ESSURE
Report
- Report Number
- 2951250-2017-07839
- Event Type
- Injury
- Date Received
- November 23, 2017
- Report Date
- April 30, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN'), GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING'), MULTIPLE SCLEROSIS ('AUTOIMMUNE DISORDER TYPE OF DISORDER: DIGNOSED WITH MS AND TESTED FOR LUPIS AND FIBROMYALGIA, SUSPECTED MS "FLAIR UP", ONLY MY "MS" WAS A MISDIAGNOSIS FROM HAVING MIRENA YEARS EARLIER / NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MS SYMPTOMS'), MUSCLE RUPTURE ('TORN SHOULDER') AND MYOCARDIAL INFARCTION ('HEART ATTACK BY THIS TIME') IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C06463) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED FIBROMYALGIA, VITAMIN DEFICIENCY, HYPERACUSIS, HYPERMENORRHEA, CHOLECYSTECTOMY, D & C, INNER EAR OPERATION, WISDOM TEETH REMOVAL AND VOCAL TONE DISORDER. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MIRENA IUD FROM 2004 TO NOVEMBER 2013. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, CONSTIPATION, GAIT DISTURBANCE, JOINT PAIN, MUSCULAR WEAKNESS AND MENOMETRORRHAGIA. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE (WELLBUTRIN), CODEINE, MAGNESIUM OXIDE, PREDNISONE AND PREGABALIN (LYRICA). ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN AUGUST 2015, THE PATIENT EXPERIENCED TOOTHACHE ("DENTAL ISSUES/DENTAL PROBLEMS GUM DEGENERATION, NEED COMPLETE GUM GRAPHS OVER ENTIRE MOUTH/PAIN TEETH"), ANXIETY ("ANXIETY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), MEMORY IMPAIRMENT ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: FORGETFULNESS, DEPRESSION, ANXIETY"), ACARODERMATITIS ("NICKEL ALLERGY PHYSICIAN THOUGHT I HAD SCABIES") AND GUM DISORDER ("GUM DEGENERATION NEED COMPLETE GUM GRAPHS OVER ENTIRE MOUTH"). IN SEPTEMBER 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MULTIPLE SCLEROSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PSORIASIS ("RASHES OR SKIN CONDITIONS TYPE: THREE DIFFERENT TYPES OF PSORIASIS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN OCTOBER 2015, THE PATIENT EXPERIENCED VULVOVAGINAL MYCOTIC INFECTION ("YEAST INFECTION/INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: YEAST INFECTIONS"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI'S") AND INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR INCONTINENCE ISSUES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/LOSS (SPECIFY WHICH ONE) GAINED OVER 65 POUNDS"). IN NOVEMBER 2015, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE) STOPPED BEING INTIMATE DUE TO PAIN"), CHRONIC SINUSITIS ("INFECTION (OTHER) DESCRIBE: CHRONIC SINUS INFECTION INABILITY TO HEAL"), PYREXIA ("INFECTION (OTHER) DESCRIBE: CHRONIC SINUS INFECTION INABILITY TO HEAL, FEVERS DAILY"), ALLODYNIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: ALLODYNIA,"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRED VISION"), BACK PAIN ("BACK PAIN"), ARTHRALGIA ("JOINT PAIN"), BONE PAIN ("BONE PAIN/CRANIIAL REGION PAIN"), ASTHENIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: LOSS OF MEMORY / NEUROLOGICAL CONDITIONS OR PROBLEMS- TYPE: LOSS OF STRENGTH"), HYPOAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS- TYPE:NUMBNESS"), PARAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MS SYMPTOMS, ALLODYNIA, LOSS OF MEMORY, NEUROLOGICAL CONDITIONS OR PROBLEMS- TYPE:NUMBNESS, TINGLING, LOSS OF STRENGTH") AND PHARYNGEAL SWELLING ("THROAT CONGESTION"). IN DECEMBER 2015, THE PATIENT WAS FOUND TO HAVE WHITE BLOOD CELL COUNT INCREASED ("BLOOD OR HEART DISORDER/CONDITION TYPE: ELEVATED WBC COUNT") AND EXPERIENCED FATIGUE ("FATIGUE"). IN JANUARY 2016, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES"), MIGRAINE ("MIGRAINES / HEADACHES") AND NAUSEA ("NAUSEA"). ON (B)(6) 2016, THE PATIENT EXPERIENCED GINGIVAL DISORDER ("GUM DETENTION"), 1 YEAR 1 MONTH AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), AMNESIA ("AMNESIA/NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: LOSS OF MEMORY"), TACHYCARDIA ("BLOOD OR HEART DISORDER/CONDITION TYPE: TACHYCARDIA, ELEVATED WBC COUNT"), ALLERGY TO METALS ("NICKEL ALLERGY, NICKEL ALLERGY PHYSICIAN THOUGHT I HAD SCABIES"), MYALGIA ("MUSCLES PAIN"), PAIN OF SKIN ("PAIN SKIN/ALLODYNIA/PSORIASIS"), MUSCLE RUPTURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MYOCARDIAL INFARCTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VERTIGO ("VERTIGO"), DENTAL CARIES ("CAVITY"), IMPAIRED QUALITY OF LIFE ("INTERFERING WITH MY DAILY LIFE AND JOB") AND IMPAIRED HEALING ("INABILITY TO HEAL"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF), VACCINIUM MACROCARPON (CRANBERRY NS), VITAMINS NOS, CAVITY FILLING AND SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HEADACHE, ALOPECIA, TOOTHACHE, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, CHRONIC SINUSITIS, PYREXIA, AMNESIA, MULTIPLE SCLEROSIS, INCONTINENCE, MIGRAINE, TACHYCARDIA, WHITE BLOOD CELL COUNT INCREASED, NAUSEA, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, VISION BLURRED, FATIGUE, WEIGHT INCREASED, BACK PAIN, ARTHRALGIA, ASTHENIA, HYPOAESTHESIA, PARAESTHESIA, ACARODERMATITIS, PAIN OF SKIN, MYOCARDIAL INFARCTION, PHARYNGEAL SWELLING, GINGIVAL DISORDER, VERTIGO, DENTAL CARIES, GUM DISORDER, IMPAIRED QUALITY OF LIFE AND IMPAIRED HEALING OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE, ANXIETY, VULVOVAGINAL MYCOTIC INFECTION, MOOD SWINGS, DEPRESSION, PSORIASIS, ALLODYNIA, BONE PAIN, MEMORY IMPAIRMENT AND MYALGIA HAD RESOLVED AND THE MUSCLE RUPTURE HAD NOT RESOLVED. THE REPORTER CONSIDERED ACARODERMATITIS, ALLERGY TO METALS, ALLODYNIA, ALOPECIA, AMNESIA, ANXIETY, ARTHRALGIA, ASTHENIA, BACK PAIN, BONE PAIN, CHRONIC SINUSITIS, DENTAL CARIES, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, GUM DISORDER, HEADACHE, HYPOAESTHESIA, IMPAIRED QUALITY OF LIFE, INCONTINENCE, MEMORY IMPAIRMENT, MENORRHAGIA, MIGRAINE, MOOD SWINGS, MULTIPLE SCLEROSIS, MUSCLE RUPTURE, MYALGIA, MYOCARDIAL INFARCTION, NAUSEA, PAIN OF SKIN, PARAESTHESIA, PELVIC PAIN, PHARYNGEAL SWELLING, PSORIASIS, PYREXIA, TACHYCARDIA, TOOTHACHE, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VERTIGO, VISION BLURRED, VULVOVAGINAL MYCOTIC INFECTION, WEIGHT INCREASED, WHITE BLOOD CELL COUNT INCREASED AND GINGIVAL DISORDER TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: PATIENT NEED FOR ADDITIONAL SURGERY CROSS REFERENCED WITH PLAINTIFF CASE NUMBER : (B)(4) CURRENT WEIGHT 210 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.8 KG/SQM. HYSTEROSALPINGOGRAM - IN AUGUST 2015: TOTAL BILATERAL OCCLUSION.. PREGNANCY TEST URINE - ON (B)(6) 2015: NEGATIVE.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: YEAST INFECTION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED VIA MEDICAL RECORDS: MIGRAINES, FATIGUE, HEADACHES. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS RECEIVED: LOT NUMBER WAS ADDED. EVENT: MOOD SWINGS, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), UTI'S, YEAST INFECTIONS, APAREUNIA, CHRONIC SINUS INFECTION INABILITY TO HEAL, FEVERS DAILY, FORGETFULNESS, DEPRESSION, ANXIETY, AMNESIA, MS SYMPTOMS, ALLODYNIA, LOSS OF MEMORY, FIBROMYALGIA, PSORIASIS, INCONTINENCE ISSUE, MIGRAINES, HEADACHES, TACHYCARDIA, ELEVATED WBC COUNT, NAUSEA, NUMBNESS, TINGLING, LOSS OF STRENGTH, BACK PAIN, JOINT PAIN, BONE PAIN, NICKEL ALLERGY, SCABIES, DYSMENORRHEA (CRAMPING), DYSPAREUNIA, VAGINAL DISCHARGE, BLURRED VISION, FATIGUE, WEIGHT GAIN, MUSCLES PAIN, PAIN SKIN, PSORIASIS, TORN SHOULDER, HEART ATTACK, VERTIGO, DENTAL CAVITY, INTERFERING WITH MY DAILY LIFE AND JOB, GINGIVAL DISORDER, GUM DEGENERATION, THROAT CONGESTION WERE ADDED. OUTCOME OF GENITAL HEMORRHAGE AND ANXIETY WERE UPDATED. ONSET DATE OF EVENT HEADACHE, ALOPECIA, ANXIETY AND FUNGAL INFECTION WERE ADDED. PATIENT DEMOGRAPHICS WERE ADDED. NEW REPORTER AKA WERE ADDED AND CONSUMER ADDRESS WERE ADDED. MEDICAL HISTORY, LAB DATA AND CONCOMITANT DRUGS WERE ADDED. ON (B)(6) 2019: MEDICAL RECORDS RECEIVED. REPORTER INFORMATION UPDATED. PRODUCT INFORMATION DETAILS UPDATED. OTHER RELEVANT HISTORY AND LAB DATA 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-CONFORMANCE'S 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'), GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING'), MULTIPLE SCLEROSIS ('AUTOIMMUNE DISORDER TYPE OF DISORDER: DIGNOSED WITH MS AND TESTED FOR LUPUS AND FIBROMYALGIA, SUSPECTED MS "FLAIR UP", ONLY MY "MS" WAS A MISDIAGNOSIS FROM HAVING MIRENA YEARS EARLIER / NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MS SYMPTOMS'), MUSCLE RUPTURE ('TORN SHOULDER') AND MYOCARDIAL INFARCTION ('HEART ATTACK BY THIS TIME') IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C06463) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED FIBROMYALGIA, VITAMIN DEFICIENCY, HYPERACUSIS, HYPERMENORRHEA, CHOLECYSTECTOMY, D & C, INNER EAR OPERATION, WISDOM TEETH REMOVAL AND VOCAL TONE DISORDER. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MIRENA IUD FROM 2004 TO (B)(6) 2013. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, CONSTIPATION, GAIT DISTURBANCE, JOINT PAIN, MUSCULAR WEAKNESS AND MENOMETRORRHAGIA. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE (WELLBUTRIN), CODEINE, MAGNESIUM OXIDE, PREDNISONE AND PREGABALIN (LYRICA). ON(B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED TOOTHACHE ("DENTAL ISSUES/DENTAL PROBLEMS GUM DEGENRATION, NEED COMPLETE GUM GRAPHS OVER ENTIRE MOUTH/PAIN TEETH"), ANXIETY ("ANXIETY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), MEMORY IMPAIRMENT ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: FORGETFULNESS, DEPRESSION, ANXIETY") AND ACARODERMATITIS ("NICKEL ALLERGY PHYSICIAN THOUGHT I HAD SCABIES") AND UNDERWENT GINGIVAL GRAFT ("GUM DEGENERATION NEED COMPLETE GUM GRAPHS OVER ENTIRE MOUTH"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MULTIPLE SCLEROSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PSORIASIS ("RASHES OR SKIN CONDITIONS TYPE: THREE DIFFERENT TYPES OF PSORIASIS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED VULVOVAGINAL MYCOTIC INFECTION ("YEAST INFECTION/INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: YEAST INFECTIONS"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI'S") AND URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR INCONTINENCE ISSUES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/LOSS (SPECIFY WHICH ONE) GAINED OVER 65 POUNDS"). IN (B)(6) 2015, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE) STOPPED BEING INTIMATE DUE TO PAIN"), CHRONIC SINUSITIS ("INFECTION (OTHER) DESCRIBE: CHRONIC SINUS INFECTION INABILITY TO HEAL"), PYREXIA ("INFECTION (OTHER) DESCRIBE: CHRONIC SINUS INFECTION INABILITY TO HEAL, FEVERS DAILY"), ALLODYNIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: ALLODYNIA,"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRED VISION"), BACK PAIN ("BACK PAIN"), ARTHRALGIA ("JOINT PAIN"), BONE PAIN ("BONE PAIN/CRANIIAL REGION PAIN"), ASTHENIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: LOSS OF MEMORY / NEUROLOGICAL CONDITIONS OR PROBLEMS- TYPE: LOSS OF STRENGTH"), HYPOAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS- TYPE:NUMBNESS"), PARAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MS SYMPTOMS, ALLODYNIA, LOSS OF MEMORY, NEUROLOGICAL CONDITIONS OR PROBLEMS- TYPE:NUMBNESS, TINGLING, LOSS OF STRENGTH") AND PHARYNGEAL SWELLING ("THROAT CONGESTION"). IN (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE WHITE BLOOD CELL COUNT INCREASED ("BLOOD OR HEART DISORDER/CONDITION TYPE: ELEVATED WBC COUNT") AND EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2016, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES"), MIGRAINE ("MIGRAINES / HEADACHES") AND NAUSEA ("NAUSEA"). ON (B)(6) 2016, THE PATIENT EXPERIENCED GINGIVAL DISORDER ("GUM DEGENATION"), 1 YEAR 1 MONTH AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), AMNESIA ("AMNESIA/NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: LOSS OF MEMORY"), TACHYCARDIA ("BLOOD OR HEART DISORDER/CONDITION TYPE: TACHYCARDIA, ELEVATED WBC COUNT"), ALLERGY TO METALS ("NICKEL ALLERGY, NICKEL ALLERGY PHYSICIAN THOUGHT I HAD SCABIES"), MYALGIA ("MUSCLES PAIN"), PAIN OF SKIN ("PAIN SKIN/ALLODYNIA/PSORIASIS"), MUSCLE RUPTURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MYOCARDIAL INFARCTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VERTIGO ("VERTIGO"), DENTAL CARIES ("CAVITY") AND IMPAIRED HEALING ("INABILITY TO HEAL") AND WAS FOUND TO HAVE QUALITY OF LIFE DECREASED ("INTERFERING WITH MY DAILY LIFE AND JOB"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF), VACCINIUM MACROCARPON (CRANBERRY NS), VITAMINS NOS, CAVITY FILLING AND SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HEADACHE, ALOPECIA, TOOTHACHE, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, CHRONIC SINUSITIS, PYREXIA, AMNESIA, MULTIPLE SCLEROSIS, URINARY INCONTINENCE, MIGRAINE, TACHYCARDIA, WHITE BLOOD CELL COUNT INCREASED, NAUSEA, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, VISION BLURRED, FATIGUE, WEIGHT INCREASED, BACK PAIN, ARTHRALGIA, ASTHENIA, HYPOAESTHESIA, PARAESTHESIA, ACARODERMATITIS, PAIN OF SKIN, MYOCARDIAL INFARCTION, PHARYNGEAL SWELLING, GINGIVAL DISORDER, VERTIGO, DENTAL CARIES, GINGIVAL GRAFT, QUALITY OF LIFE DECREASED AND IMPAIRED HEALING OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE, ANXIETY, VULVOVAGINAL MYCOTIC INFECTION, MOOD SWINGS, DEPRESSION, PSORIASIS, ALLODYNIA, BONE PAIN, MEMORY IMPAIRMENT AND MYALGIA HAD RESOLVED AND THE MUSCLE RUPTURE HAD NOT RESOLVED. THE REPORTER CONSIDERED ACARODERMATITIS, ALLERGY TO METALS, ALLODYNIA, ALOPECIA, AMNESIA, ANXIETY, ARTHRALGIA, ASTHENIA, BACK PAIN, BONE PAIN, CHRONIC SINUSITIS, DENTAL CARIES, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, GINGIVAL DISORDER, GINGIVAL GRAFT, HEADACHE, HYPOAESTHESIA, IMPAIRED HEALING, MEMORY IMPAIRMENT, MENORRHAGIA, MIGRAINE, MOOD SWINGS, MULTIPLE SCLEROSIS, MUSCLE RUPTURE, MYALGIA, MYOCARDIAL INFARCTION, NAUSEA, PAIN OF SKIN, PARAESTHESIA, PELVIC PAIN, PHARYNGEAL SWELLING, PSORIASIS, PYREXIA, QUALITY OF LIFE DECREASED, TACHYCARDIA, TOOTHACHE, URINARY INCONTINENCE, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VERTIGO, VISION BLURRED, VULVOVAGINAL MYCOTIC INFECTION, WEIGHT INCREASED AND WHITE BLOOD CELL COUNT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT NEED FOR ADDITIONAL SURGERY CROSS REFERENCED WITH PLAINTIFF CASE NUMBER : (B)(4). CURRENT WEIGHT 210 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.8 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6) 2015: TOTAL BILATERAL OCCLUSION.. PREGNANCY TEST URINE - ON (B)(6) 2015: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: YEAST INFECTION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED VIA MEDICAL RECORDS: MIGRAINES, FATIGUE, HEADACHES. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-JUL-2019: QUALITY-SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). 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"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE DISEASE") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2015, 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), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HEADACHE ("HEADACHES"), ALOPECIA ("HAIR LOSS"), TOOTH DISORDER ("DENTAL ISSUES"), ANXIETY ("ANXIETY") AND FUNGAL INFECTION ("YEAST INFECTION"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, AUTOIMMUNE DISORDER, HEADACHE, ALOPECIA, TOOTH DISORDER AND ANXIETY OUTCOME WAS UNKNOWN AND THE FUNGAL INFECTION HAD RESOLVED. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, AUTOIMMUNE DISORDER, FUNGAL INFECTION, GENITAL HAEMORRHAGE, HEADACHE, PELVIC PAIN AND TOOTH DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT NEED FOR ADDITIONAL SURGERY CROSS REFERENCED WITH PLAINTIFF CASE NUMBER : (B)(6). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA:YEAST INFECTION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2018: SOCAIL MEDIA RECEIVED: THE EVENT YEAST INFECTION ADDED. REPORTERS ADDED. INCIDENT: NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN'), GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING'), MULTIPLE SCLEROSIS ('AUTOIMMUNE DISORDER TYPE OF DISORDER: DIGNOSED WITH MS AND TESTED FOR LUPIS AND FIBROMYALGIA, SUSPECTED MS "FLAIR UP", ONLY MY "MS" WAS A MISDIAGNOSIS FROM HAVING MIRENA YEARS EARLIER / NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MS SYMPTOMS'), MUSCLE RUPTURE ('TORN SHOULDER') AND MYOCARDIAL INFARCTION ('HEART ATTACK BY THIS TIME') IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C06463) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED FIBROMYALGIA, VITAMIN DEFICIENCY, HYPERACUSIS, HYPERMENORRHEA, CHOLECYSTECTOMY, D & C, INNER EAR OPERATION, WISDOM TEETH REMOVAL, VOCAL TONE DISORDER AND MISCARRIAGE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MIRENA IUD FROM 2004 TO NOVEMBER 2013. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, CONSTIPATION, GAIT DISTURBANCE, JOINT PAIN, MUSCULAR WEAKNESS, MENOMETRORRHAGIA AND INABILITY TO WORK. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE (WELLBUTRIN), CODEINE, MAGNESIUM OXIDE, PREDNISONE AND PREGABALIN (LYRICA). ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN AUGUST 2015, THE PATIENT EXPERIENCED TOOTHACHE ("DENTAL ISSUES/DENTAL PROBLEMS GUM DEGENRATION, NEED COMPLETE GUM GRAPHS OVER ENTIRE MOUTH/PAIN TEETH"), ANXIETY ("ANXIETY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), MEMORY IMPAIRMENT ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: FORGETFULNESS, DEPRESSION, ANXIETY") AND ACARODERMATITIS ("NICKEL ALLERGY PHYSICIAN THOUGHT I HAD SCABIES") AND UNDERWENT GINGIVAL GRAFT ("GUM DEGENERATION NEED COMPLETE GUM GRAPHS OVER ENTIRE MOUTH"). IN SEPTEMBER 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) / / HEMORRHAGED SO MUCH THAT I WOULD BLEED THROUGH A TAMPON"), MULTIPLE SCLEROSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PSORIASIS ("RASHES OR SKIN CONDITIONS TYPE: THREE DIFFERENT TYPES OF PSORIASIS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN OCTOBER 2015, THE PATIENT EXPERIENCED VULVOVAGINAL MYCOTIC INFECTION ("YEAST INFECTION/INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: YEAST INFECTIONS"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI'S") AND URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR INCONTINENCE ISSUES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/LOSS (SPECIFY WHICH ONE) GAINED OVER 65 POUNDS"). IN NOVEMBER 2015, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE) STOPPED BEING INTIMATE DUE TO PAIN"), CHRONIC SINUSITIS ("INFECTION (OTHER) DESCRIBE: CHRONIC SINUS INFECTION INABILITY TO HEAL"), PYREXIA ("INFECTION (OTHER) DESCRIBE: CHRONIC SINUS INFECTION INABILITY TO HEAL, FEVERS DAILY"), ALLODYNIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: ALLODYNIA,"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRED VISION"), BACK PAIN ("BACK PAIN"), ARTHRALGIA ("JOINT PAIN"), BONE PAIN ("BONE PAIN/CRANIIAL REGION PAIN"), ASTHENIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: LOSS OF MEMORY / NEUROLOGICAL CONDITIONS OR PROBLEMS- TYPE: LOSS OF STRENGTH"), HYPOAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS- TYPE:NUMBNESS"), PARAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MS SYMPTOMS, ALLODYNIA, LOSS OF MEMORY, NEUROLOGICAL CONDITIONS OR PROBLEMS- TYPE:NUMBNESS, TINGLING, LOSS OF STRENGTH") AND PHARYNGEAL SWELLING ("THROAT CONGESTION"). IN DECEMBER 2015, THE PATIENT WAS FOUND TO HAVE WHITE BLOOD CELL COUNT INCREASED ("BLOOD OR HEART DISORDER/CONDITION TYPE: ELEVATED WBC COUNT") AND EXPERIENCED FATIGUE ("FATIGUE"). IN JANUARY 2016, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES"), MIGRAINE ("MIGRAINES / HEADACHES") AND NAUSEA ("NAUSEA"). ON (B)(6) 2016, THE PATIENT EXPERIENCED GINGIVAL DISORDER ("GUM DEGENATION"), 1 YEAR 1 MONTH AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), AMNESIA ("AMNESIA/NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: LOSS OF MEMORY"), TACHYCARDIA ("BLOOD OR HEART DISORDER/CONDITION TYPE: TACHYCARDIA, ELEVATED WBC COUNT"), ALLERGY TO METALS ("NICKEL ALLERGY, NICKEL ALLERGY PHYSICIAN THOUGHT I HAD SCABIES"), MYALGIA ("MUSCLES PAIN"), PAIN OF SKIN ("PAIN SKIN/ALLODYNIA/PSORIASIS"), MUSCLE RUPTURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MYOCARDIAL INFARCTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VERTIGO ("VERTIGO"), DENTAL CARIES ("CAVITY") AND IMPAIRED HEALING ("INABILITY TO HEAL") AND WAS FOUND TO HAVE QUALITY OF LIFE DECREASED ("INTERFERING WITH MY DAILY LIFE AND JOB"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF), VACCINIUM MACROCARPON (CRANBERRY NS), VITAMINS NOS, CAVITY FILLING AND SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HEADACHE, ALOPECIA, TOOTHACHE, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, CHRONIC SINUSITIS, PYREXIA, AMNESIA, MULTIPLE SCLEROSIS, URINARY INCONTINENCE, MIGRAINE, TACHYCARDIA, WHITE BLOOD CELL COUNT INCREASED, NAUSEA, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, VISION BLURRED, FATIGUE, WEIGHT INCREASED, BACK PAIN, ARTHRALGIA, ASTHENIA, HYPOAESTHESIA, PARAESTHESIA, ACARODERMATITIS, PAIN OF SKIN, MYOCARDIAL INFARCTION, PHARYNGEAL SWELLING, GINGIVAL DISORDER, VERTIGO, DENTAL CARIES, GINGIVAL GRAFT, QUALITY OF LIFE DECREASED AND IMPAIRED HEALING OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE, ANXIETY, VULVOVAGINAL MYCOTIC INFECTION, MOOD SWINGS, DEPRESSION, PSORIASIS, ALLODYNIA, BONE PAIN, MEMORY IMPAIRMENT AND MYALGIA HAD RESOLVED AND THE MUSCLE RUPTURE HAD NOT RESOLVED. THE REPORTER CONSIDERED ACARODERMATITIS, ALLERGY TO METALS, ALLODYNIA, ALOPECIA, AMNESIA, ANXIETY, ARTHRALGIA, ASTHENIA, BACK PAIN, BONE PAIN, CHRONIC SINUSITIS, DENTAL CARIES, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, GINGIVAL DISORDER, GINGIVAL GRAFT, HEADACHE, HYPOAESTHESIA, IMPAIRED HEALING, MEMORY IMPAIRMENT, MENORRHAGIA, MIGRAINE, MOOD SWINGS, MULTIPLE SCLEROSIS, MUSCLE RUPTURE, MYALGIA, MYOCARDIAL INFARCTION, NAUSEA, PAIN OF SKIN, PARAESTHESIA, PELVIC PAIN, PHARYNGEAL SWELLING, PSORIASIS, PYREXIA, QUALITY OF LIFE DECREASED, TACHYCARDIA, TOOTHACHE, URINARY INCONTINENCE, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VERTIGO, VISION BLURRED, VULVOVAGINAL MYCOTIC INFECTION, WEIGHT INCREASED AND WHITE BLOOD CELL COUNT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT NEED FOR ADDITIONAL SURGERY CROSS REFERENCED WITH PLAINTIFF CASE NUMBER : 2016-088504 CURRENT WEIGHT 210 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.8 KG/SQM. HYSTEROSALPINGOGRAM - IN AUGUST 2015: TOTAL BILATERAL OCCLUSION.. PREGNANCY TEST URINE - ON (B)(6) 2015: NEGATIVE.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: YEAST INFECTION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED VIA MEDICAL RECORDS: MIGRAINES, FATIGUE, HEADACHES. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-NOV-2019: INFORMATION FROM DUPLICATE CASE 2019-213097 HAS BEEN TRANSFERRED TO THIS CASE, INCLUDING REPORTER INFORMATION. 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') IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C06463) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED FIBROMYALGIA, VITAMIN DEFICIENCY, HYPERACUSIS, HYPERMENORRHEA, CHOLECYSTECTOMY, D & C, INNER EAR OPERATION, WISDOM TEETH REMOVAL, VOCAL TONE DISORDER AND MISCARRIAGE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MIRENA IUD FROM 2004 TO (B)(6) 2013. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, CONSTIPATION, GAIT DISTURBANCE, JOINT PAIN, MUSCULAR WEAKNESS, MENOMETRORRHAGIA AND INABILITY TO WORK. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE (WELLBUTRIN), CODEINE, MAGNESIUM OXIDE, PREDNISONE AND PREGABALIN (LYRICA). ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED TOOTHACHE ("DENTAL ISSUES/DENTAL PROBLEMS GUM DEGENRATION, NEED COMPLETE GUM GRAPHS OVER ENTIRE MOUTH/PAIN TEETH"), ANXIETY ("ANXIETY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), MEMORY IMPAIRMENT ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: FORGETFULNESS, DEPRESSION, ANXIETY") AND ACARODERMATITIS ("NICKEL ALLERGY PHYSICIAN THOUGHT I HAD SCABIES") AND UNDERWENT GINGIVAL GRAFT ("GUM DEGENERATION NEED COMPLETE GUM GRAPHS OVER ENTIRE MOUTH"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) / / HEMORRHAGED SO MUCH THAT I WOULD BLEED THROUGH A TAMPON"), MULTIPLE SCLEROSIS ("AUTOIMMUNE DISORDER TYPE OF DISORDER: DIGNOSED WITH MS AND TESTED FOR LUPIS AND FIBROMYALGIA, SUSPECTED MS "FLAIR UP", ONLY MY "MS" WAS A MISDIAGNOSIS FROM HAVING MIRENA YEARS EARLIER / NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MS SYMPTOMS"), PSORIASIS ("RASHES OR SKIN CONDITIONS TYPE: THREE DIFFERENT TYPES OF PSORIASIS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED VULVOVAGINAL MYCOTIC INFECTION ("YEAST INFECTION/INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: YEAST INFECTIONS"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI'S") AND URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR INCONTINENCE ISSUES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/LOSS (SPECIFY WHICH ONE) GAINED OVER 65 POUNDS"). IN (B)(6) 2015, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE) STOPPED BEING INTIMATE DUE TO PAIN"), CHRONIC SINUSITIS ("INFECTION (OTHER) DESCRIBE: CHRONIC SINUS INFECTION INABILITY TO HEAL"), PYREXIA ("INFECTION (OTHER) DESCRIBE: CHRONIC SINUS INFECTION INABILITY TO HEAL, FEVERS DAILY"), ALLODYNIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: ALLODYNIA,"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRED VISION"), BACK PAIN ("BACK PAIN"), ARTHRALGIA ("JOINT PAIN"), BONE PAIN ("BONE PAIN/CRANIIAL REGION PAIN"), ASTHENIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: LOSS OF MEMORY / NEUROLOGICAL