The United States leads all other countries in the number of female cosmetic genital surgeries (FCGSs) performed each year despite limited evidence of their relevance, safety, and effi cacy. In February 2018, the Cosmetic Surgery Committee of the International Society for the Study of Vulvovaginal Disease (ISSVD) released a report on this topic. Even more recently, the FDA issued a warning about the use of energy-based treatments for vaginal rejuvenation. This column highlights recommendations from the ISSVD report on FCGS, and offers a clinical perspective from a board-certifi ed plastic surgeon.

According to the International Society of Aesthetic Plastic Surgery, the United States dominates all other countries in the annual number of aesthetic and cosmetic surgical procedures performed.¹ In 2016, U.S. healthcare providers (HCPs) performed more than 4 million aesthetic and/or cosmetic procedures, an increase of 9% over the previous year.¹ Among these procedures are those involving the vulva or vagina (e.g., labiaplasty, clitoral unhooding, vaginal tightening, G-spot amplification), which nearly half of all U.S. plastic surgeons perform.^1-3

More and more U.S. women are requesting female cosmetic genital surgery (FCGS), and plastic surgeons are responding to the increased requests by off ering newer and more advanced surgical approaches to achieving the “perfect vulva.”^2,3 This growing demand for FCGS has sparked tremendous controversy. Opponents of FCGS claim that women are being persuaded that there is only one ideal way for female genitalia to appear.⁴ Any deviation from the picture-perfect vulva is considered unattractive.² In addition, many FCGSs are advertised as being complication free and effective in improving women’s sexual pleasure—despite a lack of evidence to support such claims.^4,5

Many women are concerned about a perceived loss of vaginal tone and elasticity, redundant labia minora, presence of genital hair, and genital pigment variations.² These concerns may be heightened if these women (and perhaps their partners) view nude photographs or pornographic videos—so easily available on the Internet and social media—that have been altered so that female genital structures appear to be of a certain color, shape, or tone. It is also possible that the women appearing in these photos or videos have undergone FCGSs themselves. All of these digital and/or surgical “adjustments” provide skewed images—and therefore skewed perceptions— of what is normal, desirable, or beautiful.

Female cosmetic genital surgery recommendations

The International Society for the Study of Vulvovaginal Disease (ISSVD) released a Cosmetic Surgery Committee report on FCGS in February 2018.⁵ The first section of the report highlights the importance of HCPs’ understanding that normal female genitalia differ widely in terms of appearance, size, shape, tone, and several other parameters. The authors of this report recommend the book Femalia,⁶ which I use in my own clinic to demonstrate to my patients the enormous variations in normal female genital anatomy. Use of such literature augments the conversation about an enigmatic topic. Many women are surprised to learn that normal healthy vulvas occur in all shapes and sizes.

Additional recommendations in the ISSVD Cosmetic Surgery Committee’s report on FCGS include the following⁵:

• Surgeons should be experienced in diagnosing and treating vulvovaginal diseases before performing FCGS.
• HCPs should rule out body dysmorphic disorder, sexual dysfunction, and gynecologic pathology before referring patients for FCGS.
• When appropriate, HCPs should include a mental health and/or sexual medicine provider in the care of patients seeking FCGS.
• FCGSs such as labiaplasty should not be performed in persons younger than 18 years.
• HCPs should remind patients that FCGS is irreversible and that reliable scientific evidence on the safety and efficacy of many of these procedures is limited.
• The ISSVD Cosmetic Surgery Committee specifically advises against G-spot injections, hymenoplasty, and bleaching of vulvar and perianal tissues.
• More evidence is required before a consensus can be reached on the safety and efficacy of energy- based treatments for vaginal rejuvenation.
• HCPs should refer to published evidence when counseling patients on the risks and benefits of FCGS.
• Realistic expectations should be established between patient and HCP, and the patient should be considered an equal partner to the HCP in healthrelated decision making.
• Advertisement of FCGS services should be clear, realistic, and inclusive of published literature on safety/efficacy. In order to prevent unrealistic expectations on the part of patients, HCPs should avoid or limit the use of before-and-after photos.
• HCPs should not perform procedures or surgeries with which they do not personally agree or about which they do not feel comfortable, even if a patient requests such services.
• HCPs who offer FCGS services should have extensive knowledge of female pelvic and genital anatomy and should work with an experienced multidisciplinary team.

Energy-based devices for vaginal rejuvenation

In addition to the ISSVD recommendations regarding FCGS, the FDA recently released a warning regarding the use of energy-based devices for vaginal rejuvenation.⁷ The term vaginal rejuvenation is not clearly defined by the healthcare community, although “problems” commonly claimed to “improve” with such treatment include vaginal laxity, redundant labia, clitoral hood hypertrophy, vaginal dryness, decreased sexual pleasure, vulvovaginal pain and itching, urinary incontinence, and recurrent urogenital infections.³ To date, vaginal lasers are not FDA approved for specific conditions, although they are FDA cleared for general urogynecologic use.⁸

Immense variability exists in the reported safety and efficacy of individual devices touted to improve the integrity and function of vulvovaginal tissue. In addition, the amount and quality of published evidence for each treatment varies from none to 30+ articles. Although HCPs may integrate the term vaginal rejuvenation into marketing of energy-based lasers and radiofrequency devices, not all companies promote use of their product(s) for this purpose. In essence, energy-based devices are not all created equal.

