ESSURE
Report
- Report Number
- 2951250-2018-04476
- Event Type
- Injury
- Date Received
- October 30, 2018
- Date of Event
- April 17, 2017
- Report Date
- December 9, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('UNABLE TO GET FRAGMENT OUT'), EMBEDDED DEVICE ('ONE WAS DEEPLY EMBEDDED IN MY TISSUE'), DEVICE EXPULSION ('ONE MY COIL MIGRATED TO MY UTERUS') AND MENORRHAGIA ('HEAVY PERIODS') IN A 51-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED AUTOIMMUNE DISORDER ON (B)(6) 2007 AND GRAVIDA II. NO FAMILY HISTORY OF SJOGREN SYNDROME. THYROID HORMONE LEVEL: NORMAL. POSITIVE ANA AND RA FACTOR. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM AND BUPROPION HYDROCHLORIDE (WELLBUTRIN). ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN 2009, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE"), ANXIETY ("ANXIETY"), DEPRESSION ("EVENTUALLY DEPRESSION"), HEADACHE ("HEADACHES/CHRONIC HEADACHES ESCALATED OVER TIME AND BECAME AN ALMOST DAILY"), FATIGUE ("FATIGUE"), THE FIRST EPISODE OF DISTURBANCE IN ATTENTION ("POOR CONCENTRATION"), UTERINE PAIN ("PAIN: AROUND UTERUS") AND ARTHRALGIA ("JOINT PAIN/ACHING JOINTS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE PAIN WITH MENSTRUATION/DYSMENORRHEA (CRAMPING)"). IN 2016, THE PATIENT EXPERIENCED ALOPECIA ("SEVERE HAIR LOSS"). ON (B)(6) 2017, THE PATIENT EXPERIENCED THE FIRST EPISODE OF BUTTERFLY RASH ("VARIOUS RASHES/BUTTERFLY SHAPED RASH ON FACE"), 8 YEARS 6 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2017, THE PATIENT EXPERIENCED SJOGREN'S SYNDROME ("SJOGREN'S R/O LUPUS SX INC"), SOLAR DERMATITIS ("SUN RASH") AND SYSTEMIC LUPUS ERYTHEMATOSUS ("SJOGREN'S R/O LUPUS SX INC"). ON (B)(6) 2017, THE PATIENT EXPERIENCED CORNEAL ABRASION ("DUE TO CORNEAL ABRASIONS") AND DRY EYE ("DRY EYES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), URTICARIA ("H/O HIVES"), DYSPNOEA ("TROUBLE BREATHING NEAR ALLERGIES"), THE SECOND EPISODE OF DISTURBANCE IN ATTENTION ("POOR CONCENTRATION"), THE SECOND EPISODE OF BUTTERFLY RASH ("BUTTERFLY RASH"), FEELING ABNORMAL ("BRAIN FOG"), ASTHENIA ("LOW ENERGY"), LETHARGY ("LETHARGY"), COMPLICATION OF DEVICE REMOVAL ("UNABLE TO GET FRAGMENT OUT"), ALLERGY TO METALS ("NICKEL ALLERGY"), LYMPHADENOPATHY ("ENLARGED PELVIC LYMPH NODE"), ABDOMINAL DISTENSION ("BLOATING"), PELVIC PAIN ("PAIN IN PELVIC AREA"), NAUSEA ("NAUSEOUS"), BURNING SENSATION ("BURNING SENSATION"), DISCOMFORT ("PRESSURE SENSATION"), FIBROMYALGIA ("FIBROMYALGIA"), BIPOLAR DISORDER ("BIPOLAR DISORDER"), ONYCHOCLASIS ("NAILS BREAKING/MY THUMB NAILS WERE TERRIBLE, THEY ALWAYS BROKE AT THE BASE") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE DISEASE") AND WAS FOUND TO HAVE CERVIX CARCINOMA STAGE II ("CERVICAL CANCER (STAGE 2B)"). THE PATIENT WAS TREATED WITH CAFFEINE;PARACETAMOL (EXCEDRIN), HYDROXYCHLOROQUINE SULFATE (PLAQUINOL), STEROID ANTIBACTERIALS, SURGERY (SHE UNDERWENT HYSTERECTOMY WITH BILATERAL SALPINGECTOMY - KEPT OVARIES AND SHE UNDERWENT REMOVAL OF PELVIC LYMPH NODE) AND BLOOD TRANSFUSIONS. ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, EMBEDDED DEVICE, DEVICE EXPULSION, GENITAL HAEMORRHAGE, DYSMENORRHOEA, ALOPECIA, MIGRAINE, URTICARIA, DYSPNOEA, THE LAST EPISODE OF DISTURBANCE IN ATTENTION, ANXIETY, DEPRESSION, SJOGREN'S SYNDROME, SOLAR DERMATITIS, THE LAST EPISODE OF BUTTERFLY RASH, CORNEAL ABRASION, DRY EYE, SYSTEMIC LUPUS ERYTHEMATOSUS, ARTHRALGIA, FEELING ABNORMAL, ASTHENIA, LETHARGY, COMPLICATION OF DEVICE REMOVAL, ALLERGY TO METALS, LYMPHADENOPATHY, CERVIX CARCINOMA STAGE II, ABDOMINAL DISTENSION, NAUSEA, BURNING SENSATION, DISCOMFORT, FIBROMYALGIA, BIPOLAR DISORDER AND AUTOIMMUNE DISORDER OUTCOME WAS UNKNOWN, THE MENORRHAGIA, HEADACHE, FATIGUE, UTERINE PAIN, PELVIC PAIN AND ONYCHOCLASIS HAD RESOLVED AND THE WEIGHT INCREASED WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALLERGY TO METALS, ALOPECIA, ANXIETY, ARTHRALGIA, ASTHENIA, AUTOIMMUNE DISORDER, BIPOLAR DISORDER, BURNING SENSATION, CERVIX CARCINOMA STAGE II, COMPLICATION OF DEVICE REMOVAL, CORNEAL ABRASION, DEPRESSION, DEVICE BREAKAGE, DEVICE EXPULSION, DISCOMFORT, DRY EYE, DYSMENORRHOEA, DYSPNOEA, EMBEDDED DEVICE, FATIGUE, FEELING ABNORMAL, FIBROMYALGIA, GENITAL HAEMORRHAGE, HEADACHE, LETHARGY, LYMPHADENOPATHY, MENORRHAGIA, MIGRAINE, NAUSEA, ONYCHOCLASIS, PELVIC PAIN, SJOGREN'S SYNDROME, SOLAR DERMATITIS, SYSTEMIC LUPUS ERYTHEMATOSUS, URTICARIA, UTERINE PAIN, WEIGHT INCREASED, THE FIRST EPISODE OF BUTTERFLY RASH, THE FIRST EPISODE OF DISTURBANCE IN ATTENTION, THE SECOND EPISODE OF BUTTERFLY RASH AND THE SECOND EPISODE OF DISTURBANCE IN ATTENTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE WILL BE FORCED TO UNDERGO A HYSTERECTOMY WITH REMOVAL OF THE ESSURE DEVICES. CURRENT WEIGHT 144 LBS. PER MEDICAL RECORD: INSERTION DETAIL: TRAILING COILS IN FALLOPIAN TUBE- RIGHT- 4 COILS, LEFT- 3 COILS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS IN A STABLE CONDITION. PER SOCIAL MEDIA: POST OPT ALL MY ISSUES FROM COIL ARE GONE. SHE HAD SOME ISSUES POP UP, BUT THOSE ARE TRACED TO BAD GENES. POST 18 MONTHS, MOST OF HER SYMPTOMS HAD DIMINISHED. REMOVAL DETAIL: THE ROBOT WAS DOCKED AND SINGLE INCISION ROBOTIC DA VINCI CANNULA INTRODUCED. THEY PROCEEDED TO PERFORM THE HYSTERECTOMY THE LEFT AND THE RIGHT UTEROOVARIAN LIGAMENTS WERE CAUTERIZED AND TRANSECTED. THE LEFT AND THE RIGHT MESOSALPINX WAS CAUTERIZED AND TRANSECTED, SO AS TO FREE THE FALLOPIAN TUBES FROM ITS ATTACHMENTS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO RECOVERY ROOM AWAKE AND IN STABLE CONDITION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2009: RESULTS: TOTAL BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS SOCIAL MEDIA: DEVICE BREAKAGE, EMBEDDED DEVICE, DEVICE EXPULSION, ARTHRALGIA, FEELING ABNORMAL, ASTHENIA, LETHARGY, ALLERGY TO METALS, LYMPHADENOPATHY, CERVICAL CANCER, ABDOMINAL DISTENSION, PELVIC AREA, NAUSEA, BURNING SENSATION, MENORRHAGIA, FIBROMYALGIA, BIPOLAR DISORDER, ONYCHOCLASIS. RASH, ALOPECIA, BRAIN FOG, DEPRESSION, FATIGUE, QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT FURTHER COMPANY FOLLOW-UP WITCH THE CONSUMER, LAWYER, LAWYER, CONSUMER, CONSUMER OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-JAN-2020: CONTENT FROM SOCIAL MEDIA RECEIVED. EVENT AUTOIMMUNE DISEASE WAS ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER, AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('UNABLE TO GET FRAGMENT OUT'), EMBEDDED DEVICE ('ONE WAS DEEPLY EMBEDDED IN MY TISSUE'), DEVICE EXPULSION ('ONE MY COIL MIGRATED TO MY UTERUS') AND MENORRHAGIA ('HEAVY PERIODS'). IN A 51-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED: AUTOIMMUNE DISORDER ON (B)(6) 2007 AND GRAVIDA II. NO FAMILY HISTORY OF SJOGREN SYNDROME. THYROID HORMONE LEVEL: NORMAL. POSITIVE ANA AND RA FACTOR. CONCURRENT CONDITIONS INCLUDED: BODY MASS INDEX NORMAL. CONCOMITANT PRODUCTS INCLUDED: ALPRAZOLAM AND BUPROPION HYDROCHLORIDE (WELLBUTRIN). ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN 2009, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE"), ANXIETY ("ANXIETY"), DEPRESSION ("EVENTUALLY DEPRESSION"), HEADACHE ("HEADACHES/CHRONIC HEADACHES ESCALATED OVER TIME AND BECAME AN ALMOST DAILY"), FATIGUE ("FATIGUE"). THE FIRST EPISODE OF DISTURBANCE IN ATTENTION ("POOR CONCENTRATION"), UTERINE PAIN ("PAIN: AROUND UTERUS") AND ARTHRALGIA ("JOINT PAIN/ACHING JOINTS"). AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE PAIN WITH MENSTRUATION/DYSMENORRHEA (CRAMPING)"). IN 2016, THE PATIENT EXPERIENCED ALOPECIA ("SEVERE HAIR LOSS"). ON (B)(6) 2017, THE PATIENT EXPERIENCED THE FIRST EPISODE OF BUTTERFLY RASH ("VARIOUS RASHES/BUTTERFLY SHAPED RASH ON FACE"), (B)(6) YEARS (B)(6) MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2017, THE PATIENT EXPERIENCED SJOGREN'S SYNDROME ("SJOGREN'S R/O LUPUS SX INC"), SOLAR DERMATITIS ("SUN RASH") AND SYSTEMIC LUPUS ERYTHEMATOSUS ("SJOGREN'S R/O LUPUS SX INC"). ON (B)(6) 2017, THE PATIENT EXPERIENCED CORNEAL ABRASION ("DUE TO CORNEAL ABRASIONS") AND DRY EYE ("DRY EYES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), URTICARIA ("H/O HIVES"), DYSPNOEA ("TROUBLE BREATHING NEAR ALLERGIES"). THE SECOND EPISODE OF DISTURBANCE IN ATTENTION ("POOR CONCENTRATION"), THE SECOND EPISODE OF BUTTERFLY RASH ("BUTTERFLY RASH"), FEELING ABNORMAL ("BRAIN FOG"), ASTHENIA ("LOW ENERGY"), LETHARGY ("LETHARGY"), COMPLICATION OF DEVICE REMOVAL ("UNABLE TO GET FRAGMENT OUT"), ALLERGY TO METALS ("NICKEL ALLERGY"), LYMPHADENOPATHY ("ENLARGED PELVIC LYMPH NODE"), ABDOMINAL DISTENSION ("BLOATING"), PELVIC PAIN ("PAIN IN PELVIC AREA"), NAUSEA ("NAUSEOUS"), BURNING SENSATION ("BURNING SENSATION"), DISCOMFORT ("PRESSURE SENSATION"), FIBROMYALGIA ("FIBROMYALGIA"), BIPOLAR DISORDER ("BIPOLAR DISORDER"), ONYCHOCLASIS ("NAILS BREAKING/MY THUMB NAILS WERE TERRIBLE, THEY ALWAYS BROKE AT THE BASE"). AND AUTOIMMUNE DISORDER ("AUTOIMMUNE DISEASE"). AND WAS FOUND TO HAVE CERVIX CARCINOMA STAGE II. ("CERVICAL CANCER (STAGE 2B)"). THE PATIENT WAS TREATED WITH CAFFEINE;PARACETAMOL (EXCEDRIN), HYDROXYCHLOROQUINE SULFATE (PLAQUINOL), STEROID ANTIBACTERIALS, SURGERY (SHE UNDERWENT HYSTERECTOMY, WITH BILATERAL SALPINGECTOMY. KEPT OVARIES AND SHE UNDERWENT REMOVAL OF PELVIC LYMPH NODE) AND BLOOD TRANSFUSIONS. ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, EMBEDDED DEVICE, DEVICE EXPULSION, GENITAL HAEMORRHAGE, DYSMENORRHOEA, ALOPECIA, MIGRAINE, URTICARIA, DYSPNOEA, THE LAST EPISODE OF DISTURBANCE IN ATTENTION, ANXIETY, DEPRESSION, SJOGREN'S SYNDROME, SOLAR DERMATITIS, THE LAST EPISODE OF BUTTERFLY RASH, CORNEAL ABRASION, DRY EYE, SYSTEMIC LUPUS ERYTHEMATOSUS, ARTHRALGIA, FEELING ABNORMAL, ASTHENIA, LETHARGY, COMPLICATION OF DEVICE REMOVAL, ALLERGY TO METALS, LYMPHADENOPATHY, CERVIX CARCINOMA STAGE II, ABDOMINAL DISTENSION, NAUSEA, BURNING SENSATION, DISCOMFORT, FIBROMYALGIA, BIPOLAR DISORDER AND AUTOIMMUNE DISORDER OUTCOME WAS UNKNOWN. THE MENORRHAGIA, HEADACHE, FATIGUE, UTERINE PAIN, PELVIC PAIN AND ONYCHOCLASIS HAD RESOLVED. AND THE WEIGHT INCREASED WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALLERGY TO METALS, ALOPECIA, ANXIETY, ARTHRALGIA, ASTHENIA, AUTOIMMUNE DISORDER, BIPOLAR DISORDER, BURNING SENSATION, CERVIX CARCINOMA STAGE II, COMPLICATION OF DEVICE REMOVAL, CORNEAL ABRASION, DEPRESSION, DEVICE BREAKAGE, DEVICE EXPULSION, DISCOMFORT, DRY EYE, DYSMENORRHOEA, DYSPNOEA, EMBEDDED DEVICE, FATIGUE, FEELING ABNORMAL, FIBROMYALGIA, GENITAL HAEMORRHAGE, HEADACHE, LETHARGY, LYMPHADENOPATHY, MENORRHAGIA, MIGRAINE, NAUSEA, ONYCHOCLASIS, PELVIC PAIN, SJOGREN'S SYNDROME, SOLAR DERMATITIS, SYSTEMIC LUPUS ERYTHEMATOSUS, URTICARIA, UTERINE PAIN, WEIGHT INCREASED, THE FIRST EPISODE OF BUTTERFLY RASH, THE FIRST EPISODE OF DISTURBANCE IN ATTENTION, THE SECOND EPISODE OF BUTTERFLY RASH AND THE SECOND EPISODE OF DISTURBANCE IN ATTENTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE WILL BE FORCED TO UNDERGO A HYSTERECTOMY WITH REMOVAL OF THE ESSURE DEVICES. CURRENT WEIGHT 144 LBS. PER MEDICAL RECORD: INSERTION DETAIL; TRAILING COILS IN FALLOPIAN TUBE, RIGHT: 4 COILS, LEFT: 3 COILS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS IN A STABLE CONDITION. PER SOCIAL MEDIA: POST OPT, ALL MY ISSUES FROM COIL ARE