ESSURE
Report
- Report Number
- 2951250-2016-02795
- Event Type
- Injury
- Date Received
- December 21, 2016
- Date of Event
- August 24, 2013
- Report Date
- July 31, 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
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ("EXTREME AND ABNORMAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING") IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822369) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 2 ((B)(6) 1993) AND C-SECTION. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, ENDOMETRIAL POLYP, VITAMIN D DEFICIENCY, MENSTRUAL DISORDER NOS, SMOKER AND ALCOHOL USE. FAMILY HISTORY INCLUDED STROKE (MOTHER) IN (B)(6) 2013, HYPERTENSION (FATHER), DIABETES (FATHER), ISCHEMIC HEART DISEASE (FATHER), PAGET'S DISEASE (FATHER), MACULAR DEGENERATION (FATHER), PARKINSON'S DISEASE (FATHER), COLON CANCER (BROTHER), ULCERATIVE COLITIS (BROTHER), PYLORIC STENOSIS (SON) AND PATENT DUCTUS ARTERIOSUS (SON). CONCOMITANT PRODUCTS INCLUDED ANAESTHETICS (ANESTHESIA), COLECALCIFEROL (VITAMIN D3) SINCE (B)(6) 2013, ERGOCALCIFEROL SINCE (B)(6) 2013, FERROUS SULFATE (FERROUS SULPHATE) SINCE (B)(6) 2013 AND MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, 2 YEARS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). IN (B)(6) 2015, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), IRON DEFICIENCY ANAEMIA ("IRON DEFICIENCY ANEMIA"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), FATIGUE ("FATIGUE"), DEPRESSION ("DEPRESSION"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH NORMENSAL (ETHINYLESTRADIOL W/NORETHINDRONE), SURGERY (HYSTERECTOMY WITH BILATERAL OOPHORECTOMY AND REMOVAL OF ESSURE DEVICE, HYSTEROSCOPIC POLYPECTOMY) AND SURGERY (DILATION AND CURETTAGE USING TRUCLEAR SYSTEM, THE ABLATION IN 2013). ESSURE WAS REMOVED IN (B)(6) 2015. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, MENORRHAGIA, UTERINE HAEMORRHAGE, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, WEIGHT INCREASED AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN, THE IRON DEFICIENCY ANAEMIA, DEPRESSION AND DYSPAREUNIA HAD RESOLVED AND THE FATIGUE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, IRON DEFICIENCY ANAEMIA, MENORRHAGIA, UTERINE HAEMORRHAGE, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.5 KG/SQM. ULTRASOUND SCAN - IN (B)(6) 2011: ESSURE CONFIRMATION. CONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: UTERINE HAEMORRHAGE (CONFIRMING GENITAL HAEMORRHAGE), MENORRHAGIA. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT 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. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MED DRA LLT CAN BE PROVIDED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, 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 22-FEB-2018: PFS AND MR RECEIVED: NEW REPORTERS, PATIENT DEMOGRAPHIC INFORMATION, ONSET DATE AND STOP DATE UPDATED, TREATMENT DRUGS, HISTORICAL DRUGS AND CONDITIONS, CONCOMITANT DRUGS AND CONDITIONS, LAB DATA, NEW EVENTS VAGINAL HAEMORRHAGE, DYSMENORRHEA, DYSPAREUNIA, VAGINAL DISCHARGE, WEIGHT INCREASED AND ABNORMAL UTERINE BLEEDING(FROM MR) ADDED. OUTCOME FOR THE EVENTS ANAEMIA, DEPRESSION, DYSPAREUNIA, ADDED AS RECOVERED / RESOLVED AND FOR EVENT FATIGUE ADDED AS RECOVERING / RESOLVING. EVENT ANEMIA UPDATED TO IRON DEFICIENCY ANEMIA. 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. 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 GENITAL HAEMORRHAGE ("EXTREME AND ABNORMAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING") IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822369) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 2 ((B)(6) 1993) AND C-SECTION. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, ENDOMETRIAL POLYP, VITAMIN D DEFICIENCY, MENSTRUAL DISORDER NOS, SMOKER AND ALCOHOL USE. FAMILY HISTORY INCLUDED STROKE (MOTHER) IN (B)(6) 2013, HYPERTENSION (FATHER), DIABETES (FATHER), ISCHEMIC HEART DISEASE (FATHER), PAGET'S DISEASE (FATHER), MACULAR DEGENERATION (FATHER), PARKINSON'S DISEASE (FATHER), COLON CANCER (BROTHER), ULCERATIVE COLITIS (BROTHER), PYLORIC STENOSIS (SON) AND PATENT DUCTUS ARTERIOSUS (SON). CONCOMITANT PRODUCTS INCLUDED ANAESTHETICS (ANESTHESIA), COLECALCIFEROL (VITAMIN D3) SINCE (B)(6) 2013, ERGOCALCIFEROL SINCE (B)(6) 2013, FERROUS SULFATE (FERROUS SULPHATE) SINCE (B)(6) 2013 AND MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED IRON DEFICIENCY ANAEMIA ("IRON DEFICIENCY ANEMIA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2013, 2 YEARS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). IN (B)(6) 2014, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING") AND DEPRESSION ("DEPRESSION"). THE PATIENT WAS TREATED WITH NORMENSAL (ETHINYLESTRADIOL W/NORETHINDRONE), SURGERY (HYSTERECTOMY WITH BILATERAL OOPHORECTOMY AND REMOVAL OF ESSURE DEVICE, HYSTEROSCOPIC POLYPECTOMY) AND SURGERY (DILATION AND CURETTAGE USING TRUCLEAR SYSTEM, THE ABLATION IN 2013). ESSURE WAS REMOVED IN (B)(6) 2015. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, MENORRHAGIA, UTERINE HAEMORRHAGE, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, WEIGHT INCREASED AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN, THE IRON DEFICIENCY ANAEMIA, DEPRESSION AND DYSPAREUNIA HAD RESOLVED AND THE FATIGUE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, IRON DEFICIENCY ANAEMIA, MENORRHAGIA, UTERINE HAEMORRHAGE, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.5 KG/SQM. ULTRASOUND SCAN - IN (B)(6) 2011: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: UTERINE HAEMORRHAGE (CONFIRMING GENITAL HAEMORRHAGE), MENORRHAGIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-JUL-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.
FOLLOW-UP RECEIVED ON 22-DEC-2016: QUALITY SAFETY EVALUATION OF PTC PTC GLOBAL NUMBER: (B)(4). SAMPLE NOT 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. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MED DRA LLT CAN BE PROVIDED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, 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. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED SPONTANEOUS LEGAL CASE REPORT REFERS TO AN ADULT FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND SHE PRESENTED EXTREME AND ABNORMAL BLEEDING (SEEN AS GENITAL BLEEDING). A HYSTERECTOMY WAS PERFORMED TO REMOVE MICRO-INSERTS AROUND 2 YEARS AND 6 MONTHS AFTER INSERTION. THE REPORTED EVENT IS SERIOUS DUE TO MEDICAL IMPORTANCE AND ANTICIPATED IN ESSURE'S REFERENCE SAFETY INFORMATION. AFTER ESSURE INSERTION, ABNORMAL GENITAL BLEEDING AND MENSES PATTERN CHANGES MAY OCCUR. IN THIS SPECIFIC CASE, CONSUMER PRESENTED THE EVENTS AFTER INSERTION. CONSIDERING COMPATIBLE TEMPORAL RELATIONSHIP AND ABSENCE OF ALTERNATIVE EXPLANATION, CAUSALITY CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT, SINCE DEVICE REMOVAL WAS REQUIRED. A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ("EXTREME AND ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO RECEIVED ESSURE FOR STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT STARTED ESSURE AT AN UNSPECIFIED DOSE AND FREQUENCY. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED), MENORRHAGIA ("MENORRHAGIA"), ANAEMIA ("ANEMIA"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), FATIGUE ("FATIGUE") AND DEPRESSION ("DEPRESSION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY TO REMOVE ESSURE). ESSURE WAS WITHDRAWN. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, MENORRHAGIA, ANAEMIA, ABDOMINAL PAIN LOWER, FATIGUE AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED GENITAL HAEMORRHAGE, MENORRHAGIA, ANAEMIA, ABDOMINAL PAIN LOWER, FATIGUE AND DEPRESSION TO BE RELATED TO ESSURE. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED SPONTANEOUS LEGAL CASE REPORT REFERS TO AN ADULT FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND SHE PRESENTED EXTREME AND ABNORMAL BLEEDING (SEEN AS GENITAL BLEEDING). A HYSTERECTOMY WAS PERFORMED TO REMOVE MICRO-INSERTS AROUND 2 YEARS AND 6 MONTHS AFTER INSERTION. THE REPORTED EVENT IS SERIOUS DUE TO MEDICAL IMPORTANCE AND ANTICIPATED IN ESSURE'S REFERENCE SAFETY INFORMATION. AFTER ESSURE INSERTION, ABNORMAL GENITAL BLEEDING AND MENSES PATTERN CHANGES MAY OCCUR. IN THIS SPECIFIC CASE, CONSUMER PRESENTED THE EVENTS AFTER INSERTION. CONSIDERING COMPATIBLE TEMPORAL RELATIONSHIP AND ABSENCE OF ALTERNATIVE EXPLANATION, CAUSALITY CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT, SINCE DEVICE REMOVAL WAS REQUIRED. THE PRODUCT TECHNICAL ANALYSIS HAS BEEN SOUGHT. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 847064 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 822369 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Other| R | ANESTHESIA| ANESTHESIA| DEPO-PROVERA| DEPO-PROVERA| ERGOCALCIFEROL| ERGOCALCIFEROL| FERROUS SULPHATE| FERROUS SULPHATE| VITAMIN D3| VITAMIN D3 |