BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 19163788 · Received April 23, 2024

    Report

    Report Number
    2951250-2024-00297
    Event Type
    Injury
    Date Received
    April 23, 2024
    Report Date
    May 3, 2024
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4) ON 17-APR-2024. THE MOST RECENT INFORMATION WAS RECEIVED ON 29-APR-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ("STINGING BACK PAIN ") IN A 64 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 624301) FOR PERMANENT CONTRACEPTIVE TUBAL IMPLANT. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2007, THE PATIENT HAD ESSURE INSERTED. ON 29-NOV-2007, 43 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED CHEST PAIN ("IN THE EVENING, LEFT SUB-MAMMARY PAIN "), DYSPNOEA ("DIFFICULTY BREATHING "), TREMOR ("TREMORS "), ANXIETY ("ANXIETY"), PNEUMONIA ("PNEUMONIA") AND LUNG DISORDER ("STILL EXPERIENCING LUNG PROBLEMS"). IN 2013 SHE EXPERIENCED ARTHRALGIA ("REFERRED TO A RHEUMATOLOGIST AT THE END OF 2013, FOR GENERAL ARTHRALGIA FOR 1 YEAR"). ON UNKNOWN DATE SHE EXPERIENCED BACK PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), MORPHOEA ("LOCALIZED SCLERODERMA"), CHOLANGITIS ("CHOLANGITIS"), DRY EYE ("DRY EYE SYNDROME "), VITAMIN B12 DEFICIENCY ("LACK OF VITAMIN B12 "), WRIST PAIN ("RIGHT WRIST PAIN FOR 2 YEARS"), DIZZINESS ("DIZZINESS"), HYPERHIDROSIS ("SWEATING") AND VISUAL IMPAIRMENT ("VISUAL PROBLEMS"). THE PATIENT WAS TREATED WITH ANTIBIOTICS AND B12-VITAMIN (CYANOCOBALAMIN). AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO CHEST PAIN, DYSPNOEA, TREMOR, ANXIETY, PNEUMONIA, LUNG DISORDER, ARTHRALGIA, MORPHOEA, CHOLANGITIS, BACK PAIN, DRY EYE, VITAMIN B12 DEFICIENCY, WRIST PAIN, DIZZINESS, HYPERHIDROSIS OR VISUAL IMPAIRMENT. THE REPORTER COMMENTED: I AM MAKING THIS REPORT BECAUSE I RECENTLY DISCOVERED THE RESIST ASSOCIATION, AND THEREFORE, WONDER ABOUT THE CAUSE OF ALL MY PROBLEMS! SO I HADN'T INFORMED THE DOCTORS WHO WERE FOLLOWING ME OF THE PRESENCE OF ESSURE IMPLANTS! GOING BACK THROUGH MY ARCHIVES, THE EVENTS STARTED ONE MONTH AFTER THE INSERTION! SINCE 2012, I HAVE ADOPTED A VEGETARIAN DIET, NO TREATMENT APART FROM VITAMIN 12, NO PAINKILLERS, THE PAIN COMES AND GOES!. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 62 KG. [CHEST X-RAY] (DATE UNKNOWN): PNEUMONIA LOT NUMBER: 624301,MANUFACTURE DATE:2007-04,EXPIRATION DATE:2009-03. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 29-APR-2024: QUALITY SAFETY EVALUATION OF PTC. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA, SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 0

    THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4) ON 17-APR-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ("STINGING BACK PAIN") IN A 64 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 624301) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2007, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2007, 43 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED BREAST PAIN ("IN THE EVENING, LEFT SUB-MAMMARY PAIN, DIFFICULTY BREATHING, TREMORS, ANXIETY"), DYSPNOEA ("DIFFICULTY BREATHING"), TREMOR ("TREMORS"), ANXIETY ("ANXIETY"), PNEUMONIA ("PNEUMONIA") AND LUNG DISORDER ("STILL EXPERIENCING LUNG PROBLEMS!"). IN 2013 SHE EXPERIENCED ARTHRALGIA ("REFERRED TO A RHEUMATOLOGIST AT THE END OF 2013, FOR GENERAL ARTHRALGIA FOR 1 YEAR"). ON UNKNOWN DATE SHE EXPERIENCED BACK PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), MORPHOEA ("LOCALIZED SCLERODERMA,"), CHOLANGITIS ("CHOLANGITIS"), DRY EYE ("DRY EYE SYNDROME"), VITAMIN B12 DEFICIENCY ("LACK OF VITAMIN B12"), WRIST PAIN ("RIGHT WRIST PAIN FOR 2 YEARS"), DIZZINESS ("DIZZINESS"), HYPERHIDROSIS ("SWEATING") AND VISUAL IMPAIRMENT (" VISUAL PROBLEMS"). THE PATIENT WAS TREATED WITH ANTIBIOTICS AND B12-VITAMIN (CYANOCOBALAMIN). AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO BREAST PAIN, DYSPNOEA, TREMOR, ANXIETY, PNEUMONIA, LUNG DISORDER, ARTHRALGIA, MORPHOEA, CHOLANGITIS, BACK PAIN, DRY EYE, VITAMIN B12 DEFICIENCY, WRIST PAIN, DIZZINESS, HYPERHIDROSIS OR VISUAL IMPAIRMENT. THE REPORTER COMMENTED: I AM MAKING THIS REPORT BECAUSE I RECENTLY DISCOVERED THE RESIST ASSOCIATION, AND THEREFORE, WONDER ABOUT THE CAUSE OF ALL MY PROBLEMS! SO I HADN'T INFORMED THE DOCTORS WHO WERE FOLLOWING ME OF THE PRESENCE OF ESSURE IMPLANTS! GOING BACK THROUGH MY ARCHIVES, THE EVENTS STARTED ONE MONTH AFTER THE INSERTION! SINCE 2012, I HAVE ADOPTED A VEGETARIAN DIET, NO TREATMENT APART FROM VITAMIN 12, NO PAINKILLERS, THE PAIN COMES AND GOES!. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 62 KG. [CHEST X-RAY] (DATE UNKNOWN): PNEUMONIA A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA, SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942883 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 624301 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Other