BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9254317 · Received October 30, 2019

    Report

    Report Number
    2951250-2019-10870
    Event Type
    Injury
    Date Received
    October 30, 2019
    Date of Event
    July 1, 2011
    Report Date
    May 4, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('MENORRHAGIA(HEAVY MENSTRUAL BLEEDING)/ ABNORMAL BLEEDING ( MENORRHAGIA)'), DEVICE DISLOCATION ('ESSURE COIL MIGRATION') AND GENITAL HAEMORRHAGE ('GEN. ABNORMAL. BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841532) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCURRENT CONDITIONS INCLUDED ADENOMYOSIS, FATIGUE, NIGHT SWEATS, MULTI GRAVIDA, PARITY 4, METRORRHAGIA, NAUSEA, PHOTOPHOBIA, DYSURIA, DIZZINESS, LIGHTHEADEDNESS AND OVARIAN CYST. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;NORETHISTERONE ACETATE (MICROGESTIN) (B)(6) 2018 TO (B)(6) 2019, IBUPROFEN, NAPROXEN, NSAIDS SINCE (B)(6)2011, PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2011, PARACETAMOL (TYLENOL), RIBOFLAVIN AND SUMATRIPTAN SUCCINATE (IMITREX). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PHYSICAL PAIN"), DYSMENORRHOEA ("DYSMENNORHEA(CRAMPING)"), MIGRAINE ("MIGRAINE, MIGRAINES/HEADACHES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), HOT FLUSH ("HORMONAL CHANGES DESCRIBE: HOT FLASHES"), DEPRESSION ("PSYCH INJURY/ PSYCHOLOGICAL OR PSYCHIATRIC CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC CONDITION: MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), METRORRHAGIA ("METRORRHAGIA((BLEEDING B/W PERIODS)"), BLADDER DISORDER ("BLADDER/URINARY PROBLEMS") AND URINARY TRACT DISORDER ("BLADDER/URINARY PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION). AT THE TIME OF THE REPORT, THE MENORRHAGIA, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, METRORRHAGIA, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, VAGINAL HAEMORRHAGE, DYSPAREUNIA, HOT FLUSH, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, BLADDER DISORDER, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HOT FLUSH, MENORRHAGIA, METRORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR PAIN, BLEEDING, PSYCH INJURY, OTHER INJURIES/SYMPTOM. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE DESCRIBED IN PATIENTS MEDICAL RECORD: MENORRHAGIA, DYSMENORRHEA, DYSPAREUNIA, HOT FLASHES. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-OCT-2019: QUALITY SAFETY EVALUATION OF PTC. 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('MENORRHAGIA(HEAVY MENSTRUAL BLEEDING)/ ABNORMAL BLEEDING MENORRHAGIA)'), DEVICE DISLOCATION ('ESSURE COIL MIGRATION') AND GENITAL HAEMORRHAGE ('GEN. ABNORMAL. BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841532) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BODY MASS INDEX NORMAL. CURRENT WEIGHT 140 LBS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCURRENT CONDITIONS INCLUDED ADENOMYOSIS, FATIGUE, NIGHT SWEATS, MULTI GRAVIDA, PARITY 4, METRORRHAGIA, NAUSEA, PHOTOPHOBIA, DYSURIA, DIZZINESS, LIGHTHEADEDNESS AND OVARIAN CYST. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL; NORETHISTERONE ACETATE (MICROGESTIN) (B)(6) 2018 TO (B)(6) 2019, IBUPROFEN, NAPROXEN, NSAIDS SINCE (B)(6) 2011, PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2011, PARACETAMOL (TYLENOL), RIBOFLAVIN AND SUMATRIPTAN SUCCINATE (IMITREX). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PHYSICAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), MIGRAINE ("MIGRAINE, MIGRAINES/HEADACHES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), HOT FLUSH ("HORMONAL CHANGES DESCRIBE: HOT FLASHES"), DEPRESSION ("PSYCH INJURY/ PSYCHOLOGICAL OR PSYCHIATRIC CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC CONDITION: MENTAL ANGUISH") AND FATIGUE ("FATIGUE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), METRORRHAGIA ("METRORRHAGIA((BLEEDING B/W PERIODS)"), BLADDER DISORDER ("BLADDER/URINARY PROBLEMS") AND URINARY TRACT DISORDER ("BLADDER/URINARY PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION). AT THE TIME OF THE REPORT, THE MENORRHAGIA, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, METRORRHAGIA, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, VAGINAL HAEMORRHAGE, DYSPAREUNIA, HOT FLUSH, DEPRESSION, ANXIETY AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, BLADDER DISORDER, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HOT FLUSH, MENORRHAGIA, METRORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR PAIN, BLEEDING, PSYCH INJURY, OTHER INJURIES/SYMPTOM. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-APR-2020: PLAINTIFF FACT SHEET WAS RECEIVED. EVENT ADDED FROM PFS- FATIGUE. EVENT ONSET DATE WERE 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('MENORRHAGIA(HEAVY MENSTRUAL BLEEDING)/ ABNORMAL BLEEDING ( MENORRHAGIA)'), GENITAL HAEMORRHAGE ('GEN. ABNORMAL. BLEEDING') AND DEVICE DISLOCATION ('ESSURE COIL MIGRATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841532) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCURRENT CONDITIONS INCLUDED ADENOMYOSIS, FATIGUE, NIGHT SWEATS, MULTI GRAVIDA, PARITY 4, METRORRHAGIA, NAUSEA, PHOTOPHOBIA, DYSURIA, DIZZINESS, LIGHTHEADEDNESS AND OVARIAN CYST. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;NORETHISTERONE ACETATE (MICROGESTIN) (B)(6) 2018 TO (B)(6) 2019, IBUPROFEN, NAPROXEN, NSAIDS SINCE (B)(6) 2011, PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2011, PARACETAMOL (TYLENOL), RIBOFLAVIN AND SUMATRIPTAN SUCCINATE (IMITREX). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PHYSICAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), MIGRAINE ("MIGRAINE, MIGRAINES/HEADACHES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), HOT FLUSH ("HORMONAL CHANGES DESCRIBE: HOT FLASHES"), DEPRESSION ("PSYCH INJURY/ PSYCHOLOGICAL OR PSYCHIATRIC CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC CONDITION: MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), METRORRHAGIA ("METRORRHAGIA((BLEEDING B/W PERIODS)"), BLADDER DISORDER ("BLADDER/URINARY PROBLEMS") AND URINARY TRACT DISORDER ("BLADDER/URINARY PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION). AT THE TIME OF THE REPORT, THE MENORRHAGIA, GENITAL HAEMORRHAGE, DEVICE DISLOCATION, PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, METRORRHAGIA, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, VAGINAL HAEMORRHAGE, DYSPAREUNIA, HOT FLUSH, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, BLADDER DISORDER, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HOT FLUSH, MENORRHAGIA, METRORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR PAIN, BLEEDING, PSYCH INJURY, OTHER INJURIES/SYMPTOM. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM ON (B)(6) 2011: BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE DESCRIBED IN PATIENTS MEDICAL RECORD: MENORRHAGIA, DYSMENORRHEA, DYSPAREUNIA, HOT FLASHES. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS&MR RECEIVED REPORTER INFORMATION, LOT NO WAS ADDED. NEW EVENT ADDED DEVICE DISLOCATION, VAGINAL BLEEDING, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE, HOT FLASHES, MENTAL ANGUISH, DEPRESSION UPDATED TO PSYCH INJURY. SEVERITY ADDED PELVIC PAIN. MEDICAL HISTORY AND CONCOMITANT DRUGS 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
    1050402 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 841532 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other| R ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IMITREX [SUMATRIPTAN SUCCINATE]| IMITREX [SUMATRIPTAN SUCCINATE]| IMITREX [SUMATRIPTAN SUCCINATE]| MICROGESTIN| MICROGESTIN| MICROGESTIN| NAPROXEN| NAPROXEN| NAPROXEN| NSAIDS| NSAIDS| NSAIDS| RIBOFLAVIN| RIBOFLAVIN| RIBOFLAVIN| TYLENOL| TYLENOL| TYLENOL