ESSURE
Report
- Report Number
- 2951250-2017-09477
- Event Type
- Injury
- Date Received
- November 30, 2017
- Report Date
- October 29, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN'), GENITAL HAEMORRHAGE ('PAIN WITH VERY HEAVY BLEEDING') AND MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802744) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BLOOD IN STOOL, WEIGHT LOSS, VENEREAL DISEASE NOS, MALIGNANT NEOPLASM OF CERVIX UTERI, UTERINE LEIOMYOMA, MENSTRUAL DISORDER, BLOOD IN URINE, OBESITY, ENDOCERVICAL CURETTAGE, ENDOMETRIAL CURETTAGE, FATIGUE, ENDOMETRIAL THICKENING, BLEEDING TIME DECREASED, MYOMECTOMY, LAPAROSCOPICALLY ASSISTED HYSTERECTOMY, LAPAROTOMY, INFECTION, LATE EFFECT OF INTERNAL INJURY TO INTRAABDOMINAL ORGANS, ESSENTIAL HYPERTENSION, KNEE ARTHRITIS (LEFT KNEE PAIN), GUM DISORDER, NAUSEA, UMBILICAL HERNIA, MULTIPLE CAESAREAN SECTIONS, MISCARRIAGE, OVARIAN CYST, ULTRASOUND BREAST, ENDOCERVICAL CURETTAGE AND URINARY INCONTINENCE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MEGACE, HYDROGEN PEROXIDE AND BACITRACIN. CONCURRENT CONDITIONS INCLUDED DECREASED APPETITE SINCE (B)(6) 2016, PARATUBAL CYST SINCE (B)(6) 2016, PAIN IN HIP AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED AMOXICILLIN AND MEDROXYPROGESTERONE ACETATE (PROVERA). IN (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ABDOMINAL PAIN LOWER ("PAIN WITH VERY HEAVY BLEEDING"). IN 2013, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"), TOOTH DISORDER ("DENTAL PROBLEMS"), VISUAL IMPAIRMENT ("DEPLETION IN VISION") AND FATIGUE ("FATIGUE / TIRED") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("UTERINE FIBROIDS"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN 2015, THE PATIENT EXPERIENCED BLADDER DISORDER ("BLADDER PROBLEMS") AND URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VULVOVAGINAL PAIN ("VAGINAL AREA PAIN"), FIBROMYALGIA ("FIBROMYALGIA") AND ANXIETY ("ANXIETY"). THE PATIENT WAS TREATED WITH D AND C, D AND C- (B)(6) 2015 AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHERECTOMY). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, ABDOMINAL PAIN LOWER AND VULVOVAGINAL PAIN HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, DEPRESSION, FIBROMYALGIA, BLADDER DISORDER, URINARY TRACT DISORDER, UTERINE LEIOMYOMA, TOOTH DISORDER, VISUAL IMPAIRMENT, FATIGUE AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ANXIETY, BLADDER DISORDER, DEPRESSION, FATIGUE, FIBROMYALGIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, TOOTH DISORDER, URINARY TRACT DISORDER, UTERINE LEIOMYOMA, VAGINAL HAEMORRHAGE, VISUAL IMPAIRMENT AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY IN INSERTION DATES- INSERTION DATES: (B)(6) 2010 AND (B)(6) 2011. REMOVAL DATES: (B)(6) 2016 AND (B)(6) 2016. NEED FOR ADDITIONAL SURGERY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON AN UNKNOWN DATE: NEGATIVE. ULTRASOUND SCAN VAGINA - ON AN UNKNOWN DATE: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENTS MEDICAL RECORD: MENORRHAGIA, DEPRESSION, HEAVY VAGINAL BLEEDING, PAIN, GENITAL HAEMORRHAGE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-SEP-2019: MEDICAL RECORDS RECEIVED: ESSURE LOT NUMBER, REPORTERS AND MEDICAL HISTORY ADDED. 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 PELVIC PAIN ('PAIN'), GENITAL HAEMORRHAGE ('PAIN WITH VERY HEAVY BLEEDING') AND MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ABDOMINAL PAIN LOWER ("PAIN WITH VERY HEAVY BLEEDING"). IN 2013, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"), TOOTH DISORDER ("DENTAL PROBLEMS"), VISUAL IMPAIRMENT ("DEPLETION IN VISION") AND FATIGUE ("FATIGUE / TIRED") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("UTERINE FIBROIDS"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN 2015, THE PATIENT EXPERIENCED BLADDER DISORDER ("BLADDER PROBLEMS") AND URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FIBROMYALGIA ("FIBROMYALGIA"), VULVOVAGINAL PAIN ("VAGINAL AREA PAIN") AND ANXIETY ("ANXIETY"). THE PATIENT WAS TREATED WITH D AND C, D AND C (B)(6) 2015 AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHERECTOMY). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, ABDOMINAL PAIN LOWER AND VULVOVAGINAL PAIN HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, DEPRESSION, FIBROMYALGIA, BLADDER DISORDER, URINARY TRACT DISORDER, UTERINE LEIOMYOMA, TOOTH DISORDER, VISUAL IMPAIRMENT, FATIGUE AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ANXIETY, BLADDER DISORDER, DEPRESSION, FATIGUE, FIBROMYALGIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, TOOTH DISORDER, URINARY TRACT DISORDER, UTERINE LEIOMYOMA, VAGINAL HAEMORRHAGE, VISUAL IMPAIRMENT AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY IN INSERTION DATES- INSERTION DATES: (B)(6) 2010 AND (B)(6) 2011. REMOVAL DATES: (B)(6) 2016 AND (B)(6) 2016. NEED FOR ADDITIONAL SURGERY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN VAGINA - ON AN UNKNOWN DATE: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-JUN-2019: PFS RECEIVED- EVENTS- "ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), DEPRESSION, ANXIETY, FIBROMYALGIA, BLADDER PROBLEMS, URINARY PROBLEMS OR CHANGES, UTERINE FIBROIDS, DENTAL PROBLEMS, DEPLETION IN VISION, FATIGUE, PAIN WITH VERY HEAVY BLEEDING, VAGINAL AREA PAIN", REPORTER, LAB DATA 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN'), GENITAL HAEMORRHAGE ('PAIN WITH VERY HEAVY BLEEDING') AND MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802744) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BLOOD IN STOOL, WEIGHT LOSS, VENEREAL DISEASE NOS, MALIGNANT NEOPLASM OF CERVIX UTERI, UTERINE LEIOMYOMA, MENSTRUAL DISORDER, BLOOD IN URINE, OBESITY, ENDOCERVICAL CURETTAGE, ENDOMETRIAL CURETTAGE, FATIGUE, ENDOMETRIAL THICKENING, BLEEDING TIME DECREASED, MYOMECTOMY, LAPAROSCOPICALLY ASSISTED HYSTERECTOMY, LAPAROTOMY, INFECTION, LATE EFFECT OF INTERNAL INJURY TO INTRAABDOMINAL ORGANS, ESSENTIAL HYPERTENSION, KNEE ARTHRITIS (LEFT KNEE PAIN), GUM DISORDER, NAUSEA, UMBILICAL HERNIA, MULTIPLE CAESAREAN SECTIONS, MISCARRIAGE, OVARIAN CYST, ULTRASOUND BREAST, ENDOCERVICAL CURETTAGE AND URINARY INCONTINENCE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MEGACE, HYDROGEN PEROXIDE AND BACITRACIN. CONCURRENT CONDITIONS INCLUDED DECREASED APPETITE SINCE (B)(6) 2016, PARATUBAL CYST SINCE (B)(6) 2016, PAIN IN HIP AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED AMOXICILLIN AND MEDROXYPROGESTERONE ACETATE (PROVERA). IN (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ABDOMINAL PAIN LOWER ("PAIN WITH VERY HEAVY BLEEDING"). IN 2013, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"), TOOTH DISORDER ("DENTAL PROBLEMS"), VISUAL IMPAIRMENT ("DEPLETION IN VISION") AND FATIGUE ("FATIGUE / TIRED") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("UTERINE FIBROIDS"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN 2015, THE PATIENT EXPERIENCED BLADDER DISORDER ("BLADDER PROBLEMS") AND URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VULVOVAGINAL PAIN ("VAGINAL AREA PAIN"), FIBROMYALGIA ("FIBROMYALGIA") AND ANXIETY ("ANXIETY"). THE PATIENT WAS TREATED WITH D AND C, D AND C-(B)(6) 2015 AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHERECTOMY). ESSURE WAS REMOVED IN MAY 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, ABDOMINAL PAIN LOWER AND VULVOVAGINAL PAIN HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, DEPRESSION, FIBROMYALGIA, BLADDER DISORDER, URINARY TRACT DISORDER, UTERINE LEIOMYOMA, TOOTH DISORDER, VISUAL IMPAIRMENT, FATIGUE AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ANXIETY, BLADDER DISORDER, DEPRESSION, FATIGUE, FIBROMYALGIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, TOOTH DISORDER, URINARY TRACT DISORDER, UTERINE LEIOMYOMA, VAGINAL HAEMORRHAGE, VISUAL IMPAIRMENT AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY IN INSERTION DATES- INSERTION DATES:(B)(6) 2010 AND (B)(6) 2011 REMOVAL DATES: (B)(6) 2016 AND (B)(6) 2016 NEED FOR ADDITIONAL SURGERY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON AN UNKNOWN DATE: NEGATIVE. ULTRASOUND SCAN VAGINA - ON AN UNKNOWN DATE: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENTS MEDICAL RECORD: MENORRHAGIA, DEPRESSION, HEAVY VAGINAL BLEEDING, PAIN, GENITAL HAEMORRHAGE. LOT NUMBER: 802744 MANUFACTURE DATE: 2010-11 EXPIRATION DATE: 2013-11 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-OCT-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 PELVIC PAIN ("PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. IN (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NEED FOR ADDITIONAL SURGERY. 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 |
|---|---|---|---|---|---|---|---|
| 850200 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 802744 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other| R | AMOXICILLIN| AMOXICILLIN| PROVERA| PROVERA |