Lawsuit Mona Lisa Touch

Mona Lisa Touch Lawsuit

Cynosure Inc., the medical aesthetics company, is facing fraudulent marketing charges. The complaint pertains to Cynosure’s laser-based MonaLisa Touch gynecological equipment.

The lawsuit claims that the device’s benefits and applications were misrepresented due to FDA approval problems. The plaintiffs suffered financial losses because Cynosure deceived them regarding the FDA approvals of the MonaLisa Touch.

The lawsuit was revised in October 2018 but is still ongoing.

Mona Lisa Touch Lawsuit Details

The company is accused of promoting the MonaLisa Touch laser for vaginal rejuvenation despite a lack of FDA approval for this specific purpose.

The case, initially filed in August 2018 and amended two months later, brings to light concerns about unanticipated charges related to the usage of the MonaLisa Touch system. Consumers allegedly weren’t prepared for these costs, which adds another layer to the lawsuit.

Moreover, the lawsuit highlights the risks associated with the MonaLisa Touch device. It’s claimed that the use of this laser system for vaginal rejuvenation presents unforeseen health hazards. This is especially concerning considering the FDA’s lack of approval for such use.

Parties involved

  1. Cynosure, Inc.: This corporation manufactured the MonaLisa Touch, a laser system that’s now under scrutiny. As the company facing the lawsuit, they’re at the heart of the issue.
  2. Class Action Plaintiffs: These are the individuals who used the MonaLisa Touch system and are now seeking compensation. They assert that Cynosure’s marketing misled them.
  3. FDA: The Food and Drug Administration’s role is critical, as it’s alleged that Cynosure didn’t obtain FDA approval for the system’s intended uses. This is a major point in the plaintiffs’ argument.
  4. Consumers: Lastly, there are the consumers who underwent the treatment and experienced surprise charges. They may not be directly involved in the lawsuit, but their experiences are central to the case.

The cause of action

We find allegations against Cynosure, Inc. for deceptive marketing practices and concerns about the laser system’s risks. The crux of the issue lies in the company’s alleged misleading advertising, which promoted the laser system in ways not supported by the FDA.

The FDA issued a public notice highlighting that the MonaLisa Touch laser system isn’t approved for the uses advertised by Cynosure. These deceptive marketing practices led to the initiation of a class-action lawsuit, as the company’s claims didn’t align with the product’s FDA-authorized uses.

Consumers believed they were receiving a safe and effective treatment. However, some individuals have reported experiencing discomfort and severe vaginal burns post-procedure, adding further fuel to the lawsuit. The reported physical harm raises questions about the product’s safety, especially considering the lack of FDA approval for the stated uses.

Relief being sought

  1. Compensation for Deceptive Marketing Practices: The plaintiffs believe that the company used deceptive marketing to promote the device. They argue that it was marketed for purposes of vaginal rejuvenation without approval from the FDA Commissioner.
  2. Surprise Charges: The lawsuit alleges that consumers weren’t informed about the potential costs associated with the MonaLisa Touch procedures. They’re seeking a refund for these unexpected expenses.
  3. Recognition of Adverse Events: The lawsuit highlights the risks associated with the MonaLisa Touch laser system. It alleges that the company didn’t properly warn consumers about the potential for adverse events affecting vaginal tissue.
  4. Amendments to Marketing Claims: Lastly, the class action lawsuit demands that the company correct its marketing claims about the device.

Key events and timeline

Here is the sequence of events that led to the class-action lawsuit against Cynosure, Inc., beginning with the initial complaint filed in August 2018. The lawsuit revolved around the MonaLisa Touch, a device developed by Cynosure, with allegations of deceptive marketing practices.

The story began when unsuspecting consumers purchased the MonaLisa Touch product, expecting it to deliver as advertised. However, they were greeted with surprise charges that accumulated from the treatment. This led to a surge in consumer complaints and began to raise suspicions about the product’s FDA approval status.

Further investigations revealed that the FDA hadn’t approved the MonaLisa Touch for its intended uses. This critical piece of information had been hidden in the marketing materials, making the consumers believe they were receiving an FDA-approved treatment.

As awareness about the issue grew, a class-action lawsuit was filed in August 2018. The original complaint was then amended in October of the same year.

Key arguments

  1. Deceptive Marketing: The class-action lawsuit alleges that Cynosure, Inc. used misleading and untruthful promotional strategies. These deceptive marketing practices led consumers to believe that the MonaLisa Touch system was safer and more effective than it was.
  2. FDA Non-Approval: The lawsuit highlights the fact that the MonaLisa Touch wasn’t FDA-approved for its marketed uses. This non-disclosure of the FDA’s non-approval status was a significant part of the company’s deceptive practices.
  3. Surprise Charges: The consumer complaints include unexpected fees associated with the use of the MonaLisa Touch system. These surprise charges added to the financial burden of the consumers, who were already misled about the product’s effectiveness.
  4. Risky Side-effects: Consumers weren’t fully informed about the potential risks and side-effects associated with the use of the MonaLisa Touch system. This lack of transparency further contributed to the company’s deceptive practices.

Current status

In the current situation, the law firm Schmidt Firm, PLLC, has stopped accepting cases related to MonaLisa Touch vaginal rejuvenation.

However, the U.S. Food and Drug Administration has raised concerns about the safety and effectiveness of the MonaLisa Touch, along with other similar brands. The main issue stems from reports of severe side effects experienced by some users. It’s not just about discomfort or mild reactions; the consequences are serious enough to warrant legal action. This has naturally led to a notable decrease in faith in the product.

The decision of the Schmidt Firm, a law firm that once handled MonaLisa Touch cases, to stop accepting any more lawsuits is a significant development. It reflects the ongoing apprehensions about the device’s safety.

Lawsuit Mona Lisa Touch


To paint a clearer picture, let’s consider these implications:

  1. The lawsuit shows the repercussions of deceptive marketing practices. Companies must ensure their advertising isn’t misleading, or they risk legal consequences.
  2. It highlights the significance of FDA approval. Non-approval for intended purposes can lead to lawsuits, damaging a company’s reputation and bottom line.
  3. This class-action lawsuit demonstrates the power of consumer complaints. When consumers voice their concerns, it can lead to significant legal action.
  4. The lawsuit emphasizes the need for transparency in healthcare. Patients must have accurate information about the potential risks and benefits of medical devices.

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