The FDA needs to reevaluate laser

By Kristin E. RojasFeb. 22, 2022

Laser procedures promising "vaginal rejuvenation" are being promoted to women in advertisements online, in spa windows, and even in some doctors’ offices. If my patient group is any guide, women receiving treatment for cancer may be especially interested in obtaining the benefits touted in these ads, as some cancer treatments cause sexual health side effects.

Yet the use of lasers in the vagina is not only ineffective but dangerous, and the Food and Drug Administration should immediately restrict such use.

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Using lasers to treat skin conditions goes back as early as 1963 as a method for destroying pigmented skin elements. In the years since, however, the beauty industry — sometimes called the medical aesthetics industry — has gone beyond applying this technology outside the body to using it in the vagina, claiming it can treat a broad range of gynecologic and urologic conditions.

Products with gentle-sounding names (Mona Lisa Touch and FemTouch are two examples) are advertised as improving vaginal dryness and urinary incontinence. But their use is far from gentle: The high heat of the lasers causes thermal burns. The appropriate medical term for what they do is necrosis, because these lasers kill segments of tissue.

Many plastic surgery and medi-spa websites repeat manufacturers’ claims that these devices can create a "firmer, more youthful vaginal area" and a tighter vagina — something that doesn't really exist, as vaginal tissue naturally expands and contracts over time (as with childbirth). Websites for Cynosure, Lumenis, and Alma Lasers direct clinicians to employ the lasers in the vagina, and say the procedure is "painless." But I’ve seen many women instead suffer very painful outcomes.

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As a breast cancer surgeon and a board-certified gynecologist, I am especially concerned about how these devices may be causing harm to 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 their cancer treatment. Women with estrogen-sensitive tumors are typically prescribed estrogen-blocking medications, which can cause the tissues of the vagina to become thinner, dryer, and less elastic. If this state persists for years, the vagina can shorten and narrow, making penetrative intercourse next to impossible, leading women to seek ways to alleviate their symptoms.

Over the last five years, I have seen an influx of cancer patients looking for help after getting vaginal laser treatment. Some came to me with chronic bladder pain; others experience burning sensations on the vulva (the external part of the vagina) or internally. I’ve even seen scarring that causes the vaginal walls to cohere.

The more women I see with these injuries, the more I have come to suspect that the lure of "vaginal rejuvenation" might hold extra appeal for cancer patients, which appalls me. It's not that I don't want my patients to get relief; I do. What I want is to spare them the risks and costs of a procedure that multiple peer-reviewed studies have shown to be no better than traditional therapies, 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 in dermatology." However, the process under which it received clearance, a fast-tracking program known as 510(k), is not an "approval" in the way the FDA approves medications to be safe for consumption, but is essentially a mechanism for manufacturers to register their devices.

As part of this pathway, the FDA has not had to examine whether lasers like the MonaLisa Touch are safe or even effective for use in "vaginal rejuvenation" since they are Class II devices. Only Class III devices — those that "support life, are implanted, or present potential unreasonable risk of illness or injury" such as pacemakers and breast implants — require premarket approval, which is the FDA's process of scientific and regulatory review to evaluate a device's safety and effectiveness.

Four years after the 510(k) registration for Cynosure's product, the FDA issued a notice alerting providers and patients that the safety of these devices has not been established for cosmetic procedures on the vulva or in the vagina. In the advisory, then-FDA Commissioner Scott Gottlieb warned consumers about "bad actors" who promote the "unapproved, deceptive product" and described how devices marketed as providing "vaginal rejuvenation" caused "numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain."

Yet four years after that warning, claims and advertisements for laser-based vaginal rejuvenation persist.

In February 2022, I conducted an informal review of the FDA's Manufacturer and User Facility Device Experience (MAUDE) online database for brand names of laser devices used for "vaginal rejuvenation." I found 41 adverse event reports over 10 years, with the number increasing after the FDA's 2018 warning. As worrisome as those numbers may be, it is likely that there have been even more adverse events, as the database relies on voluntary reporting by patients or physicians, many of whom may not be aware of MAUDE's existence. Furthermore, the database does not invite users to report adverse emotional events associated with these devices, although one woman wrote that since treatment, her bladder pain has been so severe that she has contemplated suicide.

Although the medical community has been studying vaginal lasers, high-quality data have been in short supply. One recent carefully designed study was the first of its kind to use a "sham" procedure arm: Half of the participants received treatment with a vaginal laser according to the manufacturer's instructions. For the other half, the laser wand was placed in the vagina and the machine was turned on, but at minimal settings that did not deliver laser energy to the vaginal wall. The results, published in JAMA in October 2021, showed that the laser procedure was no better than the sham.

Reliable data are needed on procedures marketed to women as vaginal rejuvenation. After receiving treatment for breast cancer, more than 70% of women report sexual health concerns. Sexual health changes can also occur with almost any type of cancer treatment. In 2022, more than 8.8 million women will be returning to their oncologists for surveillance, their gynecologists for annual exams, and their primary care doctors for checkups. Providers and patients alike need to be aware of the potential dangers of these devices — and why cancer patients may be especially vulnerable to their marketing messages.

The FDA has warned at least seven manufacturers to cease advertising their products for unapproved uses. But that isn't enough.

Given manufacturers’ ads, the popular appetite for quick-fix solutions, and the damage vaginal lasers can wreak, these devices must immediately be reclassified as Class III devices and their use restricted by the FDA.

Former FDA Commissioner Gottlieb told the public, "We are deeply concerned women are being harmed." So am I.

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 Fellow of The OpEd Project.

advocacy

cancer

FDA

reproductive health

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