BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5220035 · Received November 12, 2015

    Report

    Report Number
    2951250-2015-01438
    Event Type
    Injury
    Date Received
    November 12, 2015
    Report Date
    January 20, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATA CORRECTION: THE PRODUCT CODE KNH WAS REPLACED WITH HHS.

    Additional Manufacturer Narrative · 1

    RESULT AND ASSESSMENT OF THE PRODUCT TECHNICAL COMPLAINT INVESTIGATION RECEIVED ON 07-NOV-2015: THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: (B)(4). FINAL ASSESSMENT: FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. FOR CASES WHERE AN INSERT IS REMOVED AT A LATER TIME AFTER INSERTION, WE TYPICALLY DO NOT CONDUCT AN INSPECTION OF THE INSERT. IN THIS CASE, NO PRODUCT WAS RETURNED. 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. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. MEDICAL ASSESSMENT: NO PRODUCT QUALITY DEFECT WAS CONFIRMED THEREFORE A RELATIONSHIP TO THE REPORTED MEDICAL EVENT(S) IS EXCLUDED. THE REPORTED MEDICAL EVENT(S) ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENT(S) AND A QUALITY DEFECT. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS NON-MEDICALLY CONFIRMED CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND HAD HEAVY MENSES. SHE UNDERWENT A NOVASURE PROCEDURE 3 YEARS AFTER ESSURE INSERTION. THYROID HURTHLE CELL CANCER AND SJOGRENS SYNDROME WERE ALSO REPORTED. THESE EVENTS WERE CONSIDERED SERIOUS DUE TO MEDICAL SIGNIFICANCE. HEAVY MENSES IS A LISTED EVENT IN THE REFERENCE SAFETY INFORMATION FOR ESSURE, THE OTHER EVENTS ARE UNLISTED. AFTER ESSURE INSERTION MENSES PATTERN CHANGES MAY OCCUR. IN THE PRESENT CASE, LIMITED INFORMATION WAS PROVIDED. THE EXACT TEMPORAL RELATIONSHIP BETWEEN ESSURE INSERTION AND EVENT ONSET WAS NOT REPORTED. HOWEVER, GIVEN THE NATURE OF THIS EVENT A CONTRIBUTORY ROLE OF ESSURE CANNOT BE EXCLUDED. EVENTS THYROID HURTHLE CELL CANCER AND SJOGRENS SYNDROME WERE ASSESSED AS UNRELATED TO ESSURE, GIVEN THEIR PATHOPHYSIOLOGY AND CONSIDERING THE LOCAL EFFECT OF ESSURE IN THE FALLOPIAN TUBES. NON-SERIOUS EVENTS WERE ALSO REPORTED. THIS CASE WAS REGARDED AS INCIDENT SINCE A MEDICAL INTERVENTION WAS PERFORMED. THE PRODUCT TECHNICAL ANALYSIS CONCLUDED THAT BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS AND A QUALITY DEFECT. NO ACTIVE FOLLOW-UP WILL BE PURSUED, AS THIS CASE WAS IDENTIFIED DURING HEALTH AUTHORITY WEBSITE MONITORING.

