ESSURE
Report
- Report Number
- 2951250-2017-10441
- Event Type
- Injury
- Date Received
- December 8, 2017
- Report Date
- November 2, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PERFORATION ("PERFORATION OF ORGANS"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING/ABNORMAL BLEEDING (GENERAL),"), PELVIC INFLAMMATORY DISEASE ("PELVIC INFLAMMATORY DISEASE") AND DEVICE DISLOCATION ("ESSURE DEVICE POSITIONED LOW") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OVARIAN VEIN THROMBOSIS. IN 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FATIGUE ("FATIGUE,"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT INFECTION"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), NAUSEA ("NAUSEA,"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("PAINFUL INTERCOURSE"), ABDOMINAL DISTENSION ("BLOATING"), PELVIC PAIN ("PAIN"), UTERINE PAIN ("PAIN IN UTERUS"), PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND INVESTIGATION NONCOMPLIANCE ("SHE DID NOT UNDERGO CONFIRMATION TEST"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PERFORATION, GENITAL HAEMORRHAGE, DYSPAREUNIA, ABDOMINAL DISTENSION, PELVIC PAIN, FATIGUE, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, NAUSEA, DYSMENORRHOEA, VAGINAL DISCHARGE, WEIGHT INCREASED, UTERINE PAIN, PELVIC INFLAMMATORY DISEASE, DEVICE DISLOCATION AND INVESTIGATION NONCOMPLIANCE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, BLADDER DISORDER, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, INVESTIGATION NONCOMPLIANCE, MENORRHAGIA, NAUSEA, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PERFORATION, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS: (B)(6) 2012, RADIOLOGY REPORT: NO EVIDENCE FOR CHOLELITHIASIS OR SECONDARY SIGNS OF ACUTE CHOLECYSTITIS. ABNORMAL ULTRASOUND OF ABDOMEN: ESSURE DEVICE POSITIONED LOW. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS PELVIC INFLAMMATORY DISEASE, DEVICE DISLOCATION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-JUN-2018: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED: REPORTERS DETAILS ADDED. EVENT ADDED AS SHE DID NOT UNDERGO CONFIRMATION TEST, PELVIC INFLAMMATORY DISEASE, ESSURE DEVICE POSITIONED LOW, ABNORMAL BLEEDING (GENERAL), HYSTERECTOMY (FULL), ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT INFECTION, APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), BLADDER OR URINARY PROBLEMS OR CHANGES, NAUSEA, DYSMENORRHEA (CRAMPING), PAIN, VAGINAL DISCHARGE, FATIGUE, WEIGHT GAIN. LOT NUMBER ADDED. CASE MEDICALLY CONFIRMED. HISTORICAL, CONCOMITANT CONDITION AND RELEVANT LAB DATA 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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION OF ORGANS-FALLOPIAN TUBE"), UTERINE PERFORATION ("PERFORATION OF ORGANS-UTERINE PERFORATION"), PELVIC INFLAMMATORY DISEASE ("PELVIC INFLAMMATORY DISEASE"), DEVICE DISLOCATION ("ESSURE DEVICE POSITIONED LOW") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING/ABNORMAL BLEEDING (GENERAL),") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037) 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 UNDERGO CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OVARIAN VEIN THROMBOSIS. IN 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FATIGUE ("FATIGUE,"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT INFECTION"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), NAUSEA ("NAUSEA,"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN"). ON (B)(6) 2017, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE/ DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL DISTENSION ("BLOATING"), UTERINE PAIN ("PAIN IN UTERUS") AND OVARIAN VEIN THROMBOSIS ("OVARIAN VEIN THROMBOSIS"). THE PATIENT WAS TREATED WITH RIVAROXABAN (XARELTO), SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), HYSTERECTOMY(FULL) ON (B)(6) 2017).ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, PELVIC INFLAMMATORY DISEASE, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, DYSPAREUNIA, ABDOMINAL DISTENSION, PELVIC PAIN, FATIGUE, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, NAUSEA, DYSMENORRHOEA, VAGINAL DISCHARGE, WEIGHT INCREASED, UTERINE PAIN AND OVARIAN VEIN THROMBOSIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, BLADDER DISORDER, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, MENORRHAGIA, NAUSEA, OVARIAN VEIN THROMBOSIS, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE PAIN, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANT INFORMATION IN REMOVAL DATES- (B)(6) 2018 AND (B)(6) 2018. DIAGNOSTIC RESULTS: (B)(6) 2012, RADIOLOGY REPORT: NO EVIDENCE FOR CHOLELITHIASIS OR SECONDARY SIGNS OF ACUTE CHOLECYSTITIS ABNORMAL ULTRASOUND OF ABDOMEN: ESSURE DEVICE POSITIONED LOW. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS PELVIC INFLAMMATORY DISEASE, DEVICE DISLOCATION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET RECEIVED. EVENT OVARIAN VEIN THROMBOSIS WAS ADDED. EVENT ONSET DATE WAS ADDED. PLAINTIFF'S DATE OF BIRTH WAS UPDATED. TREATMENT DRUG WAS ADDED. REMOVAL SURGERY WERE ADDED. PERFORATION OF ORGANS PT UPDATED TO UTERINE AND FALLOPIAN TUBE PERFORATION. 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PERFORATION ("PERFORATION OF ORGANS"), PELVIC INFLAMMATORY DISEASE ("PELVIC INFLAMMATORY DISEASE"), DEVICE DISLOCATION ("ESSURE DEVICE POSITIONED LOW") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING/ABNORMAL BLEEDING (GENERAL),") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OVARIAN VEIN THROMBOSIS. IN 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FATIGUE ("FATIGUE,"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT INFECTION"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), NAUSEA ("NAUSEA,"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("PAINFUL INTERCOURSE"), ABDOMINAL DISTENSION ("BLOATING"), PELVIC PAIN ("PAIN"), UTERINE PAIN ("PAIN IN UTERUS") AND INVESTIGATION NONCOMPLIANCE ("SHE DID NOT UNDERGO CONFIRMATION TEST"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PERFORATION, PELVIC INFLAMMATORY DISEASE, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, DYSPAREUNIA, ABDOMINAL DISTENSION, PELVIC PAIN, FATIGUE, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, NAUSEA, DYSMENORRHOEA, VAGINAL DISCHARGE, WEIGHT INCREASED, UTERINE PAIN AND INVESTIGATION NONCOMPLIANCE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, BLADDER DISORDER, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, INVESTIGATION NONCOMPLIANCE, MENORRHAGIA, NAUSEA, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PERFORATION, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS: 19MAY2012, RADIOLOGY REPORT: NO EVIDENCE FOR CHOLELITHIASIS OR SECONDARY SIGNS OF ACUTE CHOLECYSTITIS ABNORMAL ULTRASOUND OF ABDOMEN: ESSURE DEVICE POSITIONED LOW. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS PELVIC INFLAMMATORY DISEASE, DEVICE DISLOCATION . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PERFORATION ("PERFORATION OF ORGANS") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("PAINFUL INTERCOURSE"), ABDOMINAL DISTENSION ("BLOATING") AND PELVIC PAIN ("PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PERFORATION, GENITAL HAEMORRHAGE, DYSPAREUNIA, ABDOMINAL DISTENSION AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, DYSPAREUNIA, GENITAL HAEMORRHAGE, PELVIC PAIN AND PERFORATION 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 |
|---|---|---|---|---|---|---|---|
| 880934 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 893037 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Other| R |