BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 20844177 · Received December 4, 2024

    Report

    Report Number
    9617229-2024-25489
    Event Type
    Injury
    Date Received
    December 4, 2024
    Date of Event
    November 11, 2024
    Report Date
    December 4, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Removal / Correction Number
    2011068-7/2/19-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: MARES, THEODOR, IONESCU, RADU, DIMA, DANIEL ET AL. BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA IN ROMANIA: FIRST CASE SERIES OF ALL DOCUMENTED CASES. JOURNAL OF PLASTIC, RECONSTRUCTIVE, AND AESTHETIC SURGERY 99 (2024); 602-607. THE EVENTS OF LYMPHOMA - ALCL AND SEROMA ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: LYMPHOMA - ALCL; LATE SEROMA.

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE "BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA IN ROMANIA: FIRST CASE SERIES OF ALL DOCUMENTED CASES", AUTHORS REPORT A PATIENT DIAGNOSED RIGHT SIDE BIA-ALCL AND LATE SEROMA; BIOMARKERS OF CD30 POSITIVE AND ALK NEGATIVE HAVE BEEN REPORTED. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2059520 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention| L