ESSURE
Report
- Report Number
- 2951250-2017-06057
- Event Type
- Injury
- Date Received
- November 3, 2017
- Date of Event
- September 1, 2012
- Report Date
- August 10, 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
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN / PAIN"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING"), SYSTEMIC LUPUS ERYTHEMATOSUS ("POSSIBLE LUPUS") AND RHEUMATOID ARTHRITIS ("RHEUMATOID ARTHRITIS") IN A 26-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 PAST MEDICAL HISTORY INCLUDED PAIN IN JOINT, PLATELET COUNT LOW AND DELIVERY ON (B)(6) 2012. CONCURRENT CONDITIONS INCLUDED UTERINE FIBROID. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2013, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2014, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"), ANXIETY ("ANXIETY") AND STRESS ("STRESS"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS") AND FATIGUE ("CHRONIC FATIGUE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN / DYSMENORRHAGIA(CRAMPING)"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN EVEN WHEN NOT MENSTRUATING"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATIONS"), ANAEMIA ("ANEMIA"), SYSTEMIC LUPUS ERYTHEMATOSUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), RHEUMATOID ARTHRITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SEROLOGY NEGATIVE ("SERONEGATIVE"), SPONDYLOARTHROPATHY ("SPONDYLOARTHROPATHY"), BACK PAIN ("LOWER BACK PAIN") AND ABDOMINAL PAIN UPPER ("STOMACH PAIN"). THE PATIENT WAS TREATED WITH IRON, COLECALCIFEROL (VITAMIN D), METHOTREXATE, SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY) AND SURGERY (UTERINE ABLATION AND DILATION AND CURETTAGE). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA AND VAGINAL HAEMORRHAGE WAS RESOLVING AND THE DYSMENORRHOEA, ABDOMINAL PAIN LOWER, DYSPAREUNIA, ALOPECIA, FATIGUE, WEIGHT FLUCTUATION, ANAEMIA, SYSTEMIC LUPUS ERYTHEMATOSUS, RHEUMATOID ARTHRITIS, SEROLOGY NEGATIVE, SPONDYLOARTHROPATHY, ALLERGY TO METALS, ANXIETY, STRESS, WEIGHT INCREASED, BACK PAIN AND ABDOMINAL PAIN UPPER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALLERGY TO METALS, ALOPECIA, ANAEMIA, ANXIETY, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MENORRHAGIA, PELVIC PAIN, RHEUMATOID ARTHRITIS, SEROLOGY NEGATIVE, SPONDYLOARTHROPATHY, STRESS, SYSTEMIC LUPUS ERYTHEMATOSUS, VAGINAL HAEMORRHAGE, WEIGHT FLUCTUATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SINCE HER REMOVAL SURGERY, PATIENT'S SYMPTOMS HAVE MOSTLY RESOLVED, THOUGH SOME REMAIN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES; ON (B)(6) 2012: FALLOPIAN TUBES ARE OCCLUDED BILATERALLY CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENT: PELVIC PAIN, MENORRHAGIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-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 PELVIC PAIN ("SEVERE PELVIC PAIN / PAIN"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING"), SYSTEMIC LUPUS ERYTHEMATOSUS ("POSSIBLE LUPUS") AND RHEUMATOID ARTHRITIS ("RHEUMATOID ARTHRITIS") IN A 26-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 PAST MEDICAL HISTORY INCLUDED PAIN IN JOINT, PLATELET COUNT LOW AND DELIVERY ON (B)(6) 2012. CONCURRENT CONDITIONS INCLUDED UTERINE FIBROID. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2013, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2014, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"), ANXIETY ("ANXIETY") AND STRESS ("STRESS"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS") AND FATIGUE ("CHRONIC FATIGUE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN / DYSMENORRHAGIA(CRAMPING)"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN EVEN WHEN NOT MENSTRUATING"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATIONS"), ANAEMIA ("ANEMIA"), SYSTEMIC LUPUS ERYTHEMATOSUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), RHEUMATOID ARTHRITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SEROLOGY NEGATIVE ("SERONEGATIVE"), SPONDYLOARTHROPATHY ("SPONDYLOARTHROPATHY"), BACK PAIN ("LOWER BACK PAIN") AND ABDOMINAL PAIN UPPER ("STOMACH PAIN"). THE PATIENT WAS TREATED WITH IRON, COLECALCIFEROL (VITAMIN D), METHOTREXATE, SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY) AND SURGERY (UTERINE ABLATION AND DILATION AND CURETTAGE). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA AND VAGINAL HAEMORRHAGE WAS RESOLVING AND THE DYSMENORRHOEA, ABDOMINAL PAIN LOWER, DYSPAREUNIA, ALOPECIA, FATIGUE, WEIGHT FLUCTUATION, ANAEMIA, SYSTEMIC LUPUS ERYTHEMATOSUS, RHEUMATOID ARTHRITIS, SEROLOGY NEGATIVE, SPONDYLOARTHROPATHY, ALLERGY TO METALS, ANXIETY, STRESS, WEIGHT INCREASED, BACK PAIN AND ABDOMINAL PAIN UPPER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALLERGY TO METALS, ALOPECIA, ANAEMIA, ANXIETY, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MENORRHAGIA, PELVIC PAIN, RHEUMATOID ARTHRITIS, SEROLOGY NEGATIVE, SPONDYLOARTHROPATHY, STRESS, SYSTEMIC LUPUS ERYTHEMATOSUS, VAGINAL HAEMORRHAGE, WEIGHT FLUCTUATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SINCE HER REMOVAL SURGERY, PATIENT'S SYMPTOMS HAVE MOSTLY RESOLVED, THOUGH SOME REMAIN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES; ON (B)(6) 2012: FALLOPIAN TUBES ARE OCCLUDED BILATERALLY . CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENT: PELVIC PAIN, MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-MAR-2018: PFS+MR RECEIVED, REPORTER ADDED,PATIENT DEMOGRAPHICS ADDED, LOT NUMBER RECEIVED, PATIENT HISTORICAL AND CONCOMITANT CONDITION ADDED, TREATMENT DRUG ADDED, EVENTS ADDED AS :-VAGINAL HAEMORRHAGE, SYSTEMIC LUPUS ERYTHEMATOSUS, RHEUMATOID ARTHRITIS,SEROLOGY NEGATIVE,SPONDYLOARTHROPATHY, ANEMIA, ALLERGY TO METAL, ANXIETY, STRESS, WEIGHT INCREASED, BACK PAIN, ABDOMINAL PAIN UPPER. 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 PELVIC PAIN ("SEVERE PELVIC PAIN") AND MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN EVEN WHEN NOT MENSTRUATING"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), ALOPECIA ("HAIR LOSS"), FATIGUE ("CHRONIC FATIGUE"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATIONS") AND ANAEMIA ("ANEMIA"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A BILATERAL SALPINGECTOMY) AND SURGERY (UTERINE ABLATION AND DILATION AND CURETTAGE). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, DYSMENORRHOEA, ABDOMINAL PAIN LOWER, DYSPAREUNIA, ALOPECIA, FATIGUE, WEIGHT FLUCTUATION AND ANAEMIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANAEMIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MENORRHAGIA, PELVIC PAIN AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SINCE HER REMOVAL SURGERY, PATIENT'S SYMPTOMS HAVE MOSTLY RESOLVED, THOUGH SOME REMAIN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES. 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 |
|---|---|---|---|---|---|---|---|
| 778828 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 893037 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Other| R |