BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLERGAN GUMMY GEL BREAST IMPLANT

    MDR report key: 8008937 · Received October 25, 2018

    Report

    Report Number
    MW5080821
    Event Type
    Injury
    Date Received
    October 25, 2018
    Date of Event
    May 11, 2018
    Report Date
    October 22, 2018
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I REPORTED TO DR (B)(6) IN (B)(6) THAT I HAD A LUMP IN MY BREAST THAT WAS CAUSING PAIN IN MY BREAST SHOULDER AND NECK. I HAVE AN ALLERGAN GUMMY SILICONE IMPLANT THAT WAS PLACED IN MY BREAST BY DR (B)(6) IN (B)(6) IN 2012. I WENT FOR A SONOGRAM IN (B)(6) 2018 TO CHECK THE BREAST, AND WAS TOLD THEY DID NOT SEE ANYTHING BUT I WAS GIVEN AN ANTIBIOTIC AND THIS HELPED. A FEW WEEKS PASSED AND THE PAIN STARTED UP AGAIN, SO I TOOK AN ANTIBIOTIC THAT WAS LEFT OVER FROM MY SON HAVING SURGERY AND IT HELPED. A FEW WEEKS LATER I AM IN SO MUCH PAIN, I DROVE TO THE EMERGENCY ROOM IN (B)(6) WHERE THEY DID ANOTHER SONOGRAM AND NOTICE AN AREA OF SCAR TISSUE IN MY BREAST. I WAS GIVEN PAIN MEDS AND ANTIBIOTIC. A FEW WEEKS LATER, PAIN IS SEVERE IN RIGHT SHOULDER, ARM, AND BREAST AND MY FINGERS ARE NUMB AND TINGLING WITH ELBOW JOINT PAIN. I BELIEVE I HAVE A SILENT RUPTURE BUT I HAVE TRAVELED AROUND THE COUNTRY SEEKING THE HELP OF SPECIALIZED BREAST SURGEONS WHO WILL NOT HELP ME BECAUSE OF CRIMINAL ACTIVITY IN OUR STATES MEDICAL BOARD. I HAVE BEEN REPORTING THIS ACTIVITY TO THE DOJ AND FBI. I NEED THIS IMPLANT REMOVED. IT IS 6 YEARS OLD AND I KNOW THAT IS WHAT IS HURTING ME. I HAVE EVEN EMAILED DR (B)(6) OFFICE TO TELL THEM I BELIEVE MY IMPLANT HAS RUPTURED AND I HAVE SEVERE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844243 ALLERGAN GUMMY GEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL SILICONE GEL-FILLED FTR ALLERGAN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other