FDA Warns Women That Vaginal Rejuvenation Can Trigger Pain And Burns

Enlarge  Food and Drug Administration Commissioner Scott Gottleib is not

On 30 June, FDA Commissioner Scott Gottlieb, M.D. warned against laser treatment for "vaginal rejuvenation" or other procedure with a cosmetic objective. "We are deeply concerned women are being harmed", says the FDA warning.

The FDA said "vaginal "rejuvenation" is an ill-defined term; however, it is sometimes used to describe non-surgical procedures meant to treat vaginal symptoms and/or conditions including, but not limited to: vaginal laxity; vaginal atrophy, dryness, or itching; pain during sexual intercourse; pain during urination; and decreased sexual sensation".

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

Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women's health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for "vaginal rejuvenation" [news release].

We haven't reviewed or approved these devices for use in such procedures.

"The treatment of these symptoms or conditions by applying energy-based therapies to the vagina may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain", FDA said.

"The deceptive marketing of unproven treatments may not only cause injuries, but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions", said Gottlieb, in a statement.

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Some treatments use the devices to destroy or reshape vaginal tissue, which the manufacturers say can solve some problems related to dryness or other ailments.

Be aware that the safety and effectiveness of energy-based devices to perform vaginal "rejuvenation" or cosmetic vaginal procedures have not been established. But these reports indicate these procedures can cause serious harm.

The companies targeted by the FDA on Monday were Inmode; Sciton; Alma Lasers; Thermigen; BTL Aesthetics, BTL Industries; and Cynosure.

Jane G. Mazur, a spokeswoman for Hologic Inc. whose subsidiary sells the MonaLisa Touch, said they were reviewing the FDA notice.

In addition to warning consumers, the FDA revealed that it has taken action, sending warning letters to seven companies marketing "energy-based" devices that are being used outside of their cleared or approved intended uses. If the companies fail to respond, the FDA said, it will consider next steps, which might include "potential enforcement actions". They advised healthcare providers to report any adverse effects of such unapproved procedures to the FDA Safety Information and Adverse Event Reporting program, MedWatch.

So, for women who are experiencing incontinence or painful sex as a result of menopause, the best advice is to speak to your doctor about possible procedures which do work and to avoid vaginal rejuvenation procedures until more serious testing has been done.

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