ESSURE
Report
- Report Number
- 2951250-2017-01087
- Event Type
- Injury
- Date Received
- March 27, 2017
- Date of Event
- October 11, 2011
- Report Date
- October 17, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION"), FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE(S))") AND ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("ECTOPIC PREGNANCY") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2014, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND PELVIC PAIN ("PELVIC PAIN"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF HER ESSURE BY HYSTERECTOMY IN (B)(6) 2015). ESSURE WAS REMOVED IN (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, MENORRHAGIA, VAGINAL HAEMORRHAGE AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. 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. BASED ON THE AVAILABLE 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 OR LACK OF EFFICACY CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE MEDICAL EVENTS AND LACK OF EFFICACY 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-FEB-2018: PLAINTIFF FACT SHEET RECEIVED :REPORTER, PATIENT DEMOGRAPHIC, ESSURE LOT NUMBER 822365 AND EVENTS (ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), PERFORATION (FALLOPIAN TUBE, PELVIC PAIN) WERE ADDED. 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 DEVICE DISLOCATION ("MIGRATION"), FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE(S))"), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("ECTOPIC PREGNANCY") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA). ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2014, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). 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 SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY IN (B)(6) 2015). ESSURE WAS REMOVED IN (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, MENORRHAGIA AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, MENORRHAGIA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: FIVE COILS WERE NOTED PROTRUDING FROM OSTIUM INTO THE UTERINE CAVITY.ON THE RIGHT FOUR COIL WERE NOTED OSTIUM INTO THE UTERINE CAVITY ON THE LEFT. PATIENT COMPLAINT OF PAIN AND DISCOMFORT. DISCRIPANCY NOTED IN ESSURE INSERTION DATES: (B)(6) 2013 & (B)(6) 2009 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. BASED ON THE AVAILABLE 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 OR LACK OF EFFICACY CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE MEDICAL EVENTS AND LACK OF EFFICACY 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-MAR-2018: PLAINTIFF FACT SHEET RECEIVED. EVENT GENITAL BLEEDING WAS ADDED. PRODUCT, PATIENT & REPORTER INFORMATION 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE"), FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE(S))"), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("ECTOPIC PREGNANCY/PREGNANCY (ECTOPIC)/ PREGNANCY TERMINATION") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2009, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"), 1 DAY AFTER INSERTION OF ESSURE. ON (B)(6) 2011, THE PATIENT WAS FOUND TO HAVE AN ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2014, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY IN (B)(6) 2015). ESSURE WAS REMOVED IN (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, DEPRESSION AND ANXIETY HAD NOT 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 TRIMESTER. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DEVICE DISLOCATION, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, MENORRHAGIA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: FIVE COILS WERE NOTED PROTRUDING FROM OSTIUM INTO THE UTERINE CAVITY. ON THE RIGHT FOUR COIL WERE NOTED OSTIUM INTO THE UTERINE CAVITY ON THE LEFT. PATIENT COMPLAINT OF PAIN AND DISCOMFORT. DISCREPANCY NOTED IN ESSURE INSERTION DATES: (B)(6) 2013 & (B)(6) 2009. DIAGNOSTIC RESULTS: HOME PREGNANCY TEST ON (B)(6) 2011: ECTOPIC PREGNANCY. ON (B)(6) 2013, HYSTEROSALPINGOGRAM WAS DONE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-NOV-2018: PLAINTIFF FACT SHEET RECEIVED. PRODUCT INFORMATION UPDATED. OUTCOME OF EVENTS MENTAL ANGUISH, DEPRESSION, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) WAS UPDATED FROM "UNKNOWN" TO "NOT RECOVERED/RESOLVED¿. 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 DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE"), FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE(S))"), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("ECTOPIC PREGNANCY") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA). ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON 11-NOV-2011, 1 YEAR 11 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2014, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). 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 SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY IN SEP 2015). ESSURE WAS REMOVED IN SEPTEMBER 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION AND ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE HAD NOT RESOLVED AND THE FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, MENORRHAGIA AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, MENORRHAGIA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: FIVE COILS WERE NOTED PROTRUDING FROM OSTIUM INTO THE UTERINE CAVITY.ON THE RIGHT FOUR COIL WERE NOTED OSTIUM INTO THE UTERINE CAVITY ON THE LEFT. PATIENT COMPLAINT OF PAIN AND DISCOMFORT. DISCRIPANCY NOTED IN ESSURE INSERTION DATES: 25FEB2013 & 30-NOV-2009 DIAGNOSTIC RESULTS: HOME PREGNANCY TEST ON 11-NOV-2011: ECTOPIC PREGNANCY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-MAY-2018: PFS WAS RECEIVED: A HOME PREGNANCY TEST PERFORMED ON 11-NOV-2011 SHOWED ECTOPIC PREGNANCY. THE ONSET DATE OF EVENT ECTOPIC PREGNANCY HAS BEEN CHANGED TO 11-NOV-2011. THE PLAINTIFF REPORTED THE INTENSITY OF PELVIC PAIN AS SEVERE. THE PLAINTIFF DID NOT RECOVERED FROM EVENTS MIGRATION OF ESSURE DEVICE AND ECTOPIC PREGNANCY AFTER ESSURE REMOVAL. IT WAS REPORTED THAT SHE EXPERIENCE COMPLICATIONS OF HER UNINTENDED PREGNANCY OR DELIVERY AS ECTOPIC PREGNANCY (UNSPECIFIED). 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.
ROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE"), FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE(S))"), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("ECTOPIC PREGNANCY/PREGNANCY (ECTOPIC)") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA). ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, 1 YEAR 11 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2014, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY IN (B)(6) 2015). ESSURE WAS REMOVED IN SEPTEMBER 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION AND ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE HAD NOT RESOLVED AND THE FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, MENORRHAGIA AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DEVICE DISLOCATION, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, MENORRHAGIA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: FIVE COILS WERE NOTED PROTRUDING FROM OSTIUM INTO THE UTERINE CAVITY.ON THE RIGHT FOUR COIL WERE NOTED OSTIUM INTO THE UTERINE CAVITY ON THE LEFT. PATIENT COMPLAINT OF PAIN AND DISCOMFORT. DISCRIPANCY NOTED IN ESSURE INSERTION DATES: (B)(6) 2013 & (B)(6) -2009 DIAGNOSTIC RESULTS: HOME PREGNANCY TEST ON (B)(6) 2011: ECTOPIC PREGNANCY. ON (B)(6) 2013, HYSTEROSALPINGOGRAM WAS DONE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-JUL-2018: UPDATING QUALITY-SAFETY EVALUATION OF PTC ON 14-AUG-2018: FOLLOW-UP 7 AND 8 PROCESSED TOGETHER. PLAINTIFF FACT SHEET- MENTAL ANGUISH, DEPRESSION WAS ADDED. 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE'), FALLOPIAN TUBE PERFORATION ('PERFORATION (FALLOPIAN TUBE(S))'), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ('ECTOPIC PREGNANCY/PREGNANCY (ECTOPIC)/ PREGNANCY TERMINATION') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA I, MULTIGRAVIDA AND PARITY 4 ((B)(6) 2001, (B)(6) 2007, (B)(6) 2009, (B)(6) 2015.). HOME PREGNANCY TEST ON (B)(6) 2011: ECTOPIC PREGNANCY. ON (B)(6) 2013, HYSTEROSALPINGOGRAM WAS DONE. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6) 2009 TO (B)(6) 2010, NSAIDS FROM (B)(6) 2009 TO (B)(6) 2015 AND PARACETAMOL (ACETAMINOPHEN) SINCE 2009. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2010, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"), 2 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2011, THE PATIENT WAS FOUND TO HAVE AN ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2014, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY IN (B)(6) 2015). ESSURE WAS REMOVED IN (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, DEPRESSION AND ANXIETY HAD NOT RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 5, PARA 4. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DEVICE DISLOCATION, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, MENORRHAGIA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: FIVE COILS WERE NOTED PROTRUDING FROM OSTIUM INTO THE UTERINE CAVITY. ON THE RIGHT FOUR COIL WERE NOTED OSTIUM INTO THE UTERINE CAVITY ON THE LEFT. PATIENT COMPLAINT OF PAIN AND DISCOMFORT. DISCREPANCY NOTED IN ESSURE INSERTION DATES: (B)(6) 2013 & (B)(6) 2009. ESSURE DID NOT CAUSED BIRTH DEFECTS. LOT NUMBER: 822365, MANUFACTURING DATE: 2011/01, EXPIRATION DATE: 2014/01. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-SEP-2019: QUALITY-SAFETY EVALUATION OF PTC. (PRODUCT TECHNICAL COMPLAINT). 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.
