BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 2980617 · Received February 20, 2013

    Report

    Report Number
    MW5029120
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    August 11, 2011
    Report Date
    February 20, 2013
    Manufacturer
    CONCEPTUS, INC.
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM REPORTER ON (B)(6) 2013: I WAS MISTAKEN ON MY IMPLANTING DATE IT WAS ACTUALLY (B)(6) 2011 NOT THE (B)(6). WHEN I LAST UPDATED I SAID THE DR HAD SCHEDULED A HYSTERECTOMY. HERE IS WHAT THEY HAD FOUND BEFORE MY HYSTERECTOMY: SUPERFICIAL ADENOMYOSIS UTERI, NABOTHIAN CYST, CERVIX UTERI. THERE IS A SUGGESTION OF POSSIBLE ADENOMYOSIS IN THE ADJACENT MYOMETRIUM. CROSS SECTION OF THE CORNEAL DEMONSTRATES VERY FOCAL HEMORRHAGE. MASS LESION IS NOT NOTED. A1 THROUGH A4 ARE SECTIONS OF ENDOMETRIUM AND MYOMETRIUM, INCLUDING CORNEAL HEMORRHAGE. SECTIONS OF CORPUS UTERUS SHOW SECRETORY ENDOMETRIUM AND SUPERFICIAL ADENOMYOSIS UTERI. SO THIS IS WHAT I READ AFTER MY HYSTERECTOMY THAT I HAD ON (B)(6)2013 TO HAVE ESSURE TAKEN OUT. I HAVE HEAVY METAL TOXIC POISONING FROM THE ESSURE BEING IN MY BODY, NICKEL DOES HARM YOU NO MATTER HOW LITTLE IS IN THE PRODUCT AND NOW NEED TO DO DETOXING ON MYSELF. PLEASE LOOK INTO RECALLING THIS PRODUCT OFF THE MARKET IT IS NOT SAFE TO BE IN ANY WOMEN'S BODIES!!!! I HAVE HAD TO GO EVERY 3 MONTHS FOR FOLLOW UPS FOR MIGRAINE PREVENTIVE MEDS AS THE MIGRAINES GOT SO BAD TO 20 A MONTH THEY PUT ME ON THOSE TO STOP THE MIGRAINES. I AM STILL ON THESE AS SO SOON AFTER SURGERY DR IS NOT WILLING TO TAKE ME OFF THEM SO QUICK.

    Description of Event or Problem · 1

    I HAD THE ESSURE PLACED (B)(6) 2011, I WAS SUPPOSED TO HAVE A PLASTIC ONE PLACED, BUT UPON THE FDA TAKING OFF THE WARNING FOR THE NICKEL ALLERGY, THE DOCTOR DECIDED, I NO LONGER NEEDED THE PLASTIC ONE SINCE YOU GUYS FELT EVERYONE WOULD BE FINE. WELL, NOT EVERYONE IS FINE, I HAVE BAD ALLERGIES TO NICKEL AND I ARGUED THE POINT CONSTANTLY AND IN THE END THEY SAID IT WAS JUST A SMALL BIT OF NICKEL AND IT REALLY WOULDN'T HARM ME AND I FIGURED OK IF YOU GUYS TOOK OFF THE WARNING AND THEY WERE MY DOCTOR'S I SHOULD BE FINE. WELL TWO YEARS LATER, SIX YEAST INFECTIONS LATER AND A LOT OF PAIN LATER I CAN TELL YOU TAKING THE WARNING OFF WAS A MISTAKE AND ME HAVING IT DONE WAS A MISTAKE AND I AM IN THE PROCESS OF VISITING MY DOCTOR TO SEE WHAT OTHER DAMAGE HAS BEEN DONE WITH THE ESSURE PRODUCT AS I SEEM TO HAVE A LOT MORE PAIN. I GO IN (B)(6) TO MY DOCTOR, BUT I HAVE GONE IN JUST THIS PAST TUESDAY AND TO THE CLINIC AND SUNDAY TO THE EMERGENCY ROOM TO BE TREATED. I HAVE BEEN TREATED IN (B)(6) FOR A YEAST INFECTION ALSO, AND (B)(6) I HAD ONE IN (B)(6), IT WAS A URINARY TRACT INFECTION AND (B)(6) 2011, I HAD A YEAST INFECTION AFTER THE PROCEDURE FOLLOWED BY A URINARY TRACT INFECTION, ALL TREATED BY DOCTOR'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73345 ESSURE ESSURE HHS CONCEPTUS, INC. 855630

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other