ESSURE
Report
- Report Number
- 2951250-2019-03885
- Event Type
- Injury
- Date Received
- July 16, 2019
- Date of Event
- October 21, 2016
- Report Date
- July 18, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PLACENTA ACCRETA ('REMOVED CERVIX AND UTERUS BECAUSE MY PLACENTA HAD GROWN INTO MY UTERUS DURING PREGNANCY'), INDUCED LABOUR ('2 WEEKS BED REST; 5 WEEKS HOSPITALIZATION; INDUCED LABOR AT 36 WEEKS GESTATION AND PERFORMED CESAREAN') AND PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY (WITH COMPLICATIONS)') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822369) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ESSURE AND THERMACHOICE ENDOMETRIAL ABLATION" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED ENLARGED THYROID IN (B)(6) 2016, ENDOMETRIOSIS ON (B)(6) 2013, TENOSYNOVITIS IN 2010, ABORTION INDUCED IN 2007, GRAVIDA II AND PARITY 2 ((B)(6) 2009, (B)(6) 2016). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: WELLBURTIN FROM 2009 TO (B)(6) 2019, APRISO FROM (B)(6) 2017 TO (B)(6) 2019 AND SEASONALE. CONCURRENT CONDITIONS INCLUDED ULCERATIVE COLITIS SINCE (B)(6) 2017, OVERWEIGHT, MENORRHAGIA, DYSMENORRHEA AND UTERINE FIBROID. CONCOMITANT PRODUCTS INCLUDED CEFIXIME (FLEXERIL) SINCE (B)(6) 2017, IBUPROFEN SINCE 2013 AND MESALAZINE (APRISO) SINCE (B)(6) 2017. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2016, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"). IN (B)(6) 2016, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2016, THE PATIENT EXPERIENCED PLACENTA ACCRETA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND INDUCED LABOUR (SERIOUSNESS CRITERIA HOSPITALIZATION AND MEDICALLY SIGNIFICANT), 3 YEARS 9 MONTHS AFTER INSERTION OF ESSURE. IN (B)(6) 2016, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), FEELING ABNORMAL ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:BRAIN FOG"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION"), MOOD SWINGS ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:MOOD SWINGS") AND ENDOMETRIAL ATROPHY ("CESAREAN SECTION DUE TO A THIN UTERINE WALL"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL) AND CESAREAN). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PLACENTA ACCRETA, INDUCED LABOUR, PREGNANCY WITH CONTRACEPTIVE DEVICE, ANXIETY, FEELING ABNORMAL, DEPRESSION, MOOD SWINGS, WEIGHT INCREASED, ABDOMINAL DISTENSION, ALOPECIA AND ENDOMETRIAL ATROPHY OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, ANXIETY, DEPRESSION, ENDOMETRIAL ATROPHY, FEELING ABNORMAL, INDUCED LABOUR, MOOD SWINGS, PLACENTA ACCRETA, PREGNANCY WITH CONTRACEPTIVE DEVICE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED AS PREVIOUSLY FROM SUMMONS DATE OF INSERTION AS REPORTED AS 2010, NOW IN CURRENT PFS DATE OF INSERTION WAS REPORTED AS (B)(6) 2013. DISCREPANCY NOTED PER PFS AS : HAVE YOU HAD YOUR ESSURE (OR ANY PART OF THE DEVICE) REMOVED? NO, PLAINTIFF WAS NOT PLANNING FOR REMOVAL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: AS PER PFS:THE IMPLANT WAS IN PLACE. AS PER MR:UNSUCCESSFUL OPACIFICATION OF UTERINE CAVITY TO DETERMINE PATENCY OF THE FALLOPIAN TUBES. THE ESSURE DEVICES WERE EQUALLY POSITIONED WITHIN THE PELVIS LATERAL TO THE OPACIFIED ENDOCERVICAL CANAL SUGGESTING APPROPRIATE PLACEMENT.. QUALITY-SAFETY EVALUATION OF PTC: QUALITY SAFETY EVALUATION OF PTC. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-JUL-2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PLACENTA ACCRETA ('REMOVED CERVIX AND UTERUS BECAUSE MY PLACENTA HAD GROWN INTO MY UTERUS DURING PREGNANCY'), INDUCED LABOUR ('2 WEEKS BED REST; 5 WEEKS HOSPITALIZATION; INDUCED LABOR AT (B)(6) GESTATION AND PERFORMED CESAREAN') AND PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY (WITH COMPLICATIONS)') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822369) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" AND MEDICAL DEVICE MONITORING ERROR "ESSURE AND THERMACHOICE ENDOMETRIAL ABLATION". THE PATIENT'S MEDICAL HISTORY INCLUDED ENLARGED THYROID IN (B)(6) 2016, ENDOMETRIOSIS ON (B)(6) 2013, TENOSYNOVITIS IN 2010, ABORTION INDUCED IN 2007, GRAVIDA II AND PARITY 2 ((B)(6) 2009, (B)(6) 2016). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: WELLBURTIN FROM 2009 TO (B)(6) 2019, APRISO FROM (B)(6) 2017 TO (B)(6) 2019 AND SEASONALE. CONCURRENT CONDITIONS INCLUDED ULCERATIVE COLITIS SINCE (B)(6) 2017, OVERWEIGHT, MENORRHAGIA, DYSMENORRHEA AND UTERINE FIBROID. CONCOMITANT PRODUCTS INCLUDED CEFIXIME (FLEXERIL) SINCE (B)(6) 2017, IBUPROFEN SINCE 2013 AND MESALAZINE (APRISO) SINCE (B)(6) 2017. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2016, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"). IN (B)(6) 2016, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2016, THE PATIENT EXPERIENCED PLACENTA ACCRETA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND INDUCED LABOUR (SERIOUSNESS CRITERIA HOSPITALIZATION AND MEDICALLY SIGNIFICANT), 3 YEARS 9 MONTHS AFTER INSERTION OF ESSURE. IN (B)(6) 2016, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:ANXIETY"), FEELING ABNORMAL ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:BRAIN FOG"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION"), MOOD SWINGS ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:MOOD SWINGS") AND ENDOMETRIAL ATROPHY ("CESAREAN SECTION DUE TO A THIN UTERINE WALL"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL) AND CESAREAN). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PLACENTA ACCRETA, INDUCED LABOUR, PREGNANCY WITH CONTRACEPTIVE DEVICE, ANXIETY, FEELING ABNORMAL, DEPRESSION, MOOD SWINGS, WEIGHT INCREASED, ABDOMINAL DISTENSION, ALOPECIA AND ENDOMETRIAL ATROPHY OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, ANXIETY, DEPRESSION, ENDOMETRIAL ATROPHY, FEELING ABNORMAL, INDUCED LABOUR, MOOD SWINGS, PLACENTA ACCRETA, PREGNANCY WITH CONTRACEPTIVE DEVICE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED AS PREVIOUSLY FROM SUMMONS DATE OF INSERTION AS REPORTED AS 2010, NOW IN CURRENT PFS DATE OF INSERTION WAS REPORTED AS (B)(6) 2013. DISCREPANCY NOTED PER PFS AS : HAVE YOU HAD YOUR ESSURE (OR ANY PART OF THE DEVICE) REMOVED? NO, PLAINTIFF WAS NOT PLANNING FOR REMOVAL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: AS PER PFS:THE IMPLANT WAS IN PLACE. AS PER MR:UNSUCCESSFUL OPACIFICATION OF UTERINE CAVITY TO DETERMINE PATENCY OF THE FALLOPIAN TUBES. THE ESSURE DEVICES WERE EQUALLY POSITIONED WITHIN THE PELVIS LATERAL TO THE OPACIFIED ENDOCERVICAL CANAL SUGGESTING APPROPRIATE PLACEMENT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JUL-2019: PFS AND MR RECEIVED. CASE BECOME VALID. INJURY NOS REPLACED WITH NEW EVENTS. LOT NUMBER WAS ADDED. ADDED EVENT - REMOVED CERVIX AND UTERUS BECAUSE MY PLACENTA HAD GROWN INTO MY UTERUS DURING PREGNANCY, INDUCED LABOR , PREGNANCY (WITH COMPLICATIONS), ANXIETY, BRAIN FOG, DEPRESSION, MOOD SWINGS, WEIGHT GAIN, BLOATING. HAIR LOSS. EVENT ONSET DATE WAS ADDED. MEDICAL HISTORY, HISTORICAL CONDITION, CONCOMITANT CONDITIONS, CONCOMITANT DRUG, LAB DATA WERE ADDED. DATE OF INSERTION WAS UPDATED. REPORTER'S INFORMATION WAS ADDED. PATIENT'S DEMOGRAPHICS WAS ADDED. INCIDENT: WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 586887 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 822369 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Hospitalization| O| R | APRISO| APRISO| FLEXERIL [CEFIXIME]| FLEXERIL [CEFIXIME]| IBUPROFEN| IBUPROFEN| APRISO| FLEXERIL [CEFIXIME]| IBUPROFEN |