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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EL.EN. ELECTRONIC ENGINEERING SPA MONA LISA TOUCH; POWERED LASER SURGICAL INSTRUMENT

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EL.EN. ELECTRONIC ENGINEERING SPA MONA LISA TOUCH; POWERED LASER SURGICAL INSTRUMENT Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/05/2020
Event Type  Injury  
Event Description
Hello, i left a phone message as well.I'm hoping to file a complaint on a laser procedure called mona lisa touch.In early (b)(6) i had one of three recommended mona lisa treatments.I'd consulted a local women's health specialist due to menopausal symptoms.I saw dr (b)(6) with (b)(6) health.I explained to her some symptoms i was experiencing after a hysterectomy i'd had in 2017.I explained about vaginal dryness and painful intercourse.She asked if i had pain or discomfort not related to sexual activity.I told her i did not.I explained that i'm also a breast cancer survivor and can't use hormonal treatments.The mona lisa procedure was positioned, by dr (b)(6), as my "only option" for relief of my vaginal dryness symptoms.She said the laser treatment inspired rejuvenation of the vaginal tissue, which becomes inflexible with menopause.She indicated the procedure would reverse this process and would be a "permanent solution." she said some of her patients go in for a yearly procedure because they don't want to risk losing the benefits they have gained.She explained about people in my age group and beyond who found great results and were able to resume intercourse with no discomfort.I was concerned about it as the doctor explained it's not fda approved.But she was very enthusiastic telling me that laser treatments have been used for a long time for many health issues and she positioned it as a safe procedure for vaginal rejuvenation.She also explained it was self-pay.All three treatments would end up costing around (b)(6).She told me of many of her patients who had dramatically positive results from the mona lisa procedure.She recommended a yearly treatment beyond the initial three.I was referred to (b)(6), md.(b)(6) didn't do any kind of consultation with me.The person who scheduled my appointment said that my visit with dr (b)(6) would suffice for a consolation.I had the procedure at (b)(6) health's "generations" clinic.Part of the procedure focused on interior tissue and part focused on exterior tissue.I had no clue they were going to do anything on exterior tissue until it was happening.I was told some women notice immediate results after the week healing period.I did all the self care they recommended.My husband and i attempted intimacy after the healing period but i noticed a lot of pain still so we gave it some more time.Currently i am experiencing worse discomfort and new pain than i have ever felt in the region where the laser treatment was applied.I hurt in places i have never hurt before.I have an intense burning and stinging that is quite devastating after attempting even mild exterior intimacy with my husband.I've never experienced anything like this until i had that laser treatment.After even a mild exterior intimacy attempt it hurts to even sit let alone walk or move.It feels like my tissue in the entire region is on fire.This was never the case before the treatment.I should have healed weeks ago.But i have ongoing pain and sensitivity and any form of intimacy aggravates the tissue even more and make it so severely painful.This is scary and i'm so upset that it has made everything worse.I'm afraid to even attempt any form of intimacy with my husband.I went in with the hope of having our intimate life enhanced and it appears to have severely damaged it instead.I wanted to make my experience known in hopes of helping others to make a wise decision about a procedure that doctors are using on vulnerable patients that hasn't been approved by the fda.(b)(6).This was the date of my procedure.Fda safety report id # (b)(4).
 
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Brand Name
MONA LISA TOUCH
Type of Device
POWERED LASER SURGICAL INSTRUMENT
Manufacturer (Section D)
EL.EN. ELECTRONIC ENGINEERING SPA
MDR Report Key11116826
MDR Text Key225345627
Report NumberMW5098664
Device Sequence Number1
Product Code GEX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/04/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age56 YR
Patient Weight57
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