ESSURE
Report
- Report Number
- 2951250-2021-03619
- Event Type
- Injury
- Date Received
- December 15, 2021
- Date of Event
- November 1, 2011
- Report Date
- February 20, 2023
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM, REFERENCE NUMBER: (B)(4)) ON 13-DEC-2021. THE MOST RECENT INFORMATION WAS RECEIVED ON 20-JAN-2022. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN'), DEVICE BREAKAGE ('ESSURE INSERTS PRESENT BILATERALLY AFTER LEFT ADNEXECTOMY (B)(6), FRAGMENT PRESENT AFTER LEFT SIDE AFTER SALPINGECTOMY, HYSTERECOMY (B)(6) / PIECE OF IMPLANT STILL SOMEWHERE IN HER BODY'), DEVICE EXPULSION ('RIGHT ESSURE INSERT MIGRATED INTO UTERINE MUSCLE'), EMBEDDED DEVICE ('RIGHT ESSURE INSERT MIGRATED INTO UTERINE MUSCLE') AND DEVICE DISLOCATION ('ESSURE FRAGMENT LOCALIZED IN THE ABDOMEN, IN PELVIS') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810874) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "SHE GOT TOTALLY PREGNANT DESPITE THE ESSURE IMPLANTS" IN 2011. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("SHE GOT TOTALLY PREGNANT DESPITE THE ESSURE IMPLANTS") AND EXPERIENCED AMNESIA ("MEMORY LOSS") AND TINNITUS ("TINNITUS"). IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), DIZZINESS ("DIZZINESS"), FATIGUE ("FATIGUE"), BACK PAIN ("CHRONIC LUMBAR PAIN"), INTERVERTEBRAL DISC PROTRUSION ("HERNIATED DISC"), ARTHRALGIA ("JOINT PAIN / JOINT PAIN OVER HER BODY"), THE FIRST EPISODE OF FIBROMYALGIA ("FIBROMYALGIA"), PYREXIA ("FEVER"), NAUSEA ("NAUSEA") AND VOMITING ("VOMITING") AND UNDERWENT JOINT INJECTION ("INFILTRATION OF POSTERIOR JOINTS"). IN 2012, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"), SUICIDE ATTEMPT ("ATTEMPTED SUICIDE") AND THE SECOND EPISODE OF FIBROMYALGIA ("FIBROMYALGIA"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION INTERVENTION REQUIRED) AND THE FIRST EPISODE OF COMPLICATION OF DEVICE REMOVAL ("ESSURE INSERTS PRESENT BILATERALLY AFTER LEFT ADNEXECTOMY"), 2 YEARS 7 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2017, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY FOUND IN TEST"). ON (B)(6) 2017, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERION INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERION INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED) AND THE SECOND EPISODE OF COMPLICATION OF DEVICE REMOVAL ("PRESENCE OF ESSURE FRAGMENT IN THE LEFT SIDE AREA AFTER LEFT SALPINGECTOMY, HYSTEROSCOPY, HYSTERECTOMY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("HAEMORRHAGE") AND ENDOMETRIOSIS ("ENDOMETRIOSIS"). THE PATIENT WAS TREATED WITH MORPHINE AND SURGERY ((B)(6) 2013: LEFT ADNEXECTOMY, TUBAL LIGAT. (B)(6) 2017: LEFT SALPINGECT, HYSTERECT. (B)(6) 2017: TOTAL HYSTERECT AND HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE BREAKAGE, DEVICE DISLOCATION, THE LAST EPISODE OF COMPLICATION OF DEVICE REMOVAL, DIZZINESS AND ALLERGY TO METALS HAD NOT RESOLVED, THE DEVICE EXPULSION, EMBEDDED DEVICE AND PREGNANCY WITH CONTRACEPTIVE DEVICE HAD RESOLVED AND THE FATIGUE, BACK PAIN, INTERVERTEBRAL DISC PROTRUSION, ARTHRALGIA, JOINT INJECTION, PYREXIA, NAUSEA, VOMITING, AMNESIA, TINNITUS, GENITAL HAEMORRHAGE, DEPRESSION, SUICIDE ATTEMPT, THE LAST EPISODE OF FIBROMYALGIA AND ENDOMETRIOSIS 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 TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED ALLERGY TO METALS, AMNESIA, ARTHRALGIA, BACK PAIN, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DEVICE EXPULSION, DIZZINESS, EMBEDDED DEVICE, ENDOMETRIOSIS, FATIGUE, GENITAL HAEMORRHAGE, INTERVERTEBRAL DISC PROTRUSION, JOINT INJECTION, NAUSEA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, PYREXIA, SUICIDE ATTEMPT, TINNITUS, VOMITING, THE FIRST EPISODE OF COMPLICATION OF DEVICE REMOVAL, THE FIRST EPISODE OF FIBROMYALGIA, THE SECOND EPISODE OF COMPLICATION OF DEVICE REMOVAL AND THE SECOND EPISODE OF FIBROMYALGIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: IN 2011, SHE WENT TO SEE HER GYNECOLOGIST, SHE WAS 37 YEARS OLD, AND NO LONGER ABLE TO TAKE THE PILL OR USE COILS. HE RECOMMENDED THESE IMPLANTS, AND TOLD HER THAT THERE WAS NOTHING TO WORRY ABOUT. I DECIDED TO HAVE THE IMPLANTS REMOVED, BUT THINGS WENT WRONG. THEY TOOK OUT MY UTERUS, ONE OVARY, AND DISCOVERED THAT I HAD ENDOMETRIOSIS, AND A PIECE OF THE IMPLANT IS STILL SOMEWHERE IN MY BODY. DESPITE LEFT ADNEXECTOMY (REMOVAL OF FALLOPIAN TUBE AND OVARY/HYSTEROSALPINGO-OOPHORECTOMY) AND TUBAL LIGATION FOR SERIOUS PELVIC PAIN ON (B)(6) 2013, SYMPTOMS PERSISTED. ON (B)(6) 2014, ULTRASOUND SHOWED THAT ESSURE WAS STILL PRESENT. ON (B)(6) 2017, THE PATIENT UNDERWENT ESSURE REMOVAL BY SALPINGECTOMY VIA LAPAROSCOPY FOR THE LEFT INSERT. HYSTEROSCOPY FOR THE RIGHT INSERT DUE TO DIFFICULTY REMOVING THE INSERT. PRESENCE OF NEXPLANON WAS DISCLOSED IN THE LEFT TUBAL AREA ADDITIONALLY TO RIGHT ESSURE INSERT ( INCONSISTENT INFORMATION NOTED). THE RIGHT ESSURE INSERT MIGRATED INTO UTERINE MUSCLE. DURING THE HYSTERECTOMY, ADENOMYOSIS AND ENDOMETRIOSIS WERE DISCLOSED. DESPITE THE REMOVAL, THE PATIENT WAS STILL EXPERIENCING PAIN ON RIGHT SIDE. ON (B)(6) 2017, PELVIS CT SCAN SHOWED ESSURE FRAGMENT IN LEFT SIDE AREA. ON (B)(6) 2017, TOTAL HYSTERECTOMY BECAUSE SHE WAS STILL EXPERIENCING VIOLENT PELVIC PAIN. THE REMAINING ESSURE FRAGMENT NOT FOUND FOLLOWING HISTOLOGICAL EXAMINATION OF THE UTERUS. ON (B)(6) 2017, X-RAY SHOWED METALLIC FEATURE IN PELVIS. PATIENT'S SYMPTOMS WERE STILL PERSISTENT. THE ESSURE FRAGMENT LOCALIZED IN THE ABDOMEN HAD NOT BEEN REMOVED DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ALLERGY TEST - ON (B)(6) 2017: NICKEL ALLERGY. COMPUTERISED TOMOGRAM - ON (B)(6) 2015: ESSURE INSERTS STILL PRESENT BILATERALLY; ON (B)(6) 2017: ESSURE INSERTS STILL PRESENT BILATERALLY; ON (B)(6) 2017: PRESENCE OF ESSURE FRAGMENT IN THE LEFT SIDE AREA. HYSTEROSCOPY - ON (B)(6) 2017: RIGHT INSERT DIFFICULT TO REMOVE. PATHOLOGY TEST - ON (B)(6) 2013: EXAMINATION OF TUBE AND OVARY DIDN'T SHOW ANYTHING REMARKABLE; ON (B)(6) 2017: AFTER HYSTERECTOMY: ADENOMYOSIS AND ENDOMETRIOSIS DISCLOSED; ON (B)(6) 2017: AFTER TOTAL HYSTERECTOMY: HISTOLOGY OF UTERUS: REMAINING ESSURE FRAGMENT NOT FOUND. ULTRASOUND PELVIS - ON (B)(6) 2014: ESSURE WAS STILL PRESENT AFTER LEFT ADNEXECTOMY; ON (B)(6) 2015: ESSURE INSERTS STILL PRESENT BILATERALLY; ON (B)(6) 2017: ESSURE INSERTS STILL PRESENT BILATERALLY. X-RAY - ON (B)(6) 2017: PRESENCE OF METALLIC FEATURE IN PELVIS. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. 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 COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-JAN-2022: UPON INTERNAL REVIEW WAS IDENTIFIED THE CASE (B)(4) LEGACY DEVICE REPORT NUMBER 2951250-2022-00026 WAS DUPLICATED, ALL THE INFORMATION WAS TRANSFER TO THIS CASE. 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM, REFERENCE NUMBER: (B)(4)) ON 13-DEC-2021. THE MOST RECENT INFORMATION WAS RECEIVED ON 11-JAN-2022. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN'), DEVICE BREAKAGE ('ESSURE INSERTS PRESENT BILATERALLY AFTER LEFT ADNEXECTOMY DEC-13, FRAGMENT PRESENT AFTER LEFT SIDE AFTER SALPINGECTOMY, HYSTERECOMY MAR-17'), DEVICE EXPULSION ('RIGHT ESSURE INSERT MIGRATED INTO UTERINE MUSCLE'), EMBEDDED DEVICE ('RIGHT ESSURE INSERT MIGRATED INTO UTERINE MUSCLE') AND DEVICE DISLOCATION ('ESSURE FRAGMENT LOCALIZED IN THE ABDOMEN, IN PELVIS') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810874) 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" IN 2011. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("DESPITE ESSURE PREGNANCY") AND EXPERIENCED AMNESIA ("MEMORY LOSS") AND TINNITUS ("TINNITUS"). IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), DIZZINESS ("DIZZINESS"), FATIGUE ("FATIGUE"), BACK PAIN ("CHRONIC LUMBAR PAIN"), INTERVERTEBRAL DISC PROTRUSION ("HERNIATED DISC"), ARTHRALGIA ("JOINT PAIN"), FIBROMYALGIA ("FIBROMYALGIA"), PYREXIA ("FEVER"), NAUSEA ("NAUSEA") AND VOMITING ("VOMITING") AND UNDERWENT JOINT INJECTION ("INFILTRATION OF POSTERIOR JOINTS"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION INTERVENTION REQUIRED) AND THE FIRST EPISODE OF COMPLICATION OF DEVICE REMOVAL ("ESSURE INSERTS PRESENT BILATERALLY AFTER LEFT ADNEXECTOMY"), 2 YEARS 7 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2017, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY FOUND IN TEST"). ON (B)(6) 2017, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERION INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERION INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED) AND THE SECOND EPISODE OF COMPLICATION OF DEVICE REMOVAL ("PRESENCE OF ESSURE FRAGMENT IN THE LEFT SIDE AREA AFTER LEFT SALPINGECTOMY, HYSTEROSCOPY, HYSTERECTOMY"). THE PATIENT WAS TREATED WITH MORPHINE AND SURGERY ((B)(6) 2013: LEFT ADNEXECTOMY, TUBAL LIGAT. (B)(6) 2017: LEFT SALPINGECT, HYSTERECT, (B)(6) 2017:TOTAL HYSTERECT AND HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE BREAKAGE, DEVICE DISLOCATION, THE LAST EPISODE OF COMPLICATION OF DEVICE REMOVAL, DIZZINESS AND ALLERGY TO METALS HAD NOT RESOLVED, THE DEVICE EXPULSION, EMBEDDED DEVICE AND PREGNANCY WITH CONTRACEPTIVE DEVICE HAD RESOLVED AND THE FATIGUE, BACK PAIN, INTERVERTEBRAL DISC PROTRUSION, ARTHRALGIA, JOINT INJECTION, FIBROMYALGIA, PYREXIA, NAUSEA, VOMITING, AMNESIA AND TINNITUS 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 TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED ALLERGY TO METALS, AMNESIA, ARTHRALGIA, BACK PAIN, DEVICE BREAKAGE, DEVICE DISLOCATION, DEVICE EXPULSION, DIZZINESS, EMBEDDED DEVICE, FATIGUE, FIBROMYALGIA, INTERVERTEBRAL DISC PROTRUSION, JOINT INJECTION, NAUSEA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, PYREXIA, TINNITUS, VOMITING, THE FIRST EPISODE OF COMPLICATION OF DEVICE REMOVAL AND THE SECOND EPISODE OF COMPLICATION OF DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DESPITE LEFT ADNEXECTOMY (REMOVAL OF FALLOPIAN TUBE AND OVARY/HYSTEROSALPINGO-OOPHORECTOMY) AND TUBAL LIGATION FOR SERIOUS PELVIC PAIN ON (B)(6) 2013, SYMPTOMS PERSISTED. ON (B)(6) 2014, ULTRASOUND SHOWED THAT ESSURE WAS STILL PRESENT. ON (B)(6) 2017, THE PATIENT UNDERWENT ESSURE REMOVAL BY SALPINGECTOMY VIA LAPAROSCOPY FOR THE LEFT INSERT. HYSTEROSCOPY FOR THE RIGHT INSERT DUE TO DIFFICULTY REMOVING THE INSERT. PRESENCE OF NEXPLANON WAS DISCLOSED IN THE LEFT TUBAL AREA ADDITIONALLY TO RIGHT ESSURE INSERT ( INCONSISTENT INFORMATION NOTED). THE RIGHT ESSURE INSERT MIGRATED INTO UTERINE MUSCLE. DURING THE HYSTERECTOMY, ADENOMYOSIS AND ENDOMETRIOSIS WERE DISCLOSED. DESPITE THE REMOVAL, THE PATIENT WAS STILL EXPERIENCING PAIN ON RIGHT SIDE. ON (B)(6) 2017, PELVIS CT SCAN SHOWED ESSURE FRAGMENT IN LEFT SIDE AREA. ON (B)(6) 2017, TOTAL HYSTERECTOMY BECAUSE SHE WAS STILL EXPERIENCING VIOLENT PELVIC PAIN. THE REMAINING ESSURE FRAGMENT NOT FOUND FOLLOWING HISTOLOGICAL EXAMINATION OF THE UTERUS. ON (B)(6) 2017, X-RAY SHOWED METALLIC FEATURE IN PELVIS. PATIENT¿S SYMPTOMS WERE STILL PERSISTENT. THE ESSURE FRAGMENT LOCALIZED IN THE ABDOMEN HAD NOT BEEN REMOVED DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ALLERGY TEST - ON (B)(6) 2017: NICKEL ALLERGY. COMPUTERISED TOMOGRAM - ON (B)(6) 2015: ESSURE INSERTS STILL PRESENT BILATERALLY; ON (B)(6) 2017: ESSURE INSERTS STILL PRESENT BILATERALLY; ON (B)(6) 2017: PRESENCE OF ESSURE FRAGMENT IN THE LEFT SIDE AREA. HYSTEROSCOPY - ON (B)(6) 2017: RIGHT INSERT DIFFICULT TO REMOVE. PATHOLOGY TEST - ON (B)(6) 2013: EXAMINATION OF TUBE AND OVARY DIDN¿T SHOW ANYTHING REMARKABLE; ON (B)(6) 2017: AFTER HYSTERECTOMY: ADENOMYOSIS AND ENDOMETRIOSIS DISCLOSED; ON (B)(6) 2017: AFTER TOTAL HYSTERECTOMY: HISTOLOGY OF UTERUS: REMAINING ESSURE FRAGMENT NOT FOUND. ULTRASOUND PELVIS - ON (B)(6) 2014: ESSURE WAS STILL PRESENT AFTER LEFT ADNEXECTOMY; ON (B)(6) 2015: ESSURE INSERTS STILL PRESENT BILATERALLY; ON (B)(6) 2017: ESSURE INSERTS STILL PRESENT BILATERALLY. X-RAY - ON (B)(6) 2017: PRESENCE OF METALLIC FEATURE IN PELVIS. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. 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 COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-JAN-2022: HEALTH AUTHORITY REPORTED THAT THIS RECORD IS A DUPLICATE TO HEALTH AUTHORITY NUMBER R1716040 (BAYER REPORT # (B)(4), THEREFORE DUPLICATE BAYER RECORD # (B)(4) (MEDWATCH 3500A MFR NUMBER 2951250-2017-05816) WILL BE DELETED IN BAYER SAFETY DATABASE, ALL INFORMATION WILL BE RETAINED IN THIS DUPLICATE BAYER RECORD NUMBER (B)(4) (HA NUMBER (B)(4)). NEW REPORTER ADDED: FRENCH HEALTH AUTHORITY. ESSURE LOT NUMBER ADDED: 810874. NEW EVENTS ADDED: AMNESIA, TINNITUS. ON 11-JAN-2022: QUALITY SAFETY EVALUATION OF PTC UPDATE. 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM, REFERENCE NUMBER: (B)(4)) ON 13-DEC-2021. THE MOST RECENT INFORMATION WAS RECEIVED ON 11-JAN-2022. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN'), DEVICE BREAKAGE ('ESSURE INSERTS PRESENT BILATERALLY AFTER LEFT ADNEXECTOMY (B)(6) 2013, FRAGMENT PRESENT AFTER LEFT SIDE AFTER SALPINGECTOMY, HYSTERECOMY (B)(6) 2017'), DEVICE EXPULSION ('RIGHT ESSURE INSERT MIGRATED INTO UTERINE MUSCLE'), EMBEDDED DEVICE ('RIGHT ESSURE INSERT MIGRATED INTO UTERINE MUSCLE') AND DEVICE DISLOCATION ('ESSURE FRAGMENT LOCALIZED IN THE ABDOMEN, IN PELVIS') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810874) 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" IN 2011. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("DESPITE ESSURE PREGNANCY") AND EXPERIENCED AMNESIA ("MEMORY LOSS") AND TINNITUS ("TINNITUS"). IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), DIZZINESS ("DIZZINESS"), FATIGUE ("FATIGUE"), BACK PAIN ("CHRONIC LUMBAR PAIN"), INTERVERTEBRAL DISC PROTRUSION ("HERNIATED DISC"), ARTHRALGIA ("JOINT PAIN"), FIBROMYALGIA ("FIBROMYALGIA"), PYREXIA ("FEVER"), NAUSEA ("NAUSEA") AND VOMITING ("VOMITING") AND UNDERWENT JOINT INJECTION ("INFILTRATION OF POSTERIOR JOINTS"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION INTERVENTION REQUIRED) AND THE FIRST EPISODE OF COMPLICATION OF DEVICE REMOVAL ("ESSURE INSERTS PRESENT BILATERALLY AFTER LEFT ADNEXECTOMY"), 2 YEARS 7 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2017, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY FOUND IN TEST"). ON (B)(6) 2017, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERION INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERION INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED) AND THE SECOND EPISODE OF COMPLICATION OF DEVICE REMOVAL ("PRESENCE OF ESSURE FRAGMENT IN THE LEFT SIDE AREA AFTER LEFT SALPINGECTOMY, HYSTEROSCOPY, HYSTERECTOMY"). THE PATIENT WAS TREATED WITH MORPHINE AND SURGERY ((B)(6) 2013: LEFT ADNEXECTOMY, TUBAL LIGAT..MAR-17: LEFT SALPINGECT, HYSTERECT, AUG-17:TOTAL HYSTERECT AND HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE BREAKAGE, DEVICE DISLOCATION, THE LAST EPISODE OF COMPLICATION OF DEVICE REMOVAL, DIZZINESS AND ALLERGY TO METALS HAD NOT RESOLVED, THE DEVICE EXPULSION, EMBEDDED DEVICE AND PREGNANCY WITH CONTRACEPTIVE DEVICE HAD RESOLVED AND THE FATIGUE, BACK PAIN, INTERVERTEBRAL DISC PROTRUSION, ARTHRALGIA, JOINT INJECTION, FIBROMYALGIA, PYREXIA, NAUSEA, VOMITING, AMNESIA AND TINNITUS 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 TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED ALLERGY TO METALS, AMNESIA, ARTHRALGIA, BACK PAIN, DEVICE BREAKAGE, DEVICE DISLOCATION, DEVICE EXPULSION, DIZZINESS, EMBEDDED DEVICE, FATIGUE, FIBROMYALGIA, INTERVERTEBRAL DISC PROTRUSION, JOINT INJECTION, NAUSEA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, PYREXIA, TINNITUS, VOMITING, THE FIRST EPISODE OF COMPLICATION OF DEVICE REMOVAL AND THE SECOND EPISODE OF COMPLICATION OF DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DESPITE LEFT ADNEXECTOMY (REMOVAL OF FALLOPIAN TUBE AND OVARY/HYSTEROSALPINGO-OOPHORECTOMY) AND TUBAL LIGATION FOR SERIOUS PELVIC PAIN ON (B)(6) 2013, SYMPTOMS PERSISTED. ON (B)(6) 2014, ULTRASOUND SHOWED THAT ESSURE WAS STILL PRESENT. ON (B)(6) 2017, THE PATIENT UNDERWENT ESSURE REMOVAL BY SALPINGECTOMY VIA LAPAROSCOPY FOR THE LEFT INSERT. HYSTEROSCOPY FOR THE RIGHT INSERT DUE TO DIFFICULTY REMOVING THE INSERT. PRESENCE OF NEXPLANON WAS DISCLOSED IN THE LEFT TUBAL AREA ADDITIONALLY TO RIGHT ESSURE INSERT ( INCONSISTENT INFORMATION NOTED). THE RIGHT ESSURE INSERT MIGRATED INTO UTERINE MUSCLE. DURING THE HYSTERECTOMY, ADENOMYOSIS AND ENDOMETRIOSIS WERE DISCLOSED. DESPITE THE REMOVAL, THE PATIENT WAS STILL EXPERIENCING PAIN ON RIGHT SIDE. ON (B)(6) 2017, PELVIS CT SCAN SHOWED ESSURE FRAGMENT IN LEFT SIDE AREA. ON (B)(6) 2017, TOTAL HYSTERECTOMY BECAUSE SHE WAS STILL EXPERIENCING VIOLENT PELVIC PAIN. THE REMAINING ESSURE FRAGMENT NOT FOUND FOLLOWING HISTOLOGICAL EXAMINATION OF THE UTERUS. ON (B)(6) 2017, X-RAY SHOWED METALLIC FEATURE IN PELVIS. PATIENT¿S SYMPTOMS WERE STILL PERSISTENT. THE ESSURE FRAGMENT LOCALIZED IN THE ABDOMEN HAD NOT BEEN REMOVED DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ALLERGY TEST - ON (B)(6) 2017: NICKEL ALLERGY. COMPUTERISED TOMOGRAM - ON (B)(6) 2015: ESSURE INSERTS STILL PRESENT BILATERALLY; ON (B)(6) 2017: ESSURE INSERTS STILL PRESENT BILATERALLY; ON (B)(6) 2017: PRESENCE OF ESSURE FRAGMENT IN THE LEFT SIDE AREA. HYSTEROSCOPY - ON (B)(6) 2017: RIGHT INSERT DIFFICULT TO REMOVE. PATHOLOGY TEST - ON (B)(6) 2013: EXAMINATION OF TUBE AND OVARY DIDN¿T SHOW ANYTHING REMARKABLE; ON (B)(6) 2017: AFTER HYSTERECTOMY: ADENOMYOSIS AND ENDOMETRIOSIS DISCLOSED; ON (B)(6) 2017: AFTER TOTAL HYSTERECTOMY: HISTOLOGY OF UTERUS: REMAINING ESSURE FRAGMENT NOT FOUND. ULTRASOUND PELVIS - ON (B)(6) 2014: ESSURE WAS STILL PRESENT AFTER LEFT ADNEXECTOMY; ON (B)(6) 2015: ESSURE INSERTS STILL PRESENT BILATERALLY; ON (B)(6) 2017: ESSURE INSERTS STILL PRESENT BILATERALLY. X-RAY - ON (B)(6) 2017: PRESENCE OF METALLIC FEATURE IN PELVIS. 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 11-JAN-2022: QUALITY SAFETY EVALUATION OF PTC. 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4)) ON 13-DEC-2021. THE MOST RECENT INFORMATION WAS RECEIVED ON 15-FEB-2023. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) WITH ADDITIONAL INFORMATION RECEIVED THROUGH SOCIAL MEDIA AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN"), DEVICE BREAKAGE ("ESSURE INSERTS PRESENT BILATERALLY AFTER LEFT ADNEXECTOMY DEC-13, FRAGMENT PRESENT AFTER LEFT SIDE AFTER SALPINGECTOMY, HYSTERECOMY MAR-17 / PIECE OF IMPLANT STILL SOMEWHERE IN HER BODY"), DEVICE EXPULSION ("RIGHT ESSURE INSERT MIGRATED INTO UTERINE MUSCLE"), EMBEDDED DEVICE ("RIGHT ESSURE INSERT MIGRATED INTO UTERINE MUSCLE") AND DEVICE DISLOCATION ("ESSURE FRAGMENT LOCALIZED IN THE ABDOMEN, IN PELVIS / RADIOGRAPHY SHOWED PERSISTENCE OF ESSURE IN THE RIGHT ILIAC FOSSA") IN A 37 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 810874) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: SEVERAL EPISODES OF CONTRACEPTIVE DEVICE REMOVAL INCOMPLETE ("PRESENCE OF ESSURE FRAGMENT IN THE LEFT SIDE AREA AFTER LEFT SALPINGECTOMY, HYSTEROSCOPY, HYSTERECTOMY" ON (B)(6) 2017 AND "ESSURE INSERTS PRESENT BILATERALLY AFTER LEFT ADNEXECTOMY" ON (B)(6) 2013) AND DEVICE INEFFECTIVE ("SHE GOT TOTALLY PREGNANT DESPITE THE ESSURE IMPLANTS" IN 2011). THE PATIENT HAD A MEDICAL HISTORY OF PARITY 2 IN 1997, PELVIC PAIN IN 1994, ABORTION IN 1993, GESTATIONAL HYPERTENSION AND PREGNANCY (DELIVERY OF A BOY WEIGHT 3800G) IN 1992 AND PENICILLIN ALLERGY AND MULTIGRAVIDA. ALLERGY TO VISCERALGINE FORTE (TIEMONIUM METHYLSULFATE) AND SOME CURARE (ATRACURIUM AND MIVACURIUM). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011 SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), DIZZINESS ("DIZZINESS"), FATIGUE ("FATIGUE"), BACK PAIN ("CHRONIC LUMBAR PAIN"), INTERVERTEBRAL DISC PROTRUSION ("HERNIATED DISC"), MUSCULOSKELETAL PAIN ("MUSCULAR AND ARTICULAR PAIN"), A FIRST EPISODE OF FIBROMYALGIA ("FIBROMYALGIA"), PYREXIA ("FEVER"), NAUSEA ("NAUSEA"), VOMITING ("VOMITING") AND ARTHRALGIA ("JOINT PAIN / JOINT PAIN OVER HER BODY") AND UNDERWENT JOINT INJECTION ("INFILTRATION OF POSTERIOR JOINTS"). IN 2011 SHE EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE ("SHE GOT TOTALLY PREGNANT DESPITE THE ESSURE IMPLANTS"), AMNESIA ("MEMORY LOSS") AND TINNITUS ("TINNITUS"). IN 2012 SHE EXPERIENCED DEPRESSION ("DEPRESSION") AND A SECOND EPISODE OF FIBROMYALGIA ("FIBROMYALGIA") AND ATTEMPTED SUICIDE ("ATTEMPTED SUICIDE"). ON (B)(6) 2013 SHE EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ON (B)(6) 2017 SHE EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY FOUND IN TEST"). ON (B)(6) 2017 SHE EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERION INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERION INTERVENTION REQUIRED) AND DEVICE DISLOCATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED). AN UNKNOWN TIME LATER SHE EXPERIENCED GENITAL HAEMORRHAGE ("HAEMORRHAGE"), ENDOMETRIOSIS ("ENDOMETRIOSIS") AND SCIATICA ("CHRONIC LEFT SCIATIC PAIN S1 NOT IMPROVED BY ANTALGIC TREATMENTS LEVEL 1 AND LEVEL 3 OR INFILTRATION"). THE PATIENT WAS TREATED WITH MORPHINE AS WELL AS SURGERY (06-DEC-13: LEFT ADNEXECTOMY, TUBAL LIGAT..MAR-17: LEFT SALPINGECT, HYSTERECT, AUG-17:TOTAL HYSTERECT AND HYSTERECTOMY). AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, EMBEDDED DEVICE AND PREGNANCY WITH CONTRACEPTIVE DEVICE HAD RESOLVED AND THE PELVIC PAIN, DEVICE BREAKAGE, DEVICE DISLOCATION, DIZZINESS AND ALLERGY TO METALS HAD NOT RESOLVED. THE OUTCOMES FOR FATIGUE, BACK PAIN, INTERVERTEBRAL DISC PROTRUSION, MUSCULOSKELETAL PAIN, JOINT INJECTION, PYREXIA, NAUSEA, VOMITING, AMNESIA, TINNITUS, GENITAL HAEMORRHAGE, DEPRESSION, SUICIDE ATTEMPT, ENDOMETRIOSIS, ARTHRALGIA AND THE LAST EPISODE OF FIBROMYALGIA WERE UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT'S TREATMENT DATES SUGGEST POTENTIAL FETAL EXPOSURE TO ESSURE DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED ALLERGY TO METALS, AMNESIA, ARTHRALGIA, BACK PAIN, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DEVICE EXPULSION, DIZZINESS, EMBEDDED DEVICE, ENDOMETRIOSIS, FATIGUE, THE FIRST EPISODE OF FIBROMYALGIA, THE SECOND EPISODE OF FIBROMYALGIA, GENITAL HAEMORRHAGE, INTERVERTEBRAL DISC PROTRUSION, JOINT INJECTION, MUSCULOSKELETAL PAIN, NAUSEA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, PYREXIA, SCIATICA, SUICIDE ATTEMPT, TINNITUS AND VOMITING TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: THE PATIENT DECIDED TO HAVE THE IMPLANTS REMOVED, BUT THINGS WENT WRONG. THEY TOOK OUT HER UTERUS, ONE OVARY, AND DISCOVERED THAT SHE HAD ENDOMETRIOSIS, AND A PIECE OF THE IMPLANT WAS STILL IN HER BODY. DESPITE LEFT ADNEXECTOMY (FALLOPIAN TUBE REMOVAL AND OVARY/HYSTEROSALPINGO-OOPHORECTOMY) AND TUBAL LIGATION FOR SERIOUS PELVIC PAIN ON (B)(6) 2013, SYMPTOMS PERSISTED. (B)(6) 2017, ESSURE REMOVED BY SALPINGECTOMY VIA LAPAROSCOPY FOR LEFT INSERT. HYSTEROSCOPY FOR RIGHT INSERT DUE TO DIFFICULTY REMOVING THE INSERT. PRESENCE OF NEXPLANON WAS DISCLOSED IN LEFT TUBAL AREA ADDITIONALLY TO RIGHT ESSURE (INCONSISTENT INFORMATION NOTED). THE RIGHT ESSURE INSERT MIGRATED INTO UTERINE MUSCLE. DURING THE HYSTERECTOMY, ADENOMYOSIS AND ENDOMETRIOSIS WERE DISCLOSED. DESPITE REMOVAL, SHE WAS STILL EXPERIENCING PAIN ON RIGHT SIDE. (B)(6) 2017, TOTAL HYSTERECTOMY BECAUSE WAS STILL EXPERIENCING VIOLENT PELVIC PAIN. THE REMAINING ESSURE FRAGMENT NOT FOUND FOLLOWING HISTOLOGICAL EXAMINATION OF UTERUS. (B)(6) 2017, HER SYMPTOMS WERE STILL PERSISTENT. ESSURE FRAGMENT LOCALIZED IN ABDOMEN HAD NOT BEEN REMOVED. FU INFORMATION FROM 15-FEB-2023: (B)(6) 2013, LAPAROSCOPIC SALPINGECTOMY WAS PERFORMED BECAUSE OF ESSURE FAILURE. PATIENT WAS HOSPITALIZED FOR 2 DAYS. LEFT FALLOPIAN TUBE AND LEFT OVARY WERE NOT IDENTIFIED AS PATHOLOGIC. (B)(6) 2014, PELVIC AND RENAL ULTRASOUND WHICH SHOWED ESSURE STILL IN PLACE. IT WAS CONFIRMED BY SEVERAL MEDICAL IMAGING PERFORMED LATER. (B)(6) 2017, REMOVAL BY LAPAROSCOPIC SALPINGECTOMY FOR ESSURE LOCATED ON LEFT AND HYSTEROSCOPY FOR THE ONE ON RIGHT (BECAUSE IT WAS DIFFICULT TO REMOVE THE IMPLANT). (B)(6) 2017 TOTAL VAGINAL HYSTERECTOMY BECAUSE OF PELVIC PAIN DESPITE THE REMOVAL OF ESSURE AND WITH VERY SENSITIVE UTERUS. AT THE DATE OF THIS REPORT, PART OF ESSURE WAS NOT REMOVED, AND ARTICULAR SYMPTOMS PERSISTED BUT LINK BETWEEN THEM AND ESSURE WAS NOT ESTABLISHED BY REPORTER. IT WAS NOT POSSIBLE TO FORMALLY LINK THESE RHEUMATOLOGICAL PATHOLOGIES AND ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [ALLERGY TEST] ON (B)(6) 2017: NICKEL ALLERGY [COMPUTERISED TOMOGRAM] ON (B)(6) 2015: ESSURE INSERTS STILL PRESENT BILATERALLY; ON (B)(6) 2017: ESSURE INSERTS STILL PRESENT BILATERALLY; ON (B)(6) 2017: PRESENCE OF ESSURE FRAGMENT IN THE LEFT SIDE AREA [HYSTEROSCOPY] ON (B)(6) 2017: RIGHT INSERT DIFFICULT TO REMOVE [PATHOLOGY TEST] ON (B)(6) 2013: EXAMINATION OF TUBE AND OVARY DIDN¿T SHOW ANYTHING REMARKABLE; ON (B)(6) 2017: AFTER HYSTERECTOMY: ADENOMYOSIS AND ENDOMETRIOSIS DISCLOSED; ON (B)(6) 2017: AFTER TOTAL HYSTERECTOMY: HISTOLOGY OF UTERUS: REMAINING ESSURE FRAGMENT NOT FOUND; ON (B)(6) 2017: ANATOMO PATHOLOGICAL EXAMINATION OF THE SURGICAL SPECIMEN SHOWED BENIGN TYPICAL LEIOMYOMAS AND ADENOMYOSIS LESIONS. NO MALIGNANT ELEMENT. [ULTRASOUND PELVIS] ON (B)(6) 2014: ESSURE WAS STILL PRESENT AFTER LEFT ADNEXECTOMY; ON (B)(6) 2015: ESSURE INSERTS STILL PRESENT BILATERALLY; ON (B)(6) 2017: ESSURE INSERTS STILL PRESENT BILATERALLY [X-RAY] ON (B)(6) 2017: PRESENCE OF METALLIC FEATURE IN PELVIS; ON (B)(6) 2017: SHOWED PERSISTENCE OF ESSURE IN THE RIGHT ILIAC FOSSA. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. 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 COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 15-FEB-2023: REPORTER¿S INFORMATION WAS UPDATED AND A NEW REPORTER WAS ADDED. PATIENT¿S INFORMATION WAS ADDED AND HER INITIALS WAS UPDATED. LAB DATA RESULTS INCLUDING ANATOMO PATHOLOGICAL EXAMINATION WERE PROVIDED AND THE EVENTS ARTHRALGIA AND SCIATICA WERE ADDED. 