BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 8001196 · Received October 24, 2018

    Report

    Report Number
    9617229-2018-08087
    Event Type
    Death
    Date Received
    October 24, 2018
    Date of Event
    June 1, 2018
    Report Date
    November 12, 2019
    Manufacturer
    UNKNOWN MANUFACTURER
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: "BREAST IMPLANT ASSOCIATED-ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL): THE FRENCH LYMPHOMA STUDY ASSOCIATION (LYSA) REGISTRY DATA." HAIOUN, CORINNE; LAURENT, CAMILLE; LE BRAS, FABIEN; DAO, THU HA; ITTI, EMMANUEL; MALHAIRE, CAROLINE, DOI: 10.1200/JCO.2018.36.15_SUPPL.7554, JOURNAL OF CLINICAL ONCOLOGY, 1/JUN/2018. (B)(4). 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 LYMPHOMA - ALCL, SEROMA, LUMP/NODULE AND DEATH ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION REGARDING AUTHOR CONTACT INFORMATION HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    IN RESPONSE TO FDA REPORT NUMBER: MW5087742. REASON FOR REOPERATION: UNKNOWN IF REOPERATION HAS OCCURRED. THESE ARE KNOWN POTENTIAL ADVERSE EVENTS ADDRESSED IN THE PRODUCT LABELING.

    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 FOUR PATIENTS WHO HAVE DIED.

    Description of Event or Problem · 1

    FOUR PATIENTS WITH TUMOR MASS PRESENTATION HAVE DIED, EITHER FROM LYMPHOMA PROGRESSION ALONE OR WITH CONCOMITANT ACTIVE BREAST CANCER. THIS RECORD REPRESENTS THREE OF THE FOUR PATIENTS WHO HAVE DIED, IN WHICH SPECIFIC PATIENT INFORMATION WAS NOT PROVIDED. ADDITIONALLY HEALTH PROFESSIONAL REPORTED A PATIENT DEATH RELATED TO DIAGNOSIS OF RIGHT SIDE ALCL PRESENTED AS SEROMA. HISTOPATHOLOGICAL MARKERS WERE PROVIDED AS CD30 POSITIVE AND ALK NEGATIVE. STATUS OF THE DEVICE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840814 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM UNKNOWN MANUFACTURER NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death