BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6952106 · Received October 16, 2017

    Report

    Report Number
    2951250-2017-04800
    Event Type
    Injury
    Date Received
    October 16, 2017
    Date of Event
    May 4, 2012
    Report Date
    September 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 BACK PAIN ("LOWER BACK PAIN"), UTERINE PERFORATION ("PERFORATION (UTERUS)") AND DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: BLADDER") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872990) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 5, MISCARRIAGE, CAESAREAN SECTION, MORBID OBESITY, ANESTHESIA, VOMITING AND BREAST REDUCTION. CONCURRENT CONDITIONS INCLUDED OBESITY, TYPE 2 DIABETES MELLITUS, DYSFUNCTIONAL UTERINE BLEEDING, SWELLING OF FEET, MENORRHAGIA, HYPOTHYROIDISM AND CHRONIC CERVICITIS. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), ABDOMINAL DISTENSION ("BLOATING"), SWELLING ("SWELLING"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), PELVIC PAIN ("PAIN"), WEIGHT INCREASED ("WEIGHT GAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL SURGERY/ TOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE BACK PAIN, MENSTRUATION IRREGULAR, ABDOMINAL DISTENSION, SWELLING, DYSMENORRHOEA, PELVIC PAIN AND ABDOMINAL PAIN WAS RESOLVING AND THE UTERINE PERFORATION, DEVICE DISLOCATION, NAUSEA AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, MENSTRUATION IRREGULAR, NAUSEA, PELVIC PAIN, SWELLING, UTERINE PERFORATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SINCE HER REMOVAL SURGERY, ALMOST ALL OF PATIENT'S SYMPTOMS HAVE RESOLVED, THOUGH SOME REMAIN. DISCREPANCY NOTED AS PER PFS: DATE OF REMOVAL: (B)(6) 2012. PREVIOUSLY GONE IT WAS -(B)(6) 2012. AS PER PFS: FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBES. IN INSERTION DETAILS: THERE WERE 3 COILS DISTAL TO THE OPENING AND ON THE LEFT, THERE WERE 8 COILS NOTED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 34 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBES, CONCERNING ALL THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONCE WERE CONFIRMED IN PATIENT'S MEDICAL RECORD: DYSMENORRHEA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-JUL-2018: PLAINTIFF FACT SHEET AND MEDICAL RECORD RECEIVED. EVENT ADDED: MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: BLADDER, NAUSEA, DYSMENORRHEA (CRAMPING), PAIN, PERFORATION (UTERUS), WEIGHT GAIN. CONCOMITANT AND HISTORICAL CONDITIONS WERE ADDED. ON 3-JUL-2018: 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

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION (UTERUS)"), DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: BLADDER") AND BACK PAIN ("LOWER BACK PAIN") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872990) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 5, MISCARRIAGE, CAESAREAN SECTION, MORBID OBESITY, ANESTHESIA, VOMITING AND BREAST REDUCTION. CONCURRENT CONDITIONS INCLUDED OBESITY, TYPE 2 DIABETES MELLITUS, DYSFUNCTIONAL UTERINE BLEEDING, SWELLING OF FEET, MENORRHAGIA, HYPOTHYROIDISM AND CHRONIC CERVICITIS. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), ABDOMINAL DISTENSION ("BLOATING"), SWELLING ("SWELLING"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), PELVIC PAIN ("PAIN"), WEIGHT INCREASED ("WEIGHT GAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL SURGERY/ TOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE DISLOCATION, NAUSEA AND WEIGHT INCREASED OUTCOME WAS UNKNOWN AND THE BACK PAIN, MENSTRUATION IRREGULAR, ABDOMINAL DISTENSION, SWELLING, DYSMENORRHOEA, PELVIC PAIN AND ABDOMINAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, MENSTRUATION IRREGULAR, NAUSEA, PELVIC PAIN, SWELLING, UTERINE PERFORATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SINCE HER REMOVAL SURGERY, ALMOST ALL OF PATIENT'S SYMPTOMS HAVE RESOLVED, THOUGH SOME REMAIN. DISCREPANCY NOTED AS PER PFS: DATE OF REMOVAL: (B)(6) 2012. PREVIOUSLY GONE IT WAS IN (B)(6) 2012. AS PER PFS: FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBES. IN INSERTION DETAILS: THERE WERE 3 COILS DISTAL TO THE OPENING AND ON THE LEFT, THERE WERE 8 COILS NOTED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 34 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBES. CONCERNING ALL THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONCE WERE CONFIRMED IN PATIENT'S MEDICAL RECORD: DYSMENORRHEA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-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 ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION (UTERUS) / MIGRATION OF ESSURE DEVICE : LOCATION: SECOND COIL ON THE UTERUS / LODGED IN THE LOWER UTERINE SEGMENT BELOW THE SEROSA"), DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: BLADDER") AND BACK PAIN ("LOWER BACK PAIN") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872990) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 5, MISCARRIAGE, CAESAREAN SECTION, MORBID OBESITY, ANESTHESIA, VOMITING AND BREAST REDUCTION. CONCURRENT CONDITIONS INCLUDED OBESITY, TYPE 2 DIABETES MELLITUS, DYSFUNCTIONAL UTERINE BLEEDING, SWELLING OF FEET, MENORRHAGIA, HYPOTHYROIDISM AND CHRONIC CERVICITIS. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA). ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2012, 4 MONTHS 23 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6)2012, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), PELVIC PAIN ("PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), ABDOMINAL DISTENSION ("BLOATING"), SWELLING ("SWELLING") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL SURGERY/ TOTAL HYSTERECTOMY), SURGERY (REMOVAL SURGERY/ TOTAL HYSTERECTOMY) AND SURGERY (REMOVAL SURGERY/ TOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6)2012. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE DISLOCATION, NAUSEA, WEIGHT INCREASED, VAGINAL HAEMORRHAGE AND MENORRHAGIA OUTCOME WAS UNKNOWN AND THE BACK PAIN, MENSTRUATION IRREGULAR, ABDOMINAL DISTENSION, SWELLING, DYSMENORRHOEA, PELVIC PAIN AND ABDOMINAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, MENORRHAGIA, MENSTRUATION IRREGULAR, NAUSEA, PELVIC PAIN, SWELLING, UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SINCE HER REMOVAL SURGERY, ALMOST ALL OF PATIENT'S SYMPTOMS HAVE RESOLVED, THOUGH SOME REMAIN. DISCREPANCY NOTED AS PER PFS: DATE OF REMOVAL: (B)(6)2012. PREVIOUSLY GONE IT WAS (B)(6)2012. AS PER PFS: FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBES. IN INSERTION DETAILS: THERE WERE 3 COILS DISTAL TO THE OPENING AND ON THE LEFT, THERE WERE 8 COILS NOTED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 34 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)2012: FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBES, CONCERNING ALL THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONCE WERE CONFIRMED IN PATIENT'S MEDICAL RECORD: DYSMENORRHEA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2018: EVENTS- "ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA)" 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 BACK PAIN ("LOWER BACK PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. 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 BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), ABDOMINAL DISTENSION ("BLOATING") AND SWELLING ("SWELLING"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL SURGERY/ TOTAL HYSTERECTOMY). ESSURE WAS REMOVED IN (B)(6) 2012. AT THE TIME OF THE REPORT, THE BACK PAIN, MENSTRUATION IRREGULAR, ABDOMINAL DISTENSION AND SWELLING WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, BACK PAIN, MENSTRUATION IRREGULAR AND SWELLING TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SINCE HER REMOVAL SURGERY, ALMOST ALL OF PATIENT'S SYMPTOMS HAVE 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
    731093 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 872990

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other| R DEPO PROVERA,| DEPO PROVERA,| DEPO PROVERA.