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. BASED ON THE AVAILABLE 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 OR LACK OF EFFICACY CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE MEDICAL EVENTS AND LACK OF EFFICACY 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-MAR-2017: QUALITY-SAFETY EVALUATION OF PTC. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REPORT IS UNDER LITIGATION AND REFERS TO A FEMALE CONSUMER WHO HAD ESSURE INSERTED AND EXPERIENCED AN ECTOPIC PREGNANCY AND MIGRATION (DEVICE DISLOCATION). PLAINTIFF UNDERWENT ESSURE REMOVAL BY HYSTERECTOMY MORE THAN FIVE YEARS AFTER INSERTION. DEVICE DISLOCATION AND ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ARE ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. PREGNANCIES HAVE BEEN REPORTED AMONG WOMEN WITH ESSURE MICRO-INSERTS IN PLACE. WHEN A 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 ESSURE IN PLACE. THE EXACT DATE AND MECHANISM OF DISLOCATION AND THE ONSET DATE OF BOTH ECTOPIC PREGNANCY AND DEVICE DISLOCATION ARE NOT KNOWN. HOWEVER, CONSIDERING THE INFORMATION PROVIDED FOR THIS CASE, A CAUSAL RELATIONSHIP BETWEEN THE EVENTS AND ESSURE CAN FORMALLY NOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT, DUE TO THE SERIOUS INJURIES RELATED TO ESSURE. 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 OR LACK OF EFFICACY CANNOT BE TOTALLY EXCLUDED. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION") AND ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("ECTOPIC PREGNANCY") IN A FEMALE PATIENT WHO RECEIVED ESSURE FOR CONTRACEPTION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2009, THE PATIENT STARTED ESSURE. THE PATIENT'S LAST MENSTRUAL PERIOD WAS ON AN UNKNOWN DATE AND ESTIMATED DATE OF DELIVERY WAS ON AN UNKNOWN DATE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED) AND ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF HER ESSURE BY HYSTERECTOMY IN (B)(6) 2015). ESSURE WAS WITHDRAWN. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION AND ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION AND ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REPORT IS UNDER LITIGATION AND REFERS TO A FEMALE CONSUMER WHO HAD ESSURE INSERTED AND EXPERIENCED AN ECTOPIC PREGNANCY AND MIGRATION (DEVICE DISLOCATION). PLAINTIFF UNDERWENT ESSURE REMOVAL BY HYSTERECTOMY MORE THAN FIVE YEARS AFTER INSERTION. DEVICE DISLOCATION AND ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ARE ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. PREGNANCIES HAVE BEEN REPORTED AMONG WOMEN WITH ESSURE MICRO-INSERTS IN PLACE. WHEN A 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 ESSURE IN PLACE. THE EXACT DATE AND MECHANISM OF DISLOCATION AND THE ONSET DATE OF BOTH ECTOPIC PREGNANCY AND DEVICE DISLOCATION ARE NOT KNOWN. HOWEVER, CONSIDERING THE INFORMATION PROVIDED FOR THIS CASE, A CAUSAL RELATIONSHIP BETWEEN THE EVENTS AND ESSURE CAN FORMALLY NOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT, DUE TO THE SERIOUS INJURIES RELATED TO ESSURE. A PRODUCT TECHNICAL ANALYSIS IS EXPECTED. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 218482 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 822365 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| NSAIDS |