BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9147270 · Received October 2, 2019

    Report

    Report Number
    2951250-2019-09243
    Event Type
    Injury
    Date Received
    October 2, 2019
    Report Date
    April 2, 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 DEVICE DISLOCATION ('MIGRATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882481-NOT VALID,B82481) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HEMORRHAGE ("HEAVY AND PERSISTENT BLEEDING/GENERAL ABNORMAL BLEED"), PELVIC PAIN ("PELVIC PAIN"), MIGRAINE ("MIGRAINE HEADACHES"), THE FIRST EPISODE OF ALOPECIA ("HAIR LOSS"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), RASH ("RASHES"), PROLONGED HEAVY PERIODS ("HEAVIER AND LONGER MENSTRUAL CYCLES"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENNORHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), BLEEDING MENSTRUAL HEAVY ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), METRORRHAGIA ("METRORHAGIA (BLEEDING B/W PERIODS)"), SKIN RASH ("RASH/SKIN CONDITION"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), BLADDER DISORDER ("BLADDER PROBLEMS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), THE SECOND EPISODE OF ALOPECIA ("HAIR LOSS"), TOOTH DISORDER ("DENTAL PROBLEMS"), NAUSEA ("NAUSEA"), BACK PAIN ("BACK PAIN") AND HEADACHE ("HEADACHE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"), WEIGHT DECREASED ("WEIGHT LOSS") AND HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN, MIGRAINE, WEIGHT INCREASED, ABDOMINAL PAIN LOWER, RASH, PROLONGED HEAVY PERIODS, ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, BLEEDING MENSTRUAL HEAVY, METRORRHAGIA, SKIN RASH, PSYCHOLOGICAL TRAUMA, BLADDER DISORDER, VAGINAL DISCHARGE, FATIGUE, THE LAST EPISODE OF ALOPECIA, TOOTH DISORDER, NAUSEA, WEIGHT DECREASED, HORMONE LEVEL ABNORMAL, BACK PAIN AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BACK PAIN, BLADDER DISORDER, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, METRORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, PROLONGED HEAVY PERIODS, PSYCHOLOGICAL TRAUMA, RASH, TOOTH DISORDER, VAGINAL DISCHARGE, WEIGHT DECREASED, WEIGHT INCREASED, THE FIRST EPISODE OF ALOPECIA, BLEEDING MENSTRUAL HEAVY, SKIN RASH AND THE SECOND EPISODE OF ALOPECIA TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: THE RIGHT AND LEFT FALLOPIAN TUBES APPEAR TO BE OCCLUDED. THERE WERE NO ABNORMAL FILLING DEFECTS IN THE UTERINE CAVITY. THE PROXIMAL ONE-THIRD OF THE LEFT ESSURE DEVICE IS IN THE UTERINE CAVITY.. IMAGING PROCEDURE - ON (B)(6) 2014: BILATERAL OCCLUSION. LOT NUMBER (882481) IS INVALID. LOT NUMBER:B82481. MANUFACTURING DATE:2013-10-19. EXPIRATION DATE:2016-10-31. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-MAR-2020: UPDATE OF INFORMATION (BATCH IS NOT VALID). FU 3 AND 4 PROCESSED TOGETHER. ON 27-MAR-2020: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882481, B82481) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE ("HEAVY AND PERSISTENT BLEEDING/GENERAL ABNORMAL BLEED"), PELVIC PAIN ("PELVIC PAIN"), MIGRAINE ("MIGRAINE HEADACHES"), THE FIRST EPISODE OF ALOPECIA ("HAIR LOSS"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), RASH ("RASHES"), PROLONGED HEAVY PERIODS ("HEAVIER AND LONGER MENSTRUAL CYCLES"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENNORHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), BLEEDING MENSTRUAL HEAVY ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), METRORRHAGIA ("METRORHAGIA (BLEEDING B/W PERIODS)"), SKIN RASH ("RASH/SKIN CONDITION"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), BLADDER DISORDER ("BLADDER PROBLEMS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), THE SECOND EPISODE OF ALOPECIA ("HAIR LOSS"), TOOTH DISORDER ("DENTAL PROBLEMS"), NAUSEA ("NAUSEA"), BACK PAIN ("BACK PAIN") AND HEADACHE ("HEADACHE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"), WEIGHT DECREASED ("WEIGHT LOSS") AND HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN, MIGRAINE, WEIGHT INCREASED, ABDOMINAL PAIN LOWER, RASH, PROLONGED HEAVY PERIODS, ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, BLEEDING MENSTRUAL HEAVY, METRORRHAGIA, SKIN RASH, PSYCHOLOGICAL TRAUMA, BLADDER DISORDER, VAGINAL DISCHARGE, FATIGUE, THE LAST EPISODE OF ALOPECIA, TOOTH DISORDER, NAUSEA, WEIGHT DECREASED, HORMONE LEVEL ABNORMAL, BACK PAIN AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BACK PAIN, BLADDER DISORDER, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, METRORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, PROLONGED HEAVY PERIODS, PSYCHOLOGICAL TRAUMA, RASH, TOOTH DISORDER, VAGINAL DISCHARGE, WEIGHT DECREASED, WEIGHT INCREASED, THE FIRST EPISODE OF ALOPECIA, BLEEDING MENSTRUAL HEAVY, SKIN RASH AND THE SECOND EPISODE OF ALOPECIA TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: THE RIGHT AND LEFT FALLOPIAN TUBES APPEAR TO BE OCCLUDED. THERE WERE NO ABNORMAL FILLING DEFECTS IN THE UTERINE CAVITY. THE PROXIMAL ONE-THIRD OF THE LEFT ESSURE DEVICE IS IN THE UTERINE CAVITY.. IMAGING PROCEDURE - ON (B)(6) 2014: BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-MAR-2020: PFS RECEIVED: EVENT BACK PAIN AND HEADACHE WERE ADDED. HYSTEROSALPINGOGRAM RESULT WAS PROVIDED.LOT NUMBER WAS PROVIDED. 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, 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 DEVICE DISLOCATION ('MIGRATION') AND GENITAL HAEMORRHAGE ('HEAVY AND PERSISTENT BLEEDING/GENERAL ABNORMAL BLEED') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN"), MIGRAINE ("MIGRAINE HEADACHES"), THE FIRST EPISODE OF ALOPECIA ("HAIR LOSS"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), RASH ("RASHES"), PROLONGED HEAVY PERIODS ("HEAVIER AND LONGER MENSTRUAL CYCLES"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), BLEEDING MENSTRUAL HEAVY ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), METRORRHAGIA ("METRORRHAGIA (BLEEDING B/W PERIODS)"), SKIN RASH ("RASH/SKIN CONDITION"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), BLADDER DISORDER ("BLADDER PROBLEMS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), THE SECOND EPISODE OF ALOPECIA ("HAIR LOSS"), TOOTH DISORDER ("DENTAL PROBLEMS") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"), WEIGHT DECREASED ("WEIGHT LOSS") AND HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN, MIGRAINE, WEIGHT INCREASED, ABDOMINAL PAIN LOWER, RASH, PROLONGED HEAVY PERIODS, ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, BLEEDING MENSTRUAL HEAVY, METRORRHAGIA, SKIN RASH, PSYCHOLOGICAL TRAUMA, BLADDER DISORDER, VAGINAL DISCHARGE, FATIGUE, THE LAST EPISODE OF ALOPECIA, TOOTH DISORDER, NAUSEA, WEIGHT DECREASED AND HORMONE LEVEL ABNORMAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BLADDER DISORDER, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, METRORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, PROLONGED HEAVY PERIODS, PSYCHOLOGICAL TRAUMA, RASH, TOOTH DISORDER, VAGINAL DISCHARGE, WEIGHT DECREASED, WEIGHT INCREASED, THE FIRST EPISODE OF ALOPECIA, BLEEDING MENSTRUAL HEAVY, SKIN RASH AND THE SECOND EPISODE OF ALOPECIA TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2014: BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-SEP-2019: PLAINTIFF FACT SHEET RECEIVED: NEW EVENTS - ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), METRORRHAGIA (BLEEDING B/W PERIODS), RASH/SKIN CONDITION, PSYCH INJURY, MIGRATION, BLADDER PROBLEMS, VAGINAL DISCHARGE, FATIGUE, HAIR LOSS, DENTAL PROBLEMS, HORMONAL CHANGES, NAUSEA, WEIGHT LOSS WERE ADDED. CASE IS NOW INCIDENT. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942267 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 882481-NOT VALID,B82481 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other