ESSURE
Report
- Report Number
- 2951250-2020-12859
- Event Type
- Injury
- Date Received
- August 6, 2020
- Date of Event
- March 23, 2018
- Report Date
- September 24, 2021
- 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
- ES
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN'), DEVICE BREAKAGE ('REMAINS OF ESSURE IN RIGHT UTERINE HORN'), EMBEDDED DEVICE ('ON ULTRASOUND ESSURE INTRAMYOMETRIAL IN RIGHT HORN') AND POST PROCEDURAL FISTULA ('LEFT URETEROVAGINAL FISTULA/ POSTOPERATIVE FISTULA') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810877) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CAESAREAN SECTION (1) IN 2005, GRAVIDA II, PARITY 2, VAGINAL DELIVERY (1), BREAST FEEDING, CONTRACEPTION (BARRIER METHOD), DRUG INTOLERANCE, CONTACT DERMATITIS (YEARS AGO), POLLEN ALLERGY (RHINOCONJUNCTIVITIS TREATED SUCCESSFULLY WITH ANTIHISTAMINES IN ADOLESCENCE) AND APPENDECTOMY (AGE 18). NO PROBLEMS WITH HAIR DYES OR MAKE-UP. NO PROBLEMS WITH LATEX. FAMILY HISTORY WITHOUT RELEVANCE. NORMAL MENSTRUAL CYCLE. DATE OF LAST PERIOD BEFORE ESSURE INSERTION STARTED ON (B)(6) 2012. UTERUS ANTEVERTED. CONCURRENT CONDITIONS INCLUDED VON WILLEBRAND'S DISEASE SINCE 2011. FAMILY HISTORY INCLUDED ACUTE MYOCARDIAL INFARCTION (IN FATHER). CONCOMITANT PRODUCTS INCLUDED DESOGESTREL (CERAZETTE) SINCE (B)(6) 2012 FOR ORAL CONTRACEPTION. ON 1(B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED HEADACHE ("PERMANENT HEADACHE, SEVERE HEADACHE, STRONG HEADACHE"), METAL POISONING ("METALLOSIS"), FATIGUE ("TIREDNESS / CHRONIC FATIGUE / CHRONIC TIREDNESS") AND ARTHRALGIA ("JOINT PAIN (KNEES, SHOULDERS, WRISTS, FINGERS) / JOINT PAIN"). ON (B)(6) 2018, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), EMBEDDED DEVICE (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED) AND COMPLICATION OF DEVICE REMOVAL ("ESSURE REMOVAL INCOMPLETE"). ON (B)(6) 2019, THE PATIENT EXPERIENCED CERVICITIS ("CHRONIC CERVICITIS"). IN (B)(6) 2019, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING GREATER THAN HER PERIODS AFTER HYSTERECTOMY, METRORRHAGIA"). ON (B)(6) 2019, THE PATIENT EXPERIENCED POST PROCEDURAL FISTULA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH POST PROCEDURAL URINE LEAK AND MICTURITION URGENCY. ON (B)(6) 2019, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAIN AFTER LAPAROTOMY 6 DAYS AGO"). ON (B)(6) 2019, THE PATIENT EXPERIENCED URINARY TRACT DISORDER ("URINARY SPASMS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), ALLERGY TO METALS ("NICKEL ALLERGY") AND SWELLING ("SWELLING"). THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2018 TO (B)(6) 2018 AND THEN FROM (B)(6) 2019 TO (B)(6) 2019. THE PATIENT WAS TREATED WITH CEFUROXIME, HYOSCINE BUTYLBROMIDE (BUSCOPAN), METAMIZOLE MAGNESIUM (NOLOTIL), PARACETAMOL, TRANEXAMIC ACID (AMCHAFIBRIN) AND SURGERY (ESSURE REMOVAL 1ST BILATERAL SALPINGECTOMY (B)(6) 2018 AND 2ND TOTAL HYSTERECTOMY (B)(6) 2019, CATHETER ON (B)(6) 2019, CLOSURE OF LEFT FISTULA (B)(6) 2019, DOUBLE J URETHRAL CATHETER UNTIL (B)(6) 2019 AND LAPAROSCOPIC TOTAL HYSTERECTOMY ON (B)(6) 2019 WITH VAGINAL PIECE REMOVED TO EXTRACT ESSURE REMAINS). ESSURE WAS REMOVED ON (B)(6) 2019. IN (B)(6) 2019, THE VAGINAL HAEMORRHAGE HAD RESOLVED. ON (B)(6) 2019, THE POST PROCEDURAL FISTULA HAD RESOLVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, EMBEDDED DEVICE, PROCEDURAL PAIN AND URINARY TRACT DISORDER HAD RESOLVED, THE DEVICE BREAKAGE, METAL POISONING, SWELLING, COMPLICATION OF DEVICE REMOVAL AND CERVICITIS OUTCOME WAS UNKNOWN AND THE ALLERGY TO METALS, HEADACHE, FATIGUE AND ARTHRALGIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ALLERGY TO METALS, ARTHRALGIA, CERVICITIS, COMPLICATION OF DEVICE REMOVAL, DEVICE BREAKAGE, EMBEDDED DEVICE, FATIGUE, HEADACHE, METAL POISONING, PELVIC PAIN, POST PROCEDURAL FISTULA, PROCEDURAL PAIN, SWELLING, URINARY TRACT DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: ESSURE INSERTION WITHOUT DIFFICULTY. ESSURE REMOVAL WERE PERFORMED THROUGH TWO SURGICAL INTERVENTIONS: ON (B)(6) 2018 THROUGH A BILATERAL SALPINGECTOMY, AND ON (B)(6) 2019 A TOTAL HYSTERECTOMY. SHE HAD SUFFERED PSYCHOLOGICAL SEQUELAE, AND THEIR QUALITY OF LIFE, AS WELL AS THEIR PERSONAL AND FAMILY RELATIONSHIPS WERE DAMAGED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BLOOD GLUCOSE - ON (B)(6) 2019: ABNORMAL: 107. BLOOD TEST - IN 2011: (B)(6). C-REACTIVE PROTEIN - ON (B)(6) 2019: ABNORMAL: 13.3. CYSTOGRAM - ON (B)(6) 2019: CT INTRODUCED THROUGH BLADDER CATHETER, OBSERVING ADEQUATE FILLING OF BLADDER WITH THICKENING AND IRREGULARITY OF ITS LEFT POSTEROSUPERIOR WALL, AND RAPID EXTRAVASATION OF CONTRAST WITH DIRECT PASSAGE TO VAGINA BUT WITHOUT IDENTIFYING LEAKING POINT ON THIS EXAMINATION. CYSTOSCOPY - ON (B)(6) 2019: MEATUS AT THE LEVEL OF THE APEX -LEFT; LEFT URETHRAL CATHETER IS REMOVED. GYNAECOLOGICAL EXAMINATION - ON (B)(6) 2012: NORMAL EXTERNAL GENITALIA. CERVIX: MACROSCOPICALLY HEALTHY, NO BLEEDING, NO LEUCORRHOEA. UTERUS IN MOBILE ANTEVERSION, NO PAIN ON MOBILIZATION. SOFT AND NON-TENDER ABDOMEN; ON (B)(6) 2019: HEALTHY LOOKING EXTERNAL GENITALIA. WHEN INTRODUCING A SPECULUM, CLEAR FLUID SEEN TO COME OUT THROUGH VAGINA. VAGINAL CAVITY WITHOUT BLOOD REMAINS OR ACTIVE BLEEDING AT THE PRESENT TIME. COMPRESS PLACED INSIDE THE VAGINA. BLADDER CATHETERIZATION PERFORMED. METHYLENE BLUE IS INJECTED THROUGH THE URETHRA. THE COMPRESS INSERTED IN VAGINA IS NOW METHYLENE BLUE STAINED. CASE DISCUSSED WITH UROLOGY SERVICE WHO REQUESTS COMPUTERISED TOMOGRAPHY UROGRAM, CYSTOGRAPHY AND THEN CONTROL IN UROLOGY, NEED FOR PERMANENT BLADDER CATHETERIZATION FOR 2 MONTHS AND EVALUATION OF RESULTS; ON (B)(6) 2019: SPECULUM: AFTER INSERTING A PROBE, CLEAR FLUID AND LIGHT BLEEDING FLOW. TISSUE IN VAGINAL APEX. HAEMOGLOBIN (G/DL) - ON (B)(6) 2019: 13.4 G/DL; ON (B)(6) 2019: 12.4 G/DL. HYSTEROSCOPY - ON (B)(6) 2012: SATISFACTORY PROCEDURE. PATENT CERVIX. TYPE II CAVITY. ATROPHIC ENDOMETRIUM. OSTIA DISPLAYED. GOOD TOLERANCE. ESSURE INSERTION IS PERFORMED WITHOUT ANY DIFFICULTIES. RIGHT OSTIUM: 4 COILS IN CAVITY. LEFT OSTIUM: 4 COILS IN CAVITY. TIME: 5 MINUTES. LAPAROTOMY - ON (B)(6) 2019: EXPLORATORY: CLOSURE OF LEFT URETEROVAGINAL FISTULA WITH URETHRAL REIMPLANTATION WITH RICARD-TYPE ANTIREFLUX TECHNIQUE INTUBATED WITH DOUBLE J URETHRAL CATHETER. DIAGNOSIS: LEFT URETEROVAGINAL FISTULA. LEFT DOUBLE J CATHETER. PATHOLOGY TEST - ON (B)(6) 2019: MACROSCOPIC: HYSTERECTOMY PIECE WEIGHT 110 GRAMS MEASURES 9 X 6.5 X 2.5 CM. SMOOTH SEROUS SURFACE. EXTERNAL CERVICAL ORIFICE IS TORN, EXOCERVIX WHITISH SHOWS FOCAL REDDISH AREAS. AFTER OPENING, ENDOCERVICAL CANAL FREE, AS IS THE ENDOMETRIAL CAVITY. ENDOMETRIUM 2 MM THICK, MYOMETRIUM 20 MM THICK. ON THE SEROUS SURFACE, AT LEVEL OF ONE OF THE UTERINE HORNS, RAISED AREA OF 8 X 5 MM OBSERVED, WHITISH COLOUR, ARRANGED IN SERIES AND INCLUDED IN ITS ENTIRETY. THE CONTRALATERAL ZONE, THE SURFACE OF THE OTHER UTERINE HORN, DOES NOT PRESENT MACROSCOPIC ALTERATIONS, IT IS ALSO ARRANGED IN SERIES AND INCLUDED IN ITS ENTIRETY. NO METALLIC DEVICE HAS BEEN OBSERVED. MICROSCOPIC: HISTOLOGY: AT LEVEL OF ONE OF THE UTERINE HORNS, WHERE RAISED AND WHITISH AREA OF 8 X 5 MM IS MACROSCOPICALLY OBSERVED, A FOREIGN BODY TYPE GRANULOMA CONSISTING OF PALISADED HISTIOCYTES, CHRONIC INFLAMMATION AND PIGMENT IRON DEPOSIT IDENTIFIED. FIBRIN OBSERVED INSIDE THE GRANULOMA. NO FOREIGN BODY CONTAINED. IN THE OTHER CORNUAL AREA OF THE PIECE, NO HISTOLOGICAL LESIONS IDENTIFIED. DIAGNOSIS: FOREIGN BODY GRANULOMA IN THE UTERINE HORN REGION (SEE MACROSCOPIC AND MICROSCOPIC DESCRIPTION). PROLIFERATIVE ENDOMETRIUM. CHRONIC CERVICITIS; ON 03-JUN-2019: LEFT DISTAL UROTHELIUM: CHRONIC INFLAMMATION AND FRAGMENTS OF FISTULOUS TRACT COMPATIBLE WITH CLINICAL DIAGNOSIS (URETEROVAGINAL FISTULA). ABSENCE OF EPITHELIAL DYSPLASIA. CYSTIC OVARIAN LESION: SIMPLE CYST. PLATELET COUNT (GIGA/L) - ON (B)(6) 2019: 366.0 GIGA/L; ON (B)(6) 2019: 468.0 GIGA/L. SKIN TEST - ON (B)(6) 2018: POSITIVE FOR NICKEL +++. NEGATIVE FOR THE REMAINDER OF THE TRUE TEST: CADMIUM, ALUMINIUM, ZINC, COPPER, TITANIUM, VANADIUM, IRON, ZIRCONIUM, MOLYBDENUM, TUNGSTEN, MANGANESE AND NIOBIUM. DIAGNOSIS: NICKEL ALLERGY. ULTRASOUND SCAN - ON (B)(6) 2012: UTERUS IN REGULAR ANTEVERSION POSITION, EMPTY, WITH MEDIAN LINING OF MM. NORMAL ANNEXES. FREE DOUGLAS; ON (B)(6) 2018: UTERUS IN ANTEVERTED POSITION. LENGTH: 89.0 . ANTEROPOSTERIOR DIAMETER: 42.0. TRANSVERSE DIAMETER: 48.0. INTRAMYOMETRIAL IN RIGHT HORN, HYPER REFRINGENT IMAGING THAT SUGGEST 8 MM. ENDOMETRIUM: THICKNESS: 12. RIGHT OVARY DIAMETER: 27 X 17. LEFT OVARY DIAMETER: 24 X 14 DIAGNOSIS: SUGGESTING REMAINS OF ESSURE IN RIGHT UTERINE HORN.. URINE ANALYSIS - ON (B)(6) 2019: RED BLOOD CELLS (HAEMOGLOBIN): LEUKOCYTES (ESTERASE): TRACES . NITRITES: NEGATIVE. URINARY SEDIMENT: AUTOMATED RED BLOOD CELLS PER FIELD: 5 . YEASTS: MODERATE CULTURE. CULTURE IN URINARY CATHETER: STERILE.; ON (B)(6) 2019: PH URINE ISOLATED SAMPLE 6.5 (5.0 - 6.5), GLUCOSE: NEGATIVE (), KETONE BODIES: NEGATIVE (), BILIRUBIN: NEGATIVE (), UROBILINOGEN: 0.2 EU/DL (0.0 - 1.0), PROTEINS: NEGATIVE (), NITRITES: NEGATIVE (); ON (B)(6) 2019: STERILE URINE CULTURE. UROGRAM - ON (B)(6) 2019: CT: LEFT URETEROVAGINAL FISTULA AND RETROVESICAL FLUID COLLECTION CONNECTED TO THE FISTULA; ON (B)(6) 2019: CT WITH SINGLE PHASE INTRAVENOUS CONTRAST: KIDNEYS OF NORMAL SIZE, MORPHOLOGY AND PARENCHYMA, WITH AN ADEQUATE NEPHROGRAM, WITH NO EVIDENCE OF SIGNIFICANT DILATION OF EXCRETORY TRACT. LEFT RENAL DOUBLE J CATHETER, WITHOUT LITHIASIC IMAGES OR DILATION OF EXCRETORY SYSTEM. OTHER FINDINGS: GALLBLADDER WITH SMALL LITHIASIS AND A NODULE IN THE FUNDUS OF ABOUT 17 MM. TO ASSESS POSSIBLE ADENOMYOMATOSIS OR TUMOUR. POSSIBLY FUNCTIONAL RIGHT OVARIAN CYST OF 33 MM. SMALL HEPATIC SIMPLE CYST; ON (B)(6) 2019: INTRAVENOUS CONTRAST MEDIUM: KIDNEYS LOCATED IN IPSILATERAL RENAL FOSSAE, NORMAL SIZE AND MORPHOLOGY. BILATERAL, SYMMETRIC NEPHROGRAM WITH CONTRAST UPTAKE AND REMOVAL BY BOTH KIDNEYS. NORMAL COLLECTING SYSTEMS AND URETERS. REPLENISHED BLADDER, OBSERVING ALTERATION OF THE MORPHOLOGY AT LEVEL OF LEFT VESICOURETERAL MEATUS, PROBABLY SECONDARY TO PREVIOUS SURGERY. NO INTRAVENOUS CONTRAST EXTRAVASATIONS IDENTIFIED. DIAGNOSTIC JUDGEMENT: ALTERATION OF MORPHOLOGY AT LEVEL OF LEFT VESICOURETERAL MEATUS, PROBABLY SECONDARY TO PREVIOUS SURGERY. NO INTRAVENOUS CONTRAST EXTRAVASATIONS IDENTIFIED.. WHITE BLOOD CELL COUNT (GIGA/L) - ON (B)(6) 2019: 8.80 GIGA/L; ON (B)(6) -2019: 12.40 GIGA/L. LOT NUMBER:810877 MANUFACTURE DATE: 2010-12 EXPIRATION DATE: 2013-12. 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. FURTHER COMPANY FOLLOW-UP WITH THE LAWYER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-MAY-2021: 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 ('PELVIC PAIN'), DEVICE BREAKAGE ('REMAINS OF ESSURE IN RIGHT UTERINE HORN'), EMBEDDED DEVICE ('ON ULTRASOUND ESSURE INTRAMYOMETRIAL IN RIGHT HORN') AND POST PROCEDURAL FISTULA ('LEFT URETEROVAGINAL FISTULA/ POSTOPERATIVE FISTULA') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810877) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CAESAREAN SECTION (1) IN 2005, GRAVIDA II, PARITY 2, VAGINAL DELIVERY (1), BREAST FEEDING, CONTRACEPTION (BARRIER METHOD), DRUG INTOLERANCE, CONTACT DERMATITIS (YEARS AGO), POLLEN ALLERGY (RHINOCONJUNCTIVITIS TREATED SUCCESSFULLY WITH ANTIHISTAMINES IN ADOLESCENCE) AND APPENDECTOMY (AGE 18). NO PROBLEMS WITH HAIR DYES OR MAKE-UP. NO PROBLEMS WITH LATEX. FAMILY HISTORY WITHOUT RELEVANCE. NORMAL MENSTRUAL CYCLE. DATE OF LAST PERIOD BEFORE ESSURE INSERTION STARTED ON (B)(6) 2012. UTERUS ANTEVERTED. CONCURRENT CONDITIONS INCLUDED VON WILLEBRAND'S DISEASE SINCE 2011. FAMILY HISTORY INCLUDED ACUTE MYOCARDIAL INFARCTION (IN FATHER). CONCOMITANT PRODUCTS INCLUDED DESOGESTREL (CERAZETTE) SINCE (B)(6) 2012 FOR ORAL CONTRACEPTION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED HEADACHE ("PERMANENT HEADACHE, SEVERE HEADACHE, STRONG HEADACHE"), METAL POISONING ("METALLOSIS"), FATIGUE ("TIREDNESS / CHRONIC FATIGUE / CHRONIC TIREDNESS") AND ARTHRALGIA ("JOINT PAIN (KNEES, SHOULDERS, WRISTS, FINGERS) / JOINT PAIN"). ON (B)(6) 2018, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), EMBEDDED DEVICE (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED) AND COMPLICATION OF DEVICE REMOVAL ("ESSURE REMOVAL INCOMPLETE"). ON (B)(6) 2019, THE PATIENT EXPERIENCED CERVICITIS ("CHRONIC CERVICITIS"). IN (B)(6) 2019, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING GREATER THAN HER PERIODS AFTER HYSTERECTOMY, METRORRHAGIA"). ON (B)(6) 2019, THE PATIENT EXPERIENCED POST PROCEDURAL FISTULA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH POST PROCEDURAL URINE LEAK AND MICTURITION URGENCY. ON (B)(6) 2019, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAIN AFTER LAPAROTOMY 6 DAYS AGO"). ON (B)(6) 2019, THE PATIENT EXPERIENCED URINARY TRACT DISORDER ("URINARY SPASMS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), ALLERGY TO METALS ("NICKEL ALLERGY") AND SWELLING ("SWELLING"). THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2018 TO (B)(6) 2018 AND THEN FROM (B)(6) 2019 TO (B)(6) 2019. THE PATIENT WAS TREATED WITH CEFUROXIME, HYOSCINE BUTYLBROMIDE (BUSCOPAN), METAMIZOLE MAGNESIUM (NOLOTIL), PARACETAMOL, TRANEXAMIC ACID (AMCHAFIBRIN) AND SURGERY (ESSURE REMOVAL 1ST BILATERAL SALPINGECTOMY (B)(6) 2018 AND 2ND TOTAL HYSTERECTOMY (B)(6) 2019, CATHETER ON 26(B)(6) 2019, CLOSURE OF LEFT FISTULA (B)(6) 2019, DOUBLE J URETHRAL CATHETER UNTIL (B)(6) 2019 AND LAPAROSCOPIC TOTAL HYSTERECTOMY ON (B)(6) 2019 WITH VAGINAL PIECE REMOVED TO EXTRACT ESSURE REMAINS). ESSURE WAS REMOVED ON (B)(6) 2019. IN (B)(6) 2019, THE VAGINAL HAEMORRHAGE HAD RESOLVED. ON (B)(6) 2019, THE POST PROCEDURAL FISTULA HAD RESOLVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, EMBEDDED DEVICE, PROCEDURAL PAIN AND URINARY TRACT DISORDER HAD RESOLVED, THE DEVICE BREAKAGE, METAL POISONING, SWELLING, COMPLICATION OF DEVICE REMOVAL AND CERVICITIS OUTCOME WAS UNKNOWN AND THE ALLERGY TO METALS, HEADACHE, FATIGUE AND ARTHRALGIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ALLERGY TO METALS, ARTHRALGIA, CERVICITIS, COMPLICATION OF DEVICE REMOVAL, DEVICE BREAKAGE, EMBEDDED DEVICE, FATIGUE, HEADACHE, METAL POISONING, PELVIC PAIN, POST PROCEDURAL FISTULA, PROCEDURAL PAIN, SWELLING, URINARY TRACT DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION WITHOUT DIFFICULTY. ESSURE REMOVAL WERE PERFORMED THROUGH TWO SURGICAL INTERVENTIONS: ON (B)(6) 2018 THROUGH A BILATERAL SALPINGECTOMY, AND ON (B)(6) 2019 A TOTAL HYSTERECTOMY. SHE HAD SUFFERED PSYCHOLOGICAL SEQUELAE, AND THEIR QUALITY OF LIFE, AS WELL AS THEIR PERSONAL AND FAMILY RELATIONSHIPS WERE DAMAGED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BLOOD GLUCOSE - ON (B)(6) 2019: ABNORMAL: 107. BLOOD TEST - IN 2011: FACTOR VIII COAGULANT 75%, VON WILLEBRAND FACTOR 39%, RISTOCETIN COFACTOR 41.9%. PLATELET FUNCTION ANALYSER EPINEPHRINE 156, PLATELET FUNCTION ANALYSER ADENOSINE DIPHOSPHATE 120, WITH OPTIMAL RESPONSE FROM DESMOPRESSIN (FACTOR VIII COAGULANT 230, VON WILLEBRAND FACTOR ANTIGEN 111, RISTOCETIN COFACTOR 102, PLATELET FUNCTION ANALYSER EPINEPHRINE 55). C-REACTIVE PROTEIN - ON (B)(6) 2019: ABNORMAL: 13.3. CYSTOGRAM - ON (B)(6) 2019: CT INTRODUCED THROUGH BLADDER CATHETER, OBSERVING ADEQUATE FILLING OF BLADDER WITH THICKENING AND IRREGULARITY OF ITS LEFT POSTEROSUPERIOR WALL, AND RAPID EXTRAVASATION OF CONTRAST WITH DIRECT PASSAGE TO VAGINA BUT WITHOUT IDENTIFYING LEAKING POINT ON THIS EXAMINATION. CYSTOSCOPY - ON (B)(6) 2019: MEATUS AT THE LEVEL OF THE APEX -LEFT; LEFT URETHRAL CATHETER IS REMOVED. GYNAECOLOGICAL EXAMINATION - ON (B)(6) 2012: NORMAL EXTERNAL GENITALIA. CERVIX: MACROSCOPICALLY HEALTHY, NO BLEEDING, NO LEUCORRHOEA. UTERUS IN MOBILE ANTEVERSION, NO PAIN ON MOBILIZATION. SOFT AND NON-TENDER ABDOMEN; ON (B)(6) 2019: HEALTHY LOOKING EXTERNAL GENITALIA. WHEN INTRODUCING A SPECULUM, CLEAR FLUID SEEN TO COME OUT THROUGH VAGINA. VAGINAL CAVITY WITHOUT BLOOD REMAINS OR ACTIVE BLEEDING AT THE PRESENT TIME. COMPRESS PLACED INSIDE THE VAGINA. BLADDER CATHETERIZATION PERFORMED. METHYLENE BLUE IS INJECTED THROUGH THE URETHRA. THE COMPRESS INSERTED IN VAGINA IS NOW METHYLENE BLUE STAINED. CASE DISCUSSED WITH UROLOGY SERVICE WHO REQUESTS COMPUTERISED TOMOGRAPHY UROGRAM, CYSTOGRAPHY AND THEN CONTROL IN UROLOGY, NEED FOR PERMANENT BLADDER CATHETERIZATION FOR 2 MONTHS AND EVALUATION OF RESULTS; ON (B)(6) 2019: SPECULUM: AFTER INSERTING A PROBE, CLEAR FLUID AND LIGHT BLEEDING FLOW. TISSUE IN VAGINAL APEX. HAEMOGLOBIN (G/DL) - ON (B)(6) 2019: 13.4 G/DL; ON (B)(6) 2019: 12.4 G/DL. HYSTEROSCOPY - ON (B)(6) 2012: SATISFACTORY PROCEDURE. PATENT CERVIX. TYPE II CAVITY. ATROPHIC ENDOMETRIUM. OSTIA DISPLAYED. GOOD TOLERANCE. ESSURE INSERTION IS PERFORMED WITHOUT ANY DIFFICULTIES. RIGHT OSTIUM: 4 COILS IN CAVITY. LEFT OSTIUM: 4 COILS IN CAVITY. TIME: 5 MINUTES. LAPAROTOMY - ON (B)(6) 2019: EXPLORATORY: CLOSURE OF LEFT URETEROVAGINAL FISTULA WITH URETHRAL REIMPLANTATION WITH RICARD-TYPE ANTIREFLUX TECHNIQUE INTUBATED WITH DOUBLE J URETHRAL CATHETER. DIAGNOSIS: LEFT URETEROVAGINAL FISTULA. LEFT DOUBLE J CATHETER. PATHOLOGY TEST - ON (B)(6) 2019: MACROSCOPIC: HYSTERECTOMY PIECE WEIGHT 110 GRAMS MEASURES 9 X 6.5 X 2.5 