ESSURE
Report
- Report Number
- 2951250-2017-07809
- Event Type
- Injury
- Date Received
- November 23, 2017
- Report Date
- August 27, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
SPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN / SORENESS IN PELVIC AREA"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (WITH COMPLICATION)") AND TONSILLITIS ("TONSILLITIS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810890) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "PREGNANCY (WITH COMPLICATION)". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ASTHMA, OSTEOARTHRITIS KNEE AND VITAMIN D DEFICIENCY. CONCOMITANT PRODUCTS INCLUDED SALBUTAMOL (ALBUTEROL). 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), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA / HEAVY BLEDS WITH CLOTS"), ENDOMETRIOSIS ("ENDOMETRIOSIS"), TONSILLITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HEADACHE ("HEADACHES / SEVERE HEADACHES"), ADENOMYOSIS ("ADENOMYOSIS"), ANAEMIA ("ANEMIA"), MOOD SWINGS ("MOOD SWINGS"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), DEPRESSION ("DEPRESSION"), MIGRAINE ("MIGRAINES"), HYPOAESTHESIA ("NUMBNESS - TINGLING IN HANDS"), PARAESTHESIA ("NUMBNESS - TINGLING IN HANDS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/ SEVERE CRAMPING"), BACK PAIN ("LOWER BACK PAIN"), FATIGUE ("FATIGUE / TIRED ALL THE TIME"), WEIGHT INCREASED ("WEIGHT GAIN (30LBS)") AND DYSPAREUNIA ("DYSPAREUNIA"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. THE PATIENT WAS TREATED WITH ANTIDEPRESSANTS, SURGERY (PARTIAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY ON 24-OCT-2012) AND SURGERY (TONSILLECTOMY). ESSURE WAS REMOVED ON 24-OCT-2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD NOT RESOLVED AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE, MENORRHAGIA, ENDOMETRIOSIS, HEADACHE, ADENOMYOSIS, ANAEMIA, MOOD SWINGS, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, MIGRAINE, HYPOAESTHESIA, PARAESTHESIA, DYSMENORRHOEA, BACK PAIN, FATIGUE, WEIGHT INCREASED AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS UNKNOWN TO THE REPORTER. THE REPORTER CONSIDERED ADENOMYOSIS, ANAEMIA, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HEADACHE, HYPOAESTHESIA, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PARAESTHESIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, TONSILLITIS, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NEED FOR ADDITIONAL SURGERY INSERTION DETAILS: NORMAL APPEARING UTERINE CAVITY, BILATERAL TUBAL OSTIA VISUALIZED, ESSURE VISUALIZED BILATERALLY IN THE TUBAL OSTIA AFTER THE PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32.8 KG/SQM. HYSTEROSALPINGOGRAM - ON 5-OCT-2012: TOTAL BILATERAL OCCLUSION NUCLEAR MAGNETIC RESONANCE IMAGING - ON 14-AUG-2015: APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 157 LBS (B)(6) 2015 MRI OF THE LUMBAR SPINE - AT L5/S1 THERE IS A SMALL BROAD-BASED LEFT PARASAGITTAL PROTRUSION WHICH IS PERHAPS SLIGHTLY LESS FOCAL WHEN COMPARED TO (B)(6) 2009 RESULTING IN MILD NARROWING OF THE LEFT LATERAL RECESS WHICH IS ALSO MILDLY DECREASED. T2 HYPER INTENSE CYSTIC APPEARING FOCUS INVOLVING THE LEFT ADNEXA MEASURING 3.4 CM. THIS CAN BE FURTHER EVALUATED WITH PELVIC ULTRASOUND. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS : HEADACHE, MIGRAINE, MENORRHAGIA, ADENOMYOSIS , BACK PAIN, ANEMIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED. ADDED NEW REPORTERS, PATIENT'S DATE OF BIRTH, HEIGHT AND WEIGHT. ADDED RELEVANT HISTORY AND LAB DATA.ADDED ESSURE'S INDICATION AND BATCH NUMBER, UPDATED THERAPY DATES. ADDED EVENTS VAGINAL HAEMORRHAGE , MENORRHAGIA, ADENOMYOSIS , ANAEMIA, MOOD SWINGS , FEMALE SEXUAL DYSFUNCTION, DEPRESSION , MIGRAINE, PARAESTHESIA , HYPOAESTHESIA, DYSMENORRHOEA , BACK PAIN, FATIGUE , WEIGHT INCREASED, DYSPAREUNIA, ENDOMETRIOSIS, PREGNANCY WITH CONTRACEPTIVE DEVICE, DEVICE INEFFECTIVE, TONSILLITIS. UPDATED AS REPORTED TERM AND OUTCOME FOR PELVIC PAIN. 