ESSURE
Report
- Report Number
- 2951250-2019-02573
- Event Type
- Injury
- Date Received
- June 6, 2019
- Date of Event
- February 6, 2013
- Report Date
- January 2, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ('MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS,') AND MENORRHAGIA ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') IN A 24-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863570) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BODY MASS INDEX NORMAL AND MUSCLE CRAMPS. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN,"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN, PELVIC PAIN,"). IN (B)(6) 2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), MENOMETRORRHAGIA ("OTHER INJURY(IES) OR COMPLICATION(S) PLEASE DESCRIBE: MENOMETRORRHAGIA"), ARTHRALGIA ("JOINT PAIN") AND INSOMNIA ("INSOMNIA"). IN (B)(6) 2016, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN 2016, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN (B)(6) 2018, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)\CRAMPS AND PELVIC PAIN WITH MENSTRUATION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:ANXIETY"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL AREA"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION-2013 AND TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, MENORRHAGIA, VAGINAL HAEMORRHAGE, ANXIETY, DEPRESSION, URINARY TRACT DISORDER, BLADDER DISORDER, MIGRAINE, HEADACHE, DYSMENORRHOEA, FATIGUE, WEIGHT INCREASED, MENOMETRORRHAGIA, ARTHRALGIA AND INSOMNIA OUTCOME WAS UNKNOWN, THE PELVIC PAIN AND ABDOMINAL PAIN LOWER HAD RESOLVED AND THE ALOPECIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, ARTHRALGIA, BLADDER DISORDER, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, FATIGUE, HEADACHE, INSOMNIA, MENOMETRORRHAGIA, MENORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE OF INSERTION: (B)(6) 2011, (B)(6) 2013. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE DESCRIBED IN PATIENTS MEDICAL RECORD:MENORRHAGIA, HEAVY MENSTRUAL BLEEDING, MENOMETRORRHAGIA, PELVIC PAIN, DYSMENORRHEA. LOT NUMBER:863570 MANUFACTURE DATE:2011-05 EXPIRATION DATE: 2014-05 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: QUALITY-SAFETY EVALUATION OF PTC INCIDENT 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 DEVICE EXPULSION ('MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS,') AND MENORRHAGIA ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') IN A 24-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863570) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BODY MASS INDEX NORMAL AND MUSCLE CRAMPS. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN,"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN, PELVIC PAIN,"). IN (B)(6) 2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), MENOMETRORRHAGIA ("OTHER INJURY(IES) OR COMPLICATION(S) PLEASE DESCRIBE: MENOMETRORRHAGIA"), ARTHRALGIA ("JOINT PAIN") AND INSOMNIA ("INSOMNIA"). IN (B)(6) 2016, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN 2016, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN (B)(6) 2018, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)\CRAMPS AND PELVIC PAIN WITH MENSTRUATION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:ANXIETY"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL AREA"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION-2013 AND TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, MENORRHAGIA, VAGINAL HAEMORRHAGE, ANXIETY, DEPRESSION, URINARY TRACT DISORDER, BLADDER DISORDER, MIGRAINE, HEADACHE, DYSMENORRHOEA, FATIGUE, WEIGHT INCREASED, MENOMETRORRHAGIA, ARTHRALGIA AND INSOMNIA OUTCOME WAS UNKNOWN, THE PELVIC PAIN AND ABDOMINAL PAIN LOWER HAD RESOLVED AND THE ALOPECIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, ARTHRALGIA, BLADDER DISORDER, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, FATIGUE, HEADACHE, INSOMNIA, MENOMETRORRHAGIA, MENORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE OF INSERTION: (B)(6) 2011, (B)(6) 2013. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE DESCRIBED IN PATIENTS MEDICAL RECORD:MENORRHAGIA, HEAVY MENSTRUAL BLEEDING, MENOMETRORRHAGIA, PELVIC PAIN, DYSMENORRHEA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-NOV-2019: PFS RECEIVED. LOT NUMBER ADDED. EVENTS ONSET DATE UPDATED. 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 DEVICE EXPULSION ('MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS,') AND MENORRHAGIA ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BODY MASS INDEX NORMAL AND MUSCLE CRAMPS. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED MENOMETRORRHAGIA ("OTHER INJURY(IES) OR COMPLICATION(S) PLEASE DESCRIBE: MENOMETRORRHAGIA"), ARTHRALGIA ("JOINT PAIN") AND INSOMNIA ("INSOMNIA"). IN (B)(6) 2018, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"). ON (B)(6) 2018, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:ANXIETY"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), PELVIC PAIN ("PAIN, PELVIC PAIN"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL AREA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION-2013 AND TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, MENORRHAGIA, VAGINAL HAEMORRHAGE, ANXIETY, DEPRESSION, URINARY TRACT DISORDER, BLADDER DISORDER, MIGRAINE, HEADACHE, DYSMENORRHOEA, FATIGUE, WEIGHT INCREASED, MENOMETRORRHAGIA, ARTHRALGIA AND INSOMNIA OUTCOME WAS UNKNOWN, THE PELVIC PAIN AND ABDOMINAL PAIN LOWER HAD RESOLVED AND THE ALOPECIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, ARTHRALGIA, BLADDER DISORDER, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, FATIGUE, HEADACHE, INSOMNIA, MENOMETRORRHAGIA, MENORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE OF INSERTION: (B)(6) 2011, (B)(6) 2013. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE DESCRIBED IN PATIENTS MEDICAL RECORD:MENORRHAGIA, HEAVY MENSTRUAL BLEEDING, MENOMETRORRHAGIA, PELVIC PAIN, DYSMENORRHEA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-MAY-2019: PFS AND MR RECEIVED. CASE BECOMES VALID AND INCIDENT. REPORTER INFORMATION AND ESSURE DATES ADDED, INJURY NOS WAS REPLACED NEW EVENT WAS ADDED VAGINAL HEMORRHAGE, MENORRHAGIA, DEVICE EXPULSION, ANXIETY, DEPRESSION, URINARY TRACT DISORDER, BLADDER DISORDER, MIGRAINES, HEADACHES , DYSMENORRHEA (CRAMPING), PELVIC PAIN, FATIGUE, WEIGHT GAIN, HAIR LOSS, MENOMETRORRHAGIA, JOINT PAIN, INSOMNIA, LOWER ABDOMINAL PAIN. OUTCOME ADDED , LOWER ABDOMINAL PAIN, PELVIC PAIN, HAIR LOSS. MEDICAL HISTORY AND LAB TEST WAS ADDED. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 470142 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 863570 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Other| R |