CM. SMOOTH SEROUS SURFACE. EXTERNAL CERVICAL ORIFICE IS TORN, EXOCERVIX WHITISH SHOWS FOCAL REDDISH AREAS. AFTER OPENING, ENDOCERVICAL CANAL FREE, AS IS THE ENDOMETRIAL CAVITY. ENDOMETRIUM 2 MM THICK, MYOMETRIUM 20 MM THICK. ON THE SEROUS SURFACE, AT LEVEL OF ONE OF THE UTERINE HORNS, RAISED AREA OF 8 X 5 MM OBSERVED, WHITISH COLOUR, ARRANGED IN SERIES AND INCLUDED IN ITS ENTIRETY. THE CONTRALATERAL ZONE, THE SURFACE OF THE OTHER UTERINE HORN, DOES NOT PRESENT MACROSCOPIC ALTERATIONS, IT IS ALSO ARRANGED IN SERIES AND INCLUDED IN ITS ENTIRETY. NO METALLIC DEVICE HAS BEEN OBSERVED. MICROSCOPIC: HISTOLOGY: AT LEVEL OF ONE OF THE UTERINE HORNS, WHERE RAISED AND WHITISH AREA OF 8 X 5 MM IS MACROSCOPICALLY OBSERVED, A FOREIGN BODY TYPE GRANULOMA CONSISTING OF PALISADED HISTIOCYTES, CHRONIC INFLAMMATION AND PIGMENT IRON DEPOSIT IDENTIFIED. FIBRIN OBSERVED INSIDE THE GRANULOMA. NO FOREIGN BODY CONTAINED. IN THE OTHER CORNUAL AREA OF THE PIECE, NO HISTOLOGICAL LESIONS IDENTIFIED. DIAGNOSIS: FOREIGN BODY GRANULOMA IN THE UTERINE HORN REGION (SEE MACROSCOPIC AND MICROSCOPIC DESCRIPTION). PROLIFERATIVE ENDOMETRIUM. CHRONIC CERVICITIS; ON (B)(6) 2019: LEFT DISTAL UROTHELIUM: CHRONIC INFLAMMATION AND FRAGMENTS OF FISTULOUS TRACT COMPATIBLE WITH CLINICAL DIAGNOSIS (URETEROVAGINAL FISTULA). ABSENCE OF EPITHELIAL DYSPLASIA. CYSTIC OVARIAN LESION: SIMPLE CYST. PLATELET COUNT (GIGA/L) - ON (B)(6) 2019: 366.0 GIGA/L; ON (B)(6) 2019: 468.0 GIGA/L. SKIN TEST - ON (B)(6) 2018: POSITIVE FOR NICKEL +++. NEGATIVE FOR THE REMAINDER OF THE TRUE TEST: CADMIUM, ALUMINIUM, ZINC, COPPER, TITANIUM, VANADIUM, IRON, ZIRCONIUM, MOLYBDENUM, TUNGSTEN, MANGANESE AND NIOBIUM. DIAGNOSIS: NICKEL ALLERGY. ULTRASOUND SCAN - ON (B)(6) 2012: UTERUS IN REGULAR ANTEVERSION POSITION, EMPTY, WITH MEDIAN LINING OF MM. NORMAL ANNEXES. FREE DOUGLAS; ON (B)(6) 2018: UTERUS IN ANTEVERTED POSITION. LENGTH: 89.0 . ANTEROPOSTERIOR DIAMETER: 42.0. TRANSVERSE DIAMETER: 48.0. INTRAMYOMETRIAL IN RIGHT HORN, HYPER REFRINGENT IMAGING THAT SUGGEST 8 MM. ENDOMETRIUM: THICKNESS: 12. RIGHT OVARY DIAMETER: 27 X 17. LEFT OVARY DIAMETER: 24 X 14 DIAGNOSIS: SUGGESTING REMAINS OF ESSURE IN RIGHT UTERINE HORN.. URINE ANALYSIS - ON (B)(6) 2019: RED BLOOD CELLS (HAEMOGLOBIN): LEUKOCYTES (ESTERASE): TRACES . NITRITES: NEGATIVE. URINARY SEDIMENT: AUTOMATED RED BLOOD CELLS PER FIELD: 5 . YEASTS: MODERATE CULTURE. CULTURE IN URINARY CATHETER: STERILE.; ON (B)(6) 2019: PH URINE ISOLATED SAMPLE 6.5 (5.0 - 6.5), GLUCOSE: NEGATIVE (), KETONE BODIES: NEGATIVE (), BILIRUBIN: NEGATIVE (), UROBILINOGEN: 0.2 EU/DL (0.0 - 1.0), PROTEINS: NEGATIVE (), NITRITES: NEGATIVE (); ON (B)(6) 2019: STERILE URINE CULTURE. UROGRAM - ON (B)(6) 2019: CT: LEFT URETEROVAGINAL FISTULA AND RETROVESICAL FLUID COLLECTION CONNECTED TO THE FISTULA; ON (B)(6) 2019: CT WITH SINGLE PHASE INTRAVENOUS CONTRAST: KIDNEYS OF NORMAL SIZE, MORPHOLOGY AND PARENCHYMA, WITH AN ADEQUATE NEPHROGRAM, WITH NO EVIDENCE OF SIGNIFICANT DILATION OF EXCRETORY TRACT. LEFT RENAL DOUBLE J CATHETER, WITHOUT LITHIASIC IMAGES OR DILATION OF EXCRETORY SYSTEM. OTHER FINDINGS: GALLBLADDER WITH SMALL LITHIASIS AND A NODULE IN THE FUNDUS OF ABOUT 17 MM. TO ASSESS POSSIBLE ADENOMYOMATOSIS OR TUMOUR. POSSIBLY FUNCTIONAL RIGHT OVARIAN CYST OF 33 MM. SMALL HEPATIC SIMPLE CYST; ON (B)(6) 2019: INTRAVENOUS CONTRAST MEDIUM: KIDNEYS LOCATED IN IPSILATERAL RENAL FOSSAE, NORMAL SIZE AND MORPHOLOGY. BILATERAL, SYMMETRIC NEPHROGRAM WITH CONTRAST UPTAKE AND REMOVAL BY BOTH KIDNEYS. NORMAL COLLECTING SYSTEMS AND URETERS. REPLENISHED BLADDER, OBSERVING ALTERATION OF THE MORPHOLOGY AT LEVEL OF LEFT VESICOURETERAL MEATUS, PROBABLY SECONDARY TO PREVIOUS SURGERY. NO INTRAVENOUS CONTRAST EXTRAVASATIONS IDENTIFIED. DIAGNOSTIC JUDGEMENT: ALTERATION OF MORPHOLOGY AT LEVEL OF LEFT VESICOURETERAL MEATUS, PROBABLY SECONDARY TO PREVIOUS SURGERY. NO INTRAVENOUS CONTRAST EXTRAVASATIONS IDENTIFIED.. WHITE BLOOD CELL COUNT (GIGA/L) - ON (B)(6) 2019: 8.80 GIGA/L; ON (B)(6) 2019: 12.40 GIGA/L. LOT NUMBER: 810877, MANUFACTURING DATE: 2010/12, AND EXPIRATION DATE: 2013/12. 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. FURTHER COMPANY FOLLOW-UP WITH THE LAWYER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-MAY-2021: THE CASE (B)(4) LEGACY DEVICE REPORT NUM (B)(4) WAS IDENTIFIED AS DUPLICATE CASE AND THE FOLLOW INFORMATION WERE UPDATED TO THIS CASE HEADACHE STRONG WAS ADDED TO EVENT HEADACHE, FATIGUE, CHRONIC FATIGUE TO EVENT FATIGUE, NO-DRUG TREATMENT NOTES WAS ADDED ESSURE REMOVAL 1ST BILATERAL SALPINGECTOMY (B)(6) 2018 AND 2ND TOTAL HYSTERECTOMY (B)(6) 2019, ON RCC WAS ADDED ESSURE REMOVAL WERE PERFORMED THROUGH TWO SURGICAL INTERVENTIONS: ON (B)(6) 2018 THROUGH A BILATERAL SALPINGECTOMY, AND ON (B)(6) 2019 A TOTAL HYSTERECTOMY. SHE HAD SUFFERED PSYCHOLOGICAL SEQUELAE, AND THEIR QUALITY OF LIFE, AS WELL AS THEIR PERSONAL AND FAMILY RELATIONSHIPS WERE DAMAGED. 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 ('PELVIC PAIN'), DEVICE BREAKAGE ('ABDOMINAL X-RAY, A 3-4 MM FRAGMENT AND ANOTHER PROXIMAL MILLIMETER FRAGMENT ARE IDENTIFIED./ REMAINS OF ESSURE IN RIGHT UTERINE HORN'), EMBEDDED DEVICE ('ON ULTRASOUND ESSURE INTRAMYOMETRIAL IN RIGHT HORN') AND POST PROCEDURAL FISTULA ('LEFT URETEROVAGINAL FISTULA/ POSTOPERATIVE FISTULA') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810877) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CAESAREAN SECTION (1) IN 2005, GRAVIDA II, PARITY 2, VAGINAL DELIVERY (1), BREAST FEEDING, CONTRACEPTION (BARRIER METHOD), DRUG INTOLERANCE, CONTACT DERMATITIS (YEARS AGO), POLLEN ALLERGY (RHINOCONJUNCTIVITIS TREATED SUCCESSFULLY WITH ANTIHISTAMINES IN ADOLESCENCE), APPENDECTOMY (AGE 18) AND TENSION HEADACHE. NO PROBLEMS WITH HAIR DYES OR MAKE-UP. NO PROBLEMS WITH LATEX. FAMILY HISTORY WITHOUT RELEVANCE. NORMAL MENSTRUAL CYCLE. DATE OF LAST PERIOD BEFORE ESSURE INSERTION STARTED ON (B)(6) 2012. UTERUS ANTEVERTED. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR TENSION HEADACHE: TRYPTIZOL 25; FOR VON WILLEBRAND DISEASE: DDAVP; FOR AN UNREPORTED INDICATION: CELEBREX. CONCURRENT CONDITIONS INCLUDED VON WILLEBRAND'S DISEASE (WITH GOOD RESPONSE TO DDAVP. SHE CANNOT TAKE ASA OR NSAIDS. NO IM INJECTIONS. IN CASE OF SURGERY, SHE SHOULD RECEIVE TREATMENT WITH DESMOPRESSIN OR F VIII CONCENTRATES RICH IN VWF. SHE CAN TAKE CELEBREX.) SINCE 2011. FAMILY HISTORY INCLUDED ACUTE MYOCARDIAL INFARCTION (IN FATHER). CONCOMITANT PRODUCTS INCLUDED DESOGESTREL (CERAZETTE) SINCE (B)(6) 2012 FOR ORAL CONTRACEPTION AS WELL AS INFLUENZA VACCINE (FLU VACCINE VII) SINCE (B)(6) 2013. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED HEADACHE ("PERMANENT HEADACHE, SEVERE HEADACHE, STRONG HEADACHE"), METAL POISONING ("METALLOSIS"), FATIGUE ("TIREDNESS / CHRONIC FATIGUE / CHRONIC TIREDNESS") AND ARTHRALGIA ("JOINT PAIN (KNEES, SHOULDERS, WRISTS, FINGERS) / JOINT PAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED RHINITIS ALLERGIC ("ALLERGIC RHINITIS IN SPRING, RECURRENT"). ON (B)(6) 2014, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DENTAL CARIES ("DENTAL CARIES / TOOTHACHE"). ON (B)(6) 2015, THE PATIENT EXPERIENCED BACK PAIN ("LUMBAGO"). ON (B)(6) 2016, THE PATIENT EXPERIENCED POLYARTHRITIS ("POLYARTHRITIS NOS HAND") WITH PARAESTHESIA AND ARTHROPATHY ("POLYARTHROPATHY HAND"). ON (B)(6) 2016, THE PATIENT EXPERIENCED NODAL OSTEOARTHRITIS ("NODULAR ARTHROSIS OF HANDS"). ON (B)(6) 2016, THE PATIENT EXPERIENCED CARPAL TUNNEL SYNDROME ("MODERATE BILATERAL CARPAL TUNNEL SYNDROME"). ON (B)(6) 2017, THE PATIENT EXPERIENCED AMENORRHOEA ("MENSTRUAL ABSENCE, RECURRENT"). ON (B)(6) 2018, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED) AND COMPLICATION OF DEVICE REMOVAL ("ESSURE REMOVAL INCOMPLETE"). ON (B)(6) 2018, THE PATIENT EXPERIENCED STITCH ABSCESS ("STICH HAS OPENED, SHE UNDERWENT SURGERY BILATERAL SALPINGECTOMY ON ON (B)(6) 2018"). ON (B)(6) 2018, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). ON (B)(6) 2018, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2019, THE PATIENT EXPERIENCED CERVICITIS ("CHRONIC CERVICITIS"). ON (B)(6) 2019, THE PATIENT EXPERIENCED CONSTIPATION ("CONSTIPATION"). IN (B)(6) 2019, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING GREATER THAN HER PERIODS AFTER HYSTERECTOMY, METRORRHAGIA"), INTERMENSTRUAL BLEEDING ("INCREASED METRORRHAGIA WITH CONSTANT URINE LOSS WITHOUT MICTURITION SYNDROME") AND URINARY INCONTINENCE ("INCREASED METRORRHAGIA WITH CONSTANT URINE LOSS WITHOUT MICTURITION SYNDROME"). ON (B)(6) 2019, THE PATIENT EXPERIENCED POST PROCEDURAL FISTULA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH POST PROCEDURAL URINE LEAK AND MICTURITION URGENCY. ON (B)(6) 2019, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAIN AFTER LAPAROTOMY 6 DAYS AGO"). ON (B)(6) 2019, THE PATIENT EXPERIENCED URINARY TRACT DISORDER ("URINARY SPASMS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), SWELLING ("SWELLING"), ABDOMINAL DISTENSION ("ABDOMINAL DISTENSION") AND MUSCULOSKELETAL STIFFNESS ("MORNING STIFFNESS"). THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2018 TO (B)(6) 2018 AND THEN FROM (B)(6) 2019 TO (B)(6) 2019. THE PATIENT WAS TREATED WITH AMITRIPTYLINE HYDROCHLORIDE (TRYPTIZOL), AMOXICILLIN;CLAVULANIC ACID (AUGMENTINE), BUDESONIDE, CALCIFEDIOL (HIDROFEROL), CEFUROXIME, CELECOXIB (CELEBREX), CHONDROITIN SULFATE (CONDROSAN), CIPROFLOXACIN, DIAZEPAM, DIETHANOLAMINE FUSIDATE (FUCIDINE), EBASTINE (EBASTIN), ETORICOXIB (ARCOXIA), HYOSCINE BUTYLBROMIDE (BUSCOPAN), METAMIZOLE MAGNESIUM (NOLOTIL), METAMIZOLE SODIUM (METAMIZOLE), OMEPRAZOLE, PARACETAMOL, PARACETAMOL;TRAMADOL HYDROCHLORIDE (TRAMADOL / PARACETAMOL MYLAN), PROPRANOLOL HYDROCHLORIDE (SUMIAL), SUMATRIPTAN, TRANEXAMIC ACID (AMCHAFIBRIN) AND SURGERY (ESSURE REMOVAL 1ST BILATERAL SALPINGECTOMY (B)(6) 2018 AND 2ND TOTAL HYSTERECTOMY (B)(6) 2019, CATHETER ON (B)(6) 2019, CLOSURE OF LEFT FISTULA (B)(6) 2019, DOUBLE J URETHRAL CATHETER UNTIL (B)(6) 2019 AND LAPAROSCOPIC TOTAL HYSTERECTOMY ON (B)(6) 2019 WITH VAGINAL PIECE REMOVED TO EXTRACT ESSURE REMAINS). ESSURE WAS REMOVED ON (B)(6) 2019. IN (B)(6) 2019, THE VAGINAL HAEMORRHAGE HAD RESOLVED. ON (B)(6) 2019, THE POST PROCEDURAL FISTULA HAD RESOLVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, EMBEDDED DEVICE, PROCEDURAL PAIN AND URINARY TRACT DISORDER HAD RESOLVED, THE DEVICE BREAKAGE, METAL POISONING, SWELLING, COMPLICATION OF DEVICE REMOVAL, CERVICITIS, NODAL OSTEOARTHRITIS, RHINITIS ALLERGIC, DENTAL CARIES, POLYARTHRITIS, BACK PAIN, CARPAL TUNNEL SYNDROME, ARTHROPATHY, ABDOMINAL DISTENSION, AMENORRHOEA, MUSCULOSKELETAL STIFFNESS, STITCH ABSCESS, INTERMENSTRUAL BLEEDING, CONSTIPATION AND URINARY INCONTINENCE OUTCOME WAS UNKNOWN AND THE ALLERGY TO METALS, HEADACHE, FATIGUE, ARTHRALGIA AND MIGRAINE HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALLERGY TO METALS, AMENORRHOEA, ARTHRALGIA, ARTHROPATHY, BACK PAIN, CARPAL TUNNEL SYNDROME, CERVICITIS, COMPLICATION OF DEVICE REMOVAL, CONSTIPATION, DENTAL CARIES, DEVICE BREAKAGE, EMBEDDED DEVICE, FATIGUE, HEADACHE, INTERMENSTRUAL BLEEDING, METAL POISONING, MIGRAINE, MUSCULOSKELETAL STIFFNESS, NODAL OSTEOARTHRITIS, PELVIC PAIN, POLYARTHRITIS, POST PROCEDURAL FISTULA, PROCEDURAL PAIN, RHINITIS ALLERGIC, STITCH ABSCESS, SWELLING, URINARY INCONTINENCE, URINARY TRACT DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION WITHOUT DIFFICULTY. ESSURE REMOVAL WERE PERFORMED THROUGH TWO SURGICAL INTERVENTIONS: ON (B)(6) 2018 THROUGH A BILATERAL SALPINGECTOMY, AND ON (B)(6) 2019 A TOTAL HYSTERECTOMY, POSTOPERATIVE WITHIN NORMALITY, FOR WHICH SHE WAS DISCHARGED HOME ON (B)(6) 2019. SHE HAD SUFFERED PSYCHOLOGICAL SEQUELAE, AND THEIR QUALITY OF LIFE, AS WELL AS THEIR PERSONAL AND FAMILY RELATIONSHIPS WERE DAMAGED. ON (B)(6) 2019 CHOLELITHIASIS, IN 2019 DUE TO FEMALE UROGENITAL FISTULA SHE WAS TREATED WITH ORAL PHOSPHOMYCIN 500 MG/ EVERY 8 HOURS/8 DAYS, ORAL NITROFURANTOIN 50 MG/ EVERY 8 HOURS/7 DAYS, CEFUROXIME NORMON 250 MG/ EVERY 14 HOURS/10 DAYS. ON (B)(6) 2019, PYELOGRAPHY AND URETERAL CATHETERIZATION WERE PERFORMED. A CONTRAST LEAK IS FOUND ON THE LEFT SIDE AT THE LEVEL OF THE SACRAL URETER WITHOUT SOLUTION OF THE CONTINUITY OF THE URETER. ON (B)(6) 2019 EXPLORATORY LAPAROTOMY: CLOSURE OF THE LEFT URETEROVAGINAL FISTULA WITH URETERAL REIMPLANTATION USING THE RICARD-TYPE ANTIREFLUX TECHNIQUE INTUBATED WITH A DOUBLE-J URETERAL CATHETER. ON (B)(6) 2019 ASYMPTOMATIC WITHOUT URINE LEAKAGE OR LOW BACK PAIN THE LEFT URETERAL CATHETER IS REMOVED, ON (B)(6) 2021 DETERIORATION OF URINARY ELIMINATION, ON (B)(6) 2021 ABDOMINAL PAIN, UNCOMPLICATED LEFT RENOURETERAL COLIC DIAGNOSTIC WITH RENAL COLIC, ON (B)(6) 2021 CT SHOWED GALLBLADDER ADENOMYOMA, ON (B)(6) 2021 LEFT URETEROVAGINAL FISTULA OPERATED WITHOUT FUNCTIONAL REPERCUSSION, ON (B)(6) 2021 COVID VACCINE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ABDOMINAL X-RAY - ON (B)(6) 2018: ABDOMINAL X-RAY, A 3-4 MM FRAGMENT AND ANOTHER PROXIMAL MILLIMETER FRAGMENT ARE IDENTIFIED. ALLERGY TEST - ON (B)(6) 2018: POSITIVE PATCH TESTS FOR NICKEL +++. NEGATIVE REST OF TRUE TEST, CADMIUM, ALUMINUM, ZINC, COPPER, TITANIUM, VANADIUM, IRON, ZIRCONIUM, MOLYBDENUM, TUNGSTEN, MANGANESE, AND NIOBIUM. OTHER DIAGNOSES: NICKEL ALLERGY. ANTI FACTOR VIII ANTIBODY TEST (60 - 120 %) - ON (B)(6) 2017: 288 %; ON (B)(6) 2017: 241 %. BLOOD CHOLESTEROL (MG/DL) - ON (B)(6) 2016: 182.0 MG/DL. BLOOD GLUCOSE - ON (B)(6) 2019: ABNORMAL: 107. BLOOD TEST - IN 2011: FACTOR VIII COAGULANT 75%, VON WILLEBRAND FACTOR 39%, RISTOCETIN COFACTOR 41.9%. PLATELET FUNCTION ANALYSER EPINEPHRINE 156, PLATELET FUNCTION ANALYSER ADENOSINE DIPHOSPHATE 120, WITH OPTIMAL RESPONSE FROM DESMOPRESSIN (FACTOR VIII COAGULANT 230, VON WILLEBRAND FACTOR ANTIGEN 111, RISTOCETIN COFACTOR 102, PLATELET FUNCTION ANALYSER EPINEPHRINE 55). C-REACTIVE PROTEIN (MG/L) - ON (B)(6) 2016: 4.2 MG/L; ON (B)(6) 2017: 1.4 MG/L; ON (B)(6) 2019: 13.3 MG/L. COMPUTERISED TOMOGRAM - ON (B)(6) 2019: THE RIGHT URETER IS VISUALIZED IN ITS ENTIRETY. THE LEFT URETER IS IDENTIFIED WITH CONTRAST UP TO L4. AT THE RETROVESICAL LEVEL, IN THE HYSTERECTOMY AREA, A LIQUID COLLECTION WITH IRREGULAR BORDERS IS IDENTIFIED. CLOSELY RELATED TO THE LEFT BORDER, AN IMAGE OF CONTRAST EXTRAVASATION APPEARS IN THE THEORETICAL DISTAL URETERAL PATH. COMPUTERISED TOMOGRAM HEAD - ON (B)(6) 2014: NO IMAGE OF INTRACRANIAL BLEEDING IS OBSERVED. CYSTOGRAM - ON (B)(6) 2019: CT INTRODUCED THROUGH BLADDER CATHETER, OBSERVING ADEQUATE FILLING OF BLADDER WITH THICKENING AND IRREGULARITY OF ITS LEFT POSTEROSUPERIOR WALL, AND RAPID EXTRAVASATION OF CONTRAST WITH DIRECT PASSAGE TO VAGINA BUT WITHOUT IDENTIFYING LEAKING POINT ON THIS EXAMINATION. CYSTOSCOPY - ON (B)(6) 2019: NORMAL URETHRA, BLADDER OF GOOD CAPACITY. RAISED ERYTHEMATOUS AREA ON THE LEFT SIDE WITHOUT EVIDENCE OF A FISTULOUS ORIFICE. LEFT URETERAL ORIFICE RAISED, RIGHT ONE IS NORMAL. DURING THE EXAMINATION, THE BLADDER IS DISTENDED WITHOUT EVIDENCE OF SIMULTANEOUS URINE LEAKAGE; ON (B)(6) 2019: MEATUS AT THE LEVEL OF THE APEX -LEFT; LEFT URETHRAL CATHETER IS REMOVED. ELECTROMYOGRAM - ON (B)(6) 2016: MODERATE BILATERAL CARPAL TUNNEL SYNDROME. GYNAECOLOGICAL EXAMINATION - ON (B)(6) 2012: NORMAL EXTERNAL GENITALIA. CERVIX: MACROSCOPICALLY HEALTHY, NO BLEEDING, NO LEUCORRHOEA. UTERUS IN MOBILE ANTEVERSION, NO PAIN ON MOBILIZATION. SOFT AND NON-TENDER ABDOMEN; ON (B)(6) 2016: CONTROL AFTER WITHDRAWAL OF ESSURE, BILATERAL SALPINGECTOMY WAS PERFORMED WITH REMOVAL OF BOTH IMPLANTS, SCARS IN GOOD CONDITION; ON (B)(6) 2018: PATIENT UNDERWENT SURGERY ON (B)(6) 2018 BY LAPAROSCOPY PERFORMING BILATERAL SALPINGECTOMY. DAILY CLEANING AND DRESSINGS, REMOVAL OF STITCHES IN 10 DAYS. COMES FOR CLEANING AND DRESSINGS. EXPLORATION NO SIGNS OF INFECTION OR INFLAMMATION. DIAGNOSTICS:DECAY OF SKIN INTEGRITY; ON (B)(6) 2019: HEALTHY LOOKING EXTERNAL GENITALIA. WHEN INTRODUCING A SPECULUM, CLEAR FLUID SEEN TO COME OUT THROUGH VAGINA. VAGINAL CAVITY WITHOUT BLOOD REMAINS OR ACTIVE BLEEDING AT THE PRESENT TIME. COMPRESS PLACED INSIDE THE VAGINA. BLADDER CATHETERIZATION PERFORMED. METHYLENE BLUE IS INJECTED THROUGH THE URETHRA. THE COMPRESS INSERTED IN VAGINA IS NOW METHYLENE BLUE STAINED. CASE DISCUSSED WITH UROLOGY SERVICE WHO REQUESTS COMPUTERISED TOMOGRAPHY UROGRAM, CYSTOGRAPHY AND THEN CONTROL IN UROLOGY, NEED FOR PERMANENT BLADDER CATHETERIZATION FOR 2 MONTHS AND EVALUATION OF RESULTS; ON (B)(6) 2019: WHEN INTRODUCING THE SPECULUM, CLEAR FLUID IS SEEN TO ESCAPE THROUGH THE VAGINA. VAGINAL CAVITY WITHOUT HEMATIC REMAINS OR ACTIVE BLEEDING AT THE PRESENT TIME. COMPRESS IS PLACED INSIDE THE VAGINA, BLADDER CATHETERIZATION IS PERFORMED, METHYLENE BLUE INJECTION IS MADE THROUGH THE URETHRA, VAGINAL COMPRESS STAINED WITH METHYLENE BLUE IS OBSERVED; ON (B)(6) 2019: SPECULUM: AFTER INSERTING A PROBE, CLEAR FLUID AND LIGHT BLEEDING FLOW. TISSUE IN VAGINAL APEX. HAEMOGLOBIN (G/DL) - ON (B)(6) 2016: 13.6 G/DL; ON (B)(6) 2017: 13.4 G/DL; ON (B)(6) 2019: 13.4 G/DL; ON (B)(6) 2019: 12.4 G/DL. HIGH DENSITY LIPOPROTEIN (45 - 75 MG/DL) - ON (B)(6) 2016: 42 MG/DL. HYSTEROSCOPY - ON (B)(6) 2012: SATISFACTORY PROCEDURE. PATENT CERVIX. TYPE II CAVITY. ATROPHIC ENDOMETRIUM. OSTIA DISPLAYED. GOOD TOLERANCE. ESSURE INSERTION IS PERFORMED WITHOUT ANY DIFFICULTIES. RIGHT OSTIUM: 