BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10065950 · Received May 18, 2020

    Report

    Report Number
    2951250-2020-07826
    Event Type
    Injury
    Date Received
    May 18, 2020
    Date of Event
    September 1, 2014
    Report Date
    May 28, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN/PELVIC PAIN AREA/PAIN') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA ON (B)(6) 2014, POSTPARTUM STATE, HEADACHE UNILATERAL, GRAND MULTIPARITY AND MULTIGRAVIDA. CONCURRENT CONDITIONS INCLUDED UTERINE BLEEDING, METRORRHAGIA, HEADACHE, NAUSEA, VOMITING, CEREBROVASCULAR ACCIDENT, ASTHMA, ANEMIA, MULTIPLE ALLERGIES, NUMBNESS IN FACE, NUMBNESS OF UPPER EXTREMITIES, HANDS WEAKNESS OF, BLURRING OF EYES, MIGRAINE, FACIAL WEAKNESS, DIARRHEA, MUSCLE SPASMS, NECK PAIN, PARESTHESIA, FLANK PAIN AND OVARIAN CYST. CONCOMITANT PRODUCTS INCLUDED NORETHISTERONE (ORTHO MICRONOR) FROM (B)(6) 2014 TO (B)(6) 2014 FOR BIRTH CONTROL, ETHINYLESTRADIOL;NORGESTIMATE (SPRINTEC) FROM (B)(6) 2019 TO (B)(6) 2019 FOR MENSTRUAL CYCLE MANAGEMENT AS WELL AS ASCORBIC ACID;BETACAROTENE;CALCIUM CARBONATE;COLECALCIFEROL;DOCOSAHEXAENOIC ACID;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;VITAMIN B12 NOS;ZINC OXIDE (PRENATAL MULTIVITAMIN + DHA) FROM (B)(6) 2014 TO (B)(6) 2017, FERROUS SULFATE (FERROUS) FROM (B)(6) 2014 TO (B)(6) 2017, IBUPROFEN (IBUPROFENO) FROM (B)(6) 2014 TO (B)(6) 2017, NSAIDS SINCE (B)(6) 2014, PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2014 AND SERTRALINE HYDROCHLORIDE (ZOLOFT) FROM (B)(6) 2014 TO (B)(6) 2017. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), DYSMENORRHOEA ("DYSMENNORHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE") AND MIGRAINE ("MIGRAINES / HEADACHES"). ON (B)(6) 2019, THE PATIENT EXPERIENCED HAEMORRHAGIC CYST ("HEMORRHAGO CYST"), 4 YEARS 5 MONTHS AFTER INSERTION OF ESSURE. IN (B)(6) 2019, THE PATIENT EXPERIENCED DEPRESSION ("PSYCH INJURY/DEPRESSION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), METRORRHAGIA ("METORHAGIA (BLEEDING B/W PERIODS)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), ANXIETY ("ANXIETY/ MENTAL ANGUISH"), HEADACHE ("HEADACHES"), PROCEDURAL PAIN ("POST REMOVAL COMPLICATION") AND POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATION") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (CYSTECTOMY AND SHE HAD UNDERGONE ESSURE REMOVAL SURGERY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, METRORRHAGIA, FATIGUE AND HEADACHE HAD RESOLVED AND THE HAEMORRHAGIC CYST, ABDOMINAL PAIN, BACK PAIN, DEPRESSION, VAGINAL HAEMORRHAGE, MIGRAINE, ANXIETY, PROCEDURAL PAIN, POST PROCEDURAL COMPLICATION AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HAEMORRHAGIC CYST, HEADACHE, MENORRHAGIA, METRORRHAGIA, MIGRAINE, PELVIC PAIN, POST PROCEDURAL COMPLICATION, PROCEDURAL PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR- PELVIC PAIN, DYSPAREUNIA, DYSMENORRHEA, GENERAL ABNORMAL BLEEDING, METRORRHAGIA, MENORRHAGIA, FATIGUE, HEADACHE. NORMAL UTERUS AND OSTIA WITH THE COILS OF 3 ON THE RIGHT AND 4 ON THE LEFT. AS DISCREPANCY NOTED IN ESSURE CONFIRMATION TEST: PREVIOUSLY REPORTED ESSURE CONFIRMATION TEST, NOW PLAINTIFF CLAIMED DOES NOT UNDERGO ESSURE CONFIRMATION TEST. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.. ULTRASOUND SCAN - ON AN UNKNOWN DATE: UTERINE LENGTH OF 9.1 CM WITH AN ENDOMETRIAL THICKNESS OF 0.96 CM/RIGHT OVARY MEASURES 2.8 CM THE LEFT 3.2 CM. THERE IS A LEFT OVARIAN CYST APPROXIMATELY 2 CM AND SIMPLE IN APPEARANCE; ON AN UNKNOWN DATE: OVARIAN CYST. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PLAINTIFF INFORMATION FORM RECEIVED. EVENT¿ WEIGHT GAIN AND POST PROCEDURAL COMPLICATION¿ WAS ADDED. 