ESSURE
Report
- Report Number
- 2951250-2017-08992
- Event Type
- Injury
- Date Received
- November 27, 2017
- Date of Event
- October 1, 2012
- Report Date
- September 1, 2020
- 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
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION (UTERUS)"), DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE (LOCATION OF DEVICE: SCAR TISSUE IN UTERUS FROM ESSURE PLACEMENT"), PELVIC PAIN ("SEVERE PELVIC PAIN/ PAIN"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS"), COMPLICATION OF DEVICE INSERTION ("MALPOSITION OF ESSURE DEVICE (LOCATION OF DEVICE: COMPLICATION WITH PLACEMENT IN FALLOPIAN TUBE),"), UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING"), ADNEXA UTERI CYST ("PARATUBAL CYSTS") AND ENDOMETRIOSIS ("ENDOMETRIOSIS") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 50658291, 901333) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX), CITALOPRAM HYDROBROMIDE (CELEXA), GABAPENTIN (NEURONTIN), LAMOTRIGINE (LAMICTAL) AND TRAMADOL. ON AN UNKNOWN DATE, THE PATIENT STARTED LYRICA AT AN UNSPECIFIED DOSE AND FREQUENCY. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), COMPLICATION OF DEVICE INSERTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MOOD SWINGS ("MOOD SWINGS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL INFECTION ("VAGINAL INFECTION/ VAGINITIS"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), DEPRESSION ("WORSENING OF DEPRESSION"), HOT FLUSH ("HOT SWEATS"), URTICARIA ("HIVES"), RASH ("RASHES"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), ALLERGY TO METALS ("NICKEL ALLERGY"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE EXHAUSTION ONGOING WORSENING"), WEIGHT DECREASED ("WEIGHT LOSS"), ALOPECIA ("HAIR LOSS"), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("UNABLE TO DO DAILY ACTIVITIES"), CERVIX INFLAMMATION ("ACUTE AND CHRONIC INFLAMMATION OF CERVIX"), VULVOVAGINITIS ("VULVOVAGINITIS") AND PERINEAL PAIN ("PERINEAL PAIN"). IN (B)(6) 2014, THE PATIENT EXPERIENCED SYSTEMIC LUPUS ERYTHEMATOSUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ADNEXA UTERI CYST (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ENDOMETRIOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ARTHRALGIA ("HIP PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), ABDOMINAL DISTENSION ("BLOATING"), IRRITABILITY ("IRRITABILITY"), EPIPLOIC APPENDAGITIS ("BOWEL EPIPLOICA NODULE"), INFLAMMATION ("INFLAMMATION"), UTERINE SCAR ("MIGRATION OF ESSURE DEVICE (LOCATION OF DEVICE: SCAR TISSUE IN UTERUS FROM ESSURE PLACEMENT"), VISUAL IMPAIRMENT ("WORSENED VISION") AND FIBROMYALGIA ("FIBROMYALGIA"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY - REMOVAL OF ESSURE DEVICES), SURGERY (LAPAROSCOPY, BILATERAL SALPINGECTOMY WITH CORNEAL RESECTION, REMOVAL OF ESSURE DEVICES), SURGERY (EXCISION ENDOMETRIOSIS) AND SURGERY (EXCISION OF BOWEL EPIPLOICA NODULE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE EXPULSION, SYSTEMIC LUPUS ERYTHEMATOSUS, COMPLICATION OF DEVICE INSERTION, ADNEXA UTERI CYST, ENDOMETRIOSIS, EPIPLOIC APPENDAGITIS, FEMALE SEXUAL DYSFUNCTION, HOT FLUSH, INFLAMMATION, UTERINE SCAR, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, VISUAL IMPAIRMENT, FATIGUE, WEIGHT DECREASED, ALOPECIA, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, CERVIX INFLAMMATION AND FIBROMYALGIA OUTCOME WAS UNKNOWN, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ARTHRALGIA, BACK PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL DISTENSION AND IRRITABILITY HAD RESOLVED AND THE UTERINE HAEMORRHAGE, ABDOMINAL PAIN, MOOD SWINGS, VAGINAL HAEMORRHAGE, MENORRHAGIA, VAGINAL INFECTION, DEPRESSION, URTICARIA, RASH, MIGRAINE, HEADACHE, NAUSEA, VULVOVAGINITIS AND PERINEAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ADNEXA UTERI CYST, ALLERGY TO METALS, ALOPECIA, ARTHRALGIA, BACK PAIN, CERVIX INFLAMMATION, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, EPIPLOIC APPENDAGITIS, FATIGUE, FEMALE SEXUAL DYSFUNCTION, FIBROMYALGIA, GENITAL HAEMORRHAGE, HEADACHE, HOT FLUSH, INFLAMMATION, IRRITABILITY, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, PERINEAL PAIN, RASH, SYSTEMIC LUPUS ERYTHEMATOSUS, URTICARIA, UTERINE HAEMORRHAGE, UTERINE PERFORATION, UTERINE SCAR, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISUAL IMPAIRMENT, VULVOVAGINITIS AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT UNDERWENT AN OPERATIVE LAPAROSCOPY, BILATERAL SALPINGECTOMY WITH CORNEAL RESECTION, REMOVAL ESSURE DEVICES, EXCISION ENDOMETRIOSIS AND EXCISION OF BOWEL EPIPLOICA NODULE ON (B)(6) 2017. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: ESSURE WIRES PRESENT IN THE REGION OF THE FALLOPIA; ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. (B)(6) 2013 : HYSTEROSALPINGOGRAM : ESSURE WIRES PRESENT IN THE REGION OF THE FALLOPIAN TUBES BILATERALLY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: CONFIRMS PELVIC PAIN, PARATUBAL CYSTS, ENDOMETRIOSIS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: INFORMATION FROM PFS AND MR. NEW REPORTER ADDED. PATIENT¿S DEMOGRAPHICS ADDED. INDICATION ADDED. LOT NUMBER ADDED. CONMEDS ADDED. NEW EVENTS ADDED: MOOD SWINGS; ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), VAGINAL INFECTION/ VAGINITIS, APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), WORSENING OF DEPRESSION, LUPUS, MALPOSITION OF ESSURE DEVICE (LOCATION OF DEVICE: COMPLICATION WITH PLACEMENT IN FALLOPIAN TUBE), HOT SWEATS; HIVES; RASHES; INFLAMMATION, MIGRAINES, HEADACHES, MIGRATION OF ESSURE DEVICE (LOCATION OF DEVICE: SCAR TISSUE IN UTERUS FROM ESSURE PLACEMENT, NAUSEA, NICKEL ALLERGY, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), VAGINAL DISCHARGE, WORSENED VISION, FATIGUE, PERFORATION (UTERUS), WEIGHT LOSS, HAIR LOSS AND UNABLE TO DO DAILY ACTIVITIES; ACUTE AND CHRONIC INFLAMMATION OF CERVIX; PARATUBAL CYSTS, ABNORMAL UTERINE BLEEDING, VULVOVAGINITIS, PERINEAL PAIN, FIBROMYALGIA. 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 UTERINE PERFORATION ("PERFORATION (UTERUS)"), DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE (LOCATION OF DEVICE: SCAR TISSUE IN UTERUS FROM ESSURE PLACEMENT"), PELVIC PAIN ("SEVERE PELVIC PAIN/ PAIN"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS"), COMPLICATION OF DEVICE INSERTION ("MALPOSITION OF ESSURE DEVICE (LOCATION OF DEVICE: COMPLICATION WITH PLACEMENT IN FALLOPIAN TUBE),"), UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING"), ADNEXA UTERI CYST ("PARATUBAL CYSTS") AND ENDOMETRIOSIS ("ENDOMETRIOSIS") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 50658291, 901333) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX), CITALOPRAM HYDROBROMIDE (CELEXA), GABAPENTIN (NEURONTIN), LAMOTRIGINE (LAMICTAL), PREGABALIN (LYRICA) AND TRAMADOL. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), COMPLICATION OF DEVICE INSERTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MOOD SWINGS ("MOOD SWINGS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL INFECTION ("VAGINAL INFECTION/ VAGINITIS"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), DEPRESSION ("WORSENING OF DEPRESSION"), HOT FLUSH ("HOT SWEATS"), URTICARIA ("HIVES"), RASH ("RASHES"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), ALLERGY TO METALS ("NICKEL ALLERGY"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE EXHAUSTION ONGOING WORSENING"), WEIGHT DECREASED ("WEIGHT LOSS"), ALOPECIA ("HAIR LOSS"), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("UNABLE TO DO DAILY ACTIVITIES"), CERVIX INFLAMMATION ("ACUTE AND CHRONIC INFLAMMATION OF CERVIX"), VULVOVAGINITIS ("VULVOVAGINITIS") WITH VAGINAL DISCHARGE AND PERINEAL PAIN ("PERINEAL PAIN"). IN (B)(6) 2014, THE PATIENT EXPERIENCED SYSTEMIC LUPUS ERYTHEMATOSUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ADNEXA UTERI CYST (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ENDOMETRIOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ARTHRALGIA ("HIP PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), ABDOMINAL DISTENSION ("BLOATING"), IRRITABILITY ("IRRITABILITY"), EPIPLOIC APPENDAGITIS ("BOWEL EPIPLOICA NODULE"), INFLAMMATION ("INFLAMMATION"), UTERINE SCAR ("MIGRATION OF ESSURE DEVICE (LOCATION OF DEVICE: SCAR TISSUE IN UTERUS FROM ESSURE PLACEMENT"), VISUAL IMPAIRMENT ("WORSENED VISION") AND FIBROMYALGIA ("FIBROMYALGIA"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY - REMOVAL OF ESSURE DEVICES), SURGERY (BILATERAL SALPINGECTOMY - REMOVAL OF ESSURE DEVICES), SURGERY (LAPAROSCOPY, BILATERAL SALPINGECTOMY WITH CORNEAL RESECTION, REMOVAL OF ESSURE DEVICES), SURGERY (EXCISION ENDOMETRIOSIS) AND SURGERY (EXCISION OF BOWEL EPIPLOICA NODULE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE EXPULSION, SYSTEMIC LUPUS ERYTHEMATOSUS, COMPLICATION OF DEVICE INSERTION, ADNEXA UTERI CYST, ENDOMETRIOSIS, EPIPLOIC APPENDAGITIS, FEMALE SEXUAL DYSFUNCTION, HOT FLUSH, INFLAMMATION, UTERINE SCAR, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, VISUAL IMPAIRMENT, FATIGUE, WEIGHT DECREASED, ALOPECIA, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, CERVIX INFLAMMATION AND FIBROMYALGIA OUTCOME WAS UNKNOWN, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ARTHRALGIA, BACK PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL DISTENSION AND IRRITABILITY HAD RESOLVED AND THE UTERINE HAEMORRHAGE, ABDOMINAL PAIN, MOOD SWINGS, VAGINAL HAEMORRHAGE, MENORRHAGIA, VAGINAL INFECTION, DEPRESSION, URTICARIA, RASH, MIGRAINE, HEADACHE, NAUSEA, VULVOVAGINITIS AND PERINEAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ADNEXA UTERI CYST, ALLERGY TO METALS, ALOPECIA, ARTHRALGIA, BACK PAIN, CERVIX INFLAMMATION, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, EPIPLOIC APPENDAGITIS, FATIGUE, FEMALE SEXUAL DYSFUNCTION, FIBROMYALGIA, GENITAL HAEMORRHAGE, HEADACHE, HOT FLUSH, INFLAMMATION, IRRITABILITY, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, PERINEAL PAIN, RASH, SYSTEMIC LUPUS ERYTHEMATOSUS, URTICARIA, UTERINE HAEMORRHAGE, UTERINE PERFORATION, UTERINE SCAR, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISUAL IMPAIRMENT, VULVOVAGINITIS AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT UNDERWENT AN OPERATIVE LAPAROSCOPY, BILATERAL SALPINGECTOMY WITH CORNEAL RESECTION, REMOVAL ESSURE DEVICES, EXCISION ENDOMETRIOSIS AND EXCISION OF BOWEL EPIPLOICA NODULE ON (B)(6) 2017. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: ESSURE WIRES PRESENT IN THE REGION OF THE FALLOPIA; ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. (B)(6) 2013 : HYSTEROSALPINGOGRAM : ESSURE WIRES PRESENT IN THE REGION OF THE FALLOPIAN TUBES BILATERALLY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: CONFIRMS PELVIC PAIN, PARATUBAL CYSTS, ENDOMETRIOSIS BATCH NUMBER: 50658291 EXP DATE: 2012/04 MAN DATE: 2015/04. BATCH NUMBER: 901333 EXP DATE: 2011/09 MAN DATE: 2014/09. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-AUG-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 UTERINE PERFORATION ('PERFORATION (UTERUS)'), DEVICE EXPULSION ('MIGRATION OF ESSURE DEVICE (LOCATION OF DEVICE: SCAR TISSUE IN UTERUS FROM ESSURE PLACEMENT'), PELVIC PAIN ('SEVERE PELVIC PAIN/ PAIN'), GENITAL HAEMORRHAGE ('HEAVY BLEEDING'), SYSTEMIC LUPUS ERYTHEMATOSUS ('LUPUS'), COMPLICATION OF DEVICE INSERTION ('MALPOSITION OF ESSURE DEVICE (LOCATION OF DEVICE: COMPLICATION WITH PLACEMENT IN FALLOPIAN TUBE),'), UTERINE HAEMORRHAGE ('ABNORMAL UTERINE BLEEDING'), ADNEXA UTERI CYST ('PARATUBAL CYSTS') AND ENDOMETRIOSIS ('ENDOMETRIOSIS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 50658291,901333) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: DEPO PROVERA. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX), CITALOPRAM HYDROBROMIDE (CELEXA), GABAPENTIN (NEURONTIN), LAMOTRIGINE (LAMICTAL), PREGABALIN (LYRICA) AND TRAMADOL. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), COMPLICATION OF DEVICE INSERTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MOOD SWINGS ("MOOD SWINGS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL INFECTION ("VAGINAL INFECTION/ VAGINITIS"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), DEPRESSION ("WORSENING OF DEPRESSION"), HYPERHIDROSIS ("HOT SWEATS"), URTICARIA ("HIVES"), RASH ("RASHES"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), ALLERGY TO METALS ("NICKEL ALLERGY"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE EXHAUSTION ONGOING WORSENING"), ALOPECIA ("HAIR LOSS"), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("UNABLE TO DO DAILY ACTIVITIES"), CERVIX INFLAMMATION ("ACUTE AND CHRONIC INFLAMMATION OF CERVIX"), VULVOVAGINITIS ("VULVOVAGINITIS") WITH VAGINAL DISCHARGE AND PERINEAL PAIN ("PERINEAL PAIN") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED SYSTEMIC LUPUS ERYTHEMATOSUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ADNEXA UTERI CYST (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ENDOMETRIOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ARTHRALGIA ("HIP PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), ABDOMINAL DISTENSION ("BLOATING"), IRRITABILITY ("IRRITABILITY"), EPIPLOIC APPENDAGITIS ("BOWEL EPIPLOICA NODULE"), INFLAMMATION ("INFLAMMATION"), UTERINE SCAR ("MIGRATION OF ESSURE DEVICE (LOCATION OF DEVICE: SCAR TISSUE IN UTERUS FROM ESSURE PLACEMENT"), VISUAL IMPAIRMENT ("WORSENED VISION") AND FIBROMYALGIA ("FIBROMYALGIA"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY - REMOVAL OF ESSURE DEVICES, EXCISION ENDOMETRIOSIS, EXCISION OF BOWEL EPIPLOICA NODULE AND LAPAROSCOPY, BILATERAL SALPINGECTOMY WITH CORNEAL RESECTION, REMOVAL OF ESSURE DEVICES). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE EXPULSION, SYSTEMIC LUPUS ERYTHEMATOSUS, COMPLICATION OF DEVICE INSERTION, ADNEXA UTERI CYST, ENDOMETRIOSIS, EPIPLOIC APPENDAGITIS, FEMALE SEXUAL DYSFUNCTION, HYPERHIDROSIS, INFLAMMATION, UTERINE SCAR, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, VISUAL IMPAIRMENT, FATIGUE, WEIGHT DECREASED, ALOPECIA, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, CERVIX INFLAMMATION AND FIBROMYALGIA OUTCOME WAS UNKNOWN, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ARTHRALGIA, BACK PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL DISTENSION AND IRRITABILITY HAD RESOLVED AND THE UTERINE HAEMORRHAGE, ABDOMINAL PAIN, MOOD SWINGS, VAGINAL HAEMORRHAGE, MENORRHAGIA, VAGINAL INFECTION, DEPRESSION, URTICARIA, RASH, MIGRAINE, HEADACHE, NAUSEA, VULVOVAGINITIS AND PERINEAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ADNEXA UTERI CYST, ALLERGY TO METALS, ALOPECIA, ARTHRALGIA, BACK PAIN, CERVIX INFLAMMATION, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, EPIPLOIC APPENDAGITIS, FATIGUE, FEMALE SEXUAL DYSFUNCTION, FIBROMYALGIA, GENITAL HAEMORRHAGE, HEADACHE, HYPERHIDROSIS, INFLAMMATION, IRRITABILITY, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, PERINEAL PAIN, RASH, SYSTEMIC LUPUS ERYTHEMATOSUS, URTICARIA, UTERINE HAEMORRHAGE, UTERINE PERFORATION, UTERINE SCAR, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISUAL IMPAIRMENT, VULVOVAGINITIS AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT UNDERWENT AN OPERATIVE LAPAROSCOPY, BILATERAL SALPINGECTOMY WITH CORNEAL RESECTION, REMOVAL ESSURE DEVICES, EXCISION ENDOMETRIOSIS AND EXCISION OF BOWEL EPIPLOICA NODULE ON (B)(6) 2017. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULTS: ESSURE WIRES PRESENT IN THE REGION OF THE FALLOPIAN TUBES BILATERALLY; ON (B)(6) 2013: RESULTS: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: CONFIRMS PELVIC PAIN, PARATUBAL CYSTS, ENDOMETRIOSIS BATCH NUMBER: 50658291, EXP DATE: 2012/04, MAN DATE: 2015/04, BATCH NUMBER: 901333, EXP DATE: 2011/09, MAN DATE: 2014/09, QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-NOV-2019: PFS RECEIVED- EVENT HOT FLUSH UPDATED TO HOT SWEATS. HISTORICAL DRUG WERE ADDED. INCIDENT- WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ('PERFORATION (UTERUS)'), DEVICE EXPULSION ('MIGRATION OF ESSURE DEVICE (LOCATION OF DEVICE: SCAR TISSUE IN UTERUS FROM ESSURE PLACEMENT'), PELVIC PAIN ('SEVERE PELVIC PAIN/ PAIN'), GENITAL HAEMORRHAGE ('HEAVY BLEEDING'), SYSTEMIC LUPUS ERYTHEMATOSUS ('LUPUS'), COMPLICATION OF DEVICE INSERTION ('MALPOSITION OF ESSURE DEVICE (LOCATION OF DEVICE: COMPLICATION WITH PLACEMENT IN FALLOPIAN TUBE),'), UTERINE HAEMORRHAGE ('ABNORMAL UTERINE BLEEDING'), ADNEXA UTERI CYST ('PARATUBAL CYSTS') AND ENDOMETRIOSIS ('ENDOMETRIOSIS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 50658291,901333) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: DEPO PROVERA. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX), GABAPENTIN (NEURONTIN), LAMOTRIGINE (LAMICTAL), PREGABALIN (LYRICA) AND TRAMADOL. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), COMPLICATION OF DEVICE INSERTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MOOD SWINGS ("MOOD SWINGS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL INFECTION ("VAGINAL INFECTION/ VAGINITIS"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), DEPRESSION ("WORSENING OF DEPRESSION"), FEELING HOT ("HOT SWEAT"), URTICARIA ("HIVES"), RASH ("RASHES"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), ALLERGY TO METALS ("NICKEL ALLERGY"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE EXHAUSTION ONGOING WORSENING"), ALOPECIA ("HAIR LOSS"), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("UNABLE TO DO DAILY ACTIVITIES"), CERVIX INFLAMMATION ("ACUTE AND CHRONIC INFLAMMATION OF CERVIX"), VULVOVAGINITIS ("VULVOVAGINITIS") WITH VAGINAL DISCHARGE AND PERINEAL PAIN ("PERINEAL PAIN") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED SYSTEMIC LUPUS ERYTHEMATOSUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ADNEXA UTERI CYST (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ENDOMETRIOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ARTHRALGIA ("HIP PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), ABDOMINAL DISTENSION ("BLOATING"), IRRITABILITY ("IRRITABILITY"), EPIPLOIC APPENDAGITIS ("BOWEL EPIPLOICA NODULE"), HYPERHIDROSIS ("SWEAT"), INFLAMMATION ("INFLAMMATION"), UTERINE SCAR ("MIGRATION OF ESSURE DEVICE (LOCATION OF DEVICE: SCAR TISSUE IN UTERUS FROM ESSURE PLACEMENT"), VISUAL IMPAIRMENT ("WORSENED VISION") AND FIBROMYALGIA ("FIBROMYALGIA"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY - REMOVAL OF ESSURE DEVICES, EXCISION ENDOMETRIOSIS, EXCISION OF BOWEL EPIPLOICA NODULE AND LAPAROSCOPY, BILATERAL SALPINGECTOMY WITH CORNEAL RESECTION, REMOVAL OF ESSURE DEVICES). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE EXPULSION, SYSTEMIC LUPUS ERYTHEMATOSUS, COMPLICATION OF DEVICE INSERTION, ADNEXA UTERI CYST, ENDOMETRIOSIS, EPIPLOIC APPENDAGITIS, FEMALE SEXUAL DYSFUNCTION, FEELING HOT, HYPERHIDROSIS, INFLAMMATION, UTERINE SCAR, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, VISUAL IMPAIRMENT, FATIGUE, WEIGHT DECREASED, ALOPECIA, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, CERVIX INFLAMMATION AND FIBROMYALGIA OUTCOME WAS UNKNOWN, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ARTHRALGIA, BACK PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL DISTENSION AND IRRITABILITY HAD RESOLVED AND THE UTERINE HAEMORRHAGE, ABDOMINAL PAIN, MOOD SWINGS, VAGINAL HAEMORRHAGE, MENORRHAGIA, VAGINAL INFECTION, DEPRESSION, URTICARIA, RASH, MIGRAINE, HEADACHE, NAUSEA, VULVOVAGINITIS AND PERINEAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ADNEXA UTERI CYST, ALLERGY TO METALS, ALOPECIA, ARTHRALGIA, BACK PAIN, CERVIX INFLAMMATION, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, EPIPLOIC APPENDAGITIS, FATIGUE, FEELING HOT, FEMALE SEXUAL DYSFUNCTION, FIBROMYALGIA, GENITAL HAEMORRHAGE, HEADACHE, HYPERHIDROSIS, INFLAMMATION, IRRITABILITY, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, PERINEAL PAIN, RASH, SYSTEMIC LUPUS ERYTHEMATOSUS, URTICARIA, UTERINE HAEMORRHAGE, UTERINE PERFORATION, UTERINE SCAR, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISUAL IMPAIRMENT, VULVOVAGINITIS AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT UNDERWENT AN OPERATIVE LAPAROSCOPY, BILATERAL SALPINGECTOMY WITH CORNEAL RESECTION, REMOVAL ESSURE DEVICES, EXCISION ENDOMETRIOSIS AND EXCISION OF BOWEL EPIPLOICA NODULE ON (B)(6) 2017. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULTS: ESSURE WIRES PRESENT IN THE REGION OF THE FALLOPIAN TUBES BILATERALLY; ON (B)(6) 2013: RESULTS: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: CONFIRMS PELVIC PAIN, PARATUBAL CYSTS, ENDOMETRIOSIS BATCH NUMBER: 50658291 EXP DATE: 2012/04 MAN DATE: 2015/04. BATCH NUMBER: 901333 EXP DATE: 2011/09 MAN DATE: 2014/09. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: CODING REQUEST RECEIVED. CORRECTION DUE TO DISCREPANCY BETWEEN CODING ACTION ITEM AND MATCH POINT CODER QUERY. EVENT : HOT SWEAT PT : FEELING HOT WERE UPDATED TO HYPERHIDROSIS . NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ('PERFORATION UTERUS'), DEVICE EXPULSION ('MIGRATION OF ESSURE DEVICE (LOCATION OF DEVICE: SCAR TISSUE IN UTERUS FROM ESSURE PLACEMENT'), PELVIC PAIN ('SEVERE PELVIC PAIN/ PAIN / PARALYZING PAIN CONSTANTLY') AND ENDOMETRIOSIS ('ENDOMETRIOSIS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 50658291,901333) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: DEPO PROVERA. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX), GABAPENTIN (NEURONTIN), LAMOTRIGINE (LAMICTAL), PREGABALIN (LYRICA) AND TRAMADOL. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION, DISABILITY, MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), COMPLICATION OF DEVICE INSERTION ("MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: COMPLICATION WITH PLACEMENT IN FALLOPIAN TUBE"), UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING"), MOOD SWINGS ("MOOD SWINGS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"), VAGINAL INFECTION ("VAGINAL INFECTION/ VAGINITIS"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA INABILITY TO HAVE SEXUAL INTERCOURSE"), DEPRESSION ("WORSENING OF DEPRESSION"), FEELING HOT ("HOT SWEAT"), URTICARIA ("HIVES"), RASH ("RASHES"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), ALLERGY TO METALS ("NICKEL ALLERGY"), DYSMENORRHOEA ("DYSMENORRHEA CRAMPING"), DYSPAREUNIA ("DYSPAREUNIA PAINFUL SEXUAL INTERCOURSE"), FATIGUE ("FATIGUE EXHAUSTION ONGOING WORSENING"), ALOPECIA ("HAIR LOSS"), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("UNABLE TO DO DAILY ACTIVITIES"), CERVIX INFLAMMATION ("ACUTE AND CHRONIC INFLAMMATION OF CERVIX"), VULVOVAGINITIS ("VULVOVAGINITIS") WITH VAGINAL DISCHARGE AND PERINEAL PAIN ("PERINEAL PAIN") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS / RECENTLY DIAGNOSED WITH LUPUS "). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), ADNEXA UTERI CYST ("PARATUBAL CYSTS"), ENDOMETRIOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ARTHRALGIA ("HIP PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), ABDOMINAL DISTENSION ("BLOATING"), IRRITABILITY ("IRRITABILITY"), EPIPLOIC APPENDAGITIS ("BOWEL EPIPLOICA NODULE"), HYPERHIDROSIS ("SWEAT"), INFLAMMATION ("INFLAMMATION / CONSTANT STRESS OF ALL THE INFLAMMATION "), UTERINE SCAR ("MIGRATION OF ESSURE DEVICE (LOCATION OF DEVICE: SCAR TISSUE IN UTERUS FROM ESSURE PLACEMENT"), VISUAL IMPAIRMENT ("WORSENED VISION"), FIBROMYALGIA ("FIBROMYALGIA / INCE ESSURE MY FIBROMYALGIA HAS GOTTEN WORSE "), HERPES ZOSTER ("BREAK OUT IN SHINGLES ") AND STRESS ("CONSTANT STRESS OF ALL THE INFLAMMATION "). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY REMOVAL OF ESSURE DEVICES, EXCISION ENDOMETRIOSIS, EXCISION OF BOWEL EPIPLOICA NODULE AND LAPAROSCOPY, BILATERAL SALPINGECTOMY WITH CORNEAL RESECTION, REMOVAL OF ESSURE DEVICES). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE EXPULSION, SYSTEMIC LUPUS ERYTHEMATOSUS, COMPLICATION OF DEVICE INSERTION, ADNEXA UTERI CYST, ENDOMETRIOSIS, EPIPLOIC APPENDAGITIS, FEMALE SEXUAL DYSFUNCTION, FEELING HOT, HYPERHIDROSIS, INFLAMMATION, UTERINE SCAR, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, VISUAL IMPAIRMENT, FATIGUE, WEIGHT DECREASED, ALOPECIA, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, CERVIX INFLAMMATION, FIBROMYALGIA, HERPES ZOSTER AND STRESS OUTCOME WAS UNKNOWN, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ARTHRALGIA, BACK PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL DISTENSION AND IRRITABILITY HAD RESOLVED AND THE UTERINE HAEMORRHAGE, ABDOMINAL PAIN, MOOD SWINGS, VAGINAL HAEMORRHAGE, MENORRHAGIA, VAGINAL INFECTION, DEPRESSION, URTICARIA, RASH, MIGRAINE, HEADACHE, NAUSEA, VULVOVAGINITIS AND PERINEAL PAIN WAS RESOLVING. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR HERPES ZOSTER AND STRESS WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ADNEXA UTERI CYST, ALLERGY TO METALS, ALOPECIA, ARTHRALGIA, BACK PAIN, CERVIX INFLAMMATION, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, EPIPLOIC APPENDAGITIS, FATIGUE, FEELING HOT, FEMALE SEXUAL DYSFUNCTION, FIBROMYALGIA, GENITAL HAEMORRHAGE, HEADACHE, HYPERHIDROSIS, INFLAMMATION, IRRITABILITY, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, PERINEAL PAIN, RASH, SYSTEMIC LUPUS ERYTHEMATOSUS, URTICARIA, UTERINE HAEMORRHAGE, UTERINE PERFORATION, UTERINE SCAR, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISUAL IMPAIRMENT, VULVOVAGINITIS AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT UNDERWENT AN OPERATIVE LAPAROSCOPY, BILATERAL SALPINGECTOMY WITH CORNEAL RESECTION, REMOVAL ESSURE DEVICES, EXCISION ENDOMETRIOSIS AND EXCISION OF BOWEL EPIPLOICA NODULE ON (B)(6) 2017. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.2 KG/SQM. HYSTEROSALPINGOGRAM ON (B)(6) 2013: RESULTS: ESSURE WIRES PRESENT IN THE REGION OF THE FALLOPIAN TUBES BILATERALLY; ON (B)(6) 2013: RESULTS: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: CONFIRMS PELVIC PAIN, PARATUBAL CYSTS, ENDOMETRIOSIS BATCH NUMBER: 50658291, EXP DATE: 2012/04; MAN DATE: 2015/04 . BATCH NUMBER: 901333 , EXP DATE: 2011/09; MAN DATE: 2014/09 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-JUL-2020: PIF RECEIVED : NO NEW INFORMATION ADDED. AMENDMENT: THE REPORT WAS ALSO AMENDED FOR THE FOLLOWING REASON: CASE (B)(4) WAS FOUND TO BE DUPLICATE OF THIS CASE AND WILL BE DELETED. EVENTS- "BREAK OUT IN SHINGLES, CONSTANT STRESS OF ALL THE INFLAMMATION", REFERENCES, DOCUMENTS FROM CASE (B)(4) WERE TRANSFERRED TO THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ('PERFORATION (UTERUS)'), DEVICE EXPULSION ('MIGRATION OF ESSURE DEVICE (LOCATION OF DEVICE: SCAR TISSUE IN UTERUS FROM ESSURE PLACEMENT'), PELVIC PAIN ('SEVERE PELVIC PAIN/ PAIN / PARALYZING PAIN CONSTANTLY') AND ENDOMETRIOSIS ('ENDOMETRIOSIS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 50658291,901333) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: DEPO PROVERA. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX), GABAPENTIN (NEURONTIN), LAMOTRIGINE (LAMICTAL), PREGABALIN (LYRICA) AND TRAMADOL. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION, DISABILITY, MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), COMPLICATION OF DEVICE INSERTION ("MALPOSITION OF ESSURE DEVICE (LOCATION OF DEVICE: COMPLICATION WITH PLACEMENT IN FALLOPIAN TUBE),"), UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING"), MOOD SWINGS ("MOOD SWINGS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL INFECTION ("VAGINAL INFECTION/ VAGINITIS"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), DEPRESSION ("WORSENING OF DEPRESSION"), FEELING HOT ("HOT SWEAT"), URTICARIA ("HIVES"), RASH ("RASHES"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), ALLERGY TO METALS ("NICKEL ALLERGY"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE EXHAUSTION ONGOING WORSENING"), ALOPECIA ("HAIR LOSS"), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("UNABLE TO DO DAILY ACTIVITIES"), CERVIX INFLAMMATION ("ACUTE AND CHRONIC INFLAMMATION OF CERVIX"), VULVOVAGINITIS ("VULVOVAGINITIS") WITH VAGINAL DISCHARGE AND PERINEAL PAIN ("PERINEAL PAIN") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS / RECENTLY DIAGNOSED WITH LUPUS "). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), ADNEXA UTERI CYST ("PARATUBAL CYSTS"), ENDOMETRIOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ARTHRALGIA ("HIP PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), ABDOMINAL DISTENSION ("BLOATING"), IRRITABILITY ("IRRITABILITY"), EPIPLOIC APPENDAGITIS ("BOWEL EPIPLOICA NODULE"), HYPERHIDROSIS ("SWEAT"), INFLAMMATION ("INFLAMMATION / CONSTANT STRESS OF ALL THE INFLAMMATION "), UTERINE SCAR ("MIGRATION OF ESSURE DEVICE (LOCATION OF DEVICE: SCAR TISSUE IN UTERUS FROM ESSURE PLACEMENT"), VISUAL IMPAIRMENT ("WORSENED VISION"), FIBROMYALGIA ("FIBROMYALGIA / INCE ESSURE MY FIBROMYALGIA HAS GOTTEN WORSE "), HERPES ZOSTER ("BREAK OUT IN SHINGLES ") AND STRESS ("CONSTANT STRESS OF ALL THE INFLAMMATION "). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY - REMOVAL OF ESSURE DEVICES, EXCISION ENDOMETRIOSIS, EXCISION OF BOWEL EPIPLOICA NODULE AND LAPAROSCOPY, BILATERAL SALPINGECTOMY WITH CORNEAL RESECTION, REMOVAL OF ESSURE DEVICES). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE EXPULSION, SYSTEMIC LUPUS ERYTHEMATOSUS, COMPLICATION OF DEVICE INSERTION, ADNEXA UTERI CYST, ENDOMETRIOSIS, EPIPLOIC APPENDAGITIS, FEMALE SEXUAL DYSFUNCTION, FEELING HOT, HYPERHIDROSIS, INFLAMMATION, UTERINE SCAR, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, VISUAL IMPAIRMENT, FATIGUE, WEIGHT DECREASED, ALOPECIA, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, CERVIX INFLAMMATION, FIBROMYALGIA, HERPES ZOSTER AND STRESS OUTCOME WAS UNKNOWN, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ARTHRALGIA, BACK PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL DISTENSION AND IRRITABILITY HAD RESOLVED AND THE UTERINE HAEMORRHAGE, ABDOMINAL PAIN, MOOD SWINGS, VAGINAL HAEMORRHAGE, MENORRHAGIA, VAGINAL INFECTION, DEPRESSION, URTICARIA, RASH, MIGRAINE, HEADACHE, NAUSEA, VULVOVAGINITIS AND PERINEAL PAIN WAS RESOLVING. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR HERPES ZOSTER AND STRESS WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ADNEXA UTERI CYST, ALLERGY TO METALS, ALOPECIA, ARTHRALGIA, BACK PAIN, CERVIX INFLAMMATION, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, EPIPLOIC APPENDAGITIS, FATIGUE, FEELING HOT, FEMALE SEXUAL DYSFUNCTION, FIBROMYALGIA, GENITAL HAEMORRHAGE, HEADACHE, HYPERHIDROSIS, INFLAMMATION, IRRITABILITY, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, PERINEAL PAIN, RASH, SYSTEMIC LUPUS ERYTHEMATOSUS, URTICARIA, UTERINE HAEMORRHAGE, UTERINE PERFORATION, UTERINE SCAR, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISUAL IMPAIRMENT, VULVOVAGINITIS AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT UNDERWENT AN OPERATIVE LAPAROSCOPY, BILATERAL SALPINGECTOMY WITH CORNEAL RESECTION, REMOVAL ESSURE DEVICES, EXCISION ENDOMETRIOSIS AND EXCISION OF BOWEL EPIPLOICA NODULE ON (B)(6) 2017. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULTS: ESSURE WIRES PRESENT IN THE REGION OF THE FALLOPIAN TUBES BILATERALLY; ON (B)(6) 2013: RESULTS: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: CONFIRMS PELVIC PAIN, PARATUBAL CYSTS, ENDOMETRIOSIS LOT NUMBER:50658291 MANUFACTURING DATE:2012/04 EXPIRATION DATE:2015/04. LOT NUMBER:901333 MANUFACTURING DATE:2011/09 EXPIRATION DATE:2014/09. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-SEP-2020: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS 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"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING") AND ENDOMETRIOSIS ("ENDOMETRIOSIS") 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), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ENDOMETRIOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ARTHRALGIA ("HIP PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), ABDOMINAL DISTENSION ("BLOATING"), IRRITABILITY ("IRRITABILITY") AND EPIPLOIC APPENDAGITIS ("BOWEL EPIPLOICA NODULE"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPY, BILATERAL SALPINGECTOMY WITH CORNEAL RESECTION, REMOVAL OF ESSURE DEVICES, (EXCISION ENDOMETRIOSIS AND EXCISION OF BOWEL EPIPLOICA NODULE. ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ARTHRALGIA, ABDOMINAL PAIN, BACK PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL DISTENSION AND IRRITABILITY HAD RESOLVED AND THE ENDOMETRIOSIS AND EPIPLOIC APPENDAGITIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ARTHRALGIA, BACK PAIN, ENDOMETRIOSIS, EPIPLOIC APPENDAGITIS, GENITAL HAEMORRHAGE, IRRITABILITY AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT UNDERWENT AN OPERATIVE LAPAROSCOPY, BILATERAL SALPINGECTOMY WITH CORNEAL RESECTION, REMOVAL ESSURE DEVICES, EXCISION ENDOMETRIOSIS AND EXCISION OF BOWEL EPIPLOICA NODULE ON (B)(6) 2017. DIAGNOSTIC RESULTS: (B)(6) 2013 : HYSTEROSALPINGOGRAM : ESSURE WIRES PRESENT IN THE REGION OF THE FALLOPIAN TUBES BILATERALLY. 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 |
|---|---|---|---|---|---|---|---|
| 839680 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 50658291,901333 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Hospitalization| O| R| S | CELEXA.| CELEXA.| CELEXA.| LAMICTAL.| LAMICTAL.| LAMICTAL.| LAMICTAL.| LAMICTAL.| LAMICTAL.| LYRICA.| LYRICA.| LYRICA.| LYRICA.| LYRICA.| NEURONTIN.| NEURONTIN.| NEURONTIN.| NEURONTIN.| NEURONTIN.| NEURONTIN.| OTHER THERAPEUTIC PRODUCTS.| OTHER THERAPEUTIC PRODUCTS.| OTHER THERAPEUTIC PRODUCTS.| TRAMADOL.| TRAMADOL.| TRAMADOL.| TRAMADOL.| TRAMADOL.| TRAMADOL.| XANAX.| XANAX.| XANAX.| XANAX.| XANAX.| XANAX. |