BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESSURE

    MDR report key: 2195416 · Received August 2, 2011

    Report

    Report Number
    MW5021632
    Event Type
    Other
    Date Received
    August 2, 2011
    Date of Event
    July 21, 2011
    Report Date
    August 2, 2011
    Manufacturer
    CONCEPTUS
    Product Code
    HHS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN (B)(6) 2008, I GOT ESSURE (PRODUCT BY CONCEPTUS) DONE - NON INVASIVE PERMANENT FORM OF BIRTH CONTROL. IT TOOK 12 MONTHS FOR MY FALLOPIAN TUBES TO BE FULLY BLOCKED, AS WHERE NO EGG WILL GET OUT AND NO SPERM WILL BE ABLE TO PASS. SHORTLY AFTER GETTING ESSURE, I EXPERIENCED HEAVIER THAN NORMAL MENSTRUAL BLEEDING AND CRAMPING, WHICH I DIDN'T HAVE ISSUES WITH BEFORE THE PROCEDURE. IT SEEMS LIKE, AS THE MONTHS WENT BY, THE MORE HEAVIER THE PERIODS AND MORE SEVERE THE CRAMPS. SINCE I DIDN'T BLEED THROUGH A TAMPON IN 1 HR (EVEN THOUGH IT WAS MORE LIKE A TAMPON EVERY 1 HR AND A HALF) THE DR SAID TO JUST TAKE IT EASY AND TAKE MOTRIN FOR THE PAIN. AFTER READING SEVERAL FORUMS ONLINE ABOUT OTHER PTS WHO'VE HAD ESSURE; THEY HAVE SIMILAR STORIES AS ME OR WORSE, SPRINGS/COILS MIGRATE TO OTHER PARTS OF THE BODY CAUSING SEVERE PAIN OR OTHER HEALTH PROBLEMS. NOW, ON (B)(6) 2011, I WAS TOLD THAT I WAS PREGNANT. WE CONFIRMED THE PREGNANCY ON (B)(6) 2011. HOW AM I PREGNANT IF ESSURE IS A PERMANENT FORM OF BIRTH CONTROL?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSURE ESSURE HHS CONCEPTUS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other