BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10369915 · Received August 5, 2020

    Report

    Report Number
    2951250-2020-12779
    Event Type
    Injury
    Date Received
    August 5, 2020
    Report Date
    August 19, 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 ABDOMINAL PAIN ('ABDOMINAL PAIN THAT RADIATES TO LOWER BACK') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872882-NOT VALID) 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". THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA I AND OBESITY. CONCOMITANT PRODUCTS INCLUDED NAPROXEN, PARACETAMOL (TYLENOL) AND TRAMADOL. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2016, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (STILLBIRTH OR MISCARRIAGE)") AND EXPERIENCED ABORTION SPONTANEOUS ("MISCARRIAGE"). IN (B)(6) 2017, THE PATIENT EXPERIENCED URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES: WEAKENED BLADDER"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("ABDOMINAL PAIN THAT RADIATES TO LOWER BACK"), ALLERGY TO METALS ("NICKEL ALLERGY"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), MIGRAINE ("MIGRAINE/HEADACHE"), HEADACHE ("MIGRAINE/HEADACHE") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, BACK PAIN, ALLERGY TO METALS, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, VAGINAL DISCHARGE, URINARY INCONTINENCE, URINARY TRACT INFECTION, FATIGUE, ALOPECIA, MIGRAINE, HEADACHE, NAUSEA AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 1. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, ALLERGY TO METALS, ALOPECIA, BACK PAIN, DYSMENORRHOEA, FATIGUE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PREGNANCY WITH CONTRACEPTIVE DEVICE, URINARY INCONTINENCE, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 270 LBS. INSERTION DETAILS:- LEFT TUBE: 5 COILS. RIGHT TUBE: 4 COILS . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 39.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION, THE BILATERAL FALLOPIAN TUBES ARE OCCLUDED AFTER AN ESSURE PROCEDURE. LOT NUMBER REPORTED 872882 IS NOT VALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-AUG-2020: QUALITY SAFETY EVALUATION OF PTC (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 · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('ABDOMINAL PAIN THAT RADIATES TO LOWER BACK') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872882-NOT VALID) 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". THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA I AND OBESITY. CONCOMITANT PRODUCTS INCLUDED NAPROXEN, PARACETAMOL (TYLENOL) AND TRAMADOL. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2016, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (STILLBIRTH OR MISCARRIAGE)") AND EXPERIENCED ABORTION SPONTANEOUS ("MISCARRIAGE"). IN (B)(6) 2017, THE PATIENT EXPERIENCED URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES: WEAKENED BLADDER"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("ABDOMINAL PAIN THAT RADIATES TO LOWER BACK"), ALLERGY TO METALS ("NICKEL ALLERGY"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), MIGRAINE ("MIGRAINE/HEADACHE"), HEADACHE ("MIGRAINE/HEADACHE") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, BACK PAIN, ALLERGY TO METALS, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, VAGINAL DISCHARGE, URINARY INCONTINENCE, URINARY TRACT INFECTION, FATIGUE, ALOPECIA, MIGRAINE, HEADACHE, NAUSEA AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 1. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, ALLERGY TO METALS, ALOPECIA, BACK PAIN, DYSMENORRHOEA, FATIGUE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PREGNANCY WITH CONTRACEPTIVE DEVICE, URINARY INCONTINENCE, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT (B)(4). INSERTION DETAILS:- LEFT TUBE: 5 COILS. RIGHT TUBE: 4 COILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 39.7 KG/SQM. HYSTEROSALPINGOGRAM ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION, THE BILATERAL FALLOPIAN TUBES ARE OCCLUDED AFTER AN ESSURE PROCEDURE. LOT NUMBER REPORTED 872882 IS NOT VALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-JUL-2020: PFS RECEIVED NEW REPORTER INFORMATION WAS ADDED. CASE BECOME INCIDENT REMOVAL DATE WAS ADDED. 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
    833036 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 872882-NOT VALID 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R NAPROXEN| NAPROXEN| TRAMADOL| TRAMADOL| TYLENOL| TYLENOL