BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 110 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 2231135 · Received August 26, 2011

    Report

    Report Number
    2024601-2011-00566
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    February 1, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH EXTENSION REQUESTED ON 04/JUN/2011 AND GRANTED UNTIL 29/AUG/2011. MEDWATCH SUBMITTED ON 26/AUG/2011. DEVICE LABELING REVIEWED. THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL, FOR PTS IN THE CORE STUDY, IN THE LABELING FOR SILICONE IMPLANTS. DEVICE LABELING ADDRESSES BREAST PAIN AS FOLLOWS: THE CORE STUDY: 7 YR ADVERSE EVENT RATES: FOR PRIMARY AUGMENTATION PTS, PAIN RATE = 11.4%. DEVICE ANALYSIS: ANALYSIS NOTED A FLAT CREASE ON SHELL. ALSO NOTED WAS A SHARP UNIDENTIFIED OPENING ON THE POSTERIOR SHELL WHICH EXTENDED TO THE RADIUS/ANTERIOR, ETIOLOGY UNK.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS BILATERAL LYMPHOMA, PAIN AND SILICONE MIGRATION. THIS MW REPRESENTS THE RIGHT SIDE. SEE MFR REPORT NUMBER 2024601-2011-00565 FOR THE LEFT. SEVERAL ATTEMPTS WERE MADE TO GATHER INFO REGARDING THE REPORTED EVENTS, HOWEVER ALLERGAN HAS NOT RECEIVED ANY F/U INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STYLE 110 SILICONE GEL FILLED BREAST IMPLANT FTR ALLERGAN NA 330799

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention