ESSURE
Report
- Report Number
- 2951250-2017-03766
- Event Type
- Injury
- Date Received
- September 18, 2017
- Date of Event
- April 1, 2014
- Report Date
- May 18, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION AND MIGRATION /PERFORATION (FALLOPIAN TUBE(S)/ FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S)"), DEVICE BREAKAGE ("THE LEFT-SIDED THE COIL HAS FRACTURED"), DEVICE DISLOCATION ("PERFORATION AND MIGRATION/MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: PERITONEUM / : LEFT COLON"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") AND SEIZURE ("SEIZURES") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) SINCE 2010 TO (B)(6) 2014, SERTRALINE (ZOLOFT), SUMATRIPTAN SINCE (B)(6) 2016 AND TOPIRAMATE FROM (B)(6) 2016. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED PELVIC PAIN ("SEVERE PELVIC PAIN"), CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: BLADDER"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2016, THE PATIENT EXPERIENCED SEIZURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND FUNGAL INFECTION ("YEAST INFECTION"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPY AND BILATERAL FILSHIE CLIP PLACEMENT DUE TO COMPLICATIONS FROM THE ESSURE DEVICE), SURGERY (LAPAROSCOPY AND BILATERAL FILSHIE CLIP PLACEMENT DUE TO COMPLICATIONS FROM THE ESSURE DEVICE) AND SURGERY (LAPAROSCOPY AND BILATERAL FILSHIE CLIP PLACEMENT DUE TO COMPLICATIONS FROM THE ESSURE DEVICE). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, SEIZURE, PELVIC PAIN, CYSTITIS, FUNGAL INFECTION, MIGRAINE, HEADACHE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED CYSTITIS, DEVICE BREAKAGE, DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, FUNGAL INFECTION, GENITAL HAEMORRHAGE, HEADACHE, MIGRAINE, PELVIC PAIN, SEIZURE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28.9 KG/SQM. HYSTEROSALPINGOGRAM: ON (B)(6) 014: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-APR-2018: PFS AND MEDICAL RECORD RECEIVED- REPORTER INFORMATION, PATIENT DETAILS, OTHER RELEVANT HISTORY, PRODUCT INFORMATION, CONCOMITANT DRUGS, EVENTS- PERFORATION (FALLOPIAN TUBE(S) CLUBBED WITH PERFORATION NOS, THE LEFT-SIDED THE COIL HAS FRACTURED, ABNORMAL BLEEDING (GENERAL), BLADDER/ URINARY TRACT/VAGINAL) TYPE: BLADDER, YEAST INFECTION, MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT COLON, MIGRAINES, HEADACHES, SEIZURES, WEIGHT GAIN. THE EVENT¿ MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: PERITONEUM¿ CLUBBED WITH ¿PERFORATION AND MIGRATION¿. 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION AND MIGRATION /PERFORATION (FALLOPIAN TUBE(S)/ FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S)/ESSURE DEVICE LOCATION OF DEVICE: PERITONEUM"), DEVICE BREAKAGE ("THE LEFT-SIDED THE COIL HAS FRACTURED/DEVICE BREAKAGE"), DEVICE DISLOCATION ("PERFORATION AND MIGRATION/MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: PERITONEUM / : LEFT COLON"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") AND SEIZURE ("SEIZURES") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED HEADACHE (NOT RECOVERED PRIOR TO ESSURE) AND MIGRAINE (NOT RECOVERED PRIOR TO ESSURE). CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) SINCE 2010 TO APRIL 2014, SERTRALINE (ZOLOFT), SUMATRIPTAN SINCE OCTOBER 2016 AND TOPIRAMATE FROM SEPTEMBER 2016 TO DECEMBER 2016. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN APRIL 2014, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2014, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("SEVERE PELVIC PAIN"), CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: BLADDER"), MIGRAINE ("MIGRAINES/MIGRAINE/HEADACHE"), HEADACHE ("HEADACHES/MIGRAINE/HEADACHE"), WEIGHT INCREASED ("WEIGHT GAIN/WEIGHT GAIN/LOSS: GAIN"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY/AND MENTAL ANGUISH"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). IN SEPTEMBER 2016, THE PATIENT EXPERIENCED SEIZURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND VULVOVAGINAL MYCOTIC INFECTION ("YEAST INFECTION"). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN), NSAID'S, SURGERY (LAPAROSCOPY AND BILATERAL FILSHIE CLIP PLACEMENT DUE TO COMPLICATIONS FROM THE ESSURE DEVICE), SURGERY (LAPAROSCOPY AND BILATERAL FILSHIE CLIP PLACEMENT DUE TO COMPLICATIONS FROM THE ESSURE DEVICE) AND SURGERY (LAPAROSCOPY AND BILATERAL FILSHIE CLIP PLACEMENT DUE TO COMPLICATIONS FROM THE ESSURE DEVICE). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, SEIZURE, PELVIC PAIN, CYSTITIS, VULVOVAGINAL MYCOTIC INFECTION, MIGRAINE, HEADACHE, WEIGHT INCREASED, ANXIETY, DEPRESSION, VAGINAL HAEMORRHAGE AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, CYSTITIS, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, SEIZURE, VAGINAL HAEMORRHAGE, VULVOVAGINAL MYCOTIC INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TUBAL LIGATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28.9 KG/SQM. HYSTEROSALPINGOGRAM - ON 27-JUN-2014: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-AUG-2018: QUALITY-SAFETY EVALUATION OF PTC. 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION AND MIGRATION /PERFORATION (FALLOPIAN TUBE(S)/ FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S)/ESSURE DEVICE LOCATION OF DEVICE: PERITONEUM"), DEVICE BREAKAGE ("THE LEFT-SIDED THE COIL HAS FRACTURED/DEVICE BREAKAGE"), DEVICE DISLOCATION ("PERFORATION AND MIGRATION/MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: PERITONEUM / : LEFT COLON"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") AND SEIZURE ("SEIZURES") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED HEADACHE (NOT RECOVERED PRIOR TO ESSURE) AND MIGRAINE (NOT RECOVERED PRIOR TO ESSURE). CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) SINCE 2010 TO APRIL 2014, SERTRALINE (ZOLOFT), SUMATRIPTAN SINCE OCTOBER 2016 AND TOPIRAMATE FROM (B)(6) 2016. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2014, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("SEVERE PELVIC PAIN"), CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: BLADDER"), MIGRAINE ("MIGRAINES/MIGRAINE/HEADACHE"), HEADACHE ("HEADACHES/MIGRAINE/HEADACHE"), WEIGHT INCREASED ("WEIGHT GAIN/WEIGHT GAIN/LOSS: GAIN"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY/AND MENTAL ANGUISH"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). IN (B)(6) 2016, THE PATIENT EXPERIENCED SEIZURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND VULVOVAGINAL MYCOTIC INFECTION ("YEAST INFECTION"). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN), NSAID'S, SURGERY (LAPAROSCOPY AND BILATERAL FILSHIE CLIP PLACEMENT DUE TO COMPLICATIONS FROM THE ESSURE DEVICE), SURGERY (LAPAROSCOPY AND BILATERAL FILSHIE CLIP PLACEMENT DUE TO COMPLICATIONS FROM THE ESSURE DEVICE) AND SURGERY (LAPAROSCOPY AND BILATERAL FILSHIE CLIP PLACEMENT DUE TO COMPLICATIONS FROM THE ESSURE DEVICE). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, SEIZURE, PELVIC PAIN, CYSTITIS, VULVOVAGINAL MYCOTIC INFECTION, MIGRAINE, HEADACHE, WEIGHT INCREASED, ANXIETY, DEPRESSION, VAGINAL HAEMORRHAGE AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, CYSTITIS, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, SEIZURE, VAGINAL HAEMORRHAGE, VULVOVAGINAL MYCOTIC INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TUBAL LIGATION DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED. EVENTS PER PFS: MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: PERITONEUM (CLUBBED WITH PREVIOUS EVENT), ANXIETY, DEPRESSION, VAGINAL BLEEDING, MENORRHAGIA WERE ADDED. PATIENT'S MEDICAL HISTORY WAS ADDED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION AND MIGRATION /PERFORATION (FALLOPIAN TUBE(S)/ FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S)/ESSURE