ESSURE
Report
- Report Number
- 2951250-2017-05621
- Event Type
- Injury
- Date Received
- October 27, 2017
- Date of Event
- February 7, 2014
- Report Date
- July 31, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN/ PELVIC PAIN"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING") IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A36520) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 ((B)(6) 2007, (B)(6) 2009 AND (B)(6) 2012.), ANEMIA, HEADACHE, HUMAN PAPILLOMA VIRUS INFECTION, ABNORMAL LOSS OF WEIGHT, HERPES SIMPLEX AND CLEFT PALATE. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL AND SOMATIC DYSFUNCTIONAL SYMPTOMS. FAMILY HISTORY INCLUDED HYPERTENSION (MATERNAL HISTORY) AND BREAST CANCER (MATERNAL HISTORY). CONCOMITANT PRODUCTS INCLUDED AXOTAL (BUTALBITAL, ACETAMINOPHEN & CAFFEINE) SINCE (B)(6) 2012FOR MIGRAINE HEADACHE AS WELL AS DHA PACLITAXEL FROM (B)(6) 2012 TO (B)(6) 2013 AND INTEGRA F FROM (B)(6) 2012 TO (B)(6) 2013. IN 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, 1 YEAR 1 MONTH AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MIGRAINE ("MIGRAINE HEADACHE"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY), SURGERY (LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY) AND SURGERY (LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, DYSMENORRHOEA, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, DYSPAREUNIA AND MIGRAINE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION PROCEDURA: A PARACERVICAL BLOCK WAS PERFORMED. , CERVICAL DILATION SIZE 6 CM, BILATERAL OSTIA IDENTIFIED, ESSURE PLACED, 1 COILS VISUALIZED ON THE RIGHT, 3 COILS VISUALIZED ON THE LEFT. THE PATIENT TOLERATED THE PROCEDURE WELL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION ON (B)(6) 2013: XR HYSTEROSALPINGOGRAM: INDICATION HISTORY: 29 YEAR-OLD FEMALE STATUS POST ESSURE PLACEMENT TECHNIQUE: A SINGLE CONTRAST HYSTEROSALPINGOGRAM WAS PERFORMED. THE UTERUS WAS STERILELY CATHETERIZED AND INJECTED WITH 10 ML SOVUE 300. EXAM WAS PERFORMED UNDER FLUOROSCOPY AT 2 FRAMES FLUOROSCOPY TIME: 0.21 MINUTES CUMULATIVE RADIATION EXPOSURE DOSE: 74.90 U GYM F[NDINGS: UTERUS: NO FILLING DEFECT OR ANOMALY. UTERINE TUBES: OCCLUDED UTERINE TUBES. MINIMAL CONTRAST EXTENDING INTO THE INFUNDIBULAR REGIONS IS DEMONSTRATED. NO CONTRAST EXTENDS INTO THE AREA OF THE ESSURE COILS AND THERE IS NO EVIDENCE OF CONTRAST SPILLAGE. LOWER UTERINE SEGMENT: UNREMARKABLE IMPRESSION: NORMA! ESSURE PLACEMENT WITH OCCLUDED UTERINE TUBES (B)(6) 2014: SURGICAL PATHOLOGY REPORT: SPECIMEN DESCRIPTION: UTERUS, WITH OR WITHOUT TUBES AND OVARIES, OTHER THAN NEOPLASTIC/PROLAPSE SPECIMEN(S) SUBMITTED AS: UTERUS AND TUBES PRE-OP DIAGNOSIS: MENORRHAGIA, DYSMENORRHEA POST-OP DIAGNOSIS: MENORRHAGIA, DYSMENORRHEA FINAL DIAGNOSIS: UTERUS, RESECTION: BENIGN PROLIFERATIVE ENDOMETRIUM WITH SUPERFICIAL ADENOMYOSIS, CERVIX: MILD CHRONIC CERVICITIS, FALLOPIAN TUBES, BILATERAL: PARATUBAL CYSTS GROSS EXAMINATION: THE SPECIMEN IS LABELED WITH THE PATIENT'S INFORMATION AND "UTERUS AND TUBES'; THE SEROSA OF THIS 91.7 GRAM, 8.2 X5.0 X 3.7 CM INTACT UTERINE CORPUS AND CERVIX WITH ATTACHED BILATERAL FALLOPIAN TUBES IS PINK-TAN, SMOOTH AND GLISTENING C THE CERVICAL IS PATENT. BISECTION REVEALS A PATENT ENDO CERVICAL CANAL. SECTIONS OF ANTERIOR AND POSTERIOR CERVICAL LIPS ARE SUBMITTED. THE ENDOMETRIUM IS PINK- TAN AND RNEASLLR8S UP TO 0.1 ERN IN GREATEST THICKNESS. THE MYOMETRIUM IS PINK-TAN, SLIGHTLY TABULATED AND MEASURES UP TO 1.8 EM IN GREATEST THICKNESS. SECTIONING DOES NOT REVEAL £I WELL CIRCUMSCRIBED MASS GROSSLY. SECTIONS OF ENDOMETRIUM AND MYOMETRIUM ARE SUBMITTED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS PELVIC PAIN, MENORRHAGIA, DYSMENORRHEA, DYSPAREUNIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-JUL-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 ("PAIN/ PELVIC PAIN"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A36520) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 ((B)(6) 2007, (B)(6) 2009 AND (B)(6) 2012.), ANEMIA, HEADACHE, (B)(6), ABNORMAL LOSS OF WEIGHT, HERPES SIMPLEX AND CLEFT PALATE. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL AND SOMATIC DYSFUNCTION. FAMILY HISTORY INCLUDED HYPERTENSION (MATERNAL HISTORY) AND BREAST CANCER (MATERNAL HISTORY). CONCOMITANT PRODUCTS INCLUDED AXOTAL (BUTALBITAL, ACETAMINOPHEN & CAFFEINE) SINCE (B)(6) 2012 FOR MIGRAINE HEADACHE AS WELL AS DHA PACLITAXEL FROM (B)(6) 2012 TO (B)(6) 2013 AND INTEGRA F FROM (B)(6) 2012 TO (B)(6) 2013. IN 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, 1 YEAR 1 MONTH AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MIGRAINE ("MIGRAINE HEADACHE"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, DYSMENORRHOEA, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, DYSPAREUNIA AND MIGRAINE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION PROCEDURA: A PARACERVICAL BLOCK WAS PERFORMED. , CERVICAL DILATION SIZE 6 CM, BILATERAL OSTIA IDENTIFIED, ESSURE PLACED, 1 COILS VISUALIZED ON THE RIGHT, 3 COILS VISUALIZED ON THE LEFT. THE PATIENT TOLERATED THE PROCEDURE WELL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION . ON (B)(6) 2013: XR HYSTEROSALPINGOGRAM: INDICATION HISTORY: (B)(6) YEAR-OLD FEMALE STATUS POST ESSURE PLACEMENT TECHNIQUE: A SINGLE CONTRAST HYSTEROSALPINGOGRAM WAS PERFORMED. THE UTERUS WAS STERILELY CATHETERIZED AND INJECTED WITH 10 ML SOVUE 300. EXAM WAS PERFORMED UNDER FLUOROSCOPY AT 2 FRAMES FLUOROSCOPY TIME: 0.21 MINUTES CUMULATIVE RADIATION EXPOSURE DOSE: 74.90 U GYM F[NDINGS: UTERUS: NO FILLING DEFECT OR ANOMALY. UTERINE TUBES: OCCLUDED UTERINE TUBES. MINIMAL. CONTRAST EXTENDING INTO THE INFUNDIBULAR REGIONS IS DEMONSTRATED. NO. CONTRAST EXTENDS INTO THE AREA OF THE ESSURE COILS AND THERE IS NO EVIDENCE OF CONTRAST SPILLAGE. LOWER UTERINE SEGMENT: UNREMARKABLE. IMPRESSION: NORMA! ESSURE PLACEMENT WITH OCCLUDED UTERINE TUBES. (B)(6) 2014: SURGICAL PATHOLOGY REPORT: SPECIMEN DESCRIPTION: UTERUS, WITH OR WITHOUT TUBES AND OVARIES, OTHER THAN NEOPLASTIC/PROLAPSE SPECIMEN(S) SUBMITTED AS: UTERUS AND TUBES. PRE-OP DIAGNOSIS: MENORRHAGIA, DYSMENORRHEA. POST-OP DIAGNOSIS: MENORRHAGIA, DYSMENORRHEA. FINAL DIAGNOSIS: UTERUS, RESECTION: BENIGN PROLIFERATIVE ENDOMETRIUM WITH SUPERFICIAL ADENOMYOSIS, CERVIX: MILD CHRONIC CERVICITIS, FALLOPIAN TUBES, BILATERAL: PARATUBAL CYSTS. GROSS EXAMINATION: THE SPECIMEN IS LABELED WITH THE PATIENT'S INFORMATION AND "UTERUS AND TUBES'; THE SEROSA OF THIS 91.7 GRAM, 8.2 X5.0 X 3.7 CM INTACT UTERINE CORPUS AND CERVIX WITH ATTACHED BILATERAL FALLOPIAN TUBES IS PINK-TAN, SMOOTH AND GLISTENING C THE CERVICAL IS PATENT. BISECTION REVEALS A PATENT ENDO CERVICAL CANAL. SECTIONS OF ANTERIOR AND POSTERIOR CERVICAL LIPS ARE SUBMITTED. THE ENDOMETRIUM IS PINK- TAN AND RNEASLLR8S UP TO 0.1 ERN IN GREATEST THICKNESS. THE MYOMETRIUM IS PINK-TAN, SLIGHTLY TABULATED AND MEASURES UP TO 1.8 EM IN GREATEST THICKNESS. SECTIONING DOES NOT REVEAL £I WELL CIRCUMSCRIBED MASS GROSSLY. SECTIONS OF ENDOMETRIUM AND MYOMETRIUM ARE SUBMITTED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS PELVIC PAIN, MENORRHAGIA, DYSMENORRHEA, DYSPAREUNIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-FEB-2018: PLAINTIFF FACT SHEET & MEDICAL RECORD RECEIVED. EVENTS VAGINAL BLEEDING, MENORRHAGIA, DYSPAREUNIA, DYSMENORRHEA, PELVIC PAIN ARE ADDED. LOT NUMBER ADDED, LAB DATA UPDATED, CONCOMITANT DRUG & CONDITION ARE ADDED, HISTORICAL DRUG & CONDITION ARE ADDED. PRODUCT, PATIENT & REPORTER INFORMATION UPDATED. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, (B)(4) TO BAYER PHARMA (B)(4), AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY. 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 ABDOMINAL PAIN LOWER ("SEVERE CRAMPING") AND GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2014, UNDERWENT PELVIC SURGERY TO TRY AND ALLEVIATE THE SYMPTOMS). AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER AND GENITAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER AND GENITAL HAEMORRHAGE TO BE RELATED TO ESSURE. COMPANY CAUSALITY COMMENT. 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 |
|---|---|---|---|---|---|---|---|
| 764962 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | A36520 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Other| R | BUTALBITAL, ACETAMINOPHEN & CAFFEINE| BUTALBITAL, ACETAMINOPHEN & CAFFEINE| DHA PACLITAXEL| DHA PACLITAXEL| INTEGRA F| INTEGRA F |