BTL Industries, Inc. is accused of marketing the Exilis Ultra 360 System® for vaginal rejuvenation treatments and failing to warn women about severe side effects.
BTL Exilis Ultra 360 Femme System
BTL Industries Inc. manufactures the Exilis ULTRA 360 System®, a non-surgical “vaginal rejuvenation” device that uses radio-frequency stimulate collagen production and tighten vaginal tissues. It is advertised for a wide range of vaginal cosmetic procedures.
What is the problem?
In July 2018, BTL Industries, Inc. received a letter from the FDA because the Exilis Ultra 360 Femme System® is not approved for any type of vaginal rejuvenation treatment, and it may have serious safety risks.
Numerous women have reported suffering severe side effects after vaginal rejuvenation treatments. The FDA is concerned because the BTL Exilis was never safety tested for vaginal cosmetic 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.”
Side Effects of Vaginal Rejuvenation
- Vaginal burns
- Pain with sexual intercourse
- Significant chronic pain
- Sexual dysfunction
- And more