ESSURE
Report
- Report Number
- 2951250-2016-02559
- Event Type
- Injury
- Date Received
- November 17, 2016
- Report Date
- July 27, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS") AND GENITAL HAEMORRHAGE ("EXCESSIVE AND ABNORMAL BLEEDING") IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 827945) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 4 ( (B)(6) 2001, (B)(6)2003, (B)(6)2011), EYE PAIN, EAR PAIN, HEADACHE AND CHOLECYSTECTOMY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MIRENA FROM 2006 TO 2011. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, LOW BACK PAIN, SKIN CANCER AND THYROID CANCER. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED CYSTITIS ("INFECTION (OTHER) DESCRIBE : BLADDER"). IN (B)(6) 2015, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2015, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA") AND WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). IN 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, CYSTITIS, DYSPAREUNIA, WEIGHT INCREASED AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN AND THE NAUSEA AND DYSMENORRHOEA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, CYSTITIS, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, NAUSEA AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 18 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: EVENTS- "INFECTION (OTHER) DESCRIBE : BLADDER, MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS, NAUSEA, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN, LOWER ABDOMINAL PAIN", REPORTER, LOT NUMBER, HISTORICAL AND CONCOMITTANT CONDITION ADDED FROM PFS. 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 DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS") AND GENITAL HAEMORRHAGE ("EXCESSIVE AND ABNORMAL BLEEDING") IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 827945) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 4 ((B)(6) 2001, (B)(6) 2003, (B)(6) 2011), EYE PAIN, EAR PAIN, HEADACHE, CHOLECYSTECTOMY AND CHOLECYSTECTOMY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MIRENA FROM 2006 TO 2011. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, LOW BACK PAIN, SKIN CANCER, THYROID CANCER, BACK PAIN, ANXIETY, PANIC ATTACK, VOMITING, CHOLECYSTITIS, CHOLELITHIASIS, EAR PAIN, SHOULDER PAIN, NECK PAIN, BREAST ENLARGEMENT AND VAGINAL YEAST INFECTION. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM FROM 2012 TO 2017, FLUOXETINE SINCE 2011, IBUPROFEN SINCE 2001, LORAZEPAM SINCE 2012 AND TRAMADOL FROM 2011 TO 2016. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED CYSTITIS ("INFECTION (OTHER) DESCRIBE : BLADDER"). IN (B)(6) 2015, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2015, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA") AND WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). IN 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, CYSTITIS, DYSPAREUNIA, WEIGHT INCREASED AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN AND THE NAUSEA AND DYSMENORRHOEA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, CYSTITIS, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, NAUSEA AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.2 KG/SQM. ON (B)(6) 2011, HAD A HYSTEROSALPINGOGRAM (HSG) TEST THAT CONFIRMED SATISFACTORY PLACEMENT OF BOTH ESSURE COILS AND FULL OCCLUSION OF BOTH TUBES. CURRENT WEIGHT AS OF (B)(6) 2018: 150 LBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 135 LBS. 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 KNOWN POSSIBLE UNDESIRABLE EVENTS AND 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 CASE REPORT RECEIVED FROM A LAWYER REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND PRESENTED SEVERE CHRONIC PELVIC PAIN AND EXCESSIVE ABNORMAL BLEEDING, FOLLOWED BY A TOTAL HYSTERECTOMY 3 YEARS AFTER INSERTION. BOTH SERIOUS EVENTS DUE TO MEDICAL IMPORTANCE AND ANTICIPATED ACCORDING ESSURE REFERENCE SAFETY INFORMATION. AFTER ESSURE INSERTION, PELVIC PAIN AND CHANGES IN BLEEDING PATTERN MAY OCCUR. IN THIS CASE, EVENTS STARTED AFTER ESSURE INSERTION. CONSIDERING THIS INFORMATION AND IN THE LACK OF AN ALTERNATIVE EXPLANATION, CAUSALITY WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. OTHER NON-SERIOUS EVENT, ABDOMINAL PAIN, WAS REPORTED. THIS CASE WAS REGARDED AS INCIDENT, SINCE DEVICE REMOVAL WAS REQUIRED. THE PRODUCT TECHNICAL ANALYSIS CONCLUDED, AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE, A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. 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 PLAINTIFF IN UNITED STATES ON 27-OCT-2016 WHICH REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2012 FOR PERMANENT CONTRACEPTION. ON (B)(6) 2011, PLAINTIFF HAD A HYSTEROSALPINGOGRAM (HSG) TEST THAT CONFIRMED SATISFACTORY PLACEMENT OF BOTH ESSURE COILS AND FULL OCCLUSION OF BOTH TUBES. SHE REPORTED TO HER HEALTHCARE PROVIDER THAT SHE WAS EXPERIENCING SEVERE AND CHRONIC PELVIC AND ABDOMINAL PAIN AND EXCESSIVE AND ABNORMAL BLEEDING. ON (B)(6) 2015, PLAINTIFF SAW HER PHYSICIAN AND UNDERWENT A TOTAL HYSTERECTOMY. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT RECEIVED FROM A LAWYER REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND PRESENTED SEVERE CHRONIC PELVIC PAIN AND EXCESSIVE ABNORMAL BLEEDING, FOLLOWED BY A TOTAL HYSTERECTOMY 3 YEARS AFTER INSERTION. BOTH SERIOUS EVENTS DUE TO MEDICAL IMPORTANCE AND ANTICIPATED ACCORDING ESSURE REFERENCE SAFETY INFORMATION. AFTER ESSURE INSERTION, PELVIC PAIN AND CHANGES IN BLEEDING PATTERN MAY OCCUR. IN THIS CASE, EVENTS STARTED AFTER ESSURE INSERTION. CONSIDERING THIS INFORMATION AND IN THE LACK OF AN ALTERNATIVE EXPLANATION, CAUSALITY WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. OTHER NON-SERIOUS EVENT, ABDOMINAL PAIN, WAS REPORTED. 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 |
|---|---|---|---|---|---|---|---|
| 760350 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 827945 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other| R | ALPRAZOLAM| FLUOXETINE| IBUPROFEN| LORAZEPAM| TRAMADOL |