BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 20067591 · Received August 26, 2024

    Report

    Report Number
    2951250-2024-00536
    Event Type
    Injury
    Date Received
    August 26, 2024
    Date of Event
    January 1, 2011
    Report Date
    September 3, 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 21-AUG-2024. THE MOST RECENT INFORMATION WAS RECEIVED ON 03-SEP-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF HEADACHE ("PRESENCE OF HEADACHE") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED 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) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, 81 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED HEADACHE (SERIOUSNESS CRITERION HOSPITALISATION), DISTURBANCE IN ATTENTION ("IMPAIRED CONCENTRATION"), ARTHRALGIA ("KNEE JOINT PAIN"), MUSCLE SPASMS ("TETANIC SPASMS"), ASTHMA ("ASTHMA"), ROSACEA ("ROSACEA"), KERATITIS ("KERATITIS"), EAR INFECTION ("EAR INFECTIONS WITH DISCHARGE"), OTORRHOEA ("EAR DISCHARGE"), SINUSITIS ("RECURRING SINUSITIS") AND COUGH ("PERSISTENT COUGH") AND WAS FOUND TO HAVE GAMMA-GLUTAMYLTRANSFERASE INCREASED ("RISE IN GAMMA-GLUTAMYL TRANSFERASE (GGT) LEVELS TO 15") AND WEIGHT INCREASED ("WEIGHT GAIN"). ESSURE WAS REMOVED ON (B)(6) 2024. THE PATIENT WAS TREATED WITH ANTIBIOTICS (UNKNOWN), CORTICOSTEROIDS (UNKNOWN) AND ANALGESIC (BENZOCAINE, PHENAZONE) AS WELL AS SURGERY (ESSURE REMOVED ON (B)(6) 2024). AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO HEADACHE, DISTURBANCE IN ATTENTION, ARTHRALGIA, GAMMA-GLUTAMYLTRANSFERASE INCREASED, MUSCLE SPASMS, ASTHMA, ROSACEA, KERATITIS, WEIGHT INCREASED, EAR INFECTION, OTORRHOEA, SINUSITIS OR COUGH. THE REPORTER COMMENTED: AFTER SEVERAL YEARS OF SUFFERING, SOCIAL MEDIA REPORTING ALONE WAS THE TRIGGER THAT BROUGHT TO LIGHT ALL OF THE ILLNESSES. NO SPECIALIST COULD FIND THE CAUSE OF THE DYSFUNCTIONS: FREQUENT BLOOD TESTS, NUMEROUS ULTRASOUNDS (PARTICULARLY OF THE LIVER AREA), MEDICATION USE, TREATMENT WITH ANTIBIOTICS AND CORTICOSTEROIDS, PAINKILLERS, ETC. HOSPITALISATION IN THE RHEUMATOLOGY WARD AT , LUNG X-RAYS AND CT (COMPUTED TOMOGRAPHY) SCANS, EMERGENCY DEPARTMENT MEDICAL VISITS, ETC. ACTIONS TAKEN TO TREAT THE PATIENT IN THE HEALTHCARE FACILITY: COMMENTS AT NO TIME DID THE DOCTORS MAKE THE CONNECTION WITH THE IMPLANTS. THE MINISTRY OF HEALTH DID NOT SHARE ANY INFORMATION WITH THE PEOPLE FITTED WITH THE IMPLANTS. THE SPREAD OF HEAVY METALS IN THE BLOOD CAUSES TOXICITY AND PREVENTS THE IMPLANT USER FROM LEADING A NORMAL LIFE, IN ADDITION TO HAVING A SERIOUS PSYCHOLOGICAL EFFECT ON THAT PERSON AND ON HER FAMILY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 55 KG. [BLOOD TEST] (DATE UNKNOWN): ABNORMAL. [CHEST X-RAY] (DATE UNKNOWN): NOT AVAILABLE. [COMPUTERISED TOMOGRAM] (DATE UNKNOWN): NOT AVAILABLE. [ULTRASOUND SCAN] (DATE UNKNOWN): NOT AVAILABLE. 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: 03-SEP-2024: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 21-AUG-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF HEADACHE ("PRESENCE OF HEADACHE") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED 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) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, 81 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED HEADACHE (SERIOUSNESS CRITERION HOSPITALISATION), DISTURBANCE IN ATTENTION ("IMPAIRED CONCENTRATION"), ARTHRALGIA ("KNEE JOINT PAIN"), MUSCLE SPASMS ("TETANIC SPASMS"), ASTHMA ("ASTHMA"), ROSACEA ("ROSACEA"), KERATITIS ("KERATITIS"), EAR INFECTION ("EAR INFECTIONS WITH DISCHARGE"), OTORRHOEA ("EAR DISCHARGE"), SINUSITIS ("RECURRING SINUSITIS") AND COUGH ("PERSISTENT COUGH") AND WAS FOUND TO HAVE GAMMA-GLUTAMYLTRANSFERASE INCREASED ("RISE IN GAMMA-GLUTAMYL TRANSFERASE (GGT) LEVELS TO 15") AND WEIGHT INCREASED ("WEIGHT GAIN"). ESSURE WAS REMOVED ON (B)(6) 2024. THE PATIENT WAS TREATED WITH ANTIBIOTICS (UNKNOWN), CORTICOSTEROIDS (UNKNOWN) AND ANALGESIC (BENZOCAINE, PHENAZONE) AS WELL AS SURGERY (ESSURE REMOVED ON (B)(6) 2024. AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO HEADACHE, DISTURBANCE IN ATTENTION, ARTHRALGIA, GAMMA-GLUTAMYLTRANSFERASE INCREASED, MUSCLE SPASMS, ASTHMA, ROSACEA, KERATITIS, WEIGHT INCREASED, EAR INFECTION, OTORRHOEA, SINUSITIS OR COUGH. THE REPORTER COMMENTED: AFTER SEVERAL YEARS OF SUFFERING, SOCIAL MEDIA REPORTING ALONE WAS THE TRIGGER THAT BROUGHT TO LIGHT ALL OF THE ILLNESSES. NO SPECIALIST COULD FIND THE CAUSE OF THE DYSFUNCTIONS: FREQUENT BLOOD TESTS, NUMEROUS ULTRASOUNDS (PARTICULARLY OF THE LIVER AREA), MEDICATION USE, TREATMENT WITH ANTIBIOTICS AND CORTICOSTEROIDS, PAINKILLERS, ETC. HOSPITALISATION IN THE RHEUMATOLOGY WARD AT , LUNG X-RAYS AND CT (COMPUTED TOMOGRAPHY) SCANS, EMERGENCY DEPARTMENT MEDICAL VISITS, ETC. ACTIONS TAKEN TO TREAT THE PATIENT IN THE HEALTHCARE FACILITY: COMMENTS AT NO TIME DID THE DOCTORS MAKE THE CONNECTION WITH THE IMPLANTS. THE MINISTRY OF HEALTH DID NOT SHARE ANY INFORMATION WITH THE PEOPLE FITTED WITH THE IMPLANTS. THE SPREAD OF HEAVY METALS IN THE BLOOD CAUSES TOXICITY AND PREVENTS THE IMPLANT USER FROM LEADING A NORMAL LIFE, IN ADDITION TO HAVING A SERIOUS PSYCHOLOGICAL EFFECT ON THAT PERSON AND ON HER FAMILY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 55 KG. [BLOOD TEST] (DATE UNKNOWN): ABNORMAL [CHEST X-RAY] (DATE UNKNOWN): NOT AVAILABLE [COMPUTERISED TOMOGRAM] (DATE UNKNOWN): NOT AVAILABLE [ULTRASOUND SCAN] (DATE UNKNOWN): NOT AVAILABLE. 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
    1194542 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Hospitalization