BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9530140 · Received December 30, 2019

    Report

    Report Number
    2951250-2019-14861
    Event Type
    Injury
    Date Received
    December 30, 2019
    Report Date
    February 20, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DYSPAREUNIA ('DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)'), ABDOMINAL PAIN ('ABDOMINAL PAIN'), GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING'), MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING),') AND PELVIC PAIN ('CHRONIC PELVIC PAIN') IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863568) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OBESITY, MULTIGRAVIDA, PARITY 2, DEPRESSION, ANXIETY DISORDER, SMOKER AND ALCOHOL USE. ESSURE CONFIRMATION TEST : RESULT : TOTAL BILATERAL OCCLUSION. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN 2014, THE PATIENT EXPERIENCED DYSPAREUNIA AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN 2017, THE PATIENT EXPERIENCED OVARIAN CYST ("OVARIAN CYST"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN AND MENORRHAGIA. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA, MENORRHAGIA, ALLERGY TO METALS, MIGRAINE, HEADACHE, DYSMENORRHOEA, WEIGHT INCREASED AND OVARIAN CYST OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, OVARIAN CYST, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PELVIC, ABDOMINAL, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), GENERAL ABNORMAL BLEEDING., DIAGNOSED NICKEL ALLERGY: YES. ESSURE INSERTION DATE PROVIDED IN PFS (B)(6) 2014 (DISCREPANCY NOTED) CURRENT WEIGHT 250 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 35.4 KG/SQM. LOT NUMBER:863568, MANUFACTURING DATE:2011/05, EXPIRATION DATE:2014/05. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: AFTER INTERNAL REVIEW, THE EVENT "GENITAL HAEMORRHAGE" WAS DOWNGRADED TO NON-SERIOUS INCIDENT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863568) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MORBID OBESITY, MULTIGRAVIDA, PARITY 2, DEPRESSION, ANXIETY DISORDER, SMOKER AND ALCOHOL USE. ESSURE CONFIRMATION TEST : RESULT : TOTAL BILATERAL OCCLUSION. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN 2017, THE PATIENT EXPERIENCED OVARIAN CYST ("OVARIAN CYST"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("CHRONIC PELVIC PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING),"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA, MENORRHAGIA, ALLERGY TO METALS, MIGRAINE, HEADACHE, DYSMENORRHOEA, WEIGHT INCREASED AND OVARIAN CYST OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, OVARIAN CYST, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PELVIC, ABDOMINAL, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), GENERAL ABNORMAL BLEEDING., DIAGNOSED NICKEL ALLERGY: YES. ESSURE INSERTION DATE PROVIDED IN PFS (B)(6) 2014(DISCREPANCY NOTED) CURRENT WEIGHT (B)(6) LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 35.4 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-DEC-2019: PFS AND MR RECEIVED : EVENTS" MIGRAINES, HEADACHES, DYSMENORRHEA (CRAMPING), WEIGHT GAIN, OVARIAN CYST", REPORTER, LOT NUMBER, MEDICAL HISTORY ADDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1325489 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 863568 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other