ESSURE
Report
- Report Number
- 2951250-2018-01437
- Event Type
- Injury
- Date Received
- April 3, 2018
- Report Date
- March 26, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ("SEVERE CRAMPING") IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922606) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "HYDROTHERMAL ENDOMETRIAL ABLATION WITH ESSURE INSERTION" ON (B)(6) 2012 AND DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST: NOT PERFORMED". THE PATIENT'S MEDICAL HISTORY INCLUDED BACK PAIN, THYROID DISORDER, ACUTE CYSTITIS, PYELONEPHRITIS, HYDRONEPHROSIS, MENOMETRORRHAGIA AND CESAREAN SECTION. CONCOMITANT PRODUCTS INCLUDED DOCUSATE SODIUM (COLACE) SINCE 2014, FERROUS SULFATE SINCE 2017, HYDROCODONE BITARTRATE;PARACETAMOL (NORCO) SINCE 2014, IBUPROFEN SINCE 2014 AND LEVOTHYROXINE SODIUM (SYNTHROID) SINCE 2002. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), OVULATION PAIN ("SHARP STABBING PAIN WITH OVULATION AND MENSTRUATION"), DYSMENORRHOEA ("SHARP STABBING PAIN WITH OVULATION AND MENSTRUATION /DYSMENORRHEA (CRAMPING"), BACK PAIN ("SEVERE BACK PAIN"), ENDOMETRIOSIS ("ENDOMETRIOSIS"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH CORTICOSTEROIDS AND SURGERY (SUPRACERVICAL HYSTERECTOMY, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, OVULATION PAIN, DYSMENORRHOEA AND ENDOMETRIOSIS OUTCOME WAS UNKNOWN AND THE BACK PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE AND ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BACK PAIN, DYSMENORRHOEA, ENDOMETRIOSIS, MENORRHAGIA, OVULATION PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PLAINTIFF TOOK STEROID INJECTIONS FOR SEVERE BACK PAIN. SHE WAS SCHEDULED TO HAVE THE ESSURE DEVICE REMOVED IN (B)(6) 2018. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: RESULT WAS NOT PROVIDED. FINDINGS: NO UNEXPECTED FINDINGS. PATHOLOGY TEST - ON (B)(6) 2018: SPECIMEN SUBMITTED: UTERUS, BILATERAL FALLOPIAN TUBES PRE-DX: MENOMETRORRHAGIA AND PELVIC PAIN. FINAL DIAGNOSIS (MICROSCOPIC): UTERUS, BILATERAL FALLOPIAN TUBES: ENDOMETRIUM A. PROLIFERATIVE ENDOMETRIUM. B. NO CHRONIC ENDOMETRITIS, ATYPICAL HYPERPLASIA OR MALIGNANCY IDENTIFIED. MYOMETRIUM A. ADENOMYOSIS. B. MULTIPLE LEIOMYOMATA, INTRAMURAL. C. NO MALIGNANCY IDENTIFIED. SEGMENTS OF FIMBRIATED FALLOPIAN TUBES A. NO PATHOLOGIC DIAGNOSTIC ABNORMALITY. B. NEGATIVE FOR ENDOMETRIOSIS OR MALIGNANCY. GROSS DESCRIPTION: ESSURE COILS ARE REMOVED FROM THE CORNU EXTENDING INTO THE FALLOPIAN TUBES BILATERALLY.. 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 PRODUCT TECHNICAL COMPLAINT. 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 ABDOMINAL PAIN LOWER ("SEVERE CRAMPING") IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922606) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "HYDROTHERMAL ENDOMETRIAL ABLATION WITH ESSURE INSERTION" ON (B)(6)2012 AND DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST: NOT PERFORMED". THE PATIENT'S MEDICAL HISTORY INCLUDED BACK PAIN, THYROID DISORDER, ACUTE CYSTITIS, PYELONEPHRITIS, HYDRONEPHROSIS, MENOMETRORRHAGIA AND CESAREAN SECTION. CONCOMITANT PRODUCTS INCLUDED DOCUSATE SODIUM (COLACE) SINCE 2014, FERROUS SULFATE SINCE 2017, HYDROCODONE BITARTRATE;PARACETAMOL (NORCO) SINCE 2014, IBUPROFEN SINCE 2014 AND LEVOTHYROXINE SODIUM (SYNTHROID) SINCE 2002. ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), OVULATION PAIN ("SHARP STABBING PAIN WITH OVULATION AND MENSTRUATION"), DYSMENORRHOEA ("SHARP STABBING PAIN WITH OVULATION AND MENSTRUATION /DYSMENORRHEA (CRAMPING"), BACK PAIN ("SEVERE BACK PAIN"), ENDOMETRIOSIS ("ENDOMETRIOSIS"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH CORTICOSTEROIDS AND SURGERY (SUPRACERVICAL HYSTERECTOMY, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2018. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, OVULATION PAIN, DYSMENORRHOEA AND ENDOMETRIOSIS OUTCOME WAS UNKNOWN AND THE BACK PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE AND ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BACK PAIN, DYSMENORRHOEA, ENDOMETRIOSIS, MENORRHAGIA, OVULATION PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PLAINTIFF TOOK STEROID INJECTIONS FOR SEVERE BACK PAIN. SHE WAS SCHEDULED TO HAVE THE ESSURE DEVICE REMOVED IN (B)(6)2018. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6)2012: RESULTS: RESULT WAS NOT PROVIDED. FINDINGS: NO UNEXPECTED FINDINGS. PATHOLOGY TEST - ON (B)(6)2018: SPECIMEN SUBMITTED: UTERUS, BILATERAL FALLOPIAN TUBES PRE-DX: MENOMETRORRHAGIA AND PELVIC PAIN. FINAL DIAGNOSIS (MICROSCOPIC): UTERUS, BILATERAL FALLOPIAN TUBES: ENDOMETRIUM A. PROLIFERATIVE ENDOMETRIUM. B. NO CHRONIC ENDOMETRITIS, ATYPICAL HYPERPLASIA OR MALIGNANCY IDENTIFIED. MYOMETRIUM. A. ADENOMYOSIS. B. MULTIPLE LEIOMYOMATA, INTRAMURAL. C. NO MALIGNANCY IDENTIFIED. SEGMENTS OF FIMBRIATED FALLOPIAN TUBES A. NO PATHOLOGIC DIAGNOSTIC ABNORMALITY. B. NEGATIVE FOR ENDOMETRIOSIS OR MALIGNANCY. GROSS DESCRIPTION: ESSURE COILS ARE REMOVED FROM THE CORNU EXTENDING INTO THE FALLOPIAN TUBES BILATERALLY.. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-FEB-2019: PFS+MR RECEIVED: EVENTS ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), ESSURE CONFIRMATION TEST: NOT PERFORMED, PAIN, HYDROTHERMAL ENDOMETRIAL ABLATION WITH ESSURE INSERTION WERE ADDED. MEDICAL HISTORY, LAB DATA, LOT NUMBER ADDED. INCIDENT: WE RECEIVED A LOT NUMBER. 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 ABDOMINAL PAIN LOWER ("SEVERE CRAMPING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR BIRTH CONTROL. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), OVULATION PAIN ("SHARP STABBING PAIN WITH OVULATION AND MENSTRUATION"), DYSMENORRHOEA ("SHARP STABBING PAIN WITH OVULATION AND MENSTRUATION"), BACK PAIN ("SEVERE BACK PAIN") AND ENDOMETRIOSIS ("ENDOMETRIOSIS"). THE PATIENT WAS TREATED WITH CORTICOSTEROIDS AND WILL UNDERGO SURGERY (SCHEDULED TO HAVE THE ESSURE DEVICE REMOVED IN (B)(6) 2018). AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, OVULATION PAIN, DYSMENORRHOEA, BACK PAIN AND ENDOMETRIOSIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BACK PAIN, DYSMENORRHOEA, ENDOMETRIOSIS AND OVULATION PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PLAINTIFF TOOK STEROID INJECTIONS FOR SEVERE BACK PAIN. SHE WAS SCHEDULED TO HAVE THE ESSURE DEVICE REMOVED IN (B)(6) 2018. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULT WAS NOT PROVIDED. 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 |
|---|---|---|---|---|---|---|---|
| 234839 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 922606 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other| R | COLACE| COLACE| FERROUS SULFATE| FERROUS SULFATE| IBUPROFEN| IBUPROFEN| NORCO| NORCO| SYNTHROID| SYNTHROID |