Update on Vaginal Laser Therapy for Menopause

It still doesn't work!

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I’ve been banging the drum about the vaginal carbon dioxide (CO2) laser being an inappropriate therapy for the genitourinary syndrome of menopause (GSM) since 2019, when I wrote The Vagina Bible.

I said then that, biologically, the therapy didn’t make sense. The hypothesis is that a controlled burn or injury to the vaginal tissues could spark collagen remodeling and improve blood flow, which could then supposedly keep the vaginal mucosa (lining) healthy for up to a year. There were claims that it could even restore the healthy vaginal microbiome, except everything we know about the vaginal microbiome depends on estrogen depositing storage sugars into the cells, and it seemed impossible that injury and subsequent collagen remodeling from a laser could achieve this. (In addition, the lining of the vagina is replaced about every 96 hours, so how this therapy could be long-lasting made no sense). And finally, we regularly use cautery, which burns tissues, during vaginal surgery, but we don't see a “rejuvenation” effect or people saying, ‘Wow, my vagina has been so much more lubricated since my surgery.”

Look, I am always open to having my mind changed. That is the scientific method. I am sure the idea of penicillin or a vaccine for HPV seemed biologically implausible at one point. But then one does the appropriate studies, and, if whatever beings studied is effective and safe, after appropriate clinical trials, a new therapy emerges. And the issue with carbon dioxide laser for GSM is that when people were promoting it back in 2017 and 2018, as I was writing the Vagina Bible, the data was, ahem, shit.

To me, it was peak patriarchy to promote a therapy for vaginal health that could make some people a small fortune and was understudied for both safety and effectiveness. Quite a few people told me I was anti-progress and just too demanding. Some said that I didn't “understand” the technology. I always replied, “I suppose if you actually had data that proved your expensive device worked, you wouldn’t have to stoop to insults.”

Women deserve science. If some doctor, hospital, company, or influencer is promoting a product and doesn't have the data, don’t get upset with me for simply pointing it out…it is my duty to point it out. Look, if these types don’t want to face this kind of criticism, they always have the option of NOT promoting the product, medication, or supplement until after they have the data, ya know?

And despite a lack of quality data, people kept offering vaginal laser therapy, and I heard over and over from those who profited from it that it was so amazing. One plastic surgeon dude even entered my Instagram DMs to educate me (like, fuck right off). Yet, all we had in the literature were small, unblinded, observational studies, which, considering how women have been harmed by other inadequately studied devices like the Dalkon Shield and vaginal mesh, was unacceptable (at least to those of us who actually care about patients). In addition, I’d seen many women who had the procedure and who still experienced their symptoms (i.e., it didn’t work). Hence why they were coming to see me. I’ve also seen some complications. So, my personal experience fit with the available data. Not that my anecdotes are robust science, but then again, neither are small, unblinded observational studies.

Nevertheless, I kept hearing how the DEFINITIVE study was just around the corner. I still remember an exchange from 2021 when I was told to cool my jets because some fantastic study would be out very soon…like in a month or so…and let me tell you, folks, I am still waiting.

Eventually, we got two high-quality clinical trials that showed, guess what? Vaginal laser therapy for symptoms of menopause was no better than a sham procedure. As the sham procedure (placebo) helped some women, this calls into question the findings of any observational studies. I wrote an invited review for JAMA in 2023 about one of these clinical trials (and the state of the literature, you can find it here).

In addition, concerns were raised that perhaps the small studies that showed an improvement in the vaginal tissues (based on biopsy results) may have overcalled the laser effect. This is important as these biopsy changes were the supposed proof of the hypotheses. In 2023, a study showed no difference in biopsy results between laser and sham procedures, meaning there was no evidence the tissues were undergoing changes that could help symptoms.

In 2024, I reviewed the literature for the 2024 Menopause Society Practice Pearl on vaginal lasers for menopause (here), and my conclusions was that the highest quality data tells us it doesn’t work any better than a sham or placebo procedure. In addition, I believe that doing this procedure outside of a randomized double-blinded placebo-controlled trial is unethical.

Also, I think it’s absurd that some journals continue to publish unblinded studies with the laser. We’re beyond that. The only way to begin to disprove the good data that we have is with a multi-center, randomized, double-blind, sham controlled trial.

Two new developments have occurred this year, regarding vaginal laser technology, so let’s catch up.

