ESSURE
Report
- Report Number
- 2951250-2017-04913
- Event Type
- Injury
- Date Received
- October 18, 2017
- Date of Event
- January 1, 2013
- Report Date
- June 2, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN") AND MENORRHAGIA ("MENORRHAGIA") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 871971) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("VAGINL BLEEDING") AND INFECTION ("INFECTION (OTHER) DESCRIBE: DOES NOT KNOW OR RECALL, SEE BMR 000112"). ON (B)(6) 2017, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA / CRAMPING"), 4 YEARS 6 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUATION IRREGULAR ("IRREGULAR MENSES"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH") AND ABDOMINAL PAIN LOWER ("CRAMPING"). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN) AND SURGERY (ENDOMETRIAL ABLATION AND SUPRACERVICAL HYSTERECTOMY AND SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA AND ABDOMINAL PAIN LOWER HAD RESOLVED AND THE MENSTRUATION IRREGULAR, INFECTION, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ANXIETY, DEPRESSION, DYSMENORRHOEA, INFECTION, MENORRHAGIA, MENSTRUATION IRREGULAR, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULTS: TOTAL BILATERAL OCCLUSION. DIAGNOSTIC RESULTS: (B)(6) 2013: SCOUT IMAGE DEMONSTRATES BILATERAL ESSURE STERILIZATION DEVICES IN PLACE. THERE IS NO FREE SPILLAGE INTO THE PERITONEAL CAVITY (BILATERAL TUBES OCCLUDED) (B)(6) 2016: DILATATION AND CURETTAGE, HYSTEROSCOPY, ENDOMETRIAL ABLATION. ESSURE DEVICES WERE VISIBLE BILATERALLY IN THE OSTIA (B)(6) 2016: ENDOMETRIAL BIOPSY - FRAGMENT WITH FEATURES SUGGESTIVE OF ENDOMETRIAL POLYP FROM LOWER UTERINE SEGMENT CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: DYSMENORRHEA, MENORRHAGIA, PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-FEB-2019: PFS RECEIVED. EVENT CRAMPING 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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN") AND MENORRHAGIA ("MENORRHAGIA") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 871971) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING") AND INFECTION ("INFECTION (OTHER) DESCRIBE: DOES NOT KNOW OR RECALL, SEE BMR 000112"). ON (B)(6) 2017, 4 YEARS 6 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA / CRAMPING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUATION IRREGULAR ("IRREGULAR MENSES"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN), SURGERY (SUPRACERVICAL HYSTERECTOMY AND SALPINGECTOMY) AND SURGERY (ENDOMETRIAL ABLATION). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE AND DYSMENORRHOEA HAD RESOLVED AND THE MENSTRUATION IRREGULAR, INFECTION, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, INFECTION, MENORRHAGIA, MENSTRUATION IRREGULAR, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. (B)(6) 2013: SCOUT IMAGE DEMONSTRATES BILATERAL ESSURE STERILIZATION DEVICES IN PLACE. THERE IS NO FREE SPILLAGE INTO THE PERITONEAL CAVITY (BILATERAL TUBES OCCLUDED). (B)(6) 2016: DILATATION AND CURETTAGE, HYSTEROSCOPY, ENDOMETRIAL ABLATION. ESSURE DEVICES WERE VISIBLE BILATERALLY IN THE OSTIA. (B)(6) 2016: ENDOMETRIAL BIOPSY - FRAGMENT WITH FEATURES SUGGESTIVE OF ENDOMETRIAL POLYP FROM LOWER UTERINE SEGMENT. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: DYSMENORRHEA, MENORRHAGIA, PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED AN EVENT " PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND MENTAL ANGUISH" ARE ADDED. PATIENT, PRODUCT AND REPORTER INFORMATION ADDED. TREATMENT DRUG 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 PELVIC PAIN ('SEVERE PELVIC PAIN') AND MENORRHAGIA ('MENORRHAGIA') IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 871971) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("VAGINL BLEEDING") AND INFECTION ("INFECTION (OTHER) DESCRIBE: DOES NOT KNOW OR RECALL, SEE BMR 000112"). ON (B)(6) 2017, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA / CRAMPING"), 4 YEARS 6 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUATION IRREGULAR ("IRREGULAR MENSES"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"), ABDOMINAL PAIN LOWER ("CRAMPING"), URINARY TRACT DISORDER ("BLADDER/ URINARY PROBLEM/ BLADDER PROBLEM") AND BLADDER DISORDER ("BLADDER PROBLEM NOS"). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN) AND SURGERY (ENDOMETRIAL ABLATION AND SUPRACERVICAL HYSTERECTOMY AND SALPINGECTOMY). ESSURE WAS REMOVED ON 12-JUL-2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, ABDOMINAL PAIN LOWER, URINARY TRACT DISORDER AND BLADDER DISORDER HAD RESOLVED AND THE MENSTRUATION IRREGULAR, INFECTION, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ANXIETY, BLADDER DISORDER, DEPRESSION, DYSMENORRHOEA, INFECTION, MENORRHAGIA, MENSTRUATION IRREGULAR, PELVIC PAIN, URINARY TRACT DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON 12-JUL-2013: RESULTS: TOTAL BILATERAL OCCLUSION. DIAGNOSTIC RESULTS: 12-JUL-2013: SCOUT IMAGE DEMONSTRATES BILATERAL ESSURE STERILIZATION DEVICES IN PLACE. THERE IS NO FREE SPILLAGE INTO THE PERITONEAL CAVITY (BILATERAL TUBES OCCLUDED) 12-JUL-2016: DILATATION AND CURETTAGE, HYSTEROSCOPY, ENDOMETRIAL ABLATION. ESSURE DEVICES WERE VISIBLE BILATERALLY IN THE OSTIA 12-JUL-2016: ENDOMETRIAL BIOPSY - FRAGMENT WITH FEATURES SUGGESTIVE OF ENDOMETRIAL POLYP FROM LOWER UTERINE SEGMENT. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: DYSMENORRHEA, MENORRHAGIA, PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED. ADDED NEW EVENT BLADDER AND URINARY TRACT DISORDER. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN") AND MENORRHAGIA ("MENORRHAGIA") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 871971) INSERTED FOR FEMALE STERILISATION. 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 PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUATION IRREGULAR ("IRREGULAR MENSES"), VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING"), INFECTION ("INFECTION") AND DYSMENORRHOEA ("DYSMENORRHEA / CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (SUPRACERVICAL HYSTERECTOMY AND SALPINGECTOMY) AND SURGERY (ENDOMETRIAL ABLATION). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE AND DYSMENORRHOEA HAD RESOLVED AND THE MENSTRUATION IRREGULAR AND INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA, INFECTION, MENORRHAGIA, MENSTRUATION IRREGULAR, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: ESSURE WAS SUCCESSFULLY OCCLUDED. ON (B)(6) 2013: SCOUT IMAGE DEMONSTRATES BILATERAL ESSURE STERILIZATION DEVICES IN PLACE. THERE IS NO FREE SPILLAGE INTO THE PERITONEAL CAVITY (BILATERAL TUBES OCCLUDED). ON (B)(6) 2016: DILATATION AND CURETTAGE, HYSTEROSCOPY, ENDOMETRIAL ABLATION. ESSURE DEVICES WERE VISIBLE BILATERALLY IN THE OSTIA. ON 18-AUG-2016: ENDOMETRIAL BIOPSY - FRAGMENT WITH FEATURES SUGGESTIVE OF ENDOMETRIAL POLYP FROM LOWER UTERINE SEGMENT. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: DYSMENORRHEA, MENORRHAGIA, PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-APR-2018: PFS AND MR RECEIVED. LOT NUMBER PROVIDED (871971). EVENTS ADDED: VAGINAL BLEEDING, MENORRHAGIA, INFECTION AND DYSMENORRHEA. OUTCOME UPDATED. 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 PELVIC PAIN ("SEVERE PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. 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 PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENSTRUATION IRREGULAR ("IRREGULAR MENSES"). THE PATIENT WAS TREATED WITH SURGERY (SUPRACERVICAL HYSTERECTOMY DUE TO COMPLICATIONS FROM THE ESSURE DEVICE). AT THE TIME OF THE REPORT, THE PELVIC PAIN AND MENSTRUATION IRREGULAR OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MENSTRUATION IRREGULAR AND PELVIC PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: ESSURE WAS SUSCCESSFULLY OCCLUDED. INCIDENT. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. 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 |
|---|---|---|---|---|---|---|---|
| 737746 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 871971 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Other| R |