ESSURE
Report
- Report Number
- 2951250-2016-02718
- Event Type
- Injury
- Date Received
- December 14, 2016
- Date of Event
- June 18, 2014
- Report Date
- August 9, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
ROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MALPOSITION OF ESSURE MOVED FROM WHERE IT SUPPOSED TO BE"), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("ECTOPIC PREGNANCY"), PELVIC PAIN ("CHRONIC AND SEVERE PELVIC PAIN/PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") AND SEIZURE ("SEIZURES") IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822372) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 4 (DATES OF LIVE BIRTHS: (B)(6) 2002, (B)(6) 2005, (B)(6) 2007, (B)(6) 2010). CONCURRENT CONDITIONS INCLUDED INFECTION, DEPRESSION, PAIN IN EXTREMITY, ESSENTIAL HYPERTENSION, IRON DEFICIENCY ANEMIA, MENINGITIS, DYSPNEA, CHEST DISCOMFORT, URINARY INCONTINENCE, BACK DISORDER AND OVERWEIGHT. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE") AND DYSPAREUNIA ("DYSPAREUNIA"). IN (B)(6) 2011, 2 YEARS 10 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA ("HEAVY AND ABNORMAL BLEEDING DURING MENSTRUATION/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH NAUSEA, SEIZURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("HEAVY CRAMPING, SEVERE ABDOMINAL PAIN/STOMACH PAIN"), ALOPECIA ("HAIR LOSS"), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), RASH PRURITIC ("ITCHY RASH"), FUNGAL INFECTION ("LOT OF YEAST INFECTIONS"), ABNORMAL BEHAVIOUR ("MADE ME ACT TERRIBLE"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), TOOTH DISORDER ("DENTAL PROBLEMS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), WEIGHT INCREASED ("WEIGHT GAIN"), WEIGHT DECREASED ("WEIGHT LOSS"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"), URTICARIA ("HIVES") AND ANAEMIA ("ANEMIA"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH VICODIN (NORCO), NSAID'S, CETIRIZINE HYDROCHLORIDE, IBUPROFEN, SUMATRIPTAN SUCCINATE, PROPRANOLOL, VERAPAMIL, TOPIRAMATE, FLUCONAZOLE, FLUCONAZOLE (DIFLUCAN), PROMETHAZINE, DOCUSATE SODIUM (COLACE), SURGERY (ON (B)(6) 2016, VAGINAL HYSTERECTOMY AND ON UNKNOWN DATE BY BILATERAL SALPINGECTOMY) AND SURGERY (ON (B)(6) 2016, VAGINAL HYSTERECTOMY AND ON UNKNOWN DATE BY BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, SEIZURE, ABDOMINAL PAIN, ALOPECIA, HORMONE LEVEL ABNORMAL, FUNGAL INFECTION, ABNORMAL BEHAVIOUR, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, TOOTH DISORDER, VAGINAL DISCHARGE, WEIGHT INCREASED, WEIGHT DECREASED, GASTROINTESTINAL DISORDER, URTICARIA AND ANAEMIA OUTCOME WAS UNKNOWN, THE PELVIC PAIN AND FATIGUE WAS RESOLVING AND THE GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, RASH PRURITIC, DYSMENORRHOEA AND DYSPAREUNIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABNORMAL BEHAVIOUR, ALOPECIA, ANAEMIA, BLADDER DISORDER, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, FATIGUE, FUNGAL INFECTION, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, PELVIC PAIN, RASH PRURITIC, SEIZURE, TOOTH DISORDER, URINARY TRACT DISORDER, URTICARIA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: THE PLAINTIFF EXPERIENCED TWO MORE PREGNANCIES UNDER ESSURE (DATES NOT REPORTED). ONE OF THE TWO PREGNANCY (STILLBIRTH OR MISACARRIAGE) IS CAPTURED IN CASE (B)(4). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26.5 KG/SQM. ON (B)(6) 2011, FINDINGS INCLUDED NORMAL MOLLERIAN ANATOMY. ON PELVIC EXAM, SHE AHD AN REVERTED UTERUS THAT WAS OF NORMAL SIZE. NO ADNEXAL MASSES WERE PALPATED. SHE HAD NORMAL-APPEARING CERVIX. THE UTERINE CAVITY WAS NORMAL WITHOUT POLYPS OR FIBROIDS. BOTH TUBAL OSTIA WERE EASILY VISUALIZED, AND FOLLOWING DEPLOYMENT OF THE ESSURE DEVICES, THERE WAS 1 RING VISUALIZED BILATERALLY AT EACH OSTIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-AUG-2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAIN. 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 RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC AND SEVERE PELVIC PAIN/PAIN"), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("ECTOPIC PREGNANCY"), DEVICE DISLOCATION ("MALPOSITION OF ESSURE MOVED FROM WHERE IT SUPPOSED TO BE"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") AND SEIZURE ("SEIZURES") IN A 30-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 "DEVICE INEFFECTIVE". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED INFECTION, DEPRESSION, PAIN IN EXTREMITY, ESSENTIAL HYPERTENSION, IRON DEFICIENCY ANEMIA, MENINGITIS, DYSPNEA, CHEST DISCOMFORT AND URINARY INCONTINENCE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, 2 YEARS 10 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SEIZURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("HEAVY CRAMPING, SEVERE ABDOMINAL PAIN/STOMACH PAIN"), MENORRHAGIA ("HEAVY AND ABNORMAL BLEEDING DURING MENSTRUATION/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), ALOPECIA ("HAIR LOSS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), RASH PRURITIC ("ITCHY RASH"), FUNGAL INFECTION ("LOT OF YEAST INFECTIONS"), ABNORMAL BEHAVIOUR ("MADE ME ACT TERRIBLE"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), TOOTH DISORDER ("DENTAL PROBLEMS"), NAUSEA ("NAUSEA"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN"), WEIGHT DECREASED ("WEIGHT LOSS") AND GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH VICODIN (NORCO), NSAID'S, CETIRIZINE HYDROCHLORIDE, IBUPROFEN, SUMATRIPTAN SUCCINATE, PROPRANOLOL, VERAPAMIL, TOPIRAMATE, FLUCONAZOLE, FLUCONAZOLE (DIFLUCAN), PROMETHAZINE, DOCUSATE SODIUM (COLACE), SURGERY (ON(B)(6) 2016, VAGINAL HYSTERECTOMY AND ON UNKNOWN DATE BY BILATERAL SALPINGECTOMY) AND SURGERY (ON (B)(6) 2016, VAGINAL HYSTERECTOMY AND ON UNKNOWN DATE BY BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, SEIZURE, ABDOMINAL PAIN, MENORRHAGIA, ALOPECIA, VAGINAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, RASH PRURITIC, FUNGAL INFECTION, ABNORMAL BEHAVIOUR, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, TOOTH DISORDER, NAUSEA, VAGINAL DISCHARGE, DYSMENORRHOEA, FATIGUE, WEIGHT INCREASED, WEIGHT DECREASED AND GASTROINTESTINAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABNORMAL BEHAVIOUR, ALOPECIA, BLADDER DISORDER, DEVICE DISLOCATION, DYSMENORRHOEA, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, FATIGUE, FUNGAL INFECTION, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, RASH PRURITIC, SEIZURE, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PLAINTIFF EXPERIENCED TWO MORE PREGNANCIES UNDER ESSURE (DATES NOT REPORTED). ONE OF THE TWO PREGNANCY (STILLBIRTH OR MISCARRIAGE) IS CAPTURED IN CASE (B)(4). DIAGNOSTIC RESULTS: ON (B)(6) 2011, FINDINGS INCLUDED NORMAL MOLLERIAN ANATOMY. ON PELVIC EXAM, SHE HAD AN REVERTED UTERUS THAT WAS OF NORMAL SIZE. NO ADNEXAL MASSES WERE PALPATED. SHE HAD NORMAL-APPEARING CERVIX. THE UTERINE CAVITY WAS NORMAL WITHOUT POLYPS OR FIBROIDS. BOTH TUBAL OSTIA WERE EASILY VISUALIZED, AND FOLLOWING DEPLOYMENT OF THE ESSURE DEVICES, THERE WAS 1 RING VISUALIZED BILATERALLY AT EACH OSTIA. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NO AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. BASED ON THE AVAILABLE INFORMATION A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. BASED ON THE PROVIDED INFORMATION THE DEFECT TYPE CORRESPONDS TO THE FOLLOWING MEDDRA LLT: DEVICE INEFFECTIVE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS AND THE REPORTED LACK OF EFFICACY CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED LACK OF EFFICACY AND THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, MILPITAS TO BAYER PHARMA AG, BERLIN, AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY. NEW EVENTS ADDED- ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), HORMONAL CHANGES, ITCHY RASH, LOT OF YEAST INFECTIONS, MADE ME ACT TERRIBLE, MALPOSITION OF ESSURE MOVED FROM WHERE IT SUPPOSED TO BE, BLADDER OR URINARY PROBLEMS OR CHANGES, BLADDER OR URINARY PROBLEMS OR CHANGES, MIGRAINES, HEADACHES, DENTAL PROBLEMS, NAUSEA, SEIZURES, VAGINAL DISCHARGE, DYSMENORRHEA (CRAMPING), FATIGUE, WEIGHT GAIN, WEIGHT LOSS, GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION AND ABNORMAL BLEEDING (GENERAL). FUP 2 AND 3 PROCESSED TOGETHER. ON (B)(6) 2018: FUP 2 AND 3 PROCESSED TOGETHER. 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 RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MALPOSITION OF ESSURE MOVED FROM WHERE IT SUPPOSED TO BE"), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("ECTOPIC PREGNANCY"), PELVIC PAIN ("CHRONIC AND SEVERE PELVIC PAIN/PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") AND SEIZURE ("SEIZURES") IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822372) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 4 (DATES OF LIVE BIRTHS: (B)(6) 2002, (B)(6) 2005, (B)(6) 2007, (B)(6) 2010). CONCURRENT CONDITIONS INCLUDED INFECTION, DEPRESSION, PAIN IN EXTREMITY, ESSENTIAL HYPERTENSION, IRON DEFICIENCY ANEMIA, MENINGITIS, DYSPNEA, CHEST DISCOMFORT, URINARY INCONTINENCE, BACK DISORDER AND OVERWEIGHT. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE") AND DYSPAREUNIA ("DYSPAREUNIA"). IN (B)(6) 2011, 2 YEARS 10 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA ("HEAVY AND ABNORMAL BLEEDING DURING MENSTRUATION/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH NAUSEA, SEIZURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("HEAVY CRAMPING, SEVERE ABDOMINAL PAIN/STOMACH PAIN"), ALOPECIA ("HAIR LOSS"), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), RASH PRURITIC ("ITCHY RASH"), FUNGAL INFECTION ("LOT OF YEAST INFECTIONS"), ABNORMAL BEHAVIOUR ("MADE ME ACT TERRIBLE"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), TOOTH DISORDER ("DENTAL PROBLEMS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), WEIGHT INCREASED ("WEIGHT GAIN"), WEIGHT DECREASED ("WEIGHT LOSS"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"), URTICARIA ("HIVES") AND ANAEMIA ("ANEMIA"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH VICODIN (NORCO), NSAID'S, CETIRIZINE HYDROCHLORIDE, IBUPROFEN, SUMATRIPTAN SUCCINATE, PROPRANOLOL, VERAPAMIL, TOPIRAMATE, FLUCONAZOLE, FLUCONAZOLE (DIFLUCAN), PROMETHAZINE, DOCUSATE SODIUM (COLACE), SURGERY (ON (B)(6) 2016, VAGINAL HYSTERECTOMY AND ON UNKNOWN DATE BY BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, SEIZURE, ABDOMINAL PAIN, ALOPECIA, HORMONE LEVEL ABNORMAL, FUNGAL INFECTION, ABNORMAL BEHAVIOUR, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, TOOTH DISORDER, VAGINAL DISCHARGE, WEIGHT INCREASED, WEIGHT DECREASED, GASTROINTESTINAL DISORDER, URTICARIA AND ANAEMIA OUTCOME WAS UNKNOWN, THE PELVIC PAIN AND FATIGUE WAS RESOLVING AND THE GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, RASH PRURITIC, DYSMENORRHOEA AND DYSPAREUNIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABNORMAL BEHAVIOUR, ALOPECIA, ANAEMIA, BLADDER DISORDER, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, FATIGUE, FUNGAL INFECTION, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, PELVIC PAIN, RASH PRURITIC, SEIZURE, TOOTH DISORDER, URINARY TRACT DISORDER, URTICARIA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PLAINTIFF EXPERIENCED TWO MORE PREGNANCIES UNDER ESSURE (DATES NOT REPORTED). ONE OF THE TWO PREGNANCY (STILLBIRTH OR "MISCARRIAGE") IS CAPTURED IN CASE (B)(4). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26.5 KG/SQM. ON (B)(6) 2011, FINDINGS INCLUDED NORMAL MOLLERIAN ANATOMY. ON PELVIC EXAM, SHE "HAD" AN REVERTED UTERUS THAT WAS OF NORMAL SIZE. NO ADNEXAL MASSES WERE PALPATED. SHE HAD NORMAL-APPEARING CERVIX. THE UTERINE CAVITY WAS NORMAL WITHOUT POLYPS OR FIBROIDS. BOTH TUBAL OSTIA WERE EASILY VISUALIZED, AND FOLLOWING DEPLOYMENT OF THE ESSURE DEVICES, THERE WAS 1 RING VISUALIZED BILATERALLY AT EACH OSTIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2018: PFS RECEIVED: NEW EVENTS: ANAEMIA, DYSPAREUNIA, URTICARIA WERE ADDED. REPORTER, PATIENT DEMOGRAPHIC INFORMATION, CONCOMITANT DISEASE, PRODUCT LOT NUMBER WERE ADDED. PREVIOUSLY REPORTED EVENT GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, NAUSEA, DYSMENORRHOEA OUTCOME UPDATED. 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.
QUALITY-SAFETY EVALUATION OF PTC (PTC GLOBAL NUMBER: (B)(4)) RECEIVED ON 14-DEC-2016: SAMPLE NO AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. BASED ON THE AVAILABLE INFORMATION A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. BASED ON THE PROVIDED INFORMATION THE DEFECT TYPE CORRESPONDS TO THE FOLLOWING MEDDRA LLT: DEVICE INEFFECTIVE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS AND THE REPORTED LACK OF EFFICACY CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED LACK OF EFFICACY AND THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. NO FURTHER INFORMATION WAS PROVIDED. COMPANY CAUSALITY COMMENT: A FEMALE PLAINTIFF OF UNSPECIFIED AGE HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED CHRONIC AND SEVERE PELVIC PAIN AND HAD AN ECTOPIC PREGNANCY. A LAPAROSCOPIC-ASSISTED HYSTERECTOMY AND BILATERAL SALPINGECTOMY WAS PERFORMED. ALL THESE EVENTS ARE ANTICIPATED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. PELVIC PAIN MAY OCCUR WITH ESSURE THERAPY. ECTOPIC PREGNANCIES HAVE BEEN REPORTED AMONG WOMEN WITH ESSURE MICRO-INSERTS IN PLACE. WHEN PREGNANCY DOES OCCUR AFTER ESSURE PLACEMENT, THE RELATIVE RISK THAT IT WILL BE AN ECTOPIC PREGNANCY IS HIGHER THAN FOR WOMEN WHO DO NOT HAVE THE INSERT IN PLACE. BASED ON THE NATURE OF THE EVENTS, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT BECAUSE SURGICAL INTERVENTION WAS PERFORMED. ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. NO SAMPLE AVAILABLE FOR THIS INVESTIGATION AND NO VALID LOT NUMBER. THEREFORE, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A LAWYER IN THE UNITED STATES, ON BEHALF OF A FEMALE PLAINTIFF OF UNSPECIFIED AGE IN UNITED STATES ON 18-NOV-2016 WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) IMPLANTED ON (B)(6) 2011 FOR PERMANENT CONTRACEPTION. ON (B)(6) 2011, SHE HAD A HYSTEROSALPINGOGRAM (HSG) TEST THAT CONFIRMED SATISFACTORY PLACEMENT OF BOTH ESSURE COILS AND FULL OCCLUSION OF BOTH TUBES. SOMETIME AFTER IMPLANT OF THE ESSURE DEVICE, SHE BEGAN TO EXPERIENCE ONE OR MORE OF THE FOLLOWING SYMPTOMS, INCLUDING, BUT NOT LIMITED TO: SEVERE ABNORMAL MENSTRUAL PAIN, ABNORMAL MENSTRUAL CYCLE, EXCESSIVE BLEEDING, SEVERE PELVIC PAIN, BACK PAIN, ABDOMINAL PAIN, PAIN DURING INTERCOURSE, HEADACHES, ALLERGIC REACTION, MOOD SWINGS, MIGRATION OF THE DEVICE, UNWANTED PREGNANCY, AND FATIGUE. SHE REPORTED TO HER HEALTHCARE PROVIDER THAT SHE WAS EXPERIENCING HEAVY CRAMPING, HEAVY AND ABNORMAL BLEEDING DURING MENSTRUATION, HAIR LOSS, SEVERE ABDOMINAL PAIN, CHRONIC AND SEVERE PELVIC PAIN, AND AN ECTOPIC PREGNANCY. ON (B)(6) 2016, SHE SAW HER PHYSICIAN AND UNDERWENT A LAPAROSCOPIC-ASSISTED HYSTERECTOMY AND BILATERAL SALPINGECTOMY. COMPANY CAUSALITY COMMENT: A FEMALE PLAINTIFF OF UNSPECIFIED AGE HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED CHRONIC AND SEVERE PELVIC PAIN AND HAD AN ECTOPIC PREGNANCY. A LAPAROSCOPIC-ASSISTED HYSTERECTOMY AND BILATERAL SALPINGECTOMY WAS PERFORMED. ALL THESE EVENTS ARE ANTICIPATED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. PELVIC PAIN MAY OCCUR WITH ESSURE THERAPY. ECTOPIC PREGNANCIES HAVE BEEN REPORTED AMONG WOMEN WITH ESSURE MICRO-INSERTS IN PLACE. WHEN PREGNANCY DOES OCCUR AFTER ESSURE PLACEMENT, THE RELATIVE RISK THAT IT WILL BE AN ECTOPIC PREGNANCY IS HIGHER THAN FOR WOMEN WHO DO NOT HAVE THE INSERT IN PLACE. BASED ON THE NATURE OF THE EVENTS, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT BECAUSE SURGICAL INTERVENTION WAS PERFORMED. ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. A PRODUCT TECHNICAL ANALYSIS IS BEING SOUGHT. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 825059 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 822372 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Other| R |