BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7094732 · Received December 7, 2017

    Report

    Report Number
    2951250-2017-10115
    Event Type
    Injury
    Date Received
    December 7, 2017
    Report Date
    November 9, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN / PAIN") AND CERVIX CARCINOMA ("CERVICAL CANCER") IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 932184) 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 "ESSURE CONFIRMATION TEST(S) CONDUCTED-NO". ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2017, THE PATIENT EXPERIENCED MENORRHAGIA ("HEAVY PERIODS/ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), BLADDER DISORDER ("BLADDER PROBLEM"), URINARY TRACT DISORDER ("URINARY PROBLEMS") AND CERVIX CARCINOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL DISTENSION ("BLOATING"), BACK PAIN ("BACK PAIN") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL DISTENSION, BACK PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, BLADDER DISORDER, URINARY TRACT DISORDER AND CERVIX CARCINOMA OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, BACK PAIN, BLADDER DISORDER, CERVIX CARCINOMA, MENORRHAGIA, PELVIC PAIN, URINARY TRACT DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE HYSTEROSCOPIC IMPLANTS WERE THEN PLACED BILATERALLY WITH 5 TRAILING COILS ON THE RIGHT AND 3 COILS IN THE LEFT. DIAGNOSTIC RESULTS: URINE PREGNANCY TEST: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-JUN-2018: PFS+MR RECEIVED- NEW EVENT ABNORMAL BLEEDING (VAGINAL), BLADDER PROBLEM, URINARY PROBLEMS, CERVICAL CANCER, LOWER ABDOMEN PAIN, ESSURE CONFIRMATION TEST(S) CONDUCTED-NO WERE ADDED.NEW REPORTER, LOT NUMBER 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

    SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN / PAIN") AND CERVIX CARCINOMA ("CERVICAL CANCER") IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 932184-INVALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST(S) CONDUCTED-NO". ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2017, THE PATIENT EXPERIENCED MENORRHAGIA ("HEAVY PERIODS/ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), BLADDER DISORDER ("BLADDER PROBLEM"), URINARY TRACT DISORDER ("URINARY PROBLEMS") AND CERVIX CARCINOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL DISTENSION ("BLOATING"), BACK PAIN ("BACK PAIN") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL DISTENSION, BACK PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, BLADDER DISORDER, URINARY TRACT DISORDER AND CERVIX CARCINOMA OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, BACK PAIN, BLADDER DISORDER, CERVIX CARCINOMA, MENORRHAGIA, PELVIC PAIN, URINARY TRACT DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE HYSTEROSCOPIC IMPLANTS WERE THEN PLACED BILATERALLY WITH 5 TRAILING COILS ON THE RIGHT AND 3 COILS IN THE LEFT. DIAGNOSTIC RESULTS: URINE PREGNANCY TEST: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-AUG-2018: UPDATE OF INFORMATION (BATCH NOT INVALID). 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

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN / PAIN") IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 932184-INVALID, 932164) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST(S) CONDUCTED: NO". ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2017, THE PATIENT EXPERIENCED MENORRHAGIA ("HEAVY PERIODS/ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), BLADDER DISORDER ("BLADDER PROBLEM"), URINARY TRACT DISORDER ("URINARY PROBLEMS") AND CERVICAL DYSPLASIA ("TUMOR / TERATOMA / CANCER TYPE: CERVICAL DYSPLASIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL DISTENSION ("BLOATING"), BACK PAIN ("BACK PAIN") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL DISTENSION, BACK PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, BLADDER DISORDER, URINARY TRACT DISORDER AND CERVICAL DYSPLASIA OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, BACK PAIN, BLADDER DISORDER, CERVICAL DYSPLASIA, MENORRHAGIA, PELVIC PAIN, URINARY TRACT DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE HYSTEROSCOPIC IMPLANTS WERE THEN PLACED BILATERALLY WITH 5 TRAILING COILS ON THE RIGHT AND 3 COILS IN THE LEFT. DIAGNOSTIC RESULTS: URINE PREGNANCY TEST: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-OCT-2018: PFS RECEIVED. LOT NUMBER ADDED. EVENT CERVICAL CARCINOMA UPDATED TO CERVICAL DYSPLASIA. 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 ("PELVIC PAIN / PAIN") IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 932184-INVALID, 932164) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST(S) CONDUCTED-NO". ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2017, THE PATIENT EXPERIENCED MENORRHAGIA ("HEAVY PERIODS/ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), BLADDER DISORDER ("BLADDER PROBLEM"), URINARY TRACT DISORDER ("URINARY PROBLEMS") AND CERVICAL DYSPLASIA ("TUMOR / TERATOMA / CANCER TYPE: CERVICAL DYSPLASIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL DISTENSION ("BLOATING"), BACK PAIN ("BACK PAIN") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED),SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),). ESSURE WAS REMOVED ON (B)(6) -2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL DISTENSION, BACK PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, BLADDER DISORDER, URINARY TRACT DISORDER AND CERVICAL DYSPLASIA OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, BACK PAIN, BLADDER DISORDER, CERVICAL DYSPLASIA, MENORRHAGIA, PELVIC PAIN, URINARY TRACT DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE HYSTEROSCOPIC IMPLANTS WERE THEN PLACED BILATERALLY WITH 5 TRAILING COILS ON THE RIGHT AND 3 COILS IN THE LEFT DIAGNOSTIC RESULTS: URINE PREGNANCY TEST: NEGATIVE, CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN LOT NUMBER 932184 IS INVALID. LOT NUMBER: 932164 MANUFACTURE DATE:2011/12 EXPIRATION DATE: 2014/12 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2018: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT 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 ("PELVIC PAIN / PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL DISTENSION ("BLOATING"), BACK PAIN ("BACK PAIN") AND MENORRHAGIA ("HEAVY PERIODS"). THE PATIENT WAS TREATED WITH SURGERY (PATIENT HAD SURGERY TO REMOVE THE ESSURE.). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL DISTENSION, BACK PAIN AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, BACK PAIN, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. 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
    877723 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 932184-INVALID, 932164

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other| R