ESSURE
Report
- Report Number
- 2951250-2021-02707
- Event Type
- Injury
- Date Received
- June 25, 2021
- Date of Event
- January 1, 2017
- Report Date
- September 15, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') AND WHEELCHAIR USER ('WHEELCHAIR USER') IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882183) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED SEXUAL ABUSE (WITH MULTIPLE EMOTIONAL TRAUMAS FROM CHILDHOOD, PERMANENT FEAR, ANGUISH, PEAKS OF ANXIETY, AGITATION.), MULTIGRAVIDA, ABORTION (1), PARITY 3, ADENOMYOSIS AND LEIOMYOMA NOS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IUD, DEPO PROVERA AND ORAL CONTRACEPTIVE NOS. CONCURRENT CONDITIONS INCLUDED DEPRESSIVE DISORDER (SINCE CHILDHOOD - SERIOUS EPISODES). CONCOMITANT PRODUCTS INCLUDED RILUZOLE (RILUZOL) SINCE (B)(6) 2020 FOR AMYOTROPHIC LATERAL SCLEROSIS AND AMITRIPTYLINE (AMITRIPTILINA) AND DESVENLAFAXINE (DESVENLAFAXINA) FOR DEPRESSION AND ANXIETY. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("LIGHT COLIC IN THE RIGHT SIDE AT TIME OF ESSURE INSERTION"). IN 2017, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), HEADACHE ("HEADACHE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), URINARY TRACT INFECTION ("URINARY INFECTION (FREQUENT)"), INTERNAL HAEMORRHAGE ("INTERNAL BLEEDING"), PAIN IN EXTREMITY ("LEG PAIN"), BELLY ACHE ("PAIN IN BELLY / ABDOMINAL PAIN") AND ARTHRALGIA ("ARTICULAR PAIN"). IN 2018, THE PATIENT EXPERIENCED PARESIS ("PROGRESSIVE PARESIS"). IN (B)(6) 2018, THE PATIENT EXPERIENCED WHEELCHAIR USER (SERIOUSNESS CRITERION DISABILITY) WITH ASTHENIA AND MUSCULOSKELETAL STIFFNESS. IN (B)(6) 2019, THE PATIENT EXPERIENCED MUSCULAR WEAKNESS ("LOSS OF MUSCLE STRENGTH IN THE LEFT LOWER LIMBS"). ON (B)(6) 2020, THE PATIENT EXPERIENCED CONSTIPATION ("CONSTIPATION") WITH NEUROGENIC BOWEL AND PARKINSONISM ("PARKINSON'S SYNDROME"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL CRAMPS ("HEAVY CRAMPS"), NAUSEA ("NAUSEA"), UTERINE ENLARGEMENT ("GROWTH OF UTERUS WITH POLYGON FORMATION"), BACK PAIN ("BACK PAIN"), GAIT DISTURBANCE ("DIFFICULTY IN WALKING"), ENDOMETRIOSIS ("ENDOMETRIOSIS"), OVARIAN CYST ("OVARIAN CYSTS"), NEUROGENIC BLADDER ("NEUROGENIC BLADDER") WITH URGE INCONTINENCE AND NOCTURIA AND IRREGULAR SLEEP PHASE ("IRREGULAR SLEEP"). THE PATIENT WAS TREATED WITH SURGERY (HISTERECTOMY AND SALPINGECTOMY/ REMOVAL OF THE UTERUS AND FALLOPIAN TUBES). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE PELVIC PAIN, WHEELCHAIR USER, ABDOMINAL CRAMPS, NAUSEA, HEADACHE, ABDOMINAL PAIN, UTERINE ENLARGEMENT, URINARY TRACT INFECTION, INTERNAL HAEMORRHAGE, BACK PAIN, PAIN IN EXTREMITY, GAIT DISTURBANCE, BELLY ACHE, ARTHRALGIA, ENDOMETRIOSIS, OVARIAN CYST, NEUROGENIC BLADDER, CONSTIPATION, PARKINSONISM, IRREGULAR SLEEP PHASE, PARESIS AND PROCEDURAL PAIN OUTCOME WAS UNKNOWN AND THE MUSCULAR WEAKNESS HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ARTHRALGIA, BACK PAIN, CONSTIPATION, ENDOMETRIOSIS, GAIT DISTURBANCE, INTERNAL HAEMORRHAGE, IRREGULAR SLEEP PHASE, MUSCULAR WEAKNESS, NEUROGENIC BLADDER, OVARIAN CYST, PAIN IN EXTREMITY, PARESIS, PARKINSONISM, URINARY TRACT INFECTION, UTERINE ENLARGEMENT AND BELLY ACHE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, HEADACHE, NAUSEA, PELVIC PAIN, PROCEDURAL PAIN, WHEELCHAIR USER AND ABDOMINAL CRAMPS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE REMOVAL ALSO REPORTED ON (B)(6) 2020. SHE WAS RECOVERING FROM URGE INCONTINENCE AND NOCTURIA AND WEAKNESS IN LEG. