ESSURE
Report
- Report Number
- 2951250-2017-09251
- Event Type
- Injury
- Date Received
- November 29, 2017
- Date of Event
- January 1, 2011
- Report Date
- November 9, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF THE FIRST EPISODE OF DEVICE DISLOCATION ("MIGRATION OF THE ESSURE DEVICE"), UTERINE PERFORATION ("PERFORATION OF THE ESSURE DEVICE/MYOMETRIAL PERFORATION"), THE SECOND EPISODE OF DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: AN EMPTY UTERINE CAVITY WITH ONE ESSURE DEVICE COMING OUT OF THE RIGHT TUBAL OSTIA; THE LEFT TUBAL OSTIA COULD NOT BE VISUALIZED") AND GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING/ABNORMAL BLEEDING GENERAL") IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIPAROUS. IN 2011, THE PATIENT EXPERIENCED THE FIRST EPISODE OF DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MIGRAINE ("MIGRAINES"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 5 MONTHS 3 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED THE SECOND EPISODE OF DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK PAIN"), HEADACHE ("HEADACHE"), DEVICE BREAKAGE ("DEVICE BREAKAGE") AND MENORRHAGIA ("PERIODS WERE INCREDIBLY LONG"). THE PATIENT WAS TREATED WITH SURGERY (DIAGNOSTIC HYSTEROSCOPY AND LAPAROSCOPIC BILATERAL TUBAL LIGATION (REMOVAL OF RIGHT COIL)), SURGERY (DIAGNOSTIC HYSTEROSCOPY AND LAPAROSCOPIC BILATERAL TUBAL LIGATION (REMOVAL OF RIGHT COIL)) AND SURGERY (DIAGNOSTIC HYSTEROSCOPY AND LAPAROSCOPIC BILATERAL TUBAL LIGATION (REMOVAL OF RIGHT COIL)). AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, THE LAST EPISODE OF DEVICE DISLOCATION AND MENORRHAGIA OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, MIGRAINE, ALOPECIA, BACK PAIN, HEADACHE, DEVICE BREAKAGE AND DYSPAREUNIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ALOPECIA, BACK PAIN, DEVICE BREAKAGE, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, UTERINE PERFORATION, THE FIRST EPISODE OF DEVICE DISLOCATION AND THE SECOND EPISODE OF DEVICE DISLOCATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF REMOVAL: (B)(6) 2016, DIAGNOSTIC HYSTEROSCOPY AND LAPAROSCOPIC BILATERAL TUBAL LIGATION (REMOVAL OF RIGHT COIL). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HUMAN CHORIONIC GONADOTROPIN - ON (B)(6) 2011: NEGATIVE . CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: DEVICE DISLOCATION, UTERINE PERFORATION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JUN-2018: PLAINTIFF FACT SHEET WAS RECEIVED. EVENT PERIODS WERE INCREDIBLY LONG WAS ADDED. EVENT ONSET DATE WAS 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF THE FIRST EPISODE OF DEVICE DISLOCATION ("MIGRATION OF THE ESSURE DEVICE"), UTERINE PERFORATION ("PERFORATION OF THE ESSURE DEVICE/MYOMETRIAL PERFORATION"), THE SECOND EPISODE OF DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: AN EMPTY UTERINE CAVITY WITH ONE ESSURE DEVICE COMING OUT OF THE RIGHT TUBAL OSTIA; THE LEFT TUBAL OSTIA COULD NOT BE VISUALIZED"), DEVICE BREAKAGE ("DEVICE BREAKAGE") AND GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING/ABNORMAL BLEEDING GENERAL") IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIPAROUS. IN 2011, THE PATIENT EXPERIENCED THE FIRST EPISODE OF DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MIGRAINE ("MIGRAINES"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 5 MONTHS 3 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED THE SECOND EPISODE OF DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("BACK PAIN"), HEADACHE ("HEADACHE") AND MENORRHAGIA ("PERIODS WERE INCREDIBLY LONG"). THE PATIENT WAS TREATED WITH SURGERY (DIAGNOSTIC HYSTEROSCOPY AND LAPAROSCOPIC BILATERAL TUBAL LIGATION (REMOVAL OF RIGHT COIL)).AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, THE LAST EPISODE OF DEVICE DISLOCATION AND MENORRHAGIA OUTCOME WAS UNKNOWN AND THE DEVICE BREAKAGE, GENITAL HAEMORRHAGE, MIGRAINE, ALOPECIA, BACK PAIN, HEADACHE AND DYSPAREUNIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ALOPECIA, BACK PAIN, DEVICE BREAKAGE, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, UTERINE PERFORATION, THE FIRST EPISODE OF DEVICE DISLOCATION AND THE SECOND EPISODE OF DEVICE DISLOCATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF REMOVAL: (B)(6) 2016, DIAGNOSTIC HYSTEROSCOPY AND LAPAROSCOPIC BILATERAL TUBAL LIGATION (REMOVAL OF RIGHT COIL). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HUMAN CHORIONIC GONADOTROPIN - ON (B)(6) 2011: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: DEVICE DISLOCATION, UTERINE PERFORATION. 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 DEVICE DISLOCATION ("MIGRATION OF THE ESSURE DEVICE"), UTERINE PERFORATION ("PERFORATION OF THE ESSURE DEVICE/MYOMETRIAL PERFORATION"), DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: AN EMPTY UTERINE CAVITY WITH ONE ESSURE DEVICE COMING OUT OF THE RIGHT TUBAL OSTIA; THE LEFT TUBAL OSTIA COULD NOT BE VISUALIZED") AND GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING/ABNORMAL BLEEDING GENERAL") IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIPAROUS. IN 2011, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MIGRAINE ("MIGRAINES") AND ALOPECIA ("HAIR LOSS"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK PAIN"), HEADACHE ("HEADACHE"), DEVICE BREAKAGE ("DEVICE BREAKAGE") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). THE PATIENT WAS TREATED WITH SURGERY (DIAGNOSTIC HYSTEROSCOPY AND LAPAROSCOPIC BILATERAL TUBAL LIGATION (REMOVAL OF RIGHT COIL). AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, UTERINE PERFORATION AND DEVICE EXPULSION OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, MIGRAINE, ALOPECIA, BACK PAIN, HEADACHE, DEVICE BREAKAGE AND DYSPAREUNIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ALOPECIA, BACK PAIN, DEVICE BREAKAGE, DEVICE DISLOCATION, DEVICE EXPULSION, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MIGRAINE AND UTERINE PERFORATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF REMOVAL: (B)(6) 2016, DIAGNOSTIC HYSTEROSCOPY AND LAPAROSCOPIC BILATERAL TUBAL LIGATION (REMOVAL OF RIGHT COIL). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HUMAN CHORIONIC GONADOTROPIN - ON (B)(6) 2011: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: DEVICE DISLOCATION, UTERINE PERFORATION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-MAR-2018: PLAINTIFF'S FACT SHEET RECEIVED. EVENTS PER PFS: MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: AN EMPTY UTERINE CAVITY WITH ONE ESSURE DEVICE COMING OUT OF THE RIGHT TUBAL OSTIA; THE LEFT TUBAL OSTIA COULD NOT BE VISUALIZED, TUBAL LIGATION, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PAIN, HAIR LOSS 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER, AND DESCRIBES THE OCCURRENCE OF DEVICE MIGRATION ('MIGRATION OF THE ESSURE DEVICE'), UTERINE PERFORATION ('PERFORATION OF THE ESSURE DEVICE/MYOMETRIAL PERFORATION'), DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: AN EMPTY UTERINE CAVITY WITH ONE ESSURE DEVICE COMING OUT OF THE RIGHT TUBAL OSTIA; THE LEFT TUBAL OSTIA COULD NOT BE VISUALIZED'), DEVICE BREAKAGE ('DEVICE BREAKAGE/2 PORTIONS OF METALLIC COILED WIRE') AND GENITAL HAEMORRHAGE ('HEAVY AND IRREGULAR BLEEDING/ABNORMAL BLEEDING GENERAL'). IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191), INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED: MULTIPAROUS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON 2011, THE PATIENT EXPERIENCED DEVICE MIGRATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MIGRAINE ("MIGRAINES"). ON (B)(6) 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK PAIN"), HEADACHE ("HEADACHE") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), (B)(6) MONTHS (B)(6) DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) 2016, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND HEAVY MENSTRUAL BLEEDING ("PERIODS WERE INCREDIBLY LONG"). THE PATIENT WAS TREATED WITH SURGERY (DIAGNOSTIC HYSTEROSCOPY AND LAPAROSCOPIC BILATERAL TUBAL LIGATION (REMOVAL OF RIGHT COIL) AND HYSTERECTOMY, WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2021. AT THE TIME OF THE REPORT, THE DEVICE MIGRATION, UTERINE PERFORATION, DEVICE DISLOCATION AND HEAVY MENSTRUAL BLEEDING OUTCOME WAS UNKNOWN. AND THE DEVICE BREAKAGE, GENITAL HAEMORRHAGE, MIGRAINE, ALOPECIA, BACK PAIN, HEADACHE AND DYSPAREUNIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ALOPECIA, BACK PAIN, DEVICE BREAKAGE, DEVICE MIGRATION, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, HEAVY MENSTRUAL BLEEDING, MIGRAINE, UTERINE PERFORATION AND DEVICE DISLOCATION TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: DATE(S) OF REMOVAL: (B)(6) 2016, DIAGNOSTIC HYSTEROSCOPY AND LAPAROSCOPIC BILATERAL TUBAL LIGATION (REMOVAL OF RIGHT COIL) . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HUMAN CHORIONIC GONADOTROPIN: ON (B)(6) 2011, RESULTS: NEGATIVE. ULTRASOUND SCAN: ON AN UNKNOWN DATE, MALPOSITIONED IUD, MIGRATED TO THE RIGHT CORNEA WITH MYOMETRIAL PERFORATION. IUD REMOVAL IN HOSPITAL NEEDED. LOT NUMBER#: 882191, MANUFACTURE DATE: 2011-07, EXPIRATION DATE: 2014-07. QUALITY SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED, BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS, DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED, WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED, AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-NOV-2021, QUALITY SAFETY EVALUATION OF PTC. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE MIGRATION ('MIGRATION OF THE ESSURE DEVICE'), UTERINE PERFORATION ('PERFORATION OF THE ESSURE DEVICE/MYOMETRIAL PERFORATION'), DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: AN EMPTY UTERINE CAVITY WITH ONE ESSURE DEVICE COMING OUT OF THE RIGHT TUBAL OSTIA; THE LEFT TUBAL OSTIA COULD NOT BE VISUALIZED'), DEVICE BREAKAGE ('DEVICE BREAKAGE/2 PORTIONS OF METALLIC COILED WIRE') AND GENITAL HAEMORRHAGE ('HEAVY AND IRREGULAR BLEEDING/ABNORMAL BLEEDING GENERAL') IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIPAROUS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED DEVICE MIGRATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MIGRAINE ("MIGRAINES"). ON (B)(6) 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK PAIN"), HEADACHE ("HEADACHE") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), 5 MONTHS 3 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) 2016, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND HEAVY MENSTRUAL BLEEDING ("PERIODS WERE INCREDIBLY LONG"). THE PATIENT WAS TREATED WITH SURGERY (DIAGNOSTIC HYSTEROSCOPY AND LAPAROSCOPIC BILATERAL TUBAL LIGATION (REMOVAL OF RIGHT COIL) AND HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2021. AT THE TIME OF THE REPORT, THE DEVICE MIGRATION, UTERINE PERFORATION, DEVICE DISLOCATION AND HEAVY MENSTRUAL BLEEDING OUTCOME WAS UNKNOWN AND THE DEVICE BREAKAGE, GENITAL HAEMORRHAGE, MIGRAINE, ALOPECIA, BACK PAIN, HEADACHE AND DYSPAREUNIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ALOPECIA, BACK PAIN, DEVICE BREAKAGE, DEVICE MIGRATION, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, HEAVY MENSTRUAL BLEEDING, MIGRAINE, UTERINE PERFORATION AND DEVICE DISLOCATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF REMOVAL: (B)(6) 2016, DIAGNOSTIC HYSTEROSCOPY AND LAPAROSCOPIC BILATERAL TUBAL LIGATION (REMOVAL OF RIGHT COIL) DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HUMAN CHORIONIC GONADOTROPIN - ON (B)(6) 2011: RESULTS: NEGATIVE. ULTRASOUND SCAN - ON AN UNKNOWN DATE: MALPOSITIONED IUD, MIGRATED TO THE RIGHT CORNEA WITH MYOMETRIAL PERFORATION. IUD REMOVAL IN HOSPITAL NEEDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: DEVICE DISLOCATION, UTERINE PERFORATION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: DEVICE BREAKAGE, PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-NOV-2021: MR RECEIVED. REPORTER INFORMATION, LAB DATA ADDED. DEVICE REMOVAL DATE UPDATED. 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF THE ESSURE DEVICE"), PERFORATION ("PERFORATION OF THE ESSURE DEVICE") AND GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2011, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MIGRAINE ("MIGRAINES") AND ALOPECIA ("HAIR LOSS"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2016, UNDERWENT A PELVIC SURGERY TO TRY AND ALLEVIATE THE SYMPTOMS) AND SURGERY (ON (B)(6) 2016, UNDERWENT A PELVIC SURGERY TO TRY AND ALLEVIATE THE SYMPTOMS). AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PERFORATION, GENITAL HAEMORRHAGE, MIGRAINE AND ALOPECIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, MIGRAINE AND 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 |
|---|---|---|---|---|---|---|---|
| 847682 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 882191 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Female | Required Intervention| O |