Safety warning for ‘final frontier’

Energy-based devices don’t have FDA approval for cosmetic vaginal procedures.

It is perhaps the last frontier in the push for total body rejuvenation after skin, faces, necks, breasts, tummies, arms, and legs with all manner of nips, tucks, injections, lasers, other light-based devices, freezing, radio waves, and more. What is the final frontier? The vagina.

When women reach menopause, hormonal changes that accompany this affect many areas of the body and mind. Gone is the annoying monthly cycle, cramps, concern over an unplanned pregnancy, and the roller coaster of premenstrual syndrome. In their place, women deal with loss of bone substance, increased risk of heart disease, and annoying problems like vaginal dryness.

With the loss of estrogen, a hallmark of menopause, the lining of the vagina undergoes atrophic changes. Natural vaginal lubrication decreases, leaving irritation, itching, bleeding, and painful intercourse. There is oral estrogen hormone replacement and topical hormone creams and tablets used intravaginally that help restore the surface lining of the vagina. Estrogen therapy is not without risks, however. Post-menopausal women taking hormone replacement are at increased risk of uterine cancer, breast cancer, heart disease, strokes, and dementia. It is important to take the lowest dose of estrogen possible and be closely monitored by a gynecologist.

Recently, several companies began offering energy-based devices for cosmetic vaginal rejuvenation. These include lasers and high-frequency radio waves. Energy-based devices to treat vaginal conditions are not new. They’ve been used for years for conditions such as pre-cancerous lesions of the vagina and cervix and genital warts. What is new is the marketing of these for “cosmetic” purposes, to treat vaginal laxity, dryness, itching, painful intercourse, and decreased sexual sensation.

The popularity of these devices has exploded. All sorts of practitioners are offering vaginal rejuvenation. In addition to gynecologists, there are urologists, family practitioners, plastic surgeons, dermatologists, internists, and even medical spas. The ads make it seem like a safe, surefire way to turn back the clock, vaginally speaking, and reverse those undesirable changes. The truth is a little different.

There’s no question these devices can effect changes in the vaginal lining. The question really is, are they beneficial, reliable, or safe? The honest answer is: we don’t know. We live in an age when the promises of technology often outpace reality. However, doesn’t stop companies marketing products or medical providers using them only to discover they don’t work, don’t work very well, or are actually dangerous.

I have seen this multiple times in my career. Who remembers endermologie, laser face-lifts, face-lifts with barbed threads, and endoscopic carpal tunnel surgery, among other procedures that achieved high market penetration but disappear in a few years?

The Food and Drug Administration published a safety communication in July 2018 warning against the use of energy-based devices for vaginal rejuvenation (fda.gov/medicaldevices/safety/alertsandnotices/ucm615013.htm). It turns out the safety and effectiveness of these devices for this purpose have not been established. Women have suffered burns, scarring, chronic/recurring pain, and painful intercourse. The latter is, ironically, a problem these devices should correct.

While energy-based vaginal devices have FDA approval for treatment of the specific conditions I mentioned earlier, they do not have approval for cosmetic use. Women are well-advised to heed this warning, ignore the marketing hype, and steer clear of energy-based devices for cosmetic vaginal procedures at this time.

About the writer

Dr. Richard T. Bosshardt graduated from the University of Miami School of Medicine in 1978. He founded Bosshardt & Marzek Plastic Surgery Associates, Lake County’s first practice to provide full-time cosmetic and reconstructive plastic surgery services, in 1989.