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.
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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.
17 Comments
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GarlaMay 23, 2023 at 11:40 pm
I am so sorry to hear all of you ladies have gone through such hell, I too had 2 mins Lisa treatments am have nothing but pain , still experiencing frequent urination and at this time can not have intimacy with my husband . These procedures should be shut down . Take care . Hopefully there will be some help for all of us .
TammyMay 15, 2023 at 2:11 pm
DON'T Have monalisa procedure!!!! I had it done and I am so sorry. I thought I had a yeast infection so I went to the Dr. After talking with him and being examined he suggested I try MonaLisa laser treatment. I had the one procedure done, it was uncomfortable but i was able to deal with it because It was going to solve my dryness and the itch. After a few week I went for the second treatment wh[Show More]DON'T Have monalisa procedure!!!! I had it done and I am so sorry. I thought I had a yeast infection so I went to the Dr. After talking with him and being examined he suggested I try MonaLisa laser treatment. I had the one procedure done, it was uncomfortable but i was able to deal with it because It was going to solve my dryness and the itch. After a few week I went for the second treatment which could not be done because my vagina closed. I am going through hell now trying to get it opened. This Dr. sent me to a specialist because he was stumped. I have tried numerous creams and many different tests including CT. I am not ready to give up my sex life so I will probably have to have surgery to have it opened again.
DarleneJanuary 16, 2023 at 8:08 pm
I had the Mona Lisa treatment on Thursday of last week , I was told it was painless and that I could return back to work that same day ... I must say that it was a big lie .. I was in so much pain ...and I came across this while searching for a answer to my questions .. I have been home sick and severely depressed and the cost was 1800. Per treatment .. I have developed a severe itching [Show More]I had the Mona Lisa treatment on Thursday of last week , I was told it was painless and that I could return back to work that same day ... I must say that it was a big lie .. I was in so much pain ...and I came across this while searching for a answer to my questions .. I have been home sick and severely depressed and the cost was 1800. Per treatment .. I have developed a severe itching in both my arm pits , and as for helping my vaginal problems , well that's a bunch of BS ... I feel burnt inside as if I have a hot sauce drip installed .. a constant burning ... and the pain ..so intense ... And I only had 1 treatment done .. I will not return for the other 11 treatments .. This should be outlawed ..I have had 3 bladder mesh . And one mesh removed .. I now have what the Vanderbilt urologist call .. MESH POISON.. also had 3 bladder stimulating device's .. all of which would not shut off .. called Med Tronics device's .. they have been removed ...and as for a sex life , well I have not been sexually active in 20 yrs .. that marriage ended in divorce .. My life has Totally been wrecked for me since all this has happened from chronic intercististis .. over 100 surgeries ....This Treatment should be banned ...Thank you for allowing me to bring my story to your attention ..
DanielleJanuary 13, 2023 at 6:41 pm
Thank you for your comments, I was considering the MLT. I have decided not to get the procedure. I believe I will try the estrogen cream. Thank you Ladies for looking out for us and I wish the best for each and everyone of us.
CatDecember 27, 2022 at 1:20 am
I had 3 treatments spaced 6 weeks apart, and for me, it made the world of difference. Normal slippery vaginal secretions returned and intercourse was pain free for the first time in 23 years. For me, it worked well and it was truly a miracle, IMO. A year later, I had a 'maintenance' treatment. This time, the treatment was a bit more aggressive (as per my doctor), 3 weeks later, I started to ha[Show More]I had 3 treatments spaced 6 weeks apart, and for me, it made the world of difference. Normal slippery vaginal secretions returned and intercourse was pain free for the first time in 23 years. For me, it worked well and it was truly a miracle, IMO. A year later, I had a 'maintenance' treatment. This time, the treatment was a bit more aggressive (as per my doctor), 3 weeks later, I started to have moderate amount of watery yellow-brown vaginal drainage. Thinking I had an infection, I returned to my doctor three times for swabs, cultures and smears. There was no evidence of infection, bleeding or abnormal cells. My doctor's response? "It's vaginal atrophy". Which I found VERY odd since I never had this drainage prior to my first (annual) maintenance treatment and the Mona Lisa treatment is supposed to greatly improve symptoms of vaginal atrophy (I was also on vaginal HRT and a estrogen patch). I can't find any information from others who've experienced the same abnormal vaginal discharge after Mona Lisa treatments, but there is definitely a correlation. Especially since I had had very good results initially but then developed this abnormal drainage after the maintenance treatment. It's been two years now and I have to wear a mini pad at all times. I'd like to know if there are any other women out there who have experienced this.
LindaNovember 16, 2022 at 9:45 am
I had the 3 Mona Lisa procedures 6 weeks apart and I still suffer painful intercourse. I also use estrogen tablets twice a week but it isn’t any better.
KimberlyNovember 11, 2022 at 4:16 pm
I had this procedure done 6 years ago because of extreme vaginal dryness. It did nothing to help the dryness but it did burn me in one spot so bad that every time I try to have intercourse, the pain is intense and I bleed. Needless to say I would not recommend this as it has totally ruined my sex life. I feel so bad for my husband who tries to understand but sometimes just doesn’t.
SharonOctober 12, 2022 at 6:47 pm
I had this procedure done a few years ago. They set you up for failure from the beginning. I was told how helpful this was to so many women. After each treatment, I was given a questionnaire asking if I felt any better. II tried to be optimistic, I suffered for the next year very painful intercourse. I was embarrassed to say I was part of the one percent that it didn’t work for. I was asked to spe[Show More]I had this procedure done a few years ago. They set you up for failure from the beginning. I was told how helpful this was to so many women. After each treatment, I was given a questionnaire asking if I felt any better. II tried to be optimistic, I suffered for the next year very painful intercourse. I was embarrassed to say I was part of the one percent that it didn’t work for. I was asked to spend another couple thousand dollars for a second treatment for the second year, but something in my gut told me no. I called the office one day because I was in so much pain after intercourse I could not believe it was normal. The doctor was not available and I saw the nurse practitioner. she said that I was completely torn up. Gave me something to relieve the pain and put me on estrogen cream. Within two weeks I felt extremely better I was never offered this option. The doctor will not talk to me about it. When I asked to speak to her about it, her nurse manager called me back and told me that I had declined any hormone treatment. The treatment I declined, was the HTR that the doctor said could cause cancer, the kind taken orally. She never mentioned a cream. She’s a very thorough doctor, I’ve been going to her for years. This is the only bad experience I’ve had with her and her reluctance to speak to me about it is upsetting. She spent 45 minutes, talking me into it. But when I asked to speak to her about it, she has somebody read me my chart, basically telling me I have no legal right to stand on. Not what I was looking for. I was looking for her to tell me that maybe she had made a mistake, and I should’ve tried the cream first. The treatments were a little painful, but did not work. The third treatment was very aggressive, and I was told There may be discomfort and not to have intercourse for a week or two. I waited, no change, just worse. Long story short, I suffered an entire year after the treatment. Luckily, I found out through her nurse practitioner that all I needed was some estrogen cream. I consider myself lucky.
ConnieOctober 9, 2022 at 9:18 pm
I had this done a few years ago. The fee was $2800. for 5 treatments. At the end of the 5 treatments I had a severe burn inside the vagina Derm. biopsied it and it was vulvar ca. I am still under treatment and out $2800.. The woman who did it was nurse. I believe the machine was not calibrated right. They are not safe!
KimOctober 4, 2022 at 6:41 pm
I was/am scheduled to begin this procedure but now I’m no so sure. Are these actual posts from lovely women who are not in a better place now? I’d really like to hear actual testimony about the down side of this, not that I doubt the testimonies posted here.
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?