BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 115 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 2251798 · Received September 13, 2011

    Report

    Report Number
    2024601-2011-00780
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 22, 2011
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SUBMITTED ON (B)(4) 2011. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF SEROMA AND CAPSULAR CONTRACTURE AS FOLLOWS: THE CORE STUDY: 7 YEAR ADVERSE EVENT RATES: FOR PRIMARY AUGMENTATION PATIENTS, SEROMA RATE = 1.6 PERCENT. CAPSULAR CONTRACTURE 15.5 PERCENT. SWELLING = 7.1 PERCENT. "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

    PATIENT REPORTS VIA EMAIL A CASE OF LYMPHOMA. SHE REPORTS THAT SHE IS AN AUGMENTATION PATIENT AND WAS IMPLANTED IN 2007. SHE STATES THAT SHE NOTICED HER IMPLANT GETTING HARD AND WENT TO SEE THE DOCTOR. ON (B)(6) 2011 THE SURGEON CALLS IN TO PROVIDE ADDITIONAL INFORMATION ON THIS PATIENT. HE PRESENTS HER HISTORY AS A RECONSTRUCTION PATIENT. SHE WAS DIAGNOSED WITH RIGHT BREAST CANCER PRIOR TO IMPLANTATION. RECONSTRUCTION SURGERY TOOK PLACE ON (B)(6) 2007, WITH THE LEFT SIDE BEING DONE FOR PROPHYLACTIC PURPOSES. ON (B)(6) 2011 THE PRESENTED WITH CAPSULAR CONTRACTURE BAKER GRADE IV OF THE RIGHT BREAST AND WAS EXPLANTED. THE DIAGNOSIS OF ALCL WAS MADE FROM THE RIGHT BREAST CAPSULE SAMPLE FROM THE (B)(6) 2011 SURGERY. THE PATIENT IS SCHEDULED TO HAVE THE DEVICES REMOVED BILATERALLY (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STYLE 115 SILICONE GEL FILLED BREAST IMPLANT FTR ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention