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Cynosure Device Forbidden for “Vaginal Rejuvenation” by FDA Class Action

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MonaLisa Touch Machine

What should a company do if it’s under contract to lease a very expensive device and then receives an official warning not to use the device for its purposes? The complaint for this class action claims that Cynosure, Inc. has touted its MonaLisa Touch device as a “vaginal rejuvenator” but that the Food and Drug Administration (FDA) has issued a warning not to use the device for that purpose.

The class for this action is all purchasers or lessors of the MonaLisa Touch (the DEKA SmartXide Laser System or similar model) throughout the US.

The MonaLisa Touch is a laser system made by Cynosure, and it does have FDA approval. The FDA said that the device was approved “for incision, excision, ablation, vaporization and coagulation of soft body tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopedics, general and thorasic surgery … dental and oral surgery and genitourinary surgery.”

However, the complaint claims that these aren’t the purposes for which Cynosure markets the device. The complaint quotes the company’s website as marketing it for vaginal rejuvenation, saying that it is a “treatment that renews intimacy and changes lives” and a “treatment for the painful symptoms of menopause, including intimacy.”

The complaint also quotes from a testimonial that clearly presents the treatment as being related to intimacy and not to any surgical procedures. According to the complaint, the website had other testimonials on its homepage which were taken down on or about August 10, 2018.

However, the device was not approved for this use, the complaint says. On July 30, the FDA announced that it had warned several companies to stop marketing such laser devices for this use: “These products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed.”

It also said that “the safety and effectiveness of these devices hasn’t been evaluated or confirmed by the FDA for ‘vaginal rejuvenation.’” Companies had been engaging in “deceptive marketing of a dangerous procedure with no proven benefit,” it said, adding that the process could lead to “burns, scarring, pain during sexual intercourse, and recurring/chronic pain.”

Plaintiff Three R, LLC has a lease-to-buy contract on a MonaLisa Touch device for vaginal rejuvenation. The aggregate payments will come to over $200,000. However, when Cynosure sent out a letter advising of the FDA warning, Three R felt it could no longer safely use the device.

The complaint claims that the device is not usable for the purpose for which it was marketed. It claims violation of Massachusetts and other state laws forbidding deceptive acts or practices and also breach of implied warranty of merchantability and fitness for a particular purpose.

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