BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 21401530 · Received February 18, 2025

    Report

    Report Number
    2951250-2025-00146
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    January 1, 2011
    Report Date
    March 14, 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) MULTIPLE SIDE EFFECTS, PERSISTENT DAILY PAIN [PELVIC PAIN FEMALE] DIZZINESS [DIZZINESS] SYNCOPE [SYNCOPE] NARCOLEPSY [NARCOLEPSY] SLEEP DISTURBANCES [SLEEP DISTURBANCE] BACK PAIN [BACK PAIN] PLANTAR PAIN/ [FOOT PAIN] MUSCULAR PAIN [MUSCULAR PAIN] ABDOMINAL PAIN [ABDOMINAL PAIN] FIBROMYALGIA-LIKE PAIN [FIBROMYALGIA] DIARRHOEA [DIARRHOEA] HEADACHES [HEADACHE] NAUSEA [NAUSEA] VISION DISORDER [VISUAL DISTURBANCE] BLEEDING GUMS [GUM BLEEDING] TEETH STARTING TO LOOSEN [LOOSE TOOTH] BURNING SENSATION IN LOWER ABDOMEN [BURNING SENSATION IN ABDOMEN] BURNING SENSATIONS IN HIPS [BURNING HIP] DISABLING FATIGUE RESEMBLING EXHAUSTION [EXHAUSTION]. CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4)) ON 11-FEB-2025. THE MOST RECENT INFORMATION WAS RECEIVED ON 13-MAR-2025. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("MULTIPLE SIDE EFFECTS, PERSISTENT DAILY PAIN") IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 623209) 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)2009, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2011, 458 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), DIZZINESS ("DIZZINESS"), SYNCOPE ("SYNCOPE"), NARCOLEPSY ("NARCOLEPSY"), SLEEP DISORDER ("SLEEP DISTURBANCES"), BACK PAIN ("BACK PAIN"), PAIN IN EXTREMITY ("PLANTAR PAIN/"), MYALGIA ("MUSCULAR PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), FIBROMYALGIA ("FIBROMYALGIA-LIKE PAIN"), DIARRHOEA ("DIARRHOEA"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), VISUAL IMPAIRMENT ("VISION DISORDER"), GINGIVAL BLEEDING ("BLEEDING GUMS"), LOOSE TOOTH ("TEETH STARTING TO LOOSEN"), ABDOMINAL DISCOMFORT ("BURNING SENSATION IN LOWER ABDOMEN"), BURNING SENSATION ("BURNING SENSATIONS IN HIPS") AND FATIGUE ("DISABLING FATIGUE RESEMBLING EXHAUSTION"). AT THE TIME OF THE REPORT, THE PELVIC PAIN AND FATIGUE HAD NOT RESOLVED. THE OUTCOMES FOR DIZZINESS, SYNCOPE, NARCOLEPSY, SLEEP DISORDER, BACK PAIN, PAIN IN EXTREMITY, MYALGIA, ABDOMINAL PAIN, FIBROMYALGIA, DIARRHOEA, HEADACHE, NAUSEA, VISUAL IMPAIRMENT, GINGIVAL BLEEDING, LOOSE TOOTH, ABDOMINAL DISCOMFORT AND BURNING SENSATION WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO DIZZINESS, SYNCOPE, NARCOLEPSY, SLEEP DISORDER, BACK PAIN, PAIN IN EXTREMITY, MYALGIA, ABDOMINAL PAIN, FIBROMYALGIA, DIARRHOEA, HEADACHE, NAUSEA, VISUAL IMPAIRMENT, GINGIVAL BLEEDING, LOOSE TOOTH, ABDOMINAL DISCOMFORT, BURNING SENSATION, PELVIC PAIN OR FATIGUE. THE REPORTER COMMENTED: DIZZINESS, SYNCOPE, NARCOLEPSY, SLEEP DISTURBANCES, BACK PAIN/PLANTAR PAIN/MUSCULAR PAIN/ABDOMINAL PAIN/FIBROMYALGIA-LIKE PAIN, DIARRHEA, HEADACHES, NAUSEA, VISION DISORDERS, BLEEDING GUMS, TEETH STARTING TO LOOSEN, BURNING SENSATIONS IN THE LOWER ABDOMEN AND HIPS COMMENTS: I HAVE CONSULTED VARIOUS SPECIALISTS OVER THE YEARS FOR THE MULTIPLE SYMPTOMS BUT NOTHING HAS EVER BEEN EXPLAINED AND NO LINK HAS BEEN ESTABLISHED BETWEEN THE DIFFERENT PROBLEMS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 54 KG. LOT 623209 EXPIRATION DATE 31-MAR-2012 DATE OF MFR 31-MAR-2009. 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: (B)(6)2025: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. CASE COMMENTS: 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.

