BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 17885322 · Received October 6, 2023

    Report

    Report Number
    2951250-2023-03048
    Event Type
    Injury
    Date Received
    October 6, 2023
    Date of Event
    May 10, 2023
    Report Date
    October 20, 2023
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    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 03-OCT-2023. THE MOST RECENT INFORMATION WAS RECEIVED ON 20-OCT-2023. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("FRAGMENTATION OF THE PROXIMAL SEGMENT OF THE RIGHT-SIDE ESSURE LOCATED AT 7 MM") IN A 49 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 925789). ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. AS CONCURRENT CONDITION THE REPORT MENTIONED UTERINE ANTEFLEXION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2023, 3990 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED ON (B)(6) 2023. AN UNKNOWN TIME LATER SHE EXPERIENCED PELVIC PAIN ("PELVIC PAIN"), PAIN ("PAIN"), HEADACHE ("HEADACHE"), PAIN IN HIP ("HIP PAIN"), PAINFUL JOINTS ("PAINFUL JOINTS"), BACK PAIN ("BACK PAIN"), FATIGUE ("CHRONIC FATIGUE, SEVERE FTIGUE"), HEAVY MENSTRUAL BLEEDING ("MENORRHAGIA"), DYSMENORRHOEA ("DYSMENORRHOEA"), DYSPAREUNIA ("DYSPAREUNIA"), ASTHENIA ("INTENSE ASTHENIA"), MUSCULOSKELETAL PAIN ("MUSCULOSKELETAL PAIN"), DISTURBANCE IN ATTENTION ("ATTENTION DEFICIT"), AMNESIA ("MEMORY DEFICIT, MEMORY LOSS"), FRACTURE ("BROKEN JOINTS"), DEAFNESS ("HEARING LOSS") AND VISUAL IMPAIRMENT ("VISUAL IMPAIRMENT"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL ON (B)(6) 2023). AT THE TIME OF THE REPORT, THE PELVIC PAIN, PAIN, HEADACHE, PAIN IN HIP, PAINFUL JOINTS, BACK PAIN, FATIGUE AND MUSCULOSKELETAL PAIN HAD NOT RESOLVED. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO DEVICE BREAKAGE, PELVIC PAIN, PAIN, HEADACHE, PAIN IN HIP, BACK PAIN, HEAVY MENSTRUAL BLEEDING, DYSMENORRHOEA, DYSPAREUNIA, ASTHENIA, MUSCULOSKELETAL PAIN, DISTURBANCE IN ATTENTION, AMNESIA, PAINFUL JOINTS, FRACTURE, DEAFNESS, VISUAL IMPAIRMENT OR FATIGUE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 79 KG. [ABDOMINAL X-RAY] ON (B)(6) 2023: FRAGMENTATION OF THE PROXIMAL SEGMENT OF THE RIGHT-SIDE ESSURE, WHICH IS LOCATED AT 7 MM. NO FRAGMENTATION OF THE LEFT-SIDE DEVICE. [MAGNETIC RESONANCE IMAGING PELVIC] ON (B)(6) 2023: RESULTS: ANTEVERTED AND ANTEFLEXED UTERUS, WITH VOLUME INCREASED TO 71 MM ANTEROPOSTERIORLY X 110 MM HIGH X 75 MM TRANSVERSELY. THE ENDOMETRIUM IS REGULAR.WE CAN SEE A FIBROMATOUS FORMATION WITH TYPE 2 ENDOCAVITARY DEVELOPMENT OF 45 MM (ANTERIOR EXTERNAL). MODERATE THICKENING OF THE JUNCTIONAL ZONE. SECOND SUBSEROSAL FIBROMATOUS FORMATION OF 22 MM ON THE RIGHT. NO ABNORMALITY OF THE LEFT OVARY. THE RIGHT OVARY HAS A FUNCTIONAL FLUID-FILLED FORMATION OF 23 MM. THE LEFT-SIDE ESSURE APPEARS TO BE IN PLACE IN THE USUAL LOCATION. THE RIGHT-SIDE ONE APPEARS TO BE MORE DISTAL. PRESENCE OF A PROMONTOFIXATION STRIP. NO PELVIC ADENOMEGALY OR PERITONEAL EFFUSION. NO DEEP ENDOMETRIOSIS. LOT NUMBER: 925789. MANUFACTURE DATE: 2011-11. EXPIRATION DATE: 2014-11. 