ThermiVa Vaginal Rejuvenation Lawsuit
ThermiVa is a type of device used in procedures some women undergo in order to address complications they have in their most intimate of regions.
ThermiVa is a non-invasive, non-hormonal treatment that uses controlled radiofrequency energy to gently heat tissue, with little to no discomfort and no downtime. It has been marked by its manufacturer as a “vaginal rejuvenation” procedure.
“Vaginal rejuvenation” is a term used to describe non-surgical procedures women have in their most intimate of regions. Usually involving discomfort due to vaginal dryness, pain during sex, incontinence or laxity. Vaginal rejuvenation procedures are also used to correct urinary incontinence, infections (vaginitis) and excess pigmentation and discoloration.
The U.S. Food and Drug Administration recently issued letters to a handful of companies that manufacture devices marketed for vaginal rejuvenation. Though the FDA has cleared the devices to be used on women with severe complications, such as genital warts or cancer, the agency has not approved or cleared the devices for more “cosmetic” procedures.
The manufacturer of ThermiVa, Thermigen, Inc., was issued one such letter. “We have conducted a review of our files and are unable to identify an additional Food and Drug Administration (FDA) clearance or approval supporting the “vaginal rejuvenation” claims located on the website,” the letter said.
Furthermore, the agency said, “The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious.”
The side effects of vaginal rejuvenation can include:
- Pain during sex
- Vaginal burns
- Recurring pain
- Chronic pain