I was to get my hands on this even newer study (we’ll call it the 2023 study for clarity). Would it vindicate the laser or support the 2021 clinical trial that showed the laser didn’t work? Was this the mystery study I’d been promised? Would I learn something new about the vagina? I was open to whatever the findings might be.

I was thrilled at the quality of this new study that the folks at JAMA asked me to write about. Like the 2021 study, it was also a randomized, sham-controlled trial, this time for women with breast cancer taking aromatase inhibitors (and the study investigators should be commended for studying this specific group of women who are often neglected in clinical trials). 

I’ll cut to the chase. Once again, the laser performed no better than a sham procedure. You can find the study here if you are interested.

So I wrote my invited commentary (you can find it here). I detailed the legacy of how women have been harmed by understudied gynecological procedures, never mind the thousands of dollars that so many have paid for this procedure. And like others have done, I called for people to halt using the laser outside of clinical trials. 

I didn’t expect that to happen of course, there is too much money to be made. But I did hope the study and my biting commentary would get picked up by major news outlets. After all, thousands upon thousands of women have paid for this procedure. Many major medical centers still offer it, including the Cleveland Clinic. Isn’t it newsworthy that so many doctors and hospitals are making a small fortune from a procedure that two prospective, randomized double-blind sham-controlled trials tell us doesn’t work? 

Even though I am terminally online, I wondered if perhaps I’d missed the story? Fortunately, journals now list an Attention Score. It tells you how often a study was mentioned in a news story, how it fared on Twitter, Facebook, and blogs. It’s fascinating to see what studies get attention and which don’t. The image below is the Attention Score from the 2023 laser study. You can check it out yourself here.

The study, published in February 2023, was picked up by 9 outlets (it appeared on Medscape twice, so that’s how the number was reported as 10). It wasn’t picked up by one major English language news outlet (sorry Medscape, you are not a major news outlet).

If the study had shown it helped even 10% of women, we’d probably have seen ridiculous headlines like, “Vaginal Laser Therapy Holds Great Promise” or “An Incredible Techno Vagina Can Be Yours.” Or “Ditch the Lotions and the Potions and Laser up for Better Sex.” 

So why the silence?

I have a theory about major news outlets and reporting on studies about women’s health. A health story is more likely to be newsworthy if:

1. It serves the patriarchy or 

2. It scares women or 

3. Preferably both

Have you heard about osteonecrosis of the jaw as a complication of bisphosphonates, which are drugs to treat osteoporosis? Many women are afraid to take these medications because of this risk, in large part due to the press coverage. The risk is about 0.01-0.04% and while the condition is serious, the risks posed by untreated osteoporosis are much, much higher. Keeping women frail serves the patriarchy and the fear aspect is self-explanatory. Have you heard about the serious side effects of drugs like Viagra (phosphodiesterase inhibitors), which includes loss of vision? They are the at least as common as osteonecrosis of the jaw with bisphosphonates, and yet it seems no one has been scared away from taking them by stories in the news.

I’m not accusing editors of intentionally thinking this way (ok, one or two might), rather I think this has been so ingrained in all of us because we have been steeping in patriarchal swill for generation upon generation. I suspect we all preferentially read articles that satisfy the Gunter Women’s Research Newsworthy Equation, and of course, the news likes to feed us what we are going to click. 

Yes, thousands of women have wasted a few thousand dollars each on vaginal laser therapy, but as the treatment doesn’t work it isn’t keeping vaginas prepped for a penis (i.e. is not serving the patriarchy, the default here is always hopelessly heteronormative, but hey, that’s the patriarchy) and there were no serious complications, so who cares! But what happened back in 2018 when the FDA issued a safety alert for the vaginal laser when there was a wave of reported complications? Why, lots of headlines, of course, like this one from the New York Times. 

And so here we are with two high quality randomized double-blind sham-controlled trials showing the fractional carbon dioxide laser is ineffective for vaginal symptoms of menopause and hundreds if not thousands of practitioners offering the therapy in many countries and no one seems to care. (Although I am personally aggravated about it to no end).

I’m sure that those who offer vaginal laser therapy for menopause have lots of anecdotes about it working and have cherry picked a line from each of the two clinical trials that show the laser is a bust to try to discredit these studies. After my commentary was published earlier this year several doctors with laser centers sent me direct messages on Instagram to try to “educate me” with their “unbiased” opinions. I would have told them to fuck off, but Instagram put me in a one week time out the last time I did that, so now I just delete and send evil thoughts.

The fractional carbon dioxide laser has been around for long enough that anecdotes and low quality retrospective studies and observational data don’t cut it in the face of two quality clinical trials. Also, I can match every anecdote about the laser helping with one where it didn’t.

There are apparently more clinical trials in the works, but given we have two clinical trials that show no benefit, it’s going to take some pretty spectacular findings to change my mind. But as always, I am open to good science.

In the meantime, it should be a major news story that seemingly hundreds and thousands of doctors and large medical centers around the world are still offering this procedure and not as part of clinical trials. But it isn't.

And it is all so damn discouraging.

References

1. US Food and Drug Administration. Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women’s health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for “vaginal rejuvenation.” News release. July 30, 2018. Accessed December 19, 2022. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-efforts-safeguard-womens-health-deceptive-health-claims

2. Preti M, Vieira-Baptista P, Digesu GA, et al. The clinical role of LASER for vulvar and vaginal treatments in gynecology and female urology: an ICS/ISSVD best practice consensus document. Neurourol Urodyn. 2019;38(3):1009-1023. doi:10.1002/nau.2393

3. Filippini M, Porcari I, Ruffolo AF, et al. CO2-laser therapy and genitourinary syndrome of menopause: a systematic review and meta-analysis. J Sex Med. 2022;19(3):452-470. doi:10.1016/j.jsxm.2021.12.010

4. Li FG, Maheux-Lacroix S, Deans R, et al. Effect of fractional carbon dioxide laser vs sham treatment on symptom severity in women with postmenopausal vaginal symptoms: a randomized clinical trial. JAMA. 2021;326(14):1381-1389. doi:10.1001/jama.2021.14892.

5. Mension E, Alonso I, Anglès-Acedo S, et al. Effect of fractional carbon dioxide vs sham laser on sexual function in survivors of breast cancer receiving aromatase inhibitors for genitourinary syndrome of menopause: the LIGHT randomized clinical trial.  JAMA Netw Open. 2023;6(2):e2255697.

6. Mavrokokki T, Cheng A, Stein B, Goss A (2007) Nature and frequency of bisphosphonate-associated osteonecrosis of the jaws in Australia. J Oral Maxillofac Surg 65(3):415–423.

7. Etminan M, Sodhi M, Mikelberg FS, Maberley D. Risk of Ocular Adverse Events Associated With Use of Phosphodiesterase 5 Inhibitors in Men in the US. JAMA Ophthalmol. 2022;140(5):480–484. doi:10.1001/jamaophthalmol.2022.0663.