ESSURE
Report
- Report Number
- 2951250-2020-01303
- Event Type
- Injury
- Date Received
- February 13, 2020
- Date of Event
- January 1, 2016
- Report Date
- June 3, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('SEVERE PELVIC PAIN/ PAIN') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 883038 (NOT VALID)) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ANXIETY, BIPOLAR DISORDER AND POST-TRAUMATIC STRESS DISORDER. CONCURRENT CONDITIONS INCLUDED VULVOVAGINAL PRURITUS, ITCHING, LOWER ABDOMINAL PAIN, LOW BACK PAIN AND SUPRAPUBIC PAIN. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL; ETONOGESTREL (NUVARING) FROM (B)(6) 2017 TO (B)(6) 2017, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM (B)(6) 2017 TO (B)(6) 2017, NORETHISTERONE (MINI PILL) IN 2012 AND NSAIDS SINCE 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), RASH ("RASHES/RECURRING RASH"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MIGRAINE ("MIGRAINES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), HEADACHE ("HEADACHES"), VAGINAL INFECTION ("INFECTION ( BLADDER/URINARY TRACT/VAGINAL)TYPE:VAGINAL"), BACK PAIN ("LOWER BACK PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"), 3 YEARS 7 MONTHS AFTER INSERTION OF ESSURE. IN (B)(6) 2016, THE PATIENT EXPERIENCED FUNGAL INFECTION ("YEAST INFECTION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH, ANXIETY"). ON (B)(6) 2016, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND EXPERIENCED NAUSEA ("NAUSEA"). ON (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BIPOLAR DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS-CONDITION:BIPOLAR DISORDER"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), POLYCYSTIC OVARIES ("POLYCYSTIC OVARIAN SYNDROME"), ABDOMINAL PAIN LOWER ("CRAMPING"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS-CONDITION:DEPRESSION"), POST-TRAUMATIC STRESS DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS-CONDITION:POST-TRAUMATIC STRESS DISORDER"), ANAEMIA ("ANEMIA"), BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS") AND POST PROCEDURAL COMPLICATION ("POST PROCEDURAL COMPLICATION"). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN), SERTRALINE HYDROCHLORIDE (ZOLOFT) AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING, THE BIPOLAR DISORDER, MENSTRUAL DISORDER, VAGINAL INFECTION, BACK PAIN, ABDOMINAL PAIN, DEPRESSION, POST-TRAUMATIC STRESS DISORDER AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE, RASH, FUNGAL INFECTION, DYSMENORRHOEA, MIGRAINE, DYSPAREUNIA, FATIGUE, WEIGHT INCREASED, POLYCYSTIC OVARIES, NAUSEA, VAGINAL HAEMORRHAGE, HEADACHE, ABDOMINAL PAIN LOWER AND ANXIETY HAD NOT RESOLVED AND THE VAGINAL DISCHARGE, ANAEMIA AND BACTERIAL VAGINOSIS HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANAEMIA, ANXIETY, BACK PAIN, BACTERIAL VAGINOSIS, BIPOLAR DISORDER, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FUNGAL INFECTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, PELVIC PAIN, POLYCYSTIC OVARIES, POST PROCEDURAL COMPLICATION, POST-TRAUMATIC STRESS DISORDER, RASH, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED/CONFIRMED IN PATIENT¿S MEDICAL RECORDS: VAGINAL DISCHARGE, VAGINAL HEMORRHAGE, FUNGAL INFECTION. PATIENT UNDERGOES THE TREATMENT FOR : PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA, ANEMIA, BACTERIAL VAGINOSIS, VAGINAL DISCHARGE DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-MAY-2020: QUALITY SAFETY EVALUATION OF PTC BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('SEVERE PELVIC PAIN/ PAIN') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 883038(NOT VALID)) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ANXIETY, BIPOLAR DISORDER AND POST-TRAUMATIC STRESS DISORDER. CONCURRENT CONDITIONS INCLUDED VULVOVAGINAL PRURITUS, ITCHING, LOWER ABDOMINAL PAIN, LOW BACK PAIN AND SUPRAPUBIC PAIN. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;ETONOGESTREL (NUVARING) (B)(6) 2017, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) (B)(6) 2017, NORETHISTERONE (MINI PILL) IN 2012 AND NSAIDS SINCE 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), RASH ("RASHES/RECURRING RASH"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MIGRAINE ("MIGRAINES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), HEADACHE ("HEADACHES"), VAGINAL INFECTION ("INFECTION ( BLADDER/URINARY TRACT/VAGINAL)TYPE:VAGINAL"), BACK PAIN ("LOWER BACK PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"), 3 YEARS 7 MONTHS AFTER INSERTION OF ESSURE. IN (B)(6) 2016, THE PATIENT EXPERIENCED FUNGAL INFECTION ("YEAST INFECTION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH, ANXIETY"). ON (B)(6) 2016, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND EXPERIENCED NAUSEA ("NAUSEA"). ON (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BIPOLAR DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS-CONDITION:BIPOLAR DISORDER"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), POLYCYSTIC OVARIES ("POLYCYSTIC OVARIAN SYNDROME"), ABDOMINAL PAIN LOWER ("CRAMPING"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS-CONDITION:DEPRESSION") AND POST-TRAUMATIC STRESS DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS-CONDITION:POST-TRAUMATIC STRESS DISORDER"). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN), SERTRALINE HYDROCHLORIDE (ZOLOFT) AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING, THE BIPOLAR DISORDER, MENSTRUAL DISORDER, VAGINAL INFECTION, BACK PAIN, ABDOMINAL PAIN, DEPRESSION AND POST-TRAUMATIC STRESS DISORDER OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, RASH, FUNGAL INFECTION, DYSMENORRHOEA, MIGRAINE, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, POLYCYSTIC OVARIES, NAUSEA, VAGINAL HAEMORRHAGE, MENORRHAGIA, HEADACHE, ABDOMINAL PAIN LOWER AND ANXIETY HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, BACK PAIN, BIPOLAR DISORDER, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FUNGAL INFECTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, PELVIC PAIN, POLYCYSTIC OVARIES, POST-TRAUMATIC STRESS DISORDER, RASH, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED/CONFIRMED IN PATIENT¿S MEDICAL RECORDS: VAGINAL DISCHARGE, VAGINAL HEMORRHAGE, FUNGAL INFECTION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.; ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-APR-2020: PLAINTIFF FACT SHEET RECEIVED. EVENT OUTCOME : PAIN WERE UPDATED TO RECOVERING . BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('SEVERE PELVIC PAIN/ PAIN') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 883038 (NOT VALID)) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ANXIETY, BIPOLAR DISORDER AND POST-TRAUMATIC STRESS DISORDER. CONCURRENT CONDITIONS INCLUDED VULVOVAGINAL PRURITUS, ITCHING, LOWER ABDOMINAL PAIN, LOW BACK PAIN AND SUPRAPUBIC PAIN. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;ETONOGESTREL (NUVARING) FROM (B)(6) 2017 TO (B)(6) 2017, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM (B)(6) 2017 TO (B)(6) 2017, NORETHISTERONE (MINI PILL) IN 2012 AND NSAIDS SINCE 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), RASH ("RASHES/RECURRING RASH"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MIGRAINE ("MIGRAINES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), HEADACHE ("HEADACHES"), VAGINAL INFECTION ("INFECTION ( BLADDER/URINARY TRACT/VAGINAL)TYPE:VAGINAL"), BACK PAIN ("LOWER BACK PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"), 3 YEARS 7 MONTHS AFTER INSERTION OF ESSURE. IN (B)(6) 2016, THE PATIENT EXPERIENCED FUNGAL INFECTION ("YEAST INFECTION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH, ANXIETY"). ON (B)(6) 2016, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND EXPERIENCED NAUSEA ("NAUSEA"). ON (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BIPOLAR DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS-CONDITION: BIPOLAR DISORDER"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), POLYCYSTIC OVARIES ("POLYCYSTIC OVARIAN SYNDROME"), ABDOMINAL PAIN LOWER ("CRAMPING"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS-CONDITION:DEPRESSION"), POST-TRAUMATIC STRESS DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS-CONDITION:POST-TRAUMATIC STRESS DISORDER"), ANAEMIA ("ANEMIA"), BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS") AND POST PROCEDURAL COMPLICATION ("POST PROCEDURAL COMPLICATION"). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN), SERTRALINE HYDROCHLORIDE (ZOLOFT) AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING, THE BIPOLAR DISORDER, MENSTRUAL DISORDER, VAGINAL INFECTION, BACK PAIN, ABDOMINAL PAIN, DEPRESSION, POST-TRAUMATIC STRESS DISORDER AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE, RASH, FUNGAL INFECTION, DYSMENORRHOEA, MIGRAINE, DYSPAREUNIA, FATIGUE, WEIGHT INCREASED, POLYCYSTIC OVARIES, NAUSEA, VAGINAL HAEMORRHAGE, HEADACHE, ABDOMINAL PAIN LOWER AND ANXIETY HAD NOT RESOLVED AND THE VAGINAL DISCHARGE, ANAEMIA AND BACTERIAL VAGINOSIS HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANAEMIA, ANXIETY, BACK PAIN, BACTERIAL VAGINOSIS, BIPOLAR DISORDER, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FUNGAL INFECTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, PELVIC PAIN, POLYCYSTIC OVARIES, POST PROCEDURAL COMPLICATION, POST-TRAUMATIC STRESS DISORDER, RASH, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED/CONFIRMED IN PATIENT¿S MEDICAL RECORDS: VAGINAL DISCHARGE, VAGINAL HEMORRHAGE, FUNGAL INFECTION. PATIENT UNDERGOES THE TREATMENT FOR : PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA, ANEMIA, BACTERIAL VAGINOSIS, VAGINAL DISCHARGE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-MAY-2020: PFS RECEIVED- NEW EVENT ANEMIA, BACTERIAL VAGINOSIS AND POST PROCEDURAL COMPLICATION WERE ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('SEVERE PELVIC PAIN/ PAIN') AND BIPOLAR DISORDER ('PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS-CONDITION: BIPOLAR DISORDER') IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 883038(NOT VALID)) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ANXIETY, BIPOLAR DISORDER AND POST-TRAUMATIC STRESS DISORDER. CONCURRENT CONDITIONS INCLUDED VULVOVAGINAL PRURITUS, ITCHING, LOWER ABDOMINAL PAIN, LOW BACK PAIN AND SUPRAPUBIC PAIN. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL; ETONOGESTREL (NUVARING) FROM (B)(6) 2017 TO (B)(6) 2017, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM (B)(6) 2017 TO (B)(6) 2017, NORETHISTERONE (MINI PILL) IN 2012 AND NSAIDS SINCE 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), RASH ("RASHES/RECURRING RASH"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MIGRAINE ("MIGRAINES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), HEADACHE ("HEADACHES"), VAGINAL INFECTION ("INFECTION ( BLADDER/URINARY TRACT/VAGINAL)TYPE:VAGINAL"), BACK PAIN ("LOWER BACK PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"), 3 YEARS 7 MONTHS AFTER INSERTION OF ESSURE. IN (B)(6) 2016, THE PATIENT EXPERIENCED FUNGAL INFECTION ("YEAST INFECTION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH, ANXIETY"). ON (B)(6) 2016, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND EXPERIENCED NAUSEA ("NAUSEA"). ON (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BIPOLAR DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), POLYCYSTIC OVARIES ("POLYCYSTIC OVARIAN SYNDROME"), ABDOMINAL PAIN LOWER ("CRAMPING"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS-CONDITION:DEPRESSION") AND POST-TRAUMATIC STRESS DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS-CONDITION:POST-TRAUMATIC STRESS DISORDER"). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN), SERTRALINE HYDROCHLORIDE (ZOLOFT) AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, RASH, FUNGAL INFECTION, DYSMENORRHOEA, MIGRAINE, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, POLYCYSTIC OVARIES, NAUSEA, VAGINAL HAEMORRHAGE, MENORRHAGIA, HEADACHE, ABDOMINAL PAIN LOWER AND ANXIETY HAD NOT RESOLVED AND THE BIPOLAR DISORDER, MENSTRUAL DISORDER, VAGINAL INFECTION, BACK PAIN, ABDOMINAL PAIN, DEPRESSION AND POST-TRAUMATIC STRESS DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, BACK PAIN, BIPOLAR DISORDER, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FUNGAL INFECTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, PELVIC PAIN, POLYCYSTIC OVARIES, POST-TRAUMATIC STRESS DISORDER, RASH, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED/CONFIRMED IN PATIENT¿S MEDICAL RECORDS: VAGINAL DISCHARGE, VAGINAL HEMORRHAGE, FUNGAL INFECTION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.; ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-JAN-2020: PLAINTIFF FACT SHEET RECEIVED. DATE OF REMOVAL AND SURGERY WERE ADDED. CONCOMITANT DRUG, MEDICAL HISTORY WERE ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 170147 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 883038(NOT VALID) | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Other| R | DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| MINI PILL| MINI PILL| MINI PILL| MINI PILL| NSAIDS| NSAIDS| NSAIDS| NSAIDS| NUVARING| NUVARING| NUVARING| NUVARING |