BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 8001967 · Received October 24, 2018

    Report

    Report Number
    9617229-2018-08144
    Event Type
    Injury
    Date Received
    October 24, 2018
    Date of Event
    June 1, 2018
    Report Date
    October 15, 2021
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. HEALTH EFFECT - IMPACT CODES: F1905, F1901, F2201, F02. REASON FOR REOPERATION: SEROMA, BREAST TUMOR MASS, AND LYMPHOMA-ALCL.

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE "BREAST IMPLANT ASSOCIATED-ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL): THE FRENCH LYMPHOMA STUDY ASSOCIATION (LYSA) REGISTRY DATA," PROVIDED MORE DETAILS INCLUDING THERE WERE 88 CASES OF BIA-ALCL REGISTERED IN THE FRENCH LYMPHOPATH NETWORK INSTEAD OF 46 PREVIOUSLY REPORTED. THE TWO CLINICAL PRESENTATIONS I.E. SEROMA AND BREAST TUMOR MASS WITH OR WITHOUT SEROMA WERE MOST OFTEN CORRELATED WITH THE TWO DISTINCT HISTOLOGICAL SUBTYPES OR INFILTRATIVE. THREE PATIENTS WERE DIAGNOSED WITHOUT ANY MASS OR SEROMA (1 LYMPH NODE INVOLVEMENT, 2 IN THE CONTEXT OF SYSTEMATIC IMPLANT REMOVAL). THE MAJORITY OF PATIENTS WERE STAGE I-II WITH 13 PATIENTS WERE STAGE IV. CONSIDERING AVAILABLE INFORMATION REGARDING THE TYPE OF IMPLANTS, ALMOST ALL PATIENTS HAD AT LEAST ONE SILICONE-FILLED AND AT LEAST ONE TEXTURED IMPLANT WITH BIOCELL TEXTURATION. IMPLANT REMOVAL WITH TOTAL CAPSULECTOMY WAS PERFORMED IN 49 PATIENTS AND 17 UNDERWENT CHEMOTHERAPY BASED MOSTLY ON CHOP OR CHOP-LIKE CHEMOTHERAPY REGIMENS AND BRENTUXIMAB VEDOTIN CHP. AFTER 21 MONTHS OF MEDIAN FOLLOW-UP, 52 PATIENTS ARE ALIVE AND FREE OF EVOLUTIVE DISEASE AND ONE WAS LOST TO FOLLOW UP. FIVE PATIENT HAVE DIED, EITHER FROM LYMPHOMA PROGRESSION ALONE, OR ASSOCIATED WITH CONCOMITANT ACTIVE BREAST CANCER AND ONE DUE TO ANOTHER DISEASE. ALL HAD AN INFILTRATIVE HISTOLOGY, AND THE 2 PATIENTS WHO DIED FROM LYMPHOMA WERE STAGE IV. ALL BUT ONE RECEIVED SYSTEMIC CHEMOTHERAPY AND ONE RECEIVED PALLIATIVE CARE ONLY DUE TO CONCOMITANT ACTIVE BREAST CANCER. ONE OF THESE PATIENTS EARLY RELAPSED AFTER A FIRST COMPLETE REMISSION. AFTER THE BIA-ALCL DIAGNOSIS, BREAST RECONSTRUCTION WAS PERFORMED IN 23 PATIENTS, 17 WITH A NEW IMPLANT, LIPOFILLING IN 4 PATIENTS, WITH A FLAP IN 4 PATIENTS, AND ONE BENEFIT FROM COMBINED APPROACHES.

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: HAIOUN, CORINNE, ET AL. ¿BREAST IMPLANT ASSOCIATED-ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL): THE FRENCH LYMPHOMA STUDY ASSOCIATION (LYSA) REGISTRY DATA.¿ JOURNAL OF CLINICAL ONCOLOGY, VOL. 36, NO. 15_SUPPL, 2018, PP. 7554¿7554., DOI:10.1200/JCO.2018.36.15_SUPPL.7554. THIS EVENT IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN BOTH SALINE AND SILICONE LABELING. AS IT IS UNKNOWN WHETHER THE AFFECTED DEVICE IS SALINE OR SILICONE, NO DEVICE LABELING CAN BE SENT AT THIS TIME. THE EVENTS OF SEROMA, LUMP/NODULE, AND LYMPHOMA-ALCL ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. ALLERGAN IS UNABLE TO FOLLOW UP WITH THE AUTHOR, THEREFORE ADDITIONAL EVENT, PRODUCT, OR PATIENT DETAILS ARE NOT ATTAINABLE.

    Description of Event or Problem · 1

    THROUGH JOURNAL ARTICLE "BREAST IMPLANT ASSOCIATED-ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL): THE FRENCH LYMPHOMA STUDY ASSOCIATION (LYSA) REGISTRY DATA" IT WAS REPORTED: 46 CASES OF BIA-ALCL REGISTERED IN THE FRENCH LYMPHOPATH NETWORK. 29 OF THE CASES WERE CONFIRMED TO HAVE PRESENTED AS EFFUSION AND/OR BREAST TUMOUR MASS. TREATMENT INCLUDED: IMPLANT REMOVAL WITH CAPSULECTOMY IN 26 OUT OF THE 29 PATIENTS WITH ADDITIONAL TREATMENT BASED MOSTLY ON CHOP OR CHOP-LIKE CHEMOTHERAPY REGIMENS IN 12 PATIENTS. AFTER 2 YEARS OF MEDIAN FOLLOW-UP, 25 PATIENTS ARE ALIVE AND FREE OF DISEASE. FOUR PATIENTS WITH TUMOUR MASS PRESENTATION HAVE DIED, EITHER FROM LYMPHOMA PROGRESSION ALONE OR WITH CONCOMITANT ACTIVE BREAST CANCER. THIS RECORD REPRESENTS THE PATIENTS WHO ARE DISEASE FREE OR WHOSE DISEASE STATUS IS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840063 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM NI

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention