ESSURE
Report
- Report Number
- 2951250-2019-03036
- Event Type
- Injury
- Date Received
- June 25, 2019
- Date of Event
- October 16, 2018
- Report Date
- May 28, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UNKNOWN LOCATION') AND DEVICE BREAKAGE ('COILS BREAKING') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910512) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BOIL. CONCURRENT CONDITIONS INCLUDED INSOMNIA, HYPOTHYROIDISM, IRREGULAR MENSTRUAL CYCLE AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED BUTALBITAL;CAFFEINE;PARACETAMOL (FIORICET), ESCITALOPRAM OXALATE (LEXAPRO), LEVONORGESTREL (MIRENA), PROGESTERONE, SPIRONOLACTONE, THYROID (ARMOUR THYROID), TOPIRAMATE (TOPAMAX), TRAZODONE HYDROCHLORIDE (DESYREL) AND ZOLPIDEM TARTRATE (AMBIEN). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN/PAIN/PELVIC AREA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING(VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND ALOPECIA ("HAIR LOSS"), 19 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2018, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("SEVERE BLEEDING"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("ANXIETY AND MENTAL ANGUISH"), FATIGUE ("FATIGUE") AND HYPERSENSITIVITY ("ALLERGIC REACTION"). THE PATIENT WAS TREATED WITH CELECOXIB (CELEXA), IBUPROFEN, MEDROXYPROGESTERONE ACETATE (PROVERA) AND SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DEVICE BREAKAGE, DEPRESSION, ANXIETY, MIGRAINE AND DYSMENORRHOEA OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE, PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, ALOPECIA AND HYPERSENSITIVITY HAD RESOLVED AND THE HEADACHE AND FATIGUE WAS RESOLVING. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED AS PER PFS: PATIENT DID NOT UNDER GO ESSURE CONFIRMATION TEST BUT PATIENT UNDERWENT ESSURE CONFIRMATION TEST VIA HYSTEROSALPINGOGRAM AS PER PREVIOUS FU. TREATMENT RECEIVED PAIN, BLEEDING, ALLERGIC REACTION, MIGRATION, HAIR LOSS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORD: PELVIC PAIN, DYSMENORRHEA, MENORRHAGIA AND VAGINAL HAEMORRHAGE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED. NEW EVENTS ADDED: ALLERGIC REACTION. OUTCOME OF PREVIOUSLY ADDED EVENTS PELVIC PAIN, GEN. ABNORMAL BLEEDING AND MENORRHAGIA, HAIR LOSS WERE UPDATED TO RECOVERED/RESOLVED. 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 DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UNKNOWN LOCATION'), DEVICE BREAKAGE ('COILS BREAKING') AND GENITAL HAEMORRHAGE ('SEVERE BLEEDING') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910512) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BOIL. CONCURRENT CONDITIONS INCLUDED INSOMNIA, HYPOTHYROIDISM, IRREGULAR MENSTRUAL CYCLE AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED BUTALBITAL;CAFFEINE;PARACETAMOL (FIORICET), ESCITALOPRAM OXALATE (LEXAPRO), LEVONORGESTREL (MIRENA), PROGESTERONE, SPIRONOLACTONE, THYROID (ARMOUR THYROID), TOPIRAMATE (TOPAMAX), TRAZODONE HYDROCHLORIDE (DESYREL) AND ZOLPIDEM TARTRATE (AMBIEN). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN/PAIN/PELVIC AREA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING(VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND ALOPECIA ("HAIR LOSS"), 19 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2018, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("ANXIETY AND MENTAL ANGUISH") AND FATIGUE ("FATIGUE"). THE PATIENT WAS TREATED WITH CELECOXIB (CELEXA), IBUPROFEN, MEDROXYPROGESTERONE ACETATE (PROVERA) AND SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DEVICE BREAKAGE, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, MIGRAINE, DYSMENORRHOEA AND ALOPECIA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, HEADACHE AND FATIGUE WAS RESOLVING. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULJY OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORD: PELVIC PAIN, DYSMENORRHEA, MENORRHAGIA AND VAGINAL HAEMORRHAGE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-JUN-2019: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). 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 DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UNKNOWN LOCATION'), DEVICE BREAKAGE ('COILS BREAKING') AND GENITAL HAEMORRHAGE ('SEVERE BLEEDING') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910512) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BOIL. CONCURRENT CONDITIONS INCLUDED INSOMNIA, HYPOTHYROIDISM, IRREGULAR MENSTRUAL CYCLE AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED BUTALBITAL;CAFFEINE;PARACETAMOL (FIORICET), ESCITALOPRAM OXALATE (LEXAPRO), LEVONORGESTREL (MIRENA), PROGESTERONE, SPIRONOLACTONE, THYROID (ARMOUR THYROID), TOPIRAMATE (TOPAMAX), TRAZODONE HYDROCHLORIDE (DESYREL) AND ZOLPIDEM TARTRATE (AMBIEN). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("ANXIETY AND MENTAL ANGUISH"). ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN/PAIN/PELVIC AREA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING(VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND ALOPECIA ("HAIR LOSS"), 19 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2018, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND FATIGUE ("FATIGUE"). THE PATIENT WAS TREATED WITH CELECOXIB (CELEXA), IBUPROFEN, MEDROXYPROGESTERONE ACETATE (PROVERA) AND SURGERY (BILATERAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DEVICE BREAKAGE, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, MIGRAINE, DYSMENORRHOEA AND ALOPECIA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, HEADACHE AND FATIGUE WAS RESOLVING. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORD: PELVIC PAIN, DYSMENORRHEA, MENORRHAGIA AND VAGINAL HAEMORRHAGE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-JUN-2019: PFS AND MR RECEIVED. ESSURE LOT NUMBER, RACE AND EXPLANT DATE ADDED. PRODUCT INDICATION UPDATED. FOLLOWING EVENTS WERE ADDED: MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UNKNOWN LOCATION, COILS BREAKING, SEVERE BLEEDING, ABNORMAL BLEEDING(VAGINAL), MENORRHAGIA, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION, ANXIETY AND MENTAL ANGUISH, MIGRAINES, HEADACHES, DYSMENORRHEA (CRAMPING) HAIR LOSS AND FATIGUE. EVENT ONSET DATE WERE ADDED. EVENT OUTCOME ADDED FOR: PHYSICAL PAIN/PAIN/PELVIC AREA, HEADACHES AND FATIGUE. MEDICAL HISTORY, CONCOMITANT, TREATMENT MEDICATIONS 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-CONFORMANCE'S DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 523971 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 910512 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Other| R | AMBIEN| AMBIEN| AMBIEN| ARMOUR THYROID| ARMOUR THYROID| ARMOUR THYROID| DESYREL| DESYREL| DESYREL| FIORICET| FIORICET| FIORICET| LEXAPRO| LEXAPRO| LEXAPRO| MIRENA| MIRENA| MIRENA| PROGESTERONE| PROGESTERONE| PROGESTERONE| SPIRONOLACTONE| SPIRONOLACTONE| SPIRONOLACTONE| TOPAMAX| TOPAMAX| TOPAMAX| AMBIEN| ARMOUR THYROID| DESYREL| FIORICET| LEXAPRO| MIRENA| PROGESTERONE| SPIRONOLACTONE| TOPAMAX |