4 COILS IN CAVITY. LEFT OSTIUM: 4 COILS IN CAVITY. TIME: 5 MINUTES. INVESTIGATION - ON (B)(6) 2015: PROPORTIONAL DECREASE (CO / AG RATIO: 0.8). LAPAROTOMY - ON (B)(6) 2019: EXPLORATORY: CLOSURE OF LEFT URETEROVAGINAL FISTULA WITH URETHRAL REIMPLANTATION WITH RICARD-TYPE ANTIREFLUX TECHNIQUE INTUBATED WITH DOUBLE J URETHRAL CATHETER. DIAGNOSIS: LEFT URETEROVAGINAL FISTULA. LEFT DOUBLE J CATHETER. LOW DENSITY LIPOPROTEIN (MG/DL) - ON (B)(6) 2016: 124.0 MG/DL. LYMPHOCYTE COUNT (1.2 - 4.5 10*3/ML) - ON (B)(6) 2015: 1.20 10*3/ML; ON (B)(6) 2016: 1.60 10*3/ML; ON (B)(6) 2017: 1.50 10*3/ML; ON (B)(6) 2017: 1.3 10*3/ML. LYMPHOCYTE PERCENTAGE (19 - 48 %) - ON (B)(6) 2015: 17.5 %; ON (B)(6) 2016: 18.7 %; ON (B)(6) 2017: 18.3 %; ON (B)(6) 2017: 15.4 %. MAMMOGRAM - ON (B)(6) 2016: UNREMARKABLE; ON (B)(6) 2017: UNREMARKABLE. MONOCYTE COUNT (0.2 - 1 10*3/ML) - ON (B)(6) 2016: 0.9 10*3/ML. MONOCYTE PERCENTAGE (19 - 49 %) - ON (B)(6) 2016: 10.1 %. NEUTROPHIL COUNT (1.8 - 7.4 10*3/ML) - ON (B)(6) 2015: 5.1 10*3/ML; ON (B)(6) 2017: 5.90 10*3/ML; ON (B)(6) 2017: 6.2 10*3/ML. NEUTROPHIL PERCENTAGE (40 - 74.0 %) - ON (B)(6) 2015: 74.9 %; ON (B)(6) 2017: 74.1 %; ON (B)(6) 2017: 76.4 %. PATHOLOGY TEST - ON (B)(6) 2018: DIAGNOSTIC ORIENTATION BILATERAL SALPINGECTOMY. CARRIER OF ESSMA; MACROSCOPIC DESCRIPTION: RIGHT 7 X 0.5 CM UTERINE TUBE THAT MACROSCOPICALLY SHOWS NO ALTERATIONS PRACTICALLY TOTAL INCLUSION IN TWO BLOCKS; LEFT: UTERINE TUBE MEASURING 6.5 X 0.5 CM, MACROSCOPICALLY UNALTERED PRACTICALLY TOTAL INCLUSION IN TWO BLOCKS. DIAGNOSIS: RIGHT UTERINE TUBE WITHOUT SIGNIFICANT HISTOLOGICAL LESIONS; LEFT UTERINE TUBE WITHOUT SIGNIFICANT HISTOLOGICAL LESIONS.; ON (B)(6) 2019: MACROSCOPIC: HYSTERECTOMY PIECE WEIGHT 110 GRAMS MEASURES 9 X 6.5 X 2.5 CM. SMOOTH SEROUS SURFACE. EXTERNAL CERVICAL ORIFICE IS TORN, EXOCERVIX WHITISH SHOWS FOCAL REDDISH AREAS. AFTER OPENING, ENDOCERVICAL CANAL FREE, AS IS THE ENDOMETRIAL CAVITY. ENDOMETRIUM 2 MM THICK, MYOMETRIUM 20 MM THICK. ON THE SEROUS SURFACE, AT LEVEL OF ONE OF THE UTERINE HORNS, RAISED AREA OF 8 X 5 MM OBSERVED, WHITISH COLOUR, ARRANGED IN SERIES AND INCLUDED IN ITS ENTIRETY. THE CONTRALATERAL ZONE, THE SURFACE OF THE OTHER UTERINE HORN, DOES NOT PRESENT MACROSCOPIC ALTERATIONS, IT IS ALSO ARRANGED IN SERIES AND INCLUDED IN ITS ENTIRETY. NO METALLIC DEVICE HAS BEEN OBSERVED. MICROSCOPIC: HISTOLOGY: AT LEVEL OF ONE OF THE UTERINE HORNS, WHERE RAISED AND WHITISH AREA OF 8 X 5 MM IS MACROSCOPICALLY OBSERVED, A FOREIGN BODY TYPE GRANULOMA CONSISTING OF PALISADED HISTIOCYTES, CHRONIC INFLAMMATION AND PIGMENT IRON DEPOSIT IDENTIFIED. FIBRIN OBSERVED INSIDE THE GRANULOMA. NO FOREIGN BODY CONTAINED. IN THE OTHER CORNUAL AREA OF THE PIECE, NO HISTOLOGICAL LESIONS IDENTIFIED. DIAGNOSIS: FOREIGN BODY GRANULOMA IN THE UTERINE HORN REGION (SEE MACROSCOPIC AND MICROSCOPIC DESCRIPTION). PROLIFERATIVE ENDOMETRIUM. CHRONIC CERVICITIS; ON (B)(6) 2019: DIAGNOSTIC ORIENTATION URETERAL FISTULA AND OVARIAN CYSTIC LESION. MACROSCOPIC DESCRIPTION: LEFT DISTAL URETER6 MM LONG TUBULAR FRAGMENT. TOTAL INCLUSION IN A BLOCK. OVARIAN CYSTIC LESION A 1.5 CM TRANSLUCENT WALL CYST LESS THAN 1 MM THICK. CONTAINS SEROUS LIQUID MATERIAL. TOTAL INCLUSION IN A BLOCK. MICROSCOPIC DESCRIPTION: HISTOLOGICAL SECTIONS SHOW FRAGMENTS OF THE URETERAL WALL WITH CHRONIC LYMPHOPLASMACYTIC INFLAMMATION IN WHICH A FISTULOUS TRACT IS ALSO IDENTIFIED. THE UROTHELIUM PRESENT IN THE SAMPLE HAS NO DYSPLASIA. DIAGNOSIS: LEFT DISTAL UROTHELIUM: CHRONIC INFLAMMATION AND FISTULOUS TRAJECTORY FRAGMENTS COMPATIBLE WITH CLINICAL DIAGNOSIS. ABSENCE OF EPITHELIAL DYSPLASIA. CYSTIC OVARIAN INJURY: SIMPLE CYST. THE PETITION SHEET DOES NOT SPECIFY LATERALITY. PLATELET COUNT (GIGA/L) - ON (B)(6) 2019: 366.0 GIGA/L; ON (B)(6) 2019: 468.0 GIGA/L. PLATELET FUNCTION TEST - ON (B)(6) 2015: 100 COLLAGEN ADP 131 SECONDS (REFERENCE 69-110); ON (B)(6) 2015: 100 COLLAGEN ADR 135 SECONDS (REFERENCE 69-110); ON (B)(6) 2015: 100 COLLAGEN ADP 135 SECONDS (REFERENCE 69-110); ON (B)(6) 2015: 100 COLLAGEN ADR 188 SECONDS (REFERENCE 89-140); ON (B)(6) 2017: 100 COLLAGEN ADP 117 SECONDS (REFERENCE 69-110); ON (B)(6) 2017: 100 COLLAGEN ADR 151 SECONDS (REFERENCE 89-140); ON (B)(6) 2017: 100 COLLAGEN ADP 124 SECONDS (REFERENCE 69-110); ON (B)(6) 2017: 100 COLLAGEN ADR 189 SECONDS (REFERENCE 89-140); ON (B)(6) 2017: 100 COLLAGEN ADP 30 MIN, 41 SECONDS (REFERENCE 69-110); ON (B)(6) 2017: 100 COLLAGEN ADR 30 MIN, 62 SECONDS (REFERENCE 89-140); ON (B)(6) 2017: 100 COLLAGEN ADP 90 MIN, 38 SECONDS (REFERENCE 69-110); ON (B)(6) 2017: 100 COLLAGEN ADR 30 MIN, 67 SECONDS (REFERENCE 89-140). RHEUMATOID FACTOR - ON (B)(6) 2016: 10.0 IU/ML; ON (B)(6) 2017: 10.0 IU/ML. SKIN TEST - ON (B)(6) 2018: POSITIVE FOR NICKEL +++. NEGATIVE FOR THE REMAINDER OF THE TRUE TEST: CADMIUM, ALUMINIUM, ZINC, COPPER, TITANIUM, VANADIUM, IRON, ZIRCONIUM, MOLYBDENUM, TUNGSTEN, MANGANESE AND NIOBIUM. DIAGNOSIS: NICKEL ALLERGY. SMEAR TEST - ON (B)(6) 2013: NORMAL CERVICOVAGINAL CYTOLOGY; ON (B)(6) 2015: SAMPLE QUALITY: SATISFACTORY (THERE ARE ENDOCERVICAL CELLS AND / OR METAPLASTIC CELLS) ; MICROBIOLOGICAL ASSESSMENT: USUAL FLORA; MORPHOLOGICAL DIAGNOSIS; NEGATIVE FOR INTRAEPITHELIAL INJURY OR MALIGNITY. ULTRASOUND PELVIS - ON (B)(6) 2018: SUGGESTIVE DIAGNOSIS OF REMAINS OF ESSURE IN RIGHT UTERINE HORN; ON (B)(6) 2018: INTRAMIOMETRIAL IN RIGHT HORN. 8 MM SUGGESTIVE HYPERREFRINGENT IMAGE. SUGGESTION OF REMAINS OF ESSURE IN RIGHT UTERINE HORN.. ULTRASOUND SCAN - ON (B)(6) 2012: UTERUS IN REGULAR ANTEVERSION POSITION, EMPTY, WITH MEDIAN LINING OF MM. NORMAL ANNEXES. FREE DOUGLAS; ON (B)(6) 2018: UTERUS IN ANTEVERTED POSITION. LENGTH: 89.0 . ANTEROPOSTERIOR DIAMETER: 42.0. TRANSVERSE DIAMETER: 48.0. INTRAMYOMETRIAL IN RIGHT HORN, HYPER REFRINGENT IMAGING THAT SUGGEST 8 MM. ENDOMETRIUM: THICKNESS: 12. RIGHT OVARY DIAMETER: 27 X 17. LEFT OVARY DIAMETER: 24 X 14 DIAGNOSIS: SUGGESTING REMAINS OF ESSURE IN RIGHT UTERINE HORN. URINE ANALYSIS - ON (B)(6) 2019: RED BLOOD CELLS (HAEMOGLOBIN): LEUKOCYTES (ESTERASE): TRACES . NITRITES: NEGATIVE. URINARY SEDIMENT: AUTOMATED RED BLOOD CELLS PER FIELD: 5 . YEASTS: MODERATE CULTURE. CULTURE IN URINARY CATHETER: STERILE.; ON (B)(6) 2019: PH URINE ISOLATED SAMPLE 6.5 (5.0 - 6.5), GLUCOSE: NEGATIVE (), KETONE BODIES: NEGATIVE (), BILIRUBIN: NEGATIVE (), UROBILINOGEN: 0.2 EU/DL (0.0 - 1.0), PROTEINS: NEGATIVE (), NITRITES: NEGATIVE (); ON (B)(6) 2019: STERILE URINE CULTURE. UROGRAM - ON (B)(6) 2019: CT: LEFT URETEROVAGINAL FISTULA AND RETROVESICAL FLUID COLLECTION CONNECTED TO THE FISTULA; ON (B)(6) 2019: CT WITH SINGLE PHASE INTRAVENOUS CONTRAST: KIDNEYS OF NORMAL SIZE, MORPHOLOGY AND PARENCHYMA, WITH AN ADEQUATE NEPHROGRAM, WITH NO EVIDENCE OF SIGNIFICANT DILATION OF EXCRETORY TRACT. LEFT RENAL DOUBLE J CATHETER, WITHOUT LITHIASIC IMAGES OR DILATION OF EXCRETORY SYSTEM. OTHER FINDINGS: GALLBLADDER WITH SMALL LITHIASIS AND A NODULE IN THE FUNDUS OF ABOUT 17 MM. TO ASSESS POSSIBLE ADENOMYOMATOSIS OR TUMOUR. POSSIBLY FUNCTIONAL RIGHT OVARIAN CYST OF 33 MM. SMALL HEPATIC SIMPLE CYST; ON (B)(6) 2019: INTRAVENOUS CONTRAST MEDIUM: KIDNEYS LOCATED IN IPSILATERAL RENAL FOSSAE, NORMAL SIZE AND MORPHOLOGY. BILATERAL, SYMMETRIC NEPHROGRAM WITH CONTRAST UPTAKE AND REMOVAL BY BOTH KIDNEYS. NORMAL COLLECTING SYSTEMS AND URETERS. REPLENISHED BLADDER, OBSERVING ALTERATION OF THE MORPHOLOGY AT LEVEL OF LEFT VESICOURETERAL MEATUS, PROBABLY SECONDARY TO PREVIOUS SURGERY. NO INTRAVENOUS CONTRAST EXTRAVASATIONS IDENTIFIED. DIAGNOSTIC JUDGEMENT: ALTERATION OF MORPHOLOGY AT LEVEL OF LEFT VESICOURETERAL MEATUS, PROBABLY SECONDARY TO PREVIOUS SURGERY. NO INTRAVENOUS CONTRAST EXTRAVASATIONS IDENTIFIED. VITAMIN B12 (PG/ML) - ON (B)(6) 2017: 706.0 PG/ML. VITAMIN D (20 - 50 NG/ML) - ON (B)(6) 2016: 12 NG/ML; ON (B)(6) 2016: 12.0 NG/ML; ON (B)(6) 2017: 20.0 NG/ML. VON WILLEBRAND'S FACTOR ACTIVITY TEST (60 - 120 %) - ON (B)(6) 2015: 54 %; ON (B)(6) 2015: 44 %; ON (B)(6) 2017: 54 %; ON (B)(6) 2017: 50 %; ON (B)(6) 2017: 150 %; ON (B)(6) 2017: 150 %. VON WILLEBRAND'S FACTOR ANTIGEN TEST (60 - 120 %) - ON (B)(6) 2015: 59 %; ON (B)(6) 2015: 48 %; ON (B)(6) 2017: 52 %; ON (B)(6) 2017: 50 %; ON (B)(6) 2017: 176 %; ON (B)(6) 2017: 162 %. WHITE BLOOD CELL COUNT (GIGA/L) - ON (B)(6) 2019: 8.80 GIGA/L; ON (B)(6) 2019: 12.40 GIGA/L. X-RAY LIMB - ON (B)(6) 2016: HAND X-RAY: EARLY DEGENERATIVE SIGNS IN DISTAL INTERPHALANGEAL JOINTS. DIAGNOSTICS - NODULAR ARTHROSIS OF HANDS - RULE OUT CARPAL TUNNEL SYNDROME. X-RAY OF PELVIS AND HIP - IN (B)(6) 2012: IN THE CHECK-UP AFTER 3 MONTHS ESSURE PLACEMENT, ESSURE IS CLEARLY SEEN IN THE RIGHT TUBE, IN THE INTERSTITIAL PORTION OF THE TUBE, BUT IT IS NOT POSSIBLE TO VISUALIZE IT IN THE INTERSTITIAL PORTION OF THE LEFT TUBE. THE DEVICE IS SEEN, BUT APPARENTLY IN THE MOST DISTAL PORTION OF THE TUBE IN THE MIDDLE THIRD AND NOT IN RELATION TO THE UTERINE HORN. LOT NUMBER: 810877, MANUFACTURE DATE: 2010-12, AND EXPIRATION DATE: 2013-12. 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. FURTHER COMPANY FOLLOW-UP WITH THE LAWYER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-SEP-2021: THE FOLLOW INFORMATION WERE UPDATED MEDICAL HISTORY, HISTORICAL DRUG, LAB DATA, OTHER TREATMENT PRODUCTS, OTHER CONCOMITANT PRODUCTS, NODAL OSTEOARTHRITIS, ALLERGIC RHINITIS, MIGRAINE, DENTAL CARIES, LUMBAGO, POLYARTHRITIS, POLYARTHROPATHY, CARPAL TUNNEL SYNDROME, AMENORRHOEA, ABDOMINAL DISTENSION, EARLY MORNING STIFFNESS, POSTOPERATIVE STITCH ABSCESS, CONSTIPATION, METRORRHAGIA, DEVICE BREAKAGE ONSET DATE WAS UPDATED FROM (B)(6) 2018 TO (B)(6) 2018. 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 ('PELVIC PAIN'), DEVICE BREAKAGE ('REMAINS OF ESSURE IN RIGHT UTERINE HORN'), EMBEDDED DEVICE ('ON ULTRASOUND ESSURE INTRAMYOMETRIAL IN RIGHT HORN') AND POST PROCEDURAL FISTULA ('LEFT URETEROVAGINAL FISTULA/ POSTOPERATIVE FISTULA') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810877) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CAESAREAN SECTION (1) IN 2005, GRAVIDA II, PARITY 2, VAGINAL DELIVERY (1), BREAST FEEDING, CONTRACEPTION (BARRIER METHOD), DRUG INTOLERANCE, CONTACT DERMATITIS (YEARS AGO), POLLEN ALLERGY (RHINOCONJUNCTIVITIS TREATED SUCCESSFULLY WITH ANTIHISTAMINES IN ADOLESCENCE) AND APPENDECTOMY (AGE 18). NO PROBLEMS WITH HAIR DYES OR MAKE-UP. NO PROBLEMS WITH LATEX. FAMILY HISTORY WITHOUT RELEVANCE. NORMAL MENSTRUAL CYCLE. DATE OF LAST PERIOD BEFORE ESSURE INSERTION STARTED ON (B)(6) 2012. UTERUS ANTEVERTED. CONCURRENT CONDITIONS INCLUDED VON WILLEBRAND'S DISEASE SINCE 2011. FAMILY HISTORY INCLUDED ACUTE MYOCARDIAL INFARCTION (IN FATHER). CONCOMITANT PRODUCTS INCLUDED DESOGESTREL (CERAZETTE) SINCE (B)(6) 2012 FOR ORAL CONTRACEPTION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED HEADACHE ("PERMANENT HEADACHE, SEVERE HEADACHE"), METAL POISONING ("METALLOSIS"), FATIGUE ("TIREDNESS / CHRONIC FATIGUE") AND ARTHRALGIA ("JOINT PAIN (KNEES, SHOULDERS, WRISTS, FINGERS)"). ON (B)(6) 2018, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), EMBEDDED DEVICE (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED) AND COMPLICATION OF DEVICE REMOVAL ("ESSURE REMOVAL INCOMPLETE"). ON (B)(6) 2019, THE PATIENT EXPERIENCED CERVICITIS ("CHRONIC CERVICITIS"). IN (B)(6) 2019, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING GREATER THAN HER PERIODS AFTER HYSTERECTOMY, METRORRHAGIA"). ON (B)(6) 2019, THE PATIENT EXPERIENCED POST PROCEDURAL FISTULA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH POST PROCEDURAL URINE LEAK AND MICTURITION URGENCY. ON (B)(6) 2019, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAIN AFTER LAPAROTOMY 6 DAYS AGO"). ON (B)(6) 2019, THE PATIENT EXPERIENCED URINARY TRACT DISORDER ("URINARY SPASMS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), ALLERGY TO METALS ("NICKEL ALLERGY") AND SWELLING ("SWELLING"). THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2018 TO (B)(6) 2018 AND THEN FROM (B)(6) 2019 TO (B)(6) 2019. THE PATIENT WAS TREATED WITH CEFUROXIME, HYOSCINE BUTYLBROMIDE (BUSCOPAN), METAMIZOLE MAGNESIUM (NOLOTIL), PARACETAMOL, TRANEXAMIC ACID (AMCHAFIBRIN) AND SURGERY (BILATERAL SALPINGECTOMY ON (B)(6) 2018, CATHETER ON (B)(6) 2019, CLOSURE OF LEFT FISTULA (B)(6) 2019, DOUBLE J URETHRAL CATHETER UNTIL (B)(6) 2019 AND LAPAROSCOPIC TOTAL HYSTERECTOMY ON (B)(6) 2019 WITH VAGINAL PIECE REMOVED TO EXTRACT ESSURE REMAINS). ESSURE WAS REMOVED ON (B)(6) 2019. IN (B)(6) 2019, THE VAGINAL HAEMORRHAGE HAD RESOLVED. ON (B)(6) 2019, THE POST PROCEDURAL FISTULA HAD RESOLVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, EMBEDDED DEVICE, PROCEDURAL PAIN AND URINARY TRACT DISORDER HAD RESOLVED, THE DEVICE BREAKAGE, METAL POISONING, SWELLING, COMPLICATION OF DEVICE REMOVAL AND CERVICITIS OUTCOME WAS UNKNOWN AND THE ALLERGY TO METALS, HEADACHE, FATIGUE AND ARTHRALGIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ALLERGY TO METALS, ARTHRALGIA, CERVICITIS, COMPLICATION OF DEVICE REMOVAL, DEVICE BREAKAGE, EMBEDDED DEVICE, FATIGUE, HEADACHE, METAL POISONING, PELVIC PAIN, POST PROCEDURAL FISTULA, PROCEDURAL PAIN, SWELLING, URINARY TRACT DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION WITHOUT DIFFICULTY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BLOOD GLUCOSE - ON (B)(6) 2019: ABNORMAL: 107. BLOOD TEST - IN 2011: FACTOR VIII COAGULANT 75%, VON WILLEBRAND FACTOR 39%, RISTOCETIN COFACTOR 41.9%. PLATELET FUNCTION ANALYSER EPINEPHRINE 156, PLATELET FUNCTION ANALYSER ADENOSINE DIPHOSPHATE 120, WITH OPTIMAL RESPONSE FROM DESMOPRESSIN (FACTOR VIII COAGULANT 230, VON WILLEBRAND FACTOR ANTIGEN 111, RISTOCETIN COFACTOR 102, PLATELET FUNCTION ANALYSER EPINEPHRINE 55). C-REACTIVE PROTEIN - ON (B)(6) 2019: ABNORMAL: 13.3. CYSTOGRAM - ON (B)(6) -2019: CT INTRODUCED THROUGH BLADDER CATHETER, OBSERVING ADEQUATE FILLING OF BLADDER WITH THICKENING AND IRREGULARITY OF ITS LEFT POSTEROSUPERIOR WALL, AND RAPID EXTRAVASATION OF CONTRAST WITH DIRECT PASSAGE TO VAGINA BUT WITHOUT IDENTIFYING LEAKING POINT ON THIS EXAMINATION. CYSTOSCOPY - ON (B)(6) 2019: MEATUS AT THE LEVEL OF THE APEX -LEFT; LEFT URETHRAL CATHETER IS REMOVED. GYNAECOLOGICAL EXAMINATION - ON (B)(6) 2012: NORMAL EXTERNAL GENITALIA. CERVIX: MACROSCOPICALLY HEALTHY, NO BLEEDING, NO LEUCORRHOEA. UTERUS IN MOBILE ANTEVERSION, NO PAIN ON MOBILIZATION. SOFT AND NON-TENDER ABDOMEN; ON (B)(6) 2019: HEALTHY LOOKING EXTERNAL GENITALIA. WHEN INTRODUCING A SPECULUM, CLEAR FLUID SEEN TO COME OUT THROUGH VAGINA. VAGINAL CAVITY WITHOUT BLOOD REMAINS OR ACTIVE BLEEDING AT THE PRESENT TIME. COMPRESS PLACED INSIDE THE VAGINA. BLADDER CATHETERIZATION PERFORMED. METHYLENE BLUE IS INJECTED THROUGH THE URETHRA. THE COMPRESS INSERTED IN VAGINA IS NOW METHYLENE BLUE STAINED. CASE DISCUSSED WITH UROLOGY SERVICE WHO REQUESTS COMPUTERISED TOMOGRAPHY UROGRAM, CYSTOGRAPHY AND THEN CONTROL IN UROLOGY, NEED FOR PERMANENT BLADDER CATHETERIZATION FOR 2 MONTHS AND EVALUATION OF RESULTS; ON (B)(6) 2019: SPECULUM: AFTER INSERTING A PROBE, CLEAR FLUID AND LIGHT BLEEDING FLOW. TISSUE IN VAGINAL APEX. HAEMOGLOBIN (G/DL) - ON (B)(6) 2019: 13.4 G/DL; ON (B)(6) 2019: 12.4 G/DL. HYSTEROSCOPY - ON (B)(6) 2012: SATISFACTORY PROCEDURE. PATENT CERVIX. TYPE II CAVITY. ATROPHIC ENDOMETRIUM. OSTIA DISPLAYED. GOOD TOLERANCE. ESSURE INSERTION IS PERFORMED WITHOUT ANY DIFFICULTIES. RIGHT OSTIUM: 4 COILS IN CAVITY. LEFT OSTIUM: 4 COILS IN CAVITY. TIME: 5 MINUTES. LAPAROTOMY - ON (B)(6) 2019: EXPLORATORY: CLOSURE OF LEFT URETEROVAGINAL FISTULA WITH URETHRAL REIMPLANTATION WITH RICARD-TYPE ANTIREFLUX TECHNIQUE INTUBATED WITH DOUBLE J URETHRAL CATHETER. DIAGNOSIS: LEFT URETEROVAGINAL FISTULA. LEFT DOUBLE J CATHETER. PATHOLOGY TEST - ON (B)(6) 2019: MACROSCOPIC: HYSTERECTOMY PIECE WEIGHT 110 GRAMS MEASURES 9 X 6.5 X 2.5 CM. SMOOTH SEROUS SURFACE. EXTERNAL CERVICAL ORIFICE IS TORN, EXOCERVIX WHITISH SHOWS FOCAL REDDISH AREAS. AFTER OPENING, ENDOCERVICAL CANAL FREE, AS IS THE ENDOMETRIAL CAVITY. ENDOMETRIUM 2 MM THICK, MYOMETRIUM 20 MM THICK. ON THE SEROUS SURFACE, AT LEVEL OF ONE OF THE UTERINE HORNS, RAISED AREA OF 8 X 5 MM OBSERVED, WHITISH COLOUR, ARRANGED IN SERIES AND INCLUDED IN ITS ENTIRETY. THE CONTRALATERAL ZONE, THE SURFACE OF THE OTHER UTERINE HORN, DOES NOT PRESENT MACROSCOPIC ALTERATIONS, IT IS ALSO ARRANGED IN SERIES AND INCLUDED IN ITS ENTIRETY. NO METALLIC DEVICE HAS BEEN OBSERVED. MICROSCOPIC: HISTOLOGY: AT LEVEL OF ONE OF THE UTERINE HORNS, WHERE RAISED AND WHITISH AREA OF 8 X 5 MM IS MACROSCOPICALLY OBSERVED, A FOREIGN BODY TYPE GRANULOMA CONSISTING OF PALISADED HISTIOCYTES, CHRONIC INFLAMMATION AND PIGMENT IRON DEPOSIT IDENTIFIED. FIBRIN OBSERVED INSIDE THE GRANULOMA. NO FOREIGN BODY CONTAINED. IN THE OTHER CORNUAL AREA OF THE PIECE, NO HISTOLOGICAL LESIONS IDENTIFIED. DIAGNOSIS: FOREIGN BODY GRANULOMA IN THE UTERINE HORN REGION (SEE MACROSCOPIC AND MICROSCOPIC DESCRIPTION). PROLIFERATIVE ENDOMETRIUM. CHRONIC CERVICITIS; ON (B)(6) 2019: LEFT DISTAL UROTHELIUM: CHRONIC INFLAMMATION AND FRAGMENTS OF FISTULOUS TRACT COMPATIBLE WITH CLINICAL DIAGNOSIS (URETEROVAGINAL FISTULA). ABSENCE OF EPITHELIAL DYSPLASIA. CYSTIC OVARIAN LESION: SIMPLE CYST. PLATELET COUNT (GIGA/L) - ON (B)(6) 2019: 366.0 GIGA/L; ON (B)(6) 2019: 468.0 GIGA/L. SKIN TEST - ON (B)(6) 2018: POSITIVE FOR NICKEL +++. NEGATIVE FOR THE REMAINDER