ESSURE
Report
- Report Number
- 2951250-2020-01722
- Event Type
- Injury
- Date Received
- February 26, 2020
- Date of Event
- December 1, 2012
- Report Date
- March 24, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5039133) ON 15-JAN-2015. THE MOST RECENT INFORMATION WAS RECEIVED ON 09-MAR-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN: PELVIC') IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841532) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MORBID OBESITY AND BLOOD PRESSURE HIGH. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN AND NAPROXEN. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND BACK PAIN ("PAIN: BACK"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), HEAVY PERIODS ("EXTREMELY HEAVY MENSTRUAL CYCLES/ABNORMAL BLEEDING (MENORRHAGIA)"), FATIGUE ("TIRED/ FATIGUE"), ALOPECIA ("HAIR IS THINNING OUT/ HAIR LOSS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MIGRAINE ("MIGRAINE/HEADACHE") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/ EXTREME PAIN FROM PERIODS AND FIBROIDS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("GAINING WEIGHT/ WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUATION IRREGULAR ("IRREGULAR MENSTRUAL CYCLES"), MENSTRUAL DISORDER ("HUGE BLOOD CLOTS"), PROLONGED MENSES ("PERIODS LAST ANYWHERE FROM 11 TO 15 DAYS"), HEADACHE ("HEADACHES"), FEELING HOT ("FEEL HOT") AND ANGER ("ANGRY") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("FIBROIDS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL) WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENSTRUATION IRREGULAR, MENSTRUAL DISORDER, HEADACHE, FEELING HOT, ANGER, FATIGUE, WEIGHT INCREASED, ALOPECIA, BACK PAIN AND UTERINE LEIOMYOMA OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN, HEAVY PERIODS, PROLONGED MENSES, DYSPAREUNIA, VAGINAL HAEMORRHAGE, MIGRAINE AND DYSMENORRHOEA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANGER, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING HOT, HEADACHE, HEAVY PERIODS, MENSTRUAL DISORDER, MENSTRUATION IRREGULAR, MIGRAINE, PELVIC PAIN, UTERINE LEIOMYOMA, VAGINAL HAEMORRHAGE, WEIGHT INCREASED AND PROLONGED MENSES TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 232 LBS. RIGHT: 4 COILS LEFT: 3 COILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 40.4 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. LOT NUMBER:841532, MANUFACTURING DATE:2011/03, EXPIRATION DATE:2014/03. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-MAR-2020: QUALITY-SAFETY EVALUATION OF PTC. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5039133) ON 15-JAN-2015. THE MOST RECENT INFORMATION WAS RECEIVED ON 18-SEP-2019. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN: PELVIC') IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841532) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MORBID OBESITY AND BLOOD PRESSURE HIGH. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN AND NAPROXEN. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA PAINFUL SEXUAL INTERCOURSE") AND BACK PAIN ("PAIN: BACK"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), HEAVY PERIODS ("EXTREMELY HEAVY MENSTRUAL CYCLES/ABNORMAL BLEEDING MENORRHAGIA"), FATIGUE ("TIRED/ FATIGUE"), ALOPECIA ("HAIR IS THINNING OUT/ HAIR LOSS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"), MIGRAINE ("MIGRAINE/HEADACHE") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING) EXTREME PAIN FROM PERIODS AND FIBROIDS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("GAINING WEIGHT/ WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUATION IRREGULAR ("IRREGULAR MENSTRUAL CYCLES"), MENSTRUAL DISORDER ("HUGE BLOOD CLOTS"), PROLONGED MENSES ("PERIODS LAST ANYWHERE FROM 11 TO 15 DAYS"), HEADACHE ("HEADACHES"), FEELING HOT ("FEEL HOT") AND ANGER ("ANGRY") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("FIBROIDS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL) WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENSTRUATION IRREGULAR, MENSTRUAL DISORDER, HEADACHE, FEELING HOT, ANGER, FATIGUE, WEIGHT INCREASED, ALOPECIA, BACK PAIN AND UTERINE LEIOMYOMA OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN, HEAVY PERIODS, PROLONGED MENSES, DYSPAREUNIA, VAGINAL HAEMORRHAGE, MIGRAINE AND DYSMENORRHOEA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANGER, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING HOT, HEADACHE, HEAVY PERIODS, MENSTRUAL DISORDER, MENSTRUATION IRREGULAR, MIGRAINE, PELVIC PAIN, UTERINE LEIOMYOMA, VAGINAL HAEMORRHAGE, WEIGHT INCREASED AND PROLONGED MENSES TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 232 LBS. RIGHT: 4 COILS LEFT: 3 COILS . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 40.4 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-SEP-2019: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED : REPORTER INFORMATION UPDATED. EVENT ADDED- UTERINE LEIOMYOMA. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5039133) ON (B)(6) 2015. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6) 2020. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN: PELVIC') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841532) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MORBID OBESITY. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND BACK PAIN ("PAIN: BACK"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), BLEEDING MENSTRUAL HEAVY ("EXTREMELY HEAVY MENSTRUAL CYCLES/ABNORMAL BLEEDING (MENORRHAGIA)"), FATIGUE ("TIRED"), ALOPECIA ("HAIR IS THINNING OUT"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MIGRAINE ("MIGRAINE/HEADACHE") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND WAS FOUND TO HAVE WEIGHT INCREASED ("GAINING WEIGHT"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUATION IRREGULAR ("IRREGULAR MENSTRUAL CYCLES"), MENSTRUAL DISORDER ("HUGE BLOOD CLOTS"), PROLONGED MENSES ("PERIODS LAST ANYWHERE FROM 11 TO 15 DAYS"), HEADACHE ("HEADACHES"), FEELING HOT ("FEEL HOT") AND ANGER ("ANGRY"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENSTRUATION IRREGULAR, MENSTRUAL DISORDER, HEADACHE, FEELING HOT, ANGER, FATIGUE, WEIGHT INCREASED, ALOPECIA AND BACK PAIN OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN, BLEEDING MENSTRUAL HEAVY, PROLONGED MENSES, DYSPAREUNIA, VAGINAL HAEMORRHAGE, MIGRAINE AND DYSMENORRHOEA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANGER, BACK PAIN, BLEEDING MENSTRUAL HEAVY, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING HOT, HEADACHE, MENSTRUAL DISORDER, MENSTRUATION IRREGULAR, MIGRAINE, PELVIC PAIN, VAGINAL HAEMORRHAGE, WEIGHT INCREASED AND PROLONGED MENSES TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT (B)(6) LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 40.4 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: THIS CASE WAS UPGRADED FROM NON-SERIOUS INCIDENT TO SERIOUS INCIDENT. PLAINTIFF FACT SHEET AND MEDICAL RECORD RECEIVED. EVENTS" PAIN: PELVIC, ABNORMAL BLEEDING (VAGINAL), MIGRAINE/HEADACHE, DYSMENORRHEA (CRAMPING), AND PAIN: BACK)" WERE ADDED. PLAINTIFF DEMOGRAPHICS, LAB DATA, ESSURE REMOVAL DATE, ESSURE LOT NUMBER AND REPORTER 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 |
|---|---|---|---|---|---|---|---|
| 222872 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841532 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Other| R | IBUPROFEN| IBUPROFEN| NAPROXEN| NAPROXEN |