BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6656602 · Received June 21, 2017

    Report

    Report Number
    2951250-2017-02269
    Event Type
    Injury
    Date Received
    June 21, 2017
    Report Date
    June 18, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    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 DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: THE DOCTORS JUST TOLD ME THAT IT HAD MOVED A LITTLE BIT"), PELVIC PAIN ("PAIN / PAIN") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING / BLEEDING (GENERAL)") IN A 22-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 820759 , 820780) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED SPINAL OPERATION AND LOOP ELECTROSURGICAL EXCISION PROCEDURE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: ORAL CONTRACEPTIVE NOS. CONCURRENT CONDITIONS INCLUDED PALPITATIONS, CERVICAL DYSPLASIA AND BURNING MICTURITION. CONCOMITANT PRODUCTS INCLUDED ATENOLOL. ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2014, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). IN 2015, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN 2016, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2016, 9 YEARS 9 MONTHS AFTER INSERTION OF ESSURE (ESS205), THE PATIENT EXPERIENCED CYSTITIS ("BLADDER INFECTION") AND URINARY TRACT INFECTION ("URINARY TRACT INFECTION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER ("SEVERE CRAMPS"), NAUSEA ("NAUSEA / NAUSEA"), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), MOOD ALTERED ("MOOD CHANGES"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN"), ALOPECIA ("HAIR LOSS"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND COITAL BLEEDING ("PAINFUL INTERCOURSE W/ BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY) AND SURGERY (HYSTERECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, MOOD ALTERED, CYSTITIS, URINARY TRACT INFECTION, MIGRAINE, HEADACHE, VAGINAL DISCHARGE, FATIGUE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN AND THE NAUSEA, MENSTRUATION IRREGULAR, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA, ALOPECIA, ABDOMINAL PAIN AND COITAL BLEEDING HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, COITAL BLEEDING, CYSTITIS, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE, MOOD ALTERED, NAUSEA, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: CURRENT WEIGHT 218 LBS. DIAGNOSTIC RESULTS: PATIENT UNDERWENT ESSURE CONFIRMATION TEST. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: EVENT "PAINFUL INTERCOURSE W/ BLEEDING" ADDED FROM PFS. 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 ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: THE DOCTORS JUST TOLD ME THAT IT HAD MOVED A LITTLE BIT"), PELVIC PAIN ("PAIN / PAIN") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING / BLEEDING (GENERAL)") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 820759 , 820780) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED SPINAL OPERATION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: ORAL CONTRACEPTIVE NOS. CONCURRENT CONDITIONS INCLUDED PALPITATIONS AND CERVICAL DYSPLASIA. CONCOMITANT PRODUCTS INCLUDED ATENOLOL. ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2014, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). IN 2015, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN 2016, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2016, 9 YEARS 9 MONTHS AFTER INSERTION OF ESSURE (ESS205), THE PATIENT EXPERIENCED CYSTITIS ("BLADDER INFECTION") AND URINARY TRACT INFECTION ("URINARY TRACT INFECTION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER ("SEVERE CRAMPS"), NAUSEA ("NAUSEA / NAUSEA"), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), MOOD ALTERED ("MOOD CHANGES"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN"), ALOPECIA ("HAIR LOSS") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY) AND SURGERY (HYSTERECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, MOOD ALTERED, CYSTITIS, URINARY TRACT INFECTION, MIGRAINE, HEADACHE, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN AND THE NAUSEA, MENSTRUATION IRREGULAR, MENORRHAGIA, DYSMENORRHOEA, ALOPECIA AND ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, CYSTITIS, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE, MOOD ALTERED, NAUSEA, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: CURRENT WEIGHT (B)(6) LBS. DIAGNOSTIC RESULTS: PATIENT UNDERWENT ESSURE CONFIRMATION TEST. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-FEB-2018: EVENTS - "ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), MOOD CHANGES, BLADDER INFECTION, URINARY TRACT INFECTION, MIGRAINES, HEADACHES, MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: THE DOCTORS JUST TOLD ME THAT IT HAD MOVED A LITTLE BIT, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), VAGINAL DISCHARGE, FATIGUE, WEIGHT GAIN, HAIR LOSS, ABDOMINAL PAIN", LOT NUMBER, CONCOMITANT AND HISTORICAL CONDITION ADDED FROM PFS. 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 ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("SEVERE CRAMPS"), NAUSEA ("NAUSEA") AND MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6)2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, NAUSEA AND MENSTRUATION IRREGULAR OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE, MENSTRUATION IRREGULAR, NAUSEA AND PELVIC PAIN TO BE RELATED TO ESSURE (ESS205). COMPANY CAUSALITY COMMENT: 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
    437825 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS205 820759 , 820780

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other| R ATENOLOL| ATENOLOL