ESSURE
Report
- Report Number
- 2951250-2017-05872
- Event Type
- Injury
- Date Received
- October 31, 2017
- Date of Event
- July 8, 2014
- Report Date
- September 8, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- 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 DEVICE BREAKAGE ("FRACTURE OF THE DEVICE"), FALLOPIAN TUBE PERFORATION ("PERFORATION OF THE FALLOPIAN TUBE, MIGRATION OF THE DEVICE/PERFORATION OF THE FALLOPIAN TUBE") AND UTERINE PERFORATION ("MALPOSITION OF ESSURE DEVICE-UTERINE WALL / PERFORATION (UTERUS) / MIGRATION OF ESSURE DEVICE- LOCATION OF DEVICE- UTERINE WALL/ PERFORATION UTERINE WALL") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955814) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSION (MENTAL ILLNESSESHISTORY OF DEPRESION.) AND ANXIETY. ESSURE CONFIRMATION TEST(S) :HYSTEROSALPINGOGRAM: DONE ON(B)(6)2012. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: BIRTH CONTROL PILL AND CODEINE. CONCURRENT CONDITIONS INCLUDED VAGINITIS, VULVOVAGINITIS, CORPUS LUTEUM CYST, HEMATOMA, MYALGIA, MYOSITIS AND DYSURIA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) UNTIL 2012 FOR AND AS WELL AS NSAID'S AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2014, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRICPROBLEMS, CONDITION:MENTAL ANGUISH"), 1 YEAR 9 MONTHS AFTER INSERTION OF ESSURE. IN JUNE 2014, THE PATIENT EXPERIENCED MOOD ALTERED ("HORMONAL CHANGES : MOOD CHANGE"). ON (B)(6)2014, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN. THE PATIENT WAS TREATED WITH SERTRALINE AND SURGERY (HYSTEROSCOPY WITH REMOVAL OF FOREIGN BODY, ESSURE COILS BILATERALLY, DILATATION AND CURETTAGE). ESSURE WAS REMOVED ON (B)(6)2014. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, MOOD ALTERED, DEPRESSION, NAUSEA, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, MOOD SWINGS AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, MOOD ALTERED, MOOD SWINGS, NAUSEA, UTERINE PERFORATION AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: FILAMENT MOVED OUTSIDE OF COILS APPROX. 6-8 COILS IDENTIFIED. DISCREPANCY NOTED AS PLAINTIFF CURRENTLY PLANNING FOR ESSURE REMOVAL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6)2012: TOTAL BILATERAL OCCLUSION; IN DECEMBER 2012: RESULTS: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN AND DEVICE BREAKAGE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2018: PFS RECEIVED. ADDED EVENT MOOD SWINGS, MENTAL ANGUISH. UPDATED ONSET DATE OF EVENTS. TREATMENT DRUG, LAB DATA WERE ADDED. ON (B)(6)2018: PFS RECEIVED. LAB DATA , HISTORICAL DRUG WERE ADDED. INCIDENT WE RECEIVED A LOT NUMBER/RETURNED SAMPLE 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION OF THE FALLOPIAN TUBE, MIGRATION OF THE DEVICE/PERFORATION OF THE FALLOPIAN TUBE"), DEVICE BREAKAGE ("FRACTURE OF THE DEVICE") AND UTERINE PERFORATION ("MALPOSITION OF ESSURE DEVICE-UTERINE WALL / PERFORATION (UTERUS) / MIGRATION OF ESSURE DEVICE- LOCATION OF DEVICE- UTERINE WALL/ PERFORATION UTERINE WALL") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955814) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED DEPRESSION (MENTAL ILLNESSES HISTORY OF DEPRESSION.) AND ANXIETY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CODEINE. CONCURRENT CONDITIONS INCLUDED VAGINITIS, VULVOVAGINITIS, CORPUS LUTEUM CYST, HEMATOMA, MYALGIA, MYOSITIS AND DYSURIA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) UNTIL 2012 FOR AND AS WELL AS NSAID'S AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED MOOD ALTERED ("HORMONAL CHANGES : MOOD CHANGE"), DEPRESSION ("DEPRESSION"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND FATIGUE ("FATIGUE"). ON (B)(6) 2014, 1 YEAR 10 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (HYSTEROSCOPY WITH REMOVAL OF FOREIGN BODY, ESSURE COILS BILATERALLY, DILATATION AND CURETTAGE) AND SURGERY (HYSTEROSCOPY WITH REMOVAL OF FOREIGN BODY, ESSURE COILS BILATERALLY, DILATATION AND CURETTAGE). