ESSURE
Report
- Report Number
- 2951250-2019-03419
- Event Type
- Injury
- Date Received
- July 8, 2019
- Date of Event
- March 1, 2011
- Report Date
- May 14, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN/PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 823318-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PELVIC DISCOMFORT, NABOTHIAN CYST, HERNIA (HERNIA IN THE RIGHT ROUND LIGAMENT AREA) AND ABDOMINAL ADHESIONS (THERE WERE SOME ADHESIONS OF THE BLADDER TO THE LOWER UTERINE SEGMENT. THERE WERE ADHESIONS OF THE OMENTUM TO THE ANTERIOR ABDOMINAL WALL.). ESSURE CONFIRMATION TEST: DONE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORTHO MICRONOR, NAPROXEN AND NORETHINDRONE. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), NAUSEA ("NAUSEA,"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),") AND FATIGUE ("FATIGUE,"). IN 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ENDOMETRIOSIS ("ENDOMETRIOSIS") AND PROCTALGIA ("RECTAL AREA PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY/LAPAROSCOPY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, NAUSEA, DYSMENORRHOEA, ENDOMETRIOSIS, DYSPAREUNIA, FATIGUE AND PROCTALGIA HAD RESOLVED. THE REPORTER CONSIDERED DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FATIGUE, MENORRHAGIA, NAUSEA, PELVIC PAIN, PROCTALGIA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION DATE: (B)(6) 2007. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BIOPSY ENDOMETRIUM - ON AN UNKNOWN DATE: PROLIFERATIVE PHASE ENDOMETRIUM WITHOUT HYPERPLASIA, DYSPLASIA, OR MALIGNANCY GROSS DESCRIPTION: RESULT: THE SPECIMEN IS LABELED "ENDOMETRIAL BIOPSY "AND CONSISTS OF MOTTLED, TAN, GREY, SOFT TISSUE FRAGMENTS OF TISSUE, MEASURING 0.5 CUBIC CM IN AGGREGATE MICROSCOPIC DESCRIPTION RESULT: THE SPECIMEN CONSISTS OF PROLIFERATIVE PHASE ENDOMETRIUM . HYPERPLASIA, DYSPLASIA AND MALIGNANCY ARE NOT OBSERVED.. ULTRASOUND PELVIS - ON AN UNKNOWN DATE: FINDINGS: THE ENDOMETRIUM IS NORMAL IN APPEARANCE AND THICKNESS MEASURING 10 MM. AN INCIDENTALLY NOTED NABOTHIAN CYST IS SEEN IN THE CERVIX. IMPRESSION: NORMAL PELVIC SONOGRAPHY. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS: IT CONFIRMS EVENTS AS MENORRHAGIA, DYSMENORRHEA, ENDOMETRIOSIS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: UPDATE OF INFORMATION (BATCH IS INVALID) BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN/PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 823318) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PELVIC DISCOMFORT, NABOTHIAN CYST, HERNIA (HERNIA IN THE RIGHT ROUND LIGAMENT AREA) AND ABDOMINAL ADHESIONS (THERE WERE SOME ADHESIONS OF THE BLADDER TO THE LOWER UTERINE SEGMENT. THERE WERE ADHESIONS OF THE OMENTUM TO THE ANTERIOR ABDOMINAL WALL.). ESSURE CONFIRMATION TEST: DONE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORTHO MICRONOR, NAPROXEN AND NORETHINDRONE. IN 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), NAUSEA ("NAUSEA,"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),") AND FATIGUE ("FATIGUE,"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ENDOMETRIOSIS ("ENDOMETRIOSIS") AND PROCTALGIA ("RECTAL AREA PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY/LAPAROSCOPY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, NAUSEA, DYSMENORRHOEA, ENDOMETRIOSIS, DYSPAREUNIA, FATIGUE AND PROCTALGIA HAD RESOLVED. THE REPORTER CONSIDERED DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FATIGUE, MENORRHAGIA, NAUSEA, PELVIC PAIN, PROCTALGIA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION DATE: (B)(6) 2007. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BIOPSY ENDOMETRIUM - ON AN UNKNOWN DATE: PROLIFERATIVE PHASE ENDOMETRIUM WITHOUT HYPERPLASIA, DYSPLASIA, OR MALIGNANCY GROSS DESCRIPTION: RESULT: THE SPECIMEN IS LABELED "ENDOMETRIAL BIOPSY "AND CONSISTS OF MOTTLED, TAN, GREY, SOFT TISSUE FRAGMENTS OF TISSUE, MEASURING 0.5 CUBIC CM IN AGGREGATE MICROSCOPIC DESCRIPTION RESULT: THE SPECIMEN CONSISTS OF PROLIFERATIVE PHASE ENDOMETRIUM . HYPERPLASIA, DYSPLASIA AND MALIGNANCY ARE NOT OBSERVED. ULTRASOUND PELVIS - ON AN UNKNOWN DATE: FINDINGS: THE ENDOMETRIUM IS NORMAL IN APPEARANCE AND THICKNESS MEASURING 10 MM. AN INCIDENTALLY NOTED NABOTHIAN CYST IS SEEN IN THE CERVIX. IMPRESSION: NORMAL PELVIC SONOGRAPHY. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS: IT CONFIRMS EVENTS AS MENORRHAGIA, DYSMENORRHEA, ENDOMETRIOSIS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-APR-2020 PLAINTIFF FACT SHEET AND MEDICAL RECORD WAS RECEIVED. REPORTER INFORMATION, LOT NUMBER 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN,') IN AN ADULT 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 PELVIC DISCOMFORT, NABOTHIAN CYST, HERNIA (HERNIA IN THE RIGHT ROUND LIGAMENT AREA) AND ABDOMINAL ADHESIONS (THERE WERE SOME ADHESIONS OF THE BLADDER TO THE LOWER UTERINE SEGMENT. THERE WERE ADHESIONS OF THE OMENTUM TO THE ANTERIOR ABDOMINAL WALL). ESSURE CONFIRMATION TEST: DONE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORTHO MICRONOR, NAPROXEN AND NORETHINDRONE. IN 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), NAUSEA ("NAUSEA,"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), ENDOMETRIOSIS ("ENDOMETRIOSIS"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), FATIGUE ("FATIGUE,") AND PROCTALGIA ("RECTAL AREA PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, NAUSEA, DYSMENORRHOEA, ENDOMETRIOSIS, DYSPAREUNIA, FATIGUE AND PROCTALGIA HAD RESOLVED. THE REPORTER CONSIDERED DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FATIGUE, MENORRHAGIA, NAUSEA, PELVIC PAIN, PROCTALGIA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BIOPSY ENDOMETRIUM - ON AN UNKNOWN DATE: PROLIFERATIVE PHASE ENDOMETRIUM WITHOUT HYPERPLASIA, DYSPLASIA, OR MALIGNANCY GROSS DESCRIPTION: RESULT: THE SPECIMEN IS LABELED "ENDOMETRIAL BIOPSY "AND CONSISTS OF MOTTLED, TAN, GREY, SOFT TISSUE FRAGMENTS OF TISSUE, MEASURING 0.5 CUBIC CM IN AGGREGATE MICROSCOPIC DESCRIPTION RESULT: THE SPECIMEN CONSISTS OF PROLIFERATIVE PHASE ENDOMETRIUM . HYPERPLASIA, DYSPLASIA AND MALIGNANCY ARE NOT OBSERVED. ULTRASOUND PELVIS - ON AN UNKNOWN DATE: FINDINGS: THE ENDOMETRIUM IS NORMAL IN APPEARANCE AND THICKNESS MEASURING 10 MM. AN INCIDENTALLY NOTED NABOTHIAN CYST IS SEEN IN THE CERVIX. IMPRESSION: NORMAL PELVIC SONOGRAPHY. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS: IT CONFIRMS EVENTS AS MENORRHAGIA, DYSMENORRHEA, ENDOMETRIOSIS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-JUN-2019: PFS AND MR RECEIVED: EVENTS ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), NAUSEA, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), RECTAL AND PELVIC PAIN, FATIGUE, OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: ENDOMETRIOSIS WERE ADDED. MEDICAL HISTORY, LAB DATA, HISTORICAL DRUG WERE 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 |
|---|---|---|---|---|---|---|---|
| 562214 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 823318-NOT VALID | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other| R |