Two gynecology practices claim that they were duped into purchasing a vaginal rejuvenation laser based on misleading advertising.

Three R LLC and Obstetrical Associates Inc., gynecological practices from Rhode Island and Massachusetts respectively, claim that cosmetic laser manufacturer Cynosure mislead them and encouraged them to purchase the MonaLisa Touch product by advertising it for vaginal rejuvenation procedures. The device was reportedly represented by a sales rep as a product which “presented no risk to patients” – representations which were allegedly made during a discussion about vaginal rejuvenation.

Vaginal rejuvenation includes non-surgical procedures which are used to alter vaginal tissues for a variety of purposes. The procedures may be marketed to improve vaginal appearance and to treat vaginal conditions including dryness, itching, laxity, or atrophy. Other purposes may include the treatment of pain during sex or urination.

According to the doctors, sales reps for Cynosure also allegedly stated that the vaginal rejuvenation laser had been approved for use by the U.S. Food and Drug Administration (FDA). However, the doctors say the company failed to mention which purposes the device was approved for and left out the fact that the device was not approved for use in vaginal rejuvenation procedures.

When the FDA released a safety warning against vaginal rejuvenation in July 2018, the gynecology practices were allegedly shocked due to the representations of safety reportedly made by Cynosure.

In their warning, the FDA stated that vaginal rejuvenation laser systems are often used for the treatment of cancerous or pre-cancerous cervical or vaginal tissue and the treatment of genital warts. These devices were reportedly not approved for use in vaginal rejuvenation procedures.

“The safety and effectiveness of energy-based devices for treatment of these conditions has not been established,” the FDA said.

The FDA contacted manufacturers regarding their advertisements for these systems. Cynosure was reportedly one of the companies contacted by the agency, allegedly due to their advertising of their MonaLisa Touch device as a treatment for vaginal dryness and sexual discomfort. The company reportedly had 30 days to address the agency’s concerns with their advertising.

Six other manufacturers were also notified by the FDA regarding their vaginal rejuvenation claims, including Venus Concept (Venus Fiore), BTL Industries (Ultra Femme 360), Alma Lasers (FEMILIFT), Sciton (diVA), Thermigen (ThermiVA), and Inmode MD (FormaV and FactoraV)

Gynecology companies in the lawsuit claim that their $200,000 investment into leasing the MonaLisa Touch laser system was rendered worthless by the FDA’s announcement. They claim that they were duped by Cynosure’s advertisement and aim to hold the company accountable.

The companies were recently given leave to amend their complaint against Cynosure in a Massachusetts federal judge ruling. Cynosure claimed that the companies had plenty of time to amend their complaint since it was initially filed in August 2018, but the judge rejected their arguments that the suit could be reasonably dismissed now. The amendments to their complaint will reportedly include details from conversations with sales reps.

The Vaginal Rejuvenation Lawsuit is Three R LLC, et al. v. Cynosure Inc., Case No. 1:18-cv-30133, in the U.S. District Court for the District of Massachusetts.