Patricia Geraghty NP, Director of Women’s Health at Comprehensive Wellness explains her take on the recent FDA Statement about Vaginal Laser Therapy.
On August 1, 2018 the FDA issued a warning regarding devices for treating vaginal conditions. I read the FDA warning itself, not just the news articles. The warning has also already received an endorsement from the North American Menopause Society. However, the news articles and reports that I have seen so far, and FDA commissioner Scott Gottlieb’s comments, are much more sensationalistic than the actual FDA statement. There is certainly no call for Mr Gottlieb to call this a “dangerous procedure with no proven benefit.” Let’s review the evidence.
There are two different technologies covered in the FDA statement; CO2 fractional laser also known as ablative procedure and with a brand name of Mona Lisa Touch, and the radiothermal procedure also known as non-ablative. I can only speak to the laser therapy, the therapy offered at Comprehensive Wellness.
The warning states that there have been no “sham” studies done. This is where some subjects get the treatment and others get all the trappings but an actual treatment (the laser) is not delivered. These studies are underway at this time.
The warning also states that there is not enough research on the long term effects. This is true. The longest duration study to date is 12 months. Of course we want to know if the effects last longer and if there is later development of problems. A study was published just last month, a study not reviewed in this warning, showing for some women there is a sustained effect and failing to identify any adverse events.
The warning also said that there can be long term scarring, burns, and pelvic pain. I have read the studies carefully as I just completed one presentation on vaginal laser therapy for the cancer doctors and am submitting another presentation to the state NP association. None of the studies on the CO2 fractional laser report adverse events and this would be required for publication. I am in the process of searching for case reports, which are individual reports rather than subjects from formal studies. None have shown up in either the PubMed National Library of Medicine or the Google Scholar search engines.
Again, I can’t speak to the radiothermal procedure which appears to have a deeper effect (though no comparison studies have been done) and might then theoretically have higher risk for adverse events. Any procedure needs to be done by clinicians not only with knowledge of the technique, but with gynecological expertise to select the appropriate patient.
I also find the statement’s implied criticism of the word vaginal “rejuvenation” puzzling. This is actually the word that the FDA insisted upon and approved when the promotional material was formulated.
Most concerning to me is the warning citing a 2016 American College of Obstetricians and Gynecologist guideline. This guideline did not raise safety concerns and could not include reviews of the most recent and longest duration studies. The FDA statement also does not include information from a joint guideline issued by the North American Menopause Society and the International Society for the Study of Women’s Sexual Health just last month. This recent guideline included oncology experts as well as women’s health experts in the authorship. They carefully reviewed the data for all vaginal treatments, including laser therapy, for women at high risk for or with breast cancer.
So, in summary, more research is called for. That is something everyone, including the North American Menopause Society, can support. Finally, although I agree with the criticisms cited in the statement, these criticisms can also apply to any therapy in the first 5 to 10 years of use. We have to be careful to neither prematurely adopt therapies while also not applying unfair standards to women’s health care.
