BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK GEL BREAST IMPLANT

    MDR report key: 3030978 · Received November 20, 2012

    Report

    Report Number
    2024601-2012-01268
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    January 29, 2010
    Report Date
    January 29, 2010
    Manufacturer
    UNKNOWN MANUFACTURER
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER OF THE DEVICE IS UNKNOWN. THEREFORE, THIS FIELD IN THE MEDWATCH HAS BEEN CORRECTED TO REFLECT THIS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT WAS SUBMITTED INITIALLY VIA (B)(6). DEVICE LABELING ADDRESSES THE REPORTED EVENT OF SEROMA AS FOLLOWS: THE CORE STUDY: 7 YEAR ADVERSE EVENT RATES: FOR PRIMARY AUGMENTATION PATIENTS, SEROMA RATE = 1.6%. PRIMARY RECONSTRUCTION PATIENTS = 1.0%. (OTHER COMPLICATIONS.) SWELLING = 7.1%. "AFTER BREAST IMPLANT SURGERY THE FOLLOWING MAY OCCUR AND/OR PERSIST, WITH VARYING INTENSITY AND/OR FOR A VARYING LENGTH OF TIME: HEMATOMA/SEROMA..." (ALLERGAN SILICONE LABELING). DEVICE LABELING REVIEWED: THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL, FOR PATIENTS IN THE CORE STUDY, IN THE LABELING FOR SILICONE IMPLANTS.

    Description of Event or Problem · 1

    THROUGH MY RESEARCH REVIEW AS RN PRODUCT SUPPORT SPECIALIST, THE FOLLOWING ARTICLE CAME TO MY ATTENTION: "SEROMA-ASSOCIATED PRIMARY ANAPLASTIC LARGE-CELL LYMPHOMA ADJACENT TO BREAST IMPLANTS: AN INDOLENT T-CELL LYMPHOPROLIFERATIVE DISORDER BY ANJA RODEN ET AL. (MODEM PATHOLOGY, 2008) 21, 455-463". WITHIN THE ARTICLE THE AUTHOR PRESENTS 4 PATIENTS WITH PRIMARY ANAPLASTIC LARGE-CELL LYMPHOMA OF THE BREAST ASSOCIATED WITH A BREAST IMPLANT AND SEROMA.

    Description of Event or Problem · 1

    THROUGH MY RESEARCH REVIEW AS RN PRODUCT SUPPORT SPECIALIST, THE FOLLOWING ARTICLE CAME TO MY ATTENTION: SEROMA-ASSOCIATED PRIMARY ANAPLASTIC LARGE-CELL LYMPHOMA ADJACENT TO BREAST IMPLANTS: AN INDOLENT T-CELL LYMPHOMA PROLIFERATIVE DISORDER BY ANJA RODEN ET AL. (MODERN PATHOLOGY, 2008) 21, 455-463. WITHIN THE ARTICLE THE AUTHOR PRESENTS 4 PATIENTS WITH PRIMARY ANAPLASTIC LARGE-CELL LYMPHOMA OF THE BREAST ASSOCIATED WITH A BREAST IMPLANT AND SEROMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK GEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR UNKNOWN MANUFACTURER NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention