BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK GEL BREAST IMPLANT

    MDR report key: 17437294 · Received August 1, 2023

    Report

    Report Number
    9617229-2023-12798
    Event Type
    Injury
    Date Received
    August 1, 2023
    Date of Event
    January 15, 2021
    Report Date
    August 1, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED H.6. HEALTH EFFECT IMPACT CODE: F2203, F2201. ARTICLE CITATION: CZERNIKIEWICZ, K., MAZURKIEWICZ, L., JOKS, M., BALCERZAK, A., JOKS, M., & RUPA-MATYSEK, J. (2023). BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA AS A LATE COMPLICATION OF BREAST IMPLANT PLACEMENT: A REPORT OF THREE POLISH CASES. POLSKIE ARCHIWUM MEDYCYNY WEWNETRZNEJ-POLISH ARCHIVES OF INTERNAL MEDICINE. HTTPS://DOI.ORG/10.20452/PAMW.16531. THE EVENTS OF SEROMA AND LYMPHOMA-ALCL-SUSPECTED 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 REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: SEROMA AND BIA-ALCL.

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE TITLED "BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA AS A LATE COMPLICATION OF BREAST IMPLANT PLACEMENT: A REPORT OF THREE POLISH CASES", HEALTHCARE PROFESSIONAL REPORTS PATIENT 3 WAS DIAGNOSED WITH BIA-ALCL IN RELATION TO A TEXTURED, SILICONE ALLERGAN IMPLANT. PATIENT PRESENTED WITH LEFT BREAST EDEMA. THE PATIENT UNDERWENT ULTRASOUND, FINE NEEDLE ASPIRATION AND PET-CT EVALUATIONS WHICH IDENTIFIED A SEROMA. IMMUNOHISTOCHEMISTRY WAS REPORTED AS " CD30+, KI67+" AND ANN ARBOR (LUGANO) STAGING WAS REPORTED AS IE. HISTOPATHOLOGICAL MARKER CD30+ HAS BEEN RECEIVED. PATHOLOGICAL MARKER ALK- HAS NOT BEEN RECEIVED. THE IMPLANT WAS REMOVED WITH EN-BLOC CAPSULECTOMY. THE PATIENT IS REPORTED TO NOW BE IN GENERAL GOOD CONDITION. THIS RELATES TO THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2343200 UNK GEL BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Life Threatening