ESSURE
Report
- Report Number
- 2951250-2017-03843
- Event Type
- Injury
- Date Received
- September 20, 2017
- Report Date
- August 13, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN/PAIN") AND RECTAL HAEMORRHAGE ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION:RECTAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PREGNANCY. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY, LIGHTHEADEDNESS, NUMBNESS IN HAND, NUMBNESS IN LEG, SHORTNESS OF BREATH, VOMITING, HEADACHE, MUSCLE WEAKNESS UPPER LIMB, MUSCLE WEAKNESS LOWER LIMB AND DEPRESSION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED RECTAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("PAIN/ BACK PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), RASH ("RASHES OR SKIN CONDITIONS TYPE: RASHES"), BACTERIAL VAGINOSIS ("INFECTIONS/INFECTION (OTHER)/BACTERIAL VAGINOSIS"), CERVICITIS ("INFECTIONS/INFECTION (OTHER) /CERVICITIS"), URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES:URINARY INCONTINENCE"), FATIGUE ("FATIGUE"), NAUSEA ("NAUSEA") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN 2013, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("PAIN/ABDOMINAL PAIN"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), MIGRAINE ("MIGRAINES") AND HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, RECTAL HAEMORRHAGE, ABDOMINAL PAIN, BACK PAIN, MENSTRUAL DISORDER, DYSMENORRHOEA, MENORRHAGIA, VAGINAL HAEMORRHAGE, RASH, MIGRAINE, CERVICITIS, HORMONE LEVEL ABNORMAL, URINARY INCONTINENCE, FATIGUE AND NAUSEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, BACTERIAL VAGINOSIS, CERVICITIS, DYSMENORRHOEA, FATIGUE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, PELVIC PAIN, RASH, RECTAL HAEMORRHAGE, URINARY INCONTINENCE, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE DEVICE WAS PLACED WITHOUT DIFFICULTY WITH THREE TRAILING COILS AND THE SAME PROCEDURE WAS CARRIED OUT ON THE RIGHT SIDE, AGAIN WITH THREE TRAILING COILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 35.6 KG/SQM. HYSTEROSALPINGOGRAM: ON (B)(6) 2012: FALLOPIANS ARE OCCLUDED BILATERALLY WITH ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: URINARY INCONTINENCE,, BACK PAIN, LIGHTHEADEDNESS, ABDOMINAL PAIN ,VAGINAL DISCHARGE, NAUSEA, RECTAL BLEEDING, MIGRAINE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-APR-2018: PFS RECEIVED, EVENTS ADDED:HORMONAL CHANGES, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), INFECTION (OTHER):CERVICITIS, BACTERIAL VAGINOSIS , BLADDER OR URINARY PROBLEMS OR CHANGES:URINARY INCONTINENCE ,RASHES OR SKIN CONDITIONS TYPE: RASHES, NAUSEA, DYSMENORRHEA (CRAMPING), VAGINAL DISCHARGE, WEIGHT GAIN, GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION:RECTAL BLEEDING WERE ADDED. LAB DATA, CONCOMITANT DISEASE, HISTORICAL CONDITION 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN/PAIN") AND RECTAL HAEMORRHAGE ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION:RECTAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PREGNANCY. CONCURRENT CONDITIONS INCLUDED OBESITY, LIGHTHEADEDNESS, NUMBNESS IN HAND, NUMBNESS IN LEG, SHORTNESS OF BREATH, VOMITING, HEADACHE, MUSCLE WEAKNESS UPPER LIMB, MUSCLE WEAKNESS LOWER LIMB AND DEPRESSION. IN (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("PAIN/ABDOMINAL PAIN"), BACK PAIN ("PAIN/ BACK PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), RASH ("RASHES OR SKIN CONDITIONS TYPE: RASHES"), FATIGUE ("FATIGUE"), NAUSEA ("NAUSEA"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED RECTAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACTERIAL VAGINOSIS ("INFECTIONS/INFECTION (OTHER)/BACTERIAL VAGINOSIS"), CERVICITIS ("INFECTIONS/INFECTION (OTHER) /CERVICITIS"), URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES:URINARY INCONTINENCE") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN 2013, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), MIGRAINE ("MIGRAINES"), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWING"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, RECTAL HAEMORRHAGE, ABDOMINAL PAIN, BACK PAIN, MENSTRUAL