Vaginal Rejuvenation Lawsuit
On July 30, 2018, the U.S. Food & Drug Administration (FDA) issued a letter to manufacturers of vaginal laser and energy-based gynecological devices stating that the agency has become aware the devices are being used in an “off-label” fashion and putting women’s health at risk. The lasers are being promoted for “Vaginal Rejuvenation.”
We’ve recently become aware of a growing number of manufacturers marketing “vaginal rejuvenation” devices to women and claiming these procedures will treat conditions and symptoms related to menopause, urinary incontinence or sexual function. The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue. 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.
The FDA approved the use of these devices to treat serious medical conditions such as the destruction of abnormal or pre-cancerous cervical or vaginal tissue, as well as condylomas (genital warts). The FDA has not approved the use of these medical devices for Vaginal Rejuvenation procedures.
FDA Warning Letters to Vaginal Rejuvenation Procedure Device Manufacturers
MonaLisa Touch Complications – One of the letters released Monday went to Massachusetts-based Cynosure Inc., which sells a laser system called MonaLisa Touch. According to the letter, the product is approved for incision and vaporization of soft tissue, but it has been improperly promoted as a “clinically proven laser treatment for the painful symptoms of menopause, including intimacy.”
Learn More: Monalisa Touch Laser Vaginal Rejuvenation Lawsuit
FemiLift Complications – Another letter released Monday went to Illinois-based Alma Lasers, which sells a laser system called FemiLift. According to the letter, the product is approved for soft-tissue treatment, but it has been improperly promoted to “improve vaginal irregularities.”
Learn More: FemiLift Laser Vaginal Rejuvenation Lawsuit
Exilis Ultra 360 System Complications – This letter released Monday went to Marlborough, Massachusets based BTL Industries that manufacturers the Exilis Ultra 360 System, also known as the Ultra Femme 360. The product is approved for treatment of dermatologic and general surgical procedures for non-invasive treatment of wrinkles and rhytids but has been improperly marketed as being able to increase elastin and collagen to women’s intimate parts.
Learn More: Exilis Ultra 360 Vaginal Rejuvenation Lawsuit
FormaV and FractoraV Laser Complications – In another shocking discovery of yet another Israeli based company, the FDA in its letter cited the fact that Inmode MD Ltd. was marketing an unapproved medical device in the United States. The FormaV and FractoraV lasers are being for the therapeutic use in the treatment of sexual dysfunction, vaginal rejuvenation, and urinary stress incontinence.
Learn More: FormaV and FractoraV Vaginal Rejuvenation Lawsuit
JOULE Multi-Platform System & DiVa Laser Vaginal Therapy, aka diVaTyte Complications – In this letter, the FDA cited that it had cleared the JOULE device, made by Palo Alto, CA-based Sciton, Inc. as a laser/light powered device for multiple general uses but it had not approved the DiVa Laser Vaginal Therapy.
Learn More: DiVa Laser Vaginal Rejuvenation Lawsuit
THERMIva Complications – In the last letter to Texas-based Thermigen Inc., the FDA cited that the product was only approved for use in dermatological and general surgical procedures for electrocoagulation and hemostasis and to create lesions in nervous tissue when used in combination with Neuro Therm (previously Smith&Nephew) thermal/coagulation probes. The THERMIva device was not approved for the use in vaginal rejuvenation procedures.
Learn More: ThermiVa Vaginal Rejuvenation Lawsuit
Vaginal Rejuvenation Complications
The safety of the lasers being used in Vaginal Rejuvenation procedures has not been evaluated. In fact, after the FDA reviewed adverse event reports and published literature, they found numerous cases of:
- vaginal burns,
- pain during sexual intercourse, and
- recurring or chronic pain.