BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4020241 · Received August 19, 2014

    Report

    Report Number
    2951250-2014-00338
    Event Type
    Injury
    Date Received
    August 19, 2014
    Date of Event
    December 10, 2010
    Report Date
    December 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A CONSUMER VIA REGULATORY AUTHORITY (CASE# MW5036702) IN UNITED STATES ON (B)(6)-2014 WHICH REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE WHO RECEIVED ESSURE ((B)(4)) (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED EVENTS. ON (B)(6)-2010 THE CONSUMER HAD ESSURE ((B)(4)) (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED FOR TUBAL OCCLUSION. THE CONSUMER HAD ESSURE COILS INSERTED AND IMMEDIATELY SHE VOMITED AND EXPERIENCED LOW BLOOD PRESSURE. FOR APPROXIMATELY 4 DAYS AFTER THE INSERTION, SHE WAS IN SUCH TERRIBLE PAIN THAT SHE COULD NOT WALK UPRIGHT OR SLEEP. WITHIN A MONTH OF THE PLACEMENT SHE DEVELOPED PAINFUL BLOATING, WEIGHT GAIN AND CONTINUAL ABDOMINAL CRAMPING. HER LIFELONG ECZEMA TROUBLES SKYROCKETED AND SHE DEVELOPED IRRITABLE BOWEL SYNDROME. SIX MONTHS AFTER HAVING THEM PLACED, SHE HAD TO HAVE A FULL HYSTERECTOMY TO REMOVE THEM ON (B)(6)-2011. INTERNAL CORRECTION FROM INITIAL CASE: CASE CORRECTED FROM INCIDENT (ANTICIPATED) TO INCIDENT (UNANTICIPATED). PTC INVESTIGATION RESULT RECEIVED ON (B)(6)-2014: PTC GLOBAL NUMBER: (B)(4). FINAL ASSESSMENT: SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR AND INSPECT THE DEVICE TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. MEDICAL ASSESSMENT: THE MEDICAL EVENTS REPORTED ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. NO BATCH NUMBER WAS REPORTED. NEITHER A TECHNICAL BATCH INVESTIGATION NOR A BATCH CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE WITHOUT A BATCH NUMBER. AT THE TIME OF THIS MEDICAL ASSESSMENT THE TECHNICAL INVESTIGATION CONCLUDED "UNCONFIRMED QUALITY DEFECT". BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT. FOLLOW-UP FROM (B)(6)-2014: THE REQUIRED NUMBER OF FOLLOW-UP ATTEMPTS HAS BEEN COMPLETED, WITH NO RESPONSE TO DATE. NO FURTHER FOLLOW-UP WILL BE PURSUED. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REPORT RECEIVED VIA REGULATORY AUTHORITY, REFERS TO A FEMALE CONSUMER WHO HAD ESSURE INSERTED AND IMMEDIATELY AFTER INSERTION PROCEDURE, EXPERIENCED VOMIT AND LOW BLOOD PRESSURE. APPROXIMATELY 4 DAYS AFTER INSERTION, SHE EXPERIENCED TERRIBLE PAIN. WITHIN A MONTH OF THE PLACEMENT SHE DEVELOPED PAINFUL BLOATING, WEIGHT GAIN AND CONTINUAL ABDOMINAL CRAMPING. HER LIFELONG ECZEMA TROUBLES SKYROCKETED AND SHE DEVELOPED IRRITABLE BOWEL SYNDROME. IRRITABLE BOWEL SYNDROME AND ECZEMA TROUBLES SKYROCKETED WERE CONSIDERED SERIOUS DUE TO MEDICAL SIGNIFICANCE AND ARE UNLISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. THESE EVENTS WERE CONSIDERED INCIDENT (UNANTICIPATED) AS THEY LED TO A HYSTERECTOMY TO REMOVE ESSURE COILS. THE EVENTS VOMIT AND LOW BLOOD PRESSURE AFTER INSERTION PROCEDURE, TERRIBLE PAIN, PAINFUL BLOATING, WEIGHT GAIN, AND CONTINUAL ABDOMINAL CRAMPING WERE CONSIDERED NON-SERIOUS. IRRITABLE BOWEL SYNDROME (IBS) IS A FUNCTIONAL GI DISORDER CHARACTERIZED BY ABDOMINAL PAIN AND ALTERED BOWEL HABITS IN THE ABSENCE OF SPECIFIC AND UNIQUE ORGANIC PATHOLOGY. A COMPLEX COMBINATION OF ELEMENTS, INCLUDING PSYCHOLOGICAL STRESS, HORMONES, THE IMMUNE SYSTEM, AND NEUROTRANSMITTERS, APPEARS TO CAUSE ABNORMAL GI MUSCLE CONTRACTIONS OR SPASMS. THE ESSURE INSERT CONSISTS OF A NICKEL-TITANIUM ALLOY. ALLERGIC REACTIONS TO ESSURE ARE MORE COMMONLY RELATED TO NICKEL SENSITIVITY AND ITS MANIFESTATIONS INCLUDE SKIN ITCHING, RASH, ECZEMATOUS DERMATITIS, AND HIVES THAT RESOLVE AFTER DEVICE REMOVAL. IN THIS PARTICULAR CASE, CONSUMER HAD A LIFELONG HISTORY OF ECZEMA. HOWEVER, BASED ON POSITIVE TEMPORAL RELATIONSHIP, AND ALSO BASED ON THE INFORMATION THAT ESSURE CAN CAUSE OR AGGRAVATE HYPERSENSITIVITY REACTIONS, THE CAUSALITY BETWEEN ESSURE USE AND THESE EVENTS CANNOT BE TOTALLY EXCLUDED. THE PRODUCT TECHNICAL COMPLAINT (PTC) ANALYSIS CONCLUDED THAT BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497957 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R