BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 24570942 · Received March 11, 2026

    Report

    Report Number
    9617229-2026-04461
    Event Type
    Death
    Date Received
    March 11, 2026
    Report Date
    March 11, 2026
    Manufacturer
    UNKNOWN MANUFACTURER
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: XU, J., HSI, E., MIRANDA, R. ET AL. ANAPLASTIC LARGE CELL LYMPHOMA: UNUSUAL CLINICAL AND PATHOLOGIC FINDINGS: A REPORT OF THE 2023 SH-EA4HP LYMPHOMA WORKSHOP. AMERICAN JOURNAL OF CLINICAL PATHOLOGY. 2025, VOL. 164, NO. 1; 110-125. CLARIFICATION B2 (DATE OF DEATH): 1 YEAR AFTER DIAGNOSIS (DATE OF DIAGNOSIS IS UNKNOWN). CLARIFICATION D.6A (IMPLANT DATE): THE PATIENT HAD TEXTURED BREAST IMPLANTS FOR 10 YEARS. THE EVENT OF LYMPHOMA - ALCL IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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: LYMPHOMA-ALCL-CONFIRMED, LYMPH NODE INVOLVEMENT, RUPTURE.

    Description of Event or Problem · 0

    LITERATURE REVIEW TITLED "ANAPLASTIC LARGE CELL LYMPHOMA: UNUSUAL CLINICAL AND PATHOLOGIC FINDINGS: A REPORT OF THE 2023 SH-EA4HP LYMPHOMA WORKSHOP¿ REPORTED "A... PATIENT WITH COSMETIC TEXTURED BREAST IMPLANTS FOR APPROXIMATELY 10 YEARS PRESENTED WITH RIGHT BREAST PAIN" , "IMPLANT REPLACED DUE TO CONCERN FOR RUPTURED IMPLANT", "RIGHT BREAST ENLARGED AFTER SURGERY", BILATERAL AXILLARY LYMPH NODES AND ENLARGEMENT AND WAS DIAGNOSED WITH ADVANCED BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL). IMAGING REVEALED A CHEST WALL MASS WITH PLEURAL EFFUSION AND LYMPH NODE INVOLVEMENT. DIAGNOSTIC PROCEDURES INCLUDED CHEST X-RAY, CT SCAN, TISSUE BIOPSY, LYMPH NODE BIOPSY, AND PLEURAL FLUID ANALYSIS. THE DISEASE PROGRESSED DESPITE TREATMENT, AND THE PATIENT DIED APPROXIMATELY ONE YEAR AFTER DIAGNOSIS". PATHOLOGICAL MARKERS CD30+ AND ALK- HAVE BEEN REPORTED FOR THIS PATIENT, CONFIRMING THE EVENT OF ALCL. THE MANUFACTURER OF THE DEVICE IS UNKNOWN. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE STATUS UNKNOWN. TREATMENT: PATIENT RECEIVED NEOADJUVANT CHEMOTHERAPY WITH CYCLOPHOSPHAMIDE, DOXORUBICIN AND PREDNISONE, FOLLOWED BY RADICAL RESECTION OF THE RIGHT BREAST AND TREATMENT WITH BRENTUXIMAB VEDOTIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74934 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM UNKNOWN MANUFACTURER NI

    Patients

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