Female genital rejuvenation techniques have been called into question by the U.S. Food and Drug Administration (FDA).

According to Medical News Today, techniques to address issues related to childbirth and menopause, such as vaginal laxity or atrophy, leading to decreases in the woman’s or her partner’s sexual satisfaction, are of primary concern due to how they are advertised to women.

These conditions can also be the cause of considerable inconvenience as incontinence or the ability to hold in a tampon during menstruation may be difficult.

While vaginal laxity and atrophy have real consequences, the FDA is concerned women may be misled by some companies’ claims regarding energy-based devices for female genital rejuvenation, a term used interchangeably with vaginal rejuvenation to encompass a host of plastic surgeries and non-surgical, device-based treatments.

What is Female Genital Rejuvenation?

As indicated by the American Society of Plastic Surgeons (ASPS), female genital or vaginal rejuvenation procedures can refer to a number of things, both cosmetic and “medical.” This treatment category includes labiaplasty, labia majoraplasty, monsplasty, clitoral hood reduction, and vaginoplasty.

Labiaplasty and labia majoraplasty are surgeries to reduce the tissues of the outer and inner tissue folds surrounding the clitoris, urethra, and vagina.

Monsplasty is a surgery used to reduce the fatty mound above the pubic bone which can become pronounced and a source of embarrassment to some women.

Clitoral hood reduction is generally done to remove excess tissue that covers the clitoris above the urethra. It is typically performed in combination with labia treatments.

Finally, and the most concerning of female genital rejuvenation techniques is vaginoplasty. Vaginoplasty is a procedure to tighten the birth canal and can involve non-invasive treatments that use radiofrequency waves or lasers.

Unfortunately, many women may not know exactly what “vaginal rejuvenation” means due to a lack of any standardized medical definition. This term reportedly does not have an associated medical insurance billing code, showing just how little information is available about these procedures.

According to a survey by Cedars-Sinai Medical Center Resident Paige Kulhmann, 82.5 percent of respondents were familiar with the term “vaginal rejuvenation,” but many had differing ideas of what it meant. Some 78 percent of respondents thought vaginal rejuvenation referred to a surgery, while the remaining 32.5 percent believed the term referred to a non-surgical procedure.

“There’s such a vast difference in what people think of when they hear the term vaginal rejuvenation,” Dr. Kuhlmann told Medscape. “It’s difficult as providers to know how to manage patient expectations.”

Non-Surgical Rejuvenation Risks

Unfortunately, some companies may be taking advantage of the lack of information by marketing laser devices for non-surgical vaginal rejuvenation.

The FDA has released a warning to women and their partners being targeted by the various sales techniques for female genital rejuvenation. A U.K. Watchdog Group issued its own warning about the marketing of such procedures.

The FDA has approved energy-based devices that produce laser beams and radiofrequency waves, but only for very specific purposes, which can include removing genital warts or pre-cancerous and cancerous growths.

The agency says these same devices are being promoted for purposes outside what has been deemed safe and can cause grave harm. Although certain pelvic reconstructive surgeries and procedures, which are sometimes referred to as “vaginal rejuvenation,” have been routinely studied and documented, the off-label uses of energy devices have not been shown to be safe or effective.

Because of the growing popularity of female genital rejuvenation treatments using these devices, there has been an uptick in the number of side effects reported to the FDA.

According to Medical News Today, vaginal burns, pain during sexual intercourse, recurrent pain, and scarring have been reported. Additionally, there is reportedly no indication that the devices accomplish what they set out to do.

While the FDA has not punished anyone for claims made in advertising, the agency has sent notices to those advertising these devices that their marketing materials may be violating the Food, Drug, and Cosmetic Act (FDCA).

According to Dr. Ajay Singla, a urologist at Massachusetts General Hospital, some physicians may receive cash reimbursements for performing vaginal rejuvenation with laser devices that are not approved for such uses. He told Medscape that the FDA “calls it a gimmick and we call it a gimmick.”

“There’s no science in it,” Dr. Singla said.

Meanwhile, many that have suffered at the hands of those making these claims have joined a class action lawsuit investigation. If you are one of these women, you may benefit from becoming part of this effort and seek compensation from device manufacturers for your medical costs and pain and suffering.