BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 7973478 · Received October 17, 2018

    Report

    Report Number
    9617229-2018-08071
    Event Type
    Injury
    Date Received
    October 17, 2018
    Date of Event
    August 7, 2018
    Report Date
    October 17, 2018
    Manufacturer
    UNKNOWN MANUFACTURER
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: "TRANSCRIPTIONAL ANALYSIS DISTINGUISHES BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA FROM OTHER PERIPHERAL T-CELL LYMPHOMAS," BY DI NAPOLI, ARIANNA; DE CECCO, LORIS; PICCALUGA, PIER PAOLO; NAVARI, MOHSEN; CANCILA, VALERIA; CIPPITELLI, CLAUDIA; PEPE, GIUSEPPINA; LOPEZ, GIANLUCA; MONARDO, FRANCESCA; BIANCHI, ANTONELLA; D¿AMORE, EMANUELE STEFANO GIOVANNI; GIANELLI, UMBERTO; FACCHETTI, FABIO; BERTI, EMILIO; BHAGAT, GOVIND, MODERN PATHOLOGY, AN OFFICIAL JOURNAL OF THE UNITED STATES AND CANADIAN ACADEMY OF PATHOLOGY, INC, AUGUST 7 2018, DOI.ORG/10.1038/S41379-018-0130-7. THE EVENTS OF LYMPHOMA - ALCL AND LYMPHOMA ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. CLARIFICATION: 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. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THROUGH ARTICLE "TRANSCRIPTIONAL ANALYSIS DISTINGUISHES BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA FROM OTHER PERIPHERAL T-CELL LYMPHOMAS" 12 CASES OF ALCL WITH ALK- AND CD30+ MARKERS CONFIRMED WERE REPORTED. THE CONTROL GROUP OF THE STUDY COMPRISED OF 4 CASES OF ALK-POSITIVE ALCL, 4 CASES OF ALK-NEGATIVE ALCL AND 16 CASES OF CUTANEOUS ALCL HOWEVER NO ADDITIONAL PATHOLOGICAL MARKERS WERE PROVIDED. IT IS ALSO UNCONFIRMED WHETHER THE CONTROL GROUP PATIENTS HAD BREAST IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815146 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM UNKNOWN MANUFACTURER NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention