ESSURE
Report
- Report Number
- 2951250-2018-02599
- Event Type
- Injury
- Date Received
- June 13, 2018
- Date of Event
- January 1, 2014
- Report Date
- June 3, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE)(S)) COIL PROTRUDING RIGHT TUBAL OSTEA/PERFORATION (FALLOPIAN TUBE)(S)) COIL PROTRUDING RIGHT TUBAL OSTEA"), DEVICE EXPULSION ("MIGRATION/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS") AND MENORRHAGIA ("ABNORMAL BLEEDING( MENORRHAGIA)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HOT FLASHES, DIABETES MELLITUS, HYPERTENSION AND GERD. CONCURRENT CONDITIONS INCLUDED ANEMIA, URINARY TRACT INFECTION, ABDOMINAL PAIN, BLOATING, FATIGUE, HEARING LOSS, CHEST PAIN, PANIC ATTACKS, BACK DISCOMFORT, OVARIAN CYST, ANXIETY, DEPRESSION, TYPE II DIABETES MELLITUS AND POST-TRAUMATIC STRESS DISORDER. CONCOMITANT PRODUCTS INCLUDED CEFIXIME (FLEXERIL) SINCE (B)(6) 2017, CELECOXIB (CELEXA) SINCE (B)(6) 2012, CLONAZEPAM (KLONOPIN) SINCE (B)(6) 2010, CLONAZEPAM SINCE (B)(6) 2012, DULOXETINE HYDROCHLORIDE (CYMBALTA) SINCE (B)(6) 2010, ESOMEPRAZOLE SINCE (B)(6) 2018, ETHINYLESTRADIOL;NORGESTIMATE (SPRINTEC) FROM (B)(6) 2011 TO (B)(6) 2011, LISINOPRIL SINCE (B)(6) 2010, MAGNESIUM SINCE (B)(6) 2018, OMEPRAZOLE, PARACETAMOL (ACETAMINOFEN) SINCE (B)(6) 2011 AND SULFAMETHOXAZOLE;TRIMETHOPRIM (BACTRIM). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY AND MENTAL ANGUISH"), 1 YEAR 2 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN / PAIN/PELVIC PAIN"). IN 2014, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING(VAGINAL)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUATIONS ISSUES"), VAGINAL DISORDER ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: VAGINOSIS/INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: VAGINOSIS") AND VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), OOPHORECTOMY (BILATERAL REMOVAL OF OVARIES), SALPINGECTOMY (BILATERAL REMOVAL) AND UTERINE ABLATION,ENDOMETRIAL ABLATION, SURGERY (OTHER) TYPE OF SURGERY: DILATION AND CURETTAGE). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE EXPULSION, MENORRHAGIA, PELVIC PAIN, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, VAGINAL DISORDER, DEPRESSION, ANXIETY AND VAGINAL INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DEVICE EXPULSION, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL DISORDER, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: APPROXIMATELY 15 COILS PROTRUDED FROM THE RIGHT TUBAL OSTIUM. DISCREPANCY IN ESSURE REMOVAL DATE WAS SEEN (B)(6) 2018 AND (B)(6) 2018). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: OCCLUDED FALLOPIAN TUBES; ON (B)(6) 2014: RESULTS: TOTAL BILATERAL OCCLUSION. DIAGNOSTIC RESULTS: TRAILING COLIS LEFT 2 RIGHT 1. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS REPORTED VIA MEDICAL RECORD CONFIRMING EVENT MENORRHAGIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PLAINTIFF FACT SHEET RECEIVED. EVENTS ADDED FROM PFS- INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL. CONCOMITANT DRUG, MEDICAL HISTORY WERE ADDED. INCIDENT: 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE)(S)) COIL PROTRUDING RIGHT TUBAL OSTEA"), DEVICE EXPULSION ("MIGRATION/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS") AND MENORRHAGIA ("ABNORMAL BLEEDING( MENORRHAGIA)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ANEMIA AND URINARY TRACT INFECTION. CONCOMITANT PRODUCTS INCLUDED CO-TRIMOXAZOLE (BACTRIM). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE EXPULSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN / PAIN"), MENSTRUAL DISORDER ("MENSTRUATIONS ISSUES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING(VAGINAL)"), VAGINAL INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: VAGINOSIS"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). THE PATIENT WAS TREATED WITH SURGERY (HYSTEROSCOPY W/MYOSURE POLYPECTOMY), SURGERY (HYSTEROSCOPY W/MYOSURE POLYPECTOMY) AND SURGERY (UTERINE ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE EXPULSION, MENORRHAGIA, PELVIC PAIN, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DEVICE EXPULSION, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: APPROXIMATELY 15 COILS PROTRUDED FROM THE RIGHT TUBAL OSTIUM. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION TRAILING COLIS LEFT 2 RIGHT 1 CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS REPORTED VIA MEDICAL RECORD CONFIRMING EVENT MENORRHAGIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: QUALITY-SAFETY EVALUATION OF PTC 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE)(S)) COIL PROTRUDING RIGHT TUBAL OSTEA/PERFORATION (FALLOPIAN TUBE)(S)) COIL PROTRUDING RIGHT TUBAL OSTEA"), DEVICE EXPULSION ("MIGRATION/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS") AND MENORRHAGIA ("ABNORMAL BLEEDING( MENORRHAGIA)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ANEMIA AND URINARY TRACT INFECTION. CONCOMITANT PRODUCTS INCLUDED CEFIXIME (FLEXERIL) SINCE (B)(6) 2017, CLONAZEPAM (KLONOPIN) SINCE 2010, DULOXETINE HYDROCHLORIDE (CYMBALTA) SINCE 2010, PARACETAMOL (ACETAMINOFEN) SINCE 2011 AND SULFAMETHOXAZOLE;TRIMETHOPRIM (BACTRIM). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING(VAGINAL)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND MENTAL ANGUISH") AND ANXIETY ("MENTAL ANGUISH/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN / PAIN/PELVIC PAIN"), MENSTRUAL DISORDER ("MENSTRUATIONS ISSUES") AND VAGINAL DISORDER ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: VAGINOSIS/INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: VAGINOSIS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), OOPHORECTOMY (BILATERAL REMOVAL OF OVARIES), SALPINGECTOMY (BILATERAL REMOVAL) AND UTERINE ABLATION). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE EXPULSION, MENORRHAGIA, PELVIC PAIN, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, VAGINAL DISORDER, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DEVICE EXPULSION, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: APPROXIMATELY 15 COILS PROTRUDED FROM THE RIGHT TUBAL OSTIUM. DISCREPANCY IN ESSURE REMOVAL DATE WAS SEEN ((B)(6) 2018 AND (B)(6) 2018). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: RESULTS: TOTAL BILATERAL OCCLUSION. DIAGNOSTIC RESULTS: TRAILING COLIS LEFT 2 RIGHT 1. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS REPORTED VIA MEDICAL RECORD CONFIRMING EVENT MENORRHAGIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-NOV-2018: PFS RECEIVED. THE EVENT ONSET DATE, ESSURE REMOVAL DATE AND REMOVAL PROCEDURE WAS UPDATED. CONCOMITANT MEDICATIONS WERE ADDED. 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE)(S)) COIL PROTRUDING RIGHT TUBAL OSTEA"), DEVICE EXPULSION ("MIGRATION/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS") AND MENORRHAGIA ("ABNORMAL BLEEDING( MENORRHAGIA)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ANEMIA AND URINARY TRACT INFECTION. CONCOMITANT PRODUCTS INCLUDED CO-TRIMOXAZOLE (BACTRIM). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE EXPULSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN / PAIN"), MENSTRUAL DISORDER ("MENSTRUATIONS ISSUES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING(VAGINAL)"), VAGINAL INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: VAGINOSIS"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). THE PATIENT WAS TREATED WITH SURGERY (HYSTEROSCOPY W/MYOSURE POLYPECTOMY), AND SURGERY (UTERINE ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE EXPULSION, MENORRHAGIA, PELVIC PAIN, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DEVICE EXPULSION, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: APPROXIMATELY 15 COILS PROTRUDED FROM THE RIGHT TUBAL OSTIUM. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION TRAILING COLIS LEFT 2 RIGHT 1. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS REPORTED VIA MEDICAL RECORD CONFIRMING EVENT MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-JUL-2018: PFS RECEIVED: NEW EVENTS PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND MENTAL ANGUISH WERE ADDED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION (FALLOPIAN TUBE)(S)) COIL PROTRUDING RIGHT TUBAL OSTEA/PERFORATION (FALLOPIAN TUBE)(S)) COIL PROTRUDING RIGHT TUBAL OSTEA'), DEVICE EXPULSION ('MIGRATION/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS') AND MENORRHAGIA ('ABNORMAL BLEEDING(MENORRHAGIA)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HOT FLASHES, DIABETES MELLITUS, HYPERTENSION AND GERD. CONCURRENT CONDITIONS INCLUDED ANEMIA, URINARY TRACT INFECTION, ABDOMINAL PAIN, BLOATING, FATIGUE, HEARING LOSS, CHEST PAIN, PANIC ATTACKS, BACK DISCOMFORT, OVARIAN CYST, ANXIETY, DEPRESSION, TYPE II DIABETES MELLITUS AND POST-TRAUMATIC STRESS DISORDER. CONCOMITANT PRODUCTS INCLUDED CEFIXIME (FLEXERIL) SINCE (B)(6) 2017, CELECOXIB (CELEXA) SINCE (B)(6) 2012, CLONAZEPAM (KLONOPIN) SINCE (B)(6) 2010, CLONAZEPAM SINCE (B)(6) 2012, DULOXETINE HYDROCHLORIDE (CYMBALTA) SINCE (B)(6) 2010, ESOMEPRAZOLE SINCE (B)(6) 2018, ETHINYLESTRADIOL;NORGESTIMATE (SPRINTEC) FROM (B)(6) 2011 TO (B)(6) 2011, LISINOPRIL SINCE (B)(6) 2010, MAGNESIUM SINCE (B)(6) 2018, OMEPRAZOLE, PARACETAMOL (ACETAMINOFEN) SINCE (B)(6) 2011 AND SULFAMETHOXAZOLE;TRIMETHOPRIM (BACTRIM). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY AND MENTAL ANGUISH"), 1 YEAR 2 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN / PAIN/PELVIC PAIN"). IN 2014, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING(VAGINAL)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUATIONS ISSUES"), VAGINAL DISORDER ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: VAGINOSIS/INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: VAGINOSIS") AND VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), OOPHORECTOMY (BILATERAL REMOVAL OF OVARIES), SALPINGECTOMY (BILATERAL REMOVAL) AND UTERINE ABLATION,ENDOMETRIAL ABLATION, SURGERY (OTHER) TYPE OF SURGERY: DILATION AND CURETTAGE). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE EXPULSION, MENORRHAGIA, MENSTRUAL DISORDER, VAGINAL DISORDER, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION HAD RESOLVED. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DEVICE EXPULSION, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL DISORDER, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: APPROXIMATELY 15 COILS PROTRUDED FROM THE RIGHT TUBAL OSTIUM. DISCREPANCY IN ESSURE REMOVAL DATE WAS SEEN ((B)(6) 2018 AND (B)(6) 2018) PATIENT RECEIVED TREATMENT PAIN. BLEEDING. MIGRATION, URINARY, BLADDER PROBLEM. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: OCCLUDED FALLOPIAN TUBES; ON (B)(6) 2014: RESULTS: TOTAL BILATERAL OCCLUSION. DIAGNOSTIC RESULTS: TRAILING COLIS LEFT 2 RIGHT 1. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED, EVENT OUTCOME, RCC ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. 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 FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE)(S)) COIL PROTRUDING RIGHT TUBAL OSTEA"), DEVICE EXPULSION ("MIGRATION/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS") AND MENORRHAGIA ("ABNORMAL BLEEDING( MENORRHAGIA)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ANEMIA AND URINARY TRACT INFECTION. CONCOMITANT PRODUCTS INCLUDED CO-TRIMOXAZOLE (BACTRIM). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE EXPULSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN / PAIN"), MENSTRUAL DISORDER ("MENSTRUATIONS ISSUES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING(VAGINAL)") AND VAGINAL DISORDER ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: VAGINOSIS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTEROSCOPY W/MYOSURE POLYPECTOMY) AND SURGERY (UTERINE ABLATION). AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE EXPULSION, MENORRHAGIA, PELVIC PAIN, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE AND VAGINAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE EXPULSION, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: APPROXIMATELY 15 COILS PROTRUDED FROM THE RIGHT TUBAL OSTIUM. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION. TRAILING COLIS LEFT 2 RIGHT 1. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA MEDICAL RECORD CONFIRMING EVENTS MENORRHAGIA, MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET- ALL RELEVANT MEDICAL HISTORY CONDITION, CONCURRENT CONDITION, CONCOMITANT MEDICATION AND EVENTS FALLOPIAN TUBE PERFORATION, DEVICE EXPULSION, MENORRHAGIA, VAGINAL HAEMORRHAGE AND VAGINAL DISORDER WERE ADDED. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 438040 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 822365 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other| R | ACETAMINOFEN| ACETAMINOFEN| ACETAMINOFEN| ACETAMINOFEN| BACTRIM| BACTRIM| BACTRIM| BACTRIM| BACTRIM| BACTRIM| BACTRIM| CELEXA [CELECOXIB]| CELEXA [CELECOXIB]| CLONAZEPAM| CLONAZEPAM| CYMBALTA| CYMBALTA| CYMBALTA| CYMBALTA| ESOMEPRAZOLE| ESOMEPRAZOLE| FLEXERIL [CEFIXIME]| FLEXERIL [CEFIXIME]| FLEXERIL [CEFIXIME]| FLEXERIL [CEFIXIME]| KLONOPIN| KLONOPIN| KLONOPIN| KLONOPIN| LISINOPRIL| LISINOPRIL| MAGNESIUM| MAGNESIUM| OMEPRAZOLE| OMEPRAZOLE| SPRINTEC| SPRINTEC| BACTRIM |