Another review was published, this time in the journal Menopause, and the conclusion is as follows:

CO2 laser resulted in little to no difference in outcomes compared with sham or vaginal estrogen; the evidence is very uncertain on the effect of energy-based interventions versus all other comparators for all other outcomes.

And this week, the Therapeutic Goods Administration of Australia (TGA) has completed a “post-market review of all energy-based devices used for vaginal rejuvenation included in the Australian Register of Therapeutic Goods (ARTG).” They conclude that there is insufficient evidence to recommend the use of these devices, and “All energy-based devices intended to be used for vaginal rejuvenation sold in Australia have now been cancelled from the ARTG by the TGA or the sponsor.” It seems that when the ARTG cancels a device, it can no longer be marketed in Australia.

It’s good to see the Australian government step in, but we shouldn't expect such action in the United States. The company that makes the Mona Lisa has previously received a warning letter from the FDA several years ago about misleading and inaccurate information on their website, and while their website has been changed, that doesn’t stop a multitude of hospitals, doctors, and medispas from deceptive advertising that suggests the procedure is effective for genitourinary syndrome of menopause when the data doesn’t exist.

Vaginal laser therapy has been promoted as a treatment for genitourinary syndrome of menopause since at least 2015, and the highest quality data shows it is no better than a sham procedure. In addition, there is no difference in biopsy results between vaginal tissue treated with the laser and that exposed to sham therapy. Equally troubling is there are journals still publishing studies about these devices that don’t have a sham (placebo arm), which is disgusting as these studies add nothing to the literature and instead provide a veneer of effectiveness because people use them on their websites to show “proof” of effectiveness, where none actually exists.

Companies that make these devices could undoubtedly pay for additional studies if they really believed their devices were truly revolutionary, so it is a choice not to do the work. When hospitals, doctors, and medispas are already buying and renting these devices to offer expensive procedures, they fall into what is known in economics as the sunk cost fallacy, which is when a person is reluctant to abandon a strategy or course of action because they have invested heavily in it. Of course, for those folks who have made this investment already, the biggest issue with additional quality studies is the growing evidence that their remaining profits should evaporate in a puff of laser smoke.

In my opinion, its deeply misogynistic to profit from vaginal laser therapy for GSM, because it’s taking advantage of how society treats women as they age as well as taking advantage of women with symptoms to put profit over quality patient care.

1. Gunter J. Genitourinary Syndrome of Menopause and the False Promise of Vaginal Laser Therapy. JAMA Netw Open. 2023;6(2):e2255706. doi:10.1001/jamanetworkopen.2022.55706

2. Gunter J. Fractional CO2 laser for genitourinary syndrome of menopause: evaluating the evidence. Menopause. 2024 Mar 1;31(3):231-233. doi: 10.1097/GME.0000000000002307. PMID: 38385733.

3. Li FG, Fuchs T, Deans R, McCormack L, Nesbitt-Hawes E, Abbott J, Farnsworth A. Vaginal epithelial histology before and after fractional CO2 laser in postmenopausal women: a double-blind, sham-controlled randomized trial. Am J Obstet Gynecol. 2023 Sep;229(3):278.e1-278.e9. doi: 10.1016/j.ajog.2023.05.005. Epub 2023 May 14. PMID: 37192705.

4. Zerzan, Nicholas L. MPH1; Greer, Nancy PhD1; Ullman, Kristen E. MPH1; Sowerby, Catherine BA1; Diem, Susan MD, MPH1,2; Ensrud, Kristine MD, MPH1,2,3; Forte, Mary L. PhD, DC4; Anthony, Maylen C. MPH1; Landsteiner, Adrienne PhD, MPH1; Butler, Mary PhD4; Wilt, Timothy J. MD, MPH1,2,4; Danan, Elisheva R. MD, MPH1,2. Energy-based interventions for genitourinary syndrome of menopause: a systematic review of randomized controlled trials and prospective observational studies. Menopause 32(2):p 176-183, February 2025. | DOI: 10.1097/GME.0000000000002465

5. Mackova, K, Mazzer, AM, Mori Da Cunha, MGMC, et. al. Vaginal Er:YAG laser application in the menopausal ewe model: a randomised estrogen and sham controlled trial. BJOG 2021; 128: 1087– 1096.