The FDA recently warned the medical community that medical treatment products used for vaginal rejuvenation could cause serious health problems in women. The FDA stated products used to treat cosmetic issues like vaginal tightness could cause severe urethral and gynecological pain.

According to CNN, more specifically, the FDA stated vaginal rejuvenation devices that utilize lasers or radio frequency waves should not be used outside of their approved treatment purposes or patients face a risk of developing serious side effects.

While these laser and radio frequency devices have been approved to treat abnormal and early stage cancerous vaginal and cervical tissue, genital warts, and similar conditions, the FDA has not evaluated them as treatments for cosmetic gynecological treatment purposes.

“The treatment of these symptoms or conditions by applying energy-based therapies to the vagina may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain,” the FDA stated.

These devices have also not been approved to treat issues related to sexual dysfunction, including decreases sexual sensation or pain during urination or intercourse.

Overview of Vaginal Cosmetic Treatment Problems

Shape reports these vaginal cosmetic procedures involve tightening the skin and the vaginal tissue beneath the skin. During vaginal “rejuvenation”, the skin and tissue are tightened by the lasers or radio frequency waves from energy-based devices. The lasers and radio frequency waves from these devices reportedly work by reforming the designated tissue and skin.

Energy-based devices may be used for the treatment of abnormal or pre-cancerous cervical cells or vaginal tissue. The devices may also be used for the treatment of vaginal warts. However, these products have been reportedly used for various off-label purposes such as treating vaginal dryness, itching and laxity.

A number of celebrities have endorsed these procedures, including the Kardashians, Jada Pinkett-Smith, and the women of the Real Housewives. However, medical experts have stated that treatment with these lasers does not actually tighten the vagina and actually causes the tissue to scar.

As is the case with many treatments, doctors are split about whether or not these procedures should continue. Dr. Cheryl B. Iglesia, who serves as the director or female pelvic medicine and reconstructive surgery at MedStar Washington Hospital Center, told the New York Times that laser treatments have promise. However, Iglesia agrees with the FDA’s “conservative” stance that more studies are needed before marketing tactics pick up steam.

FDA Response to Vaginal “Rejuvenation”

These procedures can also be potentially dangerous for some patients. According to the FDA, patients can develop vaginal burns, scarring, painful intercourse, and chronic pain, if the devices are not handled properly or if a patient has an allergic reaction.

The FDA issued a warning regarding the risks associated with vaginal cosmetic treatment procedures on July 30, 2018, stating that patients and doctors should be wary of using energy based devices for such treatment purposes. The FDA stated that “the safety and effectiveness of energy-based devices for treatment of these conditions has not been established.”

Even though these devices were not cleared for cosmetic purposes, different manufacturers have been allegedly marketing them to women suffering from urinary incontinence, menopause problems, and sexual issues. Some treatments were reportedly even marketed to women who have finished breast cancer treatment and are suffering from early menopause symptoms.

The FDA sent letters to different companies, expressing concern that the way the companies are marketing their devices could be in violation of the Federal Food Drug and Cosmetic Act (FD&C Act). The FDA has already contacted Alma Lasers, BTL Aesthetics, BTL Industries, InMode, Cynosure, ThermiGen, and Sciton over these concerns.

Companies marketing these kinds of products 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

Patients who suffer vaginal laser rejuvenation related injuries after treatment are encouraged to report them to MedWatch, which is the FDA’s Safety Information and Adverse Event Reporting program. The FDA is also advising patients to consult their doctors if they have any concerns regarding their vaginal treatment procedure.

“Advancing the health of women is a priority for the FDA. As part of our action plan, we’re working to improve evidence generation about the safety and effectiveness of health technologies in clinical areas that are unique to women,” FDA Commissioner Scott Gottlieb said in a press announcement.

“And as part of these efforts, we also watch for, and take action against, bad actors who unfortunately take advantage of unsuspecting consumers by marketing unapproved, deceptive products that may pose safety risks and violate the trust of American consumers.”

There have already been serious injuries alleged by patients, with one woman describing her experience with the Mona Lisa Touch laser by Cynosure. According to the woman, she reportedly developed severe bladder and urethral pain just two days after her procedure.