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 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 PELVIC PAIN ('CHRONIC PELVIC PAIN'), DEVICE BREAKAGE ('ESSURE INSERTS PRESENT BILATERALLY AFTER LEFT ADNEXECTOMY (B)(6), FRAGMENT PRESENT AFTER LEFT SIDE AFTER SALPINGECTOMY, HYSTERECOMY (B)(6)), DEVICE EXPULSION ('RIGHT ESSURE INSERT MIGRATED INTO UTERINE MUSCLE'), EMBEDDED DEVICE ('RIGHT ESSURE INSERT MIGRATED INTO UTERINE MUSCLE') AND DEVICE DISLOCATION ('ESSURE FRAGMENT LOCALIZED IN THE ABDOMEN, IN PELVIS') IN A 37-YEAR-OLD 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 INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), DIZZINESS ("DIZZINESS"), FATIGUE ("FATIGUE"), BACK PAIN ("CHRONIC LUMBAR PAIN"), INTERVERTEBRAL DISC PROTRUSION ("HERNIATED DISC"), ARTHRALGIA ("JOINT PAIN"), FIBROMYALGIA ("FIBROMYALGIA"), PYREXIA ("FEVER"), NAUSEA ("NAUSEA") AND VOMITING ("VOMITING") AND UNDERWENT JOINT INJECTION ("INFILTRATION OF POSTERIOR JOINTS"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION INTERVENTION REQUIRED) AND THE FIRST EPISODE OF COMPLICATION OF DEVICE REMOVAL ("ESSURE INSERTS PRESENT BILATERALLY AFTER LEFT ADNEXECTOMY"), 2 YEARS 7 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2017, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY FOUND IN TEST"). ON (B)(6) 2017, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERION INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERION INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED) AND THE SECOND EPISODE OF COMPLICATION OF DEVICE REMOVAL ("PRESENCE OF ESSURE FRAGMENT IN THE LEFT SIDE AREA AFTER LEFT SALPINGECTOMY, HYSTEROSCOPY, HYSTERECTOMY"). ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("DESPITE ESSURE PREGNANCY"). THE PATIENT WAS TREATED WITH MORPHINE AND SURGERY ((B)(6) 2013: LEFT ADNEXECTOMY, TUBAL LIGAT..(B)(6): LEFT SALPINGECT, HYSTERECT, (B)(6) :TOTAL HYSTERECT AND HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE BREAKAGE, DEVICE DISLOCATION, THE LAST EPISODE OF COMPLICATION OF DEVICE REMOVAL, DIZZINESS AND ALLERGY TO METALS HAD NOT RESOLVED, THE DEVICE EXPULSION, EMBEDDED DEVICE AND PREGNANCY WITH CONTRACEPTIVE DEVICE HAD RESOLVED AND THE FATIGUE, BACK PAIN, INTERVERTEBRAL DISC PROTRUSION, ARTHRALGIA, JOINT INJECTION, FIBROMYALGIA, PYREXIA, NAUSEA AND VOMITING 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 TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED ALLERGY TO METALS, ARTHRALGIA, BACK PAIN, DEVICE BREAKAGE, DEVICE DISLOCATION, DEVICE EXPULSION, DIZZINESS, EMBEDDED DEVICE, FATIGUE, FIBROMYALGIA, INTERVERTEBRAL DISC PROTRUSION, JOINT INJECTION, NAUSEA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, PYREXIA, VOMITING, THE FIRST EPISODE OF COMPLICATION OF DEVICE REMOVAL AND THE SECOND EPISODE OF COMPLICATION OF DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DESPITE LEFT ADNEXECTOMY (REMOVAL OF FALLOPIAN TUBE AND OVARY) AND TUBAL LIGATION FOR SERIOUS PELVIC PAIN ON (B)(6) 2013, SYMPTOMS PERSISTED. ON (B)(6) 2014, ULTRASOUND SHOWED THAT ESSURE WAS STILL PRESENT. ON (B)(6) 2017, THE PATIENT UNDERWENT ESSURE REMOVAL BY SALPINGECTOMY VIA LAPAROSCOPY FOR THE LEFT INSERT. HYSTEROSCOPY FOR THE RIGHT INSERT DUE TO DIFFICULTY REMOVING THE INSERT PRESENCE OF NEXPLANON WAS DISCLOSED IN THE LEFT TUBAL AREA ADDITIONALLY TO RIGHT ESSURE INSERT ( INCONSISTENT INFORMATION NOTED). THE RIGHT ESSURE INSERT MIGRATED INTO UTERINE MUSCLE. DURING THE HYSTERECTOMY, ADENOMYOSIS AND ENDOMETRIOSIS WERE DISCLOSED. DESPITE THE REMOVAL, THE PATIENT WAS STILL EXPERIENCING PAIN ON RIGHT SIDE. ON (B)(6) 2017, PELVIS CT SCAN SHOWED ESSURE FRAGMENT IN LEFT SIDE AREA. ON (B)(6) 2017, TOTAL HYSTERECTOMY BECAUSE SHE WAS STILL EXPERIENCING VIOLENT PELVIC PAIN. THE REMAINING ESSURE FRAGMENT NOT FOUND FOLLOWING HISTOLOGICAL EXAMINATION OF THE UTERUS. ON (B)(6) 2017, X-RAY SHOWED METALLIC FEATURE IN PELVIS. PATIENT¿S SYMPTOMS WERE STILL PERSISTENT. THE ESSURE FRAGMENT LOCALIZED IN THE ABDOMEN HAD NOT BEEN REMOVED DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ALLERGY TEST - ON (B)(6) 2017: NICKEL ALLERGY. COMPUTERISED TOMOGRAM - ON (B)(6) 2015: ESSURE INSERTS STILL PRESENT BILATERALLY; ON (B)(6)2017: ESSURE INSERTS STILL PRESENT BILATERALLY; ON (B)(6) 2017: PRESENCE OF ESSURE FRAGMENT IN THE LEFT SIDE AREA. HYSTEROSCOPY - ON (B)(6) 2017: RIGHT INSERT DIFFICULT TO REMOVE. PATHOLOGY TEST - ON (B)(6) 2013: EXAMINATION OF TUBE AND OVARY DIDN¿T SHOW ANYTHING REMARKABLE; ON (B)(6) 2017: AFTER HYSTERECTOMY: ADENOMYOSIS AND ENDOMETRIOSIS DISCLOSED; ON (B)(6) 2017: AFTER TOTAL HYSTERECTOMY: HISTOLOGY OF UTERUS: REMAINING ESSURE FRAGMENT NOT FOUND. ULTRASOUND PELVIS - ON (B)(6) 2014: ESSURE WAS STILL PRESENT AFTER LEFT ADNEXECTOMY; ON (B)(6) 2015: ESSURE INSERTS STILL PRESENT BILATERALLY; ON (B)(6) 2017: ESSURE INSERTS STILL PRESENT BILATERALLY. X-RAY - ON (B)(6) 2017: PRESENCE OF METALLIC FEATURE IN PELVIS. 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 17-DEC-2021: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM, REFERENCE NUMBER: (B)(4)) ON 13-DEC-2021. THE MOST RECENT INFORMATION WAS RECEIVED ON 04-JAN-2022. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN'), DEVICE BREAKAGE ('ESSURE INSERTS PRESENT BILATERALLY AFTER LEFT ADNEXECTOMY (B)(6) 2013, FRAGMENT PRESENT AFTER LEFT SIDE AFTER SALPINGECTOMY, HYSTERECTOMY (B)(6) 2017), DEVICE EXPULSION ('RIGHT ESSURE INSERT MIGRATED INTO UTERINE MUSCLE'), EMBEDDED DEVICE ('RIGHT ESSURE INSERT MIGRATED INTO UTERINE MUSCLE') AND DEVICE DISLOCATION ('ESSURE FRAGMENT LOCALIZED IN THE ABDOMEN, IN PELVIS') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810874) 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" IN 2011. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("DESPITE ESSURE PREGNANCY") AND EXPERIENCED AMNESIA ("MEMORY LOSS") AND TINNITUS ("TINNITUS"). IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), DIZZINESS ("DIZZINESS"), FATIGUE ("FATIGUE"), BACK PAIN ("CHRONIC LUMBAR PAIN"), INTERVERTEBRAL DISC PROTRUSION ("HERNIATED DISC"), ARTHRALGIA ("JOINT PAIN"), FIBROMYALGIA ("FIBROMYALGIA"), PYREXIA ("FEVER"), NAUSEA ("NAUSEA") AND VOMITING ("VOMITING") AND UNDERWENT JOINT INJECTION ("INFILTRATION OF POSTERIOR JOINTS"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION INTERVENTION REQUIRED) AND THE FIRST EPISODE OF COMPLICATION OF DEVICE REMOVAL ("ESSURE INSERTS PRESENT BILATERALLY AFTER LEFT ADNEXECTOMY"), 2 YEARS 7 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2017, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY FOUND IN TEST"). ON (B)(6) 2017, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERION INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERION INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED) AND THE SECOND EPISODE OF COMPLICATION OF DEVICE REMOVAL ("PRESENCE OF ESSURE FRAGMENT IN THE LEFT SIDE AREA AFTER LEFT SALPINGECTOMY, HYSTEROSCOPY, HYSTERECTOMY"). THE PATIENT WAS TREATED WITH MORPHINE AND SURGERY ((B)(6) 2013: LEFT ADNEXECTOMY, TUBAL LIGAT..(B)(6) 2017: LEFT SALPINGECT, HYSTERECT, (B)(6) 2017:TOTAL HYSTERECT AND HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE BREAKAGE, DEVICE DISLOCATION, THE LAST EPISODE OF COMPLICATION OF DEVICE REMOVAL, DIZZINESS AND ALLERGY TO METALS HAD NOT RESOLVED, THE DEVICE EXPULSION, EMBEDDED DEVICE AND PREGNANCY WITH CONTRACEPTIVE DEVICE HAD RESOLVED AND THE FATIGUE, BACK PAIN, INTERVERTEBRAL DISC PROTRUSION, ARTHRALGIA, JOINT INJECTION, FIBROMYALGIA, PYREXIA, NAUSEA, VOMITING, AMNESIA AND TINNITUS 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 TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED ALLERGY TO METALS, AMNESIA, ARTHRALGIA, BACK PAIN, DEVICE BREAKAGE, DEVICE DISLOCATION, DEVICE EXPULSION, DIZZINESS, EMBEDDED DEVICE, FATIGUE, FIBROMYALGIA, INTERVERTEBRAL DISC PROTRUSION, JOINT INJECTION, NAUSEA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, PYREXIA, TINNITUS, VOMITING, THE FIRST EPISODE OF COMPLICATION OF DEVICE REMOVAL AND THE SECOND EPISODE OF COMPLICATION OF DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DESPITE LEFT ADNEXECTOMY (REMOVAL OF FALLOPIAN TUBE AND OVARY/HYSTEROSALPINGO-OOPHORECTOMY) AND TUBAL LIGATION FOR SERIOUS PELVIC PAIN ON (B)(6) 2013, SYMPTOMS PERSISTED. ON (B)(6) 2014, ULTRASOUND SHOWED THAT ESSURE WAS STILL PRESENT. ON (B)(6) 2017, THE PATIENT UNDERWENT ESSURE REMOVAL BY SALPINGECTOMY VIA LAPAROSCOPY FOR THE LEFT INSERT. HYSTEROSCOPY FOR THE RIGHT INSERT DUE TO DIFFICULTY REMOVING THE INSERT. PRESENCE OF NEXPLANON WAS DISCLOSED IN THE LEFT TUBAL AREA ADDITIONALLY TO RIGHT ESSURE INSERT ( INCONSISTENT INFORMATION NOTED). THE RIGHT ESSURE INSERT MIGRATED INTO UTERINE MUSCLE. DURING THE HYSTERECTOMY, ADENOMYOSIS AND ENDOMETRIOSIS WERE DISCLOSED. DESPITE THE REMOVAL, THE PATIENT WAS STILL EXPERIENCING PAIN ON RIGHT SIDE. ON (B)(6) 2017, PELVIS CT SCAN SHOWED ESSURE FRAGMENT IN LEFT SIDE AREA. ON (B)(6) 2017, TOTAL HYSTERECTOMY BECAUSE SHE WAS STILL EXPERIENCING VIOLENT PELVIC PAIN. THE REMAINING ESSURE FRAGMENT NOT FOUND FOLLOWING HISTOLOGICAL EXAMINATION OF THE UTERUS. ON (B)(6) 2017, X-RAY SHOWED METALLIC FEATURE IN PELVIS. PATIENT¿S SYMPTOMS WERE STILL PERSISTENT. THE ESSURE FRAGMENT LOCALIZED IN THE ABDOMEN HAD NOT BEEN REMOVED DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ALLERGY TEST - ON (B)(6) 2017: NICKEL ALLERGY. COMPUTERISED TOMOGRAM - ON (B)(6) 2015: ESSURE INSERTS STILL PRESENT BILATERALLY; ON (B)(6) 2017: ESSURE INSERTS STILL PRESENT BILATERALLY; ON (B)(6) 2017: PRESENCE OF ESSURE FRAGMENT IN THE LEFT SIDE AREA. HYSTEROSCOPY - ON (B)(6) 2017: RIGHT INSERT DIFFICULT TO REMOVE. PATHOLOGY TEST - ON (B)(6) 2013: EXAMINATION OF TUBE AND OVARY DIDN¿T SHOW ANYTHING REMARKABLE; ON (B)(6) 2017: AFTER HYSTERECTOMY: ADENOMYOSIS AND ENDOMETRIOSIS DISCLOSED; ON (B)(6) 2017: AFTER TOTAL HYSTERECTOMY: HISTOLOGY OF UTERUS: REMAINING ESSURE FRAGMENT NOT FOUND. ULTRASOUND PELVIS - ON (B)(6) 2014: ESSURE WAS STILL PRESENT AFTER LEFT ADNEXECTOMY; ON (B)(6) 2015: ESSURE INSERTS STILL PRESENT BILATERALLY; ON (B)(6) 2017: ESSURE INSERTS STILL PRESENT BILATERALLY. X-RAY - ON (B)(6) 2017: PRESENCE OF METALLIC FEATURE IN PELVIS. 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 4-JAN-2022: HEALTH AUTHORITY REPORTED THAT THIS RECORD IS A DUPLICATE TO HEALTH AUTHORITY NUMBER (B)(4) (BAYER REPORT # (B)(4)), THEREFORE DUPLICATE BAYER RECORD # (B)(4) (MEDWATCH 3500A MFR NUMBER 2951250-2017-05816) WILL BE DELETED IN BAYER SAFETY DATABASE, ALL INFORMATION WILL BE RETAINED IN THIS DUPLICATE BAYER RECORD NUMBER (B)(4) (HA NUMBER (B)(4)). NEW REPORTER ADDED: FRENCH HEALTH AUTHORITY. ESSURE LOT NUMBER ADDED: 810874. NEW EVENTS ADDED: AMNESIA, TINNITUS. 