ESSURE
Report
- Report Number
- 2951250-2020-14770
- Event Type
- Injury
- Date Received
- October 2, 2020
- Report Date
- October 7, 2020
- 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
Narratives
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM, REFERENCE NUMBER: (B)(4)) ON 29-SEP-2020. THE MOST RECENT INFORMATION WAS RECEIVED ON 06-OCT-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ('NICKEL INTOLERANCE, METAL ALLERGY') AND DEVICE BREAKAGE ('ESSURE TORN INTO PIECES IN THE UTERUS AND NOT REMOVED CORRECTLY / A FRAGMENT OF ESSURE WAS FOUND AROUND THE RIGHT UTERINE HORN AND NOT REMOVED CORRECTLY (ON FIRST SURGERY)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810874) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(4) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FATIGUE ("CHRONIC FATIGUE"), SLEEP DISORDER ("DISTURBED SLEEP"), DEAFNESS ("HEARING LOSS"), DIZZINESS ("DIZZINESS"), RHINITIS ALLERGIC ("ALLERGIC RHINITIS"), ASTHMA ("ASTHMA"), POOR PERIPHERAL CIRCULATION ("POOR BLOOD CIRCULATION (ANKLES AND FEET) / POOR BLOOD CIRCULATION") WITH LIMB DISCOMFORT, CONSTIPATION ("CONSTIPATION"), ABDOMINAL DISTENSION ("BLOATING"), BALANCE DISORDER ("LOSS OF BALANCE"), AMNESIA ("MEMORY LOSS"), HYPERHIDROSIS ("EXCESSIVE SWEATING"), LOOSE TOOTH ("LOOSE TEETH"), ALOPECIA ("ABNORMAL HAIR LOSS"), URTICARIA ("HIVES"), VISION BLURRED ("BLURRED VISION"), SWELLING OF EYELID ("PERMANENT LOWER EYELID SWELLING"), ARTHRALGIA ("JOINT PAIN"), LIGAMENT PAIN ("CHRONIC TENDON AND LIGAMENT PAIN"), TENDON PAIN ("CHRONIC TENDON AND LIGAMENT PAIN"), MYALGIA ("MUSCLE PAIN"), MUSCLE ATROPHY ("MUSCLE ATROPHY"), TEMPERATURE INTOLERANCE ("COLD ALLERGY") AND COMPLICATION OF DEVICE REMOVAL ("ESSURE DEVICE NOT REMOVED CORRECTLY"). THE PATIENT WAS TREATED WITH SURGERY (5MM RESECTION OF THE TUBES AROUND THE PROXIMAL PART OF THE ISTHMUS ON (B)(6) 2017 AND 2ND OPERATION ON (B)(6) 2020 VIA LAPAROSCOPY - BILATERAL SALPINGECTOMY AND HYSTERECTOMY) AND VISION CORRECTION. ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE ALLERGY TO METALS, DEVICE BREAKAGE, FATIGUE, SLEEP DISORDER, DEAFNESS, DIZZINESS, RHINITIS ALLERGIC, ASTHMA, POOR PERIPHERAL CIRCULATION, CONSTIPATION, ABDOMINAL DISTENSION, BALANCE DISORDER, AMNESIA, HYPERHIDROSIS, LOOSE TOOTH, ALOPECIA, URTICARIA, VISION BLURRED, SWELLING OF EYELID, ARTHRALGIA, LIGAMENT PAIN, TENDON PAIN, MYALGIA, MUSCLE ATROPHY, TEMPERATURE INTOLERANCE AND COMPLICATION OF DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALLERGY TO METALS, ALOPECIA, AMNESIA, ARTHRALGIA, ASTHMA, BALANCE DISORDER, COMPLICATION OF DEVICE REMOVAL, CONSTIPATION, DEAFNESS, DEVICE BREAKAGE, DIZZINESS, FATIGUE, HYPERHIDROSIS, LIGAMENT PAIN, LOOSE TOOTH, MUSCLE ATROPHY, MYALGIA, POOR PERIPHERAL CIRCULATION, RHINITIS ALLERGIC, SLEEP DISORDER, SWELLING OF EYELID, TEMPERATURE INTOLERANCE, TENDON PAIN, URTICARIA AND VISION BLURRED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2017, FIRST OPERATION WAS PERFORMED, VIA LAPAROSCOPY (SURGICAL REPORT EXTRACT "5 MM RESECTION OF THE TUBES AROUND THE PROXIMAL PART OF THE ISTHMUS USING A