ESSURE
Report
- Report Number
- 2951250-2017-04346
- Event Type
- Injury
- Date Received
- October 6, 2017
- Report Date
- September 6, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863578, 863579) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED DEPRESSION SINCE 2010. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), THE FIRST EPISODE OF VULVOVAGINAL PAIN ("VAGINAL PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), DYSMENORRHOEA ("DYSMENORRHEA"), DYSPAREUNIA ("DYSPAREUNIA"), FATIGUE ("FATIGUE"), CYSTITIS ("INFECTION (BLADDER/URINARY TRACT/VAGINAL"), URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL"), VAGINAL INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND THE SECOND EPISODE OF VULVOVAGINAL PAIN ("VAGINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (FORCED TO REMOVE ONE OR MORE ESSURE IMPLANTS.). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, MIGRAINE, HEADACHE, VAGINAL DISCHARGE AND THE LAST EPISODE OF VULVOVAGINAL PAIN HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL INFECTION, THE FIRST EPISODE OF VULVOVAGINAL PAIN AND THE SECOND EPISODE OF VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION LOT NUMBER: 863578 MANUFACTURE DATE: 2011/05 EXPIRATION DATE: 2014/05 LOT NUMBER: 863579 MANUFACTURE DATE: 2011/05 EXPIRATION DATE: 2014/05. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-SEP-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.
CONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863578, 863579) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED DEPRESSION SINCE 2010. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), THE FIRST EPISODE OF VULVOVAGINAL PAIN ("VAGINAL PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), DYSMENORRHOEA ("DYSMENORRHEA"), DYSPAREUNIA ("DYSPAREUNIA"), FATIGUE ("FATIGUE"), CYSTITIS ("INFECTION (BLADDER/URINARY TRACT/VAGINAL"), URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL"), VAGINAL INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND THE SECOND EPISODE OF VULVOVAGINAL PAIN ("VAGINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (FORCED TO REMOVE ONE OR MORE ESSURE IMPLANTS.). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, MIGRAINE, HEADACHE, VAGINAL DISCHARGE AND THE LAST EPISODE OF VULVOVAGINAL PAIN HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL INFECTION, THE FIRST EPISODE OF VULVOVAGINAL PAIN AND THE SECOND EPISODE OF VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-AUG-2018: PFS RECEIVED: LOT NUMBER, REPORTER INFORMATION, OTHER RELEVANT HISTORY, LAB DATA, SEVERE CRAMPING, DYSMENORRHEA, DYSPAREUNIA, FATIGUE, INFECTION (BLADDER/URINARY TRACT/VAGINAL), INFECTION (BLADDER/URINARY TRACT/VAGINAL, INFECTION (BLADDER/URINARY TRACT/VAGINAL), MIGRAINES, HEADACHE, VAGINAL DISCHARGE, VAGINAL 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 PELVIC PAIN ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL PAIN") AND ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (FORCED TO REMOVE ONE OR MORE ESSURE IMPLANTS.). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, VULVOVAGINAL PAIN AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE, PELVIC PAIN AND VULVOVAGINAL PAIN 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 |
|---|---|---|---|---|---|---|---|
| 702284 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 863578, 863579 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |