BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 8416313 · Received March 13, 2019

    Report

    Report Number
    9617229-2019-01605
    Event Type
    Injury
    Date Received
    March 13, 2019
    Report Date
    March 13, 2019
    Manufacturer
    UNKNOWN MANUFACTURER
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: CLEMENS, AND MARK W. ¿INTRODUCTION TO THE ¿CURRENT CONTROVERSIES IN BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL)" SUPPLEMENT.¿ OUP ACADEMIC, OXFORD UNIVERSITY PRESS, 31 JAN. 2019, ACADEMIC.OUP.COM/ASJ/ARTICLE/39/SUPPLEMENT_1/S1/5304921. THE EVENTS OF CAPSULAR CONTRACTURE, SEROMA-LATE, AND LYMPHOMA-ALCL 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, 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

    JOURNAL ARTICLE "2019 NCCN CONSENSUS GUIDELINES ON THE DIAGNOSIS AND TREATMENT OF BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA" FIGURE 6 REPORTED CASE 4 HAD LEFT SIDE "BIA-ALCL, PERIPROSTHETIC EFFUSION , DOUBLE CAPSULE" AND A "CAPSULAR CONTRACTURE," BAKER GRADE UNKNOWN. NO PATHOLOGICAL MARKERS WERE PROVIDED. "SURGICAL EN BLOC RESECTION WAS PERFORMED THROUGH [PATIENT'S] INFRAMAMMARY FOLD INCISION. DISEASE WAS INVASIVE INTO BUT NOT BEYOND THE CAPSULE, AND [PATIENT] WAS A STAGE 1C AND REQUIRED NO FURTHER TREATMENT." DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210130 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM UNKNOWN MANUFACTURER NI

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention