ESSURE
Report
- Report Number
- 2951250-2017-03504
- Event Type
- Injury
- Date Received
- September 11, 2017
- Report Date
- August 8, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN EVEN WHEN NOT MENSTRUATING") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863568) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST NOT PERFORM". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED HUMAN PAPILLOMA VIRUS INFECTION, CERVICAL DYSPLASIA AND HUMAN PAPILLOMA VIRUS INFECTION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IBUPROFEN. CONCURRENT CONDITIONS INCLUDED ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE, MENOMETRORRHAGIA, CERVICITIS, ENDOCERVICAL SQUAMOUS METAPLASIA, ABDOMINAL PAIN, NAUSEA, DIARRHEA, OVARIAN CYST, BACTERIAL VAGINOSIS, MULTIPAROUS, DEPRESSIVE DISORDER, ANXIETY STATE, ESOPHAGEAL REFLUX AND DIAPHRAGMATIC HERNIA. IN JANUARY 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL INFECTION ("CHRONIC VAGINAL INFECTIONS") AND WEIGHT FLUCTUATION ("WEIGHT GAIN / LOSS (SPECIFY WHICH ONE)"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("CHRONIC FATIGUE"). ON (B)(6) 2013, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6)2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN EVEN WHEN NOT MENSTRUATING"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEE"), OVARIAN CYST ("OVARIAN CYSTS"), FUNGAL INFECTION ("CHRONIC YEAST INFECTIONS") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, MENORRHAGIA, OVARIAN CYST, DYSPAREUNIA, FATIGUE AND WEIGHT INCREASED WAS RESOLVING, THE ABDOMINAL PAIN LOWER, FUNGAL INFECTION AND VAGINAL INFECTION HAD RESOLVED AND THE GENITAL HAEMORRHAGE, VAGINAL DISCHARGE AND WEIGHT FLUCTUATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FUNGAL INFECTION, GENITAL HAEMORRHAGE, MENORRHAGIA, OVARIAN CYST, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL INFECTION, WEIGHT FLUCTUATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: WT: 150. DIAGNOSTIC RESULTS: (B)(6) 2012:PATHOLOGY CERVICAL BRUSH BIOPSY. MILD DYSPLASIA (CIN II), EPITHELIAL CELL CHANGES OF HUMAN PAPILLOMA VIRUS. (B)(6) 2012:PATHOLOGY LOW GRADE SQUAMOUS INTRAEPITHELIAL LESION. (B)(6) 2015 PATHOLOGY DIAGNOSIS: CERVIX WITH CHRONIC CERVICITIS. FOCI OF MILDLY ATYPICAL SQUAMOUS EPITHELIAL METAPLASIA. NEGATIVE FOR SIGNIFICANT DYSPLASIA AND INVASIVE NEOPLASIA. MYOMETRIUM NEGATIVE FOR SIGNIFICANT HISTOPATHOLOGIC ABNORMALITIES. BILATERAL FALLOPIAN TUBES NEGATIVE FOR HISTOPATHOLOGIC ABNORMALITIES. GROSS DESCRIPTION: LEADING FROM UTERUS INTO OVIDUCTS ARE METALLIC COILS 1.3CM LENGTH AND 1MM IN GAUGE, CONSISTENT WITH THE ESSURE BIRTH CONTROL. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA PELVIC PAIN,MENORRHAGIA¿ MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET RECEIVED. EVENTS VAGINAL DISCHARGE, DEVICE MONITORING PROCEDURE NOT PERFORMED, WEIGHT FLUCTUATION ARE ADDED. CONCOMITANT & HISTORICAL CONDITIONS ARE ADDED. PRODUCT, PATIENT & REPORTER INFORMATION UPDATED. INCIDENT. AT THE TIME OF REPORTING, 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN EVEN WHEN NOT MENSTRUATING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863568) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE, MENOMETRORRHAGIA, CERVICITIS, ENDOCERVICAL SQUAMOUS METAPLASIA, ABDOMINAL PAIN, NAUSEA, DIARRHEA, OVARIAN CYST AND BACTERIAL VAGINOSIS. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN EVEN WHEN NOT MENSTRUATING"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEE"), OVARIAN CYST ("OVARIAN CYSTS"), FUNGAL INFECTION ("CHRONIC YEAST INFECTIONS"), VAGINAL INFECTION ("CHRONIC VAGINAL INFECTIONS"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), FATIGUE ("CHRONIC FATIGUE") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, ABDOMINAL PAIN LOWER, MENORRHAGIA, OVARIAN CYST, FUNGAL INFECTION, VAGINAL INFECTION, DYSPAREUNIA, FATIGUE AND WEIGHT INCREASED WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FUNGAL INFECTION, MENORRHAGIA, OVARIAN CYST, PELVIC PAIN, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: WT: 150. DIAGNOSTIC RESULTS: (B)(6) 2012:PATHOLOGY. CERVICAL BRUSH BIOPSY. MILD DYSPLASIA (CIN II), EPITHELIAL CELL CHANGES OF HUMAN PAPILLOMA VIRUS. (B)(6) 2012:PATHOLOGY. LOW GRADE SQUAMOUS INTRAEPITHELIAL LESION. (B)(6) 2015 PATHOLOGY. DIAGNOSIS: CERVIX WITH CHRONIC CERVICITIS. FOCI OF MILDLY ATYPICAL SQUAMOUS EPITHELIAL METAPLASIA. NEGATIVE FOR SIGNIFICANT DYSPLASIA AND INVASIVE NEOPLASIA. MYOMETRIUM NEGATIVE FOR SIGNIFICANT HISTOPATHOLOGIC ABNORMALITIES. BILATERAL FALLOPIAN TUBES NEGATIVE FOR HISTOPATHOLOGIC ABNORMALITIES. GROSS DESCRIPTION: LEADING FROM UTERUS INTO OVIDUCTS ARE METALLIC COILS 1.3CM LENGTH AND 1MM IN GAUGE, CONSISTENT WITH THE ESSURE BIRTH CONTROL. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE REPORTED VIA SOCIAL MEDIA PELVIC PAIN,¿ MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-MAR-2018: MEDICAL RECORD RECEIVED. REPORTER ADDED. LAB DATA AND CONCOMITANT DISEASE ADDED. LOT NUMBER ADDED. INCIDENT. AT THE TIME OF REPORTING, 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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN EVEN WHEN NOT MENSTRUATING") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863568) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST NOT PERFORM". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED HUMAN PAPILLOMA VIRUS INFECTION, CERVICAL DYSPLASIA AND HUMAN PAPILLOMA VIRUS INFECTION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IBUPROFEN. CONCURRENT CONDITIONS INCLUDED ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE, MENOMETRORRHAGIA, CERVICITIS, ENDOCERVICAL SQUAMOUS METAPLASIA, ABDOMINAL PAIN, NAUSEA, DIARRHEA, OVARIAN CYST, BACTERIAL VAGINOSIS, MULTIPAROUS, DEPRESSIVE DISORDER, ANXIETY STATE, ESOPHAGEAL REFLUX AND DIAPHRAGMATIC HERNIA. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL INFECTION ("CHRONIC VAGINAL INFECTIONS") AND WEIGHT FLUCTUATION ("WEIGHT GAIN / LOSS (SPECIFY WHICH ONE)"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("CHRONIC FATIGUE"). ON (B)(6) 2013, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN EVEN WHEN NOT MENSTRUATING"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEE"), OVARIAN CYST ("OVARIAN CYSTS"), FUNGAL INFECTION ("CHRONIC YEAST INFECTIONS") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, MENORRHAGIA, OVARIAN CYST, DYSPAREUNIA, FATIGUE AND WEIGHT INCREASED WAS RESOLVING, THE ABDOMINAL PAIN LOWER, FUNGAL INFECTION AND VAGINAL INFECTION HAD RESOLVED AND THE GENITAL HAEMORRHAGE, VAGINAL DISCHARGE AND WEIGHT FLUCTUATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FUNGAL INFECTION, GENITAL HAEMORRHAGE, MENORRHAGIA, OVARIAN CYST, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL INFECTION, WEIGHT FLUCTUATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: WT: 150. DIAGNOSTIC RESULTS: (B)(6) 2012: PATHOLOGY CERVICAL BRUSH BIOPSY. MILD DYSPLASIA (CIN II), EPITHELIAL CELL CHANGES OF HUMAN PAPILLOMA VIRUS. (B)(6) 2012:PATHOLOGY LOW GRADE SQUAMOUS INTRAEPITHELIAL LESION. (B)(6) 2015 PATHOLOGY DIAGNOSIS: CERVIX WITH CHRONIC CERVICITIS. FOCI OF MILDLY ATYPICAL SQUAMOUS EPITHELIAL METAPLASIA. NEGATIVE FOR SIGNIFICANT DYSPLASIA AND INVASIVE NEOPLASIA. MYOMETRIUM NEGATIVE FOR SIGNIFICANT HISTOPATHOLOGIC ABNORMALITIES. BILATERAL FALLOPIAN TUBES NEGATIVE FOR HISTOPATHOLOGIC ABNORMALITIES. GROSS DESCRIPTION: LEADING FROM UTERUS INTO OVIDUCTS ARE METALLIC COILS 1.3CM LENGTH AND 1MM IN GAUGE, CONSISTENT WITH THE ESSURE BIRTH CONTROL. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA PELVIC PAIN,MENORRHAGIA¿ QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: QUALITY SAFETY EVALUATION OF PTC. INCIDENT: AT THE TIME OF REPORTING, 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN EVEN WHEN NOT MENSTRUATING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. 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 PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN EVEN WHEN NOT MENSTRUATING"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEE"), OVARIAN CYST ("OVARIAN CYSTS"), FUNGAL INFECTION ("CHRONIC YEAST INFECTIONS"), VAGINAL INFECTION ("CHRONIC VAGINAL INFECTIONS"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), FATIGUE ("CHRONIC FATIGUE") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, ABDOMINAL PAIN LOWER, MENORRHAGIA, OVARIAN CYST, FUNGAL INFECTION, VAGINAL INFECTION, DYSPAREUNIA, FATIGUE AND WEIGHT INCREASED WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FUNGAL INFECTION, MENORRHAGIA, OVARIAN CYST, PELVIC PAIN, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. 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 |
|---|---|---|---|---|---|---|---|
| 635082 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 863568 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Other| R |