Vaginal Rejuvenation: FDA Cautions About Elective Procedures

By Deborah Jeanne Sergeant


Childbirth, menopause and the passage of time can affect both the appearance and function of women’s vaginal tissues. For some, dryness and lax tissue make intercourse less pleasurable and even painful.

Some health care providers, including gynecologists, dermatologists and plastic surgeons, now offer non-surgical treatments to restore both vaginal moisture and tightness.

In July, the FDA issued a cautionary statement about providers using energy-based devices for elective vaginal procedures. The FDA statement read that “the safety and effectiveness of energy-based devices for treatment of these conditions has not been established” and that “non-surgical vaginal procedures to treat symptoms related to menopause, urinary incontinence, or sexual function may be associated with serious adverse events.”

The FDA has approved energy-based devices — radiofrequency or laser — for dermatological and general purposes, including removal of genital warts, growths or pre-cancerous tissue. The FDA has not specifically approved some of these devices for vaginal procedures. It states that using the devices for cosmetic reasons may cause “vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain.”

Robert A. Jason, board-certified gynecologist and cosmetic gynecologist, believes that the FDA statement has caused a great deal of confusion, though there’s merit in warning women to approach vaginal rejuvenation carefully.

“They should go to a gynecologist who understands the benefits and pros and cons of non-invasive vaginal rejuvenation equipment,” Jason said.

Jason serves as medical director and owns the Laser Vaginal Rejuvenation Institute of New York, in New York City and Lake Success on Long Island.

He said that vaginal rejuvenation procedures such as Vaginoplasty and ThermiVa should be overseen by a gynecologist or cosmetic gynecologist physician in charge.

Patients should also maintain realistic expectations. Women seeking tighter tissue, for example, should understand that non-invasive procedures may not offer the tightness they want.

Jason said that he and other gynecologists use certain lasers or radiofrequency devices as a scalpel or knife. He added that there are also other lasers and radiofrequency devices on the market that are used as non-invasive, non-surgical devices that gynecologic and non-gynecological physicians use for non-invasive vaginal rejuvenation.

“That is the confusing part,” Jason said. “After careful examination, if the right candidate uses non-invasive procedures, myself as well as many colleagues across the country have had excellent results, over 90 percent success rates.

“The problem is that when women need more involved surgical repairs, their expectations were not met and that non-invasive procedures done by offices not well-versed in vaginal health, can have less-than desired or harmful results.”

He said that many women had procedures that were not appropriate for them and were hurt, prompting the FDA’s warning.

“To truly put this in prospective, laser hair removal in the wrong person’s hands can cause burns and harmful results also,” Jason added.

Joyce Farah, board-certified dermatologist and fellow of the American Academy of Dermatology, is an assistant professor of Medicine at SUNY Upstate Medical University and in private practice at Farah Dermatology in Syracuse.

She said that the devices her office uses were not listed among those criticized by the FDA.

“Any time you do use a heat source, there is a potential to get a burn or blister,” she said. “If devices are used within the parameters of how it should be used, it’s fine. We have encountered no problems.”

Any woman seeking vaginal rejuvenation must present clearance from her gynecologist or Farah won’t offer the procedure.

“We want to make sure that they don’t have any contraindications like an infection and that they’re good candidates,” Farah said. “We’re one of the few that does this, from what I understand.”