FDA Laser Warning on Vaginal Laser Procedures
The FDA released a warning about vaginal lasers and overzealous marking claims of laser manufactures. As a specialist practice engaged in ongoing research to bring new and innovative treatment options to our patients, we are pleased that the FDA is encouraging ongoing and more robust studies to support new therapy use. However, we are concerned that the message will cause an overreaction "fear response" and minimize or potentially take away an extremely valuable option for our patients.
We share the opinions of Dr. Ricciotti, MD from Harvard Medical School and would like to share her article below to help our patients and referring physicians aware of the concerns.
FDA warning on vaginal laser procedures should emphasize informed choices, not fear
Posted By Hope Ricciotti, MD On August 2, 2018 @ 11:02 am
Editor in Chief, Harvard Women's Health Watch
On July 30th, the FDA sent out a stern warning against the use of energy devices (laser therapy) to perform “vaginal rejuvenation,” and for procedures to treat symptoms related to sexual function, because of worries about adverse events. I agree with the FDA that these devices need more study, clear indications, informed patients, and skilled and ethical physicians to be used safely.
However, I have concerns that the FDA, in an overabundance of caution, may limit availability of innovative therapies, which when used correctly may benefit women’s reproductive health. In addition, press coverage is causing confusion about the different procedures.
Genitourinary syndrome of menopause (GSM)
The North American Menopause Society and International Society for the Study of Women’s Sexual Health recently introduced the term genitourinary syndrome of menopause (GSM) to describe the constellation of signs and symptoms associated with decreased estrogen and other hormones at the time of menopause. This syndrome affects approximately 50% of menopausal women and can cause vaginal dryness, itching, irritation, discharge, and painful sex. Vulvovaginal atrophy often worsens over time when it is not treated, unlike hot flashes that usually go away within a few years. Over 90% of women do not seek treatment for vaginal dryness and painful intercourse because of stigma, embarrassment, or doubt that there are safe therapies to help.
Standard treatments for GSM fall short for some
Standard treatment options for vulvovaginal atrophy include nonhormonal vaginal moisturizers and low-dose vaginal estrogen. In addition, maintaining regular intercourse can enhance vaginal health by increasing blood flow. Estrogen helps alleviate symptoms through enhanced lubrication, and improved pelvic muscle tone and elasticity of the vagina. However, many women do not want to use estrogen or can’t (even topically), because while absorption of vaginal estrogen is limited, some hormone exposure can pose a risk. For these women and their doctors, the limited options for effective treatment are frustrating. Vaginal laser therapy appeared to offer a promising nonhormonal option.
Vaginal laser therapy for GSM is not the same as vaginal rejuvenation
Preliminary data suggest that laser technology may offer benefits in treating vulvovaginal atrophy, but we need more data to assess its true safety and effectiveness, particularly over the long term. The FDA’s goal to protect women seeking treatment for vulvovaginal atrophy is best served by giving women accurate information about their options. Generally speaking, standard treatments should be tried first until we know more about the long-term risks and benefits of laser procedures. That said, I worry about misunderstanding of the FDA statement shutting down studies (and minds). For some women, laser-based therapies may prove to be a reasonable way to relieve GSM symptoms and improve quality of life.
So what is vaginal rejuvenation, anyway?
Typically, the term “vaginal rejuvenation” applies to procedures that alter the size or shape of the vagina or labia or recreate the hymeneal ring. The goals of these procedures are primarily cosmetic changes, or to enhance sexual satisfaction. Unfortunately, the procedures are not clearly defined. The American College of Obstetricians and Gynecologists defines vaginal rejuvenation and cosmetic procedures as “designer vaginoplasty,” “revirgination,” other cosmetic vaginal procedures, and “G-spot amplification” (injection of collagen into front wall of the vagina). These are elective procedures without a clearly defined medical purpose.
Taking the FDA warning in context
We must not forget that advances in women’s health care have been hindered by lack of rigorous studies in women, and by hesitance to openly address women’s reproductive and sexual health concerns. (Concerns about erectile dysfunction drugs causing dangerously low blood pressure did not result in warnings against using those drugs altogether.) With this history in mind, the FDA could have crafted this warning more carefully to delineate between the types of procedures, and to encourage further research on how women’s bodies respond to such innovations. In addition, off-label use of medications and procedures has often led to FDA approval of new therapies (including, interestingly, the most popular class of erectile dysfunction drugs, which were initially studied as a treatment for high blood pressure and chest pain).
Physicians must provide accurate and current information to patients, who should be fully engaged in the informed decision-making process for all medications and procedures. We should not inflame women’s fear of estrogen, and we should give them all options to consider. The FDA should not conflate cosmetic procedures with innovative treatments that may improve quality of life, and it should not engage in fearmongering with regard to women’s health and relevant technology.
I welcome the dialogue and hope the FDA will work to allow this technology to continue to be studied by gynecologists, just like it was for dermatologists treating skin conditions.