FDA Warns Women That Vaginal Rejuvenation Can Trigger Pain And Burns


More and more women undergo vaginal rejuvenation procedure without being aware of the risks involved when unapproved devices are used.

The Food and Drug Administration warned against the use of energy-based devices for the procedure or other cosmetic interventions, saying that such treatments could lead to vaginal burns, scarring, and chronic pain.

FDA also said that it has approved such devices which commonly use beams and radio frequencies for specific gynecologic uses including the destruction of precancerous cervical or vaginal tissue and also the removal of genital warts.

But, they highlighted the fact that it did not clear the devices for symptoms related to menopause, urinary incontinence or sexual function.

The FDA also noted in a safety alert that vaginal rejuvenation is often used to describe nonsurgical procedures that are intended to treat symptoms such as vaginal laxity, atrophy or dryness, and pain during urination, among others.

During menopause, the levels of estrogen in a woman’s body decrease and this may lead to symptoms such as the ones mentioned above and pain during sexual intercourse.

More and more manufacturers are marketing devices for unapproved uses

Scott Gottlieb, a commissioner of the FDA, recently stated that a growing number of manufacturers are marketing their devices for unapproved uses such a vaginal rejuvenation.

During the procedure, the tissue is destroyed or reshaped. He also said that officials have found “numerous cases” of serious harm.

FDA has recently notified seven such manufacturers expressing high concern about the inappropriate marketing and requested that they respond within 30 days.

If the FDA’s concerns are not addressed, the agency said that they will consider potential enforcement actions.

The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious,” the commissioner said.

One such company that received a letter from FDA is Cynosure, which manufactures a device called MonaLisa Touch. On the company’s official website, you can read the following:

“During a treatment, a vaginal probe is inserted into the patient’s vagina, and delivers gentle, virtually painless laser energy to the vaginal wall, stimulating a healing response.”

They recommend three, five-minute treatments over 18 weeks and says there are “virtually no side effects.”


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