ESSURE
Report
- Report Number
- 2951250-2020-14686
- Event Type
- Injury
- Date Received
- September 25, 2020
- Report Date
- February 8, 2022
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('FOREIGN BODY MATERIAL HAS BEEN REMOVED') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 915889) INSERTED. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. LOT NUMBER: 915889, MANUFACTURING DATE:2011-10, EXPIRATION DATE:2014-10. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-SEP-2020: QUALITY SAFETY EVALUATION OF PTC. ON 28-SEP-2020: HEALTH AUTHORITY REFERENCE NUMBER ADDED. 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 CONSUMER VIA A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION OF THE FALLOPIAN TUBES'), UTERINE PERFORATION ('PERFORATION OF UTERUS') AND DEVICE DISLOCATION ('ESSURE MIGRATION') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 915889) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), MENSTRUAL DISORDER ("CHANGES IN MENSTRUAL CYCLE"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), AUTOIMMUNE DISORDER ("AUTOIMMUNE PROBLEMS"), BLADDER DISORDER ("BLADDER PROBLEMS"), DYSPAREUNIA ("DYSPAREUNIA"), MENTAL DISORDER ("PSYCHOLOGICAL PROBLEMS"), FEELING ABNORMAL ("BRAIN FOG"), AMNESIA ("MEMORY LOSS"), TOOTH DISORDER ("DENTAL PROBLEMS"), NEURALGIA ("NEURALGIA IN HER RIGHT LEG"), CYST ("CYSTS"), URTICARIA ("HIVES") AND HEADACHE ("HEADACHE"). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, DEVICE DISLOCATION, PELVIC PAIN, GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, HYPERSENSITIVITY, AUTOIMMUNE DISORDER, BLADDER DISORDER, DYSPAREUNIA, MENTAL DISORDER, FEELING ABNORMAL, AMNESIA, TOOTH DISORDER, NEURALGIA, CYST, URTICARIA AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED AMNESIA, AUTOIMMUNE DISORDER, BLADDER DISORDER, CYST, DEVICE DISLOCATION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FEELING ABNORMAL, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, MENSTRUAL DISORDER, MENTAL DISORDER, NEURALGIA, PELVIC PAIN, TOOTH DISORDER, URTICARIA AND UTERINE PERFORATION TO BE RELATED TO ESSURE. LOT NUMBER: 915889, MANUFACTURING DATE: 2011-10, AND EXPIRATION DATE: 2014-10. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-JAN-2022: FOLLOW UP WAS RECEIVED VIA LAWYER: EVENTS (PREVIOUS EVENT: MEDICAL DEVICE REMOVAL) WERE SPECIFIED: PAIN, ABNORMAL BLEEDING, MIGRATION OF ESSURE, CHANGES IN MENSTRUAL CYCLE, ALLERGIC REACTIONS, AUTOIMMUNE PROBLEMS, BLADDER PROBLEMS, DYSPAREUNIA, PERFORATION OF THE FALLOPIAN TUBES, UTERINE PERFORATION, PSYCHOLOGICAL PROBLEMS, BRAIN FOG AND MEMORY LOSS, DENTAL PROBLEMS, NEURALGIA IN HER RIGHT LEG, CYSTS, HIVES AND HEADACHE. 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 CONSUMER VIA A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION OF THE FALLOPIAN TUBES'), UTERINE PERFORATION ('PERFORATION OF UTERUS') AND DEVICE DISLOCATION ('ESSURE MIGRATION') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 915889) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), MENSTRUAL DISORDER ("CHANGES IN MENSTRUAL CYCLE"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), AUTOIMMUNE DISORDER ("AUTOIMMUNE PROBLEMS"), BLADDER DISORDER ("BLADDER PROBLEMS"), DYSPAREUNIA ("DYSPAREUNIA"), MENTAL DISORDER ("PSYCHOLOGICAL PROBLEMS"), FEELING ABNORMAL ("BRAIN FOG"), AMNESIA ("MEMORY LOSS"), TOOTH DISORDER ("DENTAL PROBLEMS"), NEURALGIA ("NEURALGIA IN HER RIGHT LEG"), CYST ("CYSTS"), URTICARIA ("HIVES") AND HEADACHE ("HEADACHE"). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, DEVICE DISLOCATION, PELVIC PAIN, GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, HYPERSENSITIVITY, AUTOIMMUNE DISORDER, BLADDER DISORDER, DYSPAREUNIA, MENTAL DISORDER, FEELING ABNORMAL, AMNESIA, TOOTH DISORDER, NEURALGIA, CYST, URTICARIA AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED AMNESIA, AUTOIMMUNE DISORDER, BLADDER DISORDER, CYST, DEVICE DISLOCATION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FEELING ABNORMAL, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, MENSTRUAL DISORDER, MENTAL DISORDER, NEURALGIA, PELVIC PAIN, TOOTH DISORDER, URTICARIA AND UTERINE PERFORATION TO BE RELATED TO ESSURE. LOT NUMBER: 915889. MANUFACTURING DATE:2011-10. EXPIRATION DATE:2014-10. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: TYPE OF REPORT UPDATED TO FINAL, NO NEW ADDITIONAL INFORMATION. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. 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 CONSUMER VIA LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION OF THE FALLOPIAN TUBES'), UTERINE PERFORATION ('PERFORATION OF UTERUS') AND DEVICE DISLOCATION ('ESSURE MIGRATION') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 915889) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), MENSTRUAL DISORDER ("CHANGES IN MENSTRUAL CYCLE"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), AUTOIMMUNE DISORDER ("AUTOIMMUNE PROBLEMS"), BLADDER DISORDER ("BLADDER PROBLEMS"), DYSPAREUNIA ("DYSPAREUNIA"), MENTAL DISORDER ("PSYCHOLOGICAL PROBLEMS"), FEELING ABNORMAL ("BRAIN FOG"), AMNESIA ("MEMORY LOSS"), TOOTH DISORDER ("DENTAL PROBLEMS"), NEURALGIA ("NEURALGIA IN HER RIGHT LEG"), CYST ("CYSTS"), URTICARIA ("HIVES") AND HEADACHE ("HEADACHE"). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, DEVICE DISLOCATION, PELVIC PAIN, GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, HYPERSENSITIVITY, AUTOIMMUNE DISORDER, BLADDER DISORDER, DYSPAREUNIA, MENTAL DISORDER, FEELING ABNORMAL, AMNESIA, TOOTH DISORDER, NEURALGIA, CYST, URTICARIA AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED AMNESIA, AUTOIMMUNE DISORDER, BLADDER DISORDER, CYST, DEVICE DISLOCATION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FEELING ABNORMAL, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, MENSTRUAL DISORDER, MENTAL DISORDER, NEURALGIA, PELVIC PAIN, TOOTH DISORDER, URTICARIA AND UTERINE PERFORATION TO BE RELATED TO ESSURE. LOT NUMBER: 915889. MANUFACTURING DATE:2011-10. EXPIRATION DATE:2014-10. 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 7-FEB-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 REPORTED BY A LAWYER, AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('FOREIGN BODY MATERIAL HAS BEEN REMOVED'). IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 915889) INSERTED. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. LOT NUMBER#: 915889, MANUFACTURING DATE: 2011-10, EXPIRATION DATE: 2014-10 . QUALITY SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021, NEW REPORTER (LAWYER) ADDED AND THE PATIENT´S INITIALS UPDATED. NO NEW CLINICAL INFORMATION RECEIVED. UPDATE TO IMDRF/FDA CODES ONLY. 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 MEDICAL DEVICE REMOVAL ('FOREIGN BODY MATERIAL HAS BEEN REMOVED') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 915889) INSERTED. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-SEP-2020: QUALITY SAFETY EVALUATION OF PTC. ON 23-SEP-2020: CASE UPGRADED TO SERIOUS INCIDENT. EVENT "FOREIGN BODY MATERIAL HAS BEEN REMOVED" ADDED. 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 |
|---|---|---|---|---|---|---|---|
| 1054441 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 915889 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention| O |