WHAT’S BEING CLAIMED:
- The FDA warned companies on Monday to stop advertising that vaginal rejuvenation procedures are risk-free.
- The agency also warned doctors doing vaginal rejuvenation procedures as they were not reviewed and approved.
- The devices used in the procedure were only approved for gynecologic uses like the destruction of precancerous cervical or vaginal tissues and removal of genital warts.
Adverts for a treatment called “vaginal rejuvenation” have been flooding the internet, claiming that the treatment can reshape “undesirable” vaginas. The procedure can actually lead to serious injuries that include vaginal burns, bleeding, scarring and chronic pain.
The US Food and Drug Administration issued warning letters last week to seven companies that “inappropriately” advertise their devices and claims that vaginal rejuvenation procedures are risk-free. These companies were expected to respond within 30 days to address FDA concerns, otherwise, face enforcement actions such as mandatory recall or product seizure.
The agency also issued stern warnings to doctors against using laser, radiofrequency and energy therapies to treat sexual impairment and other problems affecting women after childbirth and menopause. Technically, the devices have been approved by the FDA, but only for gynecologic uses like destruction of precancerous cervical or vaginal tissues and removal of genital warts. They are not approved to destroy and reshape vaginal tissues as what is done in rejuvenation procedures.
“These products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed,” according to FDA Commissioner Scott Gottlieb.
Also known as “revirgination” or “G-spot amplification,” the treatment is not covered by insurance. It is also used by doctors to treat women whose cancer treatments caused them early menopause.
“The deceptive marketing of a dangerous procedure with no proven benefit, including women who have been treated for cancer is egregious,” the commissioner said.
The FDA has reviewed 29 published literature that reported burning sensations or bleeding that took three days after the procedure.
The American College of Obstetricians and Gynecologists advise doctors to be transparent with patients—letting them know about the lack of data supporting the effectiveness of these procedures and potential complications it may bring. However, internet advertisements show local doctors offering the treatments themselves.
The seven companies FDA issued notification letters to are: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen. Cynosure is a medical technology company that manufactures a device called MonaLisa Touch. Hologic Inc. a firm based in Marlborough, Massachusetts, is the parent company of Cynosure.
In a statement, the company said, “As a leader in women’s health, Hologic has a strong track record of rooting our products in science and clinical evidence so, we take the contents of this letter seriously. We will collaborate with the agency to ensure all product communications adhere to regulatory requirements.”
Source: CNBC
