ESSURE
Report
- Report Number
- 2951250-2017-07165
- Event Type
- Injury
- Date Received
- November 23, 2017
- Date of Event
- September 1, 2014
- Report Date
- October 29, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION OF UTERUS") AND DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: WAS TOLD BY THE MD THAT DID MY HYSTERECTOMY THAT 2 COILS WERE IN ONE FALLOPIAN TUBE") IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872990) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA) FOR CONTRACEPTION. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, 1 DAY AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN ("CHRONIC PAIN/PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE IMPLANT / HYSTERECTOMY). ESSURE WAS REMOVED IN (B)(6) 2014. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE DISLOCATION, DYSMENORRHOEA AND DYSPAREUNIA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN HAD RESOLVED. THE REPORTER CONSIDERED DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, PELVIC PAIN AND UTERINE PERFORATION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JUN-2018: PFS RECEIVED - NEW EVENT "DYSMENORRHEA (CRAMPING), MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: WAS TOLD BY THE MD THAT DID MY HYSTERECTOMY THAT 2 COILS WERE IN ONE FALLOPIAN TUBE, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)" WERE ADDED. LOT NUMBER WAS ADDED. PRODUCT EXPLANT DATE WAS ADDED. NEW REPORTER WERE 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.
CUTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION OF UTERUS") AND DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: WAS TOLD BY THE MD THAT DID MY HYSTERECTOMY THAT 2 COILS WERE IN ONE FALLOPIAN TUBE") IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872990) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA) FOR CONTRACEPTION. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, 1 DAY AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN ("CHRONIC PAIN/PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE IMPLANT / HYSTERECTOMY) AND SURGERY (HYSTERECTOMY). ESSURE WAS REMOVED IN (B)(6) 2014. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION AND DEVICE DISLOCATION OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, DYSMENORRHOEA AND DYSPAREUNIA HAD RESOLVED. THE REPORTER CONSIDERED DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, PELVIC PAIN AND UTERINE PERFORATION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. THE PATIENT HAD MULTIPLE ESSURE CONFIRMATION TESTS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET RECEIVED. REPORTER INFORMATION UPDATED. OUTCOME OF EVENTS DYSMENORRHEA (CRAMPING) AND DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE WAS UPDATED TO RECOVERED / RESOLVED. 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION OF UTERUS") AND DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: WAS TOLD BY THE MD THAT DID MY HYSTERECTOMY THAT 2 COILS WERE IN ONE FALLOPIAN TUBE") IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872990) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA) FOR CONTRACEPTION. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, 1 DAY AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN ("CHRONIC PAIN/PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE IMPLANT / HYSTERECTOMY). ESSURE WAS REMOVED IN (B)(6) 2014. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE DISLOCATION, DYSMENORRHOEA AND DYSPAREUNIA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN HAD RESOLVED. THE REPORTER CONSIDERED DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, PELVIC PAIN AND UTERINE PERFORATION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-AUG-2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 ("PERFORATION OF UTERUS") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PELVIC PAIN ("CHRONIC PAIN/PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN AND UTERINE PERFORATION TO BE RELATED TO ESSURE. 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 |
|---|---|---|---|---|---|---|---|
| 834764 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 872990 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other| R | DEPO PROVERA| DEPO PROVERA| DEPO PROVERA |