BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7000025 · Received November 3, 2017

    Report

    Report Number
    2951250-2017-05958
    Event Type
    Injury
    Date Received
    November 3, 2017
    Date of Event
    July 1, 2009
    Report Date
    August 21, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN / PAIN") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 902590) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGONE ESSURE CONFIRMATION TEST". ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2009, 1 MONTH 27 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN / DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING / PROLONGED MENSTRUATION/ ABNORMAL MENSTRUATION / ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL INFECTION ("CHRONIC VAGINAL INFECTIONS / VAGINAL INFECTION") WITH VAGINAL DISCHARGE, DYSPAREUNIA ("PAINFUL INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("CHRONIC FATIGUE") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING / LOWER ABDOMINAL PAIN"), URINARY TRACT INFECTION ("INFECTION(BLADDER/URINARY TRACT/VAGINAL)") AND CYSTITIS ("INFECTION(BLADDER/URINARY TRACT/VAGINAL)"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2010. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, ABDOMINAL PAIN LOWER, MENORRHAGIA, VAGINAL INFECTION, DYSPAREUNIA, FATIGUE, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION AND CYSTITIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: SINCE HER REMOVAL SURGERY, PLAINTIFF SYMPTOMS HAVE MOSTLY RESOLVED, THOUGH SOME REMAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED - NEW EVENT "ABNORMAL BLEEDING (VAGINAL), SHE DID NOT UNDERGONE ESSURE CONFIRMATION TEST" WERE ADDED. LOT LUMBER WAS ADDED. NEW REPORTER 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 ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN / PAIN") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 902590-INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGONE ESSURE CONFIRMATION TEST". ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2009, 1 MONTH 27 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN / DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING / PROLONGED MENSTRUATION/ ABNORMAL MENSTRUATION / ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL INFECTION ("CHRONIC VAGINAL INFECTIONS / VAGINAL INFECTION") WITH VAGINAL DISCHARGE, DYSPAREUNIA ("PAINFUL INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("CHRONIC FATIGUE") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING / LOWER ABDOMINAL PAIN"), URINARY TRACT INFECTION ("INFECTION(BLADDER/URINARY TRACT/VAGINAL)") AND CYSTITIS ("INFECTION(BLADDER/URINARY TRACT/VAGINAL)"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY / TOTAL VAGINAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2010. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, ABDOMINAL PAIN LOWER, MENORRHAGIA, VAGINAL INFECTION, DYSPAREUNIA, FATIGUE, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION AND CYSTITIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MENORRHAGIA, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SINCE HER REMOVAL SURGERY, PLAINTIFF SYMPTOMS HAVE MOSTLY RESOLVED, THOUGH SOME REMAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-AUG-2018: QUALITY-SAFETY EVALUATION OF PTC. INCIDENT: NO VALID 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.

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN / PAIN/PAIN IN PELVIC AREA") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 902590-INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGONE ESSURE CONFIRMATION TEST". ON(B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON(B)(6) 2009, 1 MONTH 27 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN / DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING / PROLONGED MENSTRUATION/ ABNORMAL MENSTRUATION / ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL INFECTION ("CHRONIC VAGINAL INFECTIONS / VAGINAL INFECTION") WITH VAGINAL DISCHARGE, DYSPAREUNIA ("PAINFUL INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("CHRONIC FATIGUE") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING / LOWER ABDOMINAL PAIN"), URINARY TRACT INFECTION ("INFECTION(BLADDER/URINARY TRACT/VAGINAL)") AND CYSTITIS ("INFECTION(BLADDER/URINARY TRACT/VAGINAL)"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY / TOTAL VAGINAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2010. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND MENORRHAGIA HAD RESOLVED AND THE DYSMENORRHOEA, ABDOMINAL PAIN LOWER, VAGINAL INFECTION, DYSPAREUNIA, FATIGUE, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION AND CYSTITIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MENORRHAGIA, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SINCE HER REMOVAL SURGERY, PLAINTIFF SYMPTOMS HAVE MOSTLY RESOLVED, THOUGH SOME REMAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED. EVENT OUTCOME OF ABNORMALLY HEAVY MENSTRUAL BLEEDING / PROLONGED MENSTRUATION/ ABNORMAL MENSTRUATION / ABNORMAL BLEEDING (MENORRHAGIA) AND SEVERE PELVIC PAIN / PAIN/PAIN IN PELVIC AREA WAS UPDATED AS RECOVERED / RESOLVED. INCIDENT NO VALID 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN"), ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING / LOWER ABDOMINAL PAIN"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING / PROLONGED MENSTRUATION/ ABNORMAL MENSTRUATION"), VAGINAL INFECTION ("CHRONIC VAGINAL INFECTIONS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), DYSPAREUNIA ("PAINFUL INTERCOURSE") AND FATIGUE ("CHRONIC FATIGUE"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2010. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, ABDOMINAL PAIN LOWER, MENORRHAGIA, VAGINAL INFECTION, VAGINAL DISCHARGE, DYSPAREUNIA AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MENORRHAGIA, PELVIC PAIN, VAGINAL DISCHARGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SINCE HER REMOVAL SURGERY, PLAINTIFF SYMPTOMS HAVE MOSTLY RESOLVED, THOUGH SOME REMAIN. 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
    779508 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 902590-INVALID

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other| R