BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK GEL BREAST IMPLANT

    MDR report key: 18380790 · Received December 22, 2023

    Report

    Report Number
    9617229-2023-32350
    Event Type
    Death
    Date Received
    December 22, 2023
    Date of Event
    November 20, 2023
    Report Date
    April 18, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED H6 CODE OF E2402 REPRESENTS THE EVENT OF DEATH.

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: TESFAYE, ELIORA A., ET AL. ¿FINANCIAL TOXICITY IN BREAST IMPLANT¿ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA.¿ ANNALS OF PLASTIC SURGERY, 2023, HTTPS://DOI.ORG/10.1097/SAP.0000000000003720. THE EVENTS OF "BI-ALCL, INFECTION, AND CAPSULAR CONTRACTURE" 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: BI-ALCL, CAPSULAR CONTRACTURE, RUPTURE, AND INFECTION.

    Description of Event or Problem · 0

    ADDITIONALLY REPORTED IN THE ARTICLE WAS "ONE DEATH OF DISEASE AMONG RESPONDENTS." THE CAUSE OF DEATH WAS NOT REPORTED.

    Description of Event or Problem · 0

    VIA ARTICLE, "FINANCIAL TOXICITY IN BREAST IMPLANT¿ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA," IT WAS REPORTED 32 PATIENT CONFIRMED BIA-ALCL. ADDITIONALLY, CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN), INFECTION, AND RUPTURE WERE REPORTED. TREATMENT INCLUDED SURGERY, ADJUVANT CHEMOTHERAPY, RADIATION THERAPY, AND STEM CELL TRANSPLANTATION. SPECIFICALLY, ALL PATIENTS UNDERWENT SURGERY, WHILE 9 (28%) RECEIVED ADJUVANT CHEMOTHERAPY, 2 (6%) RECEIVED RADIATION THERAPY, AND 2 (6%) RECEIVED STEM CELL TRANSPLANTATION. HISTOPATHOLOGICAL MARKERS WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2051348 UNK GEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention| L