BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK GEL BREAST IMPLANT

    MDR report key: 8660603 · Received May 31, 2019

    Report

    Report Number
    9617229-2019-05684
    Event Type
    Death
    Date Received
    May 31, 2019
    Date of Event
    January 1, 2007
    Report Date
    November 12, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IN RESPONSE TO FDA REPORT NUMBER: MW5087735. THE EVENTS OF ALCL AND SEROMA ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "CAUSE OF DEATH IS ALCL WITH MARKERS C30+, CD4+, CD43+, AND ALK- PRESENT". "[PATIENT] PRESENTED WITH SYMPTOMS OF A DELAYED SEROMA" AND WAS DIAGNOSED WITH ALCL 8 YEARS AFTER IMPLANTATION. PATIENT WAS TREATED WITH "CAPSULECTOMY", BUT HAD AN "INCOMPLETE RESECTION OF A MASS". PATIENT ALSO RECEIVED CHEMOTHERAPY AND RADIATION THERAPY. PATIENT WAS THOUGHT TO BE DISEASE FREE, BUT 5 YEARS LATER, RELAPSED "WITH WIDESPREAD DISSEMINATION OF DISEASE" AND DIED. IT IS UNKNOWN IF THE DEVICE WAS EXPLANTED.

    Additional Manufacturer Narrative · 1

    THE EVENTS OF DEATH AND LYMPHOMA ALCL ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. IT IS UNKNOWN IF REOPERATION OCCURRED. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    RESEARCHING PHYSICIAN REPORTED DEATH RELATED TO LYMPHOMA ALCL. PATHOLOGICAL MARKERS CONFIRMING ALCL HAVE NOT BEEN RECEIVED. THE DEVICE MANUFACTURER IS UNKNOWN. THIS RECORD IS FOR THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454290 UNK GEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death