On August 13, 2018, a lawsuit was filed against Cynosure, Inc., and moreover MonaLisa Touch marketers after the FDA released a statement warning against the products. The MonaLisa Touch lawsuit was sparked due to a public statement issued by the FDA at the end of last July, which warned the public against the use of energy-based devices to perform vaginal rejuvenation or Vaginal Cosmetic Procedures. The FDA stated that being “aware that certain device manufacturers may be inappropriately marketing their energy-based devices for the uses noted above that are outside of their cleared or approved intended uses. We have contacted these manufacturers to share our concerns and will be monitoring their claims about uses of their products.” Furthermore, The FDA also provided a link to the letters to Industry page, which disclosed a letter sent to Cynosure, Inc. in which the FDA states not being able to “identify . . . FDA clearance or approval supporting the use of the claims” on the smilemonalisa.com website (a Cynosure, Inc. website).
Furthermore, On July 31, 2018, Hologic, Inc. (HOLX) the publicly traded parent company of Cynosure, Inc. filed a press release on Form 8-K for the financial results of its third quarter of fiscal 2018. During a conference call, Stephen MacMillan (HOLX’s chairman, president and CEO) disclosed having received a FDA letter:
“Before we leave Cynosure, let me say that just yesterday we received the FDA letter regarding MonaLisa Touch, which represents less than 10% of Cynosure’s sales. We are still analyzing the FDA’s specific concerns, but acknowledge that this may create some market uncertainty around MLT in the short term. Having said that, we obviously agree that these products need to be marketed appropriately.”
HOLX’s stock dropped from a close of $42.91 on July 31, 2018, to a close of $41.43 on August 1, 2018, or -3.45%.
On August 13, 2018, HOLX filed a 8-K disclosing that it would suspend the marketing and distribution of its other product, the TempSure Vitalia handpiece, until HOLX had confirmed that they meet all regulatory requirements for devices in this category. HOLX added that “ Cynosure is also asking customers to return any Vitalia handpieces and unused probes they have purchased.” HOLX plans on recording the returns as a reduction to revenue in the Q4 of 2018.
HOLX’s stock price dropped from a close of $40.66 on August 10, 2018 to $39.02 on August 13, 2018, or -4.03%.
A full copy of the MonaLisa Touch Lawsuit is below:
Editor’s note on the MonaLisa Touch Lawsuit:
This piece is written about the recent MonaLisa Touch Lawsuit. If you are considered eligible to be among the class of consumers described in the class action, you may eventually be able to participate in receiving any compensation the court may award.
If you believe that what is alleged in the MonaLisa Touch Lawsuit has affected you, please don’t hesitate to reach out to us. We’d be happy to help you take a step in the right direction, fight this issue, and better enable you to join the consumer class action. If interested, please send an email to Outreach@ConsiderTheConsumer.com, find us on Twitter, Facebook, Instagram, LinkedIn, or even connect with us directly on our website! We look forward to hearing from all of you.
We have reached out to numerous physicians regarding this lawsuit and news. When we have updates, they will be provided here.