BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE BREAST IMPLANTS

    MDR report key: 8206345 · Received December 28, 2018

    Report

    Report Number
    MW5082692
    Event Type
    Injury
    Date Received
    December 28, 2018
    Date of Event
    November 25, 2011
    Report Date
    December 27, 2018
    Manufacturer
    ALLERGAN, INC.
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD BREAST AUGMENTATION IN (B)(6) 2011. THE PLASTIC SURGEON PLACED ALLERGAN IMPLANTS (STYLE 20 LOT 2121938 AND 2078559) UNDER THE PECTORAL MUSCLE. SOON AFTER I BEGAN NOTICING SYMPTOMS I HAVE NEVER HAD BEFORE: UNEXPLAINED WEIGHT GAIN, SEVERE ANXIETY, DEPRESSION, FATIGUE, INFLAMMATION, MISSED PERIODS, SUBCLINICAL HYPOTHYROIDISM, BRAIN FOG, AND A HOST OF OTHER ISSUES. I TRULY BELIEVE THESE WERE THE RESULT OF THE IMPLANTS. BREAST IMPLANT ILLNESS IS REAL, AND I URGE MORE STUDIES TO BE CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040989 SILICONE BREAST IMPLANTS PROSTHESIS, BREAST, NON INFLATABLE, INTERNAL SILICONE GEL-FILLED FTR ALLERGAN, INC. STYTLE 20 LOT 2078559
    1040990 SILICONE BREAST IMPLANTS PROSTHESIS, BREAST, NON INFLATABLE, INTERNAL SILICONE GEL-FILLED FTR ALLERGAN, INC. STYLE 20 2121938

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention| S