BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10524408 · Received September 11, 2020

    Report

    Report Number
    2951250-2020-14144
    Event Type
    Injury
    Date Received
    September 11, 2020
    Date of Event
    October 1, 2018
    Report Date
    September 29, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') AND DEVICE DISLOCATION ('MISSING COIL / MIGRATION') IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2018, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION, MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 3 YEARS 4 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PRE-ECLAMPSIA ("PRE ECLAMPSIA") AND MIGRAINE ("MIGRAINES") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL BY BILATERAL SALPINGECTOMY AND HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE DISLOCATION, PRE-ECLAMPSIA AND MIGRAINE OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH OF A CHILD WITH HEALTH PROBLEMS (LINKED CHILD CASES NO. US-BAYER-2020-193233). THE REPORTER CONSIDERED DEVICE DISLOCATION, MIGRAINE, PELVIC PAIN, PRE-ECLAMPSIA AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION DATE WAS ON (B)(6) 2012 (ALSO REPORTED). BIRTH DEFECT IN CHILD WAS MENTIONED. CHILD CASE NUMBER: 2020-193233 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-SEP-2020: QUALITY SAFETY EVALUATION OF PTC. 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN'), DEVICE DISLOCATION ('MISSING COIL / MIGRATION'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY') AND PRE-ECLAMPSIA ('PRE ECLAMPSIA') IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2018, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION, MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 3 YEARS 4 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PRE-ECLAMPSIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND MIGRAINE ("MIGRAINES") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL BY BILATERAL SALPINGECTOMY AND HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE DISLOCATION, PRE-ECLAMPSIA AND MIGRAINE OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH OF A CHILD WITH HEALTH PROBLEMS. THE REPORTER CONSIDERED DEVICE DISLOCATION, MIGRAINE, PELVIC PAIN, PRE-ECLAMPSIA AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION DATE WAS ON (B)(6) 2012 (ALSO REPORTED). BIRTH DEFECT IN CHILD WAS MENTIONED. CHILD CASE NUMBER: 2020-193233 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: THE CASE 2019-191066 WAS IDENTIFIED AS A FU OF THIS CASE AND THEREFORE THE CASE 2019-191066 WAS DELETED FROM ARGUS DATABASE AND ALL INFORMATION WAS TRANSFERRED TO THIS CASE. REPORTER'S INFORMATION UPDATED. DRUG INFORMATION ADDED. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. 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 · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN'), DEVICE DISLOCATION ('MISSING COIL / MIGRATION'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY') AND PRE-ECLAMPSIA ('PRE ECLAMPSIA') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "PREGNANCY". ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2018, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION, MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 3 YEARS 4 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PRE-ECLAMPSIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND MIGRAINE ("MIGRAINES") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL BY BILATERAL SALPINGECTOMY AND HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE DISLOCATION, PRE-ECLAMPSIA AND MIGRAINE OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH OF A CHILD WITH HEALTH PROBLEMS (LINKED CHILD CASES NO. US-BAYER (B)(4). THE REPORTER CONSIDERED DEVICE DISLOCATION, MIGRAINE, PELVIC PAIN, PRE-ECLAMPSIA AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BIRTH DEFECT IN CHILD WAS MENTIONED. CHILD CASE NUMBER: (B)(4). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. 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
    986017 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| O| R