BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7058687 · Received November 27, 2017

    Report

    Report Number
    2951250-2017-08958
    Event Type
    Injury
    Date Received
    November 27, 2017
    Report Date
    August 14, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SIGNIFICANT PAIN") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893038) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6)2013, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED ANXIETY ("ANXIOUS"), BLADDER DISORDER ("BLADDER PROBLEM"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), WEIGHT INCREASED ("WEIGHT GAIN"), ALOPECIA ("HAIR LOSS") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"). ON THE SAME DAY, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA") AND MENOMETRORRHAGIA ("MENOMETRORRHAGIA"). IN (B)(6)2013, THE PATIENT EXPERIENCED HOT FLUSH ("HOT FLASHES") AND BREAST TENDERNESS ("BREAST TENDERNESS"). IN 2014, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES HEADACHES"), NAUSEA ("NAUSEA") AND FATIGUE ("FATIGUE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ANAEMIA ("ANEMIA"), DEPRESSION ("DEPRESSED"), URINARY TRACT INFECTION ("URINARY INFECTION"), DYSMENORRHOEA ("DYSMENORRHEA"), DYSPAREUNIA ("DYSPAREUNIA"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), BREAST PAIN ("BREAST PAIN") AND HEADACHE ("MIGRAINES HEADACHES"). THE PATIENT WAS TREATED WITH ANOVLAR (LOESTRIN), ANTIBIOTICS, IRON (IRON COMPLEX), IBUPROFEN AND SURGERY (COMPLETE HYSTERECTOMY WITH OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6)2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ANXIETY, DEPRESSION, HOT FLUSH, BREAST TENDERNESS, MENORRHAGIA, MENOMETRORRHAGIA, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, NAUSEA, FATIGUE, DYSPAREUNIA, WEIGHT INCREASED, ALOPECIA, ABDOMINAL PAIN LOWER, BREAST PAIN AND HEADACHE OUTCOME WAS UNKNOWN, THE ANAEMIA, VAGINAL HAEMORRHAGE AND DYSMENORRHOEA HAD RESOLVED AND THE URINARY TRACT INFECTION AND VAGINAL DISCHARGE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANAEMIA, ANXIETY, BLADDER DISORDER, BREAST PAIN, BREAST TENDERNESS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HOT FLUSH, MENOMETRORRHAGIA, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT SOUGHT TREATMENT ON MULTIPLE OCCASIONS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)2014: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-AUG-2018: QUALITY-SAFETY EVALUATION OF PTC INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SIGNIFICANT PAIN") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893038) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED ANXIETY ("ANXIOUS"). IN 2013, THE PATIENT EXPERIENCED BLADDER DISORDER ("BLADDER PROBLEM"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), WEIGHT INCREASED ("WEIGHT GAIN"), ALOPECIA ("HAIR LOSS") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"). ON THE SAME DAY, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA") AND MENOMETRORRHAGIA ("MENOMETRORRHAGIA"). IN (B)(6) 2013, THE PATIENT EXPERIENCED HOT FLUSH ("HOT FLASHES") AND BREAST TENDERNESS ("BREAST TENDERNESS"). IN 2014, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES HEADACHES"), NAUSEA ("NAUSEA") AND FATIGUE ("FATIGUE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ANAEMIA ("ANEMIA"), DEPRESSION ("DEPRESSED"), URINARY TRACT INFECTION ("URINARY INFECTION"), DYSMENORRHOEA ("DYSMENORRHEA"), DYSPAREUNIA ("DYSPAREUNIA"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), BREAST PAIN ("BREAST PAIN") AND HEADACHE ("MIGRAINES HEADACHES"). THE PATIENT WAS TREATED WITH ANOVLAR (LOESTRIN), ANTIBIOTICS, IRON (IRON COMPLEX), IBUPROFEN AND SURGERY (COMPLETE HYSTERECTOMY WITH OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ANXIETY, DEPRESSION, HOT FLUSH, BREAST