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 PELVIC PAIN ('PHYSICAL PAIN/PELVIC PAIN AREA/PAIN') IN A (B)(6) OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA ON (B)(6) 2014, POSTPARTUM STATE, HEADACHE UNILATERAL, GRAND MULTIPARITY AND MULTIGRAVIDA. CONCURRENT CONDITIONS INCLUDED UTERINE BLEEDING, METRORRHAGIA, HEADACHE, NAUSEA, VOMITING, CEREBROVASCULAR ACCIDENT, ASTHMA, ANEMIA, MULTIPLE ALLERGIES, NUMBNESS IN FACE, NUMBNESS OF UPPER EXTREMITIES, HANDS WEAKNESS OF, BLURRING OF EYES, MIGRAINE, FACIAL WEAKNESS, DIARRHEA, MUSCLE SPASMS, NECK PAIN, PARESTHESIA, FLANK PAIN AND OVARIAN CYST. CONCOMITANT PRODUCTS INCLUDED NORETHISTERONE (ORTHO MICRONOR) FROM (B)(6) 2014 TO (B)(6) 2014 FOR BIRTH CONTROL, ETHINYLESTRADIOL NORGESTIMATE (SPRINTEC) FROM (B)(6) 2019 TO (B)(6) 2019 FOR MENSTRUAL CYCLE MANAGEMENT AS WELL AS ASCORBIC ACID; BETACAROTENE; CALCIUM CARBONATE; COLECALCIFEROL; DOCOSAHEXAENOIC ACID; FERROUS FUMARATE; FOLIC ACID; NICOTINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE;T OCOPHERYL ACETATE; VITAMIN B12 NOS;ZINC OXIDE (PRENATAL MULTIVITAMIN + DHA) FROM (B)(6) 2014 TO (B)(6) 2017, FERROUS SULFATE (FERROUS) FROM (B)(6) 2014 TO (B)(6) 2017, IBUPROFEN (IBUPROFENO) FROM (B)(6) 2014 TO (B)(6) 2017, NSAIDS SINCE (B)(6) 2014, PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2014 AND SERTRALINE HYDROCHLORIDE (ZOLOFT) FROM (B)(6) 2014 TO (B)(6) 2017. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), DYSMENORRHOEA ("DYSMENNORHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE") AND MIGRAINE ("MIGRAINES / HEADACHES"). ON (B)(6) 2019, THE PATIENT EXPERIENCED HAEMORRHAGIC CYST ("HEMORRHAGO CYST"), 4 YEARS 5 MONTHS AFTER INSERTION OF ESSURE. IN (B)(6) 2019, THE PATIENT EXPERIENCED DEPRESSION ("PSYCH INJURY/DEPRESSION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), METRORRHAGIA ("METORHAGIA (BLEEDING B/W PERIODS)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), ANXIETY ("ANXIETY/ MENTAL ANGUISH"), HEADACHE ("HEADACHES") AND PROCEDURAL PAIN ("POST REMOVAL COMPLICATION"). THE PATIENT WAS TREATED WITH SURGERY (CYSTECTOMY). ESSURE TREATMENT WAS ONGOING AT THE TIME OF THE REPORT. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, METRORRHAGIA, FATIGUE AND HEADACHE HAD RESOLVED AND THE HAEMORRHAGIC CYST, ABDOMINAL PAIN, BACK PAIN, DEPRESSION, VAGINAL HAEMORRHAGE, MIGRAINE, ANXIETY AND PROCEDURAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HAEMORRHAGIC CYST, HEADACHE, MENORRHAGIA, METRORRHAGIA, MIGRAINE, PELVIC PAIN, PROCEDURAL PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR- PELVIC PAIN, DYSPAREUNIA, DYSMENORRHEA, GENERAL ABNORMAL BLEEDING, METRORRHAGIA, MENORRHAGIA, FATIGUE, HEADACHE. NORMAL UTERUS AND OSTIA WITH THE COILS OF 3 ON THE RIGHT AND 4 ON THE LEFT. AS DISCREPANCY NOTED IN ESSURE CONFIRMATION TEST: PREVIOUSLY REPORTED ESSURE CONFIRMATION TEST, NOW PLAINTIFF CLAIMED DOES NOT UNDERGO ESSURE CONFIRMATION TEST. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. ULTRASOUND SCAN - ON AN UNKNOWN DATE: UTERINE LENGTH OF 9.1 CM WITH AN ENDOMETRIAL THICKNESS OF 0.96 CM/RIGHT OVARY MEASURES 2.8 CM THE LEFT 3.2 CM. THERE IS A LEFT OVARIAN CYST APPROXIMATELY 2 CM AND SIMPLE IN APPEARANCE; ON AN UNKNOWN DATE: OVARIAN CYST. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-MAY-2020: PFS RECEIVED: HEADACHES, POST PROCEDURAL COMPLICATION. EVENT OUTCOME WERE ADDED AND REPORTER INFORMATION WERE UPDATED. 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
    530003 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other| R ACETAMINOPHEN| ACETAMINOPHEN| FERROUS [FERROUS SULFATE]| FERROUS [FERROUS SULFATE]| IBUPROFENO| IBUPROFENO| NSAIDS| NSAIDS| ORTHO MICRONOR| ORTHO MICRONOR| PRENATAL MULTIVITAMIN + DHA| PRENATAL MULTIVITAMIN + DHA| SPRINTEC| SPRINTEC| ZOLOFT| ZOLOFT