ESSURE
Report
- Report Number
- 2951250-2022-00006
- Event Type
- Injury
- Date Received
- January 3, 2022
- Report Date
- October 20, 2023
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN'), FALLOPIAN TUBE PERFORATION ('FALLOPIAN TUBE PERFORATION'), UTERINE PERFORATION ('PERFORATION OF UTERUS (MIGRATION OF THE ESSURE DEVICE TO THE ABDOMINAL OR PELVIC CAVITY)') AND PERFORATION ('PERFORATION OTHER ORGANS') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 904752) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "UNINTENDED PREGNANCY". ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA DISABILITY, MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA HOSPITALIZATION AND MEDICALLY SIGNIFICANT), UTERINE PERFORATION (SERIOUSNESS CRITERIA HOSPITALIZATION AND MEDICALLY SIGNIFICANT), PERFORATION (SERIOUSNESS CRITERIA HOSPITALIZATION AND MEDICALLY SIGNIFICANT), BACK PAIN ("CHRONIC BACK PAIN"), ABDOMINAL PAIN ("CHRONIC ABDOMINAL PAIN"), GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING"), HYPERSENSITIVITY ("ALLERGIC REACTON"), AUTOIMMUNE DISORDER ("AUTOIMMUNE REACTIONS"), HEADACHE ("HEADACHES"), FATIGUE ("CHRONIC FATIGUE"), WEIGHT FLUCTUATION ("WEIGHT CHANGES"), ALOPECIA ("HAIR LOSS"), TOOTH LOSS ("TOOTH LOSS"), MOOD ALTERED ("MOOD CHANGES"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY / MENTAL ANGUISH") AND STRESS ("PSYCHOLOGICAL STRESS") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("UNINTENDED PREGNANCY"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL ON (B)(6) 2021). ESSURE WAS REMOVED ON (B)(6) 2021. AT THE TIME OF THE REPORT, THE PELVIC PAIN, FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, BACK PAIN, ABDOMINAL PAIN, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, AUTOIMMUNE DISORDER, HEADACHE, FATIGUE, WEIGHT FLUCTUATION, ALOPECIA, TOOTH LOSS, MOOD ALTERED, DEPRESSION AND STRESS OUTCOME WAS UNKNOWN AND THE ANXIETY HAD NOT RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, AUTOIMMUNE DISORDER, BACK PAIN, DEPRESSION, FALLOPIAN TUBE PERFORATION, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, MOOD ALTERED, PELVIC PAIN, PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, STRESS, TOOTH LOSS, UTERINE PERFORATION AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. 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 11-JAN-2022: QUALITY SAFETY EVALUATION OF PTC. 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 ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN"), FALLOPIAN TUBE PERFORATION ("FALLOPIAN TUBE PERFORATION"), UTERINE PERFORATION ("PERFORATION OF UTERUS (MIGRATION OF THE ESSURE DEVICE TO THE ABDOMINAL OR PELVIC CAVITY)") AND PERFORATION ("PERFORATION OTHER ORGANS") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 904752) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE ("UNINTENDED PREGNANCY"). THE PATIENT HAD A MEDICAL HISTORY OF CESAREAN SECTION, VOMITING, LOOP ELECTROSURGICAL EXCISION PROCEDURE, GRAVIDA I, PARITY 1 AND CERVICAL DYSPLASIA. CONCURRENT CONDITIONS WERE LISTED AS MENORRHAGIA, ABDOMINAL PAIN, NAUSEA, ABDOMINAL PAIN AND PELVIC PAIN FEMALE. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ESSURE WAS REMOVED ON (B)(6) 2021. AN UNKNOWN TIME LATER SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA DISABILITY, MEDICALLY IMPORTANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA HOSPITALISATION AND MEDICALLY IMPORTANT), UTERINE PERFORATION (SERIOUSNESS CRITERIA HOSPITALISATION AND MEDICALLY IMPORTANT), PERFORATION (SERIOUSNESS CRITERIA HOSPITALISATION AND MEDICALLY IMPORTANT), PREGNANCY WITH CONTRACEPTIVE DEVICE ("UNINTENDED PREGNANCY"), BACK PAIN ("CHRONIC BACK PAIN"), ABDOMINAL PAIN ("CHRONIC ABDOMINAL PAIN"), GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING"), HYPERSENSITIVITY ("ALLERGIC REACTON"), AUTOIMMUNE DISORDER ("AUTOIMMUNE REACTIONS"), HEADACHE ("HEADACHES"), FATIGUE ("CHRONIC FATIGUE"), WEIGHT FLUCTUATION ("WEIGHT CHANGES"), ALOPECIA ("HAIR LOSS"), TOOTH LOSS ("TOOTH LOSS"), MOOD ALTERED ("MOOD CHANGES"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY/MENTAL ANGUISH") AND STRESS ("PSYCHOLOGICAL STRESS"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY HYSTEROSCOPY). AT THE TIME OF THE REPORT, THE ANXIETY HAD NOT RESOLVED. THE OUTCOMES FOR PELVIC PAIN, FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, BACK PAIN, ABDOMINAL PAIN, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, AUTOIMMUNE DISORDER, HEADACHE, FATIGUE, WEIGHT FLUCTUATION, ALOPECIA, TOOTH LOSS, MOOD ALTERED, DEPRESSION AND STRESS WERE UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE DELIVERY OCCURRED ON AN UNKNOWN DATE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, AUTOIMMUNE DISORDER, BACK PAIN, DEPRESSION, FALLOPIAN TUBE PERFORATION, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, MOOD ALTERED, PELVIC PAIN, PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, STRESS, TOOTH LOSS, UTERINE PERFORATION AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [HYSTEROSALPINGOGRAM] ON (B)(6) 2012: MICROFILAMENTS FROM A HYSTEROSCOPIC STERILIZATION ARE VISIBLE WITHIN BOTH FALLOPIAN TUBES. THE UTERINE CAVITY APPEARS NORMAL IN OUTLINE. NO CONTRAST FLOWED INTO THE FALLOPIAN TUBES. HSG DEMONSTRATED BILATERAL TUBAL OCCLUSION. [PATHOLOGY TEST] ON (B)(6) 2021: DIAGNOSIS: FALLOPIAN TUBES, BILATERAL SALPINGECTOMIES: BENIGN FALLOPIAN TUBES WITH PARATUBAL CYST. PROMINENT TUBAL AND PERITUBULAR VASCULAR DILATION. COILS AND WIRES PRESENT, COMPATIBLE WITH BIRTH CONTROL COILS. ENDOMETRIUM, CURETTAGE: PROLIFERATIVE ENDOMETRIUM WITH FOCAL DISORDERED FEATURES. NOTE: THE WIRES AND COILS WILL BE RETURNED PER PATIENT REQUEST. CLINICAL HISTORY: 35 Y/O F W PELVIC PAIN AND HX OF ESSURE CEILINGS. REMOVED IN OR AND SENT TO PATH. (COILING¿S). GROSS DESCRIPTION: RECEIVED LABELLED ENSURE COILS AND FALLOPIAN TUBES IN FORMALIN ARE TWO FIMBRIATED FALLOPIAN TUBES OF 6.3 X 1.7 X 1.3 CM WITH AVERAGE DIAMETER OF 0.6 CM. THE SECOND FALLOPIAN TUBE IS FIMBRIATED OF 7.0 X 1.0 X 0.7 CM WITH AN AVERAGE DIAMETER OF 0.6 CM. FROM THE PROXIMAL END, EXTENDS A THIN WIRE OF 14.0 CM IN LENGTH. AT THE END OF THIS WIRE, INSIDE THE TUBE, IS A 0.5 CM THICKER WIRE COIL. CROSS SECTION REVEALS A STELLATE LUMEN. ALSO RECEIVED IN THE SAME CONTAINER, ARE TWO THIN WIRES OF 32.0 CM AND 4.0 CM. A THIRD 13.0 CM WIRE, HAS A THICKER COIL OF 0.7 CM AT THE END OF IT. IN ADDITION, THERE ARE THREE THICKER WIRE COILS OF 0.7, 1.7, AND 1.2 CM TISSUES: FALLOPIAN TUBE - BILATERAL+ ESSURE COILS. UTERINE CURETTINGS - ENDOMETRIAL. [ULTRASOUND PELVIS] ON (B)(6) 2015: THE PATIENT HAS HAD PREVIOUS PLACEMENT OF ESSURE INSERTS. THE LEFT ESSURE INSERT IS IDENTIFIED WITH IN THE UPPER LEFT UTERINE SEGMENT. THE RIGHT ONE IS MORE DIFFICULT TO SEE AND IT DOES NOT APPEAR TO BE WITHIN THE RIGHT CORNUA. THE PATIENT REFUSED AN ENDOVAGINAL ULTRASOUND TODAY. EVALUATION OF THE POSITION OF THE ESSURE INSERTS WOULD REQUIRE AN ENDOVAGINAL ULTRASOUND. ON (B)(6) 2020: METALLIC COILS ARE NOTED WITHIN THE PELVIS. PLEASE CORRELATE WITH PATIENT HISTORY RIGHT-SIDED COIL APPEARS TO BE WITHIN THE FALLOPIAN TUBE.LEFT-SIDED COIL APPEARS TO BE MIGRATED INTO THE UTERUS/ENDOMETRIAL CAVITY AND ENCROACHING BEYOND THE UTERINE CONTOUR, UNDERLYING PERFORATION CANNOT BE EXCLUDED. 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: 13-OCT-2023: MEDICAL RECORD RECEIVED. SURGICAL PATHOLOGY TEST ADDED. MEDICAL HISTORY, LAB DATA, REPORTER INFORMATION UPDATED. 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'), FALLOPIAN TUBE PERFORATION ('FALLOPIAN TUBE PERFORATION'), UTERINE PERFORATION ('PERFORATION OF UTERUS (MIGRATION OF THE ESSURE DEVICE TO THE ABDOMINAL OR PELVIC CAVITY)') AND PERFORATION ('PERFORATION OTHER ORGANS') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 904752) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "UNINTENDED PREGNANCY". ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA DISABILITY, MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA HOSPITALIZATION AND MEDICALLY SIGNIFICANT), UTERINE PERFORATION (SERIOUSNESS CRITERIA HOSPITALIZATION AND MEDICALLY SIGNIFICANT), PERFORATION (SERIOUSNESS CRITERIA HOSPITALIZATION AND MEDICALLY SIGNIFICANT), BACK PAIN ("CHRONIC BACK PAIN"), ABDOMINAL PAIN ("CHRONIC ABDOMINAL PAIN"), GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING"), HYPERSENSITIVITY ("ALLERGIC REACTION"), AUTOIMMUNE DISORDER ("AUTOIMMUNE REACTIONS"), HEADACHE ("HEADACHES"), FATIGUE ("CHRONIC FATIGUE"), WEIGHT FLUCTUATION ("WEIGHT CHANGES"), ALOPECIA ("HAIR LOSS"), TOOTH LOSS ("TOOTH LOSS"), MOOD ALTERED ("MOOD CHANGES"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY / MENTAL ANGUISH") AND STRESS ("PSYCHOLOGICAL STRESS") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("UNINTENDED PREGNANCY"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL ON (B)(6) 2021). ESSURE WAS REMOVED ON (B)(6) 2021. AT THE TIME OF THE REPORT, THE PELVIC PAIN, FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, BACK PAIN, ABDOMINAL PAIN, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, AUTOIMMUNE DISORDER, HEADACHE, FATIGUE, WEIGHT FLUCTUATION, ALOPECIA, TOOTH LOSS, MOOD ALTERED, DEPRESSION AND STRESS OUTCOME WAS UNKNOWN AND THE ANXIETY HAD NOT RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, AUTOIMMUNE DISORDER, BACK PAIN, DEPRESSION, FALLOPIAN TUBE PERFORATION, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, MOOD ALTERED, PELVIC PAIN, PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, STRESS, TOOTH LOSS, UTERINE PERFORATION AND WEIGHT FLUCTUATION TO BE RELATED TO 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 |
|---|---|---|---|---|---|---|---|
| 96523 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 904752 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other| H| R| S |