    Description of Event or Problem · 1

    THIS CASE HAS BEEN IDENTIFIED DURING MONITORING OF POSTINGS ON AN FDA HOSTED DOCKET WEBSITE, WHICH HAS BEEN ESTABLISHED IN PREPARATION OF A PUBLIC FDA ADVISORY COMMITTEE WHICH TOOK PLACE IN SEPTEMBER 2015 (CASE# FDA-2014-N-0736-1645, AWARENESS DATE 19-OCT-2015). IT REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED IN 2008. THE CONSUMER IS A MOTHER OF THREE. SHE REPORTED THE FOLLOWING LIST OF PROCEDURES AND SURGERIES NEEDED SINCE ESSURE PLACEMENT AND THE DIAGNOSIS RECEIVED: 2009- BRAIN MRL FOR MIGRAINES. 2010- MRI CERVICAL SPINE, NERVE CONDUCTION TESTS, TRIGGER POINT INJECTIONS, THYROID ULTRASOUNDS, THYROID FNAS, PARTIAL THYROIDECTOMY FOR BILATERAL CERVICAL RADICULOPATHY, MONONEUROPATHY, THYROID HURTHLE CELL CANCER, NODULES, HYPOTHYROIDISM. 2011 - BILATERAL CARPAL TUNNEL SURGERIES FOR CARPAL TUNNEL SYNDROME; NOVASURE FOR HEAVY MENSES. 2012 - THYROID ULTRASOUNDS & FNA'S, EMERGENCY EYE VISIT FOR BILATERAL SWOLLEN CORNEAS 2013-THYROID ULTRASOUNDS 2014 -THYROID ULTRASOUNDS, EEG, RHEUMATOLOGY LAB WORK, BILATERAL KNEE ORTHOVISC FOR FIBROMYALGIA, SJOGRENS SYNDROME, HEMIPLEGIC MIGRAINES AND BILATERAL KNEE OSTEOARTHRITIS. 2015 -THYROID ULTRASOUNDS & FNAS. VITAMINS D & B12 DEFICIENT AND BILATERAL KNEE SYNVISC. MORTONS NEUROMA. SHE STATED BEFORE ESSURE SHE WAS ONLY SEEING A GENERAL PRACTITIONER AND A CARDIOLOGIST FOR HER MITRAL VALVE PROLAPSE AND A FEW DOCTORS FOR HER SCOLIOSIS AND BACK PAIN. AFTER ESSURE HER LIST OF DOCTORS AND SPECIALISTS GREW AND SO DID HER DIAGNOSIS LIST. AFTER ESSURE, SHE OFTEN THOUGHT THAT PROCEDURE WAS LINKED TO HER FAILING HEALTH, UNTIL RECENTLY SHE DISCOVERED WOMEN WITH THE SAME PROBLEMS: JOINT PAIN, AUTOIMMUNE DISORDERS, THYROID MALFUNCTION AND MIGRAINES. THE CONSUMER WANTED THE DEVICES REMOVED. COMPANY CAUSALITY COMMENT THIS SPONTANEOUS NON-MEDICALLY CONFIRMED CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND HAD HEAVY MENSES. SHE UNDERWENT A NOVASURE PROCEDURE 3 YEARS AFTER ESSURE INSERTION. THYROID HURTHLE CELL CANCER AND SJOGRENS SYNDROME WERE ALSO REPORTED. THESE EVENTS WERE CONSIDERED SERIOUS DUE TO MEDICAL SIGNIFICANCE. HEAVY MESES IS A LISTED EVENT IN THE REFERENCE SAFETY INFORMATION FOR ESSURE, THE OTHER EVENTS ARE UNLISTED. AFTER ESSURE INSERTION MENSES PATTERN CHANGES MAY OCCUR. IN THE PRESENT CASE, LIMITED INFORMATION WAS PROVIDED. THE EXACT TEMPORAL RELATIONSHIP BETWEEN ESSURE INSERTION AND EVENT ONSET WAS NOT REPORTED. HOWEVER, GIVEN THE NATURE OF THIS EVENT A CONTRIBUTORY ROLE OF ESSURE CANNOT BE EXCLUDED. EVENTS THYROID HURTHLE CELL CANCER AND SJOGRENS SYNDROME WERE ASSESSED AS UNRELATED TO ESSURE, GIVEN THEIR PATHOPHYSIOLOGY AND CONSIDERING THE LOCAL EFFECT OF ESSURE IN THE FALLOPIAN TUBES. NON-SERIOUS EVENTS WERE ALSO REPORTED. THIS CASE WAS REGARDED AS INCIDENT SINCE A MEDICAL INTERVENTION WAS PERFORMED. A PRODUCT TECHNICAL ANALYSIS IS EXPECTED. NO ACTIVE FOLLOW-UP WILL BE PURSUED, AS THIS CASE WAS IDENTIFIED DURING HEALTH AUTHORITY WEBSITE MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749576 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other| R