Efforts to improve the appearance and function of the female genitalia through medicine and surgery are nothing new, but in the past decade enthusiasm for this endeavor has risen substantially. Rates of labiaplasty, the most commonly performed female genital cosmetic surgery, rose by 45% from 2014 to 2015 worldwide, while in the US they increased more than 50% between 2014 and 2018.¹ At the same time, in 2014 vaginal lasers and other energy-based devices (EBDs) were introduced to the US market, where direct-to-consumer marketing encouraged their off-label use to treat all manner of genitourinary problems, including vulvovaginal tissue atrophy, laxity, dryness, and pain, in a procedure billed as “vaginal rejuvenation.”

This interest in modifying vulvovaginal tissue appearance and quality has been controversial, and in 2018, the Food and Drug Administration issued a statement warning against the use of EBDs for vaginal rejuvenation, citing reported complications and a lack of robust evidence for benefit.² During the subsequent year, the American College of Obstetricians and Gynecologists, International Urogynecological Association, International Continence Society, and the International Society for the Study of Vulvovaginal Disease issued guidelines discouraging the use of EBDs outside of clinical trials. But in 2020, the American Urogynecologic Society published a consensus statement supporting the use of vaginal EBDs, especially laser therapies, for patients experiencing vaginal atrophy and dyspareunia in the setting of menopause.³

To make sense of this apparent contradiction, it is helpful to remember that differences between indications for regenerative or reconstructive medical and surgical intervention can meaningfully alter their risk-benefit ratio for patients. The hazards of genitourinary syndrome of menopause, which compromises not only sexual function, but also protection from lower urinary tract symptoms and infection, are greater than those of perceived vaginal laxity, such that it is reasonable to take on greater risk to treat the former than the latter. Similarly, the risks of labiaplasty are more readily balanced when the indication for surgery is vulvar disease rather than aesthetic preference or body dysmorphia, which might be more directly and safely addressed through education about body diversity and the subjectivity of beauty or psychotherapy.

The risk-benefit ratio of labiaplasty and vaginal EBDs also varies between the types of surgery and energy-based treatments performed. In the case of labiaplasty, manipulation of the anterior labia minora where they form the clitoral hood or prepuce carries a higher risk of injury to the glans clitoris and clitoral nerves than posterior surgery, with potentially devastating sexual consequences.⁴ Tissue-ablative fractional CO₂ or erbium:YAG lasers, which are designed to cause focal thermal injury and necrosis that stimulates tissue repair and remodeling through the process of wound healing, have rare reported adverse effects, but their tissue destruction can lead to significant burns, scarring, and pain.⁵

In theory, nonablative laser or acoustic wave technologies, such as low-intensity extracorporeal shock wave (LI-ESWT) or photobiomodulation (PBM) using near-infrared light ought to be a safer bet. But in practice we are lacking safety data, especially for many relevant female subpopulations, such as those who are pregnant or hoping to conceive, and those suffering from malignancy. In the absence of evidence, there is certainly reason for caution: the mechanism of LI-ESWT includes recruitment of endogenous mesenchymal stem cells and growth factors that potentially promote cancer growth, while PBM’s inhibitory effect on COX-2 could interfere with ovulation and uterine implantation or encourage dangerous thrombosis.

In addition to needing more and better safety data, it is also essential to clarify whether the offered intervention is able to achieve its putative goals. Direct-to-consumer advertisements–aimed at both patients and health care providers–claim multifarious functional and cosmetic benefits from labiaplasty, EBDs, and other regenerative medical therapies, including injection or application of cell-based therapies, such as platelet-rich plasma, microfragmented adipose tissue, and adipose-derived stem cells. There is no reliable evidence for the overwhelming majority of these claims.

What do we have evidence to support? There is currently no good quality evidence to suggest that vulvovaginal platelet-rich plasma in the minimally processed and concentrated form that is spared Food and Drug Administration regulation provides any cosmetic or functional benefit. There is scant data suggesting that vulvovaginal LI-ESWT and PBM might reduce dyspareunia, but none regarding their benefits for any other aspect of female genitourinary function or appearance.^6,7 Radiofrequency may provide some subjective improvements in vaginal tone, lower urinary tract symptoms, and urinary continence, but is less well-studied than vaginal CO₂ lasers, for which the positive findings of some randomized, controlled trials regarding their benefits for genitourinary syndrome of menopause and sexual dysfunction have failed to be replicated.⁸

In contrast, what labiaplasty offers female patients is seemingly more certain: a tailoring of the labia minora, to reduce their prominence external to the labia majora in order to provide the appearance of “a clean slit,” effectively a prepubertal contour to the external genitalia. Symptomatically, such a contour promises to decrease the friction of skin, whether against covering clothes or a penetrating phallus, to increase comfort and aid genital hygiene. Psychosocially and aesthetically, labiaplasty offers optimal femininity, particularly within the context of heterosexual function, to physically reinforce an alluring fantasy of “normal womanhood.” But in fact, none of these functional or aesthetic promises is reliably true, as identical claims are made regarding elongated labia minora in the African and diaspora communities that routinely practice and encourage labial stretching.⁹

That the putative benefits of labiaplasty are culture-bound in the imagination of the thinker and the eye of the beholder is not to say that genital cosmetic surgery should not be done. But we must recognize that when undertaking it the patient assumes the risks that are inherent in any surgery—of bleeding, tissue injury and pain, scarring and other permanent changes in their anatomy and its associated physiology and function—with only dubious promise of compensatory benefit. Thus, the requirement for robust informed consent to cosmetic surgery is particularly stringent,¹⁰ and interested patients must be educated regarding the absence of any compelling benefit to labial reduction or vulvovaginal regenerative medical procedures at this time.