BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3705455 · Received March 27, 2014

    Report

    Report Number
    MW5035258
    Event Type
    Injury
    Date Received
    March 27, 2014
    Date of Event
    August 1, 2012
    Report Date
    March 15, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I GOT ESSURE IN (B)(6) 2012. STARTED HAVING ISSUES 4-5 MONTHS, ATTRIBUTED THEM TO NOT BEING ON TOP OF MY EATING HABITS AND GETTING OLDER. HOWEVER ENDED UP IN ER ON (B)(6) 2014 DUE TO PELVIC PAIN AND SEVERE HEADACHE. THEY DID AN U/S AND I'VE DEVELOPED FIBROIDS AND HAVE AN UNKNOWN MASS ON ONE TUBE. MY LEFT COIL IS ALMOST COMPLETELY INSIDE MY UTERINE CAVITY AS WELL. OVER THE PAST YEAR AND A HALF I'VE HAD CHRONIC UTI'S, PAINFUL STABBING LIKE PAINS IN MY PELVIC AREA, 30% OF WEIGHT GAIN, NIGHTSWEATS, NUMBNESS, TINGLING IN MY LEFT BREAST, SEVERE HEADACHES, ANXIETY, THROAT INFECTIONS, PNEUMONIA, DIZZINESS, ABNORMAL PAP RESULTS FOR THE FIRST TIME IN 17 YEARS (ON THE 1ST AND ONLY TEST DONE SINCE ESSURE WAS INSERTED), FIBROIDS, UNKNOWN MASS ON A TUBE, SHORTER CYCLES, RANDOM CRAMPING, ODOR, HEARTBURN, CRAZY MOOD SWINGS, RASHES ON MY LEFT ARM, EXCESSIVE PEEING, HEAD FUZZINESS AND RINGING IN MY EARS.

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM THE REPORTER ON (B)(6) 2015: UPDATE ON (B)(6) 2014: I AM NOW SCHEDULED FOR A HYSTERECTOMY ON (B)(6). ESSURE WAS TO BE A NON INVASIVE, SAFE AND PERMANENT BIRTH CONTROL. INSTEAD I AM NOW HAVING THE HYSTERECTOMY AT (B)(6) YRS OLD WITH AT LEAST A 6 WK RECOVERY TIME. UPDATE ON (B)(6) 2014: HAD HYSTERECTOMY TO REMOVE ESSURE (B)(6). MOST ISSUES HAVE SUBSIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183522 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 34.000 YR Other