BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEXTURED BREAST IMPLANTS

    MDR report key: 9769615 · Received February 27, 2020

    Report

    Report Number
    MW5093353
    Event Type
    Injury
    Date Received
    February 27, 2020
    Date of Event
    May 4, 2006
    Report Date
    February 25, 2020
    Manufacturer
    UNKNOWN
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVICE TECHNOLOGIES. AFTER SEEING (B)(6) BREAST CLINIC WITH BREAST PAIN SWELLING PAIN ETC THAT I HAVE ENDURED FOR YEARS DUE TO BREAST IMPLANTS. I HAVE BEEN DIAGNOSED WITH BII FINALLY AFTER SEEING SEVERAL PLASTIC SURGEONS; I STARTED WITH CAPSULIZATION OF RIGHT IMPLANT AND I WAS ACCUSED OF IT HAPPENING BECAUSE I LOST WEIGHT. I SUFFER CHRONIC JOINT PAIN SO NO LONGER CAN EXERCISE OR WALK FAR BECAUSE OF PAIN AND BEING SHORT OF BREATH AND NOW I'VE DEVELOPED STOMACH AND BOWEL PROBLEMS AND UP UNTIL IMPLANTS I WAS A NORMAL HEALTHY VIBRANT PERSON. AFTER MY LAST CHILD I HAD SILICONE IMPLANTS ABOUT 11 YEARS AGO AND HAVE DETERIORATED HEALTH WISE EVER SINCE WITH NO HEALTH PROFESSIONAL BEING ABLE TO HELP ME UNTIL THE (B)(6) BREAST CENTRE. I HAVE NOW BEEN TOLD THE IMPLANT ON THE RIGHT HAS RUPTURED. LARGE CORDED TENDONS HAVE DEVELOPED AROUND IT. I DO NOT HAVE ENERGY TO FUNCTION. I CAN'T SEE PROPERLY. I HAVE BEEN DIAGNOSED WITH ANXIETY. I'M MISERABLE, FRUSTRATED AND HAVE NO ENTHUSIASM TO DO ANYTHING. I JUST WANT TO BE IN BED YET I CANT SLEEP FOR MORE THAN AN OR SO AT A TIME. I THOUGHT I WAS GOING MAD I JUST EXIST AND I WANT A LIFE BACK. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229460 TEXTURED BREAST IMPLANTS PROSTHESIS, BREAST, NON-INFLATABLE, INTERNAL SILICONE GEL-FILLED FTR UNKNOWN
    229461 TEXTURED BREAST IMPLANTS PROSTHESIS, BREAST, NON-INFLATABLE, INTERNAL SILICONE GEL-FILLED FTR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Disability