largepromising aser processes “Vaginal Resuscitation” are marketed to women in online ads, in spa windows, and even in some clinics. If my patient group is any guide, women undergoing cancer treatment may be particularly interested in obtaining the benefits advertised in these ads, as some cancer treatments cause sexual health side effects.
However, the use of lasers in the vagina is not only ineffective but also dangerous, and the Food and Drug Administration should immediately restrict this use.
The use of lasers to treat skin conditions is making a comeback as early as 1963 as a method to destroy the pigmented elements of the skin. However, in the years since, the beauty industry – sometimes called the medical aesthetics industry – has moved beyond the application of this technology outside the body to its use in the vagina, claiming it can treat a wide range of gynecological and urological conditions. .
Products with bland names (Mona Lisa Touch and FemTouch are two examples) are advertised as enhancers vaginal dryness and urinary incontinence. But their use is far from gentle: The high heat of the lasers causes thermal burns. The proper medical term for what they do is necrosisbecause these lasers kill sections of tissue.
Many plastic surgery and medical spa websites repeat the manufacturers’ claims that these devices can create a “Tighter, more youthful vaginal area” and one tighter vagina — which isn’t actually there, as vaginal tissue naturally expands and contracts over time (as with childbirth). Websites for Center of attention, Lumenisand Alma Laser directs clinicians to use the lasers in the vagina and says the procedure is “painless”. But I have seen many women have very painful results.
As a breast cancer surgeon and board-certified gynecologist, I am especially concerned about how these devices may harm my already vulnerable patients. Women with breast cancer are often instructed to avoid all estrogen products, which means they don’t have access to the most effective treatment for vaginal symptoms caused by cancer treatment. Women with estrogen-sensitive tumors are usually prescribed estrogen-blocking drugs, which can cause thinner, drier, and less elastic vaginal tissue. If this condition persists for years, the vagina can shorten and narrow, making penetrative intercourse nearly impossible, leading women to seek ways to relieve their symptoms.
Over the past five years, I have seen an influx of cancer patients seeking help after vaginal laser treatment. Some came to me with chronic bladder pain. others feel a burning sensation in the vulva (the outer part of the vagina) or inside. I have even seen scarring that causes the walls of the vagina to stick together.
The more women I see with these injuries, the more I suspect that the lure of “vaginal resuscitation” may have extra appeal to cancer patients, which scares me. It’s not that I don’t want my patients to get relief. I accept. What I want is to free them from the risks and costs of a procedure that many peer studies have shown no better than traditional treatments, and sometimes worse than them.
One of the most popular lasers, Cynosure’s MonaLisa Touch, which is powered by carbon dioxide gas, was cleared by the FDA in 2014 “for use in general and plastic surgery and dermatology”. However, the process by which it was licensed, a fast-track program known as 510(k)it’s not “approval” in the way the FDA approves drugs as safe for consumption, but it is essentially a mechanism for manufacturers to register their devices.
As part of this pathway, the FDA did not have to review whether lasers like the MonaLisa Touch are safe or even effective for use in “vaginal resurfacing,” as they are Class II devices. Only Class III devices — those that “support life, are implanted, or present a potential unreasonable risk of disease or injurysuch as pacemakers and breast implants — require premarket approval, which is the FDA’s scientific and regulatory review process for evaluating the safety and effectiveness of a device.
Four years after 510(k) registration for Cynosure’s product, the FDA issued a statement notifies providers and patients that the safety of these devices has not been established for vulvar or vaginal cosmetic procedures. In the advisory, then-FDA Commissioner Scott Gottlieb warned consumers about “bad actors” promoting the “unapproved, misleading product” and described how devices marketed as “vaginal resuscitation” caused “numerous cases of vaginal burns, scars, pain during intercourse. sexual intercourse and recurrent or chronic pain’.
However, four years after this warning, claims and advertisements for laser-based vaginal rejuvenation persist.
In February 2022, I conducted an informal review of FDA’s Manufacturer’s Device and User Facility Experience (MAUDE) electronic database for trade names of laser devices used for “vaginal resurfacing”. I found 41 adverse event reports over a 10-year period, with the number increasing after the 2018 FDA warning. As alarming as these numbers are, it is possible that there were even more adverse events, as the database is based on voluntary reports patients or doctors, many of whom may not be aware of the existence of MAUDE. Additionally, the database does not ask users to report adverse emotional events related to these devices, although one woman wrote that since treatment, her bladder pain was so severe that has thought about suicide.
Although the medical community has studied vaginal lasers, High-quality data were lacking. A recent carefully designed study was the first of its kind to use a “sham” procedure arm: Half of the participants received vaginal laser treatment according to the manufacturer’s instructions. For the other half, the laser bar was inserted into the vagina and the machine turned on, but at minimal settings that did not deliver laser energy to the vaginal wall. Results, published in JAMA October 2021showed that the laser procedure was no better than sham.
Reliable data are needed on procedures marketed to women as vaginal rejuvenation. After receiving treatment for breast cancer, over 70% of women report sexual health concerns. Changes in sexual health can also occur with almost any type of cancer treatment. In 2022, more than 8.8 million women they will return to their oncologists for surveillance, their gynecologists for annual exams, and their primary care physicians for tests. Providers and patients need to be aware of the potential risks of these devices — and why cancer patients may be especially vulnerable to their marketing messages.
The FDA has warned at least seven manufacturers to stop advertising their products for unapproved uses. But this is not enough.
Given the manufacturers’ advertising, the popular appetite for quick-fix solutions, and the damage vaginal lasers can cause, these devices should be immediately classified as Class III devices and their use restricted by the FDA.
Former FDA Commissioner Gottlieb told the audience, “We are deeply concerned that women are being harmed.” That’s how I am.
Kristin E. Rojas is a breast surgeon and gynecologist, founder of the Sexual Health After Cancer Program at the University of Miami Miller School of Medicine, and a Public Voices member of The OpEd Project.