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BLOOD TEST - ON (B)(6) 2018: EOSINOPHILS = 0,8% (1,0 - 5,0); ON (B)(6) 2019: TSH: 8,92 ¿UI/ML (REFERENCE VALUE: 0,55 - 4,78); T4: 0,82NG/DL (REFERENCE VALUE: 0,89 - 1,76);; ON (B)(6) 2021: MANGANESE: 5.0 MCG/L (REFERENCE VALUE: 8.0 - 12.0 MCG/L); ZINC: 4992.0 MCG/L (REFERENCE VALUE: 6000.0 - 7000.0 MCG/L); SELENIUM: 57.00 MCG/L (REFERENCE VALUE: 90 -130 MCG/L); BORON: LESS THAN 20 MCG/L (REFERENCE VALUE: 20 - 50 MCG/L); MERCURY: LESS THAN 2 MCG/L (REFERENCE VALUE: 2 - 20 MCG/L); CADMIUM: LESS THAN 0,3 MCG/L (REFERENCE VALUE: 0,3 - 1,2 MCG/L); ARSENIC: LESS THAN 1.0 MCG/L (REFERENCE VALUE: 1 - 4 MCG/L); BARIUM: LESS THAN 0,5MCG/L (REFERENCE VALUE: 0,5 - 2,5 MCG/L); TITANIUM: LESS THAN 0,07 MCG/L (REFERENCE VALUE: 0,07 - 1,12 MCG/L).. CSF TEST - ON (B)(6) 2020: PROTEIN CSF: (15 - 45) REFERENCE VALUE: 120 - 130; CHLORIDES CSF: (119 MEQ/L) REFERENCE VALUE: NEGATIVE; GLUCOSES CSF: (50 - 80) REFERENCE VALUE: NEGATIVE. NO GRAM-STAINABLE MICROORGANISMS WERE OBSERVED. COMPUTERISED TOMOGRAM THORAX - ON (B)(6) 2020: CALCIFIED PULMONARY MICRONODULE IN THE POSTERIOR SEGMENT OF THE RIGHT UPPER LOBE, MEASURING 0.4 CM.. ELECTRONEUROMYOGRAPHY - ON (B)(6) 2019: NORMAL. HTLV TEST - ON (B)(6) 2019: NON-REACTIVE. HUMAN CHORIONIC GONADOTROPIN - ON (B)(6) 2014: PREGNANCY NEGATIVE. MAGNETIC RESONANCE IMAGING - ON (B)(6) 2018: NORMAL; ON (B)(6) 2019: THORACIC SPINE STRUCTURES WITH NO DETECTABLE CHANGES ON RESONANCE.; ON(B)(6) 2020: SMALL FOCAL AND CENTRAL DISC PROTRUSION IN C5/C6 COMPRESSING THE ANTERIOR SURFACE OF THE DURAL SAC.. PATHOLOGY TEST - ON (B)(6) 2020: UTERINE HYPERTROPHY (142.0 G), INTRAMURAL AND SUBSEROUS UTERINE LEIOMYOMAS, SECRETORY ENDOMETRIUM, ADENOMYOSIS, EDEMA AND BILATERAL TUBAL CONGESTION.. TRANSCRANIAL ELECTRICAL MOTOR EVOKED POTENTIAL MONITORING - ON (B)(6) 2020: IMPAIRMENT OF CONDUCTION IN CORTICO-MOTONEURONAL PATHWAYS FOR ALL FOUR LIMBS.. ULTRASOUND KIDNEY - ON (B)(6) 2019: KIDNEYS AND BLADDER WITH NORMAL ULTRASOUND APPEARANCE. ULTRASOUND SCAN VAGINA - ON (B)(6) 2020: LEFT OVARY WITH REDUCED VOLUME, DOMINANT CYSTIC NODULAR FORMATION IN THE RIGHT OVARIAN PARENCHYMA. HYPERECHOIC LINEAR STRUCTURE, OCCUPYING THE ENDOMETRIAL CAVITY IN THE REGION OF THE UTERINE CONVEXITY, PERMEATES THE SEROUS LAYER WITH AN EXTRAUTERINE COMPONENT. URINE ANALYSIS - ON (B)(6) 2019: COLOR: DARK YELLOW (REFERENCE VALUE: LIGHT YELLOW); TURN ASPECT (REFERENCE VALUE: CLEAR ASPECT) ; KETONES: ++ (REFERENCE VALUE: NEGATIVE); HEMOGLOBIN: + (REFERENCE VALUE: NEGATIVE). X-RAY OF PELVIS AND HIP - ON 04-DEC-2014: PRESENCE OF TWO TUBAL MICRODEVICES; ON (B)(6) 2020: RADIOPAQUE THREADS (ESSURE) IN THE PELVIS ON THE RIGHT AND LEFT.; ON (B)(6) 2015: NORMOPOSITIONED. LOT NUMBER:882183 MANUFACTURE DATE: 2011-07 EXPIRATION DATE: 2014-07. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-SEP-2021: QUALITY SAFETY EVALUATION OF PTC. 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 ('PELVIC PAIN') IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882183) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED SEXUAL ABUSE (WITH MULTIPLE EMOTIONAL TRAUMAS FROM CHILDHOOD, PERMANENT FEAR, ANGUISH, PEAKS OF ANXIETY, AGITATION.), MULTIGRAVIDA, ABORTION (1) AND PARITY 3. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IUD, INJECTABLE CONTRACEPTIVE NOS AND ORAL CONTRACEPTIVE NOS. CONCURRENT CONDITIONS INCLUDED DEPRESSIVE DISORDER (SINCE CHILDHOOD - SERIOUS EPISODES). CONCOMITANT PRODUCTS INCLUDED RILUZOLE (RILUZOL) SINCE (B)(6) 2020 FOR AMYOTROPHIC LATERAL SCLEROSIS AND AMITRIPTYLINE (AMITRIPTILINA) AND DESVENLAFAXINE (DESVENLAFAXINA) FOR DEPRESSION AND ANXIETY. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2017, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), HEADACHE ("HEADACHE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), URINARY TRACT INFECTION ("URINARY INFECTION (FREQUENT)"), INTERNAL HAEMORRHAGE ("INTERNAL BLEEDING"), PAIN IN EXTREMITY ("LEG PAIN"), BELLY ACHE ("PAIN IN BELLY / ABDOMINAL PAIN") AND ARTHRALGIA ("ARTICULAR PAIN"). IN 2018, THE PATIENT EXPERIENCED PARESIS ("PROGRESSIVE PARESIS"). IN (B)(6) 2019, THE PATIENT EXPERIENCED MUSCULAR WEAKNESS ("LOSS OF MUSCLE STRENGTH IN THE LEFT LOWER LIMBS"). ON (B)(6) 2020, THE PATIENT EXPERIENCED CONSTIPATION ("CONSTIPATION") WITH NEUROGENIC BOWEL AND PARKINSONISM ("PARKINSON'S SYNDROME"), 5 YEARS 11 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL CRAMPS ("HEAVY CRAMPS"), NAUSEA ("NAUSEA"), UTERINE ENLARGEMENT ("GROWTH OF UTERUS WITH POLYGON FORMATION"), BACK PAIN ("BACK PAIN"), GAIT DISTURBANCE ("DIFFICULTY IN WALKING"), ENDOMETRIOSIS ("ENDOMETRIOSIS"), OVARIAN CYST ("OVARIAN CYSTS"), NEUROGENIC BLADDER ("NEUROGENIC BLADDER") WITH URGE INCONTINENCE AND NOCTURIA AND IRREGULAR SLEEP PHASE ("IRREGULAR SLEEP"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF THE UTERUS AND FALLOPIAN TUBES). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL CRAMPS, NAUSEA, HEADACHE, ABDOMINAL PAIN, UTERINE ENLARGEMENT, URINARY TRACT INFECTION, INTERNAL HAEMORRHAGE, BACK PAIN, PAIN IN EXTREMITY, GAIT DISTURBANCE, BELLY ACHE, ARTHRALGIA, ENDOMETRIOSIS, OVARIAN CYST, NEUROGENIC BLADDER, CONSTIPATION, PARKINSONISM, IRREGULAR SLEEP PHASE AND PARESIS OUTCOME WAS UNKNOWN AND THE MUSCULAR WEAKNESS HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ARTHRALGIA, BACK PAIN, CONSTIPATION, ENDOMETRIOSIS, GAIT DISTURBANCE, INTERNAL HAEMORRHAGE, IRREGULAR SLEEP PHASE, MUSCULAR WEAKNESS, NEUROGENIC BLADDER, OVARIAN CYST, PAIN IN EXTREMITY, PARESIS, PARKINSONISM, URINARY TRACT INFECTION, UTERINE ENLARGEMENT AND BELLY ACHE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, HEADACHE, NAUSEA, PELVIC PAIN AND ABDOMINAL CRAMPS TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BLOOD TEST - ON (B)(6) 2018: EOSINOPHILS = 0,8% (1,0 - 5,0); ON (B)(6) 2019: TSH: 8,92 UI/ML (REFERENCE VALUE: 0,55 - 4,78); T4: 0,82NG/DL (REFERENCE VALUE: 0,89 - 1,76);; ON (B)(6) 2021: MANGANESE: 5.0 MCG/L (REFERENCE VALUE: 8.0 - 12.0 MCG/L); ZINC: 4992.0 MCG/L (REFERENCE VALUE: 6000.0 - 7000.0 MCG/L); SELENIUM: 57.00 MCG/L (REFERENCE VALUE: 90 -130 MCG/L); BORON: LESS THAN 20 MCG/L (REFERENCE VALUE: 20 - 50 MCG/L); MERCURY: LESS THAN 2 MCG/L (REFERENCE VALUE: 2 - 20 MCG/L); CADMIUM: LESS THAN 0,3 MCG/L (REFERENCE VALUE: 0,3 - 1,2 MCG/L); ARSENIC: LESS THAN 1.0 MCG/L (REFERENCE VALUE: 1 - 4 MCG/L); BARIUM: LESS THAN 0,5MCG/L (REFERENCE VALUE: 0,5 - 2,5 MCG/L); TITANIUM: LESS THAN 0,07 MCG/L (REFERENCE VALUE: 0,07 - 1,12 MCG/L).. CSF TEST - ON (B)(6) 2020: PROTEIN CSF: (15 - 45) REFERENCE VALUE: 120 - 130; CHLORIDES CSF: (119 MEQ/L) REFERENCE VALUE: NEGATIVE; GLUCOSES CSF: (50 - 80) REFERENCE VALUE: NEGATIVE. NO GRAM-STAINABLE MICROORGANISMS WERE OBSERVED.. COMPUTERISED TOMOGRAM THORAX - ON (B)(6) 2020: CALCIFIED PULMONARY MICRONODULE IN THE POSTERIOR SEGMENT OF THE RIGHT UPPER LOBE, MEASURING 0.4 CM. ELECTRONEUROMYOGRAPHY - ON (B)(6) 2019: NORMAL. HTLV TEST - ON (B)(6) 2019: NON-REACTIVE. HUMAN CHORIONIC GONADOTROPIN - ON (B)(6) 2014: PREGNANCY NEGATIVE. MAGNETIC RESONANCE IMAGING - ON (B)(6) 2018: NORMAL; ON (B)(6) 2019: THORACIC SPINE STRUCTURES WITH NO DETECTABLE CHANGES ON RESONANCE.; ON (B)(6) 2020: SMALL FOCAL AND CENTRAL DISC PROTRUSION IN C5/C6 COMPRESSING THE ANTERIOR SURFACE OF THE DURAL SAC.. PATHOLOGY TEST - ON (B)(6) 2020: UTERINE HYPERTROPHY (142.0 G), INTRAMURAL AND SUBSEROUS UTERINE LEIOMYOMAS, SECRETORY ENDOMETRIUM, ADENOMYOSIS, EDEMA AND BILATERAL TUBAL CONGESTION. TRANSCRANIAL ELECTRICAL MOTOR EVOKED POTENTIAL MONITORING - ON (B)(6) 2020: IMPAIRMENT OF CONDUCTION IN CORTICO-MOTONEURONAL PATHWAYS FOR ALL FOUR LIMBS.. ULTRASOUND KIDNEY - ON (B)(6) 2019: KIDNEYS AND BLADDER WITH NORMAL ULTRASOUND APPEARANCE. ULTRASOUND