The Exilis Ultra 360 System is a type of device used for “vaginal rejuvenation” to treat rhytids and wrinkles.
The Exilis Ultra 360 is manufactured by BTL Industries, Inc. and has been marketed to treat an increase in elastin and collagen in women’s intimate parts. This is known as “vaginal rejuvenation,” a procedure some women describe as a “face-lift” for their vagina.
The Exilis has been used in claims of restoring and reshaping vaginal functions. According to its website, Elixis is “proven to increase elastin and collagen in the treatment area.”
It is a non-invasive procedure that is performed in a doctor’s office with desired results being reached in a matter of days. Exilis has been marketed to correct the following troubles some women experience:
- Uneven, abnormal labia minora
- Pain and discomfort
- Odor and hygiene concerns
- Decreased sensation during sexual intercourse
- Multi-directional urine streams
- Stress incontinence
The U.S. Food and Drug Administration recently issued a letter to a handful of companies that manufacture devices used for “vaginal rejuvenation” and asked them to clarify under what clearance they were approved to treat the cosmetic procedures in “female intimate parts.”
The FDA has allowed clearance for devices like Exilis Ultra 360 to treat specific, serious conditions such as cancer or genital warts, but is not intended for cosmetic use.
Some of the potential side effects of using devices like Exilis Ultra 360 touch for vaginal rejuvenation are:
- Pain during sex
- Vaginal burns
- Recurring pain
- Chronic pain
FDA commissioner Dr. Scott Gottlieb said in a statement recently, “The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious.”
BTL Industries was given a timeline to respond to the letter from the FDA. If it does not, the agency may take further action.