BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESSURE

    MDR report key: 3030383 · Received April 1, 2013

    Report

    Report Number
    MW5029557
    Event Type
    Other
    Date Received
    April 1, 2013
    Date of Event
    May 1, 2010
    Report Date
    June 26, 2015
    Manufacturer
    CONCEPTUS
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM RPTR 06/26/2015: SHE STILL SUFFERS FROM SEVERE PAIN, TEETH CRACKING AND ERODING, BLEEDING GUMS, SEVERE MIGRAINES AND RASHES ALL OVER HER BODY INCLUDING HER GENITALS WHICH IS AFFECTING HER LOVE RELATIONSHIP. CALLER WANTS THIS PRODUCT OFF THE MARKET AND BELIEVES IT IS NOT A SAFE DEVICE.

    Description of Event or Problem · 1

    ADD'L INFO REC'D ON 05/13/2014 FROM RPTR: PT STATED THAT ABOUT 8 MONTHS AFTER THE REMOVAL OF THE ESSURE, SHE SLOWLY EXPERIENCED A RELAPSE OF SYMPTOMS. SHE STATED THAT IT BEGAN WITH PAIN, HEADACHES, AND VOMITING. SHE REPORTED THAT NOW THE SYMPTOMS ARE MUCH WORSE AND MUCH MORE FREQUENT. SHE DESCRIBES THEM TO BE UNBEARABLE AND COMPLETELY TAKING OVER HER LIFE. SHE IS CURRENTLY EXPERIENCING THE FOLLOWING SYMPTOMS: RASHES, KNEE PAIN WITH FLOATING CARTILAGE AND TORN MENISCI, SEVERE BACK PAIN, 3 HERNIATED DISCS IN HER NECK, FEVER, SEVERE PELVIC PAIN, MIGRAINES THAT LAST UP TO 3 DAYS, NAUSEA AND VOMITING. SHE STATED THAT HER DOCTOR HAS DESCRIBED WHAT IS HAPPENING TO HER BODY AS WHAT SOMEONE WHO HAS SUFFERED A MAJOR ACCIDENT OR AN ATHLETE OF MANY YRS BODY SHOULD HAVE LOOKED LIKE. SHE SAID THAT SHE IS NEITHER. SHE WANTS PEOPLE TO KNOW THAT ALTHOUGH THE MAJORITY OF PTS FEEL A LOT BETTER OF THE ESSURE, THAT MANY PEOPLE EVENTUALLY SUFFER LATER DUE TO THE SMALL FRAGMENTS OF METAL LEFT BEHIND.

    Description of Event or Problem · 1

    PT CALLED TO REPORT ON ESSURE PERMANENT BIRTH CONTROL SYSTEM. SHE STATED SHE EXPERIENCED MANY ADVERSE REACTIONS SINCE THE DATE OF IMPLANT INCLUDING SEVERE PAIN, UTIS, PELVIC PAIN, FEVERS, DIARRHEA, VOMITING, RASHES, NEUROPATHY, HIGH BLOOD PRESSURE, WEIGHT GAIN, STREP THROAT, SEVERE INFECTION, CONSTANT MIGRAINES AND FIBROMYALGIA. PT SAID SHE WAS NEVER TOLD A HYSTERECTOMY WAS THE ONLY WAY OF REMOVAL OF THE DEVICE. SHE SAID SHE WAS ON PAIN MEDICATION AND ALSO HAD TO GO TO PAIN MANAGEMENT AND EXPERIENCED SEVERE ARTHRITIS. SHE SAID SHE HAD A PARTIAL HYSTERECTOMY ON (B)(6) 2012, WHICH REMOVED THE DEVICE AND SHE INSTANTLY FELT A LOT BETTER. SHE STATED SINCE THE REMOVAL OF THE DEVICE, HER PAIN HAS DRASTICALLY IMPROVED AND HER BLOOD PRESSURE HAS GONE BACK DOWN. PT WAS EXTREMELY UNHAPPY WITH DEVICE AND WOULD LIKE TO WARN OTHER PEOPLE ABOUT IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132667 ESSURE ESSURE HHS CONCEPTUS

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other