BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 22368280 · Received July 1, 2025

    Report

    Report Number
    9617229-2025-10894
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    June 24, 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, WILSON, R ET AL. IL-9 IS A BIOMARKER OF BIA-ALCL DETECTED RAPIDLY BY LATERAL FLOW ASSAY. AESTHETIC SURGERY JOURNAL. 2024 VOL. 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 15 TOTAL PATIENTS WITH BENIGN SEROMAS AMONG THE 14 US PATIENTS AND 12 AUSTRALIA PATIENTS. CLARIFICATION TO H.10 (RELATED REPORT NUMBERS): EVENTS NOTED IN THIS REPORT ARE REFLECTIVE OF THE SAME LITERATURE REVIEW/PATIENTS AS REPORTED UNDER MRN 9617229-2025-10893. THE EVENTS OF CAPSULAR CONTRACTURE 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: SEROMA; CAPSULAR CONTRACTURE, BAKER GRADE UNSPECIFIED.

    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 4 OF THE 15 BENIGN SEROMA SAMPLES ARE FROM PATIENTS WITH ALLERGAN-MANUFACTURED DEVICES, AND WERE ALSO DIAGNOSED WITH CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN). STATUS OF DEVICES AND AFFECTED SIDES ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314182 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention