BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 1932626 · Received December 14, 2010

    Report

    Report Number
    MW5018601
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    May 25, 2008
    Report Date
    December 14, 2010
    Manufacturer
    CONCEPTUS
    Product Code
    HHS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM REPORTER ON (B)(4) 2012. I HAVE HAD BAD HEADACHES, NAUSEA THAT EFFECTS MY EVERYDAY LIFE, HEADACHES EVERYDAY, WEAKNESS, UNEXPLAINED STOMACH PAINS THAT COME AND GO, INSOMNIA, ANXIETY, BAD NERVES, HOT FLASHES, NIGHT SWEATS, AND VERY PAINFUL INTERCOURSE. BEEN TO THE ER 3 TIMES. NO ANSWERS AND NO INSURANCE TO TRY TOO. NOW (B)(6) POUNDS.

    Description of Event or Problem · 1

    I HAD THE ESSURE PROCEDURE DONE IN 2008, SINCE THEN, I HAVE BEEN HAVING BAD HEALTH PROBLEMS. STARTED OUT WITH BLEEDING ALL THE TIME, NOW IN THE PAST MONTH, I'VE BEEN TO THE ER, 3 TIMES WITH NO LUCK FINDING OUT WHAT IS WRONG. I HAVE SEVERE STOMACH PAINS, TERRIBLE NAUSEA AND HEADACHES, SINCE I HAVE HAD THE IMPLANTS, ONLY NOW THEY SEEM TO BE GETTING WORSE, SENDING ME TO THE HOSPITAL! I HAVE NO HEALTH INSURANCE, SO I HAVEN'T BEEN ABLE TO GO TO THE DOCTOR, WITH THESE PROBLEMS. THE LAST ER VISIT, I WAS TOLD IT COULD BE THE ESSURE COILS, CAUSING MY PROBLEMS, BUT NOT FOR SURE. EVERY DOCTOR OR MEDICAL PERSON THAT I MENTION ESSURE TO, HAS NEVER HEARD OF IT!!! KINDA SCARY, I HAVE BEEN ON LINE AND FOUND COUNTLESS NUMBER OF WOMEN WITH THE SAME PROBLEMS, AFTER ESSURE! I WANT THESE THINGS OUT OF ME, THEY ARE MAKING ME SO SICK, I CANNOT TAKE CARE OF MY BABIES, THE WAY I NEED TO! I FOUND A DOCTOR THAT WILL TAKE THEM OUT FOR (B)(6), WHICH I SEE NO WAY OF PAYING THAT KIND OF MONEY! BUT I NEED SOME HELP OR ADVICE, ON WHAT TO DO. THANKS. DATES OF USE: (B)(6) 2008 - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: PERMANENT BIRTH CONTROL (CANNOT HAVE ANY MORE BABIES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    0 ESSURE ESSURE PERMANENT BIRTH CONTROL HHS CONCEPTUS 626598

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| O| S