ESSURE
Report
- Report Number
- 2951250-2017-10877
- Event Type
- Injury
- Date Received
- December 18, 2017
- Date of Event
- July 10, 2014
- Report Date
- March 18, 2020
- 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
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN/PAIN") AND MAST CELL ACTIVATION SYNDROME ("MAST CELL ACTIVATION SYNDROME") IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLES/DYSMENORRHEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MAST CELL ACTIVATION SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VAGINAL HAEMORRHAGE ("HEAVY VAGINAL BLEEDING/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), URINARY TRACT INFECTION ("MULTIPLE URINARY TRACT INFECTIONS/CHRONIC BLADDER URINARY TRACT INFECTION"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), FATIGUE ("FATIGUE"), CYSTITIS ("CHRONIC BLADDER URINARY TRACT INFECTION"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), ALLERGY TO METALS ("NICKEL ALLERGY"), RASH ("RASHES"), FLUSHING ("SKIN FLUSHING"), WEIGHT INCREASED ("WEIGHT GAIN"), ENDOMETRIOSIS ("ENDOMETRIOSIS"), FIBROMYALGIA ("FIBROMYALGIA"), CERVICITIS ("MILD CHRONIC CERVICITIS"), ADENOMYOSIS ("ADENOMYOSIS"), BLOOD IRON DECREASED ("EXTREME LOW IRON"), BACK PAIN ("LOW BACK PAIN") AND ENDOMETRIAL HYPERPLASIA ("ENIGN PROLIFERATIVE ENDOMETRIUM"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY TOTAL ABDOMINAL WITH BILATERAL SALPINGO-OOPHORECTOMY). ESSURE WAS REMOVED ON 16-JUL-2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MAST CELL ACTIVATION SYNDROME, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION, MENORRHAGIA, BLADDER DISORDER, URINARY TRACT DISORDER, FATIGUE, CYSTITIS, MIGRAINE, HEADACHE, ALLERGY TO METALS, RASH, FLUSHING, WEIGHT INCREASED, ENDOMETRIOSIS, FIBROMYALGIA, CERVICITIS, ADENOMYOSIS, BLOOD IRON DECREASED AND BACK PAIN HAD NOT RESOLVED AND THE DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN AND ENDOMETRIAL HYPERPLASIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADENOMYOSIS, ALLERGY TO METALS, BACK PAIN, BLADDER DISORDER, BLOOD IRON DECREASED, CERVICITIS, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIAL HYPERPLASIA, ENDOMETRIOSIS, FATIGUE, FIBROMYALGIA, FLUSHING, HEADACHE, MAST CELL ACTIVATION SYNDROME, MENORRHAGIA, MIGRAINE, PELVIC PAIN, RASH, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT: 200 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: SCAR TISSUE HAD FORMED ON ONE SIDE. ON (B)(6) 2014, SURGICAL PATHOLOGY REPORT REVEALED FINDINGS FOR UTERUS, BILATERAL TUBES AND OVARIES: MILD CHRONIC CERVICITIS. BENIGN PROLIFERATIVE ENDOMETRIUM. ADENOMYOSIS. OVARIES, BILATERAL, SHOWING NO PATHOLOGICAL FEATURES. TRANSVERSE SECTIONS OF FALLOPIAN TUBES SHOWING NO PATHOLOGIC FEATURES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS CONFIRMED IN PATIENT'S MEDICAL RECORD: ABDOMINAL PAIN AND ENDOMETRIOSIS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-APR-2018: PFS RECEIVED. NEW EVENTS ADDED- ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), MAST CELL ACTIVATION SYNDROME, BLADDER OR URINARY PROBLEMS OR CHANGES, FATIGUECHRONIC BLADDER URINARY TRACT INFECTION, MIGRAINES/HEADACHES, NICKEL ALLERGY, RASHES, SKIN FLUSHING, WEIGHT GAIN, ENDOMETRIOSIS, FIBROMYALGIA, MILD CHRONIC CERVICITIS, BENIGN PROLIFERATIVE ENDOMETRIUM, ADENOMYOSIS, EXTREME LOW IRON AND LOW BACK PAIN. LAB DATA ADDED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/PAIN') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S)". THE PATIENT'S MEDICAL HISTORY INCLUDED ANXIETY, GASTROESOPHAGEAL REFLUX DISEASE, NAUSEA, CYCLIC VOMITING SYNDROME, ASTHMA, HYPERTENSION, VITAMIN B12 DEFICIENCY, CUBITAL TUNNEL SYNDROME AND GASTROPARESIS. CONCOMITANT PRODUCTS INCLUDED ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL) SINCE 2006, CLONAZEPAM SINCE 2014, CYANOCOBALAMIN SINCE 2016, MORPHINE SINCE 2005, ONDANSETRON SINCE 2011, PROPRANOLOL SINCE 2011, RIZATRIPTAN SINCE 2014 AND SALBUTAMOL SULFATE (ALBUTEROL SULFATE) SINCE 1989. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("HEAVY VAGINAL BLEEDING/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLES/DYSMENORRHEA"), 4 MONTHS 29 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2011, THE PATIENT EXPERIENCED ALLERGY TO METALS ("MAST CELL ACTIVATION SYNDROME - TIED TO NICKEL ALLERGY"). IN (B)(6) 2011, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE") AND HEADACHE ("HEADACHE"). IN (B)(6) 2012, THE PATIENT EXPERIENCED RASH ("RASH") AND FLUSHING ("SKIN FLUSHING"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("MULTIPLE URINARY TRACT INFECTIONS/CHRONIC BLADDER URINARY TRACT INFECTION") AND CYSTITIS ("CHRONIC BLADDER URINARY TRACT INFECTION"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ENDOMETRIOSIS ("ENDOMETRIOSIS") AND ADENOMYOSIS ("ADENOMYOSIS"). IN 2013, THE PATIENT EXPERIENCED MAST CELL ACTIVATION SYNDROME ("MAST CELL ACTIVATION SYNDROME"). IN (B)(6) 2014, THE PATIENT EXPERIENCED BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES") AND URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"). ON (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN ("LOW BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), FATIGUE ("FATIGUE"), FIBROMYALGIA ("FIBROMYALGIA"), CERVICITIS ("MILD CHRONIC CERVICITIS") AND ENDOMETRIAL HYPERPLASIA ("BENIGN PROLIFERATIVE ENDOMETRIUM") AND WAS FOUND TO HAVE BLOOD IRON DECREASED ("EXTREME LOW IRON"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY TOTAL ABDOMINAL WITH BILATERAL SALPINGO-OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BACK PAIN, ALLERGY TO METALS, MAST CELL ACTIVATION SYNDROME, URINARY TRACT INFECTION, FATIGUE, CYSTITIS, MIGRAINE, HEADACHE, FLUSHING, WEIGHT INCREASED, FIBROMYALGIA, CERVICITIS AND BLOOD IRON DECREASED HAD NOT RESOLVED, THE DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN AND ENDOMETRIAL HYPERPLASIA OUTCOME WAS UNKNOWN, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, BLADDER DISORDER, URINARY TRACT DISORDER, ENDOMETRIOSIS AND ADENOMYOSIS HAD RESOLVED AND THE RASH WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADENOMYOSIS, ALLERGY TO METALS, BACK PAIN, BLADDER DISORDER, BLOOD IRON DECREASED, CERVICITIS, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIAL HYPERPLASIA, ENDOMETRIOSIS, FATIGUE, FIBROMYALGIA, FLUSHING, HEADACHE, MAST CELL ACTIVATION SYNDROME, MENORRHAGIA, MIGRAINE, PELVIC PAIN, RASH, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT: 200 LBS. DISCREPANCY NOTED IN DATE OF INSERTION (B)(6) 2011 AND (B)(6) 2011. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: SCAR TISSUE HAD FORMED ON ONE SIDE.; IN (B)(6) 2011: THEY SAID SCAR TISSUE HAD FORMED ON ONE SIDE AND THE OTHER NEEDED MORE TIME. DIAGNOSTIC RESULTS: ON (B)(6) 2014, SURGICAL PATHOLOGY REPORT REVEALED FINDINGS FOR UTERUS, BILATERAL TUBES AND OVARIES: MILD CHRONIC CERVICITIS. BENIGN PROLIFERATIVE ENDOMETRIUM. ADENOMYOSIS. OVARIES, BILATERAL, SHOWING NO PATHOLOGICAL FEATURES. TRANSVERSE SECTIONS OF FALLOPIAN TUBES SHOWING NO PATHOLOGIC FEATURES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS CONFIRMED IN PATIENT'S MEDICAL RECORD: ABDOMINAL PAIN AND ENDOMETRIOSIS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/PAIN') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S)". THE PATIENT'S MEDICAL HISTORY INCLUDED ANXIETY, GASTROESOPHAGEAL REFLUX DISEASE, NAUSEA, CYCLIC VOMITING SYNDROME, ASTHMA, HYPERTENSION, VITAMIN B12 DEFICIENCY, CUBITAL TUNNEL SYNDROME AND GASTROPARESIS. CONCOMITANT PRODUCTS INCLUDED ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL) SINCE 2006, CLONAZEPAM SINCE 2014, CYANOCOBALAMIN SINCE 2016, MORPHINE SINCE 2005, ONDANSETRON SINCE 2011, PROPRANOLOL SINCE 2011, RIZATRIPTAN SINCE 2014 AND SALBUTAMOL SULFATE (ALBUTEROL SULFATE) SINCE 1989. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("HEAVY VAGINAL BLEEDING/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLES/DYSMENORRHEA"), 4 MONTHS 29 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2011, THE PATIENT EXPERIENCED ALLERGY TO METALS ("MAST CELL ACTIVATION SYNDROME - TIED TO NICKEL ALLERGY"). IN (B)(6) 2011, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN (B)(6) 2012, THE PATIENT EXPERIENCED RASH ("RASHES") AND FLUSHING ("SKIN FLUSHING"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("MULTIPLE URINARY TRACT INFECTIONS/CHRONIC BLADDER URINARY TRACT INFECTION") AND CYSTITIS ("CHRONIC BLADDER URINARY TRACT INFECTION"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ENDOMETRIOSIS ("ENDOMETRIOSIS") AND ADENOMYOSIS ("ADENOMYOSIS"). IN 2013, THE PATIENT EXPERIENCED MAST CELL ACTIVATION SYNDROME ("MAST CELL ACTIVATION SYNDROME"). IN (B)(6) 2014, THE PATIENT EXPERIENCED BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES") AND URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"). ON (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN ("LOW BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), FATIGUE ("FATIGUE"), FIBROMYALGIA ("FIBROMYALGIA"), CERVICITIS ("MILD CHRONIC CERVICITIS") AND ENDOMETRIAL HYPERPLASIA ("BENIGN PROLIFERATIVE ENDOMETRIUM") AND WAS FOUND TO HAVE BLOOD IRON DECREASED ("EXTREME LOW IRON"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY TOTAL ABDOMINAL WITH BILATERAL SALPINGO-OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BACK PAIN, ALLERGY TO METALS, MAST CELL ACTIVATION SYNDROME, URINARY TRACT INFECTION, FATIGUE, CYSTITIS, MIGRAINE, HEADACHE, FLUSHING, WEIGHT INCREASED, FIBROMYALGIA, CERVICITIS AND BLOOD IRON DECREASED HAD NOT RESOLVED, THE DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN AND ENDOMETRIAL HYPERPLASIA OUTCOME WAS UNKNOWN, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, BLADDER DISORDER, URINARY TRACT DISORDER, ENDOMETRIOSIS AND ADENOMYOSIS HAD RESOLVED AND THE RASH WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADENOMYOSIS, ALLERGY TO METALS, BACK PAIN, BLADDER DISORDER, BLOOD IRON DECREASED, CERVICITIS, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIAL HYPERPLASIA, ENDOMETRIOSIS, FATIGUE, FIBROMYALGIA, FLUSHING, HEADACHE, MAST CELL ACTIVATION SYNDROME, MENORRHAGIA, MIGRAINE, PELVIC PAIN, RASH, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT: 200 LBS. DISCREPANCY NOTED IN DATE OF INSERTION (B)(6) 2011 AND (B)(6) 2011 DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: SCAR TISSUE HAD FORMED ON ONE SIDE.; IN (B)(6) 2011: THEY SAID SCAR TISSUE HAD FORMED ON ONE SIDE AND THE OTHER NEEDED MORE TIME. DIAGNOSTIC RESULTS: ON (B)(6) 2014, SURGICAL PATHOLOGY REPORT REVEALED FINDINGS FOR UTERUS, BILATERAL TUBES AND OVARIES: MILD CHRONIC CERVICITIS. BENIGN PROLIFERATIVE ENDOMETRIUM. ADENOMYOSIS. OVARIES, BILATERAL, SHOWING NO PATHOLOGICAL FEATURES. TRANSVERSE SECTIONS OF FALLOPIAN TUBES SHOWING NO PATHOLOGIC FEATURES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS CONFIRMED IN PATIENT'S MEDICAL RECORD: ABDOMINAL PAIN AND ENDOMETRIOSIS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-FEB-2020: PLAINTIFF FACT SHEET RECEIVED. EVENTS ADDED FROM PFS- FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S). OUTCOME OF EVENT MENORRHAGIA, VAGINAL HAEMORRHAGE, ENDOMETRIOSIS, ADENOMYOSIS, URINARY TRACT DISORDER, BLADDER DISORDER, RASH WERE UPDATED. ONSET DATE OF EVENT DYSMENORRHOEA, MIGRAINE, HEADACHE, ENDOMETRIOSIS, ADENOMYOSIS, DYSPAREUNIA, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT DISORDER, BLADDER DISORDER, ALLERGY TO METALS, FLUSHING, RASH, WEIGHT INCREASED, URINARY TRACT INFECTION WERE UPDATED. REPORTER INFORMATION, MEDICAL HISTORY, CONCOMITANT DRUG, LAB DATA WERE ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY 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) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLES"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VAGINAL HAEMORRHAGE ("HEAVY VAGINAL BLEEDING") AND URINARY TRACT INFECTION ("MULTIPLE URINARY TRACT INFECTIONS"). THE PATIENT WAS TREATED WITH SURGERY (SHE UNDERWENT A HYSTEROSALPINGECTOMY TO REMOVE THE ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, VAGINAL HAEMORRHAGE AND URINARY TRACT INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, PELVIC PAIN, URINARY TRACT INFECTION 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 |
|---|---|---|---|---|---|---|---|
| 905831 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other| R | ACYCLOVIR ABBOTT VIAL| ACYCLOVIR ABBOTT VIAL| ALBUTEROL SULFATE| ALBUTEROL SULFATE| CLONAZEPAM| CLONAZEPAM| CYANOCOBALAMIN| CYANOCOBALAMIN| MORPHINE| MORPHINE| ONDANSETRON| ONDANSETRON| PROPRANOLOL| PROPRANOLOL| RIZATRIPTAN| RIZATRIPTAN |