BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 9167627 · Received October 8, 2019

    Report

    Report Number
    9617229-2019-16009
    Event Type
    Death
    Date Received
    October 8, 2019
    Report Date
    November 4, 2020
    Manufacturer
    UNKNOWN MANUFACTURER
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED H.6. PATIENT CODE: 2093, 2439. ARTICLE CITATION: ¿BREAST IMPLANT¿ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA IN COLOMBIA: REPORT OF A MULTIDISCIPLINARY NATIONAL REGISTRY¿ CARLOS ANDRES OSSA GOMEZ, MD, JOSE FERNANDO ROBLEDO ABAD, MD, ALEJANDRO DUQUE, MD, RAMIRO HUERTAS, MD, RAMIRO HUERTAS, MD, ANA MARIA FIDALGO, MD, GIOVANNA RIVAS TAFFUR, MD, JOSE JOAQUIN CAICEDO MALLARINO, MD, FABIO TORRES, MD, WILLIAM ARMANDO MANTILLA DURAN, MD, VIRGINIA ABELLO, ROBERTO N. MIRANDA, MD, CAROLINA ECHEVERRI, MD, MARK WARREN CLEMENS, MD,; BREAST SURGERY DEPARTMENT, CLÍNICA LAS AMÉRICAS, AND HOSPITAL UNIVERSITARIO GENERAL DE MEDELLÍN, MEDELLIN, COLOMBIA; 18 AUGUST 2020; PLASTIC RECONSTRUCTIVE SURGERY GLOBAL OPEN. THE EVENTS OF LYMPHOMA ALCL, DEATH, SEROMA-LATE, LYMPHADENOPATHY, AND LUMP/NODULE ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. THE REASONS FOR REOPERATION INCLUDE: LYMPHOMA ALCL, SEROMA-LATE, LYMPHADENOPATHY, AND LUMP/NODULE.

    Description of Event or Problem · 0

    JOURNAL ARTICLE ¿BREAST IMPLANT¿ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA IN COLOMBIA: REPORT OF A MULTIDISCIPLINARY NATIONAL REGISTRY¿ DETAILED THAT PATIENT EXPERIENCED "DELAYED SEROMA", "PERI-IMPLANT MASS", "AXILLARY LYMPHADENOPATHY" AND "BREAST PAIN WITH TENDERNESS." PATHOLOGICAL MARKERS OBTAINED FROM BIOPSY OR FLOW CYTOMETRY DETERMINED ¿CLINICAL STAGE IV¿ DIAGNOSIS OF LYMPHOMA ALCL AND ¿IMMUNOHISTOCHEMICAL ANALYSIS SHOWED POSITIVE FOR CD30 AND NEGATIVE FOR ALK.¿ TREATMENT INCLUDED CHOP, TOTAL CAPSULECTOMY, IMPLANT REMOVAL, AND 3 CYCLES OF CHEMOTHERAPY. PATIENT THEN DEVELOPED HEADACHE AND BLURRED VISION, INDICATING CENTRAL NERVOUS SYSTEM INVOLVEMENT, AND PATIENT DIED 9 MONTHS FOLLOWING DIAGNOSIS. THE MANUFACTURER OF THE DEVICE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE EVENT OF LYMPHOMA ALCL SUSPECTED IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THE REASON FOR REOPERATION IS LYMPHOMA ALCL SUSPECTED. FURTHER INFORMATION FROM THE REPORTER REGARDING THE EVENTS, PRODUCT, AND PATIENT DETAILS HAVE BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING. THE STATUS OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED PATHOLOGY RESULTS ASSOCIATED WITH "ANAPLASTIC LARGE CELL LYMPHOMA" ON AN UNKNOWN SIDE. IT WAS REPORTED THAT "CASES ARE CONFIRMED, WITH IMMUNOHISTOCHEMISTRY TESTS." MARKERS WERE NOT PROVIDED. THE STATUS OF THE DEVICE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960385 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM UNKNOWN MANUFACTURER NI

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention