Thermigen, Inc. is accused of failing to warn about the risk of burns, scarring, pain, and other side effects of ThermiVa® vaginal rejuvenation treatments.
Thermigen ThermiVa Vaginal Rejuvenation
Thermigen, Inc. makes the ThermiVa® radio-frequency device as a painless, non-surgical treatment known as “vaginal rejuvenation.” This cosmetic procedure is advertised to tighten vaginal tissues, reduce labia size, treat incontinence, boost sexual pleasure, and more.
What is the problem?
In July 2018, Thermigen Inc. received a letter from the FDA because ThermiVa is not approved for any type of vaginal rejuvenation treatments.
FDA Letter
The FDA is concerned that women are not being warned about the safety risks of ThermiVa vaginal rejuvenation treatments. Furthermore, numerous women have reported suffering severe injuries.
“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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