ESSURE
Report
- Report Number
- 2951250-2017-03781
- Event Type
- Injury
- Date Received
- September 19, 2017
- Report Date
- August 30, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN / PAIN"), CYSTITIS ("INFECTION (BLADDER/URINARY TRACT/VAGINAL ¿ NUMEROUS)"), EMBEDDED DEVICE ("EMBEDDED DEVICE"), IMMUNE SYSTEM DISORDER ("AUTOIMMUNE DISORDER (IMMUNE DYSFUNCTION)/ INABILITY TO FITH INFECTIONS COLD & VIRUS") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 44-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 857800) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ABDOMINAL CRAMPS, HIDRADENITIS AND ACNE. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, CYST, IRREGULAR PERIODS, METRORRHAGIA, NIGHT SWEATS, TOBACCO ABUSE, MENSES DELAYED AND CERVICAL STEROSIS. CONCOMITANT PRODUCTS INCLUDED AMOXICILLIN SINCE (B)(6) 2012, AZITHROMYCIN (ZITROMAX) SINCE (B)(6) 2012, CLINDAMYCIN SINCE (B)(6) 2012 AND ESOMEPRAZOLE MAGNESIUM (NEXIUM) SINCE (B)(6) 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED IMMUNE SYSTEM DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND THE FIRST EPISODE OF HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: FOCD HHY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA") AND DYSPAREUNIA ("DYSPAREUNIA"). IN 2015, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), CYSTITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), THE SECOND EPISODE OF HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY (FOCD HHY)"), NASOPHARYNGITIS ("COLDS, VIRUS"), BLADDER DISORDER ("BLADDER PROBLEM"), DYSURIA ("URINARY PROBLEMS"), BLOOD DISORDER ("BLOOD DISORDER"), CARDIAC DISORDER ("HEART DISORDER/ CONDITION"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), MOOD ALTERED ("HORMONAL CHANGES (MOODINESS)"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), AMNESIA ("MEMORY LOSS"), CONFUSIONAL STATE ("CONFUSION"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS (DEPRESSION)"), ACNE ("ACNE"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VISION BLURRED ("VISION/EYE PROBLEMS (BLURRED VISION)"), WEIGHT DECREASED ("WEIGHT LOSS"), VULVOVAGINAL PAIN ("VAGINAL AREA PAIN"), VAGINAL CYST ("VAGINAL CYSTS"), URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL ¿ NUMEROUS)"), VAGINAL INFECTION ("VAGINJAL INFECTION"), INCREASED TENDENCY TO BRUISE ("BRUISING EASILY"), DIZZINESS ("DIZZY"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH") AND URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED) - LAPAROSCOPY) AND SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED) - LAPAROSCOPY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, CYSTITIS, EMBEDDED DEVICE, GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, NASOPHARYNGITIS, BLADDER DISORDER, DYSURIA, BLOOD DISORDER, CARDIAC DISORDER, DYSMENORRHOEA, ALOPECIA, MOOD ALTERED, MIGRAINE, AMNESIA, CONFUSIONAL STATE, ACNE, VAGINAL DISCHARGE, VISION BLURRED, WEIGHT DECREASED, URINARY TRACT INFECTION, VAGINAL INFECTION, INCREASED TENDENCY TO BRUISE, DIZZINESS, ANXIETY AND URINARY TRACT DISORDER OUTCOME WAS UNKNOWN AND THE IMMUNE SYSTEM DISORDER, THE LAST EPISODE OF HYPERSENSITIVITY, DYSPAREUNIA, FATIGUE, HEADACHE, DEPRESSION, VULVOVAGINAL PAIN AND VAGINAL CYST HAD RESOLVED. THE REPORTER CONSIDERED ACNE, ALOPECIA, AMNESIA, ANXIETY, BLADDER DISORDER, BLOOD DISORDER, CARDIAC DISORDER, CONFUSIONAL STATE, CYSTITIS, DEPRESSION, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, EMBEDDED DEVICE, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, IMMUNE SYSTEM DISORDER, INCREASED TENDENCY TO BRUISE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MOOD ALTERED, NASOPHARYNGITIS, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL CYST, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED, VULVOVAGINAL PAIN, WEIGHT DECREASED, THE FIRST EPISODE OF HYPERSENSITIVITY AND THE SECOND EPISODE OF HYPERSENSITIVITY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TRAILING COILS: LEFT-3 RIGHT-1 DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TEST WAS NORMAL TO SHOW SUCCESSFUL IMPLANT; ON (B)(6) 2012: CONFIRMED THAT ESSURE WAS SUCCESSFULLY OCCLUDED (B)(6) 2012:TOTAL BILATERAL OCCLUSION.HER FALLOPIAN TUBES WERE BLOCKED. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD; PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-AUG-2018: PFS RECEIVED EVENT " ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: FOCD HHY, URINARY TRACT DISORDER" EVENT WERE ADDED. CONCOMITANT DRUG 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 ("CHRONIC PELVIC PAIN / PAIN"), CYSTITIS ("INFECTION (BLADDER/URINARY TRACT/VAGINAL ¿ NUMEROUS)"), EMBEDDED DEVICE ("EMBEDDED DEVICE"), IMMUNE SYSTEM DISORDER ("AUTOIMMUNE DISORDER (IMMUNE DYSFUNCTION)/ INABILITY TO FITH INFECTIONS COLD & VIRUS") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 44-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 857800-INV) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ABDOMINAL CRAMPS, HIDRADENITIS AND ACNE. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, CYST, IRREGULAR PERIODS, METRORRHAGIA, NIGHT SWEATS, TOBACCO ABUSE AND MENSES DELAYED. CONCOMITANT PRODUCTS INCLUDED AMOXICILLIN SINCE (B)(6) 2012, AZITHROMYCIN (ZITROMAX) SINCE (B)(6) 2012, CLINDAMYCIN SINCE (B)(6) 2012 AND ESOMEPRAZOLE MAGNESIUM (NEXIUM) SINCE (B)(6) 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED IMMUNE SYSTEM DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND THE FIRST EPISODE OF HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: FOCD HHY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA") AND DYSPAREUNIA ("DYSPAREUNIA"). IN 2015, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), CYSTITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), THE SECOND EPISODE OF HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY (FOCD HHY)"), NASOPHARYNGITIS ("COLDS, VIRUS"), BLADDER DISORDER ("BLADDER PROBLEM"), DYSURIA ("URINARY PROBLEMS"), BLOOD DISORDER ("BLOOD DISORDER"), CARDIAC DISORDER ("HEART DISORDER/ CONDITION"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), MOOD ALTERED ("HORMONAL CHANGES (MOODINESS)"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), AMNESIA ("MEMORY LOSS"), CONFUSIONAL STATE ("CONFUSION"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS (DEPRESSION)"), ACNE ("ACNE"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VISION BLURRED ("VISION/EYE PROBLEMS (BLURRED VISION)"), WEIGHT DECREASED ("WEIGHT LOSS"), VULVOVAGINAL PAIN ("VAGINAL AREA PAIN"), VAGINAL CYST ("VAGINAL CYSTS"), URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL ¿ NUMEROUS)"), VAGINAL INFECTION ("VAGINJAL INFECTION"), INCREASED TENDENCY TO BRUISE ("BRUISING EASILY"), DIZZINESS ("DIZZY"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH") AND URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED) - LAPAROSCOPY) AND SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED) - LAPAROSCOPY). ESSURE WAS REMOVED ON (B)(6)2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, CYSTITIS, EMBEDDED DEVICE, GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, NASOPHARYNGITIS, BLADDER DISORDER, DYSURIA, BLOOD DISORDER, CARDIAC DISORDER, DYSMENORRHOEA, ALOPECIA, MOOD ALTERED, MIGRAINE, AMNESIA, CONFUSIONAL STATE, ACNE, VAGINAL DISCHARGE, VISION BLURRED, WEIGHT DECREASED, URINARY TRACT INFECTION, VAGINAL INFECTION, INCREASED TENDENCY TO BRUISE, DIZZINESS, ANXIETY AND URINARY TRACT DISORDER OUTCOME WAS UNKNOWN AND THE IMMUNE SYSTEM DISORDER, THE LAST EPISODE OF HYPERSENSITIVITY, DYSPAREUNIA, FATIGUE, HEADACHE, DEPRESSION, VULVOVAGINAL PAIN AND VAGINAL CYST HAD RESOLVED. THE REPORTER CONSIDERED ACNE, ALOPECIA, AMNESIA, ANXIETY, BLADDER DISORDER, BLOOD DISORDER, CARDIAC DISORDER, CONFUSIONAL STATE, CYSTITIS, DEPRESSION, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, EMBEDDED DEVICE, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, IMMUNE SYSTEM DISORDER, INCREASED TENDENCY TO BRUISE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MOOD ALTERED, NASOPHARYNGITIS, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL CYST, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED, VULVOVAGINAL PAIN, WEIGHT DECREASED, THE FIRST EPISODE OF HYPERSENSITIVITY AND THE SECOND EPISODE OF HYPERSENSITIVITY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TRAILING COILS: LEFT-3 RIGHT-1 DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TEST WAS NORMAL TO SHOW SUCCESSFUL IMPLANT; ON (B)(6) 2012: CONFIRMED THAT ESSURE WAS SUCCESSFULLY OCCLUDED (B)(6) 2012:TOTAL BILATERAL OCCLUSION.HER FALLOPIAN TUBES WERE BLOCKED. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD; PELVIC PAIN MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: UPDATE OF INFORMATION (BATCH IS NOT VALID) 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN / PAIN"), CYSTITIS ("INFECTION (BLADDER/URINARY TRACT/VAGINAL ¿ NUMEROUS)"), IMMUNE SYSTEM DISORDER ("AUTOIMMUNE DISORDER (IMMUNE DYSFUNCTION)/ INABILITY TO FIT INFECTIONS") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 44-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 857800) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL. 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), CYSTITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), IMMUNE SYSTEM DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY (FOCD HHY)"), NASOPHARYNGITIS ("COLDS, VIRUS"), BLADDER DISORDER ("BLADDER PROBLEM"), DYSURIA ("URINARY PROBLEMS"), BLOOD DISORDER ("BLOOD DISORDER"), CARDIAC DISORDER ("HEART DISORDER/ CONDITION"), DYSMENORRHOEA ("DYSMENORRHEA"), DYSPAREUNIA ("DYSPAREUNIA"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), MOOD ALTERED ("HORMONAL CHANGES (MOODINESS)"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), AMNESIA ("MEMORY LOSS"), CONFUSIONAL STATE ("CONFUSION"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS (DEPRESSION)"), ACNE ("ACNE"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VISION BLURRED ("VISION/EYE PROBLEMS (BLURRED VISION)"), WEIGHT DECREASED ("WEIGHT LOSS"), VULVOVAGINAL PAIN ("VAGINAL AREA PAIN"), VAGINAL CYST ("VAGINAL CYSTS"), URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL ¿ NUMEROUS)"), VAGINAL INFECTION ("VAGINAL INFECTION"), CONTUSION ("BRUISING EASILY") AND DIZZINESS ("DIZZY"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A LAPAROSCOPIC BILATERAL SALPINGECTOMY AND REMOVAL OF ESSURE HYSTEROSCOPIC FILAMENTS). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, CYSTITIS, GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, NASOPHARYNGITIS, BLADDER DISORDER, DYSURIA, BLOOD DISORDER, CARDIAC DISORDER, DYSMENORRHOEA, ALOPECIA, MOOD ALTERED, MIGRAINE, AMNESIA, CONFUSIONAL STATE, ACNE, VAGINAL DISCHARGE, VISION BLURRED, WEIGHT DECREASED, URINARY TRACT INFECTION, VAGINAL INFECTION, CONTUSION AND DIZZINESS OUTCOME WAS UNKNOWN AND THE IMMUNE SYSTEM DISORDER, HYPERSENSITIVITY, DYSPAREUNIA, FATIGUE, HEADACHE, DEPRESSION, VULVOVAGINAL PAIN AND VAGINAL CYST HAD RESOLVED. THE REPORTER CONSIDERED ACNE, ALOPECIA, AMNESIA, BLADDER DISORDER, BLOOD DISORDER, CARDIAC DISORDER, CONFUSIONAL STATE, CONTUSION, CYSTITIS, DEPRESSION, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, IMMUNE SYSTEM DISORDER, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MOOD ALTERED, NASOPHARYNGITIS, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL CYST, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED, VULVOVAGINAL PAIN AND WEIGHT DECREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.2 KG/SQM. HYSTEROSALPINGOGRAM ON (B)(6) 2012: TEST WAS NORMAL TO SHOW SUCCESSFUL IMPLANT; ON (B)(6) 2012: CONFIRMED THAT ESSURE WAS SUCCESSFULLY OCCLUDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED. EVENTS ADDED FROM PFS- ABNORMAL BLEEDING (GENERAL), ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), ALLERGIC OR HYPERSENSITIVITY (FOCD HHY), AUTOIMMUNE DISORDER (IMMUNE DYSFUNCTION), INABILITY TO FIT INFECTIONS, COLDS, VIRUS, BLADDER OR URINARY PROBLEMS/CHANGES, BLOOD OR HEART DISORDER/CONDITION, DYSMENORRHEA, DYSPAREUNIA, FATIGUE, HAIR LOSS, HORMONAL CHANGES (MOODINESS), INFECTION (BLADDER/URINARY TRACT/VAGINAL NUMEROUS), MIGRAINES / HEADACHES, NEUROLOGICAL CONDITIONS (MEMORY LOSS, CONFUSION), PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS (DEPRESSION), RASHES OR SKIN CONDITIONS (ACNE, CYSTS), REPRODUCTIVE SYSTEM DISORDER/CONDITION (RECURRING CYSTS), VAGINAL DISCHARGE, VISION/EYE PROBLEMS (BLURRED VISION), WEIGHT LOSS, VAGINAL AREA PAIN, VAGINAL CYSTS. CONCOMITANT DISEASE, LOT NUMBER 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 ("CHRONIC PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. 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) AND MENSTRUAL DISORDER ("MENSTRUATION ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A LAPAROSCOPIC BILATERAL SALPINGECTOMY AND REMOVAL OF ESSURE HYSTEROSCOPIC FILAMENTS). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: CONFIRMED THAT ESSURE WAS SUCCESSFULLY OCCLUDED. 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 |
|---|---|---|---|---|---|---|---|
| 655750 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 857800-INV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Other| R | AMOXICILLIN| AMOXICILLIN| CLINDAMYCIN| CLINDAMYCIN| NEXIUM| NEXIUM| ZITROMAX| ZITROMAX |