ESSURE
Report
- Report Number
- 2951250-2019-06320
- Event Type
- Injury
- Date Received
- September 12, 2019
- Date of Event
- March 1, 2014
- Report Date
- January 28, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION FALLOPIAN TUBES / MIGRATION/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: INTO LEFT FALLOPIAN TUBE CAUSING PERFORATION'), MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL)'), UTERINE HAEMORRHAGE ('ABNORMAL BLEEDING(GENERAL) UTERINE/ABNORMAL UTERINE BLEEDING') AND RECTAL HAEMORRHAGE ('ABNORMAL BLEEDING(GENERAL) RECTAL') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910616-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED IRREGULAR PERIODS, INSOMNIA, CERVICAL DYSPLASIA, ESOPHAGEAL REFLUX AND HERPES SIMPLEX. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVE PILLS. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, SULFONAMIDE ALLERGY, GENITAL HEMORRHAGE AND INTRAUTERINE SYNECHIAE. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN/CRAMPING IN ABDOMEN"), BACK PAIN ("BACK PAIN/BILATERAL BACK PAIN"), ADNEXA UTERI PAIN ("BILATERAL BACK PAIN IN AREAS OF FALLOPIAN TUBES"), FEEDING DISORDER ("UNABLE TO EAT"), IMPAIRED WORK ABILITY ("UNABLE TO WORK") AND LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("UNABLE TO GET OUT OF BED") AND WAS FOUND TO HAVE WEIGHT INCREASED ("OTHER INJURIES/SYMPTOMS: WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), RECTAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), DEPRESSION ("PSYCH INJURY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), FATIGUE ("OTHER INJURIES/SYMPTOMS: FATIGUE"), HEADACHE ("OTHER INJURIES/SYMPTOMS: HEADACHES"), MIGRAINE ("OTHER INJURIES/SYMPTOMS: MIGRAINE"), NAUSEA ("OTHER INJURIES/SYMPTOMS: NAUSEA"), PROCEDURAL PAIN ("OTHER SPINAL PAIN POST HYSTERECTOMY") AND ANXIETY ("ANXIETY"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND SALPINGECTOMY (BILATERAL), HYSTERECTOMY (FULL)). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, MENORRHAGIA, UTERINE HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA AND PROCEDURAL PAIN HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, RECTAL HAEMORRHAGE, DEPRESSION, FATIGUE, WEIGHT INCREASED, HEADACHE, MIGRAINE, NAUSEA, ANXIETY, BACK PAIN, ADNEXA UTERI PAIN, FEEDING DISORDER, IMPAIRED WORK ABILITY AND LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADNEXA UTERI PAIN, ANXIETY, BACK PAIN, DEPRESSION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, FEEDING DISORDER, HEADACHE, IMPAIRED WORK ABILITY, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, PROCEDURAL PAIN, RECTAL HAEMORRHAGE, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE ),MENORRHAGIA (HEAVY MENSTRUAL BLEEDING),PSYCH INJURY, MIGRATION, PERFORATION FALLOPIAN TUBES,FATIGUE, WEIGHT GAIN, OTHER, HEADACHES, MIGRAINE, NAUSEA,SPINAL PAIN. THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS FROM 1 FIRST TUBE AND WAS 3 FROM THE SECOND TUBE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.7 KG/SQM. PATHOLOGY TEST - ON (B)(6) 2014: CERVIX AND UTERUS WITH BILATERAL TUBES: INTRAMURAL LEIOMYOMA, 1.1 CM IN LARGEST DIMENSION. PROLIFERATIVE ENDOMETRIUM WITHOUT HYPERPLASIA, ATYPIA OR POLYPS. BILATERAL FALLOPIAN TUBES, WITH INTRATUBAL FOREIGN BODY (METALLIC WIRE) MILD CHRONIC CERVICITIS. POSTERIOR SEROSAL SURFACE, WITH FOCAL CONGESTION AND HEMORRHAGE.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: FATIGUE, DEPRESSION, ABNORMAL UTERINE BLEEDING, MENORRHAGIA AND PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-SEP-2019: UPDATE OF INFORMATION (BATCH IS NOT VALID). NO VALID LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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 FALLOPIAN TUBE PERFORATION ('PERFORATION FALLOPIAN TUBES / MIGRATION/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: INTO LEFT FALLOPIAN TUBE CAUSING PERFORATION'), MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)') AND VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910616-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED IRREGULAR PERIODS, INSOMNIA, CERVICAL DYSPLASIA, ESOPHAGEAL REFLUX AND HERPES SIMPLEX. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVE PILLS. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, SULFONAMIDE ALLERGY, GENITAL HEMORRHAGE AND INTRAUTERINE SYNECHIAE. ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2013, THE PATIENT EXPERIENCED FATIGUE ("OTHER INJURIES/SYMPTOMS: FATIGUE"). IN (B)(6)2014, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN/CRAMPING IN ABDOMEN"), BACK PAIN ("BACK PAIN/BILATERAL BACK PAIN"), ADNEXA UTERI PAIN ("BILATERAL BACK PAIN IN AREAS OF FALLOPIAN TUBES"), FEEDING DISORDER ("UNABLE TO EAT"), IMPAIRED WORK ABILITY ("UNABLE TO WORK"), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("UNABLE TO GET OUT OF BED") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("OTHER INJURIES/SYMPTOMS: WEIGHT GAIN"). IN (B)(6)2014, THE PATIENT EXPERIENCED UTERINE HAEMORRHAGE ("ABNORMAL BLEEDING(GENERAL) UTERINE/ABNORMAL UTERINE BLEEDING"). IN (B)(6)2014, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), RECTAL HAEMORRHAGE ("ABNORMAL BLEEDING(GENERAL) RECTAL"), DEPRESSION ("PSYCH INJURY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), HEADACHE ("OTHER INJURIES/SYMPTOMS: HEADACHES"), MIGRAINE ("OTHER INJURIES/SYMPTOMS: MIGRAINE") AND NAUSEA ("OTHER INJURIES/SYMPTOMS: NAUSEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), PROCEDURAL PAIN ("OTHER SPINAL PAIN POST HYSTERECTOMY") AND ANXIETY ("ANXIETY"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND SALPINGECTOMY (BILATERAL), HYSTERECTOMY (FULL)). ESSURE WAS REMOVED ON (B)(6)2014. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, MENORRHAGIA, UTERINE HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA AND PROCEDURAL PAIN HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, RECTAL HAEMORRHAGE, DEPRESSION, FATIGUE, WEIGHT INCREASED, HEADACHE, MIGRAINE, NAUSEA, ANXIETY, BACK PAIN, ADNEXA UTERI PAIN, FEEDING DISORDER, IMPAIRED WORK ABILITY, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ADNEXA UTERI PAIN, ANXIETY, BACK PAIN, DEPRESSION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, FEEDING DISORDER, HEADACHE, IMPAIRED WORK ABILITY, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, PROCEDURAL PAIN, RECTAL HAEMORRHAGE, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE ),MENORRHAGIA (HEAVY MENSTRUAL BLEEDING),PSYCH INJURY, MIGRATION, PERFORATION FALLOPIAN TUBES,FATIGUE, WEIGHT GAIN, OTHER, HEADACHES, MIGRAINE, NAUSEA,SPINAL PAIN. THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS FROM 1 FIRST TUBE AND WAS 3 FROM THE SECOND TUBE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.7 KG/SQM. PATHOLOGY TEST - ON (B)(6)2014: CERVIX AND UTERUS WITH BILATERAL TUBES: 1. INTRAMURAL LEIOMYOMA, 1.1 CM IN LARGEST DIMENSION. 2. PROLIFERATIVE ENDOMETRIUM WITHOUT HYPERPLASIA, ATYPIA OR POLYPS. 3. BILATERAL FALLOPIAN TUBES, WITH INTRATUBAL FOREIGN BODY (METALLIC WIRE) 4. MILD CHRONIC CERVICITIS. 5. POSTERIOR SEROSAL SURFACE, WITH FOCAL CONGESTION AND HEMORRHAGE.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: FATIGUE, DEPRESSION, ABNORMAL UTERINE BLEEDING, MENORRHAGIA AND PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-JAN-2020: PFS RECEIVED- NEW EVENT LOWER ABDOMINAL PAIN WAS ADDED. ONSET DATE OF THE EVENT ABNORMAL BLEEDING(GENERAL) UTERINE BLEEDING AND RECTAL, ABNORMAL BLEEDING (VAGINAL), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), DEPRESSION, MIGRAINE AND HEADACHE WAS ADDED. 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION FALLOPIAN TUBES / MIGRATION/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: INTO LEFT FALLOPIAN TUBE CAUSING PERFORATION'), MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)'), UTERINE HAEMORRHAGE ('ABNORMAL BLEEDING(GENERAL) UTERINE/ABNORMAL UTERINE BLEEDING') AND RECTAL HAEMORRHAGE ('ABNORMAL BLEEDING(GENERAL) RECTAL') IN AN ADULT 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 MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN/CRAMPING IN ABDOMEN"), BACK PAIN ("BACK PAIN/BILATERAL BACK PAIN"), ADNEXA UTERI PAIN ("BILATERAL BACK PAIN IN AREAS OF FALLOPIAN TUBES"), FEEDING DISORDER ("UNABLE TO EAT"), IMPAIRED WORK ABILITY ("UNABLE TO WORK") AND LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("UNABLE TO GET OUT OF BED") AND WAS FOUND TO HAVE WEIGHT INCREASED ("OTHER INJURIES/SYMPTOMS: WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), RECTAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), DEPRESSION ("PSYCH INJURY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), FATIGUE ("OTHER INJURIES/SYMPTOMS: FATIGUE"), HEADACHE ("OTHER INJURIES/SYMPTOMS: HEADACHES"), MIGRAINE ("OTHER INJURIES/SYMPTOMS: MIGRAINE"), NAUSEA ("OTHER INJURIES/SYMPTOMS: NAUSEA"), PROCEDURAL PAIN ("OTHER SPINAL PAIN POST HYSTERECTOMY"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND ANXIETY ("ANXIETY"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND SALPINGECTOMY (BILATERAL), HYSTERECTOMY (FULL)). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, MENORRHAGIA, UTERINE HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA AND PROCEDURAL PAIN HAD RESOLVED AND THE RECTAL HAEMORRHAGE, DEPRESSION, FATIGUE, WEIGHT INCREASED, HEADACHE, MIGRAINE, NAUSEA, VAGINAL HAEMORRHAGE, ANXIETY, BACK PAIN, ADNEXA UTERI PAIN, FEEDING DISORDER, IMPAIRED WORK ABILITY AND LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADNEXA UTERI PAIN, ANXIETY, BACK PAIN, DEPRESSION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, FEEDING DISORDER, HEADACHE, IMPAIRED WORK ABILITY, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, PROCEDURAL PAIN, RECTAL HAEMORRHAGE, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE ),MENORRHAGIA (HEAVY MENSTRUAL BLEEDING),PSYCH INJURY, MIGRATION, PERFORATION FALLOPIAN TUBES,FATIGUE, WEIGHT GAIN, OTHER, HEADACHES, MIGRAINE, NAUSEA,SPINAL PAIN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.7 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-SEP-2019: PFS RECEIVED WITH HER DEMOGRAPHIC DETAILS(DATE OF BIRTH) UPDATED. EVENTS- ABNORMAL BLEEDING(GENERAL) UTERINE/ABNORMAL UTERINE BLEEDING, ABNORMAL BLEEDING(GENERAL) RECTAL, ABNORMAL BLEEDING (VAGINAL), ANXIETY, BACK PAIN/BILATERAL BACK PAIN, BILATERAL BACK PAIN IN AREAS OF FALLOPIAN TUBES, UNABLE TO EAT, UNABLE TO WORK AND UNABLE TO GET OUT OF BED WERE ADDED. EVENT PT TERM UPDATED: FROM ¿PSYCHOLOGICAL TRAUMA¿ TO DEPRESSION. EVENT SEVERITY ADDED FOR: ABDOMINAL PAIN. EVENT CLUBBED: ABDOMINAL PAIN/CRAMPING IN ABDOMEN. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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 FALLOPIAN TUBE PERFORATION ('PERFORATION FALLOPIAN TUBES / MIGRATION/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: INTO LEFT FALLOPIAN TUBE CAUSING PERFORATION'), MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL)'), UTERINE HAEMORRHAGE ('ABNORMAL BLEEDING(GENERAL) UTERINE/ABNORMAL UTERINE BLEEDING') AND RECTAL HAEMORRHAGE ('ABNORMAL BLEEDING(GENERAL) RECTAL') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910616) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED IRREGULAR PERIODS, INSOMNIA, CERVICAL DYSPLASIA, ESOPHAGEAL REFLUX AND HERPES SIMPLEX. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVE PILLS. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, SULFONAMIDE ALLERGY, GENITAL HEMORRHAGE AND INTRAUTERINE SYNECHIAE. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN/CRAMPING IN ABDOMEN"), BACK PAIN ("BACK PAIN/BILATERAL BACK PAIN"), ADNEXA UTERI PAIN ("BILATERAL BACK PAIN IN AREAS OF FALLOPIAN TUBES"), FEEDING DISORDER ("UNABLE TO EAT"), IMPAIRED WORK ABILITY ("UNABLE TO WORK") AND LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("UNABLE TO GET OUT OF BED") AND WAS FOUND TO HAVE WEIGHT INCREASED ("OTHER INJURIES/SYMPTOMS: WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), RECTAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), DEPRESSION ("PSYCH INJURY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), FATIGUE ("OTHER INJURIES/SYMPTOMS: FATIGUE"), HEADACHE ("OTHER INJURIES/SYMPTOMS: HEADACHES"), MIGRAINE ("OTHER INJURIES/SYMPTOMS: MIGRAINE"), NAUSEA ("OTHER INJURIES/SYMPTOMS: NAUSEA"), PROCEDURAL PAIN ("OTHER SPINAL PAIN POST HYSTERECTOMY") AND ANXIETY ("ANXIETY"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND SALPINGECTOMY (BILATERAL), HYSTERECTOMY (FULL)). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, MENORRHAGIA, UTERINE HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA AND PROCEDURAL PAIN HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, RECTAL HAEMORRHAGE, DEPRESSION, FATIGUE, WEIGHT INCREASED, HEADACHE, MIGRAINE, NAUSEA, ANXIETY, BACK PAIN, ADNEXA UTERI PAIN, FEEDING DISORDER, IMPAIRED WORK ABILITY AND LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADNEXA UTERI PAIN, ANXIETY, BACK PAIN, DEPRESSION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, FEEDING DISORDER, HEADACHE, IMPAIRED WORK ABILITY, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, PROCEDURAL PAIN, RECTAL HAEMORRHAGE, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE ),MENORRHAGIA (HEAVY MENSTRUAL BLEEDING),PSYCH INJURY, MIGRATION, PERFORATION FALLOPIAN TUBES,FATIGUE, WEIGHT GAIN, OTHER, HEADACHES, MIGRAINE, NAUSEA,SPINAL PAIN. THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS FROM 1 FIRST TUBE AND WAS 3 FROM THE SECOND TUBE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.7 KG/SQM. PATHOLOGY TEST - ON (B)(6) 2014: CERVIX AND UTERUS WITH BILATERAL TUBES: 1. INTRAMURAL LEIOMYOMA, 1.1 CM IN LARGEST DIMENSION. 2. PROLIFERATIVE ENDOMETRIUM WITHOUT HYPERPLASIA, ATYPIA OR POLYPS. 3. BILATERAL FALLOPIAN TUBES, WITH INTRATUBAL FOREIGN BODY (METALLIC WIRE) 4. MILD CHRONIC CERVICITIS. 5. POSTERIOR SEROSAL SURFACE, WITH FOCAL CONGESTION AND HEMORRHAGE.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: FATIGUE, DEPRESSION, ABNORMAL UTERINE BLEEDING, MENORRHAGIA AND PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-SEP-2019: MR RECEIVED. LOT NUMBER ADDED. REPORTER INFORMATION, MEDICAL HISTORY, HISTORICAL DRUG AND LAB DATA WERE ADDED. 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION FALLOPIAN TUBES / MIGRATION') IN AN ADULT 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 MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". 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), PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), FATIGUE ("OTHER INJURIES/SYMPTOMS: FATIGUE"), HEADACHE ("OTHER INJURIES/SYMPTOMS: HEADACHES"), MIGRAINE ("OTHER INJURIES/SYMPTOMS: MIGRAINE"), NAUSEA ("OTHER INJURIES/SYMPTOMS: NAUSEA") AND SPINAL PAIN ("OTHER SPINAL PAIN POST HYSTERECTOMY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("OTHER INJURIES/SYMPTOMS: WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL), HYSTERECTOMY (FULL)). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, PSYCHOLOGICAL TRAUMA, FATIGUE, WEIGHT INCREASED, HEADACHE, MIGRAINE AND NAUSEA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA, MENORRHAGIA AND SPINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, SPINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE ), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), PSYCH INJURY, MIGRATION, PERFORATION FALLOPIAN TUBES, FATIGUE, WEIGHT GAIN, OTHER, HEADACHES, MIGRAINE, NAUSEA,SPINAL PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-SEP-2019: PFS RECEIVED. CASE BECOMES AN INCIDENT. INJURY EVENT WAS REMOVED. NEW EVENTS ADDED: MIGRATION, PERFORATION FALLOPIAN TUBES, PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), PSYCH INJURY, FATIGUE, WEIGHT GAIN, HEADACHES, MIGRAINE, NAUSEA, SPINAL PAIN, PATIENT DID NOT UNDERGO AN ESSURE CONFIRMATION TEST WERE ADDED. OUTCOME OF THE EVENTS PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), SPINAL PAIN WAS UPDATED TO RECOVERED/RESOLVED. REPORTER'S INFORMATION WAS UPDATED. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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 |
|---|---|---|---|---|---|---|---|
| 803096 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 910616-NOT VALID | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Other| R |