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, UTERINE PERFORATION, MOOD ALTERED, DEPRESSION, NAUSEA, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEPRESSION, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, MOOD ALTERED, NAUSEA, UTERINE PERFORATION AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: FILAMENT MOVED OUTSIDE OF COILS APPROX. 6-8 COILS IDENTIFIED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2012: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN AND DEVICE BREAKAGE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-AUG-2018: PREVIOUSLY REPORTED EVENT "HORMONAL CHANGES" PT CHANGE TO "MOOD ALTERED", CONCOMITANT DRUG ADDED, EVENT ONSET DATE UPDATED 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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION OF THE FALLOPIAN TUBE, MIGRATION OF THE DEVICE/PERFORATION OF THE FALLOPIAN TUBE"), DEVICE BREAKAGE ("FRACTURE OF THE DEVICE") AND UTERINE PERFORATION ("MALPOSITION OF ESSURE DEVICE-UTERINE WALL / PERFORATION (UTERUS) / MIGRATION OF ESSURE DEVICE- LOCATION OF DEVICE- UTERINE WALL/ PERFORATION UTERINE WALL") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955814) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED DEPRESSION (MENTAL ILLNESSES HISTORY OF DEPRESSION.) AND ANXIETY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CODEINE. CONCURRENT CONDITIONS INCLUDED VAGINITIS, VULVOVAGINITIS, CORPUS LUTEUM CYST, HEMATOMA, MYALGIA, MYOSITIS AND DYSURIA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) UNTIL 2012 FOR AND AS WELL AS NSAID'S AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED MOOD ALTERED ("HORMONAL CHANGES : MOOD CHANGE"), DEPRESSION ("DEPRESSION"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND FATIGUE ("FATIGUE"). ON (B)(6) 2014, 1 YEAR 10 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (HYSTEROSCOPY WITH REMOVAL OF FOREIGN BODY, ESSURE COILS BILATERALLY, DILATATION AND CURETTAGE) AND SURGERY (HYSTEROSCOPY WITH REMOVAL OF FOREIGN BODY, ESSURE COILS BILATERALLY, DILATATION AND CURETTAGE). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, UTERINE PERFORATION, MOOD ALTERED, DEPRESSION, NAUSEA, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEPRESSION, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, MOOD ALTERED, NAUSEA, UTERINE PERFORATION AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: FILAMENT MOVED OUTSIDE OF COILS APPROX. 6-8 COILS IDENTIFIED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2012: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN AND DEVICE BREAKAGE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 BREAKAGE ('FRACTURE OF THE DEVICE'), FALLOPIAN TUBE PERFORATION ('PERFORATION OF THE FALLOPIAN TUBE, MIGRATION OF THE DEVICE/PERFORATION OF THE FALLOPIAN TUBE') AND UTERINE PERFORATION ('MALPOSITION OF ESSURE DEVICE-UTERINE WALL / PERFORATION (UTERUS) / MIGRATION OF ESSURE DEVICE- LOCATION OF DEVICE- UTERINE WALL/ PERFORATION UTERINE WALL') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955814) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSION (MENTAL ILLNESSESHISTORY OF DEPRESION.) AND ANXIETY. ESSURE CONFIRMATION TEST(S) :HYSTEROSALPINGOGRAM: DONE ON (B)(6) 2012. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: BIRTH CONTROL PILL AND CODEINE. CONCURRENT CONDITIONS INCLUDED VAGINITIS, VULVOVAGINITIS, CORPUS LUTEUM CYST, HEMATOMA, MYALGIA, MYOSITIS AND DYSURIA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) UNTIL 2012 FOR AND AS WELL AS NSAIDS AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRICPROBLEMS, CONDITION:MENTAL ANGUISH"), 1 YEAR 9 MONTHS AFTER INSERTION OF ESSURE. IN (B)(6) 2014, THE PATIENT EXPERIENCED MOOD ALTERED ("HORMONAL CHANGES : MOOD CHANGE"). ON (B)(6) 2014, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN. THE PATIENT WAS TREATED WITH SERTRALINE AND SURGERY (HYSTEROSCOPY WITH REMOVAL OF FOREIGN BODY, ESSURE COILS BILATERALLY, DILATATION AND CURETTAGE). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, MOOD ALTERED, DEPRESSION, NAUSEA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MOOD SWINGS AND ANXIETY OUTCOME WAS UNKNOWN AND THE VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, MOOD ALTERED, MOOD SWINGS, NAUSEA, UTERINE PERFORATION AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: FILAMENT MOVED OUTSIDE OF COILS APPROX. 6-8 COILS IDENTIFIED. DISCREPANCY NOTED AS PLAINTIFF CURRENTLY PLANNING FOR ESSURE REMOVAL. PATIENT RECEIVED TREATMENT PAIN, BREAKAGE, MIGRATION, PERFORATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION; IN (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED, OUTCOME OF EVENT VAGINAL DISCHARGE WAS UPDATED TO RECOVERED. 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('FRACTURE OF THE DEVICE'), FALLOPIAN TUBE PERFORATION ('PERFORATION OF THE FALLOPIAN TUBE, MIGRATION OF THE DEVICE/PERFORATION OF THE FALLOPIAN TUBE') AND UTERINE PERFORATION ('MALPOSITION OF ESSURE DEVICE-UTERINE WALL / PERFORATION (UTERUS) / MIGRATION OF ESSURE DEVICE- LOCATION OF DEVICE- UTERINE WALL/ PERFORATION UTERINE WALL') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955814) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSION (MENTAL ILLNESSESHISTORY OF DEPRESION.) AND ANXIETY. ESSURE CONFIRMATION TEST(S) :HYSTEROSALPINGOGRAM: DONE ON (B)(6)2012. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: BIRTH CONTROL PILL AND CODEINE. CONCURRENT CONDITIONS INCLUDED VAGINITIS, VULVOVAGINITIS, CORPUS LUTEUM CYST, HEMATOMA, MYALGIA, MYOSITIS AND DYSURIA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) UNTIL 2012 FOR AND AS WELL AS NSAIDS AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRICPROBLEMS, CONDITION:MENTAL ANGUISH"), 1 YEAR 9 MONTHS AFTER INSERTION OF ESSURE. IN (B)(6) 2014, THE PATIENT EXPERIENCED MOOD ALTERED ("HORMONAL CHANGES : MOOD CHANGE"). ON (B)(6) 2014, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN. THE PATIENT WAS TREATED WITH SERTRALINE AND SURGERY (HYSTEROSCOPY WITH REMOVAL OF FOREIGN BODY, ESSURE COILS BILATERALLY, DILATATION AND CURETTAGE). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, MOOD ALTERED, DEPRESSION, NAUSEA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MOOD SWINGS AND ANXIETY OUTCOME WAS UNKNOWN AND THE VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, MOOD ALTERED, MOOD SWINGS, NAUSEA, UTERINE PERFORATION AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: FILAMENT MOVED OUTSIDE OF COILS APPROX. 6-8 COILS IDENTIFIED. DISCREPANCY NOTED AS PLAINTIFF CURRENTLY PLANNING FOR ESSURE REMOVAL. PATIENT RECEIVED TREATMENT PAIN, BREAKAGE, MIGRATION, PERFORATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2020: TOTAL BILATERAL OCCLUSION; IN (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-SEP-2020: QUALITY SAFETY EVALUATION OF PTC 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('FRACTURE OF THE DEVICE'), FALLOPIAN TUBE PERFORATION ('PERFORATION OF THE FALLOPIAN TUBE, MIGRATION OF THE DEVICE/PERFORATION OF THE FALLOPIAN TUBE') AND UTERINE PERFORATION ('MALPOSITION OF ESSURE DEVICE-UTERINE WALL / PERFORATION (UTERUS) / MIGRATION OF ESSURE DEVICE- LOCATION OF DEVICE- UTERINE WALL/ PERFORATION UTERINE WALL') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955814) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSION (MENTAL ILLNESSES HISTORY OF DEPRESSION.) AND ANXIETY. ESSURE CONFIRMATION TEST(S) :HYSTEROSALPINGOGRAM: DONE ON (B)(6) 2012. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: BIRTH CONTROL PILL AND CODEINE. CONCURRENT CONDITIONS INCLUDED VAGINITIS, VULVOVAGINITIS, CORPUS LUTEUM CYST, HEMATOMA, MYALGIA, MYOSITIS AND DYSURIA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) UNTIL 2012 FOR AND AS WELL AS NSAIDS AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS, CONDITION:MENTAL ANGUISH"), 1 YEAR 9 MONTHS AFTER INSERTION OF ESSURE. IN (B)(6) 2014, THE PATIENT EXPERIENCED MOOD ALTERED ("HORMONAL CHANGES : MOOD CHANGE"). ON (B)(6) 2014, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN. THE PATIENT WAS TREATED WITH SERTRALINE AND SURGERY (HYSTEROSCOPY WITH REMOVAL OF FOREIGN BODY, ESSURE COILS BILATERALLY, DILATATION AND CURETTAGE). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, MOOD ALTERED, DEPRESSION, NAUSEA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MOOD SWINGS AND ANXIETY OUTCOME WAS UNKNOWN AND THE VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, MOOD ALTERED, MOOD SWINGS, NAUSEA, UTERINE PERFORATION AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: FILAMENT MOVED OUTSIDE OF COILS APPROX. 6-8 COILS IDENTIFIED. DISCREPANCY NOTED AS PLAINTIFF CURRENTLY PLANNING FOR ESSURE REMOVAL. PATIENT RECEIVED TREATMENT PAIN, BREAKAGE, MIGRATION, PERFORATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION; IN (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED, OUTCOME OF EVENT VAGINAL DISCHARGE WAS UPDATED TO RECOVERED. 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION OF THE FALLOPIAN TUBE, MIGRATION OF THE DEVICE/PERFORATION OF THE FALLOPIAN TUBE"), DEVICE EXPULSION ("MALPOSITION OF ESSURE DEVICE-UTERINE WALL/PERFORATION (UTERUS)"), DEVICE BREAKAGE ("FRACTURE OF THE DEVICE") AND UTERINE PERFORATION ("MALPOSITION OF ESSURE DEVICE-UTERINE WALL / PERFORATION (UTERUS)") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955814) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED DEPRESSION (MENTAL ILLNESSES HISTORY OF DEPRESSION.) AND ANXIETY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CODEINE. CONCURRENT CONDITIONS INCLUDED VAGINITIS, VULVOVAGINITIS, CORPUS LUTEUM CYST, HEMATOMA, MYALGIA, MYOSITIS AND DYSURIA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) UNTIL 2012 FOR AND. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), DEPRESSION ("DEPRESSION"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND FATIGUE ("FATIGUE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTEROSCOPY WITH REMOVAL OF FOREIGN BODY, ESSURE COILS BILATERALLY, DILATATION AND CURETTAGE). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE EXPULSION, DEVICE BREAKAGE, UTERINE PERFORATION, HORMONE LEVEL ABNORMAL, DEPRESSION, NAUSEA, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEPRESSION, DEVICE BREAKAGE, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, HORMONE LEVEL ABNORMAL, NAUSEA, UTERINE PERFORATION AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: FILAMENT MOVED OUTSIDE OF COILS APPROX. 6-8 COILS IDENTIFIED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2012: CONFIRMED THAT ESSURE WAS SUCCESSFULLY OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN AND DEVICE BREAKAGE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-FEB-2018: PLAINTIFF FACT SHEET AND MEDICAL RECORD WAS RECEIVED EVENTS ADDED FROM PFS- HORMONAL CHANGES,PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS-DEPRESSION,NAUSEA,DYSMENORRHEA (CRAMPING), PERFORATION (UTERUS) UTERINE WALL. MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERINE WALL, MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: UTERINE WALL, PAIN THESE EVENTS CLUBBED TO PREVIOUS EVENTS. CONCOMITANT DISEASE, HISTORICAL CONDITION, LOT NO 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 FALLOPIAN TUBE PERFORATION ("PERFORATION OF THE FALLOPIAN TUBE, MIGRATION OF THE DEVICE"), DEVICE DISLOCATION ("PERFORATION OF THE FALLOPIAN TUBE, MIGRATION OF THE DEVICE") AND DEVICE BREAKAGE ("FRACTURE OF THE DEVICE") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH PELVIC PAIN AND DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE DISLOCATION AND DEVICE BREAKAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE BREAKAGE, DEVICE DISLOCATION AND FALLOPIAN TUBE PERFORATION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2012: CONFIRMED THAT ESSURE WAS SUCCESSFULLY OCCLUDED. COMPANY CAUSALITY COMMENT. INCIDENT. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 770485 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 955814 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| NSAID'S| NSAID'S| NSAID'S| NSAIDS| NSAIDS| NSAIDS |