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: 20-OCT-2023: 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 03-OCT-2023. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("FRAGMENTATION OF THE PROXIMAL SEGMENT OF THE RIGHT-SIDE ESSURE LOCATED AT 7 MM") IN A 49 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 925789). ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. AS CONCURRENT CONDITION THE REPORT MENTIONED UTERINE ANTEFLEXION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. AN UNKNOWN TIME LATER SHE EXPERIENCED PELVIC PAIN ("PELVIC PAIN"), PAIN ("PAIN"), HEADACHE ("HEADACHE"), PAIN IN HIP ("HIP PAIN"), PAINFUL JOINTS ("PAINFUL JOINTS"), BACK PAIN ("BACK PAIN"), FATIGUE ("CHRONIC FATIGUE, SEVERE FATIGUE"), HEAVY MENSTRUAL BLEEDING ("MENORRHAGIA"), DYSMENORRHOEA ("DYSMENORRHOEA"), DYSPAREUNIA ("DYSPAREUNIA"), ASTHENIA ("INTENSE ASTHENIA"), MUSCULOSKELETAL PAIN ("MUSCULOSKELETAL PAIN"), DISTURBANCE IN ATTENTION ("ATTENTION DEFICIT"), AMNESIA ("MEMORY DEFICIT, MEMORY LOSS"), FRACTURE ("BROKEN JOINTS"), DEAFNESS ("HEARING LOSS") AND VISUAL IMPAIRMENT ("VISUAL IMPAIRMENT"). ON (B)(6) 2023, 3990 DAYS AFTER ESSURE INSERTION, SHE WAS DIAGNOSED WITH DEVICE BREAKAGE (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL ON (B)(6) 2023). AT THE TIME OF THE REPORT, THE PELVIC PAIN, PAIN, HEADACHE, PAIN IN HIP, PAINFUL JOINTS, BACK PAIN, FATIGUE AND MUSCULOSKELETAL PAIN HAD NOT RESOLVED. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO DEVICE BREAKAGE, PELVIC PAIN, PAIN, HEADACHE, PAIN IN HIP, BACK PAIN, HEAVY MENSTRUAL BLEEDING, DYSMENORRHOEA, DYSPAREUNIA, ASTHENIA, MUSCULOSKELETAL PAIN, DISTURBANCE IN ATTENTION, AMNESIA, PAINFUL JOINTS, FRACTURE, DEAFNESS, VISUAL IMPAIRMENT OR FATIGUE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 79 KG. [ABDOMINAL X-RAY] ON (B)(6) 2023: FRAGMENTATION OF THE PROXIMAL SEGMENT OF THE RIGHT-SIDE ESSURE, WHICH IS LOCATED AT 7 MM. NO FRAGMENTATION OF THE LEFT-SIDE DEVICE. [MAGNETIC RESONANCE IMAGING PELVIC] ON (B)(6) 2023: RESULTS: ANTEVERTED AND ANTEFLEXED UTERUS, WITH VOLUME INCREASED TO 71 MM ANTEROPOSTERIORLY X 110 MM HIGH X 75 MM TRANSVERSELY. THE ENDOMETRIUM IS REGULAR. WE CAN SEE A FIBROMATOUS FORMATION WITH TYPE 2 ENDOCAVITARY DEVELOPMENT OF 45 MM (ANTERIOR EXTERNAL). MODERATE THICKENING OF THE JUNCTIONAL ZONE. SECOND SUBSEROSAL FIBROMATOUS FORMATION OF 22 MM ON THE RIGHT. NO ABNORMALITY OF THE LEFT OVARY. THE RIGHT OVARY HAS A FUNCTIONAL FLUID-FILLED FORMATION OF 23 MM. THE LEFT-SIDE ESSURE APPEARS TO BE IN PLACE IN THE USUAL LOCATION. THE RIGHT-SIDE ONE APPEARS TO BE MORE DISTAL. PRESENCE OF A PROMONTOFIXATION STRIP. NO PELVIC ADENOMEGALY OR PERITONEAL EFFUSION. NO DEEP ENDOMETRIOSIS. 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
    1071295 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 925789 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention