FDA issues warning against laser and energy-based “vaginal rejuvenation” procedures

Despite their sudden hype and growing popularity, there is no evidence that so-called “vaginal rejuvenation” therapies are either safe or effective, the U.S. Food and Drug Administration warns in a statement today.

The procedures which use energy-based devices—laser and radiofrequency waves both, to reshape and firm the vaginal tissue claim to treat many genitourinary conditions like urinary incontinence, vaginal atrophy, and dyspareunia.

In addition to treating the above conditions, manufactures and healthcare provider also assert that it improves the sex lives of perimenopausal and menopausal women.

In the statement released on Monday FDA Commissioner, Dr. Scott Gottlieb stated, “These products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed.” 

The procedures are known to cause vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain. The full extent of damage is not recognized as the devices have not been approved for “vaginal rejuvenation.”

FDA has approved and cleared these procedures for destruction of precancerous lesions of cervix and vagina and vaporization of condylomas (genital warts). But the safety and effectiveness of these devices haven’t been studied and confirmed for “vaginal rejuvenation.”

In some cases, women who have undergone treatment for breast cancer are offered these treatments under the false assertion of mitigating their symptoms of early menopause.

FDA has recently notified seven device manufacturers for concerns about the inappropriate marketing of their devices for “vaginal rejuvenation” procedures. They are Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and Thermigen.

They have 30 days to address the FDA's concerns, and if they fail to do so, FDA may consider enforcement measures.

The deceptive marketing of unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions," Dr. Gottlieb said.

"These products may be particularly appealing to women who may not be candidates for certain FDA-approved treatments to relieve vaginal dryness, and thus are seeking alternative, non-hormonal options," he explained.

He further advised, "Women considering treatment for vaginal symptoms should speak to their doctor about the potential and known benefits and risks of all available treatment options."

Dr. Gottlieb further assured that FDA will carefully monitor reports of problems associated with "vaginal rejuvenation" procedures and will keep the public informed.

He urged that patients who have suffered adverse effects with the use of these devices should report the complications to  MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Dr. Vanessa Mackay, from the UK's Royal College of Obstetricians and Gynaecologists (RCOG), said: "There is no evidence to suggest that non-surgical 'vaginal rejuvenation' devices are effective in improving vaginal muscle tone or reshaping vaginal tissue. If women are concerned about the appearance or feel of their vagina, they should speak to a healthcare professional. It is important to remember, however, that every woman's vagina is different. Labia are as individual as women themselves and vary in appearance and color.

"To strengthen the muscles around the vagina, women are encouraged to try pelvic floor exercises which can help to improve muscle tone and sensitivity during sex."

FDA Statement

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