ESSURE
Report
- Report Number
- 2951250-2018-02635
- Event Type
- Injury
- Date Received
- June 14, 2018
- Date of Event
- November 3, 2015
- Report Date
- December 17, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("MIGRATION OF ESSURE DEVICE/PERFORATION OF THE ESSURE DEVICE/ PERFORATION (UTERUS)/THE LEFT DEVICE EXTENDS BEYOND THE MYOMETRIUM OF THE UTERUS.") AND GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING") IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A26169, 825168) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTI GRAVIDA (TOTAL NUMBER OF PREGNANCIES :4), PARITY 3 (TOTAL NUMBER OF LIVE BIRTHS: 3. DOB: (B)(6) 2003 AND (B)(6) 2007 AND (B)(6) 2012. C-SECTIONS: 1. SVDS: 2.), MENARCHE (13 Y.O. (ONSET)), INDUCED ABORTION, C-SECTION, APPENDECTOMY IN 2003, OVARIAN CYST, FIBROIDS, NONSMOKER, INGUINAL HERNIA AND SURGERY (2/19 INITIALLY THEY TOLD HER IT WAS HERNIA, THEN CHANGED IT TO SOMETHING ELSE). THE PATIENT DENIES ALCOHOL USE. *DATE OF LAST PAP: (B)(6) 2010. GAVE FIRST BIRTH AT AGE 27. LAST MENSES WAS (B)(6) 2013 (B)(6) 2013:CHLAMYDIA 1 GC, URINE OR SWAB TO BE PERFORMED TODAY. SHE NEVER RECEIVED RADIOLOGY FORM FOR HSG. (B)(6) 2015, CT SCAN: REASON FOR EXAM: ASSOCIATED DIAGNOSIS: INGUINAL HERNIA (XR ABDOMEN SERIES WI CHEST 1 VIEW) ABDOMINAL DISTENTION (FLUID COLLECTION) ASCITES, INDICATION: ABDOMINAL DISTENTION IMPRESSION: THE BOWEL GAS PATTERN IS NON- OBSTRUCTIVE. NO EVIDENCE OF PNEUMOPERITONEUM ON THIS SUPINE RADIOGRAPH. NO SUSPICIOUS INTRA-ABDOMINAL CALCIFICATIONS OR OSSEOUS LESIONS. BLADDER IS DISTENDED WITH URINE. ESSURE DEVICES ARE SEEN IN THE PELVIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MEDROXYPROGESTRONE ACETATE FROM 2012 TO 2013 AND MIRENA FROM 2007 TO 2009. CONCURRENT CONDITIONS INCLUDED PREMENOPAUSE, CHLAMYDIAL INFECTION, OTALGIA, DYSURIA, NOCTURNAL FREQUENCY, PYURIA, BLOOD IN URINE, PYELONEPHRITIS, NUMBNESS IN LEG, PARAESTHESIA LOWER LIMB AND HERNIA PAIN. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL FROM 31-AUG-2012 TO 8-JUL-2013 AND MEDROXYPROGESTERONE ACETATE FROM 7-JAN-2013 TO 8-JUL-2013 FOR BIRTH CONTROL AS WELL AS ANAESTHETICS (ANESTHESIA), DOCUSATE SODIUM SINCE (B)(6) 2013, HYDROCORTISONE SINCE (B)(6) 2013 AND IBUPROFEN SINCE (B)(6) 2013. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES") AND URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), 4 MONTHS 12 DAYS AFTER INSERTION OF ESSURE. IN 2013, THE PATIENT EXPERIENCED DYSURIA ("DYSURIA"). ON (B)(6) 2013, THE PATIENT EXPERIENCED CONSTIPATION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE :CONSTIPATION"). ON (B)(6) 2013, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT INFECTION/BLADDER OR URINARY PROBLEMS OR CHANGES"). IN 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL MENORRHAGIA)"). IN 2015, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DYSPAREUNIA ("DYSPAREUNIA"). ON (B)(6) 2015, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN LOWER, PELVIC PAIN AND ABDOMINAL PAIN. ON (B)(6) 2016, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN UPPER ("UNDER THE STOMACH PAIN"). THE PATIENT WAS TREATED WITH DOCUSATE SODIUM (COLACE), HYDROCODONE BITARTRATE;PARACETAMOL (NORCO), IBUPROFEN (MOTRIN), NITROFURANTOIN (MACROBID), PARACETAMOL (TYLENOL), PHENAZOPYRIDINE HYDROCHLORIDE (PYRIDIUM), DIETARY MEASURES (TO INCREASE DIETARY FIBER INTAKE), SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),) AND TO INCREASE DIETARY FIBER INTAKE AND FLUID INTAKE. ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, GENITAL HAEMORRHAGE, DYSPAREUNIA, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, MENORRHAGIA, BLADDER DISORDER, URINARY TRACT DISORDER, CONSTIPATION, DYSURIA AND ABDOMINAL PAIN UPPER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN UPPER, BLADDER DISORDER, CONSTIPATION, DYSPAREUNIA, DYSURIA, GENITAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE PERFORATION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: CONDOMS- 31-AUG-2012 TO 20-DEC-2013 FOR BIRTH CONTROL. THREE COILS WERE VISIBLE ON THE LEFT AND FOUR COILS WERE VISIBLE ON THE RIGHT AFTER THE PLACEMENT OF MICRO-INSERTS. AS PER MR STATES PATIENT NEVER COMPLETED HSG EVALUATION AFTER ESSURE PERFORMED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.4 KG/SQM. COMPUTERISED TOMOGRAM - ON AN UNKNOWN DATE: CT ABDOMEN PELVIS WI CONTRAST CT ABDOMEN-PELVIS W/ CONTRAST-CLINICAL HISTORY: ABDOMINAL PAIN, FOCAL (SPECIFY IN ADDITIONAL FIELD); RLQ PAIN. IMPRESSION: NO CT EVIDENCE OF ACUTE PROCESS IN THE ABDOMEN OR PELVIS. OBSTRUCTION OR INFLAMMATION. ABDOMINAL WALL:SMALL PERIUMBILICAL HERNIA CONTAINS FAT, PELVIS: THERE ARE BILATERAL ESSURE IUDS IN THE UTERUS. THE LEFT DEVICE EXTENDS BEYOND THE MYOMETRIUM OF THE UTERUS. SEE IMAGE NUMBER 106 SERIES 3. THIS MAY REPRESENT A PERFORATION OF THE UTERUS AND IUD MIGRATION. RECOMMEND CORRELATION WITH HYSTERON SALPINGOGRAM. THERE IS A THICK-WALLED CYST MEASURING 1.5 CM IN THE LEFT ADNEXA ON IMAGE 100 SERIES 3. THIS COULD REPRESENT A CORPUS LUTEAL CYST. OSSEOUS STRUCTURES: NO SUSPICIOUS BONY ABNORMALITY IMPRESSION: BILATERAL ESSURE IUDS IN THE UTERUS. THE LEFT-SIDED DEVICE, EXTENDS BEYOND THE MYOMETRIUM OF THE UTERUS AND MAY REPRESENT UTERINE PERFORATION AND IUD MIGRATION. RECOMMEND FOLLOW UP WITH HYSTERON SALPINGOGRAM. MILDLY COMPLICATED LEFT OVARIAN CYST WHICH COULD REPRESENT A CORPUS LUTEAL CYST. SMALL PERIUMBILICAL HERNIA CONTAINING FAT.; ON (B)(6) 2016: TOTAL BILATERAL OCCLUSION. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULTS: TOTAL BILATERAL OCCLUSION. ULTRASOUND SCAN VAGINA - ON (B)(6) 2015: TOTAL BILATERAL OCCLUSION; ON (B)(6) 2016: ULTRA SOUND OF TRANSABDOMINAL/TRANSVAGINAL: IMPRESSION: NORMAL PELVIC ULTRASOUND. ESSURE DEVICES IDENTIFIED IMPRESSION AND PLAN: DIAGNOSIS: ABNORMAL VAGINAL BLEEDING, ACUTE LOWER UTI IMPRESSION: NORMAL PELVIC ULTRASOUND. ESSURE DEVICES IDENTIFIED.. URINARY SYSTEM X-RAY - ON AN UNKNOWN DATE: RESULTS: WITHIN NORMAL LIMITS, NONSPECIFIC BOWEL GASPATTERN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-NOV-2018: PLAINTIFF FACT SHEET RECEIVED. EVENT PER PFS: UNDER THE STOMACH PAIN WAS 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("MIGRATION OF ESSURE DEVICE/PERFORATION OF THE ESSURE DEVICE/ PERFORATION (UTERUS)/THE LEFT DEVICE EXTENDS BEYOND THE MYOMETRIUM OF THE UTERUS.") AND GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A26169, 825168) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTI GRAVIDA (TOTAL NUMBER OF PREGNANCIES :4), PARITY 3 (TOTAL NUMBER OF LIVE BIRTHS: 3. DOB: (B)(6) 2003 AND (B)(6) 2007 AND (B)(6) 2012. C-SECTIONS: 1. SVDS: 2.), MENARCHE (13 Y.O. (ONSET)), INDUCED ABORTION, C-SECTION, APPENDECTOMY IN 2003, OVARIAN CYST, FIBROIDS, NONSMOKER, INGUINAL HERNIA AND SURGERY (2/19 INITIALLY THEY TOLD HER IT WAS HERNIA, THEN CHANGED IT TO SOMETHING ELSE). THE PATIENT DENIES ALCOHOL USE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MEDROXYPROGESTRONE ACETATE FROM 2012 TO 2013 AND MIRENA FROM 2007 TO 2009. CONCURRENT CONDITIONS INCLUDED PREMENOPAUSE, CHLAMYDIAL INFECTION, OTALGIA, DYSURIA, NOCTURNAL FREQUENCY, PYURIA, BLOOD IN URINE, PYELONEPHRITIS, NUMBNESS IN LEG, PARAESTHESIA LOWER LIMB AND HERNIA PAIN. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL FROM (B)(6) 2012 TO (B)(6) 2013 AND MEDROXYPROGESTERONE ACETATE FROM (B)(6) 2013 TO (B)(6) 2013 FOR BIRTH CONTROL AS WELL AS ANAESTHETICS (ANESTHESIA), DOCUSATE SODIUM SINCE (B)(6) 2013, HYDROCORTISONE SINCE (B)(6) 2013 AND IBUPROFEN SINCE (B)(6) 2013. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, 4 MONTHS 12 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES") AND URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"). IN 2013, THE PATIENT EXPERIENCED DYSURIA ("DYSURIA"). ON (B)(6) 2013, THE PATIENT EXPERIENCED CONSTIPATION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE :CONSTIPATION"). ON (B)(6) 2013, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT INFECTION/BLADDER OR URINARY PROBLEMS OR CHANGES"). IN 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL MENORRHAGIA)"). IN 2015, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DYSPAREUNIA ("DYSPAREUNIA"). ON (B)(6) 2015, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN LOWER, PELVIC PAIN AND ABDOMINAL PAIN. ON (B)(6) 2016, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL MENORRHAGIA)"). THE PATIENT WAS TREATED WITH NITROFURANTOIN (MACROBID), PHENAZOPYRIDINE HYDROCHLORIDE (PYRIDIUM), IBUPROFEN (MOTRIN), VICODIN (NORCO), PARACETAMOL (TYLENOL), DOCUSATE SODIUM (COLACE), SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),) AND DIETARY MEASURES (TO INCREASE DIETARY FIBER INTAKE). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, GENITAL HAEMORRHAGE, DYSPAREUNIA, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, MENORRHAGIA, BLADDER DISORDER, URINARY TRACT DISORDER, CONSTIPATION AND DYSURIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BLADDER DISORDER, CONSTIPATION, DYSPAREUNIA, DYSURIA, GENITAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE PERFORATION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CONDOMS- (B)(6) 2012 TO (B)(6) 2013 FOR BIRTH CONTROL. THREE COILS WERE VISIBLE ON THE LEFT AND FOUR COILS WERE VISIBLE ON THE RIGHT AFTER THE PLACEMENT OF MICRO-INSERTS. AS PER MR STATES PATIENT NEVER COMPLETED HSG EVALUATION AFTER ESSURE PERFORMED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION URINARY SYSTEM X-RAY - ON AN UNKNOWN DATE: WITHIN NORMAL LIMITS, NONSPECIFIC BOWEL GASPATTERN. DATE OF LAST PAP: (B)(6) 2010. GAVE FIRST BIRTH AT AGE 27. LAST MENSES WAS (B)(6) 2013 ESSURE CONFIRMATION TESTS: (B)(6) 2013 AND (B)(6) 2015 AND (B)(6) 2016 TYPE OF TEST: HYSTEROSALPINGOGRAM (HSG), OTHER (PLEASE DESCRIBE) - CT ABDOMEN AND PELVIS, TRANSVAGINAL ULTRASOUND (TVU). ON (B)(6) 2013:CHLAMYDIA 1 GC, URINE OR SWAB TO BE PERFORMED TODAY. SHE NEVER RECEIVED RADIOLOGY FORM FOR HSG. ON (B)(6) 2015, CT SCAN: REASON FOR EXAM: ASSOCIATED DIAGNOSIS: INGUINAL HERNIA (XR ABDOMEN SERIES WI CHEST 1 VIEW) ABDOMINAL DISTENTION (FLUID COLLECTION) ASCITES, INDICATION: ABDOMINAL DISTENTION. IMPRESSION: THE BOWEL GAS PATTERN IS NON- OBSTRUCTIVE. NO EVIDENCE OF PNEUMOPERITONEUM ON THIS SUPINE RADIOGRAPH. NO SUSPICIOUS INTRA-ABDOMINAL CALCIFICATIONS OR OSSEOUS LESIONS. BLADDER IS DISTENDED WITH URINE. ESSURE DEVICES ARE SEEN IN THE PELVIS. CT ABDOMEN PELVIS WI CONTRAST CT ABDOMEN-PELVIS W/ CONTRAST-CLINICAL HISTORY: ABDOMINAL PAIN, FOCAL (SPECIFY IN ADDITIONAL FIELD); RLQ PAIN. IMPRESSION: NO CT EVIDENCE OF ACUTE PROCESS IN THE ABDOMEN OR PELVIS. OBSTRUCTION OR INFLAMMATION. ABDOMINAL WALL:SMALL PERIUMBILICAL HERNIA CONTAINS FAT, PELVIS: THERE ARE BILATERAL ESSURE IUDS IN THE UTERUS. THE LEFT DEVICE EXTENDS BEYOND THE MYOMETRIUM OF THE UTERUS. SEE IMAGE NUMBER (B)(4) SERIES 3. THIS MAY REPRESENT A PERFORATION OF THE UTERUS AND IUD MIGRATION. RECOMMEND CORRELATION WITH HYSTERON SALPINGOGRAM. THERE IS A THICK-WALLED CYST MEASURING 1.5 CM IN THE LEFT ADNEXA ON IMAGE 100 SERIES 3. THIS COULD REPRESENT A CORPUS LUTEAL CYST. OSSEOUS STRUCTURES: NO SUSPICIOUS BONY ABNORMALITY IMPRESSION: BILATERAL ESSURE IUDS IN THE UTERUS. THE LEFT-SIDED DEVICE, EXTENDS BEYOND THE MYOMETRIUM OF THE UTERUS AND MAY REPRESENT UTERINE PERFORATION AND IUD MIGRATION. RECOMMEND FOLLOW UP WITH HYSTERON SALPINGOGRAM. MILDLY COMPLICATED LEFT OVARIAN CYST WHICH COULD REPRESENT A CORPUS LUTEAL CYST. SMALL PERIUMBILICAL HERNIA CONTAINING FAT. ON (B)(6) 2016, ULTRA SOUND OF TRANSABDOMINAL/TRANSVAGINAL: IMPRESSION: NORMAL PELVIC ULTRASOUND. ESSURE DEVICES IDENTIFIED IMPRESSION AND PLAN: DIAGNOSIS: ABNORMAL VAGINAL BLEEDING, ACUTE LOWER UTI IMPRESSION: NORMAL PELVIC ULTRASOUND. ESSURE DEVICES IDENTIFIED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET- ALL RELEVANT MEDICAL HISTORY CONDITION, CONCURRENT CONDITION, CONCOMITANT MEDICATION AND EVENT DYSURIA WAS 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 444463 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | A26169, 825168 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Other| R | ANESTHESIA| ANESTHESIA| ANESTHETICS| DOCUSATE SODIUM| DOCUSATE SODIUM| DOCUSATE SODIUM| DOCUSATE SODIUM| DOCUSATE SODIUM| DOCUSATE SODIUM| HYDROCORTISONE| HYDROCORTISONE| HYDROCORTISONE| HYDROCORTISONE| HYDROCORTISONE| HYDROCORTISONE| IBUPROFEN| IBUPROFEN| IBUPROFEN| LEVONORGESTREL| LEVONORGESTREL| LEVONORGESTREL| MEDROXYPROGESTERONE ACETATE| MEDROXYPROGESTERONE ACETATE| MEDROXYPROGESTERONE ACETATE| ANESTHESIA| DOCUSATE SODIUM| DOCUSATE SODIUM| HYDROCORTISONE| HYDROCORTISONE| IBUPROFEN| LEVONORGESTREL| MEDROXYPROGESTERONE ACETATE |