GONE. SHE HAD SOME ISSUES POP UP, BUT THOSE ARE TRACED TO BAD GENES. POST (B)(6) MONTHS, MOST OF HER SYMPTOMS HAD DIMINISHED. REMOVAL DETAIL: THE ROBOT WAS DOCKED AND SINGLE INCISION ROBOTIC DA VINCI CANNULA INTRODUCED. THEY PROCEEDED TO PERFORM THE HYSTERECTOMY, THE LEFT AND THE RIGHT UTEROOVARIAN LIGAMENTS WERE CAUTERIZED AND TRANSECTED. THE LEFT AND THE RIGHT MESOSALPINX WAS CAUTERIZED AND TRANSECTED. SO AS TO FREE THE FALLOPIAN TUBES FROM ITS ATTACHMENTS. THE PATIENT TOLERATED THE PROCEDURE WELL. AND WAS TRANSFERRED TO RECOVERY ROOM AWAKE AND IN STABLE CONDITION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS: INDEX WAS 23 KG/SQM. HYSTEROSALPINGOGRAM: ON (B)(6) 2009, RESULTS: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS SOCIAL MEDIA: DEVICE BREAKAGE, EMBEDDED DEVICE, DEVICE EXPULSION, ARTHRALGIA, FEELING ABNORMAL, ASTHENIA, LETHARGY, ALLERGY TO METALS, LYMPHADENOPATHY, CERVICAL CANCER, ABDOMINAL DISTENSION, PELVIC AREA, NAUSEA, BURNING SENSATION, MENORRHAGIA, FIBROMYALGIA, BIPOLAR DISORDER, ONYCHOCLASIS, RASH, ALOPECIA, BRAIN FOG, DEPRESSION, FATIGUE. QUALITY SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER, LAWYER, OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020, EXTENSION OF EXPECTED DATE OF NEXT REPORT. BASED ON THE AVAILABLE INFORMATION. A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED. ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION, WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('UNABLE TO GET FRAGMENT OUT'), EMBEDDED DEVICE ('ONE WAS DEEPLY EMBEDDED IN MY TISSUE'), DEVICE EXPULSION ('ONE MY COIL MIGRATED TO MY UTERUS') AND MENORRHAGIA ('HEAVY PERIODS') IN A 51-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED AUTOIMMUNE DISORDER ON (B)(6) 2007 AND GRAVIDA II. NO FAMILY HISTORY OF SJOGREN SYNDROME. THYROID HORMONE LEVEL: NORMAL. POSITIVE ANA AND RA FACTOR. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM AND BUPROPION HYDROCHLORIDE (WELLBUTRIN). ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN 2009, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE"), ANXIETY ("ANXIETY"), DEPRESSION ("EVENTUALLY DEPRESSION"), HEADACHE ("HEADACHES/CHRONIC HEADACHES ESCALATED OVER TIME AND BECAME AN ALMOST DAILY"), FATIGUE ("FATIGUE"), THE FIRST EPISODE OF DISTURBANCE IN ATTENTION ("POOR CONCENTRATION"), UTERINE PAIN ("PAIN: AROUND UTERUS") AND ARTHRALGIA ("JOINT PAIN/ACHING JOINTS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE PAIN WITH MENSTRUATION/DYSMENORRHEA (CRAMPING)"). IN 2016, THE PATIENT EXPERIENCED ALOPECIA ("SEVERE HAIR LOSS"). ON (B)(6) 2017, THE PATIENT EXPERIENCED THE FIRST EPISODE OF BUTTERFLY RASH ("VARIOUS RASHES/BUTTERFLY SHAPED RASH ON FACE"), 8 YEARS 6 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2017, THE PATIENT EXPERIENCED SJOGREN'S SYNDROME ("SJOGREN'S R/O LUPUS SX INC"), SOLAR DERMATITIS ("SUN RASH") AND SYSTEMIC LUPUS ERYTHEMATOSUS ("SJOGREN'S R/O LUPUS SX INC"). ON (B)(6) 2017, THE PATIENT EXPERIENCED CORNEAL ABRASION ("DUE TO CORNEAL ABRASIONS") AND DRY EYE ("DRY EYES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), URTICARIA ("H/O HIVES"), DYSPNOEA ("TROUBLE BREATHING NEAR ALLERGIES"), THE SECOND EPISODE OF DISTURBANCE IN ATTENTION ("POOR CONCENTRATION"), THE SECOND EPISODE OF BUTTERFLY RASH ("BUTTERFLY RASH"), FEELING ABNORMAL ("BRAIN FOG"), ASTHENIA ("LOW ENERGY"), LETHARGY ("LETHARGY"), COMPLICATION OF DEVICE REMOVAL ("UNABLE TO GET FRAGMENT OUT"), ALLERGY TO METALS ("NICKEL ALLERGY"), LYMPHADENOPATHY ("ENLARGED PELVIC LYMPH NODE"), ABDOMINAL DISTENSION ("BLOATING"), PELVIC PAIN ("PAIN IN PELVIC AREA"), NAUSEA ("NAUSEOUS"), BURNING SENSATION ("BURNING SENSATION"), DISCOMFORT ("PRESSURE SENSATION"), FIBROMYALGIA ("FIBROMYALGIA"), BIPOLAR DISORDER ("BIPOLAR DISORDER"), ONYCHOCLASIS ("NAILS BREAKING/MY THUMB NAILS WERE TERRIBLE, THEY ALWAYS BROKE AT THE BASE") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE DISEASE") AND WAS FOUND TO HAVE CERVIX CARCINOMA STAGE II ("CERVICAL CANCER (STAGE 2B)"). THE PATIENT WAS TREATED WITH CAFFEINE;PARACETAMOL (EXCEDRIN), HYDROXYCHLOROQUINE SULFATE (PLAQUINOL), STEROID ANTIBACTERIALS, SURGERY (SHE UNDERWENT HYSTERECTOMY WITH BILATERAL SALPINGECTOMY - KEPT OVARIES AND SHE UNDERWENT REMOVAL OF PELVIC LYMPH NODE) AND BLOOD TRANSFUSIONS. ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, EMBEDDED DEVICE, DEVICE EXPULSION, GENITAL HAEMORRHAGE, DYSMENORRHOEA, ALOPECIA, MIGRAINE, URTICARIA, DYSPNOEA, THE LAST EPISODE OF DISTURBANCE IN ATTENTION, ANXIETY, DEPRESSION, SJOGREN'S SYNDROME, SOLAR DERMATITIS, THE LAST EPISODE OF BUTTERFLY RASH, CORNEAL ABRASION, DRY EYE, SYSTEMIC LUPUS ERYTHEMATOSUS, ARTHRALGIA, FEELING ABNORMAL, ASTHENIA, LETHARGY, COMPLICATION OF DEVICE REMOVAL, ALLERGY TO METALS, LYMPHADENOPATHY, CERVIX CARCINOMA STAGE II, ABDOMINAL DISTENSION, NAUSEA, BURNING SENSATION, DISCOMFORT, FIBROMYALGIA, BIPOLAR DISORDER AND AUTOIMMUNE DISORDER OUTCOME WAS UNKNOWN, THE MENORRHAGIA, HEADACHE, FATIGUE, UTERINE PAIN, PELVIC PAIN AND ONYCHOCLASIS HAD RESOLVED AND THE WEIGHT INCREASED WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALLERGY TO METALS, ALOPECIA, ANXIETY, ARTHRALGIA, ASTHENIA, AUTOIMMUNE DISORDER, BIPOLAR DISORDER, BURNING SENSATION, CERVIX CARCINOMA STAGE II, COMPLICATION OF DEVICE REMOVAL, CORNEAL ABRASION, DEPRESSION, DEVICE BREAKAGE, DEVICE EXPULSION, DISCOMFORT, DRY EYE, DYSMENORRHOEA, DYSPNOEA, EMBEDDED DEVICE, FATIGUE, FEELING ABNORMAL, FIBROMYALGIA, GENITAL HAEMORRHAGE, HEADACHE, LETHARGY, LYMPHADENOPATHY, MENORRHAGIA, MIGRAINE, NAUSEA, ONYCHOCLASIS, PELVIC PAIN, SJOGREN'S SYNDROME, SOLAR DERMATITIS, SYSTEMIC LUPUS ERYTHEMATOSUS, URTICARIA, UTERINE PAIN, WEIGHT INCREASED, THE FIRST EPISODE OF BUTTERFLY RASH, THE FIRST EPISODE OF DISTURBANCE IN ATTENTION, THE SECOND EPISODE OF BUTTERFLY RASH AND THE SECOND EPISODE OF DISTURBANCE IN ATTENTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE WILL BE FORCED TO UNDERGO A HYSTERECTOMY WITH REMOVAL OF THE ESSURE DEVICES. CURRENT WEIGHT 144 LBS. PER MEDICAL RECORD: INSERTION DETAIL: TRAILING COILS IN FALLOPIAN TUBE- RIGHT- 4 COILS, LEFT- 3 COILS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS IN A STABLE CONDITION. PER SOCIAL MEDIA: POST OPT ALL MY ISSUES FROM COIL ARE GONE. SHE HAD SOME ISSUES POP UP, BUT THOSE ARE TRACED TO BAD GENES. POST 18 MONTHS, MOST OF HER SYMPTOMS HAD DIMINISHED. REMOVAL DETAIL: THE ROBOT WAS DOCKED AND SINGLE INCISION ROBOTIC DA VINCI CANNULA INTRODUCED. THEY PROCEEDED TO PERFORM THE HYSTERECTOMY THE LEFT AND THE RIGHT UTEROOVARIAN LIGAMENTS WERE CAUTERIZED AND TRANSECTED. THE LEFT AND THE RIGHT MESOSALPINX WAS CAUTERIZED AND TRANSECTED, SO AS TO FREE THE FALLOPIAN TUBES FROM ITS ATTACHMENTS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO RECOVERY ROOM AWAKE AND IN STABLE CONDITION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2009: RESULTS: TOTAL BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS SOCIAL MEDIA: DEVICE BREAKAGE, EMBEDDED DEVICE, DEVICE EXPULSION, ARTHRALGIA, FEELING ABNORMAL, ASTHENIA, LETHARGY, ALLERGY TO METALS, LYMPHADENOPATHY, CERVICAL CANCER, ABDOMINAL DISTENSION, PELVIC AREA, NAUSEA, BURNING SENSATION, MENORRHAGIA, FIBROMYALGIA, BIPOLAR DISORDER, ONYCHOCLASIS. RASH, ALOPECIA, BRAIN FOG, DEPRESSION, FATIGUE, QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER, LAWYER, LAWYER, CONSUMER, CONSUMER OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-AUG-2020: EXTENSION OF EXPECTED DATE OF NEXT REPORT. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('UNABLE TO GET FRAGMENT OUT'), EMBEDDED DEVICE ('ONE WAS DEEPLY EMBEDDED IN MY TISSUE'), DEVICE EXPULSION ('ONE MY COIL MIGRATED TO MY UTERUS') AND MENORRHAGIA ('HEAVY PERIODS') IN A 51-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED AUTOIMMUNE DISORDER ON (B)(6) 2007, GRAVIDA II, CERVICITIS, ADENOMYOSIS, LEIOMYOMA NOS AND PARATUBAL CYST. NO FAMILY HISTORY OF SJOGREN SYNDROME. THYROID HORMONE LEVEL: NORMAL. POSITIVE ANA AND RA FACTOR. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM AND BUPROPION HYDROCHLORIDE (WELLBUTRIN). ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN 2009, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE"), ANXIETY ("ANXIETY"), DEPRESSION ("EVENTUALLY DEPRESSION"), HEADACHE ("HEADACHES/CHRONIC HEADACHES ESCALATED OVER TIME AND BECAME AN ALMOST DAILY"), FATIGUE ("FATIGUE"), THE FIRST EPISODE OF DISTURBANCE IN ATTENTION ("POOR CONCENTRATION"), UTERINE PAIN ("PAIN: AROUND UTERUS") AND ARTHRALGIA ("JOINT PAIN/ACHING JOINTS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE PAIN WITH MENSTRUATION/DYSMENORRHEA (CRAMPING)"). IN 2016, THE PATIENT EXPERIENCED ALOPECIA ("SEVERE HAIR LOSS"). ON (B)(6) 2017, THE PATIENT EXPERIENCED THE FIRST EPISODE OF BUTTERFLY RASH ("VARIOUS (B)(6) 2017, THE PATIENT EXPERIENCED SJOGREN'S SYNDROME ("SJOGREN'S R/O LUPUS SX INC"), SOLAR DERMATITIS ("SUN RASH") AND SYSTEMIC LUPUS ERYTHEMATOSUS ("SJOGREN'S R/O LUPUS SX INC"). ON (B)(6) 2017, THE PATIENT EXPERIENCED CORNEAL ABRASION ("DUE TO CORNEAL ABRASIONS") AND DRY EYE ("DRY EYES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), URTICARIA ("H/O HIVES"), DYSPNOEA ("TROUBLE BREATHING NEAR ALLERGIES"), THE SECOND EPISODE OF DISTURBANCE IN ATTENTION ("POOR CONCENTRATION"), THE SECOND EPISODE OF BUTTERFLY RASH ("BUTTERFLY RASH"), FEELING ABNORMAL ("BRAIN FOG"), ASTHENIA ("LOW ENERGY"), LETHARGY ("LETHARGY"), COMPLICATION OF DEVICE REMOVAL ("UNABLE TO GET FRAGMENT OUT"), ALLERGY TO METALS ("NICKEL ALLERGY"), LYMPHADENOPATHY ("ENLARGED PELVIC LYMPH NODE"), ABDOMINAL DISTENSION ("BLOATING"), PELVIC PAIN ("PAIN IN PELVIC AREA"), NAUSEA ("NAUSEOUS"), BURNING SENSATION ("BURNING SENSATION"), DISCOMFORT ("PRESSURE SENSATION"), FIBROMYALGIA ("FIBROMYALGIA"), BIPOLAR DISORDER ("BIPOLAR DISORDER"), ONYCHOCLASIS ("NAILS BREAKING/MY THUMB NAILS WERE TERRIBLE, THEY ALWAYS BROKE AT THE BASE") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE DISEASE") AND WAS FOUND TO HAVE CERVIX CARCINOMA STAGE II ("CERVICAL CANCER (STAGE 2B)"). THE PATIENT WAS TREATED WITH CAFFEINE;PARACETAMOL (EXCEDRIN), HYDROXYCHLOROQUINE SULFATE (PLAQUINOL), STEROID ANTIBACTERIALS, SURGERY (SHE UNDERWENT HYSTERECTOMY WITH BILATERAL SALPINGECTOMY - KEPT OVARIES AND SHE UNDERWENT REMOVAL OF PELVIC LYMPH NODE) AND BLOOD TRANSFUSIONS. ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, EMBEDDED DEVICE, DEVICE EXPULSION, GENITAL HAEMORRHAGE, DYSMENORRHOEA, ALOPECIA, MIGRAINE, URTICARIA, DYSPNOEA, THE LAST EPISODE OF DISTURBANCE IN ATTENTION, ANXIETY, DEPRESSION, SJOGREN'S SYNDROME, SOLAR DERMATITIS, THE LAST EPISODE OF BUTTERFLY RASH, CORNEAL ABRASION, DRY EYE, SYSTEMIC LUPUS ERYTHEMATOSUS, ARTHRALGIA, FEELING ABNORMAL, ASTHENIA, LETHARGY, COMPLICATION OF DEVICE REMOVAL, ALLERGY TO METALS, LYMPHADENOPATHY, CERVIX CARCINOMA STAGE II, ABDOMINAL DISTENSION, NAUSEA, BURNING SENSATION, DISCOMFORT, FIBROMYALGIA, BIPOLAR DISORDER AND AUTOIMMUNE DISORDER OUTCOME WAS UNKNOWN, THE MENORRHAGIA, HEADACHE, FATIGUE, UTERINE PAIN, PELVIC PAIN AND ONYCHOCLASIS HAD RESOLVED AND THE WEIGHT INCREASED WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALLERGY TO METALS, ALOPECIA, ANXIETY, ARTHRALGIA, ASTHENIA, AUTOIMMUNE DISORDER, BIPOLAR