CONDITIONS OR PROBLEMS- TYPE: LOSS OF STRENGTH"), HYPOAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS- TYPE:NUMBNESS"), PARAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MS SYMPTOMS, ALLODYNIA, LOSS OF MEMORY, NEUROLOGICAL CONDITIONS OR PROBLEMS- TYPE:NUMBNESS, TINGLING, LOSS OF STRENGTH") AND PHARYNGEAL SWELLING ("THROAT CONGESTION"). IN (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE WHITE BLOOD CELL COUNT INCREASED ("BLOOD OR HEART DISORDER/CONDITION TYPE: ELEVATED WBC COUNT") AND EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2016, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES"), MIGRAINE ("MIGRAINES / HEADACHES") AND NAUSEA ("NAUSEA"). ON (B)(6) 2016, THE PATIENT EXPERIENCED GINGIVAL DISORDER ("GUM DEGENRATION"), 1 YEAR 1 MONTH AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), AMNESIA ("AMNESIA/NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: LOSS OF MEMORY"), TACHYCARDIA ("BLOOD OR HEART DISORDER/CONDITION TYPE: TACHYCARDIA, ELEVATED WBC COUNT"), ALLERGY TO METALS ("NICKEL ALLERGY, NICKEL ALLERGY PHYSICIAN THOUGHT I HAD SCABIES"), MYALGIA ("MUSCLES PAIN"), PAIN OF SKIN ("PAIN SKIN/ALLODYNIA/PSORIASIS"), MUSCLE RUPTURE ("TORN SHOULDER"), MYOCARDIAL INFARCTION ("HEART ATTACK BY THIS TIME"), VERTIGO ("VERTIGO"), DENTAL CARIES ("CAVITY"), IMPAIRED HEALING ("INABILITY TO HEAL"), ENDOMETRIOSIS ("ENDOMETRIOSIS"), FIBROMYALGIA ("FIBROMYALGIA"), DIZZINESS ("DIZZINESS"), HOT FLUSH ("HOT FLASHES"), PRURITUS ("ITCHY SKIN"), INSOMNIA ("INSOMNIA"), FUNGAL INFECTION ("YEAST INFECTION"), ABDOMINAL DISTENSION ("LOWER ABDOMEN BLOATED"), ABDOMINAL PAIN ("ABDOMEN PAIN"), RHEUMATOID ARTHRITIS ("RHEUMATOID ARTHRITIS "), RASH ("RASH ALL OVER MY ARM"), HYPERTENSION ("HIGH BLOOD PRESSURE"), FEELING ABNORMAL ("BRAIN FOG"), SPINAL COLUMN INJURY ("TAILBONE ISSUE"), CONFUSIONAL STATE ("CONFUSION"), URTICARIA ("HIVES"), HAEMORRHAGE ("HEMORRHAGE"), SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS"), EYE SWELLING ("SWELLING OF MY EYES"), SWELLING FACE ("SWELLING OF MY FACE"), PALPITATIONS ("HEART PALPITATIONS"), CHEST PAIN ("CHEST PAIN") AND COMPLEX REGIONAL PAIN SYNDROME ("RSD") AND WAS FOUND TO HAVE QUALITY OF LIFE DECREASED ("INTERFERING WITH MY DAILY LIFE AND JOB"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF), VACCINIUM MACROCARPON (CRANBERRY NS), VITAMINS NOS, CAVITY FILLING AND SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HEADACHE, ALOPECIA, TOOTHACHE, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, CHRONIC SINUSITIS, PYREXIA, AMNESIA, MULTIPLE SCLEROSIS, URINARY INCONTINENCE, MIGRAINE, TACHYCARDIA, WHITE BLOOD CELL COUNT INCREASED, NAUSEA, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, VISION BLURRED, FATIGUE, WEIGHT INCREASED, BACK PAIN, ARTHRALGIA, ASTHENIA, HYPOAESTHESIA, PARAESTHESIA, ACARODERMATITIS, PAIN OF SKIN, MYOCARDIAL INFARCTION, PHARYNGEAL SWELLING, GINGIVAL DISORDER, VERTIGO, DENTAL CARIES, GINGIVAL GRAFT, QUALITY OF LIFE DECREASED, IMPAIRED HEALING, ENDOMETRIOSIS, FIBROMYALGIA, DIZZINESS, HOT FLUSH, PRURITUS, INSOMNIA, FUNGAL INFECTION, ABDOMINAL DISTENSION, ABDOMINAL PAIN, RHEUMATOID ARTHRITIS, RASH, HYPERTENSION, FEELING ABNORMAL, SPINAL COLUMN INJURY, CONFUSIONAL STATE, URTICARIA, HAEMORRHAGE, SYSTEMIC LUPUS ERYTHEMATOSUS, EYE SWELLING, SWELLING FACE, PALPITATIONS, CHEST PAIN AND COMPLEX REGIONAL PAIN SYNDROME OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE, ANXIETY, VULVOVAGINAL MYCOTIC INFECTION, MOOD SWINGS, DEPRESSION, PSORIASIS, ALLODYNIA, BONE PAIN, MEMORY IMPAIRMENT AND MYALGIA HAD RESOLVED AND THE MUSCLE RUPTURE HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ACARODERMATITIS, ALLERGY TO METALS, ALLODYNIA, ALOPECIA, AMNESIA, ANXIETY, ARTHRALGIA, ASTHENIA, BACK PAIN, BONE PAIN, CHEST PAIN, CHRONIC SINUSITIS, COMPLEX REGIONAL PAIN SYNDROME, CONFUSIONAL STATE, DENTAL CARIES, DEPRESSION, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, EYE SWELLING, FATIGUE, FEELING ABNORMAL, FEMALE SEXUAL DYSFUNCTION, FIBROMYALGIA, FUNGAL INFECTION, GENITAL HAEMORRHAGE, GINGIVAL DISORDER, GINGIVAL GRAFT, HAEMORRHAGE, HEADACHE, HOT FLUSH, HYPERTENSION, HYPOAESTHESIA, IMPAIRED HEALING, INSOMNIA, MEMORY IMPAIRMENT, MENORRHAGIA, MIGRAINE, MOOD SWINGS, MULTIPLE SCLEROSIS, MUSCLE RUPTURE, MYALGIA, MYOCARDIAL INFARCTION, NAUSEA, PAIN OF SKIN, PALPITATIONS, PARAESTHESIA, PELVIC PAIN, PHARYNGEAL SWELLING, PRURITUS, PSORIASIS, PYREXIA, QUALITY OF LIFE DECREASED, RASH, RHEUMATOID ARTHRITIS, SPINAL COLUMN INJURY, SWELLING FACE, SYSTEMIC LUPUS ERYTHEMATOSUS, TACHYCARDIA, TOOTHACHE, URINARY INCONTINENCE, URINARY TRACT INFECTION, URTICARIA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VERTIGO, VISION BLURRED, VULVOVAGINAL MYCOTIC INFECTION, WEIGHT INCREASED AND WHITE BLOOD CELL COUNT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT NEED FOR ADDITIONAL SURGERY CROSS REFERENCED WITH PLAINTIFF CASE NUMBER : (B)(4). CURRENT WEIGHT 210 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.8 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6) 2015: TOTAL BILATERAL OCCLUSION. PREGNANCY TEST URINE - ON (B)(6) 2015: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: YEAST INFECTION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED VIA MEDICAL RECORDS: MIGRAINES, FATIGUE, HEADACHES. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-JAN-2020: PFS & SOCIAL MEDIA RECEIVED. NEW EVENTS ENDOMETRIOSIS, FIBROMYALGIA, DIZZINESS, HOT FLASHES, ITCHY SKIN, INSOMNIA, YEAST INFECTION, LOWER ABDOMEN BLOATED, ABDOMEN PAIN, RHEUMATOID ARTHRITIS, RASH ALL OVER MY ARM, HIGH BLOOD PRESSURE, BRAIN FOG, TAILBONE ISSUE, CONFUSION, HIVES, HEMORRHAGE, LUPUS, SWELLING OF MY EYES, SWELLING OF MY FACE, HEART PALPITATIONS, CHEST PAIN, RSD WAS ADDED. REPORTER WAS ADDED. 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') IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C06463) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED FIBROMYALGIA, VITAMIN DEFICIENCY, HYPERACUSIS, HYPERMENORRHEA, CHOLECYSTECTOMY, D & C, INNER EAR OPERATION, WISDOM TEETH REMOVAL, VOCAL TONE DISORDER AND MISCARRIAGE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MIRENA IUD FROM 2004 TO (B)(6) 2013. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, CONSTIPATION, GAIT DISTURBANCE, JOINT PAIN, MUSCULAR WEAKNESS, MENOMETRORRHAGIA AND INABILITY TO WORK. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE (WELLBUTRIN), CODEINE, MAGNESIUM OXIDE, PREDNISONE AND PREGABALIN (LYRICA). ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED TOOTHACHE ("DENTAL ISSUES/DENTAL PROBLEMS GUM DEGENRATION, NEED COMPLETE GUM GRAPHS OVER ENTIRE MOUTH/PAIN TEETH"), ANXIETY ("ANXIETY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), MEMORY IMPAIRMENT ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: FORGETFULNESS, DEPRESSION, ANXIETY") AND ACARODERMATITIS ("NICKEL ALLERGY PHYSICIAN THOUGHT I HAD SCABIES") AND UNDERWENT GINGIVAL GRAFT ("GUM DEGENERATION NEED COMPLETE GUM GRAPHS OVER ENTIRE MOUTH"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) /HEMORRHAGED SO MUCH THAT I WOULD BLEED THROUGH A TAMPON"), MULTIPLE SCLEROSIS ("AUTOIMMUNE DISORDER TYPE OF DISORDER: DIGNOSED WITH MS AND TESTED FOR LUPIS AND FIBROMYALGIA, SUSPECTED MS "FLAIR UP", ONLY MY "MS" WAS A MISDIAGNOSIS FROM HAVING MIRENA YEARS EARLIER / NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MS SYMPTOMS"), PSORIASIS ("RASHES OR SKIN CONDITIONS TYPE: THREE DIFFERENT TYPES OF PSORIASIS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED VULVOVAGINAL MYCOTIC INFECTION ("YEAST INFECTION/INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: YEAST INFECTIONS"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI'S") AND URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR INCONTINENCE ISSUES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/LOSS (SPECIFY WHICH ONE) GAINED OVER 65 POUNDS"). IN (B)(6) 2015, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE) STOPPED BEING INTIMATE DUE TO PAIN"), CHRONIC SINUSITIS ("INFECTION (OTHER) DESCRIBE: CHRONIC SINUS INFECTION INABILITY TO HEAL"), PYREXIA ("INFECTION (OTHER) DESCRIBE: CHRONIC SINUS INFECTION INABILITY TO HEAL, FEVERS DAILY"), ALLODYNIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: ALLODYNIA,"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRED VISION"), BACK PAIN ("BACK PAIN"), ARTHRALGIA ("JOINT PAIN"), BONE PAIN ("BONE PAIN/CRANIIAL REGION PAIN"), ASTHENIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: LOSS OF MEMORY / NEUROLOGICAL CONDITIONS OR PROBLEMS- TYPE: LOSS OF