ESSURE
Report
- Report Number
- 2951250-2020-08089
- Event Type
- Injury
- Date Received
- May 22, 2020
- Date of Event
- September 11, 2011
- Report Date
- May 24, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822376) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HEAVY PERIODS AND PREGNANCY. CONCURRENT CONDITIONS INCLUDED ANEMIA, GALLBLADDER INFLAMMATION, FREQUENCY URINARY AND DYSPEPSIA. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;NORGESTREL (CRYSELLE) AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHOEA"), DEPRESSION ("PSYCH INJURY / PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS ¿ DEPRESSION"), URINARY TRACT INFECTION ("UTI,"), HEADACHE ("HEADACHES,"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (MENORRHAGIA)"), FATIGUE ("FATIGUE"), MIGRAINE ("MIGRAINE") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS ¿ MENTAL ANGUISH/ ANXIETY"). ON (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 3 MONTHS 11 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), URINARY TRACT DISORDER ("URINARY PROBLEM"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), ALOPECIA ("HAIR LOSS") AND POST PROCEDURAL COMPLICATION ("POST PROCEDURAL COMPLICATION"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, URINARY TRACT INFECTION, VAGINAL DISCHARGE, HEADACHE AND ALOPECIA HAD RESOLVED AND THE NAUSEA, ABDOMINAL PAIN, DYSMENORRHOEA, DEPRESSION, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, DYSPAREUNIA, FATIGUE, MIGRAINE, ANXIETY AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HEAVY MENSTRUAL BLEEDING, MIGRAINE, NAUSEA, PELVIC PAIN, POST PROCEDURAL COMPLICATION, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR PAIN, BLEEDING, UTI, VAGINAL DECHARGE, HAIR LOSS, HEADACHE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION; ON (B)(6) 2011: RESULT- BILATERAL OCCLUSION. 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 18-MAY-2021: QUALITY SAFETY EVALUATION OF PTC. 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 PELVIC PAIN ('PHYSICAL PAIN') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822376) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HEAVY PERIODS AND PREGNANCY. CONCURRENT CONDITIONS INCLUDED ANEMIA, GALLBLADDER INFLAMMATION, FREQUENCY URINARY AND DYSPEPSIA. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;NORGESTREL (CRYSELLE) AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHOEA"), DEPRESSION ("PSYCH INJURY / PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS ¿ DEPRESSION"), URINARY TRACT INFECTION ("UTI,"), HEADACHE ("HEADACHES,"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (MENORRHAGIA)"), FATIGUE ("FATIGUE"), MIGRAINE ("MIGRAINE") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS ¿ MENTAL ANGUISH/ ANXIETY"). ON (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 3 MONTHS 11 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), URINARY TRACT DISORDER ("URINARY PROBLEM"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), ALOPECIA ("HAIR LOSS") AND POST PROCEDURAL COMPLICATION ("POST PROCEDURAL COMPLICATION"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, URINARY TRACT INFECTION, VAGINAL DISCHARGE, HEADACHE AND ALOPECIA HAD RESOLVED AND THE NAUSEA, ABDOMINAL PAIN, DYSMENORRHOEA, DEPRESSION, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, DYSPAREUNIA, FATIGUE, MIGRAINE, ANXIETY AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HEAVY MENSTRUAL BLEEDING, MIGRAINE, NAUSEA, PELVIC PAIN, POST PROCEDURAL COMPLICATION, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR PAIN, BLEEDING, UTI, VAGINAL DECHARGE, HAIR LOSS, HEADACHE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION; ON (B)(6) 2011: RESULT- BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-APR-2021: MR RECEIVED. REPORTER INFORMATION AND ESSURE REMOVAL DATE WAS 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 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 ('PHYSICAL PAIN') IN A (B)(6) YEAR OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822376) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HEAVY PERIODS AND PREGNANCY. CONCURRENT CONDITIONS INCLUDED ANEMIA, GALLBLADDER INFLAMMATION, FREQUENCY URINARY AND DYSPEPSIA. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;NORGESTREL (CRYSELLE) AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHOEA"), DEPRESSION ("PSYCH INJURY / PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS ¿ DEPRESSION"), URINARY TRACT INFECTION ("UTI,"), HEADACHE ("HEADACHES,"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), FATIGUE ("FATIGUE"), MIGRAINE ("MIGRAINE") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS ¿ MENTAL ANGUISH/ ANXIETY"). ON (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 3 MONTHS 11 DAYS AFTER INSERTION OF ESSURE. IN SEPTEMBER 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), URINARY TRACT DISORDER ("URINARY PROBLEM"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), ALOPECIA ("HAIR LOSS") AND POST PROCEDURAL COMPLICATION ("POST PROCEDURAL COMPLICATION"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, URINARY TRACT INFECTION, VAGINAL DISCHARGE, HEADACHE AND ALOPECIA HAD RESOLVED AND THE NAUSEA, ABDOMINAL PAIN, DYSMENORRHOEA, DEPRESSION, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSPAREUNIA, FATIGUE, MIGRAINE, ANXIETY AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, POST PROCEDURAL COMPLICATION, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR PAIN, BLEEDING, UTI, VAGINAL DECHARGE, HAIR LOSS, HEADACHE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION; ON (B)(6) 2011: RESULT- BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-MAY-2020: PIF RECEIVED- CASE BECAME INCIDENT. ESSURE REMOVAL ADDED. NEW EVENT POST PROCEDURAL COMPLICATION, HAIR LOSS WERE ADDED. EVENT OUTCOME OF PAIN, BLEEDING, INFECTION OTHER WAS UPDATED. REPORTERS 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 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 |
|---|---|---|---|---|---|---|---|
| 545892 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 822376 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| CRYSELLE| CRYSELLE| CRYSELLE |