Cynosure Inc. is accused of failing to warn women about the risk of burns, pain, scarring, and other side effects of the MonaLisa Touch® for vaginal rejuvenation treatments.
Cynosure MonaLisa Touch
Cynosure, Inc. manufactures the MonaLisa Touch® device for vaginal rejuvenation. The treatment is advertised to reshape the vagina and tighten vaginal tissues using a laser.
What is the problem?
In July 2018, Cynosure Inc. received a letter from the FDA because the MonaLisa Touch® is not approved for any type of vaginal rejuvenation treatment.
FDA Letter
The FDA was concerned because numerous women have reported suffering severe side effects after vaginal rejuvenation. Furthermore, the MonaLisa Touch has never been tested for safety for these uses.
“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
- Scars
- Pain with sexual intercourse
- Significant chronic pain
- Dryness
- Numbness
- Sexual dysfunction
- And more
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