SCAN VAGINA - ON (B)(6) 2020: LEFT OVARY WITH REDUCED VOLUME, DOMINANT CYSTIC NODULAR FORMATION IN THE RIGHT OVARIAN PARENCHYMA. HYPERECHOIC LINEAR STRUCTURE, OCCUPYING THE ENDOMETRIAL CAVITY IN THE REGION OF THE UTERINE CONVEXITY, PERMEATES THE SEROUS LAYER WITH AN EXTRAUTERINE COMPONENT.. URINE ANALYSIS - ON (B)(6) 2019: COLOR: DARK YELLOW (REFERENCE VALUE: LIGHT YELLOW); TURN ASPECT (REFERENCE VALUE: CLEAR ASPECT) ; KETONES: ++ (REFERENCE VALUE: NEGATIVE); HEMOGLOBIN: + (REFERENCE VALUE: NEGATIVE). X-RAY OF PELVIS AND HIP - ON (B)(6) 2014: PRESENCE OF TWO TUBAL MICRODEVICES; ON (B)(6) 2020: RADIOPAQUE THREADS (ESSURE) IN THE PELVIS ON THE RIGHT AND LEFT.. LOT NUMBER:882183 MANUFACTURE DATE: 2011-07 EXPIRATION DATE: 2014-07. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-JUN-2021: QUALITY SAFETY EVALUATION OF PTC. 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 ('PELVIC PAIN') AND WHEELCHAIR USER ('WHEELCHAIR USER') IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882183) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED SEXUAL ABUSE (WITH MULTIPLE EMOTIONAL TRAUMAS FROM CHILDHOOD, PERMANENT FEAR, ANGUISH, PEAKS OF ANXIETY, AGITATION.), MULTIGRAVIDA, ABORTION (1), PARITY 3, ADENOMYOSIS AND LEIOMYOMA NOS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IUD, DEPO PROVERA AND ORAL CONTRACEPTIVE NOS. CONCURRENT CONDITIONS INCLUDED DEPRESSIVE DISORDER (SINCE CHILDHOOD - SERIOUS EPISODES). CONCOMITANT PRODUCTS INCLUDED RILUZOLE (RILUZOL) SINCE (B)(6) 2020 FOR AMYOTROPHIC LATERAL SCLEROSIS AND AMITRIPTYLINE (AMITRIPTILINA) AND DESVENLAFAXINE (DESVENLAFAXINA) FOR DEPRESSION AND ANXIETY. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("LIGHT COLIC IN THE RIGHT SIDE AT TIME OF ESSURE INSERTION"). IN 2017, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), HEADACHE ("HEADACHE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), URINARY TRACT INFECTION ("URINARY INFECTION (FREQUENT)"), INTERNAL HAEMORRHAGE ("INTERNAL BLEEDING"), PAIN IN EXTREMITY ("LEG PAIN"), BELLY ACHE ("PAIN IN BELLY / ABDOMINAL PAIN") AND ARTHRALGIA ("ARTICULAR PAIN"). IN 2018, THE PATIENT EXPERIENCED PARESIS ("PROGRESSIVE PARESIS"). IN (B)(6) 2018, THE PATIENT EXPERIENCED WHEELCHAIR USER (SERIOUSNESS CRITERION DISABILITY) WITH ASTHENIA AND MUSCULOSKELETAL STIFFNESS. IN (B)(6) 2019, THE PATIENT EXPERIENCED MUSCULAR WEAKNESS ("LOSS OF MUSCLE STRENGTH IN THE LEFT LOWER LIMBS"). ON (B)(6) 2020, THE PATIENT EXPERIENCED CONSTIPATION ("CONSTIPATION") WITH NEUROGENIC BOWEL AND PARKINSONISM ("PARKINSON'S SYNDROME"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL CRAMPS ("HEAVY CRAMPS"), NAUSEA ("NAUSEA"), UTERINE ENLARGEMENT ("GROWTH OF UTERUS WITH POLYGON FORMATION"), BACK PAIN ("BACK PAIN"), GAIT DISTURBANCE ("DIFFICULTY IN WALKING"), ENDOMETRIOSIS ("ENDOMETRIOSIS"), OVARIAN CYST ("OVARIAN CYSTS"), NEUROGENIC BLADDER ("NEUROGENIC BLADDER") WITH URGE INCONTINENCE AND NOCTURIA AND IRREGULAR SLEEP PHASE ("IRREGULAR SLEEP"). THE PATIENT WAS TREATED WITH SURGERY (HISTERECTOMY AND SALPINGECTOMY/ REMOVAL OF THE UTERUS AND FALLOPIAN TUBES). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL CRAMPS, NAUSEA, HEADACHE, ABDOMINAL PAIN, UTERINE ENLARGEMENT, URINARY TRACT INFECTION, INTERNAL HAEMORRHAGE, BACK PAIN, PAIN IN EXTREMITY, GAIT DISTURBANCE, BELLY ACHE, ARTHRALGIA, ENDOMETRIOSIS, OVARIAN CYST, NEUROGENIC BLADDER, CONSTIPATION, PARKINSONISM, IRREGULAR SLEEP PHASE, PARESIS, PROCEDURAL PAIN AND WHEELCHAIR USER OUTCOME WAS UNKNOWN AND THE MUSCULAR WEAKNESS HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ARTHRALGIA, BACK PAIN, CONSTIPATION, ENDOMETRIOSIS, GAIT DISTURBANCE, INTERNAL HAEMORRHAGE, IRREGULAR SLEEP PHASE, MUSCULAR WEAKNESS, NEUROGENIC BLADDER, OVARIAN CYST, PAIN IN EXTREMITY, PARESIS, PARKINSONISM, URINARY TRACT INFECTION, UTERINE ENLARGEMENT AND BELLY ACHE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, HEADACHE, NAUSEA, PELVIC PAIN, PROCEDURAL PAIN, WHEELCHAIR USER AND ABDOMINAL CRAMPS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE REMOVAL ALSO REPORTED ON (B)(6) 2020. SHE WAS RECOVERING FROM URGE INCONTINENCE AND NOCTURIA AND WEAKNESS IN LEG. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BLOOD TEST - ON (B)(6) 2018: EOSINOPHILS = 0,8% (1,0 - 5,0); ON (B)(6) 2019: TSH: 8,92 UI/ML (REFERENCE VALUE: 0,55 - 4,78); T4: 0,82NG/DL (REFERENCE VALUE: 0,89 - 1,76); ON (B)(6) 2021: MANGANESE: 5.0 MCG/L (REFERENCE VALUE: 8.0 - 12.0 MCG/L); ZINC: 4992.0 MCG/L (REFERENCE VALUE: 6000.0 - 7000.0 MCG/L); SELENIUM: 57.00 MCG/L (REFERENCE VALUE: 90 -130 MCG/L); BORON: LESS THAN 20 MCG/L (REFERENCE VALUE: 20 - 50 MCG/L); MERCURY: LESS THAN 2 MCG/L (REFERENCE VALUE: 2 - 20 MCG/L); CADMIUM: LESS THAN 0,3 MCG/L (REFERENCE VALUE: 0,3 - 1,2 MCG/L); ARSENIC: LESS THAN 1.0 MCG/L (REFERENCE VALUE: 1 - 4 MCG/L); BARIUM: LESS THAN 0,5MCG/L (REFERENCE VALUE: 0,5 - 2,5 MCG/L); TITANIUM: LESS THAN 0,07 MCG/L (REFERENCE VALUE: 0,07 - 1,12 MCG/L).. CSF TEST - ON (B)(6) 2020: PROTEIN CSF: (15 - 45) REFERENCE VALUE: 120 - 130; CHLORIDES CSF: (119 MEQ/L) REFERENCE VALUE: NEGATIVE; GLUCOSES CSF: (50 - 80) REFERENCE VALUE: NEGATIVE. NO GRAM-STAINABLE MICROORGANISMS WERE OBSERVED.. COMPUTERISED TOMOGRAM THORAX - ON (B)(6) 2020: CALCIFIED PULMONARY MICRONODULE IN THE POSTERIOR SEGMENT OF THE RIGHT UPPER LOBE, MEASURING 0.4 CM.. ELECTRONEUROMYOGRAPHY - ON (B)(6) 2019: NORMAL. HTLV TEST - ON (B)(6) 2019: NON-REACTIVE. HUMAN CHORIONIC GONADOTROPIN - ON (B)(6) 2014: PREGNANCY NEGATIVE. MAGNETIC RESONANCE IMAGING - ON (B)(6) 2018: NORMAL; ON (B)(6) 2019: THORACIC SPINE STRUCTURES WITH NO DETECTABLE CHANGES ON RESONANCE.; ON (B)(6) 2020: SMALL FOCAL AND CENTRAL DISC PROTRUSION IN C5/C6 COMPRESSING THE ANTERIOR SURFACE OF THE DURAL SAC.. PATHOLOGY TEST - ON (B)(6) 2020: UTERINE HYPERTROPHY (142.0 G), INTRAMURAL AND SUBSEROUS UTERINE LEIOMYOMAS, SECRETORY ENDOMETRIUM, ADENOMYOSIS, EDEMA AND BILATERAL TUBAL CONGESTION.. TRANSCRANIAL ELECTRICAL MOTOR EVOKED POTENTIAL MONITORING - ON (B)(6) 2020: IMPAIRMENT OF CONDUCTION IN CORTICO-MOTONEURONAL PATHWAYS FOR ALL FOUR LIMBS. ULTRASOUND KIDNEY - ON (B)(6) 2019: KIDNEYS AND BLADDER WITH NORMAL ULTRASOUND APPEARANCE.. ULTRASOUND SCAN VAGINA - ON (B)(6) 2020: LEFT OVARY WITH REDUCED VOLUME, DOMINANT CYSTIC NODULAR FORMATION IN THE RIGHT OVARIAN PARENCHYMA. HYPERECHOIC LINEAR STRUCTURE, OCCUPYING THE ENDOMETRIAL CAVITY IN THE REGION OF THE UTERINE CONVEXITY, PERMEATES THE SEROUS LAYER WITH AN EXTRAUTERINE COMPONENT.. URINE ANALYSIS - ON (B)(6) 2019: COLOR: DARK YELLOW (REFERENCE VALUE: LIGHT YELLOW); TURN ASPECT (REFERENCE VALUE: CLEAR ASPECT) ; KETONES: ++ (REFERENCE VALUE: NEGATIVE); HEMOGLOBIN: + (REFERENCE VALUE: NEGATIVE). X-RAY OF PELVIS AND HIP - ON (B)(6) 2014: PRESENCE OF TWO TUBAL MICRODEVICES; ON (B)(6) 2020: RADIOPAQUE THREADS (ESSURE) IN THE PELVIS ON THE RIGHT AND LEFT.; ON (B)(6) 2015: NORMOPOSITIONED. LOT NUMBER: 882183, MANUFACTURE DATE: 2011-07, AND EXPIRATION DATE: 2014-07. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-SEP-2021: NEW EVENTS WERE ADDED: WHEELCHAIR USER WITH SYMPTOM, LIGHT COLIC IN THE RIGHT SIDE AT TIME OF ESSURE INSERTION AND WEAKNESS ON STANDING. 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 ('PELVIC PAIN') IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882183) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED SEXUAL ABUSE (WITH MULTIPLE EMOTIONAL TRAUMAS FROM CHILDHOOD, PERMANENT FEAR, ANGUISH, PEAKS OF ANXIETY, AGITATION.), MULTIGRAVIDA, ABORTION (1) AND PARITY 3. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IUD, INJETABLE CONTRACEPTIVE NOS AND ORAL CONTRACEPTIVE NOS. CONCURRENT CONDITIONS INCLUDED DEPRESSIVE DISORDER (SINCE CHILDHOOD - SERIOUS EPISODES). CONCOMITANT PRODUCTS INCLUDED RILUZOLE (RILUZOL) SINCE (B)(6) 2020 FOR AMYOTROPHIC LATERAL SCLEROSIS AND AMITRIPTYLINE (AMITRIPTILINA) AND DESVENLAFAXINE (DESVENLAFAXINA) FOR DEPRESSION AND ANXIETY. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2017, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), HEADACHE ("HEADACHE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), URINARY TRACT INFECTION ("URINARY INFECTION (FREQUENT)"), INTERNAL HAEMORRHAGE ("INTERNAL BLEEDING"), PAIN IN EXTREMITY ("LEG PAIN"), BELLY ACHE ("PAIN IN BELLY / ABDOMINAL PAIN") AND ARTHRALGIA ("ARTICULAR PAIN"). IN 2018, THE PATIENT EXPERIENCED PARESIS ("PROGRESSIVE PARESIS"). IN (B)(6) 2019, THE PATIENT EXPERIENCED MUSCULAR WEAKNESS ("LOSS OF MUSCLE STRENGTH IN THE LEFT LOWER LIMBS"). ON (B)(6) 2020, THE PATIENT EXPERIENCED CONSTIPATION ("CONSTIPATION") WITH NEUROGENIC BOWEL AND PARKINSONISM ("PARKINSON'S SYNDROME"), 5 YEARS 11 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL CRAMPS ("HEAVY CRAMPS"), NAUSEA ("NAUSEA"), UTERINE ENLARGEMENT ("GROWTH OF UTERUS WITH POLYGON FORMATION"), BACK PAIN ("BACK PAIN"), GAIT DISTURBANCE ("DIFFICULTY IN WALKING"), ENDOMETRIOSIS ("ENDOMETRIOSIS"), OVARIAN CYST ("OVARIAN CYSTS"), NEUROGENIC BLADDER ("NEUROGENIC BLADDER") WITH URGE INCONTINENCE AND NOCTURIA AND IRREGULAR SLEEP PHASE ("IRREGULAR SLEEP"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF THE UTERUS AND FALLOPIAN TUBES). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL CRAMPS, NAUSEA, HEADACHE, ABDOMINAL PAIN, UTERINE ENLARGEMENT, URINARY TRACT INFECTION, INTERNAL HAEMORRHAGE, BACK PAIN, PAIN IN EXTREMITY, GAIT DISTURBANCE, BELLY ACHE, ARTHRALGIA, ENDOMETRIOSIS, OVARIAN CYST, NEUROGENIC BLADDER, CONSTIPATION, PARKINSONISM, IRREGULAR SLEEP PHASE AND PARESIS OUTCOME WAS UNKNOWN AND THE MUSCULAR WEAKNESS HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ARTHRALGIA, BACK PAIN, CONSTIPATION, ENDOMETRIOSIS, GAIT DISTURBANCE, INTERNAL HAEMORRHAGE, IRREGULAR SLEEP PHASE, MUSCULAR WEAKNESS, NEUROGENIC BLADDER, OVARIAN CYST, PAIN IN EXTREMITY, PARESIS, PARKINSONISM, URINARY TRACT INFECTION, UTERINE ENLARGEMENT AND BELLY ACHE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, HEADACHE, NAUSEA, PELVIC PAIN AND ABDOMINAL CRAMPS TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BLOOD TEST - ON (B)(6) 2018: EOSINOPHILS = 0,8% (1,0 - 5,0); ON (B)(6) 2019: TSH: 8,92 ¿UI/ML (REFERENCE VALUE: 0,55 - 4,78); T4: 0,82NG/DL (REFERENCE VALUE: 0,89 - 1,76); ON (B)(6) 2021: MANGANESE: 5.0 MCG/L (REFERENCE VALUE: 8.0 - 12.0 MCG/L); ZINC: 4992.0 MCG/L (REFERENCE VALUE: 6000.0 - 7000.0 MCG/L); SELENIUM: 57.00 MCG/L (REFERENCE VALUE: 90 -130 MCG/L); BORON: LESS THAN 20 MCG/L (REFERENCE VALUE: 20 - 50 MCG/L); MERCURY: LESS THAN 2 MCG/L (REFERENCE VALUE: 2 - 20 MCG/L); CADMIUM: LESS THAN 0,3 MCG/L (REFERENCE VALUE: 0,3 - 1,2 MCG/L); ARSENIC: LESS THAN 1.0 MCG/L (REFERENCE VALUE: 1 - 4 MCG/L); BARIUM: LESS THAN 0,5MCG/L (REFERENCE VALUE: 0,5 - 2,5 MCG/L); TITANIUM: LESS THAN 0,07 MCG/L (REFERENCE VALUE: 0,07 - 1,12 MCG/L).. CSF TEST - ON (B)(6) 2020: PROTEIN CSF: (15 - 45) REFERENCE VALUE: 120 - 130; CHLORIDES CSF: (119 MEQ/L) REFERENCE VALUE: NEGATIVE; GLUCOSES CSF: (50 - 80) REFERENCE VALUE: NEGATIVE. NO GRAM-STAINABLE MICROORGANISMS WERE OBSERVED.. COMPUTERISED TOMOGRAM THORAX - ON (B)(6) 2020: CALCIFIED PULMONARY MICRONODULE IN THE POSTERIOR SEGMENT OF THE RIGHT UPPER LOBE, MEASURING 0.4 CM.. ELECTRONEUROMYOGRAPHY - ON (B)(6) 2019: NORMAL. HTLV TEST - ON (B)(6) 2019: NON-REACTIVE. HUMAN CHORIONIC GONADOTROPIN - ON (B)(6) 2014: PREGNANCY NEGATIVE. MAGNETIC RESONANCE IMAGING - ON (B)(6) 2018: NORMAL; ON (B)(6) 2019: THORACIC SPINE STRUCTURES WITH NO DETECTABLE CHANGES ON RESONANCE.; ON (B)(6) 2020: SMALL FOCAL AND CENTRAL DISC PROTRUSION IN C5/C6 COMPRESSING THE ANTERIOR SURFACE OF THE DURAL SAC.. PATHOLOGY TEST - ON (B)(6) 2020: UTERINE HYPERTROPHY (142.0 G), INTRAMURAL AND SUBSEROUS UTERINE LEIOMYOMAS, SECRETORY ENDOMETRIUM, ADENOMYOSIS, EDEMA AND BILATERAL TUBAL CONGESTION.. TRANSCRANIAL ELECTRICAL MOTOR EVOKED POTENTIAL MONITORING - ON (B)(6) 2020: IMPAIRMENT OF CONDUCTION IN CORTICO-MOTONEURONAL PATHWAYS FOR ALL FOUR LIMBS. ULTRASOUND KIDNEY - ON (B)(6) 2019: KIDNEYS AND BLADDER WITH NORMAL ULTRASOUND APPEARANCE.. ULTRASOUND SCAN VAGINA - ON (B)(6) 2020: LEFT OVARY WITH REDUCED VOLUME, DOMINANT CYSTIC NODULAR FORMATION IN THE RIGHT OVARIAN PARENCHYMA. HYPERECHOIC LINEAR STRUCTURE, OCCUPYING THE ENDOMETRIAL CAVITY IN THE REGION OF THE UTERINE CONVEXITY, PERMEATES THE SEROUS LAYER WITH AN EXTRAUTERINE COMPONENT. URINE ANALYSIS - ON (B)(6) 2019: COLOR: DARK YELLOW (REFERENCE VALUE: LIGHT YELLOW); TURN ASPECT (REFERENCE VALUE: CLEAR ASPECT) ; KETONES: ++ (REFERENCE VALUE: NEGATIVE); HEMOGLOBIN: + (REFERENCE VALUE: NEGATIVE). X-RAY OF PELVIS AND HIP - ON (B)(6) 2014: PRESENCE OF TWO TUBAL MICRODEVICES; ON (B)(6) 2020: RADIOPAQUE THREADS (ESSURE) IN THE PELVIS ON THE RIGHT AND LEFT.. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-JUN-2021: PATIENT´S MEDICAL HISTORY, HISTORICAL DRUGS AND LAB DATA 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 ('PELVIC PAIN') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882183) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED SEXUAL ABUSE (WITH MULTIPLE EMOTIONAL TRAUMAS FROM CHILDHOOD, PERMANENT FEAR, ANGUISH, PEAKS OF ANXIETY, AGITATION.). CONCURRENT CONDITIONS INCLUDED DEPRESSIVE DISORDER (SINCE CHILDHOOD - SERIOUS EPISODES). CONCOMITANT PRODUCTS INCLUDED RILUZOLE (RILUZOL) SINCE (B)(6) 2020 FOR AMYOTROPHIC LATERAL SCLEROSIS AND AMITRIPTYLINE (AMITRIPTILINA) AND DESVENLAFAXINE (DESVENLAFAXINA) FOR DEPRESSION AND ANXIETY. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2017, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), HEADACHE ("HEADACHE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), URINARY TRACT INFECTION ("URINARY INFECTION (FREQUENT)"), INTERNAL HAEMORRHAGE ("INTERNAL BLEEDING"), PAIN IN EXTREMITY ("LEG PAIN"), BELLY ACHE ("PAIN IN BELLY / ABDOMINAL PAIN") AND ARTHRALGIA ("ARTICULAR PAIN"). IN 2018, THE PATIENT EXPERIENCED PARESIS ("PROGRESSIVE PARESIS"). IN (B)(6) 2019, THE PATIENT EXPERIENCED MUSCULAR WEAKNESS ("LOSS OF MUSCLE STRENGTH IN THE LEFT LOWER LIMBS"). ON (B)(6) 2020, THE PATIENT EXPERIENCED CONSTIPATION ("CONSTIPATION") WITH NEUROGENIC BOWEL AND PARKINSONISM ("PARKINSON'S SYNDROME"), 5 YEARS 11 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL CRAMPS ("HEAVY CRAMPS"), NAUSEA ("NAUSEA"), UTERINE ENLARGEMENT ("GROWTH OF UTERUS WITH POLYGON FORMATION"), BACK PAIN ("BACK PAIN"), GAIT DISTURBANCE ("DIFFICULTY IN WALKING"), ENDOMETRIOSIS ("ENDOMETRIOSIS"), OVARIAN CYST ("OVARIAN CYSTS"), NEUROGENIC BLADDER ("NEUROGENIC BLADDER") WITH URGE INCONTINENCE AND NOCTURIA AND IRREGULAR SLEEP PHASE ("IRREGULAR SLEEP"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF THE UTERUS AND FALLOPIAN TUBES). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL CRAMPS, NAUSEA, HEADACHE, ABDOMINAL PAIN, UTERINE ENLARGEMENT, URINARY TRACT INFECTION, INTERNAL HAEMORRHAGE, BACK PAIN, PAIN IN EXTREMITY, GAIT DISTURBANCE, BELLY ACHE, ARTHRALGIA, ENDOMETRIOSIS, OVARIAN CYST, NEUROGENIC BLADDER, CONSTIPATION, PARKINSONISM, IRREGULAR SLEEP PHASE AND PARESIS OUTCOME WAS UNKNOWN AND THE MUSCULAR WEAKNESS HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ARTHRALGIA, BACK PAIN, CONSTIPATION, ENDOMETRIOSIS, GAIT DISTURBANCE, INTERNAL HAEMORRHAGE, IRREGULAR SLEEP PHASE, MUSCULAR WEAKNESS, NEUROGENIC BLADDER, OVARIAN CYST, PAIN IN EXTREMITY, PARESIS, PARKINSONISM, URINARY TRACT INFECTION, UTERINE ENLARGEMENT AND BELLY ACHE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, HEADACHE, NAUSEA, PELVIC PAIN AND ABDOMINAL CRAMPS TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BLOOD TEST - ON (B)(6) 2018: EOSINOPHILS = 0,8% (1,0 - 5,0); ON (B)(6) 2019: TSH: 8,92 UI/ML (REFERENCE VALUE: 0,55 - 4,78); T4: 0,82NG/DL (REFERENCE VALUE: 0,89 - 1,76);; ON (B)(6) 2021: MANGANESE: 5.0 MCG/L (REFERENCE VALUE: 8.0 - 12.0 MCG/L); ZINC: 4992.0 MCG/L (REFERENCE VALUE: 6000.0 - 7000.0 MCG/L); SELENIUM: 57.00 MCG/L (REFERENCE VALUE: 90 -130 MCG/L); BORON: LESS THAN 20 MCG/L (REFERENCE VALUE: 20 - 50 MCG/L); MERCURY: LESS THAN 2 MCG/L (REFERENCE VALUE: 2 - 20 MCG/L); CADMIUM: LESS THAN 0,3 MCG/L (REFERENCE VALUE: 0,3 - 1,2 MCG/L); ARSENIC: LESS THAN 1.0 MCG/L (REFERENCE VALUE: 1 - 4 MCG/L); BARIUM: LESS THAN 0,5MCG/L (REFERENCE VALUE: 0,5 - 2,5 MCG/L); TITANIUM: LESS THAN 0,07 MCG/L (REFERENCE VALUE: 0,07 - 1,12 MCG/L).. CSF TEST - ON (B)(6) 2020: PROTEIN CSF: (15 - 45) REFERENCE VALUE: 120 - 130; CHLORIDES CSF: (119 MEQ/L) REFERENCE VALUE: NEGATIVE; GLUCOSES CSF: (50 - 80) REFERENCE VALUE: NEGATIVE. NO GRAM-STAINABLE MICROORGANISMS WERE OBSERVED.. COMPUTERISED TOMOGRAM THORAX - ON (B)(6) 2020: CALCIFIED PULMONARY MICRONODULE IN THE POSTERIOR SEGMENT OF THE RIGHT UPPER LOBE, MEASURING 0.4 CM.. ELECTRONEUROMYOGRAPHY - ON (B)(6) 2019: NORMAL. HTLV TEST - ON (B)(6) 2019: NON-REACTIVE. MAGNETIC RESONANCE IMAGING - ON (B)(6) 2018: NORMAL; ON (B)(6) 2019: THORACIC SPINE STRUCTURES WITH NO DETECTABLE CHANGES ON RESONANCE.; ON (B)(6) 2020: SMALL FOCAL AND CENTRAL DISC PROTRUSION IN C5/C6 COMPRESSING THE ANTERIOR SURFACE OF THE DURAL SAC.. PATHOLOGY TEST - ON (B)(6) 2020: UTERINE HYPERTROPHY (142.0 G), INTRAMURAL AND SUBSEROUS UTERINE LEIOMYOMAS, SECRETORY ENDOMETRIUM, ADENOMYOSIS, EDEMA AND BILATERAL TUBAL CONGESTION.. TRANSCRANIAL ELECTRICAL MOTOR EVOKED POTENTIAL MONITORING - ON (B)(6) 2020: IMPAIRMENT OF CONDUCTION IN CORTICO-MOTONEURONAL PATHWAYS FOR ALL FOUR LIMBS.. ULTRASOUND KIDNEY - ON (B)(6) 2019: KIDNEYS AND BLADDER WITH NORMAL ULTRASOUND APPEARANCE.. ULTRASOUND SCAN VAGINA - ON (B)(6) 2020: LEFT OVARY WITH REDUCED VOLUME, DOMINANT CYSTIC NODULAR FORMATION IN THE RIGHT OVARIAN PARENCHYMA. HYPERECHOIC LINEAR STRUCTURE, OCCUPYING THE ENDOMETRIAL CAVITY IN THE REGION OF THE UTERINE CONVEXITY, PERMEATES THE SEROUS LAYER WITH AN EXTRAUTERINE COMPONENT.. URINE ANALYSIS - ON (B)(6) 2019: COLOR: DARK YELLOW (REFERENCE VALUE: LIGHT YELLOW); TURN ASPECT (REFERENCE VALUE: CLEAR ASPECT) ; KETONES: ++ (REFERENCE VALUE: NEGATIVE); HEMOGLOBIN: + (REFERENCE VALUE: NEGATIVE). X-RAY OF PELVIS AND HIP - ON (B)(6) 2014: PRESENCE OF TWO TUBAL MICRODEVICES; ON (B)(6) 2020: RADIOPAQUE THREADS (ESSURE) IN THE PELVIS ON THE RIGHT AND LEFT. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 963189 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 882183 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention | AMITRIPTILINA [AMITRIPTYLINE]| AMITRIPTILINA [AMITRIPTYLINE]| AMITRIPTILINA [AMITRIPTYLINE]| AMITRIPTILINA [AMITRIPTYLINE]| AMITRIPTILINA [AMITRIPTYLINE]| DESVENLAFAXINA [DESVENLAFAXINE]| DESVENLAFAXINA [DESVENLAFAXINE]| DESVENLAFAXINA [DESVENLAFAXINE]| DESVENLAFAXINA [DESVENLAFAXINE]| DESVENLAFAXINA [DESVENLAFAXINE]| RILUZOL| RILUZOL| RILUZOL| RILUZOL| RILUZOL| AMITRIPTILINA [AMITRIPTYLINE]| DESVENLAFAXINA [DESVENLAFAXINE]| RILUZOL |