MONOPOLAR SCALPEL, REMOVING THE IMPLANTS") POORLY CARRIED OUT. ON (B)(6) 2020, ABDOMINAL X-RAY SHOWED A PERSISTENT FRAGMENT. ESSURE DEVICE TORN INTO PIECES IN THE UTERUS AND WAS NOT REMOVED CORRECTLY. HOWEVER, THE SURGICAL CONCLUSION WAS THAT THE DEVICE HAD BEEN CORRECTLY REMOVED. ON (B)(6) 2020, A SECOND OPERATION VIA LAPAROSCOPY WAS PERFORMED ("THE TUBES WERE STILL ALMOST INTACT. A FRAGMENT OF ESSURE WAS FOUND AROUND THE RIGHT UTERINE HORN"). BILATERAL SALPINGECTOMY AFTER COAGULATION OF THE MESOSALPINX USING BIPOLAR FORCEPS. THERMOCOAGULATION USING BIPOLAR FORCEPS FOLLOWED BY SCISSOR SECTIONING OF THE LUMBO-OVARIAN PEDICLES AND THEN OF THE ROUND LIGAMENTS. COAGULATION-SECTION OF THE LEFT UTERINE ARTERY FOLLOWED BY THE RIGHT. VESICO-UTERINE DISSECTION WAS INITIATED. VAGINAL APPROACH. PERICERVICAL COLPOTOMY USING A COLD SCALPEL. VESICO-UTERINE DISSECTION INITIATED USING A COLD SCALPEL AND COMPLETED USING A FINGER. OPENING OF THE POUCH OF DOUGLAS. THERMOFUSION-SECTION OF THE LEFT THEN RIGHT CARDINAL LIGAMENT USING BICLAMP FORCEPS. REMOVAL OF THE SURGICAL SECTION WHERE THE DEVICE WAS COMPLETELY REMOVED, IN ADDITION TO A SALPINGECTOMY AND HYSTERECTOMY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ABDOMINAL X-RAY - ON (B)(6) 2020: SHOWS A PERSISTENT FRAGMENT OF ESSURE. LOT NUMBER: 810874 MANUFACTURING DATE: 2010-12 EXPIRATION DATE: 2013-12. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-OCT-2020: QUALITY-SAFETY EVALUATION OF PTC. AMENDMENT PERFORMED: AFTER INTERNAL REVIEW, THE INFORMATION "HEAVY FEELING IN THE LEGS" WAS CONSIDERED AS SYMPTOM FROM EVENT "POOR BLOOD CIRCULATION", MALFUNCTION FIELD WAS SELECTED AND REMOVAL DATE UPDATED TO (B)(6) 2020. 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 ((B)(6), REFERENCE NUMBER: (B)(4)) ON 29-SEP-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A REGULATORY AUTHORITY AND DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ('NICKEL INTOLERANCE, METAL ALLERGY') AND DEVICE BREAKAGE ('A FRAGMENT OF ESSURE WAS FOUND AROUND THE RIGHT UTERINE HORN AND NOT REMOVED CORRECTLY (ON FIRST SURGERY)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810874) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THIS SPONTANEOUS CASE WAS REPORTED BY A REGULATORY AUTHORITY AND DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ('NICKEL INTOLERANCE, METAL ALLERGY') AND DEVICE BREAKAGE ('A FRAGMENT OF ESSURE WAS FOUND AROUND THE RIGHT UTERINE HORN AND NOT REMOVED CORRECTLY (ON FIRST SURGERY)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810874) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2020, THE PATIENT EXPERIENCED COMPLICATION OF DEVICE REMOVAL ("ESSURE DEVICE TORN INTO PIECES IN THE UTERUS AND NOT REMOVED CORRECTLY"), 9 YEARS 2 MONTHS AFTER INSERTION AND 3 YEARS 2 MONTHS AFTER REMOVAL OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FATIGUE ("CHRONIC FATIGUE"), SLEEP DISORDER ("DISTURBED SLEEP"), DEAFNESS ("HEARING LOSS"), DIZZINESS ("DIZZINESS"), RHINITIS ALLERGIC ("ALLERGIC RHINITIS"), ASTHMA ("ASTHMA"), CARDIOVASCULAR DISORDER ("POOR BLOOD CIRCULATION (ANKLES AND FEET) / POOR BLOOD CIRCULATION"), CONSTIPATION ("CONSTIPATION"), ABDOMINAL DISTENSION ("BLOATING"), BALANCE DISORDER ("LOSS OF BALANCE"), AMNESIA ("MEMORY LOSS"), HYPERHIDROSIS ("EXCESSIVE SWEATING"), LOOSE TOOTH ("LOOSE TEETH"), ALOPECIA ("ABNORMAL HAIR LOSS"), URTICARIA ("HIVES"), VISION BLURRED ("BLURRED VISION"), SWELLING OF EYELID ("PERMANENT LOWER EYELID SWELLING"), ARTHRALGIA ("JOINT PAIN"), LIGAMENT PAIN ("CHRONIC TENDON AND LIGAMENT PAIN"), TENDON PAIN ("CHRONIC TENDON AND LIGAMENT PAIN"), MYALGIA ("MUSCLE PAIN"), MUSCLE ATROPHY ("MUSCLE ATROPHY") AND TEMPERATURE INTOLERANCE ("COLD ALLERGY"). THE PATIENT WAS TREATED WITH SURGERY (ACTION TAKEN TO TREAT THE PATIENT IN THE HEALTHCARE FACILITY: 2ND OPERATION ON (B)(6) 2020 VIA LAPARO, BILATERAL SALPINGECTOMY AND A HYSTERECTOMY ON (B)(6) 2020 AND RESECTION OF THE TUBES AROUND THE PROXIMAL PART OF THE ISTHMUS N (B)(6) 2017). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE ALLERGY TO METALS, DEVICE BREAKAGE, FATIGUE, SLEEP DISORDER, DEAFNESS, DIZZINESS, RHINITIS ALLERGIC, ASTHMA, CARDIOVASCULAR DISORDER, CONSTIPATION, ABDOMINAL DISTENSION, BALANCE DISORDER, AMNESIA, HYPERHIDROSIS, LOOSE TOOTH, ALOPECIA, URTICARIA, VISION BLURRED, SWELLING OF EYELID, ARTHRALGIA, LIGAMENT PAIN, TENDON PAIN, MYALGIA AND MUSCLE ATROPHY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALLERGY TO METALS, ALOPECIA, AMNESIA, ARTHRALGIA, ASTHMA, BALANCE DISORDER, CARDIOVASCULAR DISORDER, COMPLICATION OF DEVICE REMOVAL, CONSTIPATION, DEAFNESS, DEVICE BREAKAGE, DIZZINESS, FATIGUE, HYPERHIDROSIS, LIGAMENT PAIN, LOOSE TOOTH, MUSCLE ATROPHY, MYALGIA, RHINITIS ALLERGIC, SLEEP DISORDER, SWELLING OF EYELID, TEMPERATURE INTOLERANCE, TENDON PAIN, URTICARIA AND VISION BLURRED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: "HEAVY FEELING IN THE LEGS" AND "VISION CORRECTION" WERE REPORTED WITH THE ADVERSE EVENTS. 2ND OPERATION ON (B)(6) 2020 VIA LAPAROSCOPY ("THE TUBES ARE STILL ALMOST INTACT. A FRAGMENT OF ESSURE WAS FOUND AROUND THE RIGHT UTERINE HORN. BILATERAL SALPINGECTOMY AFTER COAGULATION OF THE MESOSALPINX USING BIPOLAR FORCEPS. THERMOCOAGULATION USING BIPOLAR FORCEPS FOLLOWED BY SCISSOR SECTIONING OF THE LUMBO-OVARIAN PEDICLES AND THEN OF THE ROUND LIGAMENTS. COAGULATION-SECTION OF THE LEFT UTERINE ARTERY FOLLOWED BY THE RIGHT. VESICO-UTERINE DISSECTION WAS INITIATED. VAGINAL APPROACH. PERICERVICAL COLPOTOMY USING A COLD SCALPEL. VESICO-UTERINE DISSECTION INITIATED USING A COLD SCALPEL AND COMPLETED USING A FINGER. OPENING OF THE POUCH OF DOUGLAS. THERMOFUSION-SECTION OF THE LEFT THEN RIGHT CARDINAL LIGAMENT USING BICLAMP FORCEPS. REMOVAL OF THE SURGICAL SECTION.") WHERE THE DEVICE WAS COMPLETELY REMOVED IN ADDITION TO A SALPINGECTOMY AND A HYSTERECTOMY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ABDOMINAL X-RAY - ON (B)(6) 2020: SHOWS A PERSISTENT FRAGMENT OF ESSURE.. 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 |
|---|---|---|---|---|---|---|---|
| 1084413 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 810874 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |