BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 11641958 · Received April 9, 2021

    Report

    Report Number
    9617229-2021-06067
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    January 5, 2021
    Report Date
    April 9, 2021
    Manufacturer
    UNKNOWN MANUFACTURER
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: QUESADA, ANDRES E., ZHANG, YANMING, PTASHKIN, RYAN, ET AL. NEXT GENERATION SEQUENCING OF BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMAS REVEALS A NOVEL STAT3-JAK2 FUSION AMONG OTHER ACTIVATING GENETIC ALTERATIONS WITHIN THE JAK-STAT PATHWAY. THE BREAST JOURNAL. 05/JAN/2021; 1-8. THE EVENT OF LYMPHOMA - ALCL IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: BIA-ALCL.

    Description of Event or Problem · 1

    THROUGH JOURNAL ARTICLE ¿NEXT GENERATION SEQUENCING OF BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMAS REVEALS A NOVEL STAT3-JAK2 FUSION AMONG OTHER ACTIVATING GENETIC ALTERATIONS WITHIN THE JAK-STAT PATHWAY,¿ AUTHORS REPORT A (B)(6) YEARS OLD AND REASON FOR IMPLANT IS NOTED AS DUCTAL CARCINOMA IN SITU. PATIENT WAS IMPLANTED WITH A TEXTURED IMPLANT OF AN UNKNOWN FILL AND PRESENTED WITH FIRMNESS ABOVE THE LEFT BREAST IMPLANT AND CHANGE IN SHAPE OF IMPLANT SIX YEARS AFTER IMPLANT. THE STAGE OF ALCL WAS NOTED AS T4N2M0. TREATMENT PROVIDED AS CAPSULECTOMY, BV-CHP X 6 CYCLES, AND CONSOLIDATIVE RADIOTHERAPY. THE MANUFACTURER OF THE DEVICE IS UNKNOWN. AFFECTED SIDE IS LEFT. THE STATUS OF THE DEVICE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538924 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM UNKNOWN MANUFACTURER NI

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R