Invited Commentary | Obstetrics and Gynecology

Genitourinary Syndrome of Menopause and the False Promise

of Vaginal Laser Therapy
Jen Gunter, MD

Symptoms of genitourinary syndrome of menopause (GSM) affect up to 84% of individuals in + Related article
menopause.1 If untreated, many individuals may have symptoms for decades, since GSM does not Author affiliations and article information are
improve over time. While some individuals may manage with vaginal moisturizers and lubricants, listed at the end of this article.
many need therapy in the form of vaginal estrogen, vaginal dehydroepiandrosterone, systemic
estrogen, or oral ospemifene.1 Unfortunately, in the United States, these pharmaceuticals can be too
expensive for long-term use, and there are some individuals who do not like using them, some who
cannot tolerate them, and others with certain hormone-responsive cancers who may not be able to
use them or who may not feel comfortable with them from a safety standpoint, based on the
available data.
This is where vaginal laser therapy has been suggested for use. The messaging is clear: why
bother with messy creams or a ring or a pill when there is a practically painless and safe procedure
that can improve lubrication and moisture, improve sex, boost confidence, and even revive a
relationship?
And why would people not believe the practitioners offering this procedure? Websites, from
small private practices to large academic health care systems, present bold claims, making it appear
to an untrained eye as though vaginal laser therapy were well researched and the standard of care.2
Additionally, social media is filled with physicians and medical spa owners extolling the benefits and
promoting anecdotal data. As the procedure is often promoted as “vaginal rejuvenation,” it sounds
more like a simple technical spa treatment with no downside instead of what it really is—an
inadequately studied controlled thermal injury to the vagina.
The reality of laser for GSM and so-called vaginal rejuvenation is far different from the promises.
These devices are not cleared by the US Food and Drug Administration (FDA) for this purpose. In fact,
in 2018, the FDA, concerned about deceptive marketing, unknown risks, and unproven efficacy
regarding the use of energy-based devices for GSM and vaginal rejuvenation issued a warning to the
manufacturers of these devices.3 In addition, opinions and statements from several medical societies
recommend against laser therapy for GSM, given the low quality of the data and the lack of
information on long-term efficacy and safety.1,4
Most of the studies on vaginal laser therapy are small, many are observational, include only
short-term follow-up, and, importantly, had no sham group. A 2022 systematic review and meta-
analysis found no benefit associated with these devices over vaginal estrogen but concluded the
quality of the evidence was very low or low.5 While it would be an important finding if the device
were as effective as vaginal estrogen, given the low quality of the data, we cannot currently reach
that conclusion.
In 2021, a double-blind, sham-controlled randomized clinical trial with 12 months of follow-up
by Li et al6 was published in JAMA, finding no difference between fractional carbon dioxide vaginal
laser therapy and sham laser therapy for GSM.6 While the laser appeared safe, it did not improve
symptoms or quality of life, and there were no changes in vaginal histology vs the sham procedure.
The study by Li et al6 should have been enough to pause laser therapy outside of clinical trials.
Unfortunately, it was not.
In this study by Mension et al,7 we have another prospective, double-blind, sham-controlled
randomized clinical trial of laser therapy for GSM, this time for patients with breast cancer using

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 JAMA Network Open | Obstetrics and Gynecology Genitourinary Syndrome of Menopause and the False Promise of Vaginal Laser Therapy

aromatase inhibitors.7 This is uniquely important group for study, as they typically experience worse
symptoms and may have safety concerns with hormonal therapies. However, there were no
improvements in subjective or objective outcomes, including symptoms or histological changes on
vaginal biopsy, in the laser group compared with the sham procedure.7 The laser was safe, with only
minor adverse events reported.
The idea that the controlled thermal injury of laser therapy might stimulate blood flow and
collagen and consequently improve symptoms of GSM was a valid hypothesis, but every hypothesis
needs rigorous testing. Instead, some physicians who promote vaginal laser therapy appear to have
gone from proof-of-concept studies to offering the therapy as safe and effective.2
There is an awful legacy of inadequately tested devices in obstetrics and gynecology, with our
patients suffering the consequences, such as the Dalkon Shield, the Majzlin Spring, and vaginal mesh
for pelvic organ prolapse.8 To see that legacy continue with the ongoing promotion of inadequately
studied lasers for GSM is tragic.
There will likely be opinion pieces and lectures at conferences that explain away these 2
prospective, sham-controlled randomized clinical trials in favor of the existing low-quality data for
any variety of reasons. Perhaps they will say that the vagina needs to be prepped with estrogen first
for the laser to work, or they will cherry-pick a line from these studies, claiming it renders them
worthless.
How many quality studies showing the vaginal laser is ineffective for GSM must be published to
halt its use outside of appropriate clinical trials? This is a rhetorical question, because history tells us
that facts do not always get in the way of ego and profit. To get the Majzlin Spring off the market in
the 1970s, the FDA had to send the US Marshals to collect unused devices from the office of a
physician with a large supply who refused to stop insertions.8 At least with vaginal laser therapy, the
risk of serious physical harm appears low, but that should not discount procedural discomfort or the
emotional and financial toll. It also does not excuse the ethics of recommending and charging for a
procedure that, based on the best available evidence, performs no better than sham therapy.
It is doubtful that the clinical practice of laser therapy for GSM will halt in the United States
without FDA intervention, and many practitioners here and around the world will likely continue to
use the offensive “vaginal rejuvenation” language to coax patients into paying thousands of dollars to
treat GSM for what the most robust current evidence tells us is an ineffective procedure. There is
simply too much money to be made.

ARTICLE INFORMATION
Published: February 10, 2023. doi:10.1001/jamanetworkopen.2022.55706
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2023 Gunter J.
JAMA Network Open.
Corresponding Author: Jen Gunter, MD, Kaiser Permanente Northern California, 2238 Geary Blvd, San Francisco,
CA 94115 (jennifer.gunter@kp.org).
Author Affiliation: Kaiser Permanente Northern California, San Francisco.
Conflict of Interest Disclosures: None reported.

REFERENCES
1. The NAMS 2020 GSM Position Statement Editorial Panel. The 2020 genitourinary syndrome of menopause
position statement of the North American Menopause Society. Menopause. 2020;27(9):976-992. doi:10.1097/
GME.0000000000001609
2. University of Kansas Health System. What happens during MonaLisa Touch laser therapy? Accessed December
19, 2022. https://www.kansashealthsystem.com/care/treatments/monalisa-touch-laser-therapy#:~:text=MonaLisa
%20Touch%20laser%20therapy%20is%20completely%20hormone%2Dfree%2C%20and%20the,symptoms
%20following%20vaginal%20laser%20therapy

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3. 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
4. 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
5. 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
6. 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
7. 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. doi:10.1001/jamanetworkopen.2022.55697
8. US Food and Drug Administration. History of the US Food and Drug Administration: interview with Larry Pilot,
December 21, 2004. Accessed December 1, 2022. https://www.fda.gov/media/81346/download

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