ESSURE
Report
- Report Number
- 2951250-2019-10663
- Event Type
- Injury
- Date Received
- October 23, 2019
- Report Date
- November 4, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ('MIGRATION/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE:UTERINE WALL/EMBEDDED ESSURE COIL INTO THE UTERINE MYOMETRIUM/ IMBEDDED THEMSELVES IN MY UTERUS WALL') IN A 27-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: DEVICE MONITORING PROCEDURE NOT PERFORMED "THE PATIENT DID NOT UNDERGO CONFIRMATORY TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED ANXIETY, PANIC ATTACK, CHOLECYSTECTOMY ((B)(6)), CESAREAN SECTION ((B)(6) 2005 AND (B)(6) 2006), MULTIGRAVIDA, PARITY 2 AND ENDOMETRIAL POLYP. ON (B)(6) 2016-SURGICAL PATHOLOGY REPORT FINAL DIAGNOSIS: UTERUS AND CERVIX, HYSTERECTOMY: A. CERVIX:- MILD CHRONIC INFLAMMATION. B. ENDOCERVIX: SQUAMOUS METAPLASIA AND CHRONIC CERVICITIS, MILD. C. ENDOMETRIUM: ¿ BENIGN ENDOMETRIAL POLYP. SECRETORY ENDOMETRIUM. D. MYOMETRIUM: BENIGN LEIOMYOMA (2.2 CM IN DIAMETER WITH 0 MITOSES IN 10 HIGH POWER FIELDS). CONCURRENT CONDITIONS INCLUDED INSOMNIA, PALPITATIONS, SWEATING, SHORTNESS OF BREATH, NUMBNESS, TINGLING, ARTHRALGIA MULTIPLE, BACK PAIN, HEADACHE, FATIGUE, SUBSEROUS LEIOMYOMA OF UTERUS, OVARIAN CYST, NAUSEA, GESTATIONAL DIABETES, MENSTRUATION IRREGULAR, MENOMETRORRHAGIA AND CHRONIC CERVICITIS. FAMILY HISTORY INCLUDED BREAST CANCER. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX), OXYCODONE AND TRAMADOL HYDROCHLORIDE (TRAMADOLE). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)/ MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), 2 MONTHS 16 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), DYSMENORRHOEA ("DYSMENNORHEA (CRAMPING)") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"). IN (B)(6) 2016, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("UTI"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN/ SEVERE ABDOMINAL PAIN"), URINARY TRACT DISORDER ("URINARY PROBLEM"), PELVIC PAIN ("PELVIC PAIN/CHRONIC/ DEVASTATING PAIN"), BLADDER DISORDER ("BLADDER PROBLEMS"), ANXIETY ("ANXIETY") AND COMPLICATION OF DEVICE REMOVAL ("IT HAS BEEN A FAILED ATTEMPT AT REMOVING THE IUD"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY, BILATERAL SALPINGECTOMY, UNILATERAL OOPHERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, ANXIETY, ABDOMINAL PAIN LOWER, URINARY TRACT INFECTION AND COMPLICATION OF DEVICE REMOVAL OUTCOME WAS UNKNOWN AND THE DYSPAREUNIA, MENORRHAGIA, ABDOMINAL PAIN, DYSMENORRHOEA, URINARY TRACT DISORDER, PELVIC PAIN, BLADDER DISORDER AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, BLADDER DISORDER, COMPLICATION OF DEVICE REMOVAL, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, MENORRHAGIA, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR EVENTS ¿ PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), MIGRATION, ANXIETY INSERTION DETAILS- RIGHT 2 COILS AND LEFT 5 COILS WERE SEEN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM PELVIS - ON (B)(6) 2016: IMPRESSION: 1. VARIANT POSITION OF THE PROXIMAL TIP OF THE RIGHT ESSURE COIL, WHICH IS NOT IMPLANTED WITHIN THE SUBSTANCE OF THE MYOMETRIUM NEAR THE UTERINE CORNUA. FURTHER CLINICAL EVALUATION IS NEEDED TO EXCLUDE MALPOSITIONING OR MIGRATION. 2. THE LEFT ESSURE COIL IS IMPLANTED WITHIN THE MID LEFT MYOMETRIUM AT THE UTERINE CORNUA LEVEL.. ULTRASOUND SCAN VAGINA - ON (B)(6) 2016: IMPRESSION: 1. AS PER CLINICAL HISTORY, PATIENT HAS BILATERAL ESSURE COILS. HOWEVER, ONLY THE RIGHT ESSURE COIL WAS SONOGRAPHICALLY VISUALIZED. PELVIC RADIOGRAPH MAY BE HELPFUL TO CONFIRM THE PRESENCE OF THE LEFT ONE. 2. SMALL POSTERIOR UTERINE SUBSEROSAL LEIOMYOMA. 3. COMPLEX RIGHT OVARIAN CYST. 4. NUMEROUS LEFT OVARIAN FOLLICLES. 5. NO COMPLEX PELVIC FREE FLUID. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, ABDOMINAL PAIN, DYSMENORRHEA, PELVIC PAIN, URINARY TRACT INFECTION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-OCT-2019: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 EMBEDDED DEVICE ('MIGRATION/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERINE WALL/ EMBEDDED ESSURE COIL INTO THE UTERINE MYOMETRIUM/ IMBEDDED THEMSELVES IN MY UTERUS WALL') IN A (B)(6) 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: DEVICE MONITORING PROCEDURE NOT PERFORMED "THE PATIENT DID NOT UNDERGO CONFIRMATORY TEST" AND DEVICE DIFFICULT TO USE "IT HAS BEEN A FAILED ATTEMPT AT REMOVING THE IUD". THE PATIENT'S MEDICAL HISTORY INCLUDED ANXIETY, PANIC ATTACK, CHOLECYSTECTOMY (2007), CESAREAN SECTION ((B)(6) 2006), GRAVIDA II, PARITY 2 AND ENDOMETRIAL POLYP, (B)(6) 2016 SURGICAL PATHOLOGY REPORT: FINAL DIAGNOSIS: UTERUS AND CERVIX, HYSTERECTOMY: A. CERVIX:- MILD CHRONIC INFLAMMATION. ENDOCERVIX: SQUAMOUS METAPLASIA AND CHRONIC CERVICITIS, MILD. ENDOMETRIUM: BENIGN ENDOMETRIAL POLYP. SECRETORY ENDOMETRIUM. MYOMETRIUM: BENIGN LEIOMYOMA (2.2 CM IN DIAMETER WITH 0 MITOSES IN 10 HIGH POWER FIELDS). CONCURRENT CONDITIONS INCLUDED INSOMNIA, PALPITATIONS, SWEATING, SHORTNESS OF BREATH, NUMBNESS, TINGLING, ARTHRALGIA MULTIPLE, BACK PAIN, HEADACHE, FATIGUE, SUBSEROUS LEIOMYOMA OF UTERUS, OVARIAN CYST, NAUSEA, GESTATIONAL DIABETES, MENSTRUATION IRREGULAR, MENOMETRORRHAGIA AND CHRONIC CERVICITIS. FAMILY HISTORY INCLUDED BREAST CANCER. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX), OXYCODONE AND TRAMADOL HYDROCHLORIDE (TRAMADOLE). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)/ MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), 2 MONTHS 16 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"). IN (B)(6) 2016, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("UTI"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN/ SEVERE ABDOMINAL PAIN"), URINARY TRACT DISORDER ("URINARY PROBLEM"), PELVIC PAIN ("PELVIC PAIN/ CHRONIC/ DEVASTATING PAIN"), BLADDER DISORDER ("BLADDER PROBLEMS") AND ANXIETY ("ANXIETY"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY, BILATERAL SALPINGECTOMY, UNILATERAL OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, ANXIETY, ABDOMINAL PAIN LOWER AND URINARY TRACT INFECTION OUTCOME WAS UNKNOWN AND THE DYSPAREUNIA, MENORRHAGIA, ABDOMINAL PAIN, DYSMENORRHOEA, URINARY TRACT DISORDER, PELVIC PAIN, BLADDER DISORDER AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, MENORRHAGIA, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR EVENTS ¿ PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), MIGRATION, ANXIETY. INSERTION DETAILS - RIGHT 2 COILS AND LEFT 5 COILS WERE SEEN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM PELVIS - ON (B)(6) 2016: IMPRESSION: VARIANT POSITION OF THE PROXIMAL TIP OF THE RIGHT ESSURE COIL, WHICH IS NOT IMPLANTED WITHIN THE SUBSTANCE OF THE MYOMETRIUM NEAR THE UTERINE CORNUA. FURTHER CLINICAL EVALUATION IS NEEDED TO EXCLUDE MALPOSITIONING OR MIGRATION. THE LEFT ESSURE COIL IS IMPLANTED WITHIN THE MID LEFT MYOMETRIUM AT THE UTERINE CORNUA LEVEL. ULTRASOUND SCAN VAGINA - ON (B)(6) 2016: IMPRESSION: AS PER CLINICAL HISTORY, PATIENT HAS BILATERAL ESSURE COILS. HOWEVER, ONLY THE RIGHT ESSURE COIL WAS SONOGRAPHICALLY VISUALIZED. PELVIC RADIOGRAPH MAY BE HELPFUL TO CONFIRM THE PRESENCE OF THE LEFT ONE. SMALL POSTERIOR UTERINE SUBSEROSAL LEIOMYOMA. COMPLEX RIGHT OVARIAN CYST. NUMEROUS LEFT OVARIAN FOLLICLES. NO COMPLEX PELVIC FREE FLUID. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, ABDOMINAL PAIN, DYSMENORRHEA, PELVIC PAIN, URINARY TRACT INFECTION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-OCT-2019: PFS RECEIVED - EVENT INJURY UPDATED TO PELVIC PAIN. NEW EVENTS ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), MIGRATION, BLADDER PROBLEMS, URINARY PROBLEM, ANXIETY, THE PATIENT DID NOT UNDERGO CONFIRMATORY TEST WERE ADDED. OUTCOME OF PELVIC PAIN UPDATED TO RECOVERED / RESOLVED. PATIENT INFORMATION WERE ADDED ON 3-OCT-2019: PFS+MR RECEIVED-LOT NUMBER WERE ADDED. NEW EVENTS ABNORMAL BLEEDING (VAGINAL), UTI, LOWER ABDOMINAL PAIN, IT HAS BEEN A FAILED ATTEMPT AT REMOVING THE IUD WERE ADDED. PT OF DEVICE DISLOCATION UPDATED TO EMBEDDED DEVICE. NEW REPORTERS, HEIGHT, RACE, CONCOMITANT DRUGS, MEDICAL HISTORY, FAMILY HISTORY, LAB DATA 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 NON-CONFORMANCE'S DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1016913 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 922606 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Other| R | OXYCODONE| OXYCODONE| TRAMADOLE| TRAMADOLE| XANAX| XANAX |