TENDERNESS, MENORRHAGIA, MENOMETRORRHAGIA, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, NAUSEA, FATIGUE, DYSPAREUNIA, WEIGHT INCREASED, ALOPECIA, ABDOMINAL PAIN LOWER, BREAST PAIN AND HEADACHE OUTCOME WAS UNKNOWN, THE ANAEMIA, VAGINAL HAEMORRHAGE AND DYSMENORRHOEA HAD RESOLVED AND THE URINARY TRACT INFECTION AND VAGINAL DISCHARGE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANAEMIA, ANXIETY, BLADDER DISORDER, BREAST PAIN, BREAST TENDERNESS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HOT FLUSH, MENOMETRORRHAGIA, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT SOUGHT TREATMENT ON MULTIPLE OCCASIONS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-JUL-2018: PLAINTIFF FACT SHEET RECEIVED AND EVENT HEADACHES WERE ADDED. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SIGNIFICANT PAIN") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893038) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED ANXIETY ("ANXIOUS"), DEPRESSION ("DEPRESSED"), BLADDER DISORDER ("BLADDER PROBLEM"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), DYSMENORRHOEA ("DYSMENORRHEA"), DYSPAREUNIA ("DYSPAREUNIA"), WEIGHT INCREASED ("WEIGHT GAIN"), ALOPECIA ("HAIR LOSS") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA") AND MENOMETRORRHAGIA ("MENOMETRORRHAGIA"). IN SEPTEMBER 2013, THE PATIENT EXPERIENCED HOT FLUSH ("HOT FLASHES") AND BREAST TENDERNESS ("BREAST TENDERNESS"). IN 2014, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES HEADACHES"), NAUSEA ("NAUSEA") AND FATIGUE ("FATIGUE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ANAEMIA ("ANEMIA"), URINARY TRACT INFECTION ("URINARY INFECTION"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND BREAST PAIN ("BREAST PAIN"). THE PATIENT WAS TREATED WITH ANOVLAR (LOESTRIN), ANTIBIOTICS, IRON (IRON COMPLEX), IBUPROFEN AND SURGERY (COMPLETE HYSTERECTOMY WITH OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ANXIETY, DEPRESSION, HOT FLUSH, BREAST TENDERNESS, MENORRHAGIA, MENOMETRORRHAGIA, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, NAUSEA, FATIGUE, DYSPAREUNIA, WEIGHT INCREASED, ALOPECIA, ABDOMINAL PAIN LOWER AND BREAST PAIN OUTCOME WAS UNKNOWN, THE ANAEMIA, VAGINAL HAEMORRHAGE AND DYSMENORRHOEA HAD RESOLVED AND THE URINARY TRACT INFECTION AND VAGINAL DISCHARGE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANAEMIA, ANXIETY, BLADDER DISORDER, BREAST PAIN, BREAST TENDERNESS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HOT FLUSH, MENOMETRORRHAGIA, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT SOUGHT TREATMENT ON MULTIPLE OCCASIONS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED. ADDED PATIENT'S DATE OF BIRTH AND HEIGHT AND ESSURE LOT NUMBER (893038). RELEVANT LAB INFORMATION ADDED. NEW EVENTS: VAGINAL BLEEDING, MENORRHAGIA, HOT FLUSH, BREAST TENDERNESS, MENOMETRORRHAGIA, URINARY INFECTION, BLADDER OR URINARY PROBLEMS, MIGRAINES / HEADACHES, NAUSEA, FATIGUE, DYSMENORRHEA, DYSPAREUNIA, VAGINAL DISCHARGE, WEIGHT GAIN, HAIR LOSS, LOWER ABDOMINAL PAIN AND BREAST PAIN. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SIGNIFICANT PAIN") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ANAEMIA ("ANEMIA"), ANXIETY ("ANXIOUS") AND DEPRESSION ("DEPRESSED"). THE PATIENT WAS TREATED WITH SURGERY (UNDERGO A COMPLETE HYSTERECTOMY WITH REMOVAL OF THE ESSURE). ESSURE WAS REMOVED IN (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ANAEMIA, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANAEMIA, ANXIETY, DEPRESSION, GENITAL HAEMORRHAGE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT SOUGHT TREATMENT ON MULTIPLE OCCASIONS. INCIDENT. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840145 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 893038

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other| R