STRENGTH"), HYPOAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS- TYPE:NUMBNESS"), PARAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MS SYMPTOMS, ALLODYNIA, LOSS OF MEMORY, NEUROLOGICAL CONDITIONS OR PROBLEMS- TYPE:NUMBNESS, TINGLING, LOSS OF STRENGTH") AND PHARYNGEAL SWELLING ("THROAT CONGESTION"). IN (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE WHITE BLOOD CELL COUNT INCREASED ("BLOOD OR HEART DISORDER/CONDITION TYPE: ELEVATED WBC COUNT") AND EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2016, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES"), MIGRAINE ("MIGRAINES / HEADACHES") AND NAUSEA ("NAUSEA"). ON (B)(6) 2016, THE PATIENT EXPERIENCED GINGIVAL DISORDER ("GUM DEGENATION"), 1 YEAR 1 MONTH AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), AMNESIA ("AMNESIA/NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: LOSS OF MEMORY"), TACHYCARDIA ("BLOOD OR HEART DISORDER/CONDITION TYPE: TACHYCARDIA, ELEVATED WBC COUNT"), ALLERGY TO METALS ("NICKEL ALLERGY, NICKEL ALLERGY PHYSICIAN THOUGHT I HAD SCABIES"), MYALGIA ("MUSCLES PAIN"), PAIN OF SKIN ("PAIN SKIN/ALLODYNIA/PSORIASIS"), MUSCLE RUPTURE ("TORN SHOULDER"), MYOCARDIAL INFARCTION ("HEART ATTACK BY THIS TIME"), VERTIGO ("VERTIGO"), DENTAL CARIES ("CAVITY"), IMPAIRED HEALING ("INABILITY TO HEAL"), ENDOMETRIOSIS ("ENDOMETRIOSIS"), FIBROMYALGIA ("FIBROMYALGIA"), DIZZINESS ("DIZZINESS"), HOT FLUSH ("HOT FLASHES"), PRURITUS ("ITCHY SKIN"), INSOMNIA ("INSOMNIA"), FUNGAL INFECTION ("YEAST INFECTION"), ABDOMINAL DISTENSION ("LOWER ABDOMEN BLOATED"), ABDOMINAL PAIN ("ABDOMEN PAIN"), RHEUMATOID ARTHRITIS ("RHEUMATOID ARTHRITIS "), RASH ("RASH ALL OVER MY ARM"), HYPERTENSION ("HIGH BLOOD PRESSURE"), FEELING ABNORMAL ("BRAIN FOG"), SPINAL COLUMN INJURY ("TAILBONE ISSUE"), CONFUSIONAL STATE ("CONFUSION"), URTICARIA ("HIVES"), HAEMORRHAGE ("HEMORRHAGE"), SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS"), EYE SWELLING ("SWELLING OF MY EYES"), SWELLING FACE ("SWELLING OF MY FACE"), PALPITATIONS ("HEART PALPITATIONS"), CHEST PAIN ("CHEST PAIN"), COMPLEX REGIONAL PAIN SYNDROME ("RSD") AND BURNING SENSATION ("HIVES BURN") AND WAS FOUND TO HAVE QUALITY OF LIFE DECREASED ("INTERFERING WITH MY DAILY LIFE AND JOB"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF), VACCINIUM MACROCARPON (CRANBERRY NS), VITAMINS NOS, CAVITY FILLING AND SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HEADACHE, ALOPECIA, TOOTHACHE, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, CHRONIC SINUSITIS, PYREXIA, AMNESIA, MULTIPLE SCLEROSIS, URINARY INCONTINENCE, MIGRAINE, TACHYCARDIA, WHITE BLOOD CELL COUNT INCREASED, NAUSEA, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, VISION BLURRED, FATIGUE, WEIGHT INCREASED, BACK PAIN, ARTHRALGIA, ASTHENIA, HYPOAESTHESIA, PARAESTHESIA, ACARODERMATITIS, PAIN OF SKIN, MYOCARDIAL INFARCTION, PHARYNGEAL SWELLING, GINGIVAL DISORDER, VERTIGO, DENTAL CARIES, GINGIVAL GRAFT, QUALITY OF LIFE DECREASED, IMPAIRED HEALING, ENDOMETRIOSIS, FIBROMYALGIA, DIZZINESS, HOT FLUSH, PRURITUS, INSOMNIA, FUNGAL INFECTION, ABDOMINAL DISTENSION, ABDOMINAL PAIN, RHEUMATOID ARTHRITIS, RASH, HYPERTENSION, FEELING ABNORMAL, SPINAL COLUMN INJURY, CONFUSIONAL STATE, URTICARIA, HAEMORRHAGE, SYSTEMIC LUPUS ERYTHEMATOSUS, EYE SWELLING, SWELLING FACE, PALPITATIONS, CHEST PAIN, COMPLEX REGIONAL PAIN SYNDROME AND BURNING SENSATION OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE, ANXIETY, VULVOVAGINAL MYCOTIC INFECTION, MOOD SWINGS, DEPRESSION, PSORIASIS, ALLODYNIA, BONE PAIN, MEMORY IMPAIRMENT AND MYALGIA HAD RESOLVED AND THE MUSCLE RUPTURE HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ACARODERMATITIS, ALLERGY TO METALS, ALLODYNIA, ALOPECIA, AMNESIA, ANXIETY, ARTHRALGIA, ASTHENIA, BACK PAIN, BONE PAIN, BURNING SENSATION, CHEST PAIN, CHRONIC SINUSITIS, COMPLEX REGIONAL PAIN SYNDROME, CONFUSIONAL STATE, DENTAL CARIES, DEPRESSION, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, EYE SWELLING, FATIGUE, FEELING ABNORMAL, FEMALE SEXUAL DYSFUNCTION, FIBROMYALGIA, FUNGAL INFECTION, GENITAL HAEMORRHAGE, GINGIVAL DISORDER, GINGIVAL GRAFT, HAEMORRHAGE, HEADACHE, HOT FLUSH, HYPERTENSION, HYPOAESTHESIA, IMPAIRED HEALING, INSOMNIA, MEMORY IMPAIRMENT, MENORRHAGIA, MIGRAINE, MOOD SWINGS, MULTIPLE SCLEROSIS, MUSCLE RUPTURE, MYALGIA, MYOCARDIAL INFARCTION, NAUSEA, PAIN OF SKIN, PALPITATIONS, PARAESTHESIA, PELVIC PAIN, PHARYNGEAL SWELLING, PRURITUS, PSORIASIS, PYREXIA, QUALITY OF LIFE DECREASED, RASH, RHEUMATOID ARTHRITIS, SPINAL COLUMN INJURY, SWELLING FACE, SYSTEMIC LUPUS ERYTHEMATOSUS, TACHYCARDIA, TOOTHACHE, URINARY INCONTINENCE, URINARY TRACT INFECTION, URTICARIA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VERTIGO, VISION BLURRED, VULVOVAGINAL MYCOTIC INFECTION, WEIGHT INCREASED AND WHITE BLOOD CELL COUNT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT NEED FOR ADDITIONAL SURGERY CROSS REFERENCED WITH PLAINTIFF CASE NUMBER : (B)(4). CURRENT WEIGHT 210 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.8 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6) 2015: TOTAL BILATERAL OCCLUSION.. PREGNANCY TEST URINE - ON (B)(6) 2015: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA : DERMATITIS CONTACT. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-MAR-2020: SOCIAL MEDIA RECEIVED. REPORTER ADDED. EVENT : HIVES BURN ADDED. 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') IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C06463) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED FIBROMYALGIA, VITAMIN DEFICIENCY, HYPERACUSIS, HYPERMENORRHEA, CHOLECYSTECTOMY, D & C, INNER EAR OPERATION, WISDOM TEETH REMOVAL, VOCAL TONE DISORDER AND MISCARRIAGE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MIRENA IUD FROM 2004 TO (B)(6) 2013. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, CONSTIPATION, GAIT DISTURBANCE, JOINT PAIN, MUSCULAR WEAKNESS, MENOMETRORRHAGIA AND INABILITY TO WORK. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE (WELLBUTRIN), CODEINE, MAGNESIUM OXIDE, PREDNISONE AND PREGABALIN (LYRICA). ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED TOOTHACHE ("DENTAL ISSUES/DENTAL PROBLEMS GUM DEGENERATION, NEED COMPLETE GUM GRAPHS OVER ENTIRE MOUTH/PAIN TEETH"), ANXIETY ("ANXIETY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), MEMORY IMPAIRMENT ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: FORGETFULNESS, DEPRESSION, ANXIETY") AND ACARODERMATITIS ("NICKEL ALLERGY PHYSICIAN THOUGHT I HAD SCABIES") AND UNDERWENT GINGIVAL GRAFT ("GUM DEGENERATION NEED COMPLETE GUM GRAPHS OVER ENTIRE MOUTH"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) /HEMORRHAGED SO MUCH THAT I WOULD BLEED THROUGH A TAMPON"), MULTIPLE SCLEROSIS ("AUTOIMMUNE DISORDER TYPE OF DISORDER: DIAGNOSED WITH MS AND TESTED FOR LUPUS AND FIBROMYALGIA, SUSPECTED MS "FLARE-UP", ONLY MY "MS" WAS A MISDIAGNOSIS FROM HAVING MIRENA YEARS EARLIER / NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MS SYMPTOMS"), PSORIASIS ("RASHES OR SKIN CONDITIONS TYPE: THREE DIFFERENT TYPES OF PSORIASIS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED VULVOVAGINAL MYCOTIC INFECTION ("YEAST INFECTION/INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: YEAST INFECTIONS"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI'S") AND URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR INCONTINENCE ISSUES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/LOSS (SPECIFY WHICH ONE) GAINED OVER 65 POUNDS"). IN (B)(6) 2015, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE) STOPPED BEING INTIMATE DUE TO PAIN"), CHRONIC SINUSITIS ("INFECTION (OTHER) DESCRIBE: CHRONIC SINUS INFECTION INABILITY TO HEAL"), PYREXIA ("INFECTION (OTHER) DESCRIBE: CHRONIC SINUS INFECTION INABILITY TO HEAL, FEVERS DAILY"), ALLODYNIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: ALLODYNIA,"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRED VISION"), BACK PAIN ("BACK PAIN"), ARTHRALGIA ("JOINT PAIN"), BONE PAIN ("BONE PAIN/CRANIAL REGION PAIN"), ASTHENIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: LOSS OF MEMORY / NEUROLOGICAL CONDITIONS OR PROBLEMS- TYPE: LOSS OF STRENGTH"), HYPOAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS- TYPE:NUMBNESS"), PARAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MS SYMPTOMS, ALLODYNIA, LOSS OF MEMORY, NEUROLOGICAL CONDITIONS OR PROBLEMS- TYPE:NUMBNESS, TINGLING, LOSS OF STRENGTH") AND PHARYNGEAL SWELLING ("THROAT CONGESTION"). IN (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE WHITE BLOOD CELL COUNT INCREASED ("BLOOD OR HEART DISORDER/CONDITION TYPE: ELEVATED WBC COUNT") AND EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2016, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES"), MIGRAINE ("MIGRAINES / HEADACHES") AND NAUSEA ("NAUSEA"). ON (B)(6) 2016, THE PATIENT EXPERIENCED GINGIVAL DISORDER ("GUM DEGENERATION"), 1 YEAR 1 MONTH AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), AMNESIA ("AMNESIA/NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: LOSS OF MEMORY"), TACHYCARDIA ("BLOOD OR HEART DISORDER/CONDITION TYPE: TACHYCARDIA, ELEVATED WBC COUNT"), ALLERGY TO METALS ("NICKEL ALLERGY, NICKEL ALLERGY PHYSICIAN THOUGHT I HAD SCABIES"), MYALGIA ("MUSCLES PAIN"), PAIN OF SKIN ("PAIN SKIN/ALLODYNIA/PSORIASIS"), MUSCLE RUPTURE ("TORN SHOULDER"), MYOCARDIAL INFARCTION ("HEART ATTACK BY THIS TIME"), VERTIGO ("VERTIGO"), DENTAL CARIES ("CAVITY"), IMPAIRED HEALING ("INABILITY TO HEAL"), ENDOMETRIOSIS ("ENDOMETRIOSIS"), FIBROMYALGIA ("FIBROMYALGIA"), DIZZINESS ("DIZZINESS"), HOT FLUSH ("HOT FLASHES"), PRURITUS ("ITCHY SKIN"), INSOMNIA ("INSOMNIA"), FUNGAL INFECTION ("YEAST INFECTION"), ABDOMINAL DISTENSION ("LOWER ABDOMEN BLOATED"), ABDOMINAL PAIN ("ABDOMEN PAIN"), RHEUMATOID ARTHRITIS ("RHEUMATOID ARTHRITIS "), RASH ("RASH ALL OVER MY ARM"), HYPERTENSION ("HIGH BLOOD PRESSURE"), FEELING ABNORMAL ("BRAIN FOG"), SPINAL COLUMN INJURY ("TAILBONE ISSUE"), CONFUSIONAL STATE ("CONFUSION"), URTICARIA ("HIVES"), HAEMORRHAGE ("HEMORRHAGE"), SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS"), EYE SWELLING ("SWELLING OF MY EYES"), SWELLING FACE ("SWELLING OF MY FACE"), PALPITATIONS ("HEART PALPITATIONS"), CHEST PAIN ("CHEST PAIN") AND COMPLEX REGIONAL PAIN SYNDROME ("RSD") AND WAS FOUND TO HAVE QUALITY OF LIFE DECREASED ("INTERFERING WITH MY DAILY LIFE AND JOB"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF), VACCINIUM MACROCARPON (CRANBERRY NS), VITAMINS NOS, CAVITY FILLING AND SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HEADACHE, ALOPECIA, TOOTHACHE, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, CHRONIC SINUSITIS, PYREXIA, AMNESIA, MULTIPLE SCLEROSIS, URINARY INCONTINENCE, MIGRAINE, TACHYCARDIA, WHITE BLOOD CELL COUNT INCREASED, NAUSEA, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, VISION BLURRED, FATIGUE, WEIGHT INCREASED, BACK PAIN, ARTHRALGIA, ASTHENIA, HYPOAESTHESIA, PARAESTHESIA, ACARODERMATITIS, PAIN OF SKIN, MYOCARDIAL INFARCTION, PHARYNGEAL SWELLING, GINGIVAL DISORDER, VERTIGO, DENTAL CARIES, GINGIVAL GRAFT, QUALITY OF LIFE DECREASED, IMPAIRED HEALING, ENDOMETRIOSIS, FIBROMYALGIA, DIZZINESS, HOT FLUSH, PRURITUS, INSOMNIA, FUNGAL INFECTION, ABDOMINAL DISTENSION, ABDOMINAL PAIN, RHEUMATOID ARTHRITIS, RASH, HYPERTENSION, FEELING ABNORMAL, SPINAL COLUMN INJURY, CONFUSIONAL STATE, URTICARIA, HAEMORRHAGE, SYSTEMIC LUPUS ERYTHEMATOSUS, EYE SWELLING, SWELLING FACE, PALPITATIONS, CHEST PAIN AND COMPLEX REGIONAL PAIN SYNDROME OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE, ANXIETY, VULVOVAGINAL MYCOTIC INFECTION, MOOD SWINGS, DEPRESSION, PSORIASIS, ALLODYNIA, BONE PAIN, MEMORY IMPAIRMENT AND MYALGIA HAD RESOLVED AND THE MUSCLE RUPTURE HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ACARODERMATITIS, ALLERGY TO METALS, ALLODYNIA, ALOPECIA, AMNESIA, ANXIETY, ARTHRALGIA, ASTHENIA, BACK PAIN, BONE PAIN, CHEST PAIN, CHRONIC SINUSITIS, COMPLEX REGIONAL PAIN SYNDROME, CONFUSIONAL STATE, DENTAL CARIES, DEPRESSION, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, EYE SWELLING, FATIGUE, FEELING ABNORMAL, FEMALE SEXUAL DYSFUNCTION, FIBROMYALGIA, FUNGAL INFECTION, GENITAL HAEMORRHAGE, GINGIVAL DISORDER, GINGIVAL GRAFT, HAEMORRHAGE, HEADACHE, HOT FLUSH, HYPERTENSION, HYPOAESTHESIA, IMPAIRED HEALING, INSOMNIA, MEMORY IMPAIRMENT, MENORRHAGIA, MIGRAINE, MOOD SWINGS, MULTIPLE SCLEROSIS, MUSCLE RUPTURE, MYALGIA, MYOCARDIAL INFARCTION, NAUSEA, PAIN OF SKIN, PALPITATIONS, PARAESTHESIA, PELVIC PAIN, PHARYNGEAL SWELLING, PRURITUS, PSORIASIS, PYREXIA, QUALITY OF LIFE DECREASED, RASH, RHEUMATOID ARTHRITIS, SPINAL COLUMN INJURY, SWELLING FACE, SYSTEMIC LUPUS ERYTHEMATOSUS, TACHYCARDIA, TOOTHACHE, URINARY INCONTINENCE, URINARY TRACT INFECTION, URTICARIA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VERTIGO, VISION BLURRED, VULVOVAGINAL MYCOTIC INFECTION, WEIGHT INCREASED AND WHITE BLOOD CELL COUNT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT NEED FOR ADDITIONAL SURGERY CROSS REFERENCED WITH PLAINTIFF CASE NUMBER: (B)(4). CURRENT WEIGHT: 210 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.8 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6) 2015: TOTAL BILATERAL OCCLUSION. PREGNANCY TEST URINE - ON (B)(6) 2015: NEGATIVE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-FEB-2020: QUALITY SAFETY EVALUATION OF PTC. 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 ('PAIN') IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C06463) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED FIBROMYALGIA, VITAMIN DEFICIENCY, HYPERACUSIS, HYPERMENORRHEA, CHOLECYSTECTOMY, D & C, INNER EAR OPERATION, WISDOM TEETH REMOVAL, VOCAL TONE DISORDER AND MISCARRIAGE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MIRENA IUD FROM 2004 TO (B)(6) 2013. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, CONSTIPATION, GAIT DISTURBANCE, JOINT PAIN, MUSCULAR WEAKNESS, MENOMETRORRHAGIA AND INABILITY TO WORK. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE (WELLBUTRIN), CODEINE, MAGNESIUM OXIDE, PREDNISONE AND PREGABALIN (LYRICA). ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED TOOTHACHE ("DENTAL ISSUES/DENTAL PROBLEMS GUM DEGENERATION, NEED COMPLETE GUM GRAPHS OVER ENTIRE MOUTH/PAIN TEETH/TOOTH PAIN "), ANXIETY ("ANXIETY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), MEMORY IMPAIRMENT ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: FORGETFULNESS, DEPRESSION, ANXIETY") AND ACARODERMATITIS ("NICKEL ALLERGY PHYSICIAN THOUGHT I HAD SCABIES") AND UNDERWENT GINGIVAL GRAFT ("GUM DEGENERATION NEED COMPLETE GUM GRAPHS OVER ENTIRE MOUTH"). IN SEPTEMBER 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS/ HAIR FALLING OUT"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) /HEMORRHAGED SO MUCH THAT I WOULD BLEED THROUGH A TAMPON"), MULTIPLE SCLEROSIS ("AUTOIMMUNE DISORDER TYPE OF DISORDER: DIAGNOSED WITH MS AND TESTED FOR LUPIS AND FIBROMYALGIA, SUSPECTED MS "FLAIR UP", ONLY MY "MS" WAS A MISDIAGNOSIS FROM HAVING MIRENA YEARS EARLIER / NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MS SYMPTOMS"), PSORIASIS ("RASHES OR SKIN CONDITIONS TYPE: THREE DIFFERENT TYPES OF PSORIASIS/ PSORIASIS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED VULVOVAGINAL MYCOTIC INFECTION ("YEAST INFECTION/INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: YEAST INFECTIONS"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI'S") AND URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR INCONTINENCE ISSUES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/LOSS (SPECIFY WHICH ONE) GAINED OVER 65 POUNDS"). IN (B)(6) 2015, THE PATIENT EXPERIENCED THE FIRST EPISODE OF FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE) STOPPED BEING INTIMATE DUE TO PAIN"), CHRONIC SINUSITIS ("INFECTION (OTHER) DESCRIBE: CHRONIC SINUS INFECTION INABILITY TO HEAL"), FEBRILE INFECTION ("INFECTION (OTHER) DESCRIBE: CHRONIC SINUS INFECTION INABILITY TO HEAL, FEVERS DAILY/ FEVER"), ALLODYNIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: ALLODYNIA"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRED VISION"), BACK PAIN ("BACK PAIN"), ARTHRALGIA ("JOINT PAIN/ JOINT ISSUES"), BONE PAIN ("BONE PAIN/CRANIAL REGION PAIN"), ASTHENIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: LOSS OF MEMORY / NEUROLOGICAL CONDITIONS OR PROBLEMS- TYPE: LOSS OF STRENGTH"), HYPOAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS- TYPE:NUMBNESS"), PARAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MS SYMPTOMS, ALLODYNIA, LOSS OF MEMORY, NEUROLOGICAL CONDITIONS OR PROBLEMS- TYPE:NUMBNESS, TINGLING, LOSS OF STRENGTH") AND PHARYNGEAL SWELLING ("THROAT CONGESTION"). IN (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE WHITE BLOOD CELL COUNT INCREASED ("BLOOD OR HEART DISORDER/CONDITION TYPE: ELEVATED WBC COUNT") AND EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2016, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES"), MIGRAINE ("MIGRAINES / HEADACHES/ EXCRUCIATING MIGRAINES") AND NAUSEA ("NAUSEA"). ON (B)(6) 2016, THE PATIENT EXPERIENCED GINGIVAL DISORDER ("GUM DEGENERATION"), 1 YEAR 1 MONTH AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), AMNESIA ("AMNESIA/NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: LOSS OF MEMORY"), TACHYCARDIA ("BLOOD OR HEART DISORDER/CONDITION TYPE: TACHYCARDIA, ELEVATED WBC COUNT"), ALLERGY TO METALS ("NICKEL ALLERGY, NICKEL ALLERGY PHYSICIAN THOUGHT I HAD SCABIES"), MYALGIA ("MUSCLES PAIN"), PAIN OF SKIN ("PAIN SKIN/ALLODYNIA/PSORIASIS"), MUSCLE RUPTURE ("TORN SHOULDER"), MYOCARDIAL INFARCTION ("HEART ATTACK BY THIS TIME"), VERTIGO ("VERTIGO"), DENTAL CARIES ("CAVITY/ TOOTH DECAY"), IMPAIRED HEALING ("INABILITY TO HEAL"), ENDOMETRIOSIS ("ENDOMETRIOSIS"), FIBROMYALGIA ("FIBROMYALGIA"), DIZZINESS ("DIZZINESS"), HOT FLUSH ("HOT FLASHES"), PRURITUS ("ITCHY SKIN"), THE FIRST EPISODE OF INSOMNIA ("INSOMNIA"), FUNGAL INFECTION ("YEAST INFECTION"), ABDOMINAL DISTENSION ("LOWER ABDOMEN BLOATED"), ABDOMINAL PAIN ("ABDOMEN PAIN"), RHEUMATOID ARTHRITIS ("RHEUMATOID ARTHRITIS"), RASH ("RASH ALL OVER MY ARM"), HYPERTENSION ("HIGH BLOOD PRESSURE"), FEELING ABNORMAL ("BRAIN FOG"), SPINAL COLUMN INJURY ("TAILBONE ISSUE"), CONFUSIONAL STATE ("CONFUSION"), URTICARIA ("HIVES"), HAEMORRHAGE ("HEMORRHAGE"), SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS"), EYE SWELLING ("SWELLING OF MY EYES"), SWELLING FACE ("SWELLING OF MY FACE"), PALPITATIONS ("HEART PALPITATIONS"), CHEST PAIN ("CHEST PAIN"), COMPLEX REGIONAL PAIN SYNDROME ("RSD"), SKIN BURNING SENSATION ("HIVES BURN"), THE SECOND EPISODE OF INSOMNIA ("INSOMNIA"), LETHARGY ("LETHARGY"), INCONTINENCE ("INCONTINENCE"), ARTHROPATHY ("KNEE ISSUES"), TINNITUS ("TINNITUS SO LOUD I CAN¿T HEAR OTHER SOMETIMES"), THE SECOND EPISODE OF FEMALE SEXUAL DYSFUNCTION ("SEXUAL ISSUES"), NECK PAIN ("NECK PAIN SPREADING TO BOTH SHOULDERS"), PAIN ("NECK PAIN SPREADING TO BOTH SHOULDERS"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL ISSUES") AND MOOD ALTERED ("MOODY") AND WAS FOUND TO HAVE QUALITY OF LIFE DECREASED ("INTERFERING WITH MY DAILY LIFE AND JOB/ HAVEN¿T BEEN TO WORK SINCE JANUARY/ DON¿T HAVE A MEDICAL EXCUSE/ LOSING MY JOB "). THE PATIENT WAS TREATED WITH ANTIBIOTICS, DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF), VACCINIUM MACROCARPON (CRANBERRY NS), VITAMINS NOS, CAVITY FILLING AND SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HEADACHE, ALOPECIA, TOOTHACHE, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, CHRONIC SINUSITIS, FEBRILE INFECTION, AMNESIA, MULTIPLE SCLEROSIS, URINARY INCONTINENCE, MIGRAINE, TACHYCARDIA, WHITE BLOOD CELL COUNT INCREASED, NAUSEA, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, VISION BLURRED, FATIGUE, WEIGHT INCREASED, BACK PAIN, ARTHRALGIA, ASTHENIA, HYPOAESTHESIA, PARAESTHESIA, ACARODERMATITIS, PAIN OF SKIN, MYOCARDIAL INFARCTION, PHARYNGEAL SWELLING, GINGIVAL DISORDER, VERTIGO, DENTAL CARIES, GINGIVAL GRAFT, QUALITY OF LIFE DECREASED, IMPAIRED HEALING, ENDOMETRIOSIS, FIBROMYALGIA, DIZZINESS, HOT FLUSH, PRURITUS, FUNGAL INFECTION, ABDOMINAL DISTENSION, ABDOMINAL PAIN, RHEUMATOID ARTHRITIS, RASH, HYPERTENSION, FEELING ABNORMAL, SPINAL COLUMN INJURY, CONFUSIONAL STATE, URTICARIA, HAEMORRHAGE, SYSTEMIC LUPUS ERYTHEMATOSUS, EYE SWELLING, SWELLING FACE, PALPITATIONS, CHEST PAIN, COMPLEX REGIONAL PAIN SYNDROME, SKIN BURNING SENSATION, THE LAST EPISODE OF INSOMNIA, LETHARGY, INCONTINENCE, ARTHROPATHY, TINNITUS, THE LAST EPISODE OF FEMALE SEXUAL DYSFUNCTION, NECK PAIN, PAIN, GASTROINTESTINAL DISORDER AND MOOD ALTERED OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE, ANXIETY, VULVOVAGINAL MYCOTIC INFECTION, MOOD SWINGS, DEPRESSION, PSORIASIS, ALLODYNIA, BONE PAIN, MEMORY IMPAIRMENT AND MYALGIA HAD RESOLVED AND THE MUSCLE RUPTURE HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ACARODERMATITIS, ALLERGY TO METALS, ALLODYNIA, ALOPECIA, AMNESIA, ANXIETY, ARTHRALGIA, ARTHROPATHY, ASTHENIA, BACK PAIN, BONE PAIN, CHEST PAIN, CHRONIC SINUSITIS, COMPLEX REGIONAL PAIN SYNDROME, CONFUSIONAL STATE, DENTAL CARIES, DEPRESSION, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, EYE SWELLING, FATIGUE, FEBRILE INFECTION, FEELING ABNORMAL, FIBROMYALGIA, FUNGAL INFECTION, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, GINGIVAL DISORDER, GINGIVAL GRAFT, HAEMORRHAGE, HEADACHE, HOT FLUSH, HYPERTENSION, HYPOAESTHESIA, IMPAIRED HEALING, INCONTINENCE, LETHARGY, MEMORY IMPAIRMENT, MENORRHAGIA, MIGRAINE, MOOD ALTERED, MOOD SWINGS, MULTIPLE SCLEROSIS, MUSCLE RUPTURE, MYALGIA, MYOCARDIAL INFARCTION, NAUSEA, NECK PAIN, PAIN, PAIN OF SKIN, PALPITATIONS, PARAESTHESIA, PELVIC PAIN, PHARYNGEAL SWELLING, PRURITUS, PSORIASIS, QUALITY OF LIFE DECREASED, RASH, RHEUMATOID ARTHRITIS, SKIN BURNING SENSATION, SPINAL COLUMN INJURY, SWELLING FACE, SYSTEMIC LUPUS ERYTHEMATOSUS, TACHYCARDIA, TINNITUS, TOOTHACHE, URINARY INCONTINENCE, URINARY TRACT INFECTION, URTICARIA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VERTIGO, VISION BLURRED, VULVOVAGINAL MYCOTIC INFECTION, WEIGHT INCREASED, WHITE BLOOD CELL COUNT INCREASED, THE FIRST EPISODE OF FEMALE SEXUAL DYSFUNCTION, THE FIRST EPISODE OF INSOMNIA, THE SECOND EPISODE OF FEMALE SEXUAL DYSFUNCTION AND THE SECOND EPISODE OF INSOMNIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT NEED FOR ADDITIONAL SURGERY CROSS REFERENCED WITH PLAINTIFF CASE NUMBER : (B)(4). CURRENT WEIGHT 210 LBS. PATIENT DO NOT HAVE A MEDICAL EXCUSE AND IS LOSING HER JOB. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.8 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6) 2015: TOTAL BILATERAL OCCLUSION. PREGNANCY TEST URINE - ON (B)(6) 2015: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA : DERMATITIS CONTACT. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: SOCIAL MEDIA RECEIVED. NEW REPORTER WAS ADDED. NEW EVENTS WERE ADDED: INSOMNIA, LETHARGY, INCONTINENCE, UNSPECIFIED DISORDER OF KNEE JOINT, TINNITUS, SEXUAL PROBLEM, NECK PAIN (WITH RADIATION), SHOULDER PAIN, GASTROINTESTINAL DISORDER NOS AND MOOD ALTERED. RCC COMMENT WAS ADDED. 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 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') IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C06463) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED FIBROMYALGIA, VITAMIN DEFICIENCY, HYPERACUSIS, HYPERMENORRHEA, CHOLECYSTECTOMY, D & C, INNER EAR OPERATION, WISDOM TEETH REMOVAL, VOCAL TONE DISORDER, MISCARRIAGE, EYES SENSITIVE TO SUNLIGHT AND PAINFUL SENSITIVENESS TO SOUND. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MIRENA IUD FROM 2004 TO NOVEMBER 2013. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, CONSTIPATION, GAIT DISTURBANCE, JOINT PAIN, MUSCULAR WEAKNESS, MENOMETRORRHAGIA AND INABILITY TO WORK. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE (WELLBUTRIN), CODEINE, MAGNESIUM OXIDE, PREDNISONE AND PREGABALIN (LYRICA). ON(B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED TOOTHACHE ("DENTAL ISSUES/DENTAL PROBLEMS GUM DEGENRATION, NEED COMPLETE GUM GRAPHS OVER ENTIRE MOUTH/PAIN TEETH/TOOTH PAIN "), ANXIETY ("ANXIETY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), MEMORY IMPAIRMENT ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: FORGETFULNESS, DEPRESSION, ANXIETY") AND ACARODERMATITIS ("NICKEL ALLERGY PHYSICIAN THOUGHT I HAD SCABIES") AND UNDERWENT GINGIVAL GRAFT ("GUM DEGENERATION NEED COMPLETE GUM GRAPHS OVER ENTIRE MOUTH"). IN SEPTEMBER 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS/ HAIR FALLING OUT"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) /HEMORRHAGED SO MUCH THAT I WOULD BLEED THROUGH A TAMPON"), MULTIPLE SCLEROSIS ("AUTOIMMUNE DISORDER TYPE OF DISORDER: DIGNOSED WITH MS AND TESTED FOR LUPIS AND FIBROMYALGIA, SUSPECTED MS "FLAIR UP", ONLY MY "MS" WAS A MISDIAGNOSIS FROM HAVING MIRENA YEARS EARLIER / NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MS SYMPTOMS"), PSORIASIS ("RASHES OR SKIN CONDITIONS TYPE: THREE DIFFERENT TYPES OF PSORIASIS/ PSORIASIS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED VULVOVAGINAL MYCOTIC INFECTION ("YEAST INFECTION/INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: YEAST INFECTIONS"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI'S") AND URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR INCONTINENCE ISSUES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/LOSS (SPECIFY WHICH ONE) GAINED OVER 65 POUNDS"). IN NOVEMBER 2015, THE PATIENT EXPERIENCED THE FIRST EPISODE OF FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE) STOPPED BEING INTIMATE DUE TO PAIN"), CHRONIC SINUSITIS ("INFECTION (OTHER) DESCRIBE: CHRONIC SINUS INFECTION INABILITY TO HEAL"), FEBRILE INFECTION ("INFECTION (OTHER) DESCRIBE: CHRONIC SINUS INFECTION INABILITY TO HEAL, FEVERS DAILY/ FEVER"), ALLODYNIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: ALLODYNIA"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRED VISION"), BACK PAIN ("BACK PAIN"), ARTHRALGIA ("JOINT PAIN/ JOINT ISSUES"), BONE PAIN ("BONE PAIN/CRANIIAL REGION PAIN"), ASTHENIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: LOSS OF MEMORY / NEUROLOGICAL CONDITIONS OR PROBLEMS- TYPE: LOSS OF STRENGTH"), HYPOAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS- TYPE:NUMBNESS"), PARAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MS SYMPTOMS, ALLODYNIA, LOSS OF MEMORY, NEUROLOGICAL CONDITIONS OR PROBLEMS- TYPE:NUMBNESS, TINGLING, LOSS OF STRENGTH") AND PHARYNGEAL SWELLING ("THROAT CONGESTION"). IN DECEMBER 2015, THE PATIENT WAS FOUND TO HAVE WHITE BLOOD CELL COUNT INCREASED ("BLOOD OR HEART DISORDER/CONDITION TYPE: ELEVATED WBC COUNT") AND EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2016, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES"), MIGRAINE ("MIGRAINES / HEADACHES/ EXCRUCIATING MIGRAINES") AND NAUSEA ("NAUSEA"). ON (B)(6) 2016, THE PATIENT EXPERIENCED GINGIVAL DISORDER ("GUM DEGENATION / GUMS ARE EXPOSING ROOTS"), 1 YEAR 1 MONTH AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), AMNESIA ("AMNESIA/NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: LOSS OF MEMORY"), TACHYCARDIA ("BLOOD OR HEART DISORDER/CONDITION TYPE: TACHYCARDIA, ELEVATED WBC COUNT"), ALLERGY TO METALS ("NICKEL ALLERGY, NICKEL ALLERGY PHYSICIAN THOUGHT I HAD SCABIES"), MYALGIA ("MUSCLES PAIN"), PAIN OF SKIN ("PAIN SKIN/ALLODYNIA/PSORIASIS"), MUSCLE RUPTURE ("TORN SHOULDER"), MYOCARDIAL INFARCTION ("HEART ATTACK BY THIS TIME"), VERTIGO ("VERTIGO"), DENTAL CARIES ("CAVITY/ TOOTH DECAY"), IMPAIRED HEALING ("INABILITY TO HEAL"), ENDOMETRIOSIS ("ENDOMETRIOSIS"), FIBROMYALGIA ("FIBROMYALGIA"), DIZZINESS ("DIZZINESS"), HOT FLUSH ("HOT FLASHES"), PRURITUS ("ITCHY SKIN"), THE FIRST EPISODE OF INSOMNIA ("INSOMNIA"), FUNGAL INFECTION ("YEAST INFECTION"), ABDOMINAL DISTENSION ("LOWER ABDOMEN BLOATED"), ABDOMINAL PAIN ("ABDOMEN PAIN"), RHEUMATOID ARTHRITIS ("RHEUMATOID ARTHRITIS"), RASH ("RASH ALL OVER MY ARM"), HYPERTENSION ("HIGH BLOOD PRESSURE"), FEELING ABNORMAL ("BRAIN FOG"), SPINAL COLUMN INJURY ("TAILBONE ISSUE"), CONFUSIONAL STATE ("CONFUSION"), URTICARIA ("HIVES"), HAEMORRHAGE ("HEMORRHAGE"), SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS"), EYE SWELLING ("SWELLING OF MY EYES"), SWELLING FACE ("SWELLING OF MY FACE"), PALPITATIONS ("HEART PALPITATIONS"), CHEST PAIN ("CHEST PAIN"), COMPLEX REGIONAL PAIN SYNDROME ("RSD"), SKIN BURNING SENSATION ("HIVES BURN"), THE SECOND EPISODE OF INSOMNIA ("INSOMNIA"), LETHARGY ("LETHARGY"), INCONTINENCE ("INCONTINENCE"), ARTHROPATHY ("KNEE ISSUES"), TINNITUS ("TINNITUS SO LOUD I CAN¿T HEAR OTHER SOMETIMES"), THE SECOND EPISODE OF FEMALE SEXUAL DYSFUNCTION ("SEXUAL ISSUES"), NECK PAIN ("NECK PAIN SPREADING TO BOTH SHOULDERS"), PAIN ("NECK PAIN SPREADING TO BOTH SHOULDERS"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL ISSUES"), MOOD ALTERED ("MOODY"), ECZEMA ("DISHIDROTIC ECZEMA ON HANDS") AND TOOTH LOSS ("TEETH HAVE CRUMBLED") AND WAS FOUND TO HAVE QUALITY OF LIFE DECREASED ("INTERFERING WITH MY DAILY LIFE AND JOB/ HAVEN¿T BEEN TO WORK SINCE JANUARY/ DON¿T HAVE A MEDICAL EXCUSE/ LOSING MY JOB "). THE PATIENT WAS TREATED WITH ANTIBIOTICS, DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF), VACCINIUM MACROCARPON (CRANBERRY NS), VITAMINS NOS, CAVITY FILLING AND SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HEADACHE, ALOPECIA, TOOTHACHE, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, CHRONIC SINUSITIS, FEBRILE INFECTION, AMNESIA, MULTIPLE SCLEROSIS, URINARY INCONTINENCE, MIGRAINE, TACHYCARDIA, WHITE BLOOD CELL COUNT INCREASED, NAUSEA, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, VISION BLURRED, FATIGUE, WEIGHT INCREASED, BACK PAIN, ARTHRALGIA, ASTHENIA, HYPOAESTHESIA, PARAESTHESIA, ACARODERMATITIS, PAIN OF SKIN, MYOCARDIAL INFARCTION, PHARYNGEAL SWELLING, GINGIVAL DISORDER, VERTIGO, DENTAL CARIES, GINGIVAL GRAFT, QUALITY OF LIFE DECREASED, IMPAIRED HEALING, ENDOMETRIOSIS, FIBROMYALGIA, DIZZINESS, HOT FLUSH, PRURITUS, FUNGAL INFECTION, ABDOMINAL DISTENSION, ABDOMINAL PAIN, RHEUMATOID ARTHRITIS, RASH, HYPERTENSION, FEELING ABNORMAL, SPINAL COLUMN INJURY, CONFUSIONAL STATE, URTICARIA, HAEMORRHAGE, SYSTEMIC LUPUS ERYTHEMATOSUS, EYE SWELLING, SWELLING FACE, PALPITATIONS, CHEST PAIN, COMPLEX REGIONAL PAIN SYNDROME, SKIN BURNING SENSATION, THE LAST EPISODE OF INSOMNIA, LETHARGY, INCONTINENCE, ARTHROPATHY, TINNITUS, THE LAST EPISODE OF FEMALE SEXUAL DYSFUNCTION, NECK PAIN, PAIN, GASTROINTESTINAL DISORDER, MOOD ALTERED, ECZEMA AND TOOTH LOSS OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE, ANXIETY, VULVOVAGINAL MYCOTIC INFECTION, MOOD SWINGS, DEPRESSION, PSORIASIS, ALLODYNIA, BONE PAIN, MEMORY IMPAIRMENT AND MYALGIA HAD RESOLVED AND THE MUSCLE RUPTURE HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ACARODERMATITIS, ALLERGY TO METALS, ALLODYNIA, ALOPECIA, AMNESIA, ANXIETY, ARTHRALGIA, ARTHROPATHY, ASTHENIA, BACK PAIN, BONE PAIN, CHEST PAIN, CHRONIC SINUSITIS, COMPLEX REGIONAL PAIN SYNDROME, CONFUSIONAL STATE, DENTAL CARIES, DEPRESSION, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, ECZEMA, ENDOMETRIOSIS, EYE SWELLING, FATIGUE, FEBRILE INFECTION, FEELING ABNORMAL, FIBROMYALGIA, FUNGAL INFECTION, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, GINGIVAL DISORDER, GINGIVAL GRAFT, HAEMORRHAGE, HEADACHE, HOT FLUSH, HYPERTENSION, HYPOAESTHESIA, IMPAIRED HEALING, INCONTINENCE, LETHARGY, MEMORY IMPAIRMENT, MENORRHAGIA, MIGRAINE, MOOD ALTERED, MOOD SWINGS, MULTIPLE SCLEROSIS, MUSCLE RUPTURE, MYALGIA, MYOCARDIAL INFARCTION, NAUSEA, NECK PAIN, PAIN, PAIN OF SKIN, PALPITATIONS, PARAESTHESIA, PELVIC PAIN, PHARYNGEAL SWELLING, PRURITUS, PSORIASIS, QUALITY OF LIFE DECREASED, RASH, RHEUMATOID ARTHRITIS, SKIN BURNING SENSATION, SPINAL COLUMN INJURY, SWELLING FACE, SYSTEMIC LUPUS ERYTHEMATOSUS, TACHYCARDIA, TINNITUS, TOOTH LOSS, TOOTHACHE, URINARY INCONTINENCE, URINARY TRACT INFECTION, URTICARIA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VERTIGO, VISION BLURRED, VULVOVAGINAL MYCOTIC INFECTION, WEIGHT INCREASED, WHITE BLOOD CELL COUNT INCREASED, THE FIRST EPISODE OF FEMALE SEXUAL DYSFUNCTION, THE FIRST EPISODE OF INSOMNIA, THE SECOND EPISODE OF FEMALE SEXUAL DYSFUNCTION AND THE SECOND EPISODE OF INSOMNIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT NEED FOR ADDITIONAL SURGERY CROSS REFERENCED WITH PLAINTIFF CASE NUMBER : (B)(4). CURRENT WEIGHT 210 LBS. PATIENT DO NOT HAVE A MEDICAL EXCUSE AND IS LOSING HER JOB. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.8 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6) 2015: TOTAL BILATERAL OCCLUSION.. PREGNANCY TEST URINE - ON (B)(6) 2015: NEGATIVE.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA : DERMATITIS CONTACT THE FOLLOWING INFORMATION WAS RECEIVED FROM SOCIAL MEDIA TEETH HAVE CRUMBLED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: SOCIAL MEDIA REPORT RECEIVED: NEW REPORTER ADDED, NEWEVENT ADDED (ECZEMA) ON (B)(6) 2020: SOCIAL MEDIA RECEIVED. EVENT ADDED- TEETH HAVE CRUMBLED. REPORTER INFORMATION WERE ADDED. 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 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"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE DISEASE") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2015, 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), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HEADACHE ("HEADACHES"), ALOPECIA ("HAIR LOSS"), TOOTH DISORDER ("DENTAL ISSUES") AND ANXIETY ("ANXIETY"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, AUTOIMMUNE DISORDER, HEADACHE, ALOPECIA, TOOTH DISORDER AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, AUTOIMMUNE DISORDER, GENITAL HAEMORRHAGE, HEADACHE, PELVIC PAIN AND TOOTH DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT NEED FOR ADDITIONAL SURGERY. 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 |
|---|---|---|---|---|---|---|---|
| 835089 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | C06463 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Other| R | CODEINE| CODEINE| CODEINE| CODEINE| CODEINE| CODEINE| CODEINE| CODEINE| LYRICA| LYRICA| LYRICA| LYRICA| LYRICA| LYRICA| LYRICA| LYRICA| MAGNESIUM OXIDE| MAGNESIUM OXIDE| MAGNESIUM OXIDE| MAGNESIUM OXIDE| MAGNESIUM OXIDE| MAGNESIUM OXIDE| MAGNESIUM OXIDE| MAGNESIUM OXIDE| PREDNISONE| PREDNISONE| PREDNISONE| PREDNISONE| PREDNISONE| PREDNISONE| PREDNISONE| PREDNISONE| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN |