BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 22024542 · Received May 15, 2025

    Report

    Report Number
    2951250-2025-00333
    Event Type
    Injury
    Date Received
    May 15, 2025
    Report Date
    May 19, 2025
    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

    BAYER CASE NUMBER: (B)(4) HEAVY MENSTRUAL BLEEDING WITH CLOTS [BLEEDING MENSTRUAL HEAVY], I AM NO LONGER ABLE TO CONCENTRATE [CONCENTRATION LOSS] , MY MEMORY IS VERY POOR [MEMORY IMPAIRED] , I AM ALWAYS VERY FATIGUED [TIRED ALL THE TIME] , PELVIC PAIN DURING OR OUTSIDE OF MY PERIOD, [PAIN MENSTRUAL] , PELVIC PAIN DURING OR OUTSIDE OF MY PERIOD [PELVIC PAIN FEMALE] , HEADACHES [HEADACHE] , I¿VE HAD ITCHING IN MY LEFT EAR CANAL [EAR PRURITUS], NOTICEABLE HEARING LOSS [HEARING LOSS] , CONSTANT BUZZING [EAR BUZZING] , PARAESTHESIA IN THE MIDDLE OF THE NIGHT IN MY RIGHT HAND, [PARAESTHESIA] , I¿VE LOST HALF MY HAIR MASS [HAIR LOSS] . CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4) ON 07-MAY-2025. THE MOST RECENT INFORMATION WAS RECEIVED ON 19-MAY-2025. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF HEAVY MENSTRUAL BLEEDING ("HEAVY MENSTRUAL BLEEDING WITH CLOTS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 50750351) 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) 2014, THE PATIENT HAD ESSURE INSERTED. ON UNKNOWN DATE SHE EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), DISTURBANCE IN ATTENTION ("I AM NO LONGER ABLE TO CONCENTRATE"), MEMORY IMPAIRMENT ("MY MEMORY IS VERY POOR"), FATIGUE ("I AM ALWAYS VERY FATIGUED"), DYSMENORRHOEA ("PELVIC PAIN DURING OR OUTSIDE OF MY PERIOD,"), PELVIC PAIN ("PELVIC PAIN DURING OR OUTSIDE OF MY PERIOD"), HEADACHE ("HEADACHES"), EAR PRURITUS ("I¿VE HAD ITCHING IN MY LEFT EAR CANAL"), DEAFNESS ("NOTICEABLE HEARING LOSS"), TINNITUS ("CONSTANT BUZZING"), PARAESTHESIA ("PARAESTHESIA IN THE MIDDLE OF THE NIGHT IN MY RIGHT HAND,") AND ALOPECIA ("I¿VE LOST HALF MY HAIR MASS"). AT THE TIME OF THE REPORT, THE OUTCOMES FOR HEAVY MENSTRUAL BLEEDING, DISTURBANCE IN ATTENTION, MEMORY IMPAIRMENT, FATIGUE, DYSMENORRHOEA, PELVIC PAIN, HEADACHE, EAR PRURITUS, DEAFNESS, TINNITUS AND PARAESTHESIA WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO HEAVY MENSTRUAL BLEEDING, DISTURBANCE IN ATTENTION, MEMORY IMPAIRMENT, FATIGUE, DYSMENORRHOEA, PELVIC PAIN, HEADACHE, EAR PRURITUS, DEAFNESS, TINNITUS, PARAESTHESIA OR ALOPECIA. THE REPORTER COMMENTED: PERIOD OF OCCURRENCE: PROGRESSIVE ONSET OVER SEVERAL YEARS. BEGINNING IN 2019/2020 WHEN SOMEONE SPEAKS TO ME, I FEEL LIKE I AM NOT PRESENT. I HAVE TO MAKE A GOOD DEAL OF EFFORT TO UNDERSTAND WHAT IS BEING SAID TO ME AND TO BE ABLE TO INTERACT WITH THE PERSON I AM TALKING TO. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 57 KG. [SERUM FERRITIN] (DATE UNKNOWN): FERRITIN LEVEL DECREASED 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: 19-MAY-2025: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. CASE COMMENTS: A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAIN RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT. IN CASE A SAMPLE IS RECEIVED THE INVESTIGATION MIGHT LEAD TO DESTRUCTION OF THE SAMPLE IF REQUIRED TO PERFORM A PROPER ANALYSIS.

    Description of Event or Problem · 0

    BAYER CASE NUMBER: (B)(4). HEAVY MENSTRUAL BLEEDING WITH CLOTS [BLEEDING MENSTRUAL HEAVY], I AM NO LONGER ABLE TO CONCENTRATE [CONCENTRATION LOSS], MY MEMORY IS VERY POOR [MEMORY IMPAIRED], I AM ALWAYS VERY FATIGUED [TIRED ALL THE TIME], PELVIC PAIN DURING OR OUTSIDE OF MY PERIOD, [PAIN MENSTRUAL], PELVIC PAIN DURING OR OUTSIDE OF MY PERIOD [PELVIC PAIN FEMALE], HEADACHES [HEADACHE], I¿VE HAD ITCHING IN MY LEFT EAR CANAL [EAR PRURITUS], NOTICEABLE HEARING LOSS [HEARING LOSS], CONSTANT BUZZING [EAR BUZZING], PARAESTHESIA IN THE MIDDLE OF THE NIGHT IN MY RIGHT HAND, [PARAESTHESIA], I¿VE LOST HALF MY HAIR MASS [HAIR LOSS]. CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4)) ON 07-MAY-2025. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF HEAVY MENSTRUAL BLEEDING ("HEAVY MENSTRUAL BLEEDING WITH CLOTS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 50750351) 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) 2014, THE PATIENT HAD ESSURE INSERTED. ON UNKNOWN DATE SHE EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), DISTURBANCE IN ATTENTION ("I AM NO LONGER ABLE TO CONCENTRATE"), MEMORY IMPAIRMENT ("MY MEMORY IS VERY POOR"), FATIGUE ("I AM ALWAYS VERY FATIGUED"), DYSMENORRHOEA ("PELVIC PAIN DURING OR OUTSIDE OF MY PERIOD,"), PELVIC PAIN ("PELVIC PAIN DURING OR OUTSIDE OF MY PERIOD"), HEADACHE ("HEADACHES"), EAR PRURITUS ("I¿VE HAD ITCHING IN MY LEFT EAR CANAL"), DEAFNESS ("NOTICEABLE HEARING LOSS"), TINNITUS ("CONSTANT BUZZING"), PARAESTHESIA ("PARAESTHESIA IN THE MIDDLE OF THE NIGHT IN MY RIGHT HAND,") AND ALOPECIA ("I¿VE LOST HALF MY HAIR MASS"). AT THE TIME OF THE REPORT, THE OUTCOMES FOR HEAVY MENSTRUAL BLEEDING, DISTURBANCE IN ATTENTION, MEMORY IMPAIRMENT, FATIGUE, DYSMENORRHOEA, PELVIC PAIN, HEADACHE, EAR PRURITUS, DEAFNESS, TINNITUS AND PARAESTHESIA WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO HEAVY MENSTRUAL BLEEDING, DISTURBANCE IN ATTENTION, MEMORY IMPAIRMENT, FATIGUE, DYSMENORRHOEA, PELVIC PAIN, HEADACHE, EAR PRURITUS, DEAFNESS, TINNITUS, PARAESTHESIA OR ALOPECIA. THE REPORTER COMMENTED: PERIOD OF OCCURRENCE: PROGRESSIVE ONSET OVER SEVERAL YEARS. BEGINNING IN 2019/2020 WHEN SOMEONE SPEAKS TO ME, I FEEL LIKE I AM NOT PRESENT. I HAVE TO MAKE A GOOD DEAL OF EFFORT TO UNDERSTAND WHAT IS BEING SAID TO ME AND TO BE ABLE TO INTERACT WITH THE PERSON I AM TALKING TO. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 57 KG. [SERUM FERRITIN] (DATE UNKNOWN): FERRITIN LEVEL DECREASED. CASE COMMENTS: A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAIN RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT. IN CASE A SAMPLE IS RECEIVED THE INVESTIGATION MIGHT LEAD TO DESTRUCTION OF THE SAMPLE IF REQUIRED TO PERFORM A PROPER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1811955 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 50750351 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other