BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORY SHAPE BREAST IMPLANTS - SILICONE TEXTURED

    MDR report key: 8115557 · Received November 28, 2018

    Report

    Report Number
    MW5081704
    Event Type
    Injury
    Date Received
    November 28, 2018
    Date of Event
    February 20, 2015
    Report Date
    February 17, 2024
    Manufacturer
    MENTOR TEXAS, LP
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 17-JAN-2024 FOR MW5081704. I MADE A REPORT IN 2018 (ACCESS NUMBER MW5081704 TO THE MEDWATCH PROGRAM - MAUDE) REGARDING SILICONE BREAST IMPLANTS. I NOTICED IMMEDIATE BREAST IMPLANT ILLNESS IN 2018, BUT NO DOCTOR WOULD TAKE ACTION. AN MRI IN 2023 LED TO THE DISCOVERY OF INFLAMMATION IN MY BODY AND A SURGERY OCCURRED (B)(6) 2024, AT HIGH RISK DUE TO CONTRACTURE/RADIATION. I AM NOT ONLY DEFORMED, BUT MAY NOT HEAL COMPLETELY - THE DOCTORS WILL WATCH ME FOR A YEAR. I HAD TO RELOCATE APPROX 400 MILES TO RECEIVE CARE. THE PLASTIC SURGEON SAID THE IMPLANT WAS "SHREDDED" AND HAD TRAVELED INTO MY LYMPHS (BUT THEY DIDN'T TAKE ANY POISON FROM THE LYMPHS DUE TO CAUSING WORSE CONDITIONS FOR ME). MOST OF MY BII ISSUES RESOLVED IMMEDIATELY. I HAD BEEN TOLD THAT THE IMPLANT WOULD LAST MY LIFETIME AND NEED TO BE REMOVED AT MY DEATH. THERE IS NO WAY TO SUE FOR MEDICAL MALPRACTICE AT ANY LEVEL OF THIS ORDEAL - STARTING WITH THE ELDERLY DOCTOR WHO BOTCHED THE FIRST SURGERY (I WAS A STAGE A), AND I AM NOW NOT ABLE TO WEAR IMPLANTS. I HAVE LOST MY BEAUTY, I EXPECT TO DIE EARLIER (MY HAIR TURNING SILVER OVER THE LAST YEAR 50%), AND NO RECOURSE. I FELT LIKE AN EXPERIMENT AND I WANT EVERY PERSON WHO IS NEW TO CONSIDERING IMPLANTS TO KNOW THIS STORY. WHEN I FIRST WENT IN FOR IMPLANTS, I BROUGHT UP HISTORIC FAILURES OF IMPLANTS AND WAS TOLD THAT WAS FIXED, NOT EVEN A MAC TRUCK RUNNING OVER THEM WOULD CAUSE A PROBLEM. I WAS OUT-AND-OUT LIED TO, I WAS COERCED/TRICKED INTO GETTING IMPLANTS, AND NOW I WILL SUFFER ALL MY DAYS WITH THIS. BII SHOULD BE A LEGITIMATE DIAGNOSIS AND I WOULD BE WILLING TO ADD MY NAME TO THOSE STORIES. ON (B)(6) 2024 DOUBLE MASTECTOMY EXPLANT SURGERY. BEFORE SURGERY (B)(6) 2024 - TONS OF SYMPTOMS (DRY EYE, HAIR LOSS, JOINT PAIN, ETC). AFTER SURGERY, ONLY MILD DRY EYE. OTHERWISE, HAVE NORMAL CONDITIONS FOR MY AGE - DOING COLON CHECKS, HAVE TO GET MINOR BODY THINGS LOOKED AT LIKE DERMATOLOGIST. NO DIABETES, BUT A FATTY LIVER DEVELOPED AND AS I DON'T DRINK OR EAT THAT MUCH, HOPING THIS TOO WILL GO AWAY WITH OTHER BII SYMPTOMS.

    Description of Event or Problem · 1

    I LIVE IN (B)(6), SURGEON BOTCHED SURGERY #1, HAD TO RELOCATE. LOST JOB, HOME. "BY TIME GO TO SERVICES, BREAST CANCER SPREAD." HAD DOUBLE MASTECTOMY, LUMPECTOMY. AS DISCOVERED SPREAD, DID RADIATION AFTER RECONSTRUCTION. IMMEDIATE AND CHRONIC ISSUES KEEPING ME DISABLED. BRAIN FOG, FATIGUE, MUSCLES ATROPHY, PAIN, SWELLING, SEVERE CAPSULAR CONTRACTURE, LOW GRADE AUTO- IMMUNE ISSUES, FREQUENT ILLNESS. WORRIED LEAKAGE, SENT FOR MULTIPLE SCANS, SHOWS NOTHING. PLASTIC SURGEON RETIRED, NO ONE TAKING OVER. STILL STRUGGLING, DISABLED. MY BODY REJECTED COLLAGEN, ETC FROM SURGERY. I AM DEFORMED. NOW HAIR LOSS. NOW WORRIED ALCL MIGHT BE AN ISSUE. NO RESPONSE FROM MEDICAL DEVICE COMPANY: MENTOR, NO ONE MONITORING MY SITUATION. QUALITY OF LIFE SUCKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950454 MENTOR MEMORY SHAPE BREAST IMPLANTS - SILICONE TEXTURED PROSTHESIS, BREAST, INFLATABLE, INTERNAL SILICONE GEL-FILLED FTR MENTOR TEXAS, LP REF #354-1508 UNK
    950455 MENTOR BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR WORLDWIDE LLC. REF #334-1505

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Hospitalization| S| R DULOXETINE 30 MG