ESSURE
Report
- Report Number
- 2951250-2024-00831
- Event Type
- Injury
- Date Received
- December 16, 2024
- Report Date
- December 18, 2024
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BAYER CASE NUMBER:(B)(4). HAEMORRHAGIC PERIODS [HEAVY PERIODS] , ITCHING ON MY FACE [PRURITUS FACIAL] , DIZZY SPELLS [DIZZY SPELLS] , FATIGUE [FATIGUE] , BAD BREATH [BAD BREATH] , OXIDIZED DISCHARGE (WHICH LEFT IRON STAINS, RUST COLOUR ON UNDERWEAR AFTER WASHING ,[VAGINAL DISCHARGE], MEMORY LOSS [MEMORY LOSS] , MY VISION IMPAIRMENT [VISUAL IMPAIRMENT], 'M STARTING TO LOSE A FEW POUNDS DESPITE THE 12 KG GAINED AFTER THE INSERTION [WEIGHT INCREASED] . CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4) ON 09-AUG-2017. THE MOST RECENT INFORMATION WAS RECEIVED ON 17-DEC-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF HEAVY MENSTRUAL BLEEDING ("HAEMORRHAGIC PERIODS") AND PRURITUS ("ITCHING ON MY FACE") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 810874) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ESSURE WAS REMOVED ON (B)(6) 2017. ON UNKNOWN DATE SHE EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERION INTERVENTION REQUIRED), PRURITUS (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), DIZZINESS ("DIZZY SPELLS"), FATIGUE ("FATIGUE"), BREATH ODOUR ("BAD BREATH"), VAGINAL DISCHARGE ("OXIDIZED DISCHARGE (WHICH LEFT IRON STAINS, RUST COLOUR ON UNDERWEAR AFTER WASHING"), AMNESIA ("MEMORY LOSS") AND VISUAL IMPAIRMENT ("MY VISION IMPAIRMENT") AND WAS FOUND TO HAVE WEIGHT INCREASED ("'M STARTING TO LOSE A FEW POUNDS DESPITE THE 12 KG GAINED AFTER THE INSERTION"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL CONSERVATIVE HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE FATIGUE, VISUAL IMPAIRMENT AND WEIGHT INCREASED WERE RESOLVING AND THE HEAVY MENSTRUAL BLEEDING, PRURITUS, BREATH ODOUR, VAGINAL DISCHARGE AND AMNESIA HAD RESOLVED. THE OUTCOME OF DIZZINESS WAS UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO PRURITUS, DIZZINESS, FATIGUE, HEAVY MENSTRUAL BLEEDING, BREATH ODOUR, VAGINAL DISCHARGE, AMNESIA, VISUAL IMPAIRMENT OR WEIGHT INCREASED. THE REPORTER COMMENTED: NO MORE HEMORRHAGIC PERIODS SINCE MY UTERUS, CERVIX AND FALLOPIAN TUBES WERE REMOVED DURING THE OPERATION. ALMOST COMPLETE DISAPPEARANCE OF THE ITCHING ON MY FACE (SO NO MORE NEED FOR CORTISONE CREAM THAT I HAD BEEN USING FOR OVER 4 YEARS). DISAPPEARANCE OF BAD BREATH, OXIDIZED DISCHARGE (WHICH LEFT IRON STAINS, RUST COLOR ON UNDERWEAR AFTER WASHING, ETC.) MY MEMORY CAME BACK IMMEDIATELY, AS DID MY VISION, WHICH IS GRADUALLY RETURNING (I ALMOST NO LONGER NEED GLASSES). I AM MUCH LESS TIRED THAN BEFORE. I HAVE RETURNED TO MY FORMER SELF FROM BEFORE THE INSERTION OF THE ESSURES. I'M STARTING TO LOSE A FEW POUNDS DESPITE THE 12 KG GAINED AFTER THE INSERTION. - PATIENT PRESENTING WITH VARIED SYMPTOMS SINCE INSERTION OF ESSURE IN 2011 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. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [GYNAECOLOGICAL EXAMINATION] IN (B)(6) 2017: 3 MONTH FOLLOW-UP CARRIED OUT AND SATISFACTORY RESULT. [LAPAROSCOPY] (DATE UNKNOWN): THE EXPLORATION OF THE CAVITY IS UNREMARKABLE. THERE IS NO PERFORATION OF THE IMPLANTS - ESSURE. PERFORMANCE OF ULTRACISION HYSTERECTOMY BY COAGULATION SECTION OF THE RIGHT ROUND LIGAMENT. CONTINUATION OF THE DISSECTION BY OPENING THE ANTERIOR LAYER OF THE RIGHT BROAD LIGAMENT IN ORDER TO INITIATE VESICO-UTERINE DETACHMENT. THE SAME PROCEDURE IS PERFORMED ON THE LEFT ON THE ROUND LIGAMENT. FENESTRATION OF THE UTERO-OVARIAN LIGAMENT. COAGULATION SECTION OF THE UTERO-OVARIAN LIGAMENT. WE CARRY OUT THE SAME PROCEDURE ON THE LEFT. RETROGRADE SALPINGECTOMY THE TUBE REMAINS ATTACHED TO THE UTERUS. THE OPENING OF THE POSTERIOR LAYER OF THE BROAD LIGAMENT IS CONTINUED WITH ULTRACISION UP TO THE UTEROSACRAL LIGAMENT. COAGULATION SECTION OF THE RIGHT AND LEFT UTEROSACRAL LIGAMENT. - SELECTIVE COAGULATION OF. THE RIGHT AND THEN LEFT UTERINE ARTERY. EXTERIORISATION OF THE UTERUS THROUGH THE VAGINA. CIRCULAR COLPOTOMY TO FINALISE THE HYSTERECTOMY. CAREFUL VERIFICATION OF HAEMOSTASIS. VAGINAL CLOSURE WITH 3 VICRYL 0 X-SHAPED SUTURES. CLOSURE OF TROCAR ORIFICES WITH VICRYL 0 AND MONOCRYL 3.0. CONCLUSION: CONSERVATIVE TOTAL HYSTERECTOMY FOR ESSURE REMOVAL. THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS CODED WITH THE SAME MEDDRA PREFERRED TERM. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON (B)(6) 2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: PRURITUS. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 97 CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THIS MEDDRA PT. LOT NUMBER: 810874 MANUFACTURE DATE: 2010-12 EXPIRATION DATE: 2013-12. 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: 17-DEC-2024: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. CASE COMMENTS: 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
BAYER CASE NUMBER: (B)(4). HAEMORRHAGIC PERIODS [HEAVY PERIODS], ITCHING ON MY FACE [PRURITUS FACIAL], DIZZY SPELLS [DIZZY SPELLS], FATIGUE [FATIGUE], BAD BREATH [BAD BREATH], OXIDIZED DISCHARGE (WHICH LEFT IRON STAINS, RUST COLOUR ON UNDERWEAR AFTER WASHING [VAGINAL DISCHARGE], MEMORY LOSS [MEMORY LOSS], MY VISION IMPAIRMENT [VISUAL IMPAIRMENT], 'M STARTING TO LOSE A FEW POUNDS DESPITE THE 12 KG GAINED AFTER THE INSERTION [WEIGHT GAIN]. CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4) ON 09-AUG-2017. THE MOST RECENT INFORMATION WAS RECEIVED ON 10-DEC-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF HEAVY MENSTRUAL BLEEDING ("HAEMORRHAGIC PERIODS") AND PRURITUS ("ITCHING ON MY FACE") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO: 810874) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ESSURE WAS REMOVED ON (B)(6) 2017. ON UNKNOWN DATE SHE EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERION INTERVENTION REQUIRED), PRURITUS (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), DIZZINESS ("DIZZY SPELLS"), FATIGUE ("FATIGUE"), BREATH ODOUR ("BAD BREATH"), VAGINAL DISCHARGE ("OXIDIZED DISCHARGE (WHICH LEFT IRON STAINS, RUST COLOUR ON UNDERWEAR AFTER WASHING"), AMNESIA ("MEMORY LOSS") AND VISUAL IMPAIRMENT ("MY VISION IMPAIRMENT") AND WAS FOUND TO HAVE WEIGHT INCREASED ("'M STARTING TO LOSE A FEW POUNDS DESPITE THE 12 KG GAINED AFTER THE INSERTION"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL CONSERVATIVE HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE FATIGUE, VISUAL IMPAIRMENT AND WEIGHT INCREASED WERE RESOLVING AND THE HEAVY MENSTRUAL BLEEDING, PRURITUS, BREATH ODOUR, VAGINAL DISCHARGE AND AMNESIA HAD RESOLVED. THE OUTCOME OF DIZZINESS WAS UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO PRURITUS, DIZZINESS, FATIGUE, HEAVY MENSTRUAL BLEEDING, BREATH ODOUR, VAGINAL DISCHARGE, AMNESIA, VISUAL IMPAIRMENT OR WEIGHT INCREASED. THE REPORTER COMMENTED: NO MORE HEMORRHAGIC PERIODS SINCE MY UTERUS, CERVIX AND FALLOPIAN TUBES WERE REMOVED DURING THE OPERATION. ALMOST COMPLETE DISAPPEARANCE OF THE ITCHING ON MY FACE (SO NO MORE NEED FOR CORTISONE CREAM THAT I HAD BEEN USING FOR OVER 4 YEARS). DISAPPEARANCE OF BAD BREATH, OXIDIZED DISCHARGE (WHICH LEFT IRON STAINS, RUST COLOR ON UNDERWEAR AFTER WASHING, ETC.) MY MEMORY CAME BACK IMMEDIATELY, AS DID MY VISION, WHICH IS GRADUALLY RETURNING (I ALMOST NO LONGER NEED GLASSES). I AM MUCH LESS TIRED THAN BEFORE. I HAVE RETURNED TO MY FORMER SELF FROM BEFORE THE INSERTION OF THE ESSURES. I'M STARTING TO LOSE A FEW POUNDS DESPITE THE 12 KG GAINED AFTER THE INSERTION. - PATIENT PRESENTING WITH VARIED SYMPTOMS SINCE INSERTION OF ESSURE IN 2011 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. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [GYNAECOLOGICAL EXAMINATION] ON (B)(6) 2017: 3 MONTH FOLLOW-UP CARRIED OUT AND SATISFACTORY RESULT. [LAPAROSCOPY] (DATE UNKNOWN): THE EXPLORATION OF THE CAVITY IS UNREMARKABLE. THERE IS NO PERFORATION OF THE IMPLANTS ESSURE. PERFORMANCE OF ULTRACISION HYSTERECTOMY BY COAGULATION SECTION OF THE RIGHT ROUND LIGAMENT. CONTINUATION OF THE DISSECTION BY OPENING THE ANTERIOR LAYER OF THE RIGHT BROAD LIGAMENT IN ORDER TO INITIATE VESICO-UTERINE DETACHMENT. THE SAME PROCEDURE IS PERFORMED ON THE LEFT ON THE ROUND LIGAMENT. FENESTRATION OF THE UTERO-OVARIAN LIGAMENT. COAGULATION SECTION OF THE UTERO-OVARIAN LIGAMENT. WE CARRY OUT THE SAME PROCEDURE ON THE LEFT. RETROGRADE SALPINGECTOMY THE TUBE REMAINS ATTACHED TO THE UTERUS. THE OPENING OF THE POSTERIOR LAYER OF THE BROAD LIGAMENT IS CONTINUED WITH ULTRACISION UP TO THE UTEROSACRAL LIGAMENT. COAGULATION SECTION OF THE RIGHT AND LEFT UTEROSACRAL LIGAMENT. - SELECTIVE COAGULATION OF THE RIGHT AND THEN LEFT UTERINE ARTERY. EXTERIORISATION OF THE UTERUS THROUGH THE VAGINA. CIRCULAR COLPOTOMY TO FINALISE THE HYSTERECTOMY. CAREFUL VERIFICATION OF HAEMOSTASIS. VAGINAL CLOSURE WITH 3 VICRYL 0 X-SHAPED SUTURES. CLOSURE OF TROCAR ORIFICES WITH VICRYL 0 AND MONOCRYL 3.0. CONCLUSION: CONSERVATIVE TOTAL HYSTERECTOMY FOR ESSURE REMOVAL. THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS CODED WITH THE SAME MEDDRA PREFERRED TERM. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 05-SEP-2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: PRURITUS. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 97 CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THIS MEDDRA PT. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: UNABLE TO CONFIRM COMPLAINT. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 10-DEC-2024: NEW EVENTS HEAVY MENSES, BAD BREATH, VAGINAL DISCHARGE, MEMORY LOSS, VISION IMPAIRMENT, WEIGHT GAIN WERE ADDED. EVENT ITCHING UPDATED TO FACIAL ITCHING. EVENT OUTCOME ADDED. LAB DATA ADDED. ESSURE INSERTION & REMOVAL DATE & DETAILS UPDATED. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. CASE COMMENTS: 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2382661 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 810874 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other| R |