Is female genital cosmetic surgery going mainstream?

These energy sources hold great promise for the genitourinary syndrome of menopause (GSM) and other conditions, Dr. Karram said. “Many of these energy sources are being promoted for actual disease states, like vulvovaginal atrophy and lichen sclerosus,” he said.

Dr. Iglesia is not so sure: “This is not the fountain of youth.” She pointed out that the vasculature and innervation of the vagina and vulva are complex, with the outer one-eighth of the vagina being much more highly innervated. Laser treatment with a shallow penetration depth may not get at all of the issues that contribute to GSM.

“Is marketing ahead of the science? I would say yes,” she said. “There’s too much hype about this curing vaginal dryness and making your sex life better.”

Dr. Zahn also urged caution with the use of this technology. “The data are very limited, but, despite this, it’s become a very popular and highly-advertised approach. We need larger studies and more longitudinal data. This is especially true since one of the proposed ways this device works is by stimulating fibrosis. In every other body system, fibrosis stimulation may result in scarring. We have no idea if this is the case with this device. If it is, its application could result in worsening of bodily function, especially in regard to dyspareunia,” he said. “We clearly need more data.”

In 2016, ACOG issued a position statement about the fractional carbon dioxide and yttrium-aluminum-garnet laser systems that had received clearance from the Food and Drug Administration. The statement advised both ob.gyns. and patients that “this technology is, in fact, neither approved nor cleared by the FDA for the specific indication of treating vulvovaginal atrophy.”

Both Dr. Karram and Dr. Iglesia are investigators in an ongoing randomized, placebo- and sham-controlled trial comparing vaginal estrogen and laser therapy used both in conjunction and singly.

‘No-go’ procedures

Though Dr. Karram and Dr. Iglesia disagree on whether cosmetic labiaplasty is appropriate, they were in agreement that certain procedures are so untested, or have such potential risk with no proven benefit, that they should not be performed at all. The procedures on both physicians’ “no-go” lists included clitoral unhooding, G-spot amplification, “revirginification” in any form, vulval recontouring with autologous fat, and the so-called “O-shot,” injections of platelet-rich plasma that are touted as augmenting the sexual experience.

What’s to be done?

There is also agreement that a lack of common terminology is a significant problem. Step one, Dr. Karram said, is doing away with the term vaginal rejuvenation. “This is a terrible term. … There’s no real definition for this term.” He called for a multidisciplinary working group that would bring together gynecologists, plastic surgeons, and dermatologists to begin the work of terminology standardization.

From there, he proposed that the group develop a classification system that clarifies whether procedures are being done for cosmetic reasons, to enhance the sexual experience, or to address a specific disease state. Finally, he said, the group should recommend standardized outcome metrics that can be used to study the various interventions.

Dr. Zahn applauded this notion. “It’s a great point. I agree that multiple disciplines should be involved in examining outcomes, statistics, and criteria for evaluating procedures.”
And gynecologists should be leading this effort, Dr. Karram suggested. “Who knows this anatomy the best? We do.” He added, “If it’s going to be addressed, it should be addressed by us.”

But, Dr. Iglesia said she worries about vulnerable populations, such as adolescents and cancer survivors, who may undergo surgeries, for which the benefits may not outweigh the potential risks. For labiaplasty and laser resurfacing techniques, there have been a small number of studies on outcomes and patient satisfaction that have generally been conducted at single centers with no comparison arms and limited follow-up, she said.

“I also am concerned about pain, scarring, altered sensation, painful sex that could develop, wound complications, and what happens over time,” especially when these procedures may be performed on adolescents or women in their 20s or 30s who may later go on to have children, Dr. Iglesia said.

The question, she said, is not just whether gynecologists are better equipped than plastic surgeons or dermatologists to be performing female genital cosmetic surgery, “but should we be doing this at all?”

Dr. Zahn emphasized the need for evidence to guide decision making. “There has to be data that there is benefit and that the benefit outweighs the potential harm. There is no data on most cosmetic gynecologic procedures. If there are no data, they shouldn’t be done because we would not have the information necessary to appropriately counsel patients,” he said.

Dr. Karram has a financial relationship with Cynosure, which markets the MonaLisa Touch system in the United States. Dr. Iglesia reported that she had no relevant financial disclosures. Dr. Zahn is employed by ACOG.