BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 17236041 · Received June 30, 2023

    Report

    Report Number
    2951250-2023-02674
    Event Type
    Injury
    Date Received
    June 30, 2023
    Report Date
    July 12, 2023
    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 26-JUN-2023. THE MOST RECENT INFORMATION WAS RECEIVED ON 11-JUL-2023. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 882192) FOR PERMANENT CONTRACEPTIVE TUBAL IMPLANT. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. MEDICAL CONDITIONS: RESULTS OF THE HAIR ANALYSIS OF (B)(6) 2023 EXPOSURE LEVELS TO BE MONITORED: METAL - CONTENT (G/G)- (BASE REFERENCE LEVEL - UPPER REFERENCE LEVEL) CERIUM - 0.0163 - (0.0048- 0.0100), PRASEODYMIUM ¿ 0.0015 (0.0005 - 0.0010). HIGH-RISK EXPOSURE LEVELS: METAL - CONTENT (G/G)- (BASE REFERENCE LEVEL - UPPER REFERENCE LEVEL), MANGANESE- 0.1621- (0.1302 - 2.4100), ALUMINIUM- 20.5799- (10.0000- 25.6000), TIN - 0.1084- (0.0070 - 1.4000), GADOLINIUM- 0.0015- (0.0014 - 0.0050), LANTHANUM - 0.0074- (0.0070 - 0.0200), NEODYMIUM - 0.0043- (0.0020 - 0.0100). IN 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2018 SHE EXPERIENCED ARTHRALGIA ("CONSIDERABLE KNEE PAIN; WHENEVER I STOOPED DOWN I WAS UNABLE TO GET BACK UP"). IN (B)(6) 2023 SHE EXPERIENCED BACK PAIN ("BACK PAIN") AND SCIATICA ("SCIATICA DOWN MY LEFT LEG"). AN UNKNOWN TIME LATER SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), DYSMENORRHOEA ("HEAVY PERIODS FOR SEVERAL YEARS WITH PAIN"), HEAVY MENSTRUAL BLEEDING ("HEAVY PERIODS"), HEADACHE ("HEADACHES"), DIZZINESS ("DIZZINESS"), ASTHENIA ("ASTHENIA"), MUSCULOSKELETAL PAIN ("MUSCULOSKELETAL PAIN"), MEMORY IMPAIRMENT ("MEMORY DISORDER"), ATTENTION DEFICIT HYPERACTIVITY DISORDER ("ATTENTION DISORDERS"), ANAEMIA ("ANAEMIA"), TINNITUS ("BUZZING IN THE EARS"), TENDONITIS ("TENDINITIS") AND TENDON RUPTURE ("TORN TENDON"). AT THE TIME OF THE REPORT, THE OUTCOMES FOR PELVIC PAIN, BACK PAIN, HEAVY MENSTRUAL BLEEDING, DIZZINESS, ARTHRALGIA, ASTHENIA, MUSCULOSKELETAL PAIN, MEMORY IMPAIRMENT, ANAEMIA, TINNITUS AND TENDONITIS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO ARTHRALGIA, PELVIC PAIN, ASTHENIA, MUSCULOSKELETAL PAIN, MEMORY IMPAIRMENT, ATTENTION DEFICIT HYPERACTIVITY DISORDER, HEAVY MENSTRUAL BLEEDING, ANAEMIA, HEADACHE, DIZZINESS, TINNITUS, TENDONITIS, TENDON RUPTURE, BACK PAIN, SCIATICA OR DYSMENORRHOEA. THE REPORTER COMMENTED: INDICATION FOR PELVIC MRI (MAGNETIC RESONANCE IMAGING) ON (B)(6) 2023: LAB TESTS PRIOR TO POSSIBLE REMOVAL OF THE ESSURE DEVICES INSERTED IN 2011. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 73 KG. [BLOOD ALUMINIUM] (DATE UNKNOWN): 20.5799. [MAGNETIC RESONANCE IMAGING PELVIC] ON (B)(6) 2023: ESSURE [DEVICES] IN PLACE ON BOTH SIDES. N.B.: SLIGHT VOLUME ASYMMETRY IN THE LEFT OVARY WHICH APPEARS TO BE A LITTLE LARGER THAN THE VERY ATROPHIC RIGHT OVARY, MEASURES 15 X 20 MM, WITH SIGNS OF FIBROUS TISSUE THAT MAY WARRANT CLOSER INSPECTION, POSSIBLY BY ORDINARY ULTRASOUND IF NECESSARY. [MANGANESE] (DATE UNKNOWN): 0.1621. [ULTRASOUND SCAN] ON (B)(6) 2019: LATERAL EPICONDYLE TENDINOPATHY WITH A LONGITUDINAL INTRATENDINOUS CLEAVAGE; OPINION REGARDING ORTHOPEDIC SURGERY PENDING. [X-RAY] ON (B)(6) 2022: TENDINOPATHY OF THE INFRA-SPINATUS MUSCLE WITH SIGNIFICANT SUBACROMIAL BURSITIS. OSTEOARTHRITIS OF THE ACROMIOCLAVICULAR JOINT LOT NUMBER:882192. MANUFACTURE DATE: 2011-07. EXPIRATION DATE: 2014-07. 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: 11-JUL-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 26-JUN-2023. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 882192) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. MEDICAL CONDITIONS: RESULTS OF THE HAIR ANALYSIS OF (B)(6) 2023. EXPOSURE LEVELS TO BE MONITORED: METAL - CONTENT (G/G)- (BASE REFERENCE LEVEL - UPPER REFERENCE LEVEL), CERIUM - 0.0163 - (0.0048- 0.0100), PRASEODYMIUM ¿ 0.0015 (0.0005 - 0.0010). HIGH-RISK EXPOSURE LEVELS: METAL - CONTENT (G/G)- (BASE REFERENCE LEVEL - UPPER REFERENCE LEVEL), MANGANESE- 0.1621- (0.1302 - 2.4100), ALUMINIUM- 20.5799- (10.0000- 25.6000), TIN - 0.1084- (0.0070 - 1.4000), GADOLINIUM- 0.0015- (0.0014 - 0.0050), LANTHANUM - 0.0074- (0.0070 - 0.0200), NEODYMIUM - 0.0043- (0.0020 - 0.0100). IN 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2018 SHE EXPERIENCED ARTHRALGIA ("CONSIDERABLE KNEE PAIN; WHENEVER I STOOPED DOWN I WAS UNABLE TO GET BACK UP"). IN (B)(6) 2023 SHE EXPERIENCED BACK PAIN ("BACK PAIN") AND SCIATICA ("SCIATICA DOWN MY LEFT LEG"). AN UNKNOWN TIME LATER SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), DYSMENORRHOEA ("HEAVY PERIODS FOR SEVERAL YEARS WITH PAIN"), HEAVY MENSTRUAL BLEEDING ("HEAVY PERIODS"), HEADACHE ("HEADACHES"), DIZZINESS ("DIZZINESS"), ASTHENIA ("ASTHENIA"), MUSCULOSKELETAL PAIN ("MUSCULOSKELETAL PAIN"), MEMORY IMPAIRMENT ("MEMORY DISORDER"), ATTENTION DEFICIT HYPERACTIVITY DISORDER ("ATTENTION DISORDERS"), ANAEMIA ("ANAEMIA"), TINNITUS ("BUZZING IN THE EARS"), TENDONITIS ("TENDINITIS") AND TENDON RUPTURE ("TORN TENDON"). AT THE TIME OF THE REPORT, THE OUTCOMES FOR PELVIC PAIN, BACK PAIN, HEAVY MENSTRUAL BLEEDING, DIZZINESS, ARTHRALGIA, ASTHENIA, MUSCULOSKELETAL PAIN, MEMORY IMPAIRMENT, ANAEMIA, TINNITUS AND TENDONITIS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO ARTHRALGIA, PELVIC PAIN, ASTHENIA, MUSCULOSKELETAL PAIN, MEMORY IMPAIRMENT, ATTENTION DEFICIT HYPERACTIVITY DISORDER, HEAVY MENSTRUAL BLEEDING, ANAEMIA, HEADACHE, DIZZINESS, TINNITUS, TENDONITIS, TENDON RUPTURE, BACK PAIN, SCIATICA OR DYSMENORRHOEA. THE REPORTER COMMENTED: INDICATION FOR PELVIC MRI (MAGNETIC RESONANCE IMAGING) ON (B)(6) 2023: LAB TESTS PRIOR TO POSSIBLE REMOVAL OF THE ESSURE DEVICES INSERTED IN 2011. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 73 KG. [BLOOD ALUMINIUM] (DATE UNKNOWN): 20.5799, [MAGNETIC RESONANCE IMAGING PELVIC] ON (B)(6) 2023: ESSURE [DEVICES] IN PLACE ON BOTH SIDES. N.B.: SLIGHT VOLUME ASYMMETRY IN THE LEFT OVARY WHICH APPEARS TO BE A LITTLE LARGER THAN THE VERY ATROPHIC RIGHT OVARY, MEASURES 15 X 20 MM, WITH SIGNS OF FIBROUS TISSUE THAT MAY WARRANT CLOSER INSPECTION, POSSIBLY BY ORDINARY ULTRASOUND IF NECESSARY. [MANGANESE] (DATE UNKNOWN): 0.1621, [ULTRASOUND SCAN] ON (B)(6) 2019: LATERAL EPICONDYLE TENDINOPATHY WITH A LONGITUDINAL INTRATENDINOUS CLEAVAGE; OPINION REGARDING ORTHOPEDIC SURGERY PENDING. [X-RAY] ON (B)(6) 2022: TENDINOPATHY OF THE INFRA-SPINATUS MUSCLE WITH SIGNIFICANT SUBACROMIAL BURSITIS. OSTEOARTHRITIS OF THE ACROMIOCLAVICULAR JOINT. 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
    988957 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 882192 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other