BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 19389634 · Received May 24, 2024

    Report

    Report Number
    2951250-2024-00340
    Event Type
    Injury
    Date Received
    May 24, 2024
    Report Date
    May 28, 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-MAY-2024. THE MOST RECENT INFORMATION WAS RECEIVED ON 28-MAY-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A 45 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF MORTON'S NEUROMA, THYROID NODULE, ANEURYSM, ARTERIAL HYPERTENSION, SMOKER (20 TO 30 CIGS/DAY, STOPPED IN (B)(6) 2023), PARITY 4 AND MULTI GRAVIDA. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON UNKNOWN DATE SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), INFLAMMATION ("INFLAMMATORY FLARE-UP"), HEAVY MENSTRUAL BLEEDING ("HEAVY PERIOD"), MIGRAINE ("MIGRAINE"), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), DYSMENORRHOEA ("DYSMENORRHOEA"), DYSPAREUNIA ("DYSPAREUNIA"), STRESS URINARY INCONTINENCE ("MIXED STRESS URINARY INCONTINENCE"), URINARY RETENTION ("BLADDER EMPTYING PROBLEMS"), SUPRAPUBIC PAIN ("SUPRA PUBIC PRESSURE"), NOCTURIA ("NOCTURIA"), CYSTITIS ("RECURRENT CYSTITIS"), CONSTIPATION ("CONSTIPATION"), DIARRHOEA ("CATAMENIAL DIARRHOEA"), ADENOMYOSIS ("ADENOMYOSIS"), NEUROPATHY PERIPHERAL (" DEGENERATIVE NEUROPATHY") AND DEPRESSION ("DEPRESSION") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ESSURE WAS REMOVED ON (B)(6) 2023. THE PATIENT WAS TREATED WITH SURGERY (TOTAL VAGINAL HYSTERECTOMY + BILATERAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO WEIGHT INCREASED, INFLAMMATION, HEAVY MENSTRUAL BLEEDING, PELVIC PAIN, MIGRAINE, MENSTRUATION IRREGULAR, DYSMENORRHOEA, DYSPAREUNIA, STRESS URINARY INCONTINENCE, URINARY RETENTION, SUPRAPUBIC PAIN, NOCTURIA, CYSTITIS, CONSTIPATION, DIARRHOEA, ADENOMYOSIS, NEUROPATHY PERIPHERAL OR DEPRESSION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 75 KG. [HUMAN PAPILLOMA VIRUS TEST] (DATE UNKNOWN): NEGATIVE [MAGNETIC RESONANCE IMAGING] IN (B)(6) 2013: NOTHING ABNORMAL DETECTED, NO DEEP INFILTRATING ENDOMETRIOSIS, ESSURE IN PLACE; (DATE UNKNOWN): VAGINAL EXAMINATION, NOTHING ABNORMAL DETECTED SENSITIVE UTERUS HIGH NODULE LOCATED [ULTRASOUND SCAN] (DATE UNKNOWN): A GLOBULAR UTERUS WITH DIFFUSE ADENOMYOSIS WHICH IS PAINFUL UPON MOBILIZATION ON THE PROBE, ESSURE IMPLANTS CLEARLY VISIBLE IN CLASSIC POSITION TYPE 2 NEITHER TOO PROXIMAL NOR TOO DISTAL. THE ENDOMETRIUM IS PROLIFERATIVE WITHOUT ANY IMAGE OF MYOMA OR INTRACAVITARY POLYPS, THE OVARIES ARE NORMAL IN APPEARANCE WITHOUT EFFUSION OR OBVIOUS SIGN OF DEEP INFILTRATING ENDOMETRIOSIS WITH POST-VOID RESIDUAL VOLUME OF 27 ML QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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 AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 28-MAY-2024: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION 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-MAY-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A 45 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF MORTON'S NEUROMA, THYROID NODULE, ANEURYSM, ARTERIAL HYPERTENSION, SMOKER (20 TO 30 CIGS/DAY, STOPPED IN (B)(6) 2023), PARITY 4 AND MULTI GRAVIDA. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ESSURE WAS REMOVED ON (B)(6) 2023. ON UNKNOWN DATE SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), INFLAMMATION ("INFLAMMATORY FLARE-UP"), HEAVY MENSTRUAL BLEEDING ("HEAVY PERIOD"), MIGRAINE ("MIGRAINE"), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), DYSMENORRHOEA ("DYSMENORRHOEA"), DYSPAREUNIA ("DYSPAREUNIA"), STRESS URINARY INCONTINENCE ("MIXED STRESS URINARY INCONTINENCE"), URINARY RETENTION ("BLADDER EMPTYING PROBLEMS"), SUPRAPUBIC PAIN ("SUPRA PUBIC PRESSURE"), NOCTURIA ("NOCTURIA"), CYSTITIS ("RECURRENT CYSTITIS"), CONSTIPATION ("CONSTIPATION"), DIARRHOEA ("CATAMENIAL DIARRHOEA"), ADENOMYOSIS ("ADENOMYOSIS"), NEUROPATHY PERIPHERAL (" DEGENERATIVE NEUROPATHY") AND DEPRESSION ("DEPRESSION") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL VAGINAL HYSTERECTOMY + BILATERAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO WEIGHT INCREASED, INFLAMMATION, HEAVY MENSTRUAL BLEEDING, PELVIC PAIN, MIGRAINE, MENSTRUATION IRREGULAR, DYSMENORRHOEA, DYSPAREUNIA, STRESS URINARY INCONTINENCE, URINARY RETENTION, SUPRAPUBIC PAIN, NOCTURIA, CYSTITIS, CONSTIPATION, DIARRHOEA, ADENOMYOSIS, NEUROPATHY PERIPHERAL OR DEPRESSION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 75 KG. [HUMAN PAPILLOMA VIRUS TEST] (DATE UNKNOWN): NEGATIVE [MAGNETIC RESONANCE IMAGING] IN (B)(6) 2013: NOTHING ABNORMAL DETECTED, NO DEEP INFILTRATING ENDOMETRIOSIS, ESSURE IN PLACE; (DATE UNKNOWN): VAGINAL EXAMINATION, NOTHING ABNORMAL DETECTED SENSITIVE UTERUS HIGH NODULE LOCATED [ULTRASOUND SCAN] (DATE UNKNOWN): A GLOBULAR UTERUS WITH DIFFUSE ADENOMYOSIS WHICH IS PAINFUL UPON MOBILIZATION ON THE PROBE, ESSURE IMPLANTS CLEARLY VISIBLE IN CLASSIC POSITION TYPE 2 NEITHER TOO PROXIMAL NOR TOO DISTAL. THE ENDOMETRIUM IS PROLIFERATIVE WITHOUT ANY IMAGE OF MYOMA OR INTRACAVITARY POLYPS, THE OVARIES ARE NORMAL IN APPEARANCE WITHOUT EFFUSION OR OBVIOUS SIGN OF DEEP INFILTRATING ENDOMETRIOSIS WITH POST-VOID RESIDUAL VOLUME OF 27 ML BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2304122 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention