ESSURE
Report
- Report Number
- 2951250-2019-02533
- Event Type
- Injury
- Date Received
- June 5, 2019
- Date of Event
- January 1, 2012
- Report Date
- February 17, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN'), MENORRHAGIA ('MENORRHAGIA') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED TWIN PREGNANCY, GENERALIZED ANXIETY DISORDER, CHOLECYSTECTOMY, TONSILLECTOMY, MOTOR VEHICLE ACCIDENT AND CESAREAN SECTION. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, PSYCHOSIS, TOBACCO ABUSE, MAJOR DEPRESSION, BIPOLAR DISORDER, CHEST PAIN, SHORTNESS OF BREATH, DYSPHAGIA, VISUAL DISTURBANCE, PALPITATIONS, DIZZINESS, DROOLING, BRONCHITIS AND FLU. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM, BISMUTH SUBSALICYLATE, BUSPIRONE, CITALOPRAM, HYDROCODONE, HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN), IBUPROFEN, LABETALOL, OLANZAPINE, OXYCODONE AND PARACETAMOL (ACETAMINOPHEN). IN 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSPAREUNIA ("DYSPAREUNIA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), DEPRESSION ("DEPRESSION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 1 YEAR 5 MONTHS AFTER INSERTION OF ESSURE. IN (B)(6)2013, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND EXPERIENCED FATIGUE ("FATIGUE"), PALPITATIONS ("OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: HEART PALPITATIONS"), HYPOTENSION ("LOW BLOOD PRESSURE"), VITAMIN B COMPLEX DEFICIENCY ("VITAMIN B DEFICIENT"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ABDOMINAL DISTENSION ("BLOATING"), CYSTITIS ("BLADDER INFECTION") AND URINARY TRACT INFECTION ("UTI"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL DISCHARGE, CYSTITIS AND URINARY TRACT INFECTION HAD RESOLVED, THE GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, HYPERSENSITIVITY, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, HORMONE LEVEL ABNORMAL, NAUSEA, FATIGUE, WEIGHT INCREASED, HYPOTENSION, VITAMIN B COMPLEX DEFICIENCY, ALOPECIA, ABDOMINAL PAIN AND DYSPAREUNIA OUTCOME WAS UNKNOWN AND THE MIGRAINE, HEADACHE, ANXIETY, DEPRESSION, PALPITATIONS AND ABDOMINAL DISTENSION WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, ANXIETY, CYSTITIS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, HYPOTENSION, MENORRHAGIA, MIGRAINE, NAUSEA, PALPITATIONS, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VITAMIN B COMPLEX DEFICIENCY AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULT: TOTAL BILATERAL OCCLUSION.. PATHOLOGY TEST - ON (B)(6) 2014: RESULT: FINAL DIAGNOSIS UTERUS, CERVIX, HYSTERECTOMY: - CHRONIC CERVICITIS AND SQUAMOUS METAPLASIA UTERUS, ENDOMETRIUM, HYSTERECTOMY: - FEATURES CONSISTENT WITH PRIOR ENDOMETRIAL ABLATION UTERUS, MYOMETRIUM, HYSTERECTOMY: - NO HISTOPATHOLOGIC ABNORMALITY UTERUS, SEROSA, HYSTERECTOMY: - FIBROFATTY ADHESIONS FALLOPIAN TUBES, BILATERAL, SALPINGECTOMY: - PARATUBAL CYST MICROSCOPIC DESCRIPTION: HISTOLOGIC SECTIONS OF THE CERVIX SHOW MILD CHRONIC INFLAMMATION AND SQUAMOUS METAPLASIA. THERE IS NO EVIDENCE DYSPLASIA OR MALIGNANCY. THE ENDOMETRIUM SHOWS ELASTOTIC SCAR CONSISTENT WITH PRIOR ENDOMETRIAL ABLATION. THE MYOMETRIUM SHOWS NO HISTOPATHOLOGIC ABNORMALITY. THERE ARE SEROSAL FIBROFATTY ADHESIONS. THERE IS NO EVIDENCE OF MALIGNANCY. HISTOLOGIC SECTIONS OF THE RIGHT FALLOPIAN TUBE SHOW A BENIGN PARATUBAL CYST. THE LEFT FALLOPIAN TUBE SHOWS NO HISTOPATHOLOGIC ABNORMALITY.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORD: PELVIC PAIN, ANXIETY, ABDOMINAL PAIN, NAUSEA, FATIGUE, DEPRESSION AND HEADACHE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2019: PFS RECEIVED : EVENTS ADDED- DYSPAREUNIA, UTI, BLADDER INFECTION. EVENTS OUTCOME UPDATED. EVENTS ONSET DATE AND EVENTS SEVERITY 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-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 PELVIC PAIN ('PAIN') AND MENORRHAGIA ('MENORRHAGIA') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED TWIN PREGNANCY, GENERALIZED ANXIETY DISORDER, CHOLECYSTECTOMY, TONSILLECTOMY, MOTOR VEHICLE ACCIDENT AND CESAREAN SECTION. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, PSYCHOSIS, TOBACCO ABUSE, MAJOR DEPRESSION, BIPOLAR DISORDER, CHEST PAIN, SHORTNESS OF BREATH, DYSPHAGIA, VISUAL DISTURBANCE, PALPITATIONS, DIZZINESS, DROOLING, BRONCHITIS AND FLU. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM, BISMUTH SUBSALICYLATE, BUSPIRONE, CITALOPRAM, HYDROCODONE, HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN), IBUPROFEN, LABETALOL, OLANZAPINE, OXYCODONE AND PARACETAMOL (ACETAMINOPHEN). IN 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") AND HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 1 YEAR 5 MONTHS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), DEPRESSION ("DEPRESSION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2013, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND EXPERIENCED FATIGUE ("FATIGUE"), PALPITATIONS ("OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: HEART PALPITATIONS"), HYPOTENSION ("LOW BLOOD PRESSURE"), VITAMIN B COMPLEX DEFICIENCY ("VITAMIN B DEFICIENT"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ABDOMINAL DISTENSION ("BLOATING"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("UTI") AND MOOD SWINGS ("MOOD SWINGS"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND BILATERAL SALPINGECTOMY, HYSTERECTOMY (FULL)). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL DISCHARGE, CYSTITIS AND URINARY TRACT INFECTION HAD RESOLVED, THE GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, HYPERSENSITIVITY, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, HORMONE LEVEL ABNORMAL, NAUSEA, FATIGUE, WEIGHT INCREASED, HYPOTENSION, VITAMIN B COMPLEX DEFICIENCY, ALOPECIA, ABDOMINAL PAIN, DYSPAREUNIA AND MOOD SWINGS OUTCOME WAS UNKNOWN AND THE MIGRAINE, HEADACHE, ANXIETY, DEPRESSION, PALPITATIONS AND ABDOMINAL DISTENSION WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, ANXIETY, CYSTITIS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, HYPOTENSION, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, PALPITATIONS, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VITAMIN B COMPLEX DEFICIENCY AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULT: TOTAL BILATERAL OCCLUSION.. PATHOLOGY TEST - ON (B)(6) 2014: RESULT: FINAL DIAGNOSIS UTERUS, CERVIX, HYSTERECTOMY: CHRONIC CERVICITIS AND SQUAMOUS METAPLASIA UTERUS, ENDOMETRIUM, HYSTERECTOMY: FEATURES CONSISTENT WITH PRIOR ENDOMETRIAL ABLATION UTERUS, MYOMETRIUM, HYSTERECTOMY: NO HISTOPATHOLOGIC ABNORMALITY UTERUS, SEROSA, HYSTERECTOMY: FIBROFATTY ADHESIONS FALLOPIAN TUBES, BILATERAL, SALPINGECTOMY: PARATUBAL CYST MICROSCOPIC DESCRIPTION: HISTOLOGIC SECTIONS OF THE CERVIX SHOW MILD CHRONIC INFLAMMATION AND SQUAMOUS METAPLASIA. THERE IS NO EVIDENCE DYSPLASIA OR MALIGNANCY. THE ENDOMETRIUM SHOWS ELASTOTIC SCAR CONSISTENT WITH PRIOR ENDOMETRIAL ABLATION. THE MYOMETRIUM SHOWS NO HISTOPATHOLOGIC ABNORMALITY. THERE ARE SEROSAL FIBROFATTY ADHESIONS. THERE IS NO EVIDENCE OF MALIGNANCY. HISTOLOGIC SECTIONS OF THE RIGHT FALLOPIAN TUBE SHOW A BENIGN PARATUBAL CYST. THE LEFT FALLOPIAN TUBE SHOWS NO HISTOPATHOLOGIC ABNORMALITY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORD: PELVIC PAIN, ANXIETY, ABDOMINAL PAIN, NAUSEA, FATIGUE, DEPRESSION AND HEADACHE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-JAN-2020: PFS RECEIVED. NEW EVENT MOOD SWINGS WAS ADDED. EVENT ONSET DATE WAS UPDATED. A TECHNICAL INVESTIGATION WILL BE 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 ('PAIN'), MENORRHAGIA ('MENORRHAGIA') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED TWIN PREGNANCY, GENERALIZED ANXIETY DISORDER, CHOLECYSTECTOMY, TONSILLECTOMY, MOTOR VEHICLE ACCIDENT AND CESAREAN SECTION. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, PSYCHOSIS, TOBACCO ABUSE, MAJOR DEPRESSION, BIPOLAR DISORDER, CHEST PAIN, SHORTNESS OF BREATH, DYSPHAGIA, VISUAL DISTURBANCE, PALPITATIONS, DIZZINESS AND DROOLING. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM, BISMUTH SUBSALICYLATE, BUSPIRONE, CITALOPRAM, HYDROCODONE, HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN), IBUPROFEN, LABETALOL, OLANZAPINE, OXYCODONE AND PARACETAMOL (ACETAMINOPHEN). IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), NAUSEA ("NAUSEA"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), DEPRESSION ("DEPRESSION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON 4-NOV-2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), FATIGUE ("FATIGUE"), PALPITATIONS ("OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: HEART PALPITATIONS"), HYPOTENSION ("LOW BLOOD PRESSURE"), VITAMIN B COMPLEX DEFICIENCY ("VITAMIN B DEFICIENT"), ALOPECIA ("HAIR LOSS"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND ABDOMINAL DISTENSION ("BLOATING") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, HYPERSENSITIVITY, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, HORMONE LEVEL ABNORMAL, MIGRAINE, HEADACHE, NAUSEA, DEPRESSION, FATIGUE, WEIGHT INCREASED, VAGINAL DISCHARGE, HYPOTENSION, VITAMIN B COMPLEX DEFICIENCY, ALOPECIA AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE ANXIETY, PALPITATIONS AND ABDOMINAL DISTENSION WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, ANXIETY, DEPRESSION, DYSMENORRHOEA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, HYPOTENSION, MENORRHAGIA, MIGRAINE, NAUSEA, PALPITATIONS, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VITAMIN B COMPLEX DEFICIENCY AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULT: TOTAL BILATERAL OCCLUSION. PATHOLOGY TEST - ON 16-DEC-2014: RESULT: FINAL DIAGNOSIS UTERUS, CERVIX, HYSTERECTOMY: CHRONIC CERVICITIS AND SQUAMOUS METAPLASIA. UTERUS, ENDOMETRIUM, HYSTERECTOMY: FEATURES CONSISTENT WITH PRIOR ENDOMETRIAL ABLATION. UTERUS, MYOMETRIUM, HYSTERECTOMY: NO HISTOPATHOLOGIC ABNORMALITY. UTERUS, SEROSA, HYSTERECTOMY: FIBROFATTY ADHESIONS. FALLOPIAN TUBES, BILATERAL, SALPINGECTOMY: PARATUBAL CYST. MICROSCOPIC DESCRIPTION: HISTOLOGIC SECTIONS OF THE CERVIX SHOW MILD CHRONIC INFLAMMATION AND SQUAMOUS METAPLASIA. THERE IS NO EVIDENCE DYSPLASIA OR MALIGNANCY. THE ENDOMETRIUM SHOWS ELASTOTIC SCAR CONSISTENT WITH PRIOR ENDOMETRIAL ABLATION. THE MYOMETRIUM SHOWS NO HISTOPATHOLOGIC ABNORMALITY. THERE ARE SEROSAL FIBROFATTY ADHESIONS. THERE IS NO EVIDENCE OF MALIGNANCY. HISTOLOGIC SECTIONS OF THE RIGHT FALLOPIAN TUBE SHOW A BENIGN PARATUBAL CYST. THE LEFT FALLOPIAN TUBE SHOWS NO HISTOPATHOLOGIC ABNORMALITY.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORD: PELVIC PAIN, ANXIETY, ABDOMINAL PAIN, NAUSEA, FATIGUE, DEPRESSION AND HEADACHE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-JUN-2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLIANT. 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-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 PELVIC PAIN ('PAIN'), MENORRHAGIA ('MENORRHAGIA') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED TWIN PREGNANCY, GENERALIZED ANXIETY DISORDER, CHOLECYSTECTOMY, TONSILLECTOMY, MOTOR VEHICLE ACCIDENT AND CESAREAN SECTION. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, PSYCHOSIS, TOBACCO ABUSE, MAJOR DEPRESSION, BIPOLAR DISORDER, CHEST PAIN, SHORTNESS OF BREATH, DYSPHAGIA, VISUAL DISTURBANCE, PALPITATIONS, DIZZINESS AND DROOLING. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM, BISMUTH SUBSALICYLATE, BUSPIRONE, CITALOPRAM, HYDROCODONE, HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN), IBUPROFEN, LABETALOL, OLANZAPINE, OXYCODONE AND PARACETAMOL (ACETAMINOPHEN). IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), NAUSEA ("NAUSEA"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), DEPRESSION ("DEPRESSION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), FATIGUE ("FATIGUE"), PALPITATIONS ("OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: HEART PALPITATIONS"), HYPOTENSION ("LOW BLOOD PRESSURE"), VITAMIN B COMPLEX DEFICIENCY ("VITAMIN B DEFICIENT"), ALOPECIA ("HAIR LOSS"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND ABDOMINAL DISTENSION ("BLOATING") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, HYPERSENSITIVITY, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, HORMONE LEVEL ABNORMAL, MIGRAINE, HEADACHE, NAUSEA, DEPRESSION, FATIGUE, WEIGHT INCREASED, VAGINAL DISCHARGE, HYPOTENSION, VITAMIN B COMPLEX DEFICIENCY, ALOPECIA AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE ANXIETY, PALPITATIONS AND ABDOMINAL DISTENSION WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, ANXIETY, DEPRESSION, DYSMENORRHOEA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, HYPOTENSION, MENORRHAGIA, MIGRAINE, NAUSEA, PALPITATIONS, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VITAMIN B COMPLEX DEFICIENCY AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULT: TOTAL BILATERAL OCCLUSION.. PATHOLOGY TEST - ON 16-DEC-2014: RESULT: FINAL DIAGNOSIS UTERUS, CERVIX, HYSTERECTOMY: CHRONIC CERVICITIS AND SQUAMOUS METAPLASIA. UTERUS, ENDOMETRIUM, HYSTERECTOMY: FEATURES CONSISTENT WITH PRIOR ENDOMETRIAL ABLATION. UTERUS, MYOMETRIUM, HYSTERECTOMY: NO HISTOPATHOLOGIC ABNORMALITY. UTERUS, SEROSA, HYSTERECTOMY: FIBROFATTY ADHESIONS. FALLOPIAN TUBES, BILATERAL, SALPINGECTOMY: PARATUBAL CYST. MICROSCOPIC DESCRIPTION: HISTOLOGIC SECTIONS OF THE CERVIX SHOW MILD CHRONIC INFLAMMATION AND SQUAMOUS METAPLASIA. THERE IS NO EVIDENCE DYSPLASIA OR MALIGNANCY. THE ENDOMETRIUM SHOWS ELASTOTIC SCAR CONSISTENT WITH PRIOR ENDOMETRIAL ABLATION. THE MYOMETRIUM SHOWS NO HISTOPATHOLOGIC ABNORMALITY. THERE ARE SEROSAL FIBROFATTY ADHESIONS. THERE IS NO EVIDENCE OF MALIGNANCY. HISTOLOGIC SECTIONS OF THE RIGHT FALLOPIAN TUBE SHOW A BENIGN PARATUBAL CYST. THE LEFT FALLOPIAN TUBE SHOWS NO HISTOPATHOLOGIC ABNORMALITY.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORD: PELVIC PAIN, ANXIETY, ABDOMINAL PAIN, NAUSEA, FATIGUE, DEPRESSION AND HEADACHE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-JUN-2019: QUALITY SAFETY EVALUATION OF PTC. 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-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 PELVIC PAIN ('PAIN'), MENORRHAGIA ('MENORRHAGIA') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED TWIN PREGNANCY, GENERALIZED ANXIETY DISORDER, CHOLECYSTECTOMY, TONSILLECTOMY, MOTOR VEHICLE ACCIDENT AND CESAREAN SECTION. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, PSYCHOSIS, TOBACCO ABUSE, MAJOR DEPRESSION, BIPOLAR DISORDER, CHEST PAIN, SHORTNESS OF BREATH, DYSPHAGIA, VISUAL DISTURBANCE, PALPITATIONS, DIZZINESS AND DROOLING. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM, BISMUTH SUBSALICYLATE, BUSPIRONE, CITALOPRAM, HYDROCODONE, HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN), IBUPROFEN, LABETALOL, OLANZAPINE, OXYCODONE AND PARACETAMOL (ACETAMINOPHEN). IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), NAUSEA ("NAUSEA"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), DEPRESSION ("DEPRESSION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), FATIGUE ("FATIGUE"), PALPITATIONS ("OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: HEART PALPITATIONS"), HYPOTENSION ("LOW BLOOD PRESSURE"), VITAMIN B COMPLEX DEFICIENCY ("VITAMIN B DEFICIENT"), ALOPECIA ("HAIR LOSS"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND ABDOMINAL DISTENSION ("BLOATING") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, HYPERSENSITIVITY, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, HORMONE LEVEL ABNORMAL, MIGRAINE, HEADACHE, NAUSEA, DEPRESSION, FATIGUE, WEIGHT INCREASED, VAGINAL DISCHARGE, HYPOTENSION, VITAMIN B COMPLEX DEFICIENCY, ALOPECIA AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE ANXIETY, PALPITATIONS AND ABDOMINAL DISTENSION WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, ANXIETY, DEPRESSION, DYSMENORRHOEA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, HYPOTENSION, MENORRHAGIA, MIGRAINE, NAUSEA, PALPITATIONS, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VITAMIN B COMPLEX DEFICIENCY AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULT: TOTAL BILATERAL OCCLUSION.. PATHOLOGY TEST - ON (B)(6) 2014: RESULT: FINAL DIAGNOSIS: UTERUS, CERVIX, HYSTERECTOMY: - CHRONIC CERVICITIS AND SQUAMOUS METAPLASIA. UTERUS, ENDOMETRIUM, HYSTERECTOMY: FEATURES CONSISTENT WITH PRIOR ENDOMETRIAL ABLATION. UTERUS, MYOMETRIUM, HYSTERECTOMY: NO HISTOPATHOLOGIC ABNORMALITY. UTERUS, SEROSA, HYSTERECTOMY: FIBROFATTY ADHESIONS. FALLOPIAN TUBES, BILATERAL, SALPINGECTOMY: PARATUBAL CYST. MICROSCOPIC DESCRIPTION: HISTOLOGIC SECTIONS OF THE CERVIX SHOW MILD CHRONIC INFLAMMATION AND SQUAMOUS METAPLASIA. THERE IS NO EVIDENCE DYSPLASIA OR MALIGNANCY. THE ENDOMETRIUM SHOWS ELASTOTIC SCAR CONSISTENT WITH PRIOR ENDOMETRIAL ABLATION. THE MYOMETRIUM SHOWS NO HISTOPATHOLOGIC ABNORMALITY. THERE ARE SEROSAL FIBROFATTY ADHESIONS. THERE IS NO EVIDENCE OF MALIGNANCY. HISTOLOGIC SECTIONS OF THE RIGHT FALLOPIAN TUBE SHOW A BENIGN PARATUBAL CYST. THE LEFT FALLOPIAN TUBE SHOWS NO HISTOPATHOLOGIC ABNORMALITY.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORD: PELVIC PAIN, ANXIETY, ABDOMINAL PAIN, NAUSEA, FATIGUE, DEPRESSION AND HEADACHE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-MAY-2019: PFS RECEIVED. ESSURE LOT NUMBER ADDED. PREVIOUSLY REPORTED EVENT INJURY WAS UPDATED TO PAIN. RACE ADDED. PRODUCT INDICATION UPDATED. ESSURE EXPLANT DATE ADDED. FOLLOWING EVENTS WERE ADDED: ABNORMAL BLEEDING (GENERAL), ABNORMAL BLEEDING (VAGINAL), MENORRHAGIA, ALLERGIC OR HYPERSENSITIVITY REACTION, APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), DYSMENORRHEA (CRAMPING), HORMONAL CHANGES, MIGRAINES, HEADACHES, NAUSEA, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY, DEPRESSION, FATIGUE, WEIGHT GAIN, VAGINAL DISCHARGE, OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: HEART PALPITATIONS, LOW BLOOD PRESSURE, VITAMIN B DEFICIENT, HAIR LOSS, ABDOMINAL PAIN AND BLOATING. . EVENT OUTCOME ADDED FOR: PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY, BLOATING AND OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: HEART PALPITATIONS. MEDICAL HISTORY AND LAB DATA WERE ADDED. REPORTERS ADDED. CONCOMITANT MEDICATIONS 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-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 465751 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 880431 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ALPRAZOLAM| ALPRAZOLAM| ALPRAZOLAM| ALPRAZOLAM| ALPRAZOLAM| BISMUTH SUBSALICYLATE| BISMUTH SUBSALICYLATE| BISMUTH SUBSALICYLATE| BISMUTH SUBSALICYLATE| BISMUTH SUBSALICYLATE| BUSPIRONE| BUSPIRONE| BUSPIRONE| BUSPIRONE| BUSPIRONE| CITALOPRAM| CITALOPRAM| CITALOPRAM| CITALOPRAM| CITALOPRAM| HYDROCODONE| HYDROCODONE| HYDROCODONE| HYDROCODONE| HYDROCODONE| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| LABETALOL| LABETALOL| LABETALOL| LABETALOL| LABETALOL| OLANZAPINE| OLANZAPINE| OLANZAPINE| OLANZAPINE| OLANZAPINE| OXYCODONE| OXYCODONE| OXYCODONE| OXYCODONE| OXYCODONE| VICODIN| VICODIN| VICODIN| VICODIN| VICODIN| ACETAMINOPHEN| ALPRAZOLAM| BISMUTH SUBSALICYLATE| BUSPIRONE| CITALOPRAM| HYDROCODONE| IBUPROFEN| LABETALOL| OLANZAPINE| OXYCODONE| VICODIN |