Vaginal rejuvenation has been linked to a risk of vaginal burns, chronic pain, scarring, and other devastating side effects.
What is Vaginal Rejuvenation?
Vaginal rejuvenation is a cosmetic procedure that uses lasers or other energy-based devices to treat vaginal tightness or looseness, dryness, pain during sex, urinary incontinence, and more.
FDA Concerned About Vaginal Rejuvenation
In July 2018, the FDA issued a Safety Communication to warn that none of the devices were approved or known to be safe for vaginal rejuvenation.
Furthermore, the FDA has received numerous reports of women who experienced severe side effects after vaginal rejuvenation surgery.
Types of Vaginal Rejuvenation
The following 7 companies received letters for potentially advertising lasers for unapproved vaginal rejuvenation treatments:
- Inmode MD, Inc. — (FormaV and FractoraV lasers)
- Sciton, Inc. — (JOULE Multi-Platform System for DiVa Laser Vaginal Therapy)
- Alma Lasers — (FemiLift)
- Thermigen, Inc — (THERMIva)
- BTL Industries, Inc — (Exilis Ultra 360 System)
- Cynosure, Inc — (MonaLisa Touch)
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