ESSURE
Report
- Report Number
- 2951250-2017-06537
- Event Type
- Injury
- Date Received
- November 15, 2017
- Date of Event
- June 1, 2012
- Report Date
- January 28, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- 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 ("PELVIC PAIN / PAIN"), GENITAL HAEMORRHAGE ("BLEEDING/SPOTTING") AND MAJOR DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEM (MAJOR DEPRESSION)") IN A 49-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED HYPOTHYROIDISM, ARTHROSCOPY, OOPHORECTOMY, OSTEOARTHRITIS, OVARIAN CYSTECTOMY AND COLONOSCOPY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: LEVITHYROXINE. CONCURRENT CONDITIONS INCLUDED OBESITY, URINARY INCONTINENCE, FIBROIDS, ADENOMYOSIS, PERIMENOPAUSE, GROIN PAIN, TASTE METALLIC, FEELING SICK, HOT FLUSH, CERVICAL POLYP AND OSTEOLYTIC LESION. CONCOMITANT PRODUCTS INCLUDED TRAZODONE AND VENLAFAXINE (EFFEXOR). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED MAJOR DEPRESSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND FATIGUE ("FATIGUE"). IN (B)(6) 2012, THE PATIENT EXPERIENCED SOMNOLENCE ("HORMONAL CHANGES (SLEPT ALL THE TIME)"), MOOD ALTERED ("HORMONAL CHANGES (SLEPT ALL THE TIME, MOOD, WEIGHT CHANGES)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("MENORRHAGIA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) 2013, 8 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). IN 2017, THE PATIENT EXPERIENCED AMNESIA ("MEMORY LOSS"), SLOW SPEECH ("SPEECH IS SLOW") AND VISUAL IMPAIRMENT ("EYE SIGHT IS WORSE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), NIGHT SWEATS ("NIGHT SWEATS"), LOSS OF LIBIDO ("LOST LIBIDO"), THE FIRST EPISODE OF DYSPAREUNIA ("PAINFUL INTERCOURSE"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), RASH MACULAR ("RASHES OR SKIN CONDITIONS (BLOTCHY SKIN, RED SPOTS)"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), ALLERGY TO METALS ("NICKEL ALLERGY"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), THE SECOND EPISODE OF DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VISION BLURRED ("VISION/EYE PROBLEMS (BLURRED, EYES STRAINED)"), ASTHENOPIA ("VISION/EYE PROBLEMS (BLURRED, EYES STRAINED)"), WEIGHT INCREASED ("WEIGHT GAIN"), ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION (BLOATED, CONSTIPATION)"), CONSTIPATION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION (BLOATED, CONSTIPATION)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ARTHRALGIA ("KNEES PAIN") AND PAIN IN EXTREMITY ("LEGS PAIN"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2016: HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, OOPHERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MAJOR DEPRESSION, NIGHT SWEATS, LOSS OF LIBIDO, SOMNOLENCE, MOOD ALTERED, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, RASH MACULAR, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, NAUSEA, TOOTH DISORDER, AMNESIA, SLOW SPEECH, VISUAL IMPAIRMENT, ALLERGY TO METALS, THE LAST EPISODE OF DYSPAREUNIA, VAGINAL DISCHARGE, VISION BLURRED, ASTHENOPIA, FATIGUE, WEIGHT INCREASED, ABDOMINAL DISTENSION, CONSTIPATION AND ALOPECIA OUTCOME WAS UNKNOWN, THE DYSMENORRHOEA HAD NOT RESOLVED AND THE ABDOMINAL PAIN, ARTHRALGIA AND PAIN IN EXTREMITY HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, AMNESIA, ARTHRALGIA, ASTHENOPIA, BLADDER DISORDER, CONSTIPATION, DYSMENORRHOEA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, LOSS OF LIBIDO, MAJOR DEPRESSION, MENORRHAGIA, MIGRAINE, MOOD ALTERED, NAUSEA, NIGHT SWEATS, PAIN IN EXTREMITY, PELVIC PAIN, RASH MACULAR, SLOW SPEECH, SOMNOLENCE, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VISION BLURRED, VISUAL IMPAIRMENT, WEIGHT INCREASED, THE FIRST EPISODE OF DYSPAREUNIA AND THE SECOND EPISODE OF DYSPAREUNIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD NEED FOR ADDITIONAL SURGERY CURRENT WEIGHT 190 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. PATHOLOGY TEST - ON (B)(6) 2016: MUCINOUS DEBRIS AND DETACHED FRAGMENTS. ON (B)(6) 2016 SURGICAL PATHOLOGY TEST WAS PERFORMED HAVING RESULT CERVICAL POLYP, POLYPECTOMY: MUCINOUS DEBRIS AND DETACHED FRAGMENTS OF BENIGN SQUAMOUS EPITHELIUM. NEGATIVE FOR DIAGNOSTIC CERVICAL POLYP. NEGATIVE FOR DIAGNOSTIC MALIGNANCY. UTERUS AND BILATERAL FALLOPIAN TUBES, HYSTERECTOMY AND BILATERAL SALPINGECTOMY: CERVIX: NABOTHIAN CYSTS, NEGATIVE FOR DIAGNOSTIC MALIGNANCY. UTERUS: BENIGN ENDOMETRIUM, ADENOMYOSIS, NEGATIVE FOR DIAGNOSTIC ENDOMETRIAL HYPERPLASIA AND MALIGNANCY. BILATERAL FALLOPIAN TUBES: NEGATIVE FOR DIAGNOSTIC MALIGNANCY. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD; DEPRESSION, DYSMENORRHEA, PELVIC PAIN, LEG PAIN, NAUSEA, ABNORMAL VAGINAL BLEEDING, DYSPAREUNIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-JUL-2018: CORRECTION FOLLOWING COMPANY INTERNAL CODING REVIEW. THE EVENT "LEGS AND KNEES PAIN" WAS SPLITTED IN ORDER TO CAPTURE "ARTHRALGIA" CONCEPT. 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 ("PELVIC PAIN / PAIN"), GENITAL HAEMORRHAGE ("BLEEDING/SPOTTING") AND MAJOR DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEM (MAJOR DEPRESSION)") IN A 49-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED HYPOTHYROIDISM, ARTHROSCOPY, OOPHORECTOMY, OSTEOARTHRITIS, OVARIAN CYSTECTOMY AND COLONOSCOPY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: LEVITHYROXINE. CONCURRENT CONDITIONS INCLUDED OBESITY, URINARY INCONTINENCE, FIBROIDS, ADENOMYOSIS, PERIMENOPAUSE, GROIN PAIN, TASTE METALLIC, FEELING SICK, HOT FLUSH, CERVICAL POLYP AND OSTEOLYTIC LESION. CONCOMITANT PRODUCTS INCLUDED TRAZODONE AND VENLAFAXINE (EFFEXOR). IN (B)(6) 2012, THE PATIENT EXPERIENCED MAJOR DEPRESSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND FATIGUE ("FATIGUE"). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED SOMNOLENCE ("HORMONAL CHANGES (SLEPT ALL THE TIME)"), MOOD ALTERED ("HORMONAL CHANGES (SLEPT ALL THE TIME, MOOD, WEIGHT CHANGES)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("MENORRHAGIA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) 2013, 8 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). IN 2017, THE PATIENT EXPERIENCED AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS (MEMORY LOSS, SPEECH IS SLOW, EYE SIGHT IS WORSE)"), SLOW SPEECH ("NEUROLOGICAL CONDITIONS OR PROBLEMS (MEMORY LOSS, SPEECH IS SLOW, EYE SIGHT IS WORSE)") AND VISUAL IMPAIRMENT ("NEUROLOGICAL CONDITIONS OR PROBLEMS (MEMORY LOSS, SPEECH IS SLOW, EYE SIGHT IS WORSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), NIGHT SWEATS ("NIGHT SWEATS"), LOSS OF LIBIDO ("LOST LIBIDO"), THE FIRST EPISODE OF DYSPAREUNIA ("PAINFUL INTERCOURSE"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), RASH MACULAR ("RASHES OR SKIN CONDITIONS (BLOTCHY SKIN, RED SPOTS)"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), ALLERGY TO METALS ("NICKEL ALLERGY"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), THE SECOND EPISODE OF DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VISION