The FDA Is Coming For Your Vaginal Rejuvenation Devices

FDA Commissioner Scott Gottlieb released a statement Monday detailing health risks associated with so-called “vaginal rejuvenation” devices that claim to assist with menopause, urinary incontinence, sexual function, cosmetic purposes and more.

The FDA urges those considering these procedures to note that assertions made by device manufactures—including seven the FDA has already sent warning letters to, Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and Thermigen—aren’t based on science. And because many of them work by literally lasering off vaginal tissue to destroy/reshape it, there’s a real danger of vaginal burns, laxity, atrophy, dryness, itching, scarring, pain during intercourse, pain during urination, decreased sexual sensation, chronic pain and so much more.

Gottlieb said (via Stat News):

“We are deeply concerned women are being harmed. The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious.”

The fear is that these devices are being marketed directly to the menopausal and breast cancer patients without having gone through FDA-sanctioned examinations. Because of the way these (unnecessary) medical treatments are being marketed, the women who need actual medical treatment might be more susceptible to falling for these treatments, which, again, are not based on science, but on the false assertion that all vaginas need to look the same way and require “rejuvenation.”

If you or someone you know is still interested in vaginal rejuvenation the FDA offers the following guidelines:

Be aware that the safety and effectiveness of energy-based devices to perform vaginal “rejuvenation” or cosmetic vaginal procedures has not been established.
Understand that the FDA has not cleared or approved any energy-based medical device for vaginal “rejuvenation” or vaginal cosmetic procedures, or for the treatment of vaginal symptoms related to menopause, urinary incontinence, or sexual function.
Discuss the benefits and risks of all available treatment options for vaginal symptoms with your health care provider.
If you have undergone treatment for vaginal “rejuvenation” and experienced a complication, you are encouraged to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.