A new class action lawsuit accuses Cynosure of deceptively marketing its MonaLisa Touch laser device for vaginal rejuvenation.
The complaint, which was filed in the U.S. District Court, District of Massachusetts, on August 13th, seeks to represent medical practitioners who purchased or leased the plastic surgery laser to treat vaginal conditions associated with menopause, urinary incontinence or sexual function, including:
Cynosure was one of more than a half dozen companies that were warned by the U.S. Food & Drug Administration (FDA) regarding the marketing of energy-based devices for use in so-called vaginal rejuvenation procedures.
The agency also advised doctors not to use devices like the MonaLisa Touch laser for vaginal rejuvenation, including procedures referred to as “designer vaginoplasty,” “revirgination” or “G-spot amplification”.
“These products have serious risks and don’t have adequate evidence to support their use for these purposes,” the FDA commissioner said in a statement dated July 30th. “We are deeply concerned women are being harmed.”
Complications reported to the agency in relation to vaginal rejuvenation devices include:
Of note, lasers and other energy-based devices have never been approved by the FDA for vaginal rejuvenation, and were only approved for the treatment of abnormal or precancerous cervical or vaginal tissue, genital warts, and other serious conditions.
According to the vaginal rejuvenation lawsuit filed against Cynosure by Three R LLC, a plastic surgery practice based in Rhode Island, devices like the MonaLisa Touch sell for upwards of $150,000. Among other things, the complaint claims that the pricey laser is unreasonably dangerous and cannot be used for its advertised purpose.
“Plaintiff Three R LLC has suffered economic injury directly as a result of Cynosure’s false and deceptive marketing scheme. Plaintiff has, for two years, been making payments on a lease to purchase a MonaLisa Touch for purposes of treating vaginal atrophy,” the lawsuit states. “The aggregate lease payments exceed $200,000. In light of the July 30, 2018 FDA Warning, Three R LLC can no longer use the MonaLisa Touch unit, although payments on the unit remain due.”
The lawsuit seeks damages for breach of the implied warranty of merchantability and fitness for a particular purpose, as well as violation of Massachusetts’ Consumer Protection Act, and/or other similar laws in effect in other states. (Case 3:18-cv-30133)