BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 22368273 · Received July 1, 2025

    Report

    Report Number
    9617229-2025-10893
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    December 1, 2024
    Report Date
    June 30, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: XU, P., KOURENTZI, K., WILLSON, R., HU, H., DEVA, A., MCGUIRE, P., GLICKSMAN, C., & KADIN, M. (2024). IL-9 IS A BIOMARKER OF BIA-ALCL DETECTED RAPIDLY BY LATERAL FLOW ASSAY. AESTHETIC SURGERY JOURNAL, 44(12), 1286¿1292. CLARIFICATION TO B5 DESCRIPTION OF EVENT: AS THERE ARE NO SPECIFICS REGARDING WHICH PATIENTS WERE DIAGNOSED WITH ALCL FROM EACH COUNTRY, THIS RECORD REPRESENTS THE 11 TOTAL POSSIBLE BIA-ALCL DIAGNOSES AMONG THE 14 US PATIENTS AND 12 AUSTRALIA PATIENTS. THE EVENTS OF "LYMPHOMA-ALCL-SUSPECTED" AND "SEROMA-LATE" ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ABBVIE IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: "MALIGNANT SEROMAS"; DIAGNOSIS OF BIA-ALCL.

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE "IL-9 IS A BIOMARKER OF BIA-ALCL DETECTED RAPIDLY BY LATERAL FLOW ASSAY", HEALTHCARE PROFESSIONAL REPORTED ANALYZING ¿UNUSED PORTIONS OF 26 SEROMAS (15 BENIGN, 11 MALIGNANT)" FROM 14 US PATIENTS AND 12 AUSTRALIA PATIENTS. AT LEAST 6 OF THE 11 MALIGNANT SEROMA SAMPLES ARE FROM PATIENTS WITH ALLERGAN-MANUFACTURED DEVICES, ALL OF WHICH WERE DIAGNOSED AS "ALCL-IA". PATHOLOGICAL MARKER CD30+ WAS RECEIVED. PATHOLOGICAL MARKER ALK- WAS NOT RECEIVED. STATUS OF DEVICES AND AFFECTED SIDES ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314175 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| L