BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE BREAST IMPLANTS - LEFT

    MDR report key: 1003957 · Received February 26, 2008

    Report

    Report Number
    MW5005687
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    June 25, 2007
    Manufacturer
    MCGHAN MEDICAL, INAMED AESTHETICS
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 1997, PATIENT HAD BREAST AUGMENTATION WITH SALINE BREAST IMPLANTS. OVER THE YEARS THEY BEGAN RIPPLING, SO IN 2007, SALINE IMPLANTS WERE REPLACED WITH SILICONE IMPLANTS. SIX MONTHS EARLIER, PATIENT BEGAN EXPERIENCING EDEMA IN LEGS, ANKLES AND FEET ALONG WITH EXTREME FATIGUE. OVER THE COURSE OF NEXT 6 MONTHS, PATIENT EXPERIENCED THE FOLLOWING SYMPTOMS: DAILY HEADACHES & SORE THROATS, SINUSITIS, DIZZY, GLASSY EYES, MENTAL CONFUSION, SHORT TERM MEMORY LOSS, NAUSEA, LIGHT & NOISE SENSITIVITY, SORES ALL OVER BODY THAT WOULDN'T HEAL, NECK & BACK PAIN, BURNING IN RIGHT BREAST, FEELING OF BEING POISONED, DRY COUGH, NIGHT SWEATS, EXCESSIVE THIRST, TOE NAIL FUNGUS - LOSS OF TOENAIL, HIGH BLOOD PRESSURE, NUMBNESS IN RIGHT ARM & HAND, ITCHING ON BACK, INSOMNIA. PRIOR TO THE EVENT DATE, PATIENT HAD BEEN WORKING 3, 11-HOUR WORK DAYS. THESE SYMPTOMS CAUSED HER TO HAVE TO TAKE 2 MONTHS OFF WORK, THEN ON RETURNING TO WORK, SHE HAS ONLY BEEN ABLE TO WORK 2, 5-HOUR DAYS BEFORE BECOMING SO FATIGUED AND WEAK SHE HAS TO GO HOME. BARELY ABLE TO KEEP HER JOB AT THIS TIME ON VERY LIMITED PART-TIME BASIS. THE IMPLANTS GAVE HER SILICONE POISONING, IN 2008, SHE HAD THEM REMOVED. BLOOD PRESSURE REDUCED & OTHER SYMPTOMS NOW GOING AWAY. DATES OF USE. #1. 2004 - 2008. #2. 2004 - 2008. DIAGNOSIS OR REASON FOR USE. #1. BREAST AUGMENTATION. #2. BREAST AUGMENTATION. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? #1. YES. #2. YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE BREAST IMPLANTS - LEFT SILICONE BREAST IMPLANTS FTR MCGHAN MEDICAL, INAMED AESTHETICS 45 239364 -LEFT-
    2 SILICONE BREAST IMPLANTS - RIGHT SILICONE BREAST IMPLANTS FTR MCGHAN MEDICAL, INAMED AESTHETICS 45 1008216

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention