ESSURE
Report
- Report Number
- 2951250-2018-00820
- Event Type
- Injury
- Date Received
- February 23, 2018
- Report Date
- April 27, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATING") AND UTERINE HAEMORRHAGE ("BLEEDING FROM ADENOMYOSIS / UNCONTROLLED BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, UTERINE HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION ("ONE OF MY COIL WAS EJECTING") AND ADENOMYOSIS ("ADENOMYOSIS") WITH ABDOMINAL PAIN LOWER AND INFLAMMATION. THE PATIENT WAS TREATED WITH SURGERY (HYSTEROCTOMY) AND SURGERY (HYSTEROCTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, UTERINE HAEMORRHAGE, DEVICE EXPULSION AND ADENOMYOSIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ADENOMYOSIS, DEVICE DISLOCATION, DEVICE EXPULSION AND UTERINE HAEMORRHAGE TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED VIA SOCIAL MEDIA: HYSTERECTOMY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-JUN-2018: CONTENT FROM PLAINTIFF FACT SHEET RECEIVED. EVENTS DEVICE MIGRATION, DEVICE EXPULSION, UTERINE BLEEDING, ADENOMYOSIS, INFLAMMATION NOS WAS ADDED (REPLACED WITH INJURY NOS & HYSTERECTOMY). PRODUCT, PATIENT & REPORTER INFORMATION UPDATED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATING') AND UTERINE HAEMORRHAGE ('BLEEDING FROM ADENOMYOSIS / UNCONTROLLED BLEEDING') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, UTERINE HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION ("ONE OF MY COIL WAS EJECTING"), ADENOMYOSIS ("ADENOMYOSIS") WITH ABDOMINAL PAIN LOWER AND INFLAMMATION AND HOT FLUSH ("HOT FLASH"). THE PATIENT WAS TREATED WITH SURGERY (HYSTEROCTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, UTERINE HAEMORRHAGE, DEVICE EXPULSION AND ADENOMYOSIS OUTCOME WAS UNKNOWN AND THE HOT FLUSH HAD RESOLVED. THE REPORTER CONSIDERED ADENOMYOSIS, DEVICE DISLOCATION, DEVICE EXPULSION, HOT FLUSH AND UTERINE HAEMORRHAGE TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-FEB-2020: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATING') AND TUMOUR HAEMORRHAGE ('BLEEDING FROM ADENOMYOSIS / UNCONTROLLED BLEEDING') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, DEVICE EXPULSION ("ONE OF MY COIL WAS EJECTING"), ADENOMYOSIS ("ADENOMYOSIS") WITH ABDOMINAL PAIN LOWER AND INFLAMMATION AND HOT FLUSH ("HOT FLASH") AND WAS FOUND TO HAVE TUMOUR HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTEROCTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, TUMOUR HAEMORRHAGE, DEVICE EXPULSION AND ADENOMYOSIS OUTCOME WAS UNKNOWN AND THE HOT FLUSH HAD RESOLVED. THE REPORTER CONSIDERED ADENOMYOSIS, DEVICE DISLOCATION, DEVICE EXPULSION, HOT FLUSH AND TUMOUR HAEMORRHAGE TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED VIA SOCIAL MEDIA: HYSTERECTOMY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-JAN-2020: SOCIAL MEDIA RECEIVED. REPORTER INFORMATION ADDED . EVENT: HOT FLASH WERE ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATING') AND UTERINE HAEMORRHAGE ('BLEEDING FROM ADENOMYOSIS / UNCONTROLLED BLEEDING') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN JANUARY 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, UTERINE HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION ("ONE OF MY COIL WAS EJECTING"), ADENOMYOSIS ("ADENOMYOSIS") WITH ABDOMINAL PAIN LOWER AND INFLAMMATION AND HOT FLUSH ("HOT FLASH"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, UTERINE HAEMORRHAGE, DEVICE EXPULSION AND ADENOMYOSIS OUTCOME WAS UNKNOWN AND THE HOT FLUSH HAD RESOLVED. THE REPORTER CONSIDERED ADENOMYOSIS, DEVICE DISLOCATION, DEVICE EXPULSION, HOT FLUSH AND UTERINE HAEMORRHAGE TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED VIA SOCIAL MEDIA: HYSTERECTOMY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: THIS IS RETENTION CASE. ALL THE INFORMATION HAS BEEN TRANSFERRED FROM DELETION CASE (B)(4).REFERENCES AND REPORTERS INFORMATION WERE UPDATED. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATING') AND UTERINE HAEMORRHAGE ('BLEEDING FROM ADENOMYOSIS / UNCONTROLLED BLEEDING') IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, UTERINE HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION ("ONE OF MY COIL WAS EJECTING"), ADENOMYOSIS ("ADENOMYOSIS") WITH ABDOMINAL PAIN LOWER AND INFLAMMATION, HOT FLUSH ("HOT FLASH") AND MULTIPLE ALLERGIES ("ALLERGIES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTEROCTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, UTERINE HAEMORRHAGE, DEVICE EXPULSION AND ADENOMYOSIS OUTCOME WAS UNKNOWN, THE HOT FLUSH HAD RESOLVED AND THE MULTIPLE ALLERGIES HAD NOT RESOLVED. THE REPORTER CONSIDERED ADENOMYOSIS, DEVICE DISLOCATION, DEVICE EXPULSION, HOT FLUSH, MULTIPLE ALLERGIES AND UTERINE HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: HYSTERECTOMY DUE TO ESSURE IN 2011. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: SOCIAL MEDIA RECEIVED: NEW EVENT ALLERGIES ADDED. NEW REPORTER ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF HYSTERECTOMY ("HYSTERECTOMY AND IT SOUNDS LIKE YOU HAD A COMPLICATED SURGERY") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR BIRTH CONTROL. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INJURY ("SEVERE AND PERMANENT INJURIES") AND HYSTERECTOMY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE INJURY AND HYSTERECTOMY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED HYSTERECTOMY AND INJURY TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED VIA SOCIAL MEDIA: HYSTERECTOMY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: FINAL REPORT TICKED CASE CONSIDERED AS MEDICAL SIGNIFICANT. PFS RECEIVED. EVENT "HYSTERECTOMY" ADDED. 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 A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY¿ 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 |
|---|---|---|---|---|---|---|---|
| 137066 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Other| R |