ESSURE
Report
- Report Number
- 2951250-2017-02399
- Event Type
- Injury
- Date Received
- June 29, 2017
- Report Date
- July 30, 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
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C06469) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR TO PREVENT PREGNANCY: DEPO SHOT FROM 2013 TO 2014; FOR BIRTH CONTROL: IUD AND NORA-BE; FOR AN UNREPORTED INDICATION: BIRTH CONTROL PILLS FROM 2013 TO 2014. CONCURRENT CONDITIONS INCLUDED ASTHMA, PALPITATION, COUGH, NASAL CONGESTION, SORE THROAT, SENSATION OF PRESSURE IN EAR, SINUS PRESSURE, DIFFICULTY BREATHING, NECK PAIN AND CHEST PAIN. CONCOMITANT PRODUCTS INCLUDED CHERACOL (GUAIFENESIN/CODEINE), IBUPROFEN, NAPROXEN, SALBUTAMOL (ALBUTEROL) AND SUMATRIPTAN SUCCINATE. IN 2014, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA),") AND MENORRHAGIA ("ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA),"). IN (B)(6) 2014, THE PATIENT EXPERIENCED MOOD SWINGS ("ANXIETY/ MOOD SWING/ DEPRESSION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), ABDOMINAL PAIN LOWER ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), STOMACH PAIN AFTER INTERCOURSE"), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), DYSURIA ("DYSURIA"), ALLERGY TO METALS ("NICKEL ALLERGY"), MENTAL DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS"), RASH ("RASHES OR SKIN CONDITIONS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), ANXIETY ("ANXIETY/ MOOD SWING/ DEPRESSION"), DEPRESSION ("ANXIETY/ MOOD SWING/ DEPRESSION") AND HEADACHE ("HEADACHES"). THE PATIENT WAS TREATED WITH TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS THERAPY) (ALEVE TENS DEVICE DIRECT THERAPY UNIT) AND SURGERY (FULL HYSTERECTOMY AND SALPINGECTOMY ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. IN (B)(6) 2017, THE MIGRAINE AND HEADACHE HAD RESOLVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSPAREUNIA, DYSURIA, ANXIETY, MOOD SWINGS AND DEPRESSION WAS RESOLVING, THE VAGINAL HAEMORRHAGE HAD RESOLVED AND THE MENORRHAGIA, DYSMENORRHOEA, ABDOMINAL PAIN LOWER, HORMONE LEVEL ABNORMAL, ALLERGY TO METALS, MENTAL DISORDER, RASH, VAGINAL DISCHARGE AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, FATIGUE, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MENTAL DISORDER, MIGRAINE, MOOD SWINGS, PELVIC PAIN, RASH, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN VAGINA - ON (B)(6) 2016: RESULT WAS CORRECT LOCATION; ON (B)(6) 2016: ESSURE COILS APPEAR IN EXPECTED LOCATION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-JUL-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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C06469) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR TO PREVENT PREGNANCY: DEPO SHOT FROM 2013 TO 2014; FOR BIRTH CONTROL: IUD AND NORA-BE; FOR AN UNREPORTED INDICATION: BIRTH CONTROL PILLS FROM 2013 TO 2014. CONCURRENT CONDITIONS INCLUDED ASTHMA AND PALPITATION. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN, SALBUTAMOL (ALBUTEROL) AND SUMATRIPTAN SUCCINATE. ON (B)(6)2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA),"), MENORRHAGIA ("ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA),"), THE FIRST EPISODE OF DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), THE SECOND EPISODE OF DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), STOMACH PAIN AFTER INTERCOURSE"), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), MIGRAINE ("MIGRAINES"), DYSURIA ("DYSURIA"), ALLERGY TO METALS ("NICKEL ALLERGY"), MENTAL DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS"), RASH ("RASHES OR SKIN CONDITIONS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), ANXIETY ("ANXIETY/ MOOD SWING/ DEPRESSION"), MOOD SWINGS ("ANXIETY/ MOOD SWING/ DEPRESSION"), DEPRESSION ("ANXIETY/ MOOD SWING/ DEPRESSION") AND HEADACHE ("HEADACHES"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6)2016. IN FEBRUARY 2017, THE MIGRAINE AND HEADACHE HAD RESOLVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSPAREUNIA, DYSURIA, ANXIETY, MOOD SWINGS AND DEPRESSION WAS RESOLVING, THE VAGINAL HAEMORRHAGE HAD RESOLVED AND THE MENORRHAGIA, THE LAST EPISODE OF DYSMENORRHOEA, HORMONE LEVEL ABNORMAL, ALLERGY TO METALS, MENTAL DISORDER, RASH, VAGINAL DISCHARGE AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALLERGY TO METALS, ANXIETY, DEPRESSION, DYSPAREUNIA, DYSURIA, FATIGUE, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MENTAL DISORDER, MIGRAINE, MOOD SWINGS, PELVIC PAIN, RASH, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, THE FIRST EPISODE OF DYSMENORRHOEA AND THE SECOND EPISODE OF DYSMENORRHOEA TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN VAGINA - ON (B)(6)2016: RESULT WAS CORRECT LOCATION MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2018: PLAINTIFF FACT SHEET RECEIVED. EVENTS WERE ADDED PER PFS: ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA), DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), HORMONALCHANGES,MIGRAINES / HEADACHES, NICKEL ALLERGY, PAIN, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS, RASHES, VAGINAL DISCHARGE, FATIGUEPATIENT DEMOGRAPHICS, MEDICAL HISTORY, CONCURRENT CONDITIONS, CONCOMITANT MEDICATIONS 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 ("PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE. COMPANY CAUSALITY COMMENT: 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 |
|---|---|---|---|---|---|---|---|
| 457538 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | C06469 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Other| R | ALBUTEROL| ALBUTEROL| GUAIFENESIN/CODEINE| IBUPROFEN| IBUPROFEN| NAPROXEN| SUMATRIPTAN SUCCINATE| SUMATRIPTAN SUCCINATE |