BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MW5069625

    MDR report key: 6553778 · Received May 5, 2017

    Report

    Report Number
    MW5069625
    Event Type
    Injury
    Date Received
    May 5, 2017
    Date of Event
    February 12, 2016
    Report Date
    May 5, 2017
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD SILICONE IMPLANT IN 1986 AND LAST YEAR NOTICED MY LEFT BREAST HAD VERY HARD LUMPS. WHEN TO A DOCTOR, HAD MRI AND THE IMPLANT HAS RUPTURED. I DO NOT HAVE INSURANCE AND WANT TO HOLD DUPONT ACCOUNTABLE. MY SISTER WENT THRU SAME THING. DUPONT PAID FOR HER REMOVAL AND IMPLANTED SALINE IMPLANTS. THE DOCTOR TOLD MY SISTER OF THE PROBLEM OF HARDENED SILICONE. TWO YEARS AFTER MY SISTER'S SURGERY DOCTOR DID BIOPSY AND SHE WAS STAGE 4 CANCER. SHE PASSED 2 YEARS AGO. SO I AM SCARED AND DO NOT KNOW WHERE TO TURN FOR HELP. DIAGNOSIS OR REASON FOR USE: HAD IMPLANTS FOR BETTER LOOK. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening