Following recent warnings about the risk of problems from “vaginal rejuvenation”, the makers of the MonaLisa Touch face a class action lawsuit filed by medical practices, alleging that the plastic surgery laser device was deceptively marketed and is unreasonably dangerous.
The ccomplaint (PDF) was filed against Cynosure, Inc. in the U.S. District Court for the District of Massachusetts on August 13, seeking class action status to pursue damages for all purchasers or lessors of the MonaLisa Touch laser system.
Three R, LLC of Rhode Island is the named plaintiff in the lawsuit, indicating that it continues to make lease payments for a MonaLisa Touch, which it can no longer safely use for patient treatments.
The case stems from an FDA warning issued on July 30, which advised healthcare providers not to use “energy-based devices,” such as the MonaLisa Touch, for cosmetic vaginal procedures, or procedures intended to treat conditions such as menopause, urinary incontinence or sexual function. The FDA warned that the safety and effectiveness of the devices to perform those procedures has not been established, and it may cause serious harm for patients.
Cynosure was one of seven manufacturers who previously received warning letters from the FDA, outlining the agency’s concerns and calling for them to respond.
“To date, we have not cleared or approved for marketing any energy-based devices to treat these symptoms or conditions, or any symptoms related to menopause, urinary incontinence, or sexual function,” the FDA warned. “The treatment of these symptoms or conditions by applying energy-based therapies to the vagina may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain.”
Those types of procedures, which are commonly referred to as “vaginal rejuvenation”, are exactly what the MonaLisa Touch laser device was advertised for, according to the class action lawsuit. The device, marketed to plastic surgery facilities, cost in excess of $150,000, the complaint indicates.
“[After the FDA warnings], providers could not use the MonaLisa Touch on patients because if they did so, they would subject patients to potential adverse harms and subject themselves to the possibility of substantial liability. As such, Three R LLC immediately stopped using the MonaLisa Touch,” according to the complaint. “Plaintiff continues to make lease payments for a device that cannot be safely or economically used. The device is unmerchantable and/or unfit for the particular purpose for what it was marketed and sold by Defendant.”
The lawsuit seeks compensation for financial injury suffered by Three R and other healthcare and plastic surgery facilities who purchased the MonaLisa Touch.