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 PROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN / SORENESS IN PELVIC AREA"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (WITH COMPLICATION)") AND TONSILLITIS ("TONSILLITIS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810890) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "PREGNANCY (WITH COMPLICATION)". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ASTHMA, OSTEOARTHRITIS KNEE AND VITAMIN D DEFICIENCY. CONCOMITANT PRODUCTS INCLUDED SALBUTAMOL (ALBUTEROL). 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), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA / HEAVY BLEEDING WITH CLOTS"), ENDOMETRIOSIS ("ENDOMETRIOSIS"), TONSILLITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HEADACHE ("HEADACHES / SEVERE HEADACHES"), ADENOMYOSIS ("ADENOMYOSIS"), ANAEMIA ("ANEMIA"), MOOD SWINGS ("MOOD SWINGS"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), DEPRESSION ("DEPRESSION"), MIGRAINE ("MIGRAINES"), HYPOAESTHESIA ("NUMBNESS - TINGLING IN HANDS"), PARAESTHESIA ("NUMBNESS - TINGLING IN HANDS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/ SEVERE CRAMPING"), BACK PAIN ("LOWER BACK PAIN"), FATIGUE ("FATIGUE / TIRED ALL THE TIME"), WEIGHT INCREASED ("WEIGHT GAIN (30LBS)") AND DYSPAREUNIA ("DYSPAREUNIA"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. THE PATIENT WAS TREATED WITH ANTIDEPRESSANTS, SURGERY (PARTIAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY ON (B)(6) 2012) AND SURGERY (TONSILLECTOMY). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD NOT RESOLVED AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE, MENORRHAGIA, ENDOMETRIOSIS, HEADACHE, ADENOMYOSIS, ANAEMIA, MOOD SWINGS, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, MIGRAINE, HYPOAESTHESIA, PARAESTHESIA, DYSMENORRHOEA, BACK PAIN, FATIGUE, WEIGHT INCREASED AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS UNKNOWN TO THE REPORTER. THE REPORTER CONSIDERED ADENOMYOSIS, ANAEMIA, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HEADACHE, HYPOAESTHESIA, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PARAESTHESIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, TONSILLITIS, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NEED FOR ADDITIONAL SURGERY INSERTION DETAILS: NORMAL APPEARING UTERINE CAVITY, BILATERAL TUBAL OSTIA VISUALIZED, ESSURE VISUALIZED BILATERALLY IN THE TUBAL OSTIA AFTER THE PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION NUCLEAR MAGNETIC RESONANCE IMAGING - ON (B)(6) 2015: APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 157 LBS ON (B)(6) 2015: MRI OF THE LUMBAR SPINE - AT L5/S1 THERE IS A SMALL BROAD-BASED LEFT PARASAGITTAL PROTRUSION WHICH IS PERHAPS SLIGHTLY LESS FOCAL WHEN COMPARED TO (B)(6) 2009 RESULTING IN MILD NARROWING OF THE LEFT LATERAL RECESS WHICH IS ALSO MILDLY DECREASED. T2 HYPER INTENSE CYSTIC APPEARING FOCUS INVOLVING THE LEFT ADNEXA MEASURING 3.4 CM. THIS CAN BE FURTHER EVALUATED WITH PELVIC ULTRASOUND. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS : HEADACHE, MIGRAINE, MENORRHAGIA, ADENOMYOSIS , BACK PAIN, ANEMIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF 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) AND HEADACHE ("HEADACHES"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE IMPLANT.). ESSURE WAS REMOVED IN (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED HEADACHE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 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 |
|---|---|---|---|---|---|---|---|
| 834682 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 810890 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | ALBUTEROL| ALBUTEROL |