ESSURE
Report
- Report Number
- 2951250-2018-03089
- Event Type
- Injury
- Date Received
- July 16, 2018
- Date of Event
- December 1, 2011
- Report Date
- June 3, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: ONE MISSING COIL (LEFT)"), MENORRHAGIA ("MENORRHAGIA") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") IN A 26-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841528) 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 CONDUCTED". THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ABILIFY. CONCURRENT CONDITIONS INCLUDED ANEMIA AND HUMAN PAPILLOMA VIRUS TEST POSITIVE. CONCOMITANT PRODUCTS INCLUDED CITALOPRAM HYDROBROMIDE (CELEXA), DULOXETINE HYDROCHLORIDE (CYMBALTA), SERTRALINE (ZOLOFT) AND TOPIRAMATE (TOPOMAX). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"). IN DECEMBER 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLES") AND DYSPAREUNIA ("PAINFUL INTERCOURSE"). IN 2013, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH PELVIC PAIN AND ABDOMINAL PAIN, VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND FATIGUE ("FATIGUE,"). IN SEPTEMBER 2013, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), DYSURIA ("PAINFUL URINATION"), UTERINE LEIOMYOMA ("TUMOR / TERATOMA / CANCER TYPE :FIBROIDS(MULTIPLE)") AND ADNEXA UTERI PAIN ("OVARIAN PAIN / FALLOPIAN TUBE PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION) AND SURGERY (ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, MENORRHAGIA, VAGINAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, FEMALE SEXUAL DYSFUNCTION AND ADNEXA UTERI PAIN HAD NOT RESOLVED. THE REPORTER CONSIDERED ADNEXA UTERI PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HORMONE LEVEL ABNORMAL, MENORRHAGIA, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 39.3 KG/SQM. ON 25-05-2011 PATIENT UNDERGONE FOR POSITIVE FOR GROUP B STREP, ON 2011 PATIENT UNDERGONE FOR ABNORMAL PAP SMEAR. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-AUG-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 ('CHRONIC PELVIC PAIN'), DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: ONE MISSING COIL (LEFT)'), MENORRHAGIA ('MENORRHAGIA') AND VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL)') IN A 26-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841528) 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 CONDUCTED". THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ABILIFY. CONCURRENT CONDITIONS INCLUDED ANEMIA AND HUMAN PAPILLOMA VIRUS TEST POSITIVE. CONCOMITANT PRODUCTS INCLUDED CITALOPRAM HYDROBROMIDE (CELEXA), DULOXETINE HYDROCHLORIDE (CYMBALTA), SERTRALINE HYDROCHLORIDE (ZOLOFT) AND TOPIRAMATE. IN 2011, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLES") AND DYSPAREUNIA ("PAINFUL INTERCOURSE"). IN 2013, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH ABDOMINAL PAIN, VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND FATIGUE ("FATIGUE,"). IN (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSURIA ("PAINFUL URINATION") AND ADNEXA UTERI PAIN ("OVARIAN PAIN / FALLOPIAN TUBE PAIN") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND UTERINE LEIOMYOMA ("TUMOR / TERATOMA / CANCER TYPE :FIBROIDS(MULTIPLE)"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY.). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN AND THE DEVICE DISLOCATION, MENORRHAGIA, VAGINAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, FEMALE SEXUAL DYSFUNCTION AND ADNEXA UTERI PAIN HAD NOT RESOLVED. THE REPORTER CONSIDERED ADNEXA UTERI PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HORMONE LEVEL ABNORMAL, MENORRHAGIA, PELVIC PAIN, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2018 PREOPERATIVE DIAGNOSES: MENOMETRORRHAGIA; ANEMIA; UTERINE HYPERTROPHY. POSTOPERATIVE DIAGNOSES: MENOMETRORRHAGIA; ANEMIA; UTERINE HYPERTROPHY; PELVIC ADHESIVE DISEASE; ABDOMINAL WALL ADHESIONS. NAME OF PROCEDURES: 1. LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY. 2. LAPAROSCOPIC PELVIC ADHESIOLYSIS, EXTENSIVE. 3. LAPAROSCOPIC LYSIS OF ABDOMINAL WALL ADHESIONS. HISTORY: THE PATIENT WITH MENOMETRORRHAGIA THAT HAS NOT RESPONDED TO CONSERVATIVE MANAGEMENT INCLUDING ENDOMETRIAL ABLATION AND HORMONAL THERAPY. SHE HAS HAD BENIGN ENDOMETRIAL SAMPLING IN THE OFFICE. SHE HAS A KNOWN ENLARGED UTERUS. SHE HAS A HISTORY OF ABDOMINAL PELVIC ADHESIVE DISEASE FROM PRIOR CESAREAN SECTIONS X4. SHE NOW PRESENTS FOR LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY. FINDINGS AT SURGERY THERE WERE OMENTAL ADHESIONS ACROSS THE ANTERIOR ABDOMINAL WALL JUST BELOW THE UMBILICUS. THE UTERUS WAS DENSELY ADHERED TO THE ANTERIOR ABDOMINAL WALL PERITONEUM WITH COMPLETE OBLITERATION OF THE ANTERIOR CUL-DE-SAC. OMENTAL ADHESIONS WERE ADHERED TO THE FUNDUS OF THE UTERUS AND THE LEFT SIDE WALL OF THE UTERUS. THE OVARIES HAD FUNCTIONAL CYST PRESENT. THE TUBES WERE OF NORMAL CALIBER. THE POSTERIOR CUL-DE-SAC WAS OPENED. THE LIVER SURFACE WAS SMOOTH WITH NO ADHESIONS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 39.3 KG/SQM. ON (B)(6) 2011 PATIENT UNDERGONE FOR POSITIVE FOR GROUP B STREP, ON 2011 PATIENT UNDERGONE FOR ABNORMAL PAP SMEAR. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-MAY-2020: DESCRIPTION OF ESSURE REMOVAL PROCEDURE WAS ADDED. PELVIC PAIN WAS UPDATED TO SERIOUS EVENT. NEW REPORTER WAS ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: ONE MISSING COIL (LEFT)"), MENORRHAGIA ("MENORRHAGIA") AND PELVIC PAIN ("CHRONIC PELVIC PAIN") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841528) 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 CONDUCTED". THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ABILIFY. CONCURRENT CONDITIONS INCLUDED ANEMIA AND HUMAN PAPILLOMA VIRUS TEST POSITIVE. CONCOMITANT PRODUCTS INCLUDED CITALOPRAM HYDROBROMIDE (CELEXA), DULOXETINE HYDROCHLORIDE (CYMBALTA), SERTRALINE (ZOLOFT) AND TOPIRAMATE (TOPOMAX). IN 2011, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLES") AND DYSPAREUNIA ("PAINFUL INTERCOURSE"). IN 2013, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND FATIGUE ("FATIGUE,"). IN (B)(6) 2013, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), DYSURIA ("PAINFUL URINATION"), UTERINE LEIOMYOMA ("TUMOR / TERATOMA / CANCER TYPE :FIBROIDS(MULTIPLE)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), THE FIRST EPISODE OF ADNEXA UTERI PAIN ("OVARIAN PAIN") AND THE SECOND EPISODE OF ADNEXA UTERI PAIN ("FALLOPIAN TUBE PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, MENORRHAGIA, PELVIC PAIN, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, ABDOMINAL PAIN AND FEMALE SEXUAL DYSFUNCTION HAD NOT RESOLVED AND THE LAST EPISODE OF ADNEXA UTERI PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HORMONE LEVEL ABNORMAL, MENORRHAGIA, PELVIC PAIN, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, THE FIRST EPISODE OF ADNEXA UTERI PAIN AND THE SECOND EPISODE OF ADNEXA UTERI PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 39.3 KG/SQM. ON (B)(6) 2011 PATIENT UNDERGONE FOR POSITIVE FOR GROUP B STREP, ON 2011 PATIENT UNDERGONE FOR ABNORMAL PAP SMEAR. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-JUN-2018: PLAINTIFF FACT SHEET RECEIVED. REPORTER ADDED. PLAINTIFF DEMOGRAPHIC, HISTORICAL DRUG AND CONCOMITANT MEDICATION ADDED. LOT NUMBER ADDED. NEW EVENTS- HORMONAL CHANGES, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), VAGINAL DISCHARGE, FATIGUE, WEIGHT GAIN, DEVICE DISLOCATION, FIBROIDS, APAREUNIA, OVARIAN PAIN, FALLOPIAN TUBE PAIN AND ESSURE CONFIRMATION TEST NOT CONDUCTED WERE ADDED. EVENT ONSET DATE ADDED, SEVERITY UPDATED, OUTCOME 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 531876 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841528 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Other| R | CELEXA| CELEXA| CYMBALTA| CYMBALTA| CYMBALTA| OTHER THERAPEUTIC PRODUCTS| TOPIRAMATE| TOPOMAX| TOPOMAX| ZOLOFT| ZOLOFT| ZOLOFT| CELEXA| CYMBALTA| TOPOMAX| ZOLOFT |