DISORDER, BURNING SENSATION, CERVIX CARCINOMA STAGE II, COMPLICATION OF DEVICE REMOVAL, CORNEAL ABRASION, DEPRESSION, DEVICE BREAKAGE, DEVICE EXPULSION, DISCOMFORT, DRY EYE, DYSMENORRHOEA, DYSPNOEA, EMBEDDED DEVICE, FATIGUE, FEELING ABNORMAL, FIBROMYALGIA, GENITAL HAEMORRHAGE, HEADACHE, LETHARGY, LYMPHADENOPATHY, MENORRHAGIA, MIGRAINE, NAUSEA, ONYCHOCLASIS, PELVIC PAIN, SJOGREN'S SYNDROME, SOLAR DERMATITIS, SYSTEMIC LUPUS ERYTHEMATOSUS, URTICARIA, UTERINE PAIN, WEIGHT INCREASED, THE FIRST EPISODE OF BUTTERFLY RASH, THE FIRST EPISODE OF DISTURBANCE IN ATTENTION, THE SECOND EPISODE OF BUTTERFLY RASH AND THE SECOND EPISODE OF DISTURBANCE IN ATTENTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE WILL BE FORCED TO UNDERGO A HYSTERECTOMY WITH REMOVAL OF THE ESSURE DEVICES. CURRENT WEIGHT 144 LBS. PER MEDICAL RECORD: INSERTION DETAIL: TRAILING COILS IN FALLOPIAN TUBE- RIGHT- 4 COILS, LEFT- 3 COILS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS IN A STABLE CONDITION. PER SOCIAL MEDIA: POST OPT ALL MY ISSUES FROM COIL ARE GONE. SHE HAD SOME ISSUES POP UP, BUT THOSE ARE TRACED TO BAD GENES. POST 18 MONTHS, MOST OF HER SYMPTOMS HAD DIMINISHED. REMOVAL DETAIL: THE ROBOT WAS DOCKED AND SINGLE INCISION ROBOTIC DA VINCI CANNULA INTRODUCED. THEY PROCEEDED TO PERFORM THE HYSTERECTOMY THE LEFT AND THE RIGHT UTEROOVARIAN LIGAMENTS WERE CAUTERIZED AND TRANSECTED. THE LEFT AND THE RIGHT MESOSALPINX WAS CAUTERIZED AND TRANSECTED, SO AS TO FREE THE FALLOPIAN TUBES FROM ITS ATTACHMENTS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO RECOVERY ROOM AWAKE AND IN STABLE CONDITION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2009: RESULTS: TOTAL BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS SOCIAL MEDIA: DEVICE BREAKAGE, EMBEDDED DEVICE, DEVICE EXPULSION, ARTHRALGIA, FEELING ABNORMAL, ASTHENIA, LETHARGY, ALLERGY TO METALS, LYMPHADENOPATHY, CERVICAL CANCER, ABDOMINAL DISTENSION, PELVIC AREA, NAUSEA, BURNING SENSATION, MENORRHAGIA, FIBROMYALGIA, BIPOLAR DISORDER, ONYCHOCLASIS. RASH, ALOPECIA, BRAIN FOG, DEPRESSION, FATIGUE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER, LAWYER, LAWYER, CONSUMER, CONSUMER OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-DEC-2020: QUALITY-SAFETY EVALUATION OF PTC. ON 1-DEC-2020: MR RECEIVED: MEDICAL HISTORY, REPORTER INFORMATION WERE ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("UNABLE TO GET FRAGMENT OUT"), EMBEDDED DEVICE ("ONE WAS DEEPLY EMBEDDED IN MY TISSUE"), DEVICE EXPULSION ("ONE MY COIL MIGRATED TO MY UTERUS"), MENORRHAGIA ("HEAVY PERIODS"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), SJOGREN'S SYNDROME ("SJOGREN'S R/O LUPUS SX INC"), SYSTEMIC LUPUS ERYTHEMATOSUS ("SJOGREN'S R/O LUPUS SX INC"), CERVIX CARCINOMA STAGE II ("CERVICAL CANCER (STAGE 2B)") AND BIPOLAR DISORDER ("BIPOLAR DISORDER") IN A 51-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED AUTOIMMUNE DISORDER ON (B)(6) 2007 AND GRAVIDA II. NO FAMILY HISTORY OF SJOGREN SYNDROME. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM AND BUPROPION HYDROCHLORIDE (WELLBUTRIN XL). ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN 2009, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE"), ANXIETY ("ANXIETY"), DEPRESSION ("EVENTUALLY DEPRESSION"), HEADACHE ("HEADACHES/CHRONIC HEADACHES ESCALATED OVER TIME AND BECAME AN ALMOST DAILY"), WEIGHT INCREASED ("WEIGHT GAIN"), FATIGUE ("FATIGUE"), THE FIRST EPISODE OF DISTURBANCE IN ATTENTION ("POOR CONCENTRATION"), UTERINE PAIN ("PAIN: AROUND UTERUS") AND ARTHRALGIA ("JOINT PAIN/ACHING JOINTS"). IN 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE PAIN WITH MENSTRUATION/DYSMENORRHEA (CRAMPING)"). IN 2016, THE PATIENT EXPERIENCED ALOPECIA ("SEVERE HAIR LOSS"). ON (B)(6) 2017, 8 YEARS 6 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED THE FIRST EPISODE OF BUTTERFLY RASH ("VARIOUS RASHES/BUTTERFLY SHAPED RASH ON FACE"). ON (B)(6) 2017, THE PATIENT EXPERIENCED SJOGREN'S SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SOLAR DERMATITIS ("SUN RASH") AND SYSTEMIC LUPUS ERYTHEMATOSUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2017, THE PATIENT EXPERIENCED CORNEAL ABRASION ("DUE TO CORNEAL ABRASIONS") AND DRY EYE ("DRY EYES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), URTICARIA ("H/O HIVES"), DYSPNOEA ("TROUBLE BREATHING NEAR ALLERGIES"), THE SECOND EPISODE OF DISTURBANCE IN ATTENTION ("POOR CONCENTRATION"), THE SECOND EPISODE OF BUTTERFLY RASH ("BUTTERFLY RASH"), FEELING ABNORMAL ("BRAIN FOG"), ASTHENIA ("LOW ENERGY"), LETHARGY ("LETHARGY"), COMPLICATION OF DEVICE REMOVAL ("UNABLE TO GET FRAGMENT OUT"), ALLERGY TO METALS ("NICKEL ALLERGY"), LYMPHADENOPATHY ("ENLARGED PELVIC LYMPH NODE"), CERVIX CARCINOMA STAGE II (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL DISTENSION ("BLOATING"), PELVIC PAIN ("PAIN IN PELVIC AREA"), NAUSEA ("NAUSEOUS"), BURNING SENSATION ("BURNING SENSATION"), DISCOMFORT ("PRESSURE SENSATION"), FIBROMYALGIA ("FIBROMYALGIA"), BIPOLAR DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ONYCHOCLASIS ("NAILS BREAKING/MY THUMB NAILS WERE TERRIBLE, THEY ALWAYS BROKE AT THE BASE"). THE PATIENT WAS TREATED WITH PARA-SELTZER (EXCEDRIN), STEROID ANTIBACTERIALS, HYDROXYCHLOROQUINE SULFATE (PLAQUINOL), SURGERY (SHE UNDERWENT HYSTERECTOMY WITH BILATERAL SALPINGECTOMY - KEPT OVARIES), FLUID REPLACEMENT (BLOOD TRANSFUSIONS) AND SURGERY (SHE UNDERWENT REMOVAL OF PELVIC LYMPH NODE). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, EMBEDDED DEVICE, DEVICE EXPULSION, GENITAL HAEMORRHAGE, DYSMENORRHOEA, ALOPECIA, MIGRAINE, URTICARIA, DYSPNOEA, THE LAST EPISODE OF DISTURBANCE IN ATTENTION, ANXIETY, DEPRESSION, SJOGREN'S SYNDROME, SOLAR DERMATITIS, THE LAST EPISODE OF BUTTERFLY RASH, CORNEAL ABRASION, DRY EYE, SYSTEMIC LUPUS ERYTHEMATOSUS, ARTHRALGIA, FEELING ABNORMAL, ASTHENIA, LETHARGY, COMPLICATION OF DEVICE REMOVAL, ALLERGY TO METALS, LYMPHADENOPATHY, CERVIX CARCINOMA STAGE II, ABDOMINAL DISTENSION, NAUSEA, BURNING SENSATION, DISCOMFORT, FIBROMYALGIA AND BIPOLAR DISORDER OUTCOME WAS UNKNOWN, THE MENORRHAGIA, HEADACHE, FATIGUE, UTERINE PAIN, PELVIC PAIN AND ONYCHOCLASIS HAD RESOLVED AND THE WEIGHT INCREASED WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALLERGY TO METALS, ALOPECIA, ANXIETY, ARTHRALGIA, ASTHENIA, BIPOLAR DISORDER, BURNING SENSATION, CERVIX CARCINOMA STAGE II, COMPLICATION OF DEVICE REMOVAL, CORNEAL ABRASION, DEPRESSION, DEVICE BREAKAGE, DEVICE EXPULSION, DISCOMFORT, DRY EYE, DYSMENORRHOEA, DYSPNOEA, EMBEDDED DEVICE, FATIGUE, FEELING ABNORMAL, FIBROMYALGIA, GENITAL HAEMORRHAGE, HEADACHE, LETHARGY, LYMPHADENOPATHY, MENORRHAGIA, MIGRAINE, NAUSEA, ONYCHOCLASIS, PELVIC PAIN, SJOGREN'S SYNDROME, SOLAR DERMATITIS, SYSTEMIC LUPUS ERYTHEMATOSUS, URTICARIA, UTERINE PAIN, WEIGHT INCREASED, THE FIRST EPISODE OF BUTTERFLY RASH, THE FIRST EPISODE OF DISTURBANCE IN ATTENTION, THE SECOND EPISODE OF BUTTERFLY RASH AND THE SECOND EPISODE OF DISTURBANCE IN ATTENTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE WILL BE FORCED TO UNDERGO A HYSTERECTOMY WITH REMOVAL OF THE ESSURE DEVICES. CURRENT WEIGHT 144 LBS. PER MEDICAL RECORD: INSERTION DETAIL: TRAILING COILS IN FALLOPIAN TUBE- RIGHT- 4 COILS, LEFT- 3 COILS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS IN A STABLE CONDITION. PER SOCIAL MEDIA: POST OPT ALL MY ISSUES FROM COIL ARE GONE. SHE HAD SOME ISSUES POP UP, BUT THOSE ARE TRACED TO BAD GENES. POST 18 MONTHS, MOST OF HER SYMPTOMS HAD DIMINISHED. REMOVAL DETAIL: THE ROBOT WAS DOCKED AND SINGLE INCISION ROBOTIC DA VINCI CANNULA INTRODUCED. THEY PROCEEDED TO PERFORM THE HYSTERECTOMY THE LEFT AND THE RIGHT UTEROOVARIAN LIGAMENTS WERE CAUTERIZED AND TRANSECTED. THE LEFT AND THE RIGHT MESOSALPINX WAS CAUTERIZED AND TRANSECTED, SO AS TO FREE THE FALLOPIAN TUBES FROM ITS ATTACHMENTS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO RECOVERY ROOM AWAKE AND IN STABLE CONDITION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2009: TOTAL BILATERAL OCCLUSION . HSG TEST. THYROID HORMONE LEVEL: NORMAL. POSITIVE ANA AND RA FACTOR. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS SOCIAL MEDIA: DEVICE BREAKAGE, EMBEDDED DEVICE, DEVICE EXPULSION, ARTHRALGIA, FEELING ABNORMAL, ASTHENIA, LETHARGY, ALLERGY TO METALS, LYMPHADENOPATHY, CERVICAL CANCER, ABDOMINAL DISTENSION, PELVIC AREA, NAUSEA, BURNING SENSATION, MENORRHAGIA, FIBROMYALGIA, BIPOLAR DISORDER, ONYCHOCLASIS. RASH, ALOPECIA, BRAIN FOG, DEPRESSION, FATIGUE, QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER, LAWYER, LAWYER, CONSUMER, CONSUMER OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-NOV-2018: QUALITY SAFETY EVALUATION OF PTC. 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 DEVICE BREAKAGE ('UNABLE TO GET FRAGMENT OUT'), EMBEDDED DEVICE ('ONE WAS DEEPLY EMBEDDED IN MY TISSUE'), DEVICE EXPULSION ('ONE MY COIL MIGRATED TO MY UTERUS') AND MENORRHAGIA ('HEAVY PERIODS') IN A 51-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED AUTOIMMUNE DISORDER ON (B)(6) 2007 AND GRAVIDA II. NO FAMILY HISTORY OF SJOGREN SYNDROME. THYROID HORMONE LEVEL: NORMAL. POSITIVE ANA AND RA FACTOR. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM AND BUPROPION HYDROCHLORIDE (WELLBUTRIN). ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN 2009, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE"), ANXIETY ("ANXIETY"), DEPRESSION ("EVENTUALLY DEPRESSION"), HEADACHE ("HEADACHES/CHRONIC HEADACHES ESCALATED OVER TIME AND BECAME AN ALMOST DAILY"), FATIGUE ("FATIGUE"), THE FIRST EPISODE OF DISTURBANCE IN ATTENTION ("POOR CONCENTRATION"), UTERINE PAIN ("PAIN: AROUND UTERUS") AND ARTHRALGIA ("JOINT PAIN/ACHING JOINTS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE PAIN WITH MENSTRUATION/DYSMENORRHEA (CRAMPING)"). IN 2016, THE PATIENT EXPERIENCED ALOPECIA ("SEVERE HAIR LOSS"). ON (B)(6) 2017, THE PATIENT EXPERIENCED THE FIRST EPISODE OF BUTTERFLY RASH ("VARIOUS RASHES/BUTTERFLY SHAPED RASH ON FACE"), 8 YEARS 6 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2017, THE PATIENT EXPERIENCED SJOGREN'S SYNDROME ("SJOGREN'S R/O LUPUS SX INC"), SOLAR DERMATITIS ("SUN RASH") AND SYSTEMIC LUPUS ERYTHEMATOSUS ("SJOGREN'S R/O LUPUS SX INC"). ON (B)(6) 2017, THE PATIENT EXPERIENCED CORNEAL ABRASION ("DUE TO CORNEAL ABRASIONS") AND DRY EYE ("DRY EYES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), URTICARIA ("H/O HIVES"), DYSPNOEA ("TROUBLE BREATHING NEAR ALLERGIES"), THE SECOND EPISODE OF DISTURBANCE IN ATTENTION ("POOR CONCENTRATION"), THE SECOND EPISODE OF BUTTERFLY RASH ("BUTTERFLY RASH"), FEELING ABNORMAL ("BRAIN FOG"), ASTHENIA ("LOW ENERGY"), LETHARGY ("LETHARGY"), COMPLICATION OF DEVICE REMOVAL ("UNABLE TO GET FRAGMENT OUT"), ALLERGY TO METALS ("NICKEL ALLERGY"), LYMPHADENOPATHY ("ENLARGED PELVIC LYMPH NODE"), ABDOMINAL DISTENSION ("BLOATING"), PELVIC PAIN ("PAIN IN PELVIC AREA"), NAUSEA ("NAUSEOUS"), BURNING SENSATION ("BURNING SENSATION"), DISCOMFORT ("PRESSURE SENSATION"), FIBROMYALGIA ("FIBROMYALGIA"), BIPOLAR DISORDER ("BIPOLAR DISORDER"), ONYCHOCLASIS ("NAILS BREAKING/MY THUMB NAILS WERE TERRIBLE, THEY ALWAYS BROKE AT THE BASE") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE DISEASE") AND WAS FOUND TO HAVE CERVIX CARCINOMA STAGE II ("CERVICAL CANCER (STAGE 2B)"). THE PATIENT WAS TREATED WITH CAFFEINE;PARACETAMOL (EXCEDRIN), HYDROXYCHLOROQUINE SULFATE (PLAQUINOL), STEROID ANTIBACTERIALS, SURGERY (SHE UNDERWENT HYSTERECTOMY WITH BILATERAL SALPINGECTOMY - KEPT OVARIES AND SHE UNDERWENT REMOVAL OF PELVIC LYMPH NODE) AND BLOOD TRANSFUSIONS. ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, EMBEDDED DEVICE, DEVICE EXPULSION, GENITAL HAEMORRHAGE, DYSMENORRHOEA, ALOPECIA, MIGRAINE, URTICARIA, DYSPNOEA, THE LAST EPISODE OF DISTURBANCE IN ATTENTION, ANXIETY, DEPRESSION, SJOGREN'S SYNDROME, SOLAR DERMATITIS, THE LAST EPISODE OF BUTTERFLY RASH, CORNEAL ABRASION, DRY EYE, SYSTEMIC LUPUS ERYTHEMATOSUS, ARTHRALGIA, FEELING ABNORMAL, ASTHENIA, LETHARGY, COMPLICATION OF DEVICE REMOVAL, ALLERGY TO METALS, LYMPHADENOPATHY, CERVIX CARCINOMA STAGE II, ABDOMINAL DISTENSION, NAUSEA, BURNING SENSATION, DISCOMFORT, FIBROMYALGIA, BIPOLAR DISORDER AND AUTOIMMUNE DISORDER OUTCOME WAS UNKNOWN, THE MENORRHAGIA, HEADACHE, FATIGUE, UTERINE PAIN, PELVIC PAIN AND ONYCHOCLASIS HAD RESOLVED AND THE WEIGHT INCREASED WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALLERGY TO METALS, ALOPECIA, ANXIETY, ARTHRALGIA, ASTHENIA, AUTOIMMUNE DISORDER, BIPOLAR DISORDER, BURNING SENSATION, CERVIX CARCINOMA STAGE II, COMPLICATION OF DEVICE REMOVAL, CORNEAL ABRASION, DEPRESSION, DEVICE BREAKAGE, DEVICE EXPULSION, DISCOMFORT, DRY EYE, DYSMENORRHOEA, DYSPNOEA, EMBEDDED DEVICE, FATIGUE, FEELING ABNORMAL, FIBROMYALGIA, GENITAL HAEMORRHAGE, HEADACHE, LETHARGY, LYMPHADENOPATHY, MENORRHAGIA, MIGRAINE, NAUSEA, ONYCHOCLASIS, PELVIC PAIN, SJOGREN'S SYNDROME, SOLAR DERMATITIS, SYSTEMIC LUPUS ERYTHEMATOSUS, URTICARIA, UTERINE PAIN, WEIGHT INCREASED, THE FIRST EPISODE OF BUTTERFLY RASH, THE FIRST EPISODE OF DISTURBANCE IN ATTENTION, THE SECOND EPISODE OF BUTTERFLY RASH AND THE SECOND EPISODE OF DISTURBANCE IN ATTENTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE WILL BE FORCED TO UNDERGO A HYSTERECTOMY WITH REMOVAL OF THE ESSURE DEVICES. CURRENT WEIGHT 144 LBS. PER MEDICAL RECORD: INSERTION DETAIL: TRAILING COILS IN FALLOPIAN TUBE- RIGHT- 4 COILS, LEFT- 3 COILS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS IN A STABLE CONDITION. PER SOCIAL MEDIA: POST OPT ALL MY ISSUES FROM COIL ARE GONE. SHE HAD SOME ISSUES POP UP, BUT THOSE ARE TRACED TO BAD GENES. POST 18 MONTHS, MOST OF HER SYMPTOMS HAD DIMINISHED. REMOVAL DETAIL: THE ROBOT WAS DOCKED AND SINGLE INCISION ROBOTIC DA VINCI CANNULA INTRODUCED. THEY PROCEEDED TO PERFORM THE HYSTERECTOMY THE LEFT AND THE RIGHT UTEROOVARIAN LIGAMENTS WERE CAUTERIZED AND TRANSECTED. THE LEFT AND THE RIGHT MESOSALPINX WAS CAUTERIZED AND TRANSECTED, SO AS TO FREE THE FALLOPIAN TUBES FROM ITS ATTACHMENTS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO RECOVERY ROOM AWAKE AND IN STABLE CONDITION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2009: RESULTS: TOTAL BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS SOCIAL MEDIA: DEVICE BREAKAGE, EMBEDDED DEVICE, DEVICE EXPULSION, ARTHRALGIA, FEELING ABNORMAL, ASTHENIA, LETHARGY, ALLERGY TO METALS, LYMPHADENOPATHY, CERVICAL CANCER, ABDOMINAL DISTENSION, PELVIC AREA, NAUSEA, BURNING SENSATION, MENORRHAGIA, FIBROMYALGIA, BIPOLAR DISORDER, ONYCHOCLASIS. RASH, ALOPECIA, BRAIN FOG, DEPRESSION, FATIGUE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER, LAWYER, LAWYER, CONSUMER, CONSUMER OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-JAN-2020: CONTENT FROM SOCIAL MEDIA RECEIVED. EVENT AUTOIMMUNE DISEASE WAS ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
"NTANEOUS" CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("UNABLE TO GET FRAGMENT OUT"), EMBEDDED DEVICE ("ONE WAS DEEPLY EMBEDDED IN MY TISSUE"), DEVICE EXPULSION ("ONE MY COIL MIGRATED TO MY UTERUS"), MENORRHAGIA ("HEAVY PERIODS"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), SJOGREN'S SYNDROME ("SJOGREN'S R/O LUPUS SX INC"), SYSTEMIC LUPUS ERYTHEMATOSUS ("SJOGREN'S R/O LUPUS SX INC"), CERVIX CARCINOMA ("CERVICAL CANCER (STAGE 2B)") AND BIPOLAR DISORDER ("BIPOLAR DISORDER") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "UNABLE TO GET FRAGMENT OUT". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED AUTOIMMUNE DISORDER ON (B)(6) 2007 AND GRAVIDA II. NO FAMILY HISTORY OF SJOGREN SYNDROME. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM AND BUPROPION (WELLBUTRIN). ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN 2009, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE"), ANXIETY ("ANXIETY"), DEPRESSION ("EVENTUALLY DEPRESSION"), HEADACHE ("HEADACHES/CHRONIC HEADACHES ESCALATED OVER TIME AND BECAME AN ALMOST DAILY"), WEIGHT INCREASED ("WEIGHT GAIN"), FATIGUE ("FATIGUE"), THE FIRST EPISODE OF DISTURBANCE IN ATTENTION ("POOR CONCENTRATION"), UTERINE PAIN ("PAIN: AROUND UTERUS") AND ARTHRALGIA ("JOINT PAIN/ACHING JOINTS"). IN 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE PAIN WITH MENSTRUATION/DYSMENORRHEA (CRAMPING)"). IN 2016, THE PATIENT EXPERIENCED ALOPECIA ("SEVERE HAIR LOSS"). ON (B)(6) 2017, 8 YEARS 6 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED RASH ("VARIOUS RASHES/BUTTERFLY SHAPED RASH ON FACE"). ON (B)(6) 2017, THE PATIENT EXPERIENCED SJOGREN'S SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PHOTOSENSITIVITY REACTION ("SUN RASH") AND SYSTEMIC LUPUS ERYTHEMATOSUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2017, THE PATIENT EXPERIENCED CORNEAL ABRASION ("DUE TO CORNEAL ABRASIONS") AND DRY EYE ("DRY EYES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), URTICARIA ("H/O HIVES"), DYSPNOEA ("TROUBLE BREATHING NEAR ALLERGIES"), THE