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 PELVIC PAIN ('CHRONIC PELVIC PAIN'), DEVICE BREAKAGE ('ESSURE INSERTS PRESENT BILATERALLY AFTER LEFT ADNEXECTOMY (B)(6), FRAGMENT PRESENT AFTER LEFT SIDE AFTER SALPINGECTOMY, HYSTERECTOMY (B)(6)''), DEVICE EXPULSION ('RIGHT ESSURE INSERT MIGRATED INTO UTERINE MUSCLE'), EMBEDDED DEVICE ('RIGHT ESSURE INSERT MIGRATED INTO UTERINE MUSCLE') AND DEVICE DISLOCATION ('ESSURE FRAGMENT LOCALIZED IN THE ABDOMEN, IN PELVIS') IN A (B)(6) 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 INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), DIZZINESS ("DIZZINESS"), FATIGUE ("FATIGUE"), BACK PAIN ("CHRONIC LUMBAR PAIN"), INTERVERTEBRAL DISC PROTRUSION ("HERNIATED DISC"), ARTHRALGIA ("JOINT PAIN"), FIBROMYALGIA ("FIBROMYALGIA"), PYREXIA ("FEVER"), NAUSEA ("NAUSEA") AND VOMITING ("VOMITING") AND UNDERWENT JOINT INJECTION ("INFILTRATION OF POSTERIOR JOINTS"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION INTERVENTION REQUIRED) AND THE FIRST EPISODE OF COMPLICATION OF DEVICE REMOVAL ("ESSURE INSERTS PRESENT BILATERALLY AFTER LEFT ADNEXECTOMY"), 2 YEARS 7 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2017, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY FOUND IN TEST"). ON (B)(6) 2017, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERION INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERION INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED) AND THE SECOND EPISODE OF COMPLICATION OF DEVICE REMOVAL ("PRESENCE OF ESSURE FRAGMENT IN THE LEFT SIDE AREA AFTER LEFT SALPINGECTOMY, HYSTEROSCOPY, HYSTERECTOMY"). ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("DESPITE ESSURE PREGNANCY"). THE PATIENT WAS TREATED WITH MORPHINE AND SURGERY ((B)(6) 2013: LEFT ADNEXECTOMY, TUBAL LIGAT (B)(6) 2017: LEFT SALPINGECTOMY, HYSTERECTOMY, (B)(6) 2017: TOTAL HYSTERECT AND HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE BREAKAGE, DEVICE DISLOCATION, THE LAST EPISODE OF COMPLICATION OF DEVICE REMOVAL, DIZZINESS AND ALLERGY TO METALS HAD NOT RESOLVED, THE DEVICE EXPULSION, EMBEDDED DEVICE AND PREGNANCY WITH CONTRACEPTIVE DEVICE HAD RESOLVED AND THE FATIGUE, BACK PAIN, INTERVERTEBRAL DISC PROTRUSION, ARTHRALGIA, JOINT INJECTION, FIBROMYALGIA, PYREXIA, NAUSEA AND VOMITING 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 TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED ALLERGY TO METALS, ARTHRALGIA, BACK PAIN, DEVICE BREAKAGE, DEVICE DISLOCATION, DEVICE EXPULSION, DIZZINESS, EMBEDDED DEVICE, FATIGUE, FIBROMYALGIA, INTERVERTEBRAL DISC PROTRUSION, JOINT INJECTION, NAUSEA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, PYREXIA, VOMITING, THE FIRST EPISODE OF COMPLICATION OF DEVICE REMOVAL AND THE SECOND EPISODE OF COMPLICATION OF DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DESPITE LEFT ADNEXECTOMY (REMOVAL OF FALLOPIAN TUBE AND OVARY) AND TUBAL LIGATION FOR SERIOUS PELVIC PAIN ON (B)(6) 2013, SYMPTOMS PERSISTED. ON (B)(6) 2014, ULTRASOUND SHOWED THAT ESSURE WAS STILL PRESENT. ON (B)(6) 2017, THE PATIENT UNDERWENT ESSURE REMOVAL BY SALPINGECTOMY VIA LAPAROSCOPY FOR THE LEFT INSERT. HYSTEROSCOPY FOR THE RIGHT INSERT DUE TO DIFFICULTY REMOVING THE INSERT PRESENCE OF NEXPLANON WAS DISCLOSED IN THE LEFT TUBAL AREA ADDITIONALLY TO RIGHT ESSURE INSERT. THE RIGHT ESSURE INSERT MIGRATED INTO UTERINE MUSCLE. DURING THE HYSTERECTOMY, ADENOMYOSIS AND ENDOMETRIOSIS WERE DISCLOSED. DESPITE THE REMOVAL, THE PATIENT WAS STILL EXPERIENCING PAIN ON RIGHT SIDE. ON (B)(6) 2017, PELVIS CT SCAN SHOWED ESSURE FRAGMENT IN LEFT SIDE AREA. ON (B)(6) 2017, TOTAL HYSTERECTOMY BECAUSE SHE WAS STILL EXPERIENCING VIOLENT PELVIC PAIN. THE REMAINING ESSURE FRAGMENT NOT FOUND FOLLOWING HISTOLOGICAL EXAMINATION OF THE UTERUS. ON (B)(6) 2017, X-RAY SHOWED METALLIC FEATURE IN PELVIS. PATIENT¿S SYMPTOMS WERE STILL PERSISTENT. THE ESSURE FRAGMENT LOCALIZED IN THE ABDOMEN HAD NOT BEEN REMOVED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ALLERGY TEST - ON (B)(6) 2017: NICKEL ALLERGY. COMPUTERISED TOMOGRAM - ON (B)(6) 2015: ESSURE INSERTS STILL PRESENT BILATERALLY; ON (B)(6) 2017: ESSURE INSERTS STILL PRESENT BILATERALLY; ON (B)(6) 2017: PRESENCE OF ESSURE FRAGMENT IN THE LEFT SIDE AREA. HYSTEROSCOPY - ON (B)(6) 2017: RIGHT INSERT DIFFICULT TO REMOVE. PATHOLOGY TEST - ON (B)(6) 2013: EXAMINATION OF TUBE AND OVARY DIDN¿T SHOW ANYTHING REMARKABLE; ON (B)(6) 2017: AFTER HYSTERECTOMY: ADENOMYOSIS AND ENDOMETRIOSIS DISCLOSED; ON (B)(6) 2017: AFTER TOTAL HYSTERECTOMY: HISTOLOGY OF UTERUS: REMAINING ESSURE FRAGMENT NOT FOUND. ULTRASOUND PELVIS - ON (B)(6) 2014: ESSURE WAS STILL PRESENT AFTER LEFT ADNEXECTOMY; ON (B)(6) 2015: ESSURE INSERTS STILL PRESENT BILATERALLY; ON (B)(6) 2017: ESSURE INSERTS STILL PRESENT BILATERALLY. X-RAY - ON (B)(6) 2017: PRESENCE OF METALLIC FEATURE IN PELVIS. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1906348 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 810874 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Female | Required Intervention |