The FDA has warned that vaginal rejuvenation treatment may not be safe and in line with approved device indications.

According to the American Society of Plastic Surgeons, there are a variety of vaginal rejuvenation procedures available, some surgical and others not. Surgeries such as labiaplasty, clitoral hood reduction, and vaginoplasty are typically safe when completed by board-certified plastic surgeons.

However, some women may not want to undergo surgical genital manipulation to achieve their results – leading to the increasing popularity of non-surgical vaginal rejuvenation treatment.

Non-surgical vaginal rejuvenation is a relatively new procedure offered to treat a variety of conditions in women. These procedures often use radiofrequency or laser devices claimed to treat vaginal laxity, vaginal atrophy, dryness, or itching, pain during sex, pain during urination, and decreased sexual sensation.

Although celebrities such as Jada Pinkett-Smith have raved about the effectiveness of these treatments, the efficacy and safety of the vaginal rejuvenation procedures have reportedly not been evaluated by the FDA.

Despite the lack of evaluation of these procedures, device manufacturers are reportedly marketing their vaginal laser devices for vaginal rejuvenation. These devices were reportedly approved for the treatment of medical conditions such as pre-cancerous tissue in the vagina or cervix, the removal of genital warts, and other uses. However, the FDA says that various procedures promoted as vaginal rejuvenation are not among the approved uses of these devices.

The FDA released a warning in July 2018 to caution patients and health care professionals. The agency warned that the misuse of laser devices can lead to serious side effects including vaginal burns, scarring, pain during sex, and chronic or recurring pain.

“The use of energy-based devices to perform vaginal ‘rejuvenation,’ cosmetic vaginal procedures, or non-surgical vaginal procedures to treat symptoms related to menopause, urinary incontinence, or sexual function may be associated with serious adverse events,” the FDA warned. “The safety and effectiveness of energy-based devices for treatment of these conditions has not been established.”

Companies which have been marketing vaginal rejuvenation procedures include:

• Venus Concept – Venus Fiore
• BTL Industries – Ultra Femme 360
• Cynosure – Mona Lisa Touch
• Alma Lasers – FEMILIFT
• Sciton – diVA
• Thermigen – ThermiVA
• Inmode MD – FormaV, FactoraV

The FDA reportedly contacted these manufacturers with its concerns about their promotion of vaginal rejuvenation treatment. The agency notes that the contacted manufacturers have “responded with adequate corrections”. However, the FDA will reportedly continue to monitor the representations of gynecological laser devices and any adverse event reports related to the devices.

The crackdown on manufacturers’ representations reflects the FDA’s dedication to ensuring medical devices are used for approved applications. FDA Commissioner Dr. Scott Gottlieb reportedly stated that advancing women’s health is a priority for the agency, and that the agency will hold manufacturers accountable for failure to comply with regulations.

“Our most fundamental obligation to the American public is providing patients with access to safe and effective medical products to meet their health care needs as well as protecting them from harmful products and deceptive medical claims,” Gottlieb said, according to Medical News Today.

Gynecology Meets Technology

Allure published an article about vaginal rejuvenation procedures in March that said because about 40 percent of American women experience some sort of sexual dysfunction, many find hope in the term vaginal rejuvenation itself. Still, the field is so new and the studies so few, women must be careful with the number of cosmetic choices available today.

Allure explained that lasers target the vaginal tissues, basically stimulating the body’s own response to wounds. The lasers poke microscopic pinholes in the tissues of the vulva and vagina to increase collagen production, just like the lasers do to facial skin during anti-aging treatments.

When a radio-frequency device is used instead of a laser, a heating of the tissue elicits the collagen production. In theory, the treatment should increase lubrication and make vaginal walls fuller.

Allure spoke with Cheryl Iglesia, professor of obstetrics, gynecology, and urology at Georgetown University School of Medicine. She also researches the energy-based devices used in many vaginal procedures. She said research is in the infancy stages, and there need to be more long-term follow-ups of women who have undergone vaginal therapies, in addition to the use of placebo control groups, in order to create best-practice guidelines for using these energy devices on delicate vaginal tissues.

In regards to the use of lasers to promote plumping of the vaginal walls and lubrication, Iglesia told Allure that “lasers work by targeting water in tissue. If you use one to treat vaginal dryness and there’s no water to target, that could cause a burn.”