SECOND EPISODE OF DISTURBANCE IN ATTENTION ("POOR CONCENTRATION"), BUTTERFLY RASH ("BUTTERFLY RASH"), THE FIRST EPISODE OF FEELING ABNORMAL ("BRAIN FOG"), ASTHENIA ("LOW ENERGY"), LETHARGY ("LETHARGY"), ALLERGY TO METALS ("NICKEL ALLERGY"), LYMPHADENOPATHY ("ENLARGED PELVIC LYMPH NODE"), CERVIX CARCINOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL DISTENSION ("BLOATING"), PELVIC PAIN ("PAIN IN PELVIC AREA"), NAUSEA ("NAUSEOUS"), BURNING SENSATION ("BURNING SENSATION"), THE SECOND EPISODE OF FEELING ABNORMAL ("PRESSURE SENSATION"), FIBROMYALGIA ("FIBROMYALGIA"), BIPOLAR DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ONYCHOCLASIS ("NAILS BREAKING/MY THUMB NAILS WERE TERRIBLE, THEY ALWAYS BROKE AT THE BASE"). THE PATIENT WAS TREATED WITH PARA-SELTZER (EXCEDRIN), STEROID ANTIBACTERIALS, HYDROXYCHLOROQUINE SULFATE (PLAQUINOL), SURGERY (SHE UNDERWENT HYSTERECTOMY WITH BILATERAL SALPINGECTOMY - KEPT OVARIES), SURGERY (SHE UNDERWENT HYSTERECTOMY WITH BILATERAL SALPINGECTOMY - KEPT OVARIES), SURGERY (SHE UNDERWENT HYSTERECTOMY WITH BILATERAL SALPINGECTOMY - KEPT OVARIES), FLUID REPLACEMENT (BLOOD TRANSFUSIONS) AND SURGERY (SHE UNDERWENT REMOVAL OF PELVIC LYMPH NODE). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, EMBEDDED DEVICE, DEVICE EXPULSION, GENITAL HAEMORRHAGE, DYSMENORRHOEA, ALOPECIA, MIGRAINE, URTICARIA, DYSPNOEA, THE LAST EPISODE OF DISTURBANCE IN ATTENTION, ANXIETY, DEPRESSION, SJOGREN'S SYNDROME, PHOTOSENSITIVITY REACTION, BUTTERFLY RASH, CORNEAL ABRASION, DRY EYE, SYSTEMIC LUPUS ERYTHEMATOSUS, ARTHRALGIA, ASTHENIA, LETHARGY, ALLERGY TO METALS, LYMPHADENOPATHY, CERVIX CARCINOMA, ABDOMINAL DISTENSION, NAUSEA, BURNING SENSATION, THE LAST EPISODE OF FEELING ABNORMAL, FIBROMYALGIA AND BIPOLAR DISORDER OUTCOME WAS UNKNOWN, THE MENORRHAGIA, RASH, HEADACHE, FATIGUE, UTERINE PAIN, PELVIC PAIN AND ONYCHOCLASIS HAD RESOLVED AND THE WEIGHT INCREASED WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALLERGY TO METALS, ALOPECIA, ANXIETY, ARTHRALGIA, ASTHENIA, BIPOLAR DISORDER, BURNING SENSATION, BUTTERFLY RASH, CERVIX CARCINOMA, CORNEAL ABRASION, DEPRESSION, DEVICE BREAKAGE, DEVICE EXPULSION, DRY EYE, DYSMENORRHOEA, DYSPNOEA, EMBEDDED DEVICE, FATIGUE, FIBROMYALGIA, GENITAL HAEMORRHAGE, HEADACHE, LETHARGY, LYMPHADENOPATHY, MENORRHAGIA, MIGRAINE, NAUSEA, ONYCHOCLASIS, PELVIC PAIN, PHOTOSENSITIVITY REACTION, RASH, SJOGREN'S SYNDROME, SYSTEMIC LUPUS ERYTHEMATOSUS, URTICARIA, UTERINE PAIN, WEIGHT INCREASED, THE FIRST EPISODE OF DISTURBANCE IN ATTENTION, THE FIRST EPISODE OF FEELING ABNORMAL, THE SECOND EPISODE OF DISTURBANCE IN ATTENTION AND THE SECOND EPISODE OF FEELING ABNORMAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE WILL BE FORCED TO UNDERGO A HYSTERECTOMY WITH REMOVAL OF THE ESSURE DEVICES. CURRENT WEIGHT (B)(6). PER MEDICAL RECORD: INSERTION DETAIL: TRAILING COILS IN FALLOPIAN TUBE- RIGHT- 4 COILS, LEFT- 3 COILS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS IN A STABLE CONDITION. PER SOCIAL MEDIA: POST OPT ALL MY ISSUES FROM COIL ARE GONE. SHE HAD SOME ISSUES POP UP, BUT THOSE ARE TRACED TO BAD GENES. POST 18 MONTHS, MOST OF HER SYMPTOMS HAD DIMINISHED. REMOVAL DETAIL: THE ROBOT WAS DOCKED AND SINGLE INCISION ROBOTIC DA VINCI CANNULA INTRODUCED. THEY PROCEEDED TO PERFORM THE HYSTERECTOMY THE LEFT AND THE RIGHT UTEROOVARIAN LIGAMENTS WERE CAUTERIZED AND TRANSECTED. THE LEFT AND THE RIGHT MESOSALPINX WAS CAUTERIZED AND TRANSECTED, SO AS TO FREE THE FALLOPIAN TUBES FROM ITS ATTACHMENTS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO RECOVERY ROOM AWAKE AND IN STABLE CONDITION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2009: TOTAL BILATERAL OCCLUSION; HSG TEST. THYROID HORMONE LEVEL: NORMAL. POSITIVE ANA AND RA FACTOR. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS SOCIAL MEDIA: DEVICE BREAKAGE, EMBEDDED DEVICE, DEVICE EXPULSION, ARTHRALGIA, FEELING ABNORMAL, ASTHENIA, LETHARGY, ALLERGY TO METALS, LYMPHADENOPATHY, CERVICAL CANCER, ABDOMINAL DISTENSION, PELVIC AREA, NAUSEA, BURNING SENSATION, MENORRHAGIA, FIBROMYALGIA, BIPOLAR DISORDER, ONYCHOCLASIS. RASH, ALOPECIA, BRAIN FOG, DEPRESSION, FATIGUE. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER, LAWYER, LAWYER, CONSUMER, CONSUMER OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-OCT-2018: REPORTER INFORMATION ADDED. HIST AND CONC CONDITION,LAB DATA ADDED. ESSURE INDICATION AMENDED. ESSURE INSERTION/REMOVAL DATES UPDATED. CONC AND TREATMENT MEDICATIONS ADDED. PER PFS: H/O HIVES, TROUBLE BREATHING NEAR ALLERGIES, POOR CONCENTRATION, ANXIETY, EVENTUALLY DEPRESSION, SJOGREN'S R/O LUPUS SX INC, SUN RASH, BUTTERFLY RASH, HEADACHES/CHRONIC HEADACHES ESCALATED OVER TIME AND BECAME AN ALMOST DAILY, DUE TO CORNEAL ABRASIONS, DRY EYES, WEIGHT GAIN, FATIGUE, PAIN: AROUND UTERUS ADDED. PER SOCIAL MEDIA : UNABLE TO GET FRAGMENT OUT, ONE WAS DEEPLY EMBEDDED IN MY TISSUE, ONE MY COIL MIGRATED TO MY UTERUS), JOINT PAIN/ACHING JOINTS, BRAIN FOG, LOW ENERGY, LETHARGY, NICKEL ALLERGY, ENLARGED PELVIC LYMPH NODE, CERVICAL CANCER (STAGE 2B), BLOATING, PAIN IN PELVIC AREA, NAUSEOUS, BURNING SENSATION, PRESSURE SENSATION, HEAVY PERIODS, FIBROMYALGIA, BIPOLAR DISORDER, NAILS BREAKING/MY THUMB NAILS WERE TERRIBLE, THEY ALWAYS BROKE AT THE BASE WERE ADDED. OUTCOME FOR SOME EVENTS AMENDED. 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 |
|---|---|---|---|---|---|---|---|
| 860089 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Other| R | ALPRAZOLAM| ALPRAZOLAM| ALPRAZOLAM| ALPRAZOLAM| ALPRAZOLAM| ALPRAZOLAM| ALPRAZOLAM| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN XL |