ESSURE
Report
- Report Number
- 2951250-2018-02253
- Event Type
- Injury
- Date Received
- May 18, 2018
- Date of Event
- November 3, 2011
- Report Date
- March 26, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DYSPAREUNIA ("PAINFUL SEXUAL INTERCOURSE") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810876, 863568) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIPAROUS. CONCURRENT CONDITIONS INCLUDED UTERINE PROLAPSE AND UMBILICAL HERNIA. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSPAREUNIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PAIN"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY ON (B)(6) 2013). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE DYSPAREUNIA, BLADDER DISORDER, URINARY TRACT DISORDER AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN AND THE PELVIC PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BLADDER DISORDER, DYSPAREUNIA, PELVIC PAIN AND URINARY TRACT DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WERE PLACED WITHOUT COMPLICATIONS BUT NO COILS WERE VISUALIZED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION; ON (B)(6) 2012: SATISFACTORY PLACEMENT / BILATERAL FULL OCCLUSION FURTHER COMPANY FOLLOW-UP WITH THE LAWYER OR LAWYER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED. NEW REPORTERS ADDED. PLAINTIFF DEMOGRAPHICS AND CONCOMITANT CONDITION ADDED. ESSURE LOT NUMBER ADDED. NEW EVENTS BLADDER PROBLEMS OR CHANGES, URINARY PROBLEMS OR CHANGES, PAIN AND LOWER ABDOMINAL PAIN 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 DISLOCATION ("MIGRATION OF ESSURE DEVICE") AND DYSPAREUNIA ("PAINFUL SEXUAL INTERCOURSE / DYSPAREUNIA") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810876, 863568) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIPAROUS. CONCURRENT CONDITIONS INCLUDED UTERINE PROLAPSE AND UMBILICAL HERNIA. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES") AND URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"). ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN / PELVIC PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY).ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DYSPAREUNIA, BLADDER DISORDER, URINARY TRACT DISORDER AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN AND THE PELVIC PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BLADDER DISORDER, DEVICE DISLOCATION, DYSPAREUNIA, PELVIC PAIN AND URINARY TRACT DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WERE PLACED WITHOUT COMPLICATIONS BUT NO COILS WERE VISUALIZED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION; ON (B)(6) 2012: SATISFACTORY PLACEMENT / BILATERAL FULL OCCLUSION. FURTHER COMPANY FOLLOW-UP WITH THE LAWYER OR LAWYER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-AUG-2018: PLAINTIFF FACT SHEET RECEIVED. EVENT ADDED: "MIGRATION OF ESSURE DEVICE". 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 ESSURE DEVICE") AND DYSPAREUNIA ("PAINFUL SEXUAL INTERCOURSE / DYSPAREUNIA") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810876,863568) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIPAROUS. CONCURRENT CONDITIONS INCLUDED UTERINE PROLAPSE AND UMBILICAL HERNIA. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2012, THE PATIENT EXPERIENCED URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES- INCONTINENCE"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN / PELVIC PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, BLADDER MESH) AND SURGERY (OTHER) OVARIES) TYPE OF SURGERY: BLADDER MESH. ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DYSPAREUNIA, URINARY INCONTINENCE AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN AND THE PELVIC PAIN AND DYSMENORRHOEA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, PELVIC PAIN AND URINARY INCONTINENCE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WERE PLACED WITHOUT COMPLICATIONS BUT NO COILS WERE VISUALIZED. LEAVE TAKEN FROM THIS JOB OR OTHER JOB FOR MEDICAL REASONS- SACROCOLPOPEXY DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION; ON (B)(6) 2012: RESULTS: SATISFACTORY PLACEMENT / BILATERAL FULL OCCLUSION. LOT NUMBER : 810876 MANUFACTURING DATE : 2010/12 EXPIRATION DATE : 2013/12. LOT NUMBER :863568 MANUFACTURING DATE : 2011/05 EXPIRATION DATE : 2014/05. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE LAWYER OR LAWYER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-MAR-2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT.. INCIDENT: 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, 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 ESSURE DEVICE") AND DYSPAREUNIA ("PAINFUL SEXUAL INTERCOURSE / DYSPAREUNIA") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810876,863568) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIPAROUS. CONCURRENT CONDITIONS INCLUDED UTERINE PROLAPSE AND UMBILICAL HERNIA. ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2011, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6)2012, THE PATIENT EXPERIENCED URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES- INCONTINENCE"). IN (B)(6)2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN / PELVIC PAIN"). IN (B)(6)2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6)2012, THE PATIENT EXPERIENCED DYSPAREUNIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, BLADDER MESH) AND SURGERY (OTHER) OVARIES) TYPE OF SURGERY: BLADDER MESH. ESSURE WAS REMOVED ON (B)(6)2013. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DYSPAREUNIA, URINARY INCONTINENCE AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN AND THE PELVIC PAIN AND DYSMENORRHOEA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, PELVIC PAIN AND URINARY INCONTINENCE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WERE PLACED WITHOUT COMPLICATIONS BUT NO COILS WERE VISUALIZED. LEAVE TAKEN FROM THIS JOB OR OTHER JOB FOR MEDICAL REASONS- SACROCOLPOPEXY DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6)2012: RESULTS: TOTAL BILATERAL OCCLUSION; ON (B)(6)2012: RESULTS: SATISFACTORY PLACEMENT / BILATERAL FULL OCCLUSION. FURTHER COMPANY FOLLOW-UP WITH THE LAWYER OR LAWYER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-FEB-2019: PLAINTIFF FACT SHEET- PT OF URINARY TRACT DISORDER UPDATED TO URINARY INCONTINENCE. OUTCOME OF DYSMENORRHOEA UPDATED TO RECOVERED / RESOLVED . INCIDENT: 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, 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 ESSURE DEVICE") AND DYSPAREUNIA ("PAINFUL SEXUAL INTERCOURSE / DYSPAREUNIA") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810876,863568) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIPAROUS. CONCURRENT CONDITIONS INCLUDED UTERINE PROLAPSE AND UMBILICAL HERNIA. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES") AND URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"). ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN / PELVIC PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DYSPAREUNIA, BLADDER DISORDER, URINARY TRACT DISORDER, ABDOMINAL PAIN LOWER AND DYSMENORRHOEA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BLADDER DISORDER, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, PELVIC PAIN AND URINARY TRACT DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WERE PLACED WITHOUT COMPLICATIONS BUT NO COILS WERE VISUALIZED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION; ON (B)(6) 2012: RESULTS: SATISFACTORY PLACEMENT / BILATERAL FULL OCCLUSION. FURTHER COMPANY FOLLOW-UP WITH THE LAWYER OR LAWYER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-FEB-2019: PLAINTIFF FACT SHEET RECEIVED : NEW EVENT OF DYSMENORRHEA (CRAMPING) ADDED. LAWYERS WERE ADDED. INCIDENT: 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DYSPAREUNIA ("PAINFUL SEXUAL INTERCOURSE") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR STERILIZATION. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSPAREUNIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY ON (B)(6) 2013). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSPAREUNIA TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: SATISFACTORY PLACEMENT / BILATERAL FULL OCCLUSION. FURTHER COMPANY FOLLOW-UP WITH THE LAWYER OR LAWYER IS NOT POSSIBLE. 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 |
|---|---|---|---|---|---|---|---|
| 367630 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 810876,863568 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Other| R |