BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 18614034 · Received January 31, 2024

    Report

    Report Number
    2951250-2024-00070
    Event Type
    Injury
    Date Received
    January 31, 2024
    Date of Event
    September 5, 2018
    Report Date
    February 9, 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 (B)(6) 2024. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6) 2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A 41 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. HE011CL) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE ("SMALL PASSAGE AT THE LEVEL OF THE LEFT FALLOPIAN TUBE, SEALING NOT ACHIEVED ON THE LEFT" ON (B)(6) 2016). AS CONCURRENT CONDITION THE REPORT MENTIONED UTERINE ANTEFLEXION. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 76 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED DEVICE EXPULSION ("EXPULSION OF AN ESSURE TYPE TUBAL IMPLANT WHICH OCCURRED NATURALLY"). ON (B)(6) 2018 SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALISATION AND INTERVENTION REQUIRED), URTICARIA ("WIDESPREAD URTICARIA"), MUSCULAR WEAKNESS ("WEAKNESS IN LOWER LIMBS WITH FALLS"), FALL ("FALLS"), TENDONITIS ("WRIST TENDONITIS WHICH PROGRESSED OVER THE YEARS THAT FOLLOWED"), ASTHENIA ("ASTHENIA") AND VISUAL IMPAIRMENT ("VISION PROBLEMS"). ESSURE WAS REMOVED ON (B)(6) 2024. THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY WITH RIGHT HORN RESECTION FOR LAPAROSCOPIC ABLATION OF ESSURE DEVICE) AND PHYSICAL THERAPY. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO DEVICE EXPULSION, MUSCULAR WEAKNESS, PELVIC PAIN, TENDONITIS, ASTHENIA, VISUAL IMPAIRMENT, URTICARIA OR FALL. THE REPORTER COMMENTED: PATIENT¿S CURRENT STATUS: DEVICE EXPLANTED ON (B)(6) 2024 DUE TO POOR OUTCOME SINCE (B)(6) 2018, WORSENING OVER TIME, AFTER CARRYING OUT EXAMINATIONS THAT ALLOWED RULING OUT OTHER ETIOLOGY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [ABDOMINAL X-RAY] ON (B)(6) 2021: PLAIN ABDOMINAL X-RAY: ONLY THE RIGHT TUBAL IMPLANT IS IDENTIFIED IN PROJECTION OF PELVIC EXCAVATION. [ELECTROMYOGRAM] ON (B)(6) 2023: NORMALITY AND SYMMETRY OF SEP (SOMATOSENSORY EVOKED POTENTIAL) LATENCIES AND OF CONDUCTION TIMES IN ALL 4 LIMBS. [ELECTRONEUROMYOGRAPHY] ON (B)(6) 2023: SINCE AROUND 5 YEARS, WITH VARIATIONS, SHE HAS FELT WEAKNESS IN THE LOWER LIMBS, ESPECIALLY THE LEFT QUADRICEPS. PELVIC MRI PLANNED FOR THE END OF APRIL. HAS PHYSIOTHERAPY ONCE A WEEK + STRENGTH TRAINING AT THE GYM, WITHOUT IMPROVEMENT. NO PAIN, NO PARESTHESIA (TINGLING) CONCLUSION: SENSORY NEUROGRAPHY: NORMAL SUPERFICIAL FIBULAR AND SURAL NERVES ON THE RIGHT AND LEFT. MOTOR NEUROGRAPHY: NORMAL COMMON PERONEAL AND TIBIAL NERVES ON THE RIGHT AND LEFT. DECREASE IN THE AMPLITUDE OF THE RIGHT FEMORAL NERVE, AS COMPARED TO THE LEFT, BUT WITHOUT INCREASE IN THE MDL (METHOD DETECTION LIMIT) (PROBABLE TECHNICAL ERROR). MYOGRAPHY: ABSENCE OF SPONTANEOUS ACTIVITIES AND INTERFERENCE PATTERNS IN THE TIBIALIS ANTERIOR AND QUADRICEPS MUSCLES [HYSTEROSALPINGOGRAM] ON (B)(6) 2016: ESSURE CHECK AT 2.5 MONTHS AFTER THE PROCEDURE: ON THE FIRST FILLING IMAGE, TIP OF THE LEFT-SIDE ESSURE SEEN PARTLY WITHIN THE UTERINE CAVITY. THE RIGHT FALLOPIAN TUBE IS IMPERVIOUS. SMALL PASSAGE AT THE LEVEL OF THE LEFT FALLOPIAN TUBE.; ON (B)(6) 2017: CHECK OF ESSURE TUBAL DEVICE: NO ABNORMALITY OF THE UTERINE CAVITY. ABSENCE OF PASSAGE TO THE RIGHT FALLOPIAN TUBE. RATHER QUICK PASSAGE OF THE CONTRAST AGENT TO THE LEFT FALLOPIAN TUBE DESPITE LOW INJECTION PRESSURE. CONCLUSION: SEALING NOT ACHIEVED ON THE LEFT [LAPAROSCOPY] ON (B)(6) 2024: VISUALISATION OF RIGHT FALLOPIAN TUBE FITTED WITH AN ESSURE DEVICE. THE UTERUS SEEMS UNREMARKABLE. THE OVARIES ARE HEALTHY.THE LIVER APPEARS TO BE HEALTHY. THERE IS NO INTRA-ABDOMINAL EFFUSION. PARIETO-EPIPLOIC ADHESION(S) VISUALISED. PERFORMANCE OF A BILATERAL SALPINGECTOMY, ON THE LEFT, THEN ON THE RIGHT, AFTER PERFORATION OF THE RIGHT UTERINE HORN USING COLD SCISSORS AND COAGULATION [MAGNETIC RESONANCE IMAGING PELVIC] ON (B)(6) 2023: ASSESSMENT OF CHRONIC PAIN WITH WEAKNESS OF LOWER LIMBS: FEMALE PATIENT FITTED WITH ESSURE IMPLANT, WITH SPONTANEOUS LOSS OF THE LEFT IMPLANT. CONCLUSION: THERE IS NO CHANGE IN THE RIGHT ESSURE IMPLANT. THERE IS NO UTERINE OR OVARIAN INVOLVEMENT, NO PELVIC REMODELING. [ULTRASOUND PELVIS] ON (B)(6) 2021: CHECK AFTER EXPULSION OF AN ESSURE TYPE TUBAL IMPLANT WHICH OCCURRED NATURALLY: INTEGRITY OF THE URINARY BLADDER, STUDIED WHEN FULL (IN REPLETION). MEDIAN ANTEVERTED UTERUS, 85 MM ON THE LONG AXIS. NO CHANGE IN THE MYOMETRIUM AND ENDOMETRIUM. THE OVARIES ARE VISUALISED, OF NORMAL SIZE, WITH NO CYSTIC OR PATHOLOGICAL TISSUE FORMATION. THE RIGHT TUBAL IMPLANT IS VISUALISED IN PROJECTION OF THE FALLOPIAN TUBE WHICH APPEARS TO BE UNDILATED. NO PERITONEAL EFFUSION.; ON (B)(6) 2023: CONCLUSION: NORMAL PELVIC ULTRASOUND FINDINGS. ANTEVERTED UTERUS, WITH HARMONIOUS CONTOUR. UNREMARKABLE ANNEXA. RIGHT ESSURE - LEGENDRE TYPE 2-3 SUPERFICIAL. NO LEFT ESSURE VISUALISED. BATCH NO. HE011CL, EXPIRATION DATE: 2018-10-28. 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: 09-FEB-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 26-JAN-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A 41 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. HE011CL) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE ("SMALL PASSAGE AT THE LEVEL OF THE LEFT FALLOPIAN TUBE, SEALING NOT ACHIEVED ON THE LEFT" ON (B)(6) 2016). AS CONCURRENT CONDITION THE REPORT MENTIONED UTERINE ANTEFLEXION. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 76 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED DEVICE EXPULSION ("EXPULSION OF AN ESSURE TYPE TUBAL IMPLANT WHICH OCCURRED NATURALLY"). ON (B)(6) 2018 SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALISATION AND INTERVENTION REQUIRED), URTICARIA ("WIDESPREAD URTICARIA"), MUSCULAR WEAKNESS ("WEAKNESS IN LOWER LIMBS WITH FALLS"), FALL ("FALLS"), TENDONITIS ("WRIST TENDONITIS WHICH PROGRESSED OVER THE YEARS THAT FOLLOWED"), ASTHENIA ("ASTHENIA") AND VISUAL IMPAIRMENT ("VISION PROBLEMS"). ESSURE WAS REMOVED ON (B)(6) 2024. THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY WITH RIGHT HORN RESECTION FOR LAPAROSCOPIC ABLATION OF ESSURE DEVICE) AND PHYSICAL THERAPY. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO DEVICE EXPULSION, MUSCULAR WEAKNESS, PELVIC PAIN, TENDONITIS, ASTHENIA, VISUAL IMPAIRMENT, URTICARIA OR FALL. THE REPORTER COMMENTED: PATIENT¿S CURRENT STATUS: DEVICE EXPLANTED ON (B)(6) 2024 DUE TO POOR OUTCOME SINCE 2018, WORSENING OVER TIME, AFTER CARRYING OUT EXAMINATIONS THAT ALLOWED RULING OUT OTHER ETIOLOGY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [ABDOMINAL X-RAY] ON (B)(6) 2021: PLAIN ABDOMINAL X-RAY: ONLY THE RIGHT TUBAL IMPLANT IS IDENTIFIED IN PROJECTION OF PELVIC EXCAVATION. [ELECTROMYOGRAM] ON (B)(6) 2023: NORMALITY AND SYMMETRY OF SEP (SOMATOSENSORY EVOKED POTENTIAL) LATENCIES AND OF CONDUCTION TIMES IN ALL 4 LIMBS. [ELECTRONEUROMYOGRAPHY] ON (B)(6) 2023: SINCE AROUND 5 YEARS, WITH VARIATIONS, SHE HAS FELT WEAKNESS IN THE LOWER LIMBS, ESPECIALLY THE LEFT QUADRICEPS. PELVIC MRI PLANNED FOR THE END OF APRIL. HAS PHYSIOTHERAPY ONCE A WEEK + STRENGTH TRAINING AT THE GYM, WITHOUT IMPROVEMENT. NO PAIN, NO PARESTHESIA (TINGLING). CONCLUSION: SENSORY NEUROGRAPHY: NORMAL SUPERFICIAL FIBULAR AND SURAL NERVES ON THE RIGHT AND LEFT. MOTOR NEUROGRAPHY: NORMAL COMMON PERONEAL AND TIBIAL NERVES ON THE RIGHT AND LEFT. DECREASE IN THE AMPLITUDE OF THE RIGHT FEMORAL NERVE, AS COMPARED TO THE LEFT, BUT WITHOUT INCREASE IN THE MDL (METHOD DETECTION LIMIT) (PROBABLE TECHNICAL ERROR). MYOGRAPHY: ABSENCE OF SPONTANEOUS ACTIVITIES AND INTERFERENCE PATTERNS IN THE TIBIALIS ANTERIOR AND QUADRICEPS MUSCLES. [HYSTEROSALPINGOGRAM] ON (B)(6) 2016: ESSURE CHECK AT 2.5 MONTHS AFTER THE PROCEDURE: ON THE FIRST FILLING IMAGE, TIP OF THE LEFT-SIDE ESSURE SEEN PARTLY WITHIN THE UTERINE CAVITY. THE RIGHT FALLOPIAN TUBE IS IMPERVIOUS. SMALL PASSAGE AT THE LEVEL OF THE LEFT FALLOPIAN TUBE.; ON (B)(6) 2017: CHECK OF ESSURE TUBAL DEVICE: NO ABNORMALITY OF THE UTERINE CAVITY. ABSENCE OF PASSAGE TO THE RIGHT FALLOPIAN TUBE. RATHER QUICK PASSAGE OF THE CONTRAST AGENT TO THE LEFT FALLOPIAN TUBE DESPITE LOW INJECTION PRESSURE. CONCLUSION: SEALING NOT ACHIEVED ON THE LEFT. [LAPAROSCOPY] ON (B)(6) 2024: VISUALISATION OF RIGHT FALLOPIAN TUBE FITTED WITH AN ESSURE DEVICE. THE UTERUS SEEMS UNREMARKABLE. THE OVARIES ARE HEALTHY. THE LIVER APPEARS TO BE HEALTHY. THERE IS NO INTRA-ABDOMINAL EFFUSION. PARIETO-EPIPLOIC ADHESION(S) VISUALISED. PERFORMANCE OF A BILATERAL SALPINGECTOMY, ON THE LEFT, THEN ON THE RIGHT, AFTER PERFORATION OF THE RIGHT UTERINE HORN USING COLD SCISSORS AND COAGULATIO [MAGNETIC RESONANCE IMAGING PELVIC] ON (B)(6) 2023: ASSESSMENT OF CHRONIC PAIN WITH WEAKNESS OF LOWER LIMBS: FEMALE PATIENT FITTED WITH ESSURE IMPLANT, WITH SPONTANEOUS LOSS OF THE LEFT IMPLANT. CONCLUSION: THERE IS NO CHANGE IN THE RIGHT ESSURE IMPLANT. THERE IS NO UTERINE OR OVARIAN INVOLVEMENT, NO PELVIC REMODELING. [ULTRASOUND PELVIS] ON (B)(6) 2021: CHECK AFTER EXPULSION OF AN ESSURE TYPE TUBAL IMPLANT WHICH OCCURRED NATURALLY: INTEGRITY OF THE URINARY BLADDER, STUDIED WHEN FULL (IN REPLETION). MEDIAN ANTEVERTED UTERUS, 85 MM ON THE LONG AXIS. NO CHANGE IN THE MYOMETRIUM AND ENDOMETRIUM. THE OVARIES ARE VISUALISED, OF NORMAL SIZE, WITH NO CYSTIC OR PATHOLOGICAL TISSUE FORMATION. THE RIGHT TUBAL IMPLANT IS VISUALISED IN PROJECTION OF THE FALLOPIAN TUBE WHICH APPEARS TO BE UNDILATED. NO PERITONEAL EFFUSION.; ON (B)(6) 2023: CONCLUSION: NORMAL PELVIC ULTRASOUND FINDINGS. ANTEVERTED UTERUS, WITH HARMONIOUS CONTOUR. UNREMARKABLE ANNEXA. RIGHT ESSURE - LEGENDRE TYPE 2-3 SUPERFICIAL. NO LEFT ESSURE VISUALISED. 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
    1261868 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 HE011CL 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention| H