    Description of Event or Problem · 0

    BAYER CASE NUMBER: (B)(4) MULTIPLE SIDE EFFECTS, PERSISTENT DAILY PAIN [PELVIC PAIN FEMALE], DIZZINESS [DIZZINESS], SYNCOPE [SYNCOPE], NARCOLEPSY [NARCOLEPSY] , SLEEP DISTURBANCES [SLEEP DISTURBANCE] , BACK PAIN [BACK PAIN], PLANTAR PAIN/ [FOOT PAIN] , MUSCULAR PAIN [MUSCULAR PAIN] , ABDOMINAL PAIN [ABDOMINAL PAIN] , FIBROMYALGIA-LIKE PAIN [FIBROMYALGIA] , DIARRHOEA [DIARRHOEA] , HEADACHES [HEADACHE] , NAUSEA [NAUSEA] , VISION DISORDER [VISUAL DISTURBANCE], BLEEDING GUMS [GUM BLEEDING] , TEETH STARTING TO LOOSEN [LOOSE TOOTH] , BURNING SENSATION IN LOWER ABDOMEN [BURNING SENSATION IN ABDOMEN] , BURNING SENSATIONS IN HIPS [BURNING HIP] , DISABLING FATIGUE RESEMBLING EXHAUSTION [EXHAUSTION]. CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4) ON 11-FEB-2025. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("MULTIPLE SIDE EFFECTS, PERSISTENT DAILY PAIN") IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 623209) 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) 2009, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, 458 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), DIZZINESS ("DIZZINESS"), SYNCOPE ("SYNCOPE"), NARCOLEPSY ("NARCOLEPSY"), SLEEP DISORDER ("SLEEP DISTURBANCES"), BACK PAIN ("BACK PAIN"), PAIN IN EXTREMITY ("PLANTAR PAIN/"), MYALGIA ("MUSCULAR PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), FIBROMYALGIA ("FIBROMYALGIA-LIKE PAIN"), DIARRHOEA ("DIARRHOEA"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), VISUAL IMPAIRMENT ("VISION DISORDER"), GINGIVAL BLEEDING ("BLEEDING GUMS"), LOOSE TOOTH ("TEETH STARTING TO LOOSEN"), ABDOMINAL DISCOMFORT ("BURNING SENSATION IN LOWER ABDOMEN"), BURNING SENSATION ("BURNING SENSATIONS IN HIPS") AND FATIGUE ("DISABLING FATIGUE RESEMBLING EXHAUSTION"). AT THE TIME OF THE REPORT, THE PELVIC PAIN AND FATIGUE HAD NOT RESOLVED. THE OUTCOMES FOR DIZZINESS, SYNCOPE, NARCOLEPSY, SLEEP DISORDER, BACK PAIN, PAIN IN EXTREMITY, MYALGIA, ABDOMINAL PAIN, FIBROMYALGIA, DIARRHOEA, HEADACHE, NAUSEA, VISUAL IMPAIRMENT, GINGIVAL BLEEDING, LOOSE TOOTH, ABDOMINAL DISCOMFORT AND BURNING SENSATION WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO DIZZINESS, SYNCOPE, NARCOLEPSY, SLEEP DISORDER, BACK PAIN, PAIN IN EXTREMITY, MYALGIA, ABDOMINAL PAIN, FIBROMYALGIA, DIARRHOEA, HEADACHE, NAUSEA, VISUAL IMPAIRMENT, GINGIVAL BLEEDING, LOOSE TOOTH, ABDOMINAL DISCOMFORT, BURNING SENSATION, PELVIC PAIN OR FATIGUE. THE REPORTER COMMENTED: DIZZINESS, SYNCOPE, NARCOLEPSY, SLEEP DISTURBANCES, BACK PAIN/PLANTAR PAIN/MUSCULAR PAIN/ABDOMINAL PAIN/FIBROMYALGIA-LIKE PAIN, DIARRHEA, HEADACHES, NAUSEA, VISION DISORDERS, BLEEDING GUMS, TEETH STARTING TO LOOSEN, BURNING SENSATIONS IN THE LOWER ABDOMEN AND HIPS. COMMENTS: I HAVE CONSULTED VARIOUS SPECIALISTS OVER THE YEARS FOR THE MULTIPLE SYMPTOMS BUT NOTHING HAS EVER BEEN EXPLAINED AND NO LINK HAS BEEN ESTABLISHED BETWEEN THE DIFFERENT PROBLEMS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 54 KG. CASE COMMENTS: 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
    2539510 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 623209 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Other