BEUDAMED
    FDA Adverse Event Death Summary report: N

    STYLE 468 SALINE FILLED BREAST IMPLANT

    MDR report key: 24391120 · Received February 19, 2026

    Report

    Report Number
    9617229-2026-03313
    Event Type
    Death
    Date Received
    February 19, 2026
    Date of Event
    March 29, 2024
    Report Date
    April 22, 2026
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Removal / Correction Number
    2011068-7/2/19-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE EVENT IS LYMPHOMA-ALCL-SUSPECTED, INFORMATION IN H7 AND H9 SHOULDN'T HAVE BEEN SUBMITTED. THE EVENT OF "LYMPHOMA-ALCL-SUSPECTED" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. REASON FOR REOPERATION: LYMPHOMA-ALCL-SUSPECTED. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: H1.

    Additional Manufacturer Narrative · 0

    THE EVENT OF "LYMPHOMA BIA-ALCL" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. NO CONTACT INFORMATION WAS PROVIDED FOR THE INITIAL REPORTER, THEREFORE ADDITIONAL EVENT, PRODUCT, AND/OR PATIENT DETAILS ARE NOT ATTAINABLE. REASON FOR REOPERATION: LYMPHOMA BIA-ALCL.

    Description of Event or Problem · 0

    PATIENT REPRESENTATIVE REPORTED "DEVELOPMENT OF ANAPLASTIC LARGE CELL LYMPHOMA; PAIN AND TIGHTNESS IN BREAST; HOSPITALIZATION; DEATH AND OTHER PAST ECONOMIC AND NON-ECONOMIC DAMAGES SUCH AS BUT NOT LIMITED TO MEDICAL CARE COSTS". DIAGNOSTIC MARKERS WERE NOT REPORTED THUS, THIS EVENT CANNOT BE CONFIRMED. THIS RECORD IS FOR THE LEFT SIDE. THE EXPLANT STATUS IS UNKNOWN.

    Description of Event or Problem · 0

    PATIENT REPRESENTATIVE REPORTED "DEVELOPMENT OF ANAPLASTIC LARGE CELL LYMPHOMA; PAIN AND TIGHTNESS IN BREAST; HOSPITALIZATION; DEATH AND OTHER PAST ECONOMIC AND NON-ECONOMIC DAMAGES SUCH AS BUT NOT LIMITED TO MEDICAL CARE COSTS". DIAGNOSTIC MARKERS WERE NOT REPORTED THUS, THIS EVENT CANNOT BE CONFIRMED. THIS RECORD IS FOR THE LEFT SIDE. THE EXPLANT STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448624 STYLE 468 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Life Threatening| D| R