BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALINE BREAST IMPLANT

    MDR report key: 15419391 · Received September 13, 2022

    Report

    Report Number
    MW5112026
    Event Type
    Injury
    Date Received
    September 13, 2022
    Report Date
    September 10, 2022
    Manufacturer
    ALLERGAN (FORMERLY MCGHAN)
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD BILATERAL SALINE SMOOTH TEXTURED SUBGLANDULAR BREAST IMPLANTS (MCGHAN NOW KNOWN AS ALLERGAN) PLACED (B)(6) 2000 AND REMOVED (B)(6) 2022. AFTER YEARS OF VARIOUS ILLNESSES, ABNORMAL LABS, SYMPTOMS AND BEING PLACED ON AN IMMUNOSUPPRESSIVE MEDICATION (ETANERCEPT) THE SOLUTION TO MY AILMENTS WAS BILATERAL BREAST IMPLANT REMOVAL AND TOTAL CAPSULECTOMY. I HAVE BEEN OFF ALL MEDICATIONS FOR MY AUTOIMMUNE DISORDERS SINCE THAT TIME. PATHOLOGY OF THE SCAR TISSUE CAPSULES DEMONSTRATED CHRONIC INFLAMMATION. IT APPEARS TO BE THE CASE THAT BREAST IMPLANTS CAUSED MY ADVERSE HEALTH. NONE OF THESE WERE PRESENT UNTIL BREAST IMPLANTS WERE PLACED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2648574 SALINE BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (FORMERLY MCGHAN)
    2668238 SALINE BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (FORMERLY MCGHAN)

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Disability| R MVI WITH MINERALS | USP CERTIFIED