According to the proposed lawsuit, filed by a group of aesthetic medical centers and medical spas including Plastic Surgery Associates S.C., Infinity Spa Orlando LLC and others, the body contouring system is "effectively useless."
The complaint details claims made by Cynosure to purchasers of its SculpSure Non-Invasive Body Contouring Platform. Specifically, the plaintiffs asserts that as part of an "aggressive campaign" to get practices to purchase the relevant nearly $200,000 machine, Cynosure has made "uniform material misrepresentations regarding the key attributes" of the device, which the company markets as a way to reduce fat in a patient's midsection through laser technology.
Cynosure has claimed that patients need no pain medicine or anesthesia because SculpSure is "virtually painless," and that the procedure can be done "hands free" without a physician needing to be present, according to the complaint.
According to the clinics’ filing, SculpSure "seldom achieves results in patients after multiple treatments — much less so with just the single procedure Cynosure claimed would suffice." They allege physicians have to increase the power to such a high level just to "even have a chance at achieving results." The complaint also alleges that the procedure causes patients "intolerable pain," and the treating physicians have to remain nearby during the entire procedure in order to monitor patients' comfort as a result.
"The situation has left practices in an impossible position," the complaint states. "They have spent hundreds of thousands of dollars on a machine that does not work as Cynosure represented. At the same time, they lack the ability to recoup that cost; practices cannot continue to recommend a cosmetic procedure to their patients knowing that it is likely to involve several painful treatments, but unlikely to be effective."
Further, the plaintiffs state that SculpSure is "detrimental" to business, and that they have had to deal with complaints from unhappy patients, and that they have not been able to work with Cynosure to find a solution, according to the complaint.
The plaintiffs seek to represent all individuals and entities in the US that purchased or leased a SculpSure Non-Invasive Body Contouring Platform, and are seeking financial damages and restitution.
The plaintiffs are represented by Lauren Guth Barnes, Elizabeth A. Fegan, Mark T. Vazquez and Steve W. Berman of Hagens Berman Sobol Shapiro LLP, and David Freydin and Timothy A. Scott of Freydin Law Firm LLP.
The case is Plastic Surgery Associates S.C. et al. v. Cynosure Inc., case number 1:17-cv-11850, in the U.S. District Court for the District of Massachusetts.