BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLERGAN NATRELLE BIO TEXTURED IMPLANTS

    MDR report key: 9473007 · Received December 13, 2019

    Report

    Report Number
    MW5091678
    Event Type
    Injury
    Date Received
    December 13, 2019
    Date of Event
    October 7, 2019
    Report Date
    December 12, 2019
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM A BREAST CANCER SURVIVOR, HAD A DOUBLE MASTECTOMY ON (B)(6) 2012, HAD CHEMO AND TOOK HORMONE THERAPY FOR 5 YRS AND WAITED TO HAVE RECONSTRUCTION UNTIL I WAS CLEARED BY MY ONCOLOGIST ON (B)(6) 2017. I WAS NOTIFIED BY ALLERGAN ABOUT THE RECALL ON MY BIO TEXTURED IMPLANTS ON JULY 28, 2019 BY MAIL. IT WAS VERIFIED BY MY BOTH ALLERGAN AND MY PLASTIC SURGEON DR (B)(6) FROM (B)(6) AND (B)(6) MEDICAL CENTER THAT I HAVE BOTH IMPLANTS PUT IN ON (B)(6) 2017. I HAVE HAD SYMPTOMS OF PAIN ON BOTH BREAST, DRY SKIN, FATIGUE, LOSS OF HAIR, RASH AROUND FACE AND NECK AND ALSO AROUND MY BREAST AREAS FOR SEVERAL MONTHS. MY RIGHT BREAST WAS ALSO LARGER THAN THE OTHER, MY PS SCHEDULED ME TO HAVE MY EXPLANT ON (B)(6) 2019. IN THE MEANTIME, I HAD AN MRI DONE FOLLOWED BY AN US AND A BIOPSY BUT FOR ONLY 1 BREAST, THE RIGHT SIDE. THE RADIOLOGIST AT THE (B)(6) CENTER IN (B)(6) "FELT" IT WAS BENIGN AND DID NOT DO A BIOPSY EVEN THOUGH IT WAS A SIZE 8.5MM. THE RIGHT BREAST BY MY LYMPH NODE WAS 10.5 MM, BUT THE PATH SHOWED NEGATIVE. THE RADIOLOGIST DID NOT GET ENOUGH FLUID TO DO A CD30 TO DO A BIA ALCL. ON MY SURGERY ON (B)(6), 2019. MY PS WAS NOT ABLE TO REMOVE ALL OF THE CAPSULES ON BOTH IMPLANTS BECAUSE IT WAS STUCK AGAINST MY RIBS. ANY REMAINING CAPSULES WENT TO PATHOLOGY AT (B)(6) MEDICAL CENTER FOR TESTING AND IT WAS ALSO NEGATIVE FOR BIA ALCL, AND IT WAS NOTED THAT IMPLANTS THEMSELVES WERE INTACT AND NEGATIVE AS WELL. PLEASE NOTE THE ACTUAL IMPLANTS ARE DARK YELLOW AND HAS A BROWNISH GROWTH IN THE MIDDLE AND SIDE ALSO LOCATED ON THE SIDES WHERE THE TUMORS WERE FOUND VIA MRI AND US. I CHOSE NOT TO HAVE ANY NEW IMPLANTS TO BE REPLACED NOT A FAT TRANSFER. MY PS DID NOT HAVE THE 8.5 MM ON THE LEFT BREAST BIOPSIED OR REMOVED. I HAVE A F/U MRI IN 3 MONTHS TO SEE IF MY TUMORS HAVE GROWN. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264762 ALLERGAN NATRELLE BIO TEXTURED IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL FTR ALLERGAN
    1264763 ALLERGAN NATRELLE BIO TEXTURED IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL FTR ALLERGAN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| O| R| S