ESSURE
Report
- Report Number
- 2951250-2017-07678
- Event Type
- Injury
- Date Received
- November 23, 2017
- Report Date
- August 23, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN/PAIN") IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802745) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT PERFORM ESSURE CONFIRMATION TEST.". CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA) (B)(6) 2011 TO (B)(6) 2011. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"), MIGRAINE ("MIGRAINES") AND HEADACHE ("MIGRAINES / HEADACHES"). IN 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). IN 2012, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("INFECTION TYPE: BACTERIAL VAGINOSIS") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL DISCOMFORT ("PRESSURE"), BACK PAIN ("BACK PAIN"), WEIGHT INCREASED ("WEIGHT GAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND FATIGUE ("FATIGUE"). THE PATIENT WAS TREATED WITH SURGERY (HAD SURGERY TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL DISCOMFORT, BACK PAIN, BACTERIAL VAGINOSIS, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, WEIGHT INCREASED, MIGRAINE, HEADACHE AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE NAUSEA AND FATIGUE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISCOMFORT, ABDOMINAL PAIN, BACK PAIN, BACTERIAL VAGINOSIS, DYSMENORRHOEA, FATIGUE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT NEED FOR ADDITIONAL SURGERY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN/PAIN") IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802745) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT PERFORM ESSURE CONFIRMATION TEST." CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA)28-JAN-2011 TO APRIL 2011. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"), MIGRAINE ("MIGRAINES") AND HEADACHE ("MIGRAINES / HEADACHES"). IN 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). IN 2012, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("INFECTION TYPE: BACTERIAL VAGINOSIS") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL DISCOMFORT ("PRESSURE"), BACK PAIN ("BACK PAIN"), WEIGHT INCREASED ("WEIGHT GAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND FATIGUE ("FATIGUE"). THE PATIENT WAS TREATED WITH SURGERY (HAD SURGERY TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL DISCOMFORT, BACK PAIN, BACTERIAL VAGINOSIS, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, WEIGHT INCREASED, MIGRAINE, HEADACHE AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE NAUSEA AND FATIGUE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISCOMFORT, ABDOMINAL PAIN, BACK PAIN, BACTERIAL VAGINOSIS, DYSMENORRHOEA, FATIGUE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT NEED FOR ADDITIONAL SURGERY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-JUN-2018: PLAINTIFF FACT SHEET RECEIVED. EVENTS BACTERIAL VAGINOSIS, VAGINAL, MENORRHAGIA, NAUSEA, DYSMENORRHEA, WEIGHT GAIN, , MIGRAINES, HEADACHES, DEVICE MONITORING PROCEDURE NOT PERFORMED WAS ADDED. LOT NUMBER & LAB DATA UPDATED. CONCOMITANT & HISTORICAL DRUGS , CONDITIONS WERE ADDED. PRODUCT, PATIENT & REPORTER INFORMATION 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 PELVIC PAIN ("PELVIC PAIN/PAIN") 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 PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL DISCOMFORT ("PRESSURE") AND BACK PAIN ("BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HAD SURGERY TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL DISCOMFORT AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISCOMFORT, BACK PAIN AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT NEED FOR ADDITIONAL SURGERY 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 |
|---|---|---|---|---|---|---|---|
| 835247 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 802745 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Other| R | DEPO PROVERA| DEPO PROVERA |