BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLERGAN SILICONE IMPLANT TEXTURED

    MDR report key: 11929903 · Received June 2, 2021

    Report

    Report Number
    MW5101684
    Event Type
    Injury
    Date Received
    June 2, 2021
    Date of Event
    September 14, 2020
    Report Date
    May 23, 2021
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FIVE (5) MAMMARY LYMPH NODES DISSECTED ATTACHED TO MAMMARY ARTERY LYMPHADENOPATHY. TWO MRIS BY MAYO / JAX ON (B)(6) 2019 AND (B)(6) 2020 INDICATED ENLARGED MAMMARY LYMPHNODES. SUBSEQUENT PETSCAN ON (B)(6) 2020 - SUSPICIOUS FOR MALIGNANT / METASTATIC. PROCESS THORACOSCOPY (B)(6) 2020. AS "GS" NOR RADIOLOGY COULD SAFELY REACH ARCA. FIVE ENLARGED NODES ADHERENT TO ARTERY, SO DISSECTED MAMMARY ARTERY ALONG WITH LYMPHNODES. DR (B)(6) ADVISED ME THIS WAS DUE TO IMPLANT. AT THIS TIME I HAVE NOT HAD SURGERY TO REMOVE IMPLANT DUE TO MY AGE AND NEED FOR EXTENSIVE SURGERY AS IMPLANT UNDER MUSCLE. ALLERGAN SENT LETTER FOR FIRST TIME A FEW WEEKS AGO TO ADVICE ME OF RECALL. I FOUND OUT VIA (B)(6) OF ISSUE IN 2019 AND CONTACTED THEM TO CONFIRM I HAD RECALLED IMPLANT. FORM LETTER WAS ALL THEY SENT. DIDN'T SIGN IT NOR ADDRESS ONE BY "IVAME". I WILL BE PLEASED TO PROVIDE YOU ANY MEDICAL INFO. THIS HAS BEEN A LUMP AND DIFFERENT PROCESS TO OBTAIN HELP AS I FOUND THAT MOST DRS ARE NOT AWARE OF ISSUES WITH IMPLANTS. I CAN BE REACHED AT: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822593 ALLERGAN SILICONE IMPLANT TEXTURED PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN 115-469

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R