The FDA is warning against the use of lasers and other energy-based procedures for vaginal rejuvenation due to the risk of serious burns, scarring, and chronic pain.
What is the Problem?
The problem is that lasers and other energy-based devices are not approved for any type of vaginal rejuvenation. Federal law prohibits companies from marketing medical devices for unapproved purposes.
Side Effects of Vaginal Rejuvenation Surgery
- Vaginal burns
- Dryness
- Scarring
- Pain with sexual intercourse
- Bleeding
- Infection
- Significant chronic pain
- Adhesions
- Numbness or loss of sensation
What is the Problem?
In July 2018, the FDA issued a Safety Communication to warn that vaginal rejuvenation poses serous safety risks. Furthermore, it is being deceptively advertised for unapproved uses.
In July 2018, FDA commissioner Dr. Scott Gottlieb warned:
“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.”
What is Vaginal Rejuvenation Surgery?
Vaginal rejuvenation is advertised for women with vaginal tightness or looseness, dryness, urinary incontinence, or pain during sexual intercourse. Surgeons use a laser, radiofrequency waves, cryotherapy, or other devices to tighten vaginal tissues.
FDA Concerned About Deceptive Advertising
The FDA sent letters to the following 7 companies for possibly promoting their devices for unapproved 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)
Other Names for Vaginal Rejuvenation Surgery
- Cosmetic gynecology
- Re-virgination
- G-spot amplification
- Female genital plastic surgery
- Female genital rejuvenation surgery
- Vulvovaginal plastic surgery
- Designer vagina surgery
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