Seven companies received letters from the FDA regarding inappropriate marketing of their laser and radiofrequency devices: Alma Lasers, BTL Aesthetics, Cynosure, InMode, Sciton, Venus Concept, and ThermiGen.⁷ The letters addressed specific concerns that the FDA raised about each company’s marketing of its energy-based devices. Some of the letters cited concerns about reported serious adverse events, whereas others conveyed only minor concerns about marketing materials.⁷

Although published data on the safety and efficacy of many energy-based devices for urogenital conditions are still lacking, there are HCPs who endorse some of these devices over others. In addition to published evidence and preliminary data from ongoing studies, anecdotal evidence prompts some HCPs to support claims made by various companies. Regardless, the FDA cautions against treating urogynecologic conditions with energy-based devices not supported by evidence.⁸

A plastic surgeon’s perspective

As with all types of cosmetic surgery, the decision to pursue FCGS is ultimately up to each individual woman. When well-informed patients desire FCGS, they must first identify a board-certified plastic surgeon with experience in FCGS. J. J. Wendel, MD, a board-certified plastic surgeon in Nashville, Tennessee, provides insight into his conservative approach toward screening and counseling patients for prospective FCGS.⁹ He explains that female genital cosmetic concerns stem mostly from problems associated with excess tissue or perceived excess. When patients present for FCGS consultations, Dr. Wendel first inquires about their motivation for pursuing FCGS: I perform procedures only on women who come in motivated for themselves, not for someone else. Dr. Wendel strongly endorses proper patient selection, with consideration of the right procedure for the right patient for the right reasons at the right time. He states: It’s the provider’s fault for not selecting the right patient with regard to the various FCGSs offered nationwide. Not everyone needs a procedure.

As with all of his consults, Dr. Wendel is careful to set clear expectations during FCGS consults.⁹ He states, My goal is to bring women within the standard deviation of normalcy. He emphasizes the importance of the surgeon’s knowledge of normal genital and pelvic anatomy before embarking on this subset of cosmetic surgery. He explains that a good surgeon avoids the pudendal complex when operating on genital structures. In addition, Dr. Wendel does not perform elective surgeries for vaginal tightening. In cases of true prolapse or urethral hypermobility, he suggests referral to an appropriate urogenital surgeon.

Conclusion

Demand for FCGS continues to grow in the U.S. This demand has been met with a plethora of new devices and surgical options for women to consider. As with any other area of healthcare provision, treatment for genital cosmetic concerns warrants high-quality evidence to establish safety and efficacy of each individual modality. In the meantime, HCPs are encouraged to use proper clinical judgment in identifying appropriate patients for FCGS treatment or referral.

Brooke M. Faught is a women’s health nurse practitioner and the Clinical Director of the Women’s Institute for Sexual Health (WISH), A Division of Urology Associates, in Nashville, Tennessee. She is a Fellow of the International Society for the Study of Women’s Sexual Health (ISSWSH). The author states that she serves as a speaker and an advisory board member for AMAG, Duchesnay, and Therapeutic MD and as an advisory board member for Lupin.

References

1. International Society of Aesthetic Plastic Surgery. Demand for Cosmetic Surgery Procedures Around the World Continues to Skyrocket – USA, Brazil, Japan, Italy and Mexico Ranked in the Top Five Countries. June 27, 2017. globenewswire.com/news-release/2017/06/27/1029348/0/en/Demand-for-Cosmetic-Surgery-Procedures-Around-the-World-Continues-to-Skyrocket-USA-Brazil-Japan-Italy-and-Mexico-Ranked-in-the-Top-Five-Countries.html
2. Clerico C, Lari A, Mojallal A, Boucher F. Anatomy and aesthetics of the labia minora: the ideal vulva? Aesthetic Plast Surg. 2017;41(3):714-719.
3. Wilkie G, Bartz D. Vaginal rejuvenation: a review of female genital cosmetic surgery. Obstet Gynecol Surv. 2018;73(5):287-292.
4. Liao LM, Taghinejadi N, Creighton SM. An analysis of the content and clinical implications of online advertisements for female genital cosmetic surgery. BMJ Open. 2012;2(6):e001908.
5. Vieira-Baptista P, Almeida G, Bogliatto F, et al. International Society for the Study of Vulvovaginal Disease Recommendations Regarding Female Cosmetic Genital Surgery. J Low Genit Tract Dis. July 9, 2018. Epub ahead of print.
6. Blank J, ed. Femalia. Down There Press; 1993.
7. Fox M. FDA warns about “deceptive” vaginal rejuvenation claims. NBC News. July 30, 2018. nbcnews.com/health/health-news/fda-warns-companies-about-deceptive- vaginal-rejuvenation-claims-n895811
8. FDA. Medical Devices. FDA Warns Against Use of Energy- Based Devices to Perform Vaginal ‘Rejuvenation’ or Vaginal Cosmetic Procedures: FDA Safety Communication. July 30, 2018. fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm615013.htm
9. Wendel JJ. Personal communication. March 23, 2018.