DEVICE LOCATION OF DEVICE: PERITONEUM'), DEVICE BREAKAGE ('THE LEFT-SIDED THE COIL HAS FRACTURED/DEVICE BREAKAGE'), DEVICE DISLOCATION ('PERFORATION AND MIGRATION/MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: PERITONEUM / : LEFT COLON') AND EMBEDDED DEVICE ('AN ADDITIONAL COIL WIRE PRESENT EMBEDDED WITHIN THE LEFT ADNEXAL AREA') IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HEADACHE (NOT RECOVERED PRIOR TO ESSURE), MIGRAINE (NOT RECOVERED PRIOR TO ESSURE), SCOLIOSIS, MENSTRUATION IRREGULAR, URINARY TRACT INFECTION, MIGRAINE WITH AURA, STRESS, BRADYCARDIA, SEIZURE, CERVICITIS CYSTIC, PARATUBAL CYST AND ADENOMYOSIS. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) SINCE 2010 TO (B)(6) 2014, SERTRALINE HYDROCHLORIDE (ZOLOFT), SUMATRIPTAN SINCE (B)(6) 2016 AND TOPIRAMATE FROM (B)(6) 2016. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/MIGRAINE/HEADACHE") AND HEADACHE ("HEADACHES/MIGRAINE/HEADACHE"), 5 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2014, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("SEVERE PELVIC PAIN"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY/AND MENTAL ANGUISH") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"). ON (B)(6) 2014, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/WEIGHT GAIN/LOSS: GAIN") AND EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). IN 2014, THE PATIENT EXPERIENCED CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: BLADDER"). ON (B)(6) 2014, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2016, THE PATIENT EXPERIENCED SEIZURE ("SEIZURES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") AND VULVOVAGINAL MYCOTIC INFECTION ("YEAST INFECTION"). THE PATIENT WAS TREATED WITH NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND SURGERY (LAPAROSCOPY AND BILATERAL FILSHIE CLIP PLACEMENT DUE TO COMPLICATIONS FROM THE ESSURE DEVICE). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, DEVICE DISLOCATION, EMBEDDED DEVICE, GENITAL HAEMORRHAGE, SEIZURE, PELVIC PAIN, CYSTITIS, VULVOVAGINAL MYCOTIC INFECTION, MIGRAINE, HEADACHE, WEIGHT INCREASED, ANXIETY, DEPRESSION, VAGINAL HAEMORRHAGE AND HEAVY MENSTRUAL BLEEDING OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, CYSTITIS, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, EMBEDDED DEVICE, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, HEADACHE, HEAVY MENSTRUAL BLEEDING, MIGRAINE, PELVIC PAIN, SEIZURE, VAGINAL HAEMORRHAGE, VULVOVAGINAL MYCOTIC INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TUBAL LIGATION. PATIENT RECEIVED TREATMENT FOR PAIN, BLEEDING, PERFORATION, MIGRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: RESULTS: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-MAY-2021: QUALITY SAFETY EVALUATION OF PTC. 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 FALLOPIAN TUBE PERFORATION ('PERFORATION AND MIGRATION /PERFORATION (FALLOPIAN TUBE(S)/ FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S)/ESSURE DEVICE LOCATION OF DEVICE: PERITONEUM'), DEVICE BREAKAGE ('THE LEFT-SIDED THE COIL HAS FRACTURED/DEVICE BREAKAGE'), DEVICE DISLOCATION ('PERFORATION AND MIGRATION/MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: PERITONEUM / : LEFT COLON') AND EMBEDDED DEVICE ('AN ADDITIONAL COIL WIRE PRESENT EMBEDDED WITHIN THE LEFT ADNEXAL AREA') IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HEADACHE (NOT RECOVERED PRIOR TO ESSURE), MIGRAINE (NOT RECOVERED PRIOR TO ESSURE), SCOLIOSIS, MENSTRUATION IRREGULAR, URINARY TRACT INFECTION, MIGRAINE WITH AURA, STRESS, BRADYCARDIA, SEIZURE, CERVICITIS CYSTIC, PARATUBAL CYST AND ADENOMYOSIS. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) SINCE 2010 TO (B)(6) 2014, SERTRALINE HYDROCHLORIDE (ZOLOFT), SUMATRIPTAN SINCE (B)(6) 2016 AND TOPIRAMATE FROM (B)(6) 2016 TO (B)(6) 2016. ON (B)(6)2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2014, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/MIGRAINE/HEADACHE") AND HEADACHE ("HEADACHES/MIGRAINE/HEADACHE"), 5 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2014, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("SEVERE PELVIC PAIN"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY/AND MENTAL ANGUISH") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"). ON (B)(6)2014, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/WEIGHT GAIN/LOSS: GAIN") AND EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). IN 2014, THE PATIENT EXPERIENCED CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: BLADDER"). ON (B)(6)2014, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6)2016, THE PATIENT EXPERIENCED SEIZURE ("SEIZURES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") AND VULVOVAGINAL MYCOTIC INFECTION ("YEAST INFECTION"). THE PATIENT WAS TREATED WITH NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND SURGERY (LAPAROSCOPY AND BILATERAL FILSHIE CLIP PLACEMENT DUE TO COMPLICATIONS FROM THE ESSURE DEVICE). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, DEVICE DISLOCATION, EMBEDDED DEVICE, GENITAL HAEMORRHAGE, SEIZURE, PELVIC PAIN, CYSTITIS, VULVOVAGINAL MYCOTIC INFECTION, MIGRAINE, HEADACHE, WEIGHT INCREASED, ANXIETY, DEPRESSION, VAGINAL HAEMORRHAGE AND HEAVY MENSTRUAL BLEEDING OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, CYSTITIS, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, EMBEDDED DEVICE, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, HEADACHE, HEAVY MENSTRUAL BLEEDING, MIGRAINE, PELVIC PAIN, SEIZURE, VAGINAL HAEMORRHAGE, VULVOVAGINAL MYCOTIC INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TUBAL LIGATION. PATIENT RECEIVED TREATMENT FOR PAIN, BLEEDING, PERFORATION, MIGRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)2014: RESULTS: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-APR-2021: MR RECEIVED. REPORTER INFORMATION, PATIENT MEDICAL HISTORY, EVENT: ADDITIONAL COIL WIRE PRESENT EMBEDDED WITHIN THE LEFT ADNEXAL AREA 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 PERFORATION ("PERFORATION AND MIGRATION") AND DEVICE DISLOCATION ("PERFORATION AND MIGRATION") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PELVIC PAIN ("SEVERE PELVIC PAIN"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPY AND BILATERAL FILSHIE CLIP PLACEMENT DUE TO COMPLICATIONS FROM THE ESSURE DEVICE) AND SURGERY (LAPAROSCOPY AND BILATERAL FILSHIE CLIP PLACEMENT DUE TO COMPLICATIONS FROM THE ESSURE DEVICE). AT THE TIME OF THE REPORT, THE PERFORATION, DEVICE DISLOCATION AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, PELVIC PAIN AND PERFORATION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6)2014: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-SEP-2017: CORRECTION FOLLOWING COMPANY INTERNAL CODING REVIEW: THE EVENT PERFORATION AND MIGRATION WAS SPLIT AND RECODED TO MEDDRA LLT PERFORATION AND MEDDRA LLT DEVICE MIGRATION. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PERFORATION ("PERFORATION AND MIGRATION") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PELVIC PAIN ("SEVERE PELVIC PAIN"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPY AND BILATERAL FILSHIE CLIP PLACEMENT DUE TO COMPLICATIONS FROM THE ESSURE DEVICE). AT THE TIME OF THE REPORT, THE PERFORATION AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN AND PERFORATION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. 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 |
|---|---|---|---|---|---|---|---|
| 653883 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Other| R | MIRENA| MIRENA| MIRENA| MIRENA| MIRENA| SUMATRIPTAN| SUMATRIPTAN| SUMATRIPTAN| SUMATRIPTAN| SUMATRIPTAN| TOPIRAMATE| TOPIRAMATE| TOPIRAMATE| TOPIRAMATE| TOPIRAMATE| ZOLOFT| ZOLOFT| ZOLOFT| ZOLOFT| ZOLOFT |