ESSURE
Report
- Report Number
- 2951250-2019-05894
- Event Type
- Injury
- Date Received
- September 10, 2019
- Date of Event
- October 1, 2012
- Report Date
- May 4, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, 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: CORNUA OF THE UTERUS') AND DEVICE DISLOCATION ('MIGRATION') 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 "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED OVERWEIGHT, PARITY 4 (TOTAL NUMBER OF LIVE BIRTHS: 4), MULTIGRAVIDA (TOTAL NUMBER OF PREGNANCIES: 7) AND VAGINAL DISCHARGE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO PROVERA, SERTRALINE HCI, MEDROXYPROGESTERONE ACETATE AND CYCLOBENZAPRINE. CONCOMITANT PRODUCTS INCLUDED NSAIDS FOR PAIN AS WELL AS CALCIUM, FOLIC ACID, IRON AND MECLOZINE HYDROCHLORIDE;PYRIDOXINE HYDROCHLORIDE (PNV). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PAIN :PELVIC/ PAIN."), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING(MENORRHAGIA)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2014, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("BIRTH - NO COMPLICATION"), 2 YEARS 2 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT CAESAREAN SECTION ("CAESAREAN SECTION") AND EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)"), ABDOMINAL PAIN ("PAIN :ABDOMINAL"), DEPRESSION ("PSYCH INJURY/ PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH,"). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN), SERTRALINE, SERTRALINE HYDROCHLORIDE (ZOLOFT) AND SURGERY (HYSTERECTOMY (FULL)). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, DEVICE DISLOCATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, CAESAREAN SECTION, DEPRESSION, VAGINAL HAEMORRHAGE, MENORRHAGIA AND ANXIETY OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE, PELVIC PAIN AND ABDOMINAL PAIN HAD RESOLVED AND THE DYSMENORRHOEA WAS RESOLVING. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 7, PARA 4. 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 PAIN, ANXIETY, CAESAREAN SECTION, DEPRESSION, DEVICE DISLOCATION, DEVICE EXPULSION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD RECEIVED TREATMENT FOR EVENT "MIGRATION". DATE OF REMOVAL: (B)(6) 2014. CURRENT WEIGHT 185 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.6 KG/SQM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-JAN-2020: PFS&MR RECEIVED REPORTER INFORMATION WAS ADDED. NEW EVENT ADDED VAGINAL, BLEEDING, MENORRHAGIA, MENTAL ANGUISH, DYSMENORRHEA (CRAMPING), PARTIAL EXPULSION OF DEVICE, CAESAREAN AND OUTCOME ADDED CRAMPING AND PAIN. SEVERITY ADDED PELVIC PAIN AND CONCOMITANT, TREATMENT DRUGS WAS ADDED. MEDICAL HISTORY WAS ADDED. PSYCH INJURY EVENT UPDATED DEPRESSION. 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 DEVICE EXPULSION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: CORNUA OF THE UTERUS') AND DEVICE DISLOCATION ('MIGRATION') 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 "DEVICE INEFFECTIVE" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED OVERWEIGHT, PARITY 4 (TOTAL NUMBER OF LIVE BIRTHS: 4), MULTIGRAVIDA (TOTAL NUMBER OF PREGNANCIES: 7) AND VAGINAL DISCHARGE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO PROVERA, SERTRALINE HCI, MEDROXYPROGESTERONE ACETATE AND CYCLOBENZAPRINE. CONCOMITANT PRODUCTS INCLUDED NSAIDS FOR PAIN AS WELL AS CALCIUM, FOLIC ACID, IRON AND MECLOZINE HYDROCHLORIDE;PYRIDOXINE HYDROCHLORIDE (PNV). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PAIN :PELVIC/ PAIN."), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING(MENORRHAGIA)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2014, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("BIRTH - NO COMPLICATION"), 2 YEARS 2 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT CAESAREAN SECTION ("CAESAREAN SECTION") AND EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)"), ABDOMINAL PAIN ("PAIN :ABDOMINAL"), DEPRESSION ("PSYCH INJURY/ PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH,"). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN), SERTRALINE, SERTRALINE HYDROCHLORIDE (ZOLOFT) AND SURGERY (HYSTERECTOMY (FULL)). ESSURE WAS REMOVED ON (B)(6) 2014 AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, DEVICE DISLOCATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, CAESAREAN SECTION, DEPRESSION, VAGINAL HAEMORRHAGE, MENORRHAGIA AND ANXIETY OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE, PELVIC PAIN AND ABDOMINAL PAIN HAD RESOLVED AND THE DYSMENORRHOEA WAS RESOLVING. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 7, PARA 4. 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 PAIN, ANXIETY, CAESAREAN SECTION, DEPRESSION, DEVICE DISLOCATION, DEVICE EXPULSION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD RECEIVED TREATMENT FOR EVENT "MIGRATION". DATE OF REMOVAL: (B)(6) 2014,(B)(6) 2014. CURRENT WEIGHT 185 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.6 KG/SQM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-APR-2020: PFS RECEIVED: NEW EVENT "PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST" 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 DEVICE DISLOCATION ('MIGRATION'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('BIRTH - NO COMPLICATION') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') IN AN ADULT 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". ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PAIN :PELVIC"), ABDOMINAL PAIN ("PAIN :ABDOMINAL") AND PSYCHOLOGICAL TRAUMA ("PSYCH INJURY") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL)). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PREGNANCY WITH CONTRACEPTIVE DEVICE AND PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, PELVIC PAIN AND ABDOMINAL PAIN HAD RESOLVED. 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 PAIN, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND PSYCHOLOGICAL TRAUMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD RECEIVED TREATMENT FOR EVENT "MIGRATION". QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-SEP-2019: PLAINTIFF FACT SHEET RECEIVED. NEW EVENTS ADDED ¿MIGRATION, GEN. ABNORMAL. BLEED, PREGNANCY: BIRTH - NO COMPLICATION, PAIN: PELVIC, PAIN: ABDOMINAL, PSYCH INJURY AND DEVICE INEFFECTIVE¿. REPORTER, DEMOGRAPHICS; ESSURE INDICATION (AMENDED), ESSURE REMOVAL DATE WERE ADDED. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 772768 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other| R | CALCIUM| CALCIUM| FOLIC ACID| FOLIC ACID| IRON| IRON| NSAIDS| NSAIDS| PNV| PNV |