A response to the FDA regarding the safety and effectiveness of vaginal laser and radiofrequency procedures

It’s all about patient safety? Or is it?

The CO2 laser has been FDA approved for many years to treat precancerous cells in the vagina and genital warts, treatments delivering far more energy to the vaginal tissues than used with Mona Lisa Touch Laser or Votiva radiofrequency. Those treatments “ablate” entire areas of the vagina and vulva to destroy tissue. The Mona Lisa Touch laser makes incisions scattered throughout the vagina and vulva that are superficial and generally cannot be seen within minutes to hours after treatment. I know this as I have performed almost 300 of these procedures without any complications.

Consumers are not given the whole story however.

Last month the FDA issued a safety alert stating these procedures cause burns, scarring and chronic pain. There were 14 reports of complications from over 100,000 procedures, or less than a 0.014 % complication rate. The statement claims “these procedures” are being done without adequate evidence to support their use.

Currently, there are multiple devices on the market, some much less expensive than others, performed in many settings, including spas to physician practices, fewer in OB/Gyn offices. Some procedures are performed by nonmedical personnel, nurse practitioners or physician assistants, other physician specialists and some by OB/Gyns. Clearly, generalizing the outcomes from all these varied options would not be an accurate assessment of the risks and benefits of a procedure. Women should be evaluated for appropriateness for treatment and have a recent pelvic exam, Pap smear if indicated, and possibly tests for infection prior to the procedure. Atrophy, the condition the Mona Lisa Touch Laser treats, predisposes patients to infection, which can make it seem like the laser treatment is causing burning and pain and instead it is an undiagnosed infection. This evaluation should be done by someone who specializes in Women’s Health and better yet, treating vaginal discomfort, atrophy and incontinence.

Since the safety alert, gynecologists from Northwestern University and the Harvard Women’s Health Watch have responded in support of these procedures stating the FDA has shown an “overabundance of caution limiting the availability of innovative therapies that when used correctly benefit women. It is irresponsible to scare women away from them.” There is solid medical literature supporting the use of these procedures including two studies, one in 2014 and more recently at Stanford in 2017, both with favorable results. Scaring women away from these procedures will make it harder to get women to participate in ongoing research studies.

Where would we be without new ideas and technologies in health care? Adopting laser and radiofrequency technologies to a growing need for treatment for vaginal discomforts is no different than the development of other procedures or medications, for example Viagra, which was originally developed to treat high blood pressure. Viagra can have serious side effects such as symptoms of heart attack, loss of vision and seizures, to list a few, yet where is the FDA’s safety alert here?

Another criticism is that vaginal laser and radiofrequency procedures keep patients from accessing appropriate alternatives such as hormonal therapies. Many patients are seeking out these procedures because they cannot or do not want to use hormones, or have not had improvement in their symptoms of dryness or discomfort with intercourse or urination with hormones or lubricants alone. Many women have resigned themselves to no longer having intimacy and continued infections. The package insert for estrogen cream lists heart disease, stroke and cancer as possible increased risks of use and yet these products are FDA approved?

The question arises that pharmaceutical companies may have exerted their influence on the FDA to release this safety alert due to decreased sales of hormonal products?

Lastly, there is concern that these procedures increase women’s’ insecurities regarding their appearance. Gynecologists, who specialize in sexuality and menopause, understand that how women feel about their appearance is one of the many elements that affect a woman’s sexuality and these insecurities shouldn’t be summarily dismissed but treated sensitively with reassurance, education and multiple treatment options.

In summary, women can be appropriately consented for these procedures and therefore deserve to have options allowing them to have comfortable, pleasurable intimacy and decreased infections. They should be performed by providers who understand their needs and specialize in these gynecologic procedures.

Kim Lane M.D.

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