BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 115 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 3208898 · Received July 2, 2013

    Report

    Report Number
    2024601-2013-00554
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 15, 2013
    Report Date
    August 26, 2020
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE LABELING ADDRESSES THE EVENT OF SEROMA AS: FOR PRIMARY AUGMENTATION PTS, SEROMA RATE = 1.6%. PRIMARY RECONSTRUCTION PTS - 1.0% (OTHER COMPLICATIONS). SWELLING = 7.1%. DEVICE LABELING REVIEWED: THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL, FOR PTS IN THE CORE STUDY, IN THE LABELING FOR SILICONE IMPLANTS.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS A CASE OF ALCL OF THE RIGHT BREAST ALONG WITH SEROMA. THE PT HAD AN AUGMENTATION (DATE OF SURGERY NOT PROVIDED AT THIS TIME). THE PT PRESENTED WITH PAIN AND SWELLING ON (B)(6) 2013 AND HAD AN U/S THAT CONFIRMED SEROMA ON (B)(6) 2013. CYTOLOGY TAKEN AND SENT TO PATHOLOGY. THE PT HAD BILATERAL REMOVAL WITH CAPSULECTOMY WITHOUT REPLACEMENT (B)(6) 2013. PET SCAN PERFORMED WHICH WAS NEGATIVE. ONCOLOGY CONSULT TOOK PLACE, HOWEVER, THE NOTES ARE NOT AVAILABLE AT THIS TIME. INFO PROVIDED CONFIRMS THAT THERE IS NOT A FAMILY HISTORY OF BREAST CANCER; HOWEVER, THERE IS A POSITIVE HISTORY FOR OVARIAN CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301961 STYLE 115 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN NA 1559225

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention