Class Action: Cynosure Deceptively Marketed MonaLisa Touch Laser System for Procedures Not Approved by FDA

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Cynosure, Inc. has been hit with a proposed class action lawsuit filed by a Rhode Island OBGYN that alleges the company was not upfront about both the supposed health benefits and risks associated with its “vaginal rejuvenation” laser device.

The 17-page complaint explains that “vaginal rejuvenation” procedures are touted as being helpful in treating conditions and symptoms related to menopause, urinary continence or sexual function. Such procedures, the case says, utilize lasers or similar energy-harnessing devices to “destroy or reshape” vaginal tissue. But according to FDA Commissioner Dr. Scott Gottlieb, “vaginal rejuvenation” procedures, as well as the devices used on women, pose serious health risks and lack adequate evidence to support claims about their efficacy.

“We are deeply concerned women are being harmed,” Gottlieb said in a July 30, 2018, FDA statement.

While the FDA had given the green light to certain vaginal-based laser treatments, the agency, according to the suit, made clear that it had not confirmed the safety or effectiveness of laser devices for the purposes of “vaginal rejuvenation.” Despite the absence of the FDA’s seal of approval and amid concerns about the laser devices’ safety, companies have continued to make and sell such products without being forthright about the serious health risks involved, the lawsuit says.

The plaintiff charges that defendant Cynosure, the maker of the MonaLisa Touch laser system, is among a handful of offenders who have engaged in the deceptive marketing of a potentially dangerous product. From the complaint (emphasis ours):

“[Cynosure] has unabashedly marketed and sold its MonaLisa Touch laser system as a vaginal rejuvenation device with promises that it will increase intimacy and improve sexual function – which, as the FDA can hardly have been clearer – are purposes for which it was not approved by the FDA and for which use there is no proven benefit. The MonaLisa Touch is a most expensive device – costing doctors and health practices $150,000 or more.”

The plaintiff claims that while it’s been making lease payments on the defendant’s laser product for the last two years, the MonaLisa Touch device can no longer be used on patients.