Inmode MD, Inc. is accused of failing to warn women about severe side effects of the FormaV and FractoraV Lasers for vaginal rejuvenation treatment.
Vaginal Rejuvenation Lasers
Inmode MD advertises lasers for vaginal rejuvenation treatments. The device utilizes two different hand-held wands:
- FormaV — This device is used inside the vagina to increase collagen levels, tighten loose vaginal tissues, and eliminate protrusion of the labia minora
- FractoraV — This device is used outside the vagina to resurface the labia majora, remove wrinkles, and enhance the production of collagen
What is the Problem?
The FDA never approved the FormaV or FractoraV devices for vaginal rejuvenation. Even so, Inmode MD is accused of advertising them as an FDA-approved cosmetic procedure for a wide variety of treatments, such as incontinence, sexual dysfunction, or pain during sexual intercourse. These problem is that women are not being warned about severe side effects and these devices are not known to be safe.
FDA Letter
In July 2018, InMode MD received a letter from the FDA for potentially failing to warn about side effects of the FormaV or FractoraV devices and advertising them for unapproved vaginal rejuvenation treatments.
Vaginal Rejuvenation Side Effects
- Vaginal burns
- Scarring
- Pain with sexual intercourse
- Bleeding
- Infection
- Significant chronic pain
- Dryness
- Adhesions
- Numbness or loss of sensation
- And more
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