BLURRED ("VISION/EYE PROBLEMS (BLURRED, EYES STRAINED)"), ASTHENOPIA ("VISION/EYE PROBLEMS (BLURRED, EYES STRAINED)"), WEIGHT INCREASED ("WEIGHT GAIN"), ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION (BLOATED, CONSTIPATION)"), CONSTIPATION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION (BLOATED, CONSTIPATION)"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND PAIN IN EXTREMITY ("LEGS AND KNEES PAIN"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2016: HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, OOPHERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MAJOR DEPRESSION, NIGHT SWEATS, LOSS OF LIBIDO, SOMNOLENCE, MOOD ALTERED, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, RASH MACULAR, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, NAUSEA, TOOTH DISORDER, AMNESIA, SLOW SPEECH, VISUAL IMPAIRMENT, ALLERGY TO METALS, THE LAST EPISODE OF DYSPAREUNIA, VAGINAL DISCHARGE, VISION BLURRED, ASTHENOPIA, FATIGUE, WEIGHT INCREASED, ABDOMINAL DISTENSION, CONSTIPATION AND ALOPECIA OUTCOME WAS UNKNOWN, THE DYSMENORRHOEA HAD NOT RESOLVED AND THE ABDOMINAL PAIN AND PAIN IN EXTREMITY HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, AMNESIA, ASTHENOPIA, BLADDER DISORDER, CONSTIPATION, DYSMENORRHOEA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, LOSS OF LIBIDO, MAJOR DEPRESSION, MENORRHAGIA, MIGRAINE, MOOD ALTERED, NAUSEA, NIGHT SWEATS, PAIN IN EXTREMITY, PELVIC PAIN, RASH MACULAR, SLOW SPEECH, SOMNOLENCE, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VISION BLURRED, VISUAL IMPAIRMENT, WEIGHT INCREASED, THE FIRST EPISODE OF DYSPAREUNIA AND THE SECOND EPISODE OF DYSPAREUNIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD NEED FOR ADDITIONAL SURGERY CURRENT WEIGHT 190 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. PATHOLOGY TEST - ON (B)(6) 2016: MUCINOUS DEBRIS AND DETACHED FRAGMENTS ON (B)(6) 2016 SURGICAL PATHOLOGY TEST WAS PERFORMED HAVING RESULT CERVICAL POLYP, POLYPECTOMY: MUCINOUS DEBRIS AND DETACHED FRAGMENTS OF BENIGN SQUAMOUS EPITHELIUM. NEGATIVE FOR DIAGNOSTIC CERVICAL POLYP. NEGATIVE FOR DIAGNOSTIC MALIGNANCY. UTERUS AND BILATERAL FALLOPIAN TUBES, HYSTERECTOMY AND BILATERAL SALPINGECTOMY: CERVIX: NABOTHIAN CYSTS, NEGATIVE FOR DIAGNOSTIC MALIGNANCY. UTERUS: BENIGN ENDOMETRIUM, ADENOMYOSIS, NEGATIVE FOR DIAGNOSTIC ENDOMETRIAL HYPERPLASIA AND MALIGNANCY. BILATERAL FALLOPIAN TUBES: NEGATIVE FOR DIAGNOSTIC MALIGNANCY. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD; DEPRESSION, DYSMENORRHEA, PELVIC PAIN, LEG PAIN, NAUSEA, ABNORMAL VAGINAL BLEEDING, DYSPAREUNIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-JUN-2018: FROM PFS EVENTS " SLEPT ALL THE TIME, MOOD, ABNORMAL BLEEDING (VAGINAL), MENORRHAGIA ,APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),MAJOR DEPRESSION, BLOTCHY SKIN, RED SPOTS, BLADDER OR URINARY PROBLEMS OR CHANGES, MIGRAINES / HEADACHES, NAUSEA ,DENTAL PROBLEMS, MEMORY LOSS, SPEECH IS SLOW, EYE SIGHT IS WORSE, NICKEL ALLERGY, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), VAGINAL DISCHARGE, VISION/EYE PROBLEMS (BLURRED, EYES STRAINED), FATIGUE, WEIGHT GAIN, BLOATED, CONSTIPATION, HAIR LOSS, ABDOMINAL PAIN , LEGS AND KNEE PAIN" ARE ADDED. LOT NUMBER ADDED. PATIENT, REPORTER AND PRODUCT INFORMATION ARE ADDED. CONCOMITANT AND HISTORICAL CONDITION ARE ADDED FROM MEDICAL RECORD. OUTCOME OF EVENTS " DYSMENORRHEA" IS NOT RECOVERED/ NOT RESOLVED. CONCOMITANT DRUG ARE 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 ("PELVIC PAIN / PAIN"), GENITAL HAEMORRHAGE ("BLEEDING/SPOTTING") AND MAJOR DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEM (MAJOR DEPRESSION)") IN A 49-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED HYPOTHYROIDISM, ARTHROSCOPY, OOPHORECTOMY, OSTEOARTHRITIS, OVARIAN CYSTECTOMY AND COLONOSCOPY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: LEVITHYROXINE. CONCURRENT CONDITIONS INCLUDED OBESITY, URINARY INCONTINENCE, FIBROIDS, ADENOMYOSIS, PERIMENOPAUSE, GROIN PAIN, TASTE METALLIC, FEELING SICK, HOT FLUSH, CERVICAL POLYP AND OSTEOLYTIC LESION. CONCOMITANT PRODUCTS INCLUDED TRAZODONE AND VENLAFAXINE (EFFEXOR). IN JUNE 2012, THE PATIENT EXPERIENCED MAJOR DEPRESSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND FATIGUE ("FATIGUE"). ON 20-JUN-2012, THE PATIENT HAD ESSURE INSERTED. IN JULY 2012, THE PATIENT EXPERIENCED SOMNOLENCE ("HORMONAL CHANGES (SLEPT ALL THE TIME)"), MOOD ALTERED ("HORMONAL CHANGES (SLEPT ALL THE TIME, MOOD, WEIGHT CHANGES)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("MENORRHAGIA"). IN SEPTEMBER 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) 2013, 8 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). IN 2017, THE PATIENT EXPERIENCED AMNESIA ("MEMORY LOSS"), SLOW SPEECH ("SPEECH IS SLOW") AND VISUAL IMPAIRMENT ("EYE SIGHT IS WORSE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), NIGHT SWEATS ("NIGHT SWEATS"), LOSS OF LIBIDO ("LOST LIBIDO"), THE FIRST EPISODE OF DYSPAREUNIA ("PAINFUL INTERCOURSE"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), RASH MACULAR ("RASHES OR SKIN CONDITIONS (BLOTCHY SKIN, RED SPOTS)"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), ALLERGY TO METALS ("NICKEL ALLERGY"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), THE SECOND EPISODE OF DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VISION BLURRED ("VISION/EYE PROBLEMS (BLURRED, EYES STRAINED)"), ASTHENOPIA ("VISION/EYE PROBLEMS (BLURRED, EYES STRAINED)"), WEIGHT INCREASED ("WEIGHT GAIN"), ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION (BLOATED, CONSTIPATION)"), CONSTIPATION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION (BLOATED, CONSTIPATION)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ARTHRALGIA ("KNEES PAIN") AND PAIN IN EXTREMITY ("LEGS PAIN"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2016: HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, OOPHERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MAJOR DEPRESSION, NIGHT SWEATS, LOSS OF LIBIDO, SOMNOLENCE, MOOD ALTERED, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, RASH MACULAR, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, NAUSEA, TOOTH DISORDER, AMNESIA, SLOW SPEECH, VISUAL IMPAIRMENT, ALLERGY TO METALS, THE LAST EPISODE OF DYSPAREUNIA, VAGINAL DISCHARGE, VISION BLURRED, ASTHENOPIA, FATIGUE, WEIGHT INCREASED, ABDOMINAL DISTENSION, CONSTIPATION AND ALOPECIA OUTCOME WAS UNKNOWN, THE DYSMENORRHOEA HAD NOT RESOLVED AND THE ABDOMINAL PAIN, ARTHRALGIA AND PAIN IN EXTREMITY HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, AMNESIA, ARTHRALGIA, ASTHENOPIA, BLADDER DISORDER, CONSTIPATION, DYSMENORRHOEA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, LOSS OF LIBIDO, MAJOR DEPRESSION, MENORRHAGIA, MIGRAINE, MOOD ALTERED, NAUSEA, NIGHT SWEATS, PAIN IN EXTREMITY, PELVIC PAIN, RASH MACULAR, SLOW SPEECH, SOMNOLENCE, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VISION BLURRED, VISUAL IMPAIRMENT, WEIGHT INCREASED, THE FIRST EPISODE OF DYSPAREUNIA AND THE SECOND EPISODE OF DYSPAREUNIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD NEED FOR ADDITIONAL SURGERY CURRENT WEIGHT 190 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32 KG/SQM. HYSTEROSALPINGOGRAM - ON 19-NOV-2012: TOTAL BILATERAL OCCLUSION PATHOLOGY TEST - ON 24-AUG-2016: MUCINOUS DEBRIS AND DETACHED FRAGMENTS ON 24-08-2016 SURGICAL PATHOLOGY TEST WAS PERFORMED HAVING RESULT CERVICAL POLYP, POLYPECTOMY: MUCINOUS DEBRIS AND DETACHED FRAGMENTS OF BENIGN SQUAMOUS EPITHELIUM. - NEGATIVE FOR DIAGNOSTIC CERVICAL POLYP. - NEGATIVE FOR DIAGNOSTIC MALIGNANCY. . UTERUS AND BILATERAL FALLOPIAN TUBES, HYSTERECTOMY AND BILATERAL SALPINGECTOMY: - CERVIX: NABOTHIAN CYSTS, NEGATIVE FOR DIAGNOSTIC MALIGNANCY. - UTERUS: BENIGN ENDOMETRIUM, ADENOMYOSIS, NEGATIVE FOR DIAGNOSTIC ENDOMETRIAL HYPERPLASIA AND MALIGNANCY. - BILATERAL FALLOPIAN TUBES: NEGATIVE FOR DIAGNOSTIC MALIGNANCY. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD; DEPRESSION, DYSMENORRHEA, PELVIC PAIN, LEG PAIN, NAUSEA, ABNORMAL VAGINAL BLEEDING, DYSPAREUNIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-AUG-2018: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT INCIDENT : AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN / PAIN"), GENITAL HAEMORRHAGE ("BLEEDING/SPOTTING") AND MAJOR DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEM (MAJOR DEPRESSION)") IN A 50-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 893037) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPOTHYROIDISM, ARTHROSCOPY, OOPHORECTOMY, OSTEOARTHRITIS, OVARIAN CYSTECTOMY AND COLONOSCOPY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: LEVITHYROXINE. CONCURRENT CONDITIONS INCLUDED OBESITY, URINARY INCONTINENCE, FIBROIDS, ADENOMYOSIS, PERIMENOPAUSE, GROIN PAIN, TASTE METALLIC, FEELING SICK, HOT FLUSH, CERVICAL POLYP AND OSTEOLYTIC LESION. CONCOMITANT PRODUCTS INCLUDED TRAZODONE AND VENLAFAXINE HYDROCHLORIDE (EFFEXOR). ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MAJOR DEPRESSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND FATIGUE ("FATIGUE"). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SOMNOLENCE ("HORMONAL CHANGES (SLEPT ALL THE TIME)"), MOOD ALTERED ("HORMONAL CHANGES (SLEPT ALL THE TIME, MOOD, WEIGHT CHANGES)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), ALLERGY TO METALS ("NICKEL ALLERGY"), THE FIRST EPISODE OF DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VISION BLURRED ("VISION/EYE PROBLEMS (BLURRED, EYES STRAINED)") AND NERVOUS SYSTEM DISORDER ("NEUROLOGICAL CONDITIONS OR PROBLEMS"). ON (B)(6) 2012, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), CONSTIPATION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION (BLOATED, CONSTIPATION)") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2012, THE PATIENT EXPERIENCED RASH MACULAR ("RASHES OR SKIN CONDITIONS (BLOTCHY SKIN, RED SPOTS)"). ON (B)(6) 2013, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"), 8 MONTHS AFTER INSERTION OF ESSURE. IN 2017, THE PATIENT EXPERIENCED AMNESIA ("MEMORY LOSS"), SLOW SPEECH ("SPEECH IS SLOW") AND VISUAL IMPAIRMENT ("EYE SIGHT IS WORSE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED NIGHT SWEATS ("NIGHT SWEATS"), LOSS OF LIBIDO ("LOST LIBIDO"), THE SECOND EPISODE OF DYSPAREUNIA ("PAINFUL INTERCOURSE"), ASTHENOPIA ("VISION/EYE PROBLEMS (BLURRED, EYES STRAINED)"), ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION (BLOATED, CONSTIPATION)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ARTHRALGIA ("KNEES PAIN") AND PAIN IN EXTREMITY ("LEGS PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2016: HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, OOPHERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MAJOR DEPRESSION, NIGHT SWEATS, LOSS OF LIBIDO, THE LAST EPISODE OF DYSPAREUNIA, SOMNOLENCE, MOOD ALTERED, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, RASH MACULAR, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, NAUSEA, TOOTH DISORDER, AMNESIA, SLOW SPEECH, VISUAL IMPAIRMENT, ALLERGY TO METALS, VAGINAL DISCHARGE, VISION BLURRED, ASTHENOPIA, FATIGUE, WEIGHT INCREASED, ABDOMINAL DISTENSION, CONSTIPATION, ALOPECIA AND NERVOUS SYSTEM DISORDER OUTCOME WAS UNKNOWN, THE DYSMENORRHOEA HAD NOT RESOLVED AND THE ABDOMINAL PAIN, ARTHRALGIA AND PAIN IN EXTREMITY HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, AMNESIA, ARTHRALGIA, ASTHENOPIA, BLADDER DISORDER, CONSTIPATION, DYSMENORRHOEA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, LOSS OF LIBIDO, MAJOR DEPRESSION, MENORRHAGIA, MIGRAINE, MOOD ALTERED, NAUSEA, NERVOUS SYSTEM DISORDER, NIGHT SWEATS, PAIN IN EXTREMITY, PELVIC PAIN, RASH MACULAR, SLOW SPEECH, SOMNOLENCE, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VISION BLURRED, VISUAL IMPAIRMENT, WEIGHT INCREASED, THE FIRST EPISODE OF DYSPAREUNIA AND THE SECOND EPISODE OF DYSPAREUNIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD NEED FOR ADDITIONAL SURGERY CURRENT WEIGHT 190 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32 KG/SQM. HYSTEROSALPINGOGRAM: ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. PATHOLOGY TEST: ON (B)(6) 2016: RESULTS: MUCINOUS DEBRIS AND DETACHED FRAGMENTS CERVICAL POLYP, POLYPECTOMY: MUCINOUS DEBRIS AND DETACHED FRAGMENTS OF BENIGN SQUAMOUS EPITHELIUM. NEGATIVE FOR DIAGNOSTIC CERVICAL POLYP. NEGATIVE FOR DIAGNOSTIC MALIGNANCY. UTERUS AND BILATERAL FALLOPIAN TUBES, HYSTERECTOMY AND BILATERAL SALPINGECTOMY: CERVIX: NABOTHIAN CYSTS, NEGATIVE FOR DIAGNOSTIC MALIGNANCY. UTERUS: BENIGN ENDOMETRIUM, ADENOMYOSIS, NEGATIVE FOR DIAGNOSTIC ENDOMETRIAL HYPERPLASIA AND MALIGNANCY. BILATERAL FALLOPIAN TUBES: NEGATIVE FOR DIAGNOSTIC MALIGNANCY. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD; DEPRESSION, DYSMENORRHEA, PELVIC PAIN, LEG PAIN, NAUSEA, ABNORMAL VAGINAL BLEEDING, DYSPAREUNIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-JAN-2019: PFS RECEIVED: EVENT- NEUROLOGICAL CONDITIONS OR PROBLEMS(NEUROLOGICAL DISORDER NOS) WAS ADDED. EVENT ONSET DATE WAS ADDED. DOB WAS UPDATED. 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 ("PELVIC PAIN / PAIN") AND GENITAL HAEMORRHAGE ("BLEEDING/SPOTTING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. 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), NIGHT SWEATS ("NIGHT SWEATS"), LOSS OF LIBIDO ("LOST LIBIDO") AND DYSPAREUNIA ("PAINFUL INTERCOURSE"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, NIGHT SWEATS, LOSS OF LIBIDO AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSPAREUNIA, GENITAL HAEMORRHAGE, LOSS OF LIBIDO, NIGHT SWEATS AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD NEED FOR ADDITIONAL SURGERY. COMPANY CAUSALITY COMMENT . 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 |
|---|---|---|---|---|---|---|---|
| 814298 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 893037 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other| R | EFFEXOR| EFFEXOR| EFFEXOR| EFFEXOR| TRAZODONE| TRAZODONE| TRAZODONE| TRAZODONE |