BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATRELLE SALINE IMPLANT

    MDR report key: 3874163 · Received June 11, 2014

    Report

    Report Number
    MW5036595
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ALLERGAN
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ANAPLASTIC LARGE CELL LYMPHOMA (ALCL). BREAST IMPLANT RELATED. DISCOVERED UPON REMOVING BREAST IMPLANT CAPSULE AND SEROMA FLUID FROM RIGHT BREAST IN PT WHO HAD TEXTURED SALINE-FILLED ALLERGAN IMPLANTS PLACED FOR COSMETIC BREAST ENLARGEMENT IN (B)(6) 2009. PT NOTICED BREAST ASYMMETRY IN SUMMER OF 2013 WHICH PROGRESSED TO RIGHT BREAST NOTICEABLY LARGER THAN LEFT SIDE WITH ULTRASOUND STUDY DONE ON (B)(6) 2014 SHOWING WHAT APPEARED TO BE FLUID AROUND THE RIGHT IMPLANT - POSSIBLE DEFLATION. THIS IMPLANT WAS INTACT UPON REMOVAL BUT HAD A LARGE SURROUNDING SEROMA. BECAUSE OF SUSPICION FOR ALCL, A RIGHT BREAST IMPLANT TOTAL CAPSULECTOMY AND IMPLANT REMOVAL WAS DONE. CAPSULE AND SEROMA FLUID SPECIMENS SENT FOR HISTOLOGY/PATHOLOGY EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344269 NATRELLE SALINE IMPLANT SALINE IMPLANT FWM ALLERGAN 168 NATRELLE SALINE- FILLED

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other