OF THE TRUE TEST: CADMIUM, ALUMINIUM, ZINC, COPPER, TITANIUM, VANADIUM, IRON, ZIRCONIUM, MOLYBDENUM, TUNGSTEN, MANGANESE AND NIOBIUM. DIAGNOSIS: NICKEL ALLERGY. ULTRASOUND SCAN - ON (B)(6) 2012: UTERUS IN REGULAR ANTEVERSION POSITION, EMPTY, WITH MEDIAN LINING OF MM. NORMAL ANNEXES. FREE DOUGLAS; ON (B)(6) 2018: UTERUS IN ANTEVERTED POSITION. LENGTH: 89.0 . ANTEROPOSTERIOR DIAMETER: 42.0. TRANSVERSE DIAMETER: 48.0. INTRAMYOMETRIAL IN RIGHT HORN, HYPER REFRINGENT IMAGING THAT SUGGEST 8 MM. ENDOMETRIUM: THICKNESS: 12. RIGHT OVARY DIAMETER: 27 X 17. LEFT OVARY DIAMETER: 24 X 14 DIAGNOSIS: SUGGESTING REMAINS OF ESSURE IN RIGHT UTERINE HORN.. URINE ANALYSIS - ON (B)(6) 2019: RED BLOOD CELLS (HAEMOGLOBIN): LEUKOCYTES (ESTERASE): TRACES . NITRITES: NEGATIVE. URINARY SEDIMENT: AUTOMATED RED BLOOD CELLS PER FIELD: 5 . YEASTS: MODERATE CULTURE. CULTURE IN URINARY CATHETER: STERILE.; ON (B)(6) 2019: PH URINE ISOLATED SAMPLE 6.5 (5.0 - 6.5), GLUCOSE: NEGATIVE (), KETONE BODIES: NEGATIVE (), BILIRUBIN: NEGATIVE (), UROBILINOGEN: 0.2 EU/DL (0.0 - 1.0), PROTEINS: NEGATIVE (), NITRITES: NEGATIVE (); ON (B)(6) 2019: STERILE URINE CULTURE. UROGRAM - ON (B)(6) 2019: CT: LEFT URETEROVAGINAL FISTULA AND RETROVESICAL FLUID COLLECTION CONNECTED TO THE FISTULA; ON (B)(6) 2019: CT WITH SINGLE PHASE INTRAVENOUS CONTRAST: KIDNEYS OF NORMAL SIZE, MORPHOLOGY AND PARENCHYMA, WITH AN ADEQUATE NEPHROGRAM, WITH NO EVIDENCE OF SIGNIFICANT DILATION OF EXCRETORY TRACT. LEFT RENAL DOUBLE J CATHETER, WITHOUT LITHIASIC IMAGES OR DILATION OF EXCRETORY SYSTEM. OTHER FINDINGS: GALLBLADDER WITH SMALL LITHIASIS AND A NODULE IN THE FUNDUS OF ABOUT 17 MM. TO ASSESS POSSIBLE ADENOMYOMATOSIS OR TUMOUR. POSSIBLY FUNCTIONAL RIGHT OVARIAN CYST OF 33 MM. SMALL HEPATIC SIMPLE CYST; ON (B)(6) 2019: INTRAVENOUS CONTRAST MEDIUM: KIDNEYS LOCATED IN IPSILATERAL RENAL FOSSAE, NORMAL SIZE AND MORPHOLOGY. BILATERAL, SYMMETRIC NEPHROGRAM WITH CONTRAST UPTAKE AND REMOVAL BY BOTH KIDNEYS. NORMAL COLLECTING SYSTEMS AND URETERS. REPLENISHED BLADDER, OBSERVING ALTERATION OF THE MORPHOLOGY AT LEVEL OF LEFT VESICOURETERAL MEATUS, PROBABLY SECONDARY TO PREVIOUS SURGERY. NO INTRAVENOUS CONTRAST EXTRAVASATIONS IDENTIFIED. DIAGNOSTIC JUDGEMENT: ALTERATION OF MORPHOLOGY AT LEVEL OF LEFT VESICOURETERAL MEATUS, PROBABLY SECONDARY TO PREVIOUS SURGERY. NO INTRAVENOUS CONTRAST EXTRAVASATIONS IDENTIFIED.. WHITE BLOOD CELL COUNT (GIGA/L) - ON (B)(6) 2019: 8.80 GIGA/L; ON (B)(6) 2019: 12.40 GIGA/L. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-AUG-2020: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW AND REVIEW OF COMPLAINT RECORDS AND RECORDS OF NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN'), DEVICE BREAKAGE ('REMAINS OF ESSURE IN RIGHT UTERINE HORN'), EMBEDDED DEVICE ('ON ULTRASOUND ESSURE INTRAMYOMETRIAL IN RIGHT HORN') AND POST PROCEDURAL FISTULA ('LEFT URETEROVAGINAL FISTULA/ POSTOPERATIVE FISTULA') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810877) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CAESAREAN SECTION (1) IN 2005, GRAVIDA II, PARITY 2, VAGINAL DELIVERY (1), BREAST FEEDING, CONTRACEPTION (BARRIER METHOD), DRUG INTOLERANCE, CONTACT DERMATITIS (YEARS AGO), POLLEN ALLERGY (RHINOCONJUNCTIVITIS TREATED SUCCESSFULLY WITH ANTIHISTAMINES IN ADOLESCENCE) AND APPENDECTOMY (AGE 18). NO PROBLEMS WITH HAIR DYES OR MAKE-UP. NO PROBLEMS WITH LATEX. FAMILY HISTORY WITHOUT RELEVANCE. NORMAL MENSTRUAL CYCLE. DATE OF LAST PERIOD BEFORE ESSURE INSERTION STARTED ON (B)(6) 2012. UTERUS ANTEVERTED. CONCURRENT CONDITIONS INCLUDED VON WILLEBRAND'S DISEASE SINCE 2011. FAMILY HISTORY INCLUDED ACUTE MYOCARDIAL INFARCTION (IN FATHER). CONCOMITANT PRODUCTS INCLUDED DESOGESTREL (CERAZETTE) SINCE (B)(6) 2012 FOR ORAL CONTRACEPTION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED HEADACHE ("PERMANENT HEADACHE, SEVERE HEADACHE"), METAL POISONING ("METALLOSIS"), FATIGUE ("TIREDNESS / CHRONIC FATIGUE") AND ARTHRALGIA ("JOINT PAIN (KNEES, SHOULDERS, WRISTS, FINGERS)"). ON (B)(6) 2018, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), EMBEDDED DEVICE (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED) AND COMPLICATION OF DEVICE REMOVAL ("ESSURE REMOVAL INCOMPLETE"). ON (B)(6) 2019, THE PATIENT EXPERIENCED CERVICITIS ("CHRONIC CERVICITIS"). IN (B)(6) 2019, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING GREATER THAN HER PERIODS AFTER HYSTERECTOMY, METRORRHAGIA"). ON (B)(6) 2019, THE PATIENT EXPERIENCED POST PROCEDURAL FISTULA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH POST PROCEDURAL URINE LEAK AND MICTURITION URGENCY. ON (B)(6) 2019, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAIN AFTER LAPAROTOMY 6 DAYS AGO"). ON (B)(6) 2019, THE PATIENT EXPERIENCED URINARY TRACT DISORDER ("URINARY SPASMS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), ALLERGY TO METALS ("NICKEL ALLERGY") AND SWELLING ("SWELLING"). THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2018 TO (B)(6) 2018 AND THEN FROM (B)(6) 2019 TO (B)(6) 2019. THE PATIENT WAS TREATED WITH CEFUROXIME, HYOSCINE BUTYLBROMIDE (BUSCOPAN), METAMIZOLE MAGNESIUM (NOLOTIL), PARACETAMOL, TRANEXAMIC ACID (AMCHAFIBRIN) AND SURGERY (BILATERAL SALPINGECTOMY ON (B)(6) 2018, CATHETER ON (B)(6) 2019, CLOSURE OF LEFT FISTULA (B)(6) 2019, DOUBLE J URETHRAL CATHETER UNTIL (B)(6) 2019 AND LAPAROSCOPIC TOTAL HYSTERECTOMY ON (B)(6) 2019 WITH VAGINAL PIECE REMOVED TO EXTRACT ESSURE REMAINS). ESSURE WAS REMOVED ON (B)(6) 2019. IN (B)(6) 2019, THE VAGINAL HAEMORRHAGE HAD RESOLVED. ON (B)(6) 2019, THE POST PROCEDURAL FISTULA HAD RESOLVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, EMBEDDED DEVICE, PROCEDURAL PAIN AND URINARY TRACT DISORDER HAD RESOLVED, THE DEVICE BREAKAGE, METAL POISONING, SWELLING, COMPLICATION OF DEVICE REMOVAL AND CERVICITIS OUTCOME WAS UNKNOWN AND THE ALLERGY TO METALS, HEADACHE, FATIGUE AND ARTHRALGIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ALLERGY TO METALS, ARTHRALGIA, CERVICITIS, COMPLICATION OF DEVICE REMOVAL, DEVICE BREAKAGE, EMBEDDED DEVICE, FATIGUE, HEADACHE, METAL POISONING, PELVIC PAIN, POST PROCEDURAL FISTULA, PROCEDURAL PAIN, SWELLING, URINARY TRACT DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION WITHOUT DIFFICULTY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BLOOD GLUCOSE - ON (B)(6) 2019: ABNORMAL: 107. BLOOD TEST - IN 2011: FACTOR VIII COAGULANT 75%, VON WILLEBRAND FACTOR 39%, RISTOCETIN COFACTOR 41.9%. PLATELET FUNCTION ANALYSER EPINEPHRINE 156, PLATELET FUNCTION ANALYSER ADENOSINE DIPHOSPHATE 120, WITH OPTIMAL RESPONSE FROM DESMOPRESSIN (FACTOR VIII COAGULANT 230, VON WILLEBRAND FACTOR ANTIGEN 111, RISTOCETIN COFACTOR 102, PLATELET FUNCTION ANALYSER EPINEPHRINE 55). C-REACTIVE PROTEIN - ON (B)(6) 2019: ABNORMAL: 13.3. CYSTOGRAM - ON (B)(6) 2019: CT INTRODUCED THROUGH BLADDER CATHETER, OBSERVING ADEQUATE FILLING OF BLADDER WITH THICKENING AND IRREGULARITY OF ITS LEFT POSTEROSUPERIOR WALL, AND RAPID EXTRAVASATION OF CONTRAST WITH DIRECT PASSAGE TO VAGINA BUT WITHOUT IDENTIFYING LEAKING POINT ON THIS EXAMINATION. CYSTOSCOPY - ON (B)(6) 2019: MEATUS AT THE LEVEL OF THE APEX -LEFT; LEFT URETHRAL CATHETER IS REMOVED. GYNAECOLOGICAL EXAMINATION - ON (B)(6) 2012: NORMAL EXTERNAL GENITALIA. CERVIX: MACROSCOPICALLY HEALTHY, NO BLEEDING, NO LEUCORRHOEA. UTERUS IN MOBILE ANTEVERSION, NO PAIN ON MOBILIZATION. SOFT AND NON-TENDER ABDOMEN; ON (B)(6) 2019: HEALTHY LOOKING EXTERNAL GENITALIA. WHEN INTRODUCING A SPECULUM, CLEAR FLUID SEEN TO COME OUT THROUGH VAGINA. VAGINAL CAVITY WITHOUT BLOOD REMAINS OR ACTIVE BLEEDING AT THE PRESENT TIME. COMPRESS PLACED INSIDE THE VAGINA. BLADDER CATHETERIZATION PERFORMED. METHYLENE BLUE IS INJECTED THROUGH THE URETHRA. THE COMPRESS INSERTED IN VAGINA IS NOW METHYLENE BLUE STAINED. CASE DISCUSSED WITH UROLOGY SERVICE WHO REQUESTS COMPUTERISED TOMOGRAPHY UROGRAM, CYSTOGRAPHY AND THEN CONTROL IN UROLOGY, NEED FOR PERMANENT BLADDER CATHETERIZATION FOR 2 MONTHS AND EVALUATION OF RESULTS; ON (B)(6) 2019: SPECULUM: AFTER INSERTING A PROBE, CLEAR FLUID AND LIGHT BLEEDING FLOW. TISSUE IN VAGINAL APEX. HAEMOGLOBIN (G/DL) - ON (B)(6) 2019: 13.4 G/DL; ON (B)(6) 2019: 12.4 G/DL. HYSTEROSCOPY - ON (B)(6) 2012: SATISFACTORY PROCEDURE. PATENT CERVIX. TYPE II CAVITY. ATROPHIC ENDOMETRIUM. OSTIA DISPLAYED. GOOD TOLERANCE. ESSURE INSERTION IS PERFORMED WITHOUT ANY DIFFICULTIES. RIGHT OSTIUM: 4 COILS IN CAVITY. LEFT OSTIUM: 4 COILS IN CAVITY. TIME: 5 MINUTES. LAPAROTOMY - ON (B)(6) 2019: EXPLORATORY: CLOSURE OF LEFT URETEROVAGINAL FISTULA WITH URETHRAL REIMPLANTATION WITH RICARD-TYPE ANTIREFLUX TECHNIQUE INTUBATED WITH DOUBLE J URETHRAL CATHETER. DIAGNOSIS: LEFT URETEROVAGINAL FISTULA. LEFT DOUBLE J CATHETER. PATHOLOGY TEST - ON (B)(6) 2019: MACROSCOPIC: HYSTERECTOMY PIECE WEIGHT 110 GRAMS MEASURES 9 X 6.5 X 2.5 CM. SMOOTH SEROUS SURFACE. EXTERNAL CERVICAL ORIFICE IS TORN, EXOCERVIX WHITISH SHOWS FOCAL REDDISH AREAS. AFTER OPENING, ENDOCERVICAL CANAL FREE, AS IS THE ENDOMETRIAL CAVITY. ENDOMETRIUM 2 MM THICK, MYOMETRIUM 20 MM THICK. ON THE SEROUS SURFACE, AT LEVEL OF ONE OF THE UTERINE HORNS, RAISED AREA OF 8 X 5 MM OBSERVED, WHITISH COLOUR, ARRANGED IN SERIES AND INCLUDED IN ITS ENTIRETY. THE CONTRALATERAL ZONE, THE SURFACE OF THE OTHER UTERINE HORN, DOES NOT PRESENT MACROSCOPIC ALTERATIONS, IT IS ALSO ARRANGED IN SERIES AND INCLUDED IN ITS ENTIRETY. NO METALLIC DEVICE HAS BEEN OBSERVED. MICROSCOPIC: HISTOLOGY: AT LEVEL OF ONE OF THE UTERINE HORNS, WHERE RAISED AND WHITISH AREA OF 8 X 5 MM IS MACROSCOPICALLY OBSERVED, A FOREIGN BODY TYPE GRANULOMA CONSISTING OF PALISADED HISTIOCYTES, CHRONIC INFLAMMATION AND PIGMENT IRON DEPOSIT IDENTIFIED. FIBRIN OBSERVED INSIDE THE GRANULOMA. NO FOREIGN BODY CONTAINED. IN THE OTHER CORNUAL AREA OF THE PIECE, NO HISTOLOGICAL LESIONS IDENTIFIED. DIAGNOSIS: FOREIGN BODY GRANULOMA IN THE UTERINE HORN REGION (SEE MACROSCOPIC AND MICROSCOPIC DESCRIPTION). PROLIFERATIVE ENDOMETRIUM. CHRONIC CERVICITIS; ON (B)(6) 2019: LEFT DISTAL UROTHELIUM: CHRONIC INFLAMMATION AND FRAGMENTS OF FISTULOUS TRACT COMPATIBLE WITH CLINICAL DIAGNOSIS (URETEROVAGINAL FISTULA). ABSENCE OF EPITHELIAL DYSPLASIA. CYSTIC OVARIAN LESION: SIMPLE CYST. PLATELET COUNT (GIGA/L) - ON (B)(6) 2019: 366.0 GIGA/L; ON (B)(6) 2019: 468.0 GIGA/L. SKIN TEST - ON (B)(6) 2018: POSITIVE FOR NICKEL +++. NEGATIVE FOR THE REMAINDER OF THE TRUE TEST: CADMIUM, ALUMINIUM, ZINC, COPPER, TITANIUM, VANADIUM, IRON, ZIRCONIUM, MOLYBDENUM, TUNGSTEN, MANGANESE AND NIOBIUM. DIAGNOSIS: NICKEL ALLERGY. ULTRASOUND SCAN - ON (B)(6) 2012: UTERUS IN REGULAR ANTEVERSION POSITION, EMPTY, WITH MEDIAN LINING OF MM. NORMAL ANNEXES. FREE DOUGLAS; ON (B)(6) 2018: UTERUS IN ANTEVERTED POSITION. LENGTH: 89.0 . ANTEROPOSTERIOR DIAMETER: 42.0. TRANSVERSE DIAMETER: 48.0. INTRAMYOMETRIAL IN RIGHT HORN, HYPER REFRINGENT IMAGING THAT SUGGEST 8 MM. ENDOMETRIUM: THICKNESS: 12. RIGHT OVARY DIAMETER: 27 X 17. LEFT OVARY DIAMETER: 24 X 14 DIAGNOSIS: SUGGESTING REMAINS OF ESSURE IN RIGHT UTERINE HORN.. URINE ANALYSIS - ON (B)(6) 2019: RED BLOOD CELLS (HAEMOGLOBIN): LEUKOCYTES (ESTERASE): TRACES . NITRITES: NEGATIVE. URINARY SEDIMENT: AUTOMATED RED BLOOD CELLS PER FIELD: 5 . YEASTS: MODERATE CULTURE. CULTURE IN URINARY CATHETER: STERILE.; ON (B)(6) 2019: PH URINE ISOLATED SAMPLE 6.5 (5.0 - 6.5), GLUCOSE: NEGATIVE (), KETONE BODIES: NEGATIVE (), BILIRUBIN: NEGATIVE (), UROBILINOGEN: 0.2 EU/DL (0.0 - 1.0), PROTEINS: NEGATIVE (), NITRITES: NEGATIVE (); ON (B)(6) 2019: STERILE URINE CULTURE. UROGRAM - ON (B)(6) 2019: CT: LEFT URETEROVAGINAL FISTULA AND RETROVESICAL FLUID COLLECTION CONNECTED TO THE FISTULA; ON (B)(6) 2019: CT WITH SINGLE PHASE INTRAVENOUS CONTRAST: KIDNEYS OF NORMAL SIZE, MORPHOLOGY AND PARENCHYMA, WITH AN ADEQUATE NEPHROGRAM, WITH NO EVIDENCE OF SIGNIFICANT DILATION OF EXCRETORY TRACT. LEFT RENAL DOUBLE J CATHETER, WITHOUT LITHIASIC IMAGES OR DILATION OF EXCRETORY SYSTEM. OTHER FINDINGS: GALLBLADDER WITH SMALL LITHIASIS AND A NODULE IN THE FUNDUS OF ABOUT 17 MM. TO ASSESS POSSIBLE ADENOMYOMATOSIS OR TUMOUR. POSSIBLY FUNCTIONAL RIGHT OVARIAN CYST OF 33 MM. SMALL HEPATIC SIMPLE CYST; ON (B)(6) 2019: INTRAVENOUS CONTRAST MEDIUM: KIDNEYS LOCATED IN IPSILATERAL RENAL FOSSAE, NORMAL SIZE AND MORPHOLOGY. BILATERAL, SYMMETRIC NEPHROGRAM WITH CONTRAST UPTAKE AND REMOVAL BY BOTH KIDNEYS. NORMAL COLLECTING SYSTEMS AND URETERS. REPLENISHED BLADDER, OBSERVING ALTERATION OF THE MORPHOLOGY AT LEVEL OF LEFT VESICOURETERAL MEATUS, PROBABLY SECONDARY TO PREVIOUS SURGERY. NO INTRAVENOUS CONTRAST EXTRAVASATIONS IDENTIFIED. DIAGNOSTIC JUDGEMENT: ALTERATION OF MORPHOLOGY AT LEVEL OF LEFT VESICOURETERAL MEATUS, PROBABLY SECONDARY TO PREVIOUS SURGERY. NO INTRAVENOUS CONTRAST EXTRAVASATIONS IDENTIFIED.. WHITE BLOOD CELL COUNT (GIGA/L) - ON (B)(6) 2019: 8.80 GIGA/L; ON (B)(6) 2019: 12.40 GIGA/L. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW AND REVIEW OF COMPLAINT RECORDS AND RECORDS OF NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN'), DEVICE BREAKAGE ('REMAINS OF ESSURE IN RIGHT UTERINE HORN'), EMBEDDED DEVICE ('ON ULTRASOUND ESSURE INTRAMYOMETRIAL IN RIGHT HORN') AND POST PROCEDURAL FISTULA ('LEFT URETEROVAGINAL FISTULA/ POSTOPERATIVE FISTULA') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810877) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CAESAREAN SECTION (1) IN 2005, GRAVIDA II, PARITY 2, VAGINAL DELIVERY (1), BREAST FEEDING, CONTRACEPTION (BARRIER METHOD), DRUG INTOLERANCE, CONTACT DERMATITIS (YEARS AGO), POLLEN ALLERGY (RHINOCONJUNCTIVITIS TREATED SUCCESSFULLY WITH ANTIHISTAMINES IN ADOLESCENCE) AND APPENDECTOMY (AGE 18). NO PROBLEMS WITH HAIR DYES OR MAKE-UP. NO PROBLEMS WITH LATEX. FAMILY HISTORY WITHOUT RELEVANCE. NORMAL MENSTRUAL CYCLE. DATE OF LAST PERIOD BEFORE ESSURE INSERTION STARTED ON (B)(6) 2012. UTERUS ANTEVERTED. CONCURRENT CONDITIONS INCLUDED VON WILLEBRAND'S DISEASE SINCE 2011. FAMILY HISTORY INCLUDED ACUTE MYOCARDIAL INFARCTION (IN FATHER). CONCOMITANT PRODUCTS INCLUDED DESOGESTREL (CERAZETTE) SINCE (B)(6) 2012 FOR ORAL CONTRACEPTION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED HEADACHE ("PERMANENT HEADACHE, SEVERE HEADACHE"), METAL POISONING ("METALLOSIS"), FATIGUE ("TIREDNESS / CHRONIC FATIGUE") AND ARTHRALGIA ("JOINT PAIN (KNEES, SHOULDERS, WRISTS, FINGERS)"). ON (B)(6) 2018, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), EMBEDDED DEVICE (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED) AND COMPLICATION OF DEVICE REMOVAL ("ESSURE REMOVAL INCOMPLETE"). ON (B)(6) 2019, THE PATIENT EXPERIENCED CERVICITIS ("CHRONIC CERVICITIS"). IN (B)(6) 2019, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING GREATER THAN HER PERIODS AFTER HYSTERECTOMY, METRORRHAGIA"). ON (B)(6) 2019, THE PATIENT EXPERIENCED POST PROCEDURAL FISTULA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH POST PROCEDURAL URINE LEAK AND MICTURITION URGENCY. ON (B)(6) 2019, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAIN AFTER LAPAROTOMY 6 DAYS AGO"). ON (B)(6) 2019, THE PATIENT EXPERIENCED URINARY TRACT DISORDER ("URINARY SPASMS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), ALLERGY TO METALS ("NICKEL ALLERGY") AND SWELLING ("SWELLING"). THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2018 TO (B)(6) 2018 AND THEN FROM (B)(6) 2019 TO (B)(6) 2019. THE PATIENT WAS TREATED WITH CEFUROXIME, HYOSCINE BUTYLBROMIDE (BUSCOPAN), METAMIZOLE MAGNESIUM (NOLOTIL), PARACETAMOL, TRANEXAMIC ACID (AMCHAFIBRIN) AND SURGERY (BILATERAL SALPINGECTOMY ON (B)(6) 2018, CATHETER ON 26-FEB-19, CLOSURE OF LEFT FISTULA (B)(6) 2019, DOUBLE J URETHRAL CATHETER UNTIL OCT-19 AND LAPAROSCOPIC TOTAL HYSTERECTOMY ON (B)(6) 2019 WITH VAGINAL PIECE REMOVED TO EXTRACT ESSURE REMAINS). ESSURE WAS REMOVED ON (B)(6) 2019. IN (B)(6) 2019, THE VAGINAL HAEMORRHAGE HAD RESOLVED. ON (B)(6) 2019, THE POST PROCEDURAL FISTULA HAD RESOLVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, EMBEDDED DEVICE, PROCEDURAL PAIN AND URINARY TRACT DISORDER HAD RESOLVED, THE DEVICE BREAKAGE, METAL POISONING, SWELLING, COMPLICATION OF DEVICE REMOVAL AND CERVICITIS OUTCOME WAS UNKNOWN AND THE ALLERGY TO METALS, HEADACHE, FATIGUE AND ARTHRALGIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ALLERGY TO METALS, ARTHRALGIA, CERVICITIS, COMPLICATION OF DEVICE REMOVAL, DEVICE BREAKAGE, EMBEDDED DEVICE, FATIGUE, HEADACHE, METAL POISONING, PELVIC PAIN, POST PROCEDURAL FISTULA, PROCEDURAL PAIN, SWELLING, URINARY TRACT DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION WITHOUT DIFFICULTY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BLOOD GLUCOSE - ON (B)(6) 2019: ABNORMAL: 107. BLOOD TEST - IN 2011: FACTOR VIII COAGULANT 75%, VON WILLEBRAND FACTOR 39%, RISTOCETIN COFACTOR 41.9%. PLATELET FUNCTION ANALYSER EPINEPHRINE 156, PLATELET FUNCTION ANALYSER ADENOSINE DIPHOSPHATE 120, WITH OPTIMAL RESPONSE FROM DESMOPRESSIN (FACTOR VIII COAGULANT 230, VON WILLEBRAND FACTOR ANTIGEN 111, RISTOCETIN COFACTOR 102, PLATELET FUNCTION ANALYSER EPINEPHRINE 55). C-REACTIVE PROTEIN - ON (B)(6) 2019: ABNORMAL: 13.3. CYSTOGRAM - ON (B)(6) 2019: CT INTRODUCED THROUGH BLADDER CATHETER, OBSERVING ADEQUATE FILLING OF BLADDER WITH THICKENING AND IRREGULARITY OF ITS LEFT POSTEROSUPERIOR WALL, AND RAPID EXTRAVASATION OF CONTRAST WITH DIRECT PASSAGE TO VAGINA BUT WITHOUT IDENTIFYING LEAