MonaLisa Touch Class Action Lawsuit Filed Over Vaginal Rejuvenation Problems
Following recent warnings about the risk of problems from “vaginal rejuvenation”, the makers of the MonaLisa Touch face a class action lawsuit filed by medical practices, alleging that the plastic surgery laser device was deceptively marketed and is unreasonably dangerous.
The ccomplaint (PDF) was filed against Cynosure, Inc. in the U.S. District Court for the District of Massachusetts on August 13, seeking class action status to pursue damages for all purchasers or lessors of the MonaLisa Touch laser system.
Three R, LLC of Rhode Island is the named plaintiff in the lawsuit, indicating that it continues to make lease payments for a MonaLisa Touch, which it can no longer safely use for patient treatments.
Did You Know? Millions of Philips CPAP Machines Recalled
Philips DreamStation, CPAP and BiPAP machines sold in recent years may pose a risk of cancer, lung damage and other injuries.
Learn MoreThe case stems from an FDA warning issued on July 30, which advised healthcare providers not to use “energy-based devices,” such as the MonaLisa Touch, for cosmetic vaginal procedures, or procedures intended to treat conditions such as menopause, urinary incontinence or sexual function. The FDA warned that the safety and effectiveness of the devices to perform those procedures has not been established, and it may cause serious harm for patients.
Cynosure was one of seven manufacturers who previously received warning letters from the FDA, outlining the agency’s concerns and calling for them to respond.
“To date, we have not cleared or approved for marketing any energy-based devices to treat these symptoms or conditions, or any symptoms related to menopause, urinary incontinence, or sexual function,” the FDA warned. “The treatment of these symptoms or conditions by applying energy-based therapies to the vagina may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain.”
Those types of procedures, which are commonly referred to as “vaginal rejuvenation”, are exactly what the MonaLisa Touch laser device was advertised for, according to the class action lawsuit. The device, marketed to plastic surgery facilities, cost in excess of $150,000, the complaint indicates.
“[After the FDA warnings], providers could not use the MonaLisa Touch on patients because if they did so, they would subject patients to potential adverse harms and subject themselves to the possibility of substantial liability. As such, Three R LLC immediately stopped using the MonaLisa Touch,” according to the complaint. “Plaintiff continues to make lease payments for a device that cannot be safely or economically used. The device is unmerchantable and/or unfit for the particular purpose for what it was marketed and sold by Defendant.”
The lawsuit seeks compensation for financial injury suffered by Three R and other healthcare and plastic surgery facilities who purchased the MonaLisa Touch.
7 Comments
SarahJune 23, 2022 at 9:24 pm
I can’t believe that a medical doctor (gynecologist) performed this hellacious procedure on me. All for the sake of making money. And she was my doctor for over 20 years. She’s not my doctor any more. Unbelievably, she’s still doing this! It needs to stop!!!
RachelleMay 19, 2022 at 4:45 am
I am 46 yrs old and had 2 treatments I have no sexual feelings at all anymore. I get random stabbing pain from my vagina now. The worst thing for me is my episitomy from 26 yrs ago was hit by the laser so I have hot nerve pain from that and numbness down my leg
ColleenDecember 3, 2021 at 6:45 pm
I had This treatment, 3 to be exact , in Penticton BC 2 years ago , Ive had a heavy discharge discomfort and burning ever since , my Dr. now is running tests to try and see if there is anything that can be done , I strongly advise against this treatment , i,m in worst discomfort now , vagina dryness seems worst , I see no benefit at all .
KathleenSeptember 21, 2021 at 12:39 am
I received the MonaLisa treatment which I now regret. The GYN practice should not have given a treatment that was not FDA approved.
EnyAugust 19, 2021 at 5:52 am
Hello, I recently had the Thermiva procedure done at my GYN. In my life I have never regretted anything as much as the decision to have this procedure done. I'm 52 years old in excellent health and very athletic...well, until this. I was looking for common post -menopause relief of light incontinence and vagina dryness. I did my due diligence and could not find any negative feedback. My Dr. did w[Show More]Hello, I recently had the Thermiva procedure done at my GYN. In my life I have never regretted anything as much as the decision to have this procedure done. I'm 52 years old in excellent health and very athletic...well, until this. I was looking for common post -menopause relief of light incontinence and vagina dryness. I did my due diligence and could not find any negative feedback. My Dr. did warn me spotting can occur however, it's very rare. Well, I started spotting immediately after the procedure and within a few days bleeding which included a dark discharge of tissue. In the past four months I've had 2 UTI's, consistent abdominal pain, headaches, nausea and chills. I can't exercise or perform any extraneous activity or even have intercourse because it is painful. The quality of my life has plummeted and the fear of not knowing what I'm facing is sickening. My new GYN is trying to find the root of the problem. I am taking the time to share my negative experience so women know that there are major risks with RF Vagina procedures. Someone else's negative experience might have swayed me to not take the chance. Sadly, I did :(
GlendaApril 27, 2020 at 8:55 pm
Hi, I wish I could have had some knowledge before I did this Mona Lisa Touch. I have been suffering for close to two years now. It is terrible burn, pain and a reoccurring cut. I never know when it will leave and reappear. I have tried many of the creams prescribed by the doctor that did this procedure and to no avail. I live a very active lifestyle bike, swim ocean and pool, walk and workout[Show More]Hi, I wish I could have had some knowledge before I did this Mona Lisa Touch. I have been suffering for close to two years now. It is terrible burn, pain and a reoccurring cut. I never know when it will leave and reappear. I have tried many of the creams prescribed by the doctor that did this procedure and to no avail. I live a very active lifestyle bike, swim ocean and pool, walk and workout. It has changed my life. My sexual life has also changed drastically. I have a solid relationship for 5 years. I am a strong woman but this is a terrible thing to experience. I am in need of help and have tried to resolve this issue. I do not recommend this and warn other women . do not do this the chance that you take is not worth it.
judyJune 4, 2019 at 9:07 pm
Hello, Thank you for this. It scared me right out of signing up for the procedure! Are there testimonials I can read from women who were injured? And are there any who benefitted greatly? Thanks, Judy B Its disappointing to say the least. Can it be perfected. Who is doing that? Can I read about that?