BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8878562 · Received August 9, 2019

    Report

    Report Number
    2951250-2019-04622
    Event Type
    Injury
    Date Received
    August 9, 2019
    Report Date
    August 14, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ('PAIN LOWER BACK\ LOWER BACK PAIN WITH A BUMP ON THE LOWER LEFT SIDE OF MY BACK') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880433) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED NERVE DAMAGE, ENDOMETRIAL BIOPSY, PELVIC PAIN FEMALE, NEURITIS SCIATIC, NUMBNESS IN LEG, TINGLING, PAINFUL PERIODS, UTERINE BLEEDING, DEPRESSION, HYPERTENSION, NAUSEA, PERINEAL PAIN, HEMOSTASIS, OVARIAN CYST (14CM RIGHT OVARIAN CYST.) AND FALL. FAMILY HISTORY INCLUDED OVARIAN CANCER. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN NOVEMBER 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/ MENSTRUAL CRAMPING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MIGRAINE ("MIGRAINES / HEADACHES"), TOOTH DISORDER ("DENTAL PROBLEMS/ MULTIPLE FILLINGS AND CAPS"), ALOPECIA ("HAIR LOSS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), ARTHRALGIA ("PAIN HIP"), PAIN IN EXTREMITY ("PAIN LEFT LEG"), INFECTION ("INFECTION (OTHER)"), HEADACHE ("HEADACHES"), PARAESTHESIA ("CONSTANT TINGLING FROM MY HIP TO MY TOES IN MY LEFT LEG") AND RASH PAPULAR ("BUMP ON THE LOWER LEFT SIDE OF MY BACK"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE BACK PAIN, PARAESTHESIA AND RASH PAPULAR HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, TOOTH DISORDER, DYSMENORRHOEA, ALOPECIA, VAGINAL DISCHARGE, ARTHRALGIA, PAIN IN EXTREMITY, INFECTION AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, ARTHRALGIA, BACK PAIN, DYSMENORRHOEA, HEADACHE, INFECTION, MENORRHAGIA, MIGRAINE, PAIN IN EXTREMITY, PARAESTHESIA, RASH PAPULAR, TOOTH DISORDER, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION DATES- (B)(6) 2011 AND (B)(6)2011 DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULT- TOTAL BILATERAL OCCLUSION AND RIGHT FALLOPIAN TUBE OCCLUSION. CONTRAST SEEN EXTENDING BEYOND THE LEFT ESSURE COIL WITH COMPLETE OPACIFICATION OF THE DISTAL FALLOPIAN TUBE. ULTRASOUND PELVIS - ON (B)(6) 2018: 1 CM ECHOGENIC FOCUS WITHIN THE ENDOMETRIUM, MOST LIKELY REPRESENTING AN ENDOMETRIAL POLYP AND 14CM RIGHT OVARIAN CYST. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WAS CONFIRMED IN PATIENT MEDICAL RECORDS: LOW BACK PAIN, HIP PAIN, LEFT LEG PAIN AND DYSMENORRHEA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. INCIDENT WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCE'S DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS 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 BACK PAIN ('PAIN LOWER BACK\ LOWER BACK PAIN WITH A BUMP ON THE LOWER LEFT SIDE OF MY BACK') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880433) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED NERVE DAMAGE, ENDOMETRIAL BIOPSY, PELVIC PAIN FEMALE, NEURITIS SCIATIC, NUMBNESS IN LEG, TINGLING, PAINFUL PERIODS, UTERINE BLEEDING, DEPRESSION, HYPERTENSION, NAUSEA, PERINEAL PAIN, HEMOSTASIS, OVARIAN CYST (14CM RIGHT OVARIAN CYST.) AND FALL. FAMILY HISTORY INCLUDED OVARIAN CANCER. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/ MENSTRUAL CRAMPING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MIGRAINE ("MIGRAINES / HEADACHES"), TOOTH DISORDER ("DENTAL PROBLEMS/ MULTIPLE FILLINGS AND CAPS"), ALOPECIA ("HAIR LOSS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), ARTHRALGIA ("PAIN HIP"), PAIN IN EXTREMITY ("PAIN LEFT LEG"), INFECTION ("INFECTION (OTHER)"), HEADACHE ("HEADACHES"), PARAESTHESIA ("CONSTANT TINGLING FROM MY HIP TO MY TOES IN MY LEFT LEG") AND RASH PAPULAR ("BUMP ON THE LOWER LEFT SIDE OF MY BACK"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE BACK PAIN, PARAESTHESIA AND RASH PAPULAR HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, TOOTH DISORDER, DYSMENORRHOEA, ALOPECIA, VAGINAL DISCHARGE, ARTHRALGIA, PAIN IN EXTREMITY, INFECTION AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, ARTHRALGIA, BACK PAIN, DYSMENORRHOEA, HEADACHE, INFECTION, MENORRHAGIA, MIGRAINE, PAIN IN EXTREMITY, PARAESTHESIA, RASH PAPULAR, TOOTH DISORDER, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION DATES- (B)(6) 2011 DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULT- TOTAL BILATERAL OCCLUSION AND RIGHT FALLOPIAN TUBE OCCLUSION. CONTRAST SEEN EXTENDING BEYOND THE LEFT ESSURE COIL WITH COMPLETE OPACIFICATION OF THE DISTAL FALLOPIAN TUBE. ULTRASOUND PELVIS - ON (B)(6) 2018: 1 CM ECHOGENIC FOCUS WITHIN THE ENDOMETRIUM, MOST LIKELY REPRESENTING AN ENDOMETRIAL POLYP AND 14CM RIGHT OVARIAN CYST. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WAS CONFIRMED IN PATIENT MEDICAL RECORDS: LOW BACK PAIN, HIP PAIN, LEFT LEG PAIN AND DYSMENORRHEA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-AUG-2019: PFS & MR WAS RECEIVED. LOT NUMBER WAS ADDED. EVENTS ADDED-ABNORMAL BLEEDING (VAGINAL) AND ABNORMAL BLEEDING (MENORRHAGIA), INFECTION (OTHER), MIGRAINES / HEADACHES, DENTAL PROBLEMS, DYSMENORRHEA, HAIR LOSS, VAGINAL DISCHARGE, LOWER BACK PAIN, HIP PAIN, LEFT LEG PAIN, HEADACHES, PARAESTHESIA, BUMP ON THE LOWER LEFT SIDE OF MY BACK WERE ADDED. REPORTERS WERE ADDED. PATIENT DEMOGRAPHICS WAS ADDED. CONCOMITANT CONDITIONS WERE ADDED. EVENT ONSET DATES WERE ADDED. LAB DATA WAS ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673032 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 880433 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R