BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLERGAN SILICONE BREAST IMPLANTS

    MDR report key: 8191315 · Received December 20, 2018

    Report

    Report Number
    MW5082495
    Event Type
    Injury
    Date Received
    December 20, 2018
    Date of Event
    August 1, 2010
    Report Date
    December 19, 2018
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I FELL MYSTERIOUSLY ILL. I WAS A PERSONAL TRAINER AND FITNESS INSTRUCTOR AND HAD DEVELOPED THE FATIGUE SO BAD, I COULD BARELY GET OF MY SOFA. AFTER SOME TIME I TRIED TO RETURN BACK TO WORK BUT STRUGGLED AND MY TEETH SLOWLY DETERIORATED OVER THE NEXT 8 YRS WHERE I DEVELOPED A CONSIDERABLE NUMBER OF UNEXPLAINABLE AND LIFE CHANGING SYMPTOMS SUCH AS FATIGUE, RINGING EARS, DEPRESSION, BRAIN FOG AND REDUCED COGNITIVE CAPACITY, MUSCULAR TWITCHES, SPASMS, JOINT PAIN, WEAKNESS, LOW BLOOD PRESSURE, FAINTING , HEART PALPITATIONS, NEUROPATHY, LOSS OF BALANCE, BLADDER ISSUES, DIGESTIVE ISSUES TO NAME THE WORST ONES. EVENTUALLY I REALIZED THAT I STARTED TO FEEL UNWELL TWO YEARS AFTER IMPLANT. I INVESTIGATED THE SYMPTOMS AND RELATION TO THE IMPLANTS AND FOUND 1000S OF WOMEN STRUGGLING WITH SIMILAR ISSUES. I RESEARCHED A SURGEON WHO WAS SKILLED IN SAFE REMOVAL. HE DID NOT THINK THEY WERE RUPTURED BUT AGREED TO REMOVE THEM WITH A TOTAL ENBLOC TO REMOVE THE CAPSULES. UPON REMOVAL, IT WAS NOTED THAT THE LEFT ONE WAS COMPLETELY RUPTURED. (THE SURGEON HAS RETAINED PICTURES.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027458 ALLERGAN SILICONE BREAST IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL SILICONE GEL-FILLED FTR ALLERGAN TSF325 325G 1539842
    1027459 ALLERGAN SILICONE BREAST IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL SILICONE GEL-FILLED FTR ALLERGAN TSF325 325G 1539842

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Disability