BEUDAMED
    FDA Adverse Event Summary report: N

    TEXTURED SILICONE BREAST IMPLANT

    MDR report key: 3070387 · Received April 16, 2013

    Report

    Report Number
    MW5029841
    Date Received
    April 16, 2013
    Date of Event
    May 26, 2012
    Report Date
    April 16, 2013
    Manufacturer
    CUI
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TO WHOM IT MAY CONCERN: PURSUANT TO THE PARTNERSHIP BETWEEN THE FDA AND (B)(4) CONCERNING BREAST IMPLANT-ASSOCIATED ALCL, WE ARE REPORTING A CASE OF ALCL (ANAPLASTIC LARGE CELL LYMPHOMA) ASSOCIATED WITH A BREAST IMPLANT. PT IS (B)(6) FEMALE WHO FIRST PRESENTED LAST (B)(6) AFTER HAVING HAD BREAST AUGMENTATION IN (B)(6) SEVERAL YEARS PRIOR. SHE HAD NOTICED SWELLING OF THE LEFT BREAST WHICH EVENTUALLY BECAME PAINFUL AND CAUSED HER TO SEEK TREATMENT. WORKUP EVENTUALLY REVEALED SEROMA AROUND THE BREAST IMPLANT; THE FLUID CAME BACK AS CD 30 POSITIVE, ALK NEGATIVE, CONSISTENT WITH ANAPLASTIC LARGE CELL LYMPHOMA. HER IMPLANTS WERE REMOVED BILATERALLY, AND IT IS FELT THAT THIS IS ADEQUATE TREATMENT FOR THE PROBLEM. SHE CONTINUES TO UNDERGO SURVEILLANCE BY US IN ADDITION TO THE HEMATOLOGY/ONCOLOGY TEAM. OF NOTE, SHE WAS FOUND TO HAVE NONRUPTURED 410 CC TEXTURED SILICONE IMPLANTS MADE BY CUI (NOT AVAILABLE IN THE UNITED STATES). THE PT'S CARE WAS COORDINATED BETWEEN THE PLASTIC SURGERY AND THE HEMATOLOGY/ONCOLOGY TEAMS AT (B)((6). BREAST IMPLANTS REMOVED; NOT REPLACED. PT WILL UNDERGO SURVEILLANCE WITH MRI AND ULTRASOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164149 TEXTURED SILICONE BREAST IMPLANT TESTURED SILICONE BREAST IMPLANT, 410 CC FTR CUI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening| R