MonaLisa Touch Lawsuit: FDA Warning, Cynosure Claims, Outcome

The MonaLisa Touch lawsuit is Three R LLC v. Cynosure, Inc., a proposed federal class action filed in August 2018 by a Rhode Island OB/GYN who accused Cynosure of selling the MonaLisa Touch vaginal laser on promises of treating menopause symptoms and sexual dysfunction while hiding that the FDA had never cleared the device for those uses and that the procedure carried real risks of burns, scarring, and lasting pain.

What the FDA Actually Cleared

MonaLisa Touch is a CO2 laser system designed and produced by the Italian company DEKA and distributed in the United States by Cynosure, Inc., a Massachusetts medical aesthetics company.¹ Cynosure obtained FDA 510(k) clearance for the underlying laser (the DEKA SmartXide2) in 2014.²

That clearance was broad but generic. It covered general soft-tissue surgical uses (incision, excision, ablation, vaporization, and coagulation) across specialties such as gynecology, dermatology, and plastic surgery.³ The FDA never approved or cleared the device specifically for vaginal atrophy, menopausal symptoms, urinary incontinence, or sexual dysfunction. The 510(k) pathway, which registers a device based on substantial equivalence to something already on the market, is not a formal finding of safety or effectiveness for any specific clinical use.²

What Cynosure Was Accused of Doing

According to the amended complaint and the FDA’s own letter to the company, Cynosure’s website described the device as “a simple, safe, and clinically proven laser treatment for the painful symptoms of menopause, including intimacy” and called it “the only technology for vaginal and vulvar health with over 18+ published clinical studies.”³ It also claimed the procedure had “virtually no side effects or discomfort.”⁴

The lawsuit alleged the promotion went well beyond a website. Cynosure allegedly gave doctors waiting-room DVDs, posters, and branded presentation slides selling vaginal rejuvenation, complete with patient testimonials about restored “confidence” and “sensitivity.” Sales representatives allegedly trained physicians on how to bill patients for treatment series while telling them the device carried “no risk.” None of these materials, the complaint said, mentioned the device’s actual FDA-cleared uses or admitted that vaginal rejuvenation was not among them.⁴

The Class Action

Dr. Robert A. Salk, an OB/GYN and clinical assistant professor at Women and Infants Hospital of Rhode Island who practices in Warwick through Three R LLC, filed the case on August 13, 2018 in the U.S. District Court for the District of Massachusetts.⁵ He had leased a MonaLisa Touch device at a cost exceeding $200,000.⁶

Docketed as Three R LLC v. Cynosure, Inc., Case No. 3:18-cv-30133, the suit sought certification of a nationwide class of everyone who bought or leased the MonaLisa Touch system.⁶ The core claims were:

Deceptive marketing, in that Cynosure promoted the device for vaginal rejuvenation knowing the FDA had not cleared it for that use and failed to disclose the associated health risks.
Breach of warranty, on the theory that the device was “unmerchantable” and “unfit for the particular purpose for what it was marketed and sold.”⁷
Violation of the Massachusetts Consumer Protection Act, Mass. Gen. Laws ch. 93A, through deceptive acts and misrepresentation of the device’s safety and efficacy.⁶
Economic harm, in that Dr. Salk’s practice could no longer safely use the device for the purpose Cynosure had marketed after the FDA warning yet remained on the hook for the full lease.⁵

Cynosure was the only defendant. DEKA and its Italian parent El.En. Electronic Engineering, which made the underlying laser, were not named.⁶

How the Case Ended

Cynosure filed a motion for summary judgment in February 2021. The case was terminated on April 15, 2021, with the last docket entry on May 21, 2021.⁸ The public docket contains no opinion on that motion and does not indicate whether the case ended by ruling or by settlement, and no public statement from plaintiff’s counsel fills in the resolution.

The FDA Warning Behind the Suit

The lawsuit was filed two weeks after the FDA acted publicly. On July 30, 2018, the agency issued a safety communication warning consumers and providers against using energy-based devices for “vaginal rejuvenation” or for menopause, urinary incontinence, and sexual-function symptoms, saying such devices had been linked to “numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain.”² Then-Commissioner Scott Gottlieb called the industry’s practices “deceptive marketing of a dangerous procedure with no proven benefit.”⁹

The FDA sent letters to seven manufacturers demanding evidence supporting their gynecological marketing claims. The letter to Cynosure specifically challenged the MonaLisa Touch marketing and flagged what appeared to be an unreported modification to the device’s vaginal applicator tip.³ At the time, the FDA had reviewed 14 adverse-event reports involving vaginal energy-based devices generally.¹⁰

Reported Patient Injuries

A later academic review of the FDA’s MAUDE adverse-event database through October 2019 counted 42 unique reports involving vaginal energy-based devices, with MonaLisa Touch accounting for roughly 40 percent, the largest share of any single device. About two-thirds of complaints involved pain; severe events like third-degree burns were rare but documented.¹¹ Individual reports describe severe pain during intercourse, burning throughout the vaginal canal, and what patients characterized as irreparable tissue damage. One 2022 MAUDE report involved a 56-year-old woman who underwent two MonaLisa Touch sessions for menopausal pain and reported the treatments made her condition significantly worse, resulting in a disability classification.¹²

The American College of Obstetricians and Gynecologists has stated that no laser or energy-based treatment has been FDA-approved for vaginal cosmetic surgery, and that procedures marketed for uses beyond documented clinical indications “are not medically indicated, pose substantial risk, and their safety and effectiveness have not been established.”¹³ Insurers generally treat these procedures as cosmetic and do not reimburse for them.⁹

Where Things Stand Now

MonaLisa Touch is still on the market, and Cynosure still lists it as a product, noting it is designed and produced by DEKA in Italy.¹ No vaginal energy-based device, MonaLisa Touch included, has obtained FDA approval for treating genitourinary syndrome of menopause, vaginal atrophy, or sexual dysfunction.¹⁴ A randomized controlled trial comparing MonaLisa Touch to a sham treatment in breast cancer survivors found the laser safe but showed no statistically significant benefit over placebo at six months.¹⁵ Researchers say larger sham-controlled trials are needed before drawing conclusions about effectiveness, and some multi-site trials comparing laser treatment to estrogen-based alternatives have been initiated.⁹

One boundary worth naming: Three R LLC v. Cynosure was brought by a physician-lessee over economic loss and consumer-protection violations, not by an injured patient. Patients who believe a MonaLisa Touch procedure harmed them are in a different posture from the class Dr. Salk sought to represent, and the disposition of his case does not resolve, one way or the other, whether personal-injury claims can be brought against Cynosure or a treating provider.

1
Cynosure. MonaLisa Touch Product Page
2
STAT News. The FDA Needs to Take Another Look at Laser-Based Vaginal Rejuvenation
3
U.S. Food and Drug Administration. Cynosure Inc. Letter
4
Truth in Advertising. Three R LLC v. Cynosure Amended Complaint
5
Klafter Lesser. Cynosure Press Release
6
ClassAction.org. Three R LLC v. Cynosure Inc. Complaint
7
AboutLawsuits.com. MonaLisa Touch Class Action
8
CourtListener. Three R LLC v. Cynosure Inc. Docket
9
MDEdge. FDA Warning Shines Light on Vaginal Rejuvenation
10
WRAL. Vaginal Laser Treatments Can Cause Burns and Scarring, the FDA Says
11
PubMed. Vaginal Energy-Based Devices: Characterization of Adverse Events Based on the Last Decade of MAUDE Safety Reports
12
FDA MAUDE Database. MAUDE Adverse Event Report
13
Capital BlueCross. Laser Treatment Vulvovaginal Atrophy Vaginal Rejuvenation
14
ACOG. Vaginal Laser Therapy: What Is It
15
PubMed Central. Vaginal Energy-Based Devices Review