The U.S. Food and Drug Administration issued a warning letter to companies that perform cosmetic vaginal rejuvenation on Monday.

Vaginal rejuvenation is the process of altering the female anatomy to perform and function more effectively. It is an umbrella term used to describe non-invasive or surgical alterations to the vagina.

According to the consumer watchdog group Advocacy For Patients™ (,

“The term “vaginal rejuvenation” covers a number of different types of surgery. It is also often referred to as a kind of female genital plastic surgery, vulvovaginal plastic surgery, female genital rejuvenation surgery, designer vagina surgery, and female genital cosmetic surgery.”

The energy-based and laser treatment for more serious conditions, such as cancer, genital warts or hysterectomies, is approved by the FDA. The agency is concerned that deceptive marketing may influence women who need the surgery for severe medical conditions.

However, health care professionals have been using it for cosmetic purposes, especially among younger generations of women. Though questionable by the agency, it is legal for practitioners to use the devices for off-label use.

Women who have given birth vaginally or those undergoing menopause may experience natural complications that cause discomfort in the vaginal region.

Vaginal rejuvenation has become increasingly popular among plastic surgeons and even dermatologists who claim it can reinforce the pelvic floor, increase lubrication in the vaginal mucosa and even reshape the labia minora and majora.

Though the process is relatively new, there have already been complications from women who underwent the surgery for cosmetic purposes. Some of the side effects include pain during sex, vaginal scarring, burns and lasting pain.

FDA commissioner Dr. Scott Gottlieb said in the statement, “These products have serious risks and don’t have adequate evidence to support their use for these purposes.”

The FDA issued warning letters to Inmode, Sciton, Alma Lasers, Thermigen, BTL Aesthetics, BTL Industries, Venus Concept and Cynosure. The companies were asked to provide information on the products and under what assumption they are approved.

So far there is very little information on the amount of procedures done each year. However, the FDA has received 14 reports of adverse events from the practice of vaginal rejuvenation.