BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK GEL BREAST IMPLANT

    MDR report key: 6011770 · Received October 7, 2016

    Report

    Report Number
    9617229-2016-00143
    Event Type
    Death
    Date Received
    October 7, 2016
    Report Date
    October 7, 2016
    Manufacturer
    UNKNOWN MANUFACTURER
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON 10/07/2016. ARTICLE CITATION: ¿BREAST IMPLANT ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA IN AUSTRALIA AND NEW ZEALAND ¿ HIGHER RISK FOR MACROTEXTURED IMPLANTS SUPPORTS A BACTERIAL ETIOLOGY,¿ A. LOCH-WILKINSON, K.J. BEATH, R.J.W. KNIGHT, W.L.F. WESSELS, M. MAGNUSSON, T. PAPADOPOULOS, T. CONNELL, J. LOFTS, M. LOCKE, I. HOPPER, R. COOTER, K VICKERY, P.A. JOSHI, H.M. PRINCE & A.K. DEVA. THE EVENTS 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, AND PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. DEVICE LABELING ADDRESSES: "BASED ON INFORMATION REPORTED TO FDA AND FOUND IN MEDICAL LITERATURE, A POSSIBLE ASSOCIATION HAS BEEN IDENTIFIED BETWEEN BREAST IMPLANTS AND THE RARE DEVELOPMENT OF ANAPLASTIC LARGE CELL LYMPHOMA (ALCL), A TYPE OF NON-HODGKIN¿S LYMPHOMA. WOMEN WITH BREAST IMPLANTS MAY HAVE A VERY SMALL BUT INCREASED RISK OF DEVELOPING ALCL IN THE FLUID OR SCAR CAPSULE ADJACENT TO THE IMPLANT. ALCL HAS BEEN REPORTED GLOBALLY IN PATIENTS WITH AN IMPLANT HISTORY THAT INCLUDES ALLERGAN¿S AND OTHER MANUFACTURERS¿ BREAST IMPLANTS. YOU SHOULD CONSIDER THE POSSIBILITY OF ALCL WHEN YOU HAVE A PATIENT WITH LATE ONSET, PERSISTENT PERI-IMPLANT SEROMA. IN SOME CASES, PATIENTS PRESENTED WITH CAPSULAR CONTRACTURE OR MASSES ADJACENT TO THE BREAST IMPLANT. WHEN TESTING FOR ALCL, COLLECT FRESH SEROMA FLUID AND REPRESENTATIVE PORTIONS OF THE CAPSULE, AND SEND FOR PATHOLOGY TESTS TO RULE OUT ALCL. IF YOUR PATIENT IS DIAGNOSED WITH PERI-IMPLANT ALCL, DEVELOP AN INDIVIDUALIZED TREATMENT PLAN IN COORDINATION WITH A MULTI-DISCIPLINARY CARE TEAM. BECAUSE OF THE SMALL NUMBER OF CASES WORLDWIDE, THERE IS NO DEFINED CONSENSUS TREATMENT REGIMEN FOR PERI-IMPLANT ALCL."

    Description of Event or Problem · 1

    THROUGH ALLERGAN'S LITERATURE REVIEW OF RECENT JOURNAL ARTICLES, WE RECEIVED THE FOLLOWING ARTICLE FROM MEDICAL SAFETY: "BREAST IMPLANT ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA IN AUSTRALIA AND NEW ZEALAND - HIGHER RISK FOR MACROTEXTURED IMPLANTS SUPPORTS A BACTERIAL ETIOLOGY." TABLE 4: 'PRESENTATION OF BIA-ALCL (N=46)' IN THE ARTICLE REPORTS THE FOLLOWING: 1 CASE OF "MASS WITH METASTATIC DISEASE (AXILLA)" (TABLE 4) AND "DEATH / MASS WITH METASTATIC DISEASE TO ONE LYMPH NODE IN AXILLA" (TABLE 5). MANUFACTURER COULD NOT BE SPECIFIED AND ARTICLE STATES "BIOCELL (ALLERGAN/INAMED/MCGHAN) ACCOUNTED FOR 57.1% OF IMPLANTS IN THIS SERIES." THE ARTICLE DOES NOT PROVIDE IMPLANTING, EXPLANTING PHYSICIAN INFORMATION, DEVICE SERIAL OR LOT INFORMATION, OR SIDES OF ALCL DIAGNOSIS. ARTICLE STATES, "ALL PATIENTS UNDERWENT TOTAL CAPSULECTOMY AND REMOVAL OF IMPLANTS BOTH ON DISEASED AND NON-DISEASED SIDE. ALL TUMORS WERE CD30 POSITIVE AND ALK NEGATIVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662594 UNK GEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR UNKNOWN MANUFACTURER NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R