Despite warnings from the FDA regarding energy-based vaginal rejuvenation procedures, some spa owners are hoping that the procedure becomes as popular as manicures.

According to Refinery29, Cindy Barshop opened VSPOT Medi Spa in New York City in 2017. Two years after establishing the vaginal health spa, she is looking to expand her business to the U.K. and Dubai. According to Barshop, it is her mission to make visiting vaginal spas as common as going to the hair or nail salon.

Although there is little evidence to prove the effectiveness of energy-based vaginal rejuvenation procedures, spas such as VSPOT Medi Spa offer services including laser vaginal rejuvenation, vaginal tightening, and vaginal steaming to cater to women’s quest for youth.

While spa owners may view the growing popularity of vaginal rejuvenation procedures as a way to grow and diversify their businesses, gynecologists have joined the FDA in warning about the possible dangers of these procedures.

According to gynecologist Dr. Anne Henderson who spoke with Refinery29, vaginal rejuvenation procedures may be more dangerous than rejuvenation procedures focused on other parts of the body, such as the face or neck.

“[A]ny damage in the genital area could potentially be permanent, particularly if this involves blood vessels, nerves or the vaginal mucosa,” Dr. Henderson told Refinery29. Additionally, some gynecologists worry that women may go to their vaginal spa rather than their doctor’s office for medical advice and treatments.

Despite these concerns and warnings, vaginal rejuvenation treatments are gaining popularity as a way to regain vaginal comfort and tone that may be lost to age and motherhood.

What is vaginal rejuvenation?

According to the American Society of Plastic Surgeons, “vaginal rejuvenation” is an umbrella term used to describe several cosmetic procedures designed to treat vaginal concerns such as:

• Vaginal laxity
• Vaginal atrophy, dryness, or itching
• Pain during sexual intercourse
• Pain during urination
• Decreased sexual sensation

These treatments have been made popular by celebrities such as the Kardashians and Jada Pinkett-Smith, who claim that the procedures help women feel and look good.

Advertisements for these treatments may target women who are postmenopausal, postpartum or have recently stopped chemotherapy.

Vaginal rejuvenation treatments can either be energy-based or surgical. Energy-based treatments involve the use of lasers or radio energy. According to Cleveland Clinic, energy-based vaginal rejuvenation treatments are not permanent. The clinic goes on to explain that vaginal rejuvenation treatments are administered in multiple sessions.

Patients who have energy-based vaginal rejuvenation are advised to wait two to three days to have sex after having an energy-based vaginal rejuvenation treatment. Additionally, patients should be on the look-out for signs of an adverse reaction, like bright red bleeding, or an infection. Infections may include a bladder infection or a vaginal infection. If a patient does experience any of these occurrences, they should see a doctor, says Cleveland Clinic. 

Some insurance plans may cover vaginal rejuvenation, though many insurance plans do not cover these treatments. 

In addition to energy-based treatments, some surgical procedures fall under the umbrella of vaginal rejuvenation. Some of the energy-based treatments used to tighten or change the appearance of the vulva do have more invasive surgical counter-parts.

Surgical procedures that can qualify as vaginal rejuvenation include:

• Labiaplasty: a surgical procedure that trims excess labia minora tissue
• Clitoral hood reduction: similar to a labiaplasty, a clitoral hood reduction aims to trim the tissue around the clitoris
• Labia majoraplasty: a surgical procedure designed to reduce the size or improve the perceived fullness of the labia major
• Vaginoplasty: a procedure designed to tighten the vagina by bringing the separated muscles together.

These procedures are always done using local anesthesia to numb the area, which is sometimes combined with general anesthesia so the patient is not awake during the procedure, explains the American Society of Plastic Surgeons.

What tools are used for vaginal rejuvenation?

The energy-based devices, which may use lasers or radio energy, used for vaginal rejuvenation were initially approved by the U.S. Food and Drug Administration (FDA) for the treatment of gynecological problems. These devices are commonly used to treat abnormal or pre-cancerous tissue in the vagina or on the cervix, and may be used to the treatment of genital warts.

The two type of energy based devices used in vaginal rejuvenation are:

• Radiofrequency treatments: These devices use electromagnetic waves to focus heat into vaginal tissues; includes brand name devices such as Geneveve by Viveve and ThermiVa.
• CO2 laser treatments: Use lasers to heat the surface layers of the skin which is supposed to elicit the production of collagen; includes brand name devices such as MonaLisa Touch, FemTouch and FemiLift.

Although these devices are being used for vaginal rejuvenation, the FDA has not approved these lasers for cosmetic vaginal procedures.

“Understand that the FDA has not cleared or approved any energy-based medical device for vaginal ‘rejuvenation’ or vaginal cosmetic procedures, or for the treatment of vaginal symptoms related to menopause, urinary incontinence, or sexual function,” the FDA warns.

Is vaginal rejuvenation safe?

The lasers used in cosmetic vaginal procedures have not been approved for these off-label usages. For that reason, the FDA is unable to make any statements about the safety or efficacy of the devices for the new purposes.

“We are aware that certain device manufacturers may be marketing their energy-based medical device for vaginal ‘rejuvenation’ and/or cosmetic vaginal procedures. The safety and effectiveness of energy-based medical devices to perform these procedures has not been established,” the FDA notes.

According to the New York Times, in July 2018, the FDA sent warnings to several companies that may have been unlawfully marketing their energy based devices for vaginal rejuvenation.

These letters reportedly expressed concerns about certain marketing strategies that may violate the federal Food Drug and Cosmetic Act. Companies that received warnings include: Inmode, Sciton, Alma Lasers, Thermigen, BTL Aesthetic, BTL Industries, Venus Concept and Cynosure.

“These products have serious risks and don’t have adequate evidence to support their use for these purposes,” said FDA Commissioner Dr. Scott Gottlieb, according to the New York Times. “We are deeply concerned women are being harmed.”

The FDA has allegedly received vaginal rejuvenation reports of vaginal burns, scarring and significant pain that may be chronic following the treatments.