BEUDAMED
    FDA Adverse Event Summary report: N

    ESSURE

    MDR report key: 3030384 · Received April 1, 2013

    Report

    Report Number
    MW5029558
    Date Received
    April 1, 2013
    Date of Event
    September 1, 2011
    Report Date
    April 1, 2013
    Manufacturer
    CONCEPTUS, INC.
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT CALLED TO REPORT ON ESSURE PERMANENT BIRTH CONTROL SYSTEM. SHE STATED SHE EXPERIENCED MANY ADVERSE REACTIONS FROM THIS DEVICE AND HAD TO HAVE 3 SURGERIES. SHE STATED SHE HAD A LOT OF HEAVY BLEEDING, SEVERE CRAMPS, STABBING PAIN, BACK PAIN, PAINFUL INTERCOURSE, LOSS OF ENERGY, NAUSEA, DIZZINESS, AND SEVERE BLOATING TO THE POINT THAT SHE LOOKED PREGNANT. THE PT ALSO STATED SHE EXPERIENCED BLURRED VISION, DEPRESSION, OVARIAN CYSTS, CYSTS ON HER RIGHT FALLOPIAN TUBE AND HYDROSALPHINX, WHICH LED TO THE REMOVAL OF HER LEFT FALLOPIAN TUBE IN (B)(6) 2012. SHE ALSO STATED SHE HAD SKIN RASHES, FORGETFULNESS, INSOMNIA, PANIC ATTACKS (ABOUT 1 PER WEEK), MOOD SWINGS WHICH WERE UNCHARACTERISTIC, AND FREQUENT YEAST INFECTIONS (AT LEAST ONCE A MONTH). SHE ALSO STATED SHE HAD A SEVERE EATING DISORDER RESULTING IN DRASTIC WEIGHT LOSS AND ANOREXIA. SHE ALSO SAID THE DEVICE GAVE HER THYROID PROBLEMS AND AFFECTED HER HYPOTHYROID TO THE POINT WHERE SHE HAD TO DOUBLE HER MEDICATION. PT STATED HER ORGANS WERE FUSING TOGETHER WHICH SHE HAD TO HAVE 3 SURGERIES FOR. SHE ALSO STATED HER LIVER FUSED TO HER ABDOMINAL WALL. PT SAID SHE HAD A HYSTERECTOMY ON (B)(6) 2012, WHICH EXPLANTED THE DEVICE. SHE SAID SHE FELT A LOT BETTER IMMEDIATELY AFTER THE REMOVAL OF THE DEVICE. SHE SAID SHE CONTACTED CONCEPTUS AND INFORMED THEM OF HER ALLERGY TO NICKEL AND SAW WARNINGS WERE REMOVED. SHE STATED CONCEPTUS WAS RATHER RUDE TO HER AND BLAMES HER DOCTOR FOR PLACING THE DEVICE INSIDE HER. SHE SAID SHE WOULD LIKE TO SEE THE CLASS 3 DEVICE PROTECTION REMOVED FROM THIS DEVICE. PT WAS EXTREMELY UNHAPPY WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131771 ESSURE ESSURE PERMANENT BIRTH CONTROL SYSTEM HHS CONCEPTUS, INC. ESS305 789025

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other