BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATRELLE SILICONE-FILLED BREAST IMPLANT

    MDR report key: 19557989 · Received June 17, 2024

    Report

    Report Number
    MW5156318
    Event Type
    Injury
    Date Received
    June 17, 2024
    Date of Event
    August 17, 2021
    Report Date
    June 12, 2024
    Manufacturer
    ALLERGAN SALES, LLC.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IN (B)(6) OF 2021, I BEGAN SEEING A RHEUMATOLOGIST DUE TO INCREASING SYMPTOMS OF FATIGUE AND PAIN IN MY BODY. THEY HAVE RUN MANY TESTS AND MY INFLAMMATION MARKERS ARE STAYING HIGH BUT NO DIAGNOSES OF RA OR ANY OTHER AUTOIMMUNE DISORDER TESTED POSITIVE. THEY DIAGNOSED ME WITH FIBROMYALGIA BUT MY SYMPTOMS OF JOINT PAIN ARE STEADILY INCREASING. I HAVE ALLERGAN BREAST IMPLANTS IMPLANTED IN 2016 WHICH WERE RECALLED IN 2019 BUT MY PLASTIC SURGEON HAS SAID MULTIPLE TIMES THAT I DID NOT HAVE SIGNS OF CANCER AND DID NOT NEED TO REMOVE THE EXPANDER AND THAT ALLERGAN WOULD NOT PAY FOR THE REMOVAL WHICH WAS A FINANCIAL ISSUE FOR MY FAMILY. I RECEIVED THE EXPANDER DUE TO BEING BORN WITH A DEFORMITY, TUBULAR BREAST'S, AND WAS CORRECTING THE DEFORMITY. I FEEL LIKE I AM SUFFERING FROM BII. (BREAST IMPLANT ILLNESS). THESE BLOOD WORK TEST WENT ON FOR ALMOST 2 YEARS. REFERENCE REPORTS: MW5156317, MW5156319, MW5156320.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655669 NATRELLE SILICONE-FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN SALES, LLC. 120-500

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Disability CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE)| MULTI VITAMIN| TISSUE EXPANDERS