DISORDER, DYSMENORRHOEA, MENORRHAGIA, VAGINAL HAEMORRHAGE, RASH, MIGRAINE, CERVICITIS, HORMONE LEVEL ABNORMAL, URINARY INCONTINENCE, FATIGUE, NAUSEA, MOOD SWINGS, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, BACTERIAL VAGINOSIS, CERVICITIS, DEPRESSION, DYSMENORRHOEA, FATIGUE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, RASH, RECTAL HAEMORRHAGE, URINARY INCONTINENCE, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE DEVICE WAS PLACED WITHOUT DIFFICULTY WITH THREE TRAILING COILS AND THE SAME PROCEDURE WAS CARRIED OUT ON THE RIGHT SIDE, AGAIN WITH THREE TRAILING COILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 35.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: FALLOPIAN'S ARE OCCLUDED BILATERALLY WITH ESSURE CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: URINARY INCONTINENCE,, BACK PAIN, LIGHTHEADEDNESS, ABDOMINAL PAIN ,VAGINAL DISCHARGE, NAUSEA, RECTAL BLEEDING, MIGRAINE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET RECEIVED. EVENTS DEPRESSION, ANXIETY & MOOD SWINGS ARE ADDED. HISTORICAL & CONCOMITANT CONDITIONS ARE 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN/PAIN") AND RECTAL HAEMORRHAGE ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION:RECTAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PREGNANCY. CONCURRENT CONDITIONS INCLUDED OBESITY, LIGHTHEADEDNESS, NUMBNESS IN HAND, NUMBNESS IN LEG, SHORTNESS OF BREATH, VOMITING, HEADACHE, MUSCLE WEAKNESS UPPER LIMB, MUSCLE WEAKNESS LOWER LIMB AND DEPRESSION. IN (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("PAIN/ABDOMINAL PAIN"), BACK PAIN ("PAIN/ BACK PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), RASH ("RASHES OR SKIN CONDITIONS TYPE: RASHES"), FATIGUE ("FATIGUE"), NAUSEA ("NAUSEA"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED RECTAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACTERIAL VAGINOSIS ("INFECTIONS/INFECTION (OTHER)/BACTERIAL VAGINOSIS"), CERVICITIS ("INFECTIONS/INFECTION (OTHER) /CERVICITIS"), URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES:URINARY INCONTINENCE") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN 2013, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), MIGRAINE ("MIGRAINES"), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWING"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, RECTAL HAEMORRHAGE, ABDOMINAL PAIN, BACK PAIN, MENSTRUAL DISORDER, DYSMENORRHOEA, MENORRHAGIA, VAGINAL HAEMORRHAGE, RASH, MIGRAINE, CERVICITIS, HORMONE LEVEL ABNORMAL, URINARY INCONTINENCE, FATIGUE, NAUSEA, MOOD SWINGS, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, BACTERIAL VAGINOSIS, CERVICITIS, DEPRESSION, DYSMENORRHOEA, FATIGUE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, RASH, RECTAL HAEMORRHAGE, URINARY INCONTINENCE, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE DEVICE WAS PLACED WITHOUT DIFFICULTY WITH THREE TRAILING COILS AND THE SAME PROCEDURE WAS CARRIED OUT ON THE RIGHT SIDE, AGAIN WITH THREE TRAILING COILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 35.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: FALLOPIAN'S ARE OCCLUDED BILATERALLY WITH ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: URINARY INCONTINENCE,, BACK PAIN, LIGHTHEADEDNESS, ABDOMINAL PAIN ,VAGINAL DISCHARGE, NAUSEA, RECTAL BLEEDING, MIGRAINE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-AUG-2018: QUALITY-SAFETY EVALUATION OF PTC UPDATE (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 ("SEVERE PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. 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), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), MIGRAINE ("MIGRAINES"), FATIGUE ("FATIGUE") AND INFECTION ("INFECTIONS"). AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENSTRUAL DISORDER, MIGRAINE, FATIGUE AND INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED FATIGUE, INFECTION, MENSTRUAL DISORDER, MIGRAINE AND PELVIC 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 |
|---|---|---|---|---|---|---|---|
| 660266 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 922613 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |