ESSURE
Report
- Report Number
- 2951250-2017-10657
- Event Type
- Injury
- Date Received
- December 12, 2017
- Report Date
- August 24, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN/PAIN"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND THROMBOSIS ("BLOOD CLOT") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822608) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN AND MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THROMBOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VISION BLURRED ("BLURRED VISION"), VAGINAL HAEMORRHAGE ("HEAVY VAGINAL BLEEDING/, ABNORMAL BLEEDING (VAGINAL)"), DYSMENORRHOEA ("PAINFUL MENSTRUATION CYCLES/DYSMENORRHEA"), DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ALOPECIA ("HAIR LOSS"), DYSGEUSIA ("METALLIC TASTE IN HER MOUTH"), FEELING ABNORMAL ("BRAIN FOG"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY DISORDER"), FATIGUE ("FATIGUE"), VAGINAL INFECTION ("VAGINAL INFECTION") WITH VAGINAL DISCHARGE, MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), AMNESIA ("MEMORY LOSS"), RASH ("RASHES"), WEIGHT FLUCTUATION ("WEIGHT GAIN/LOSS") AND ADENOMYOSIS ("ADENOMYOSIS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL),/SALPINGECTOMY (BILATERAL) AND SURGERY (ABLATION). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, THROMBOSIS, VISION BLURRED, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, ALOPECIA, DYSGEUSIA, FEELING ABNORMAL, BLADDER DISORDER, URINARY TRACT DISORDER, FATIGUE, VAGINAL INFECTION, MIGRAINE, HEADACHE, AMNESIA, RASH, WEIGHT FLUCTUATION, ADENOMYOSIS AND URINARY TRACT INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADENOMYOSIS, ALOPECIA, AMNESIA, BLADDER DISORDER, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, RASH, THROMBOSIS, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE CONFIRMATION TEST. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-APR-2018: PLAINTIFF FACT SHEET WAS RECEIVED - REPORTERS ADDED AND PATIENT DEMOGRAPHIC UPDATED. THE FOLLOWING EVENTS WERE ADDED: MENORRHAGIA, BLADDER PROBLEMS, URINARY TRACT DISORDER, BLOOD CLOT, FATIGUE, VAGINAL DISCHARGE, VAGINAL INFECTION, URINARY TRACT INFECTION, MIGRAINES, HEADACHES, MEMORY LOSS, BLURRED VISION, WEIGHT FLUCTUATION, ADENOMYOSIS. LOT NUMBER 822608 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN/PAIN"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND THROMBOSIS ("BLOOD CLOT") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822608-INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THROMBOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VISION BLURRED ("BLURRED VISION"), VAGINAL HAEMORRHAGE ("HEAVY VAGINAL BLEEDING/, ABNORMAL BLEEDING (VAGINAL)"), DYSMENORRHOEA ("PAINFUL MENSTRUATION CYCLES/DYSMENORRHEA"), DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ALOPECIA ("HAIR LOSS"), DYSGEUSIA ("METALLIC TASTE IN HER MOUTH"), FEELING ABNORMAL ("BRAIN FOG"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY DISORDER"), FATIGUE ("FATIGUE"), VAGINAL INFECTION ("VAGINAL INFECTION") WITH VAGINAL DISCHARGE, MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), AMNESIA ("MEMORY LOSS"), RASH ("RASHES"), WEIGHT FLUCTUATION ("WEIGHT GAIN/LOSS") AND ADENOMYOSIS ("ADENOMYOSIS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL),/SALPINGECTOMY (BILATERAL) AND SURGERY (ABLATION). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, THROMBOSIS, VISION BLURRED, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, ALOPECIA, DYSGEUSIA, FEELING ABNORMAL, BLADDER DISORDER, URINARY TRACT DISORDER, FATIGUE, VAGINAL INFECTION, MIGRAINE, HEADACHE, AMNESIA, RASH, WEIGHT FLUCTUATION, ADENOMYOSIS AND URINARY TRACT INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADENOMYOSIS, ALOPECIA, AMNESIA, BLADDER DISORDER, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, RASH, THROMBOSIS, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE CONFIRMATION TEST. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-AUG-2018: UPDATE OF INFORMATION (BATCH IS 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("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) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("PAINFUL MENSTRUATION CYCLES"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ALOPECIA ("HAIR LOSS"), DYSGEUSIA ("METALLIC TASTE IN HER MOUTH"), FEELING ABNORMAL ("BRAIN FOG") AND VAGINAL HAEMORRHAGE ("HEAVY VAGINAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, ALOPECIA, DYSGEUSIA, FEELING ABNORMAL AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FEELING ABNORMAL, PELVIC PAIN AND VAGINAL HAEMORRHAGE 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 |
|---|---|---|---|---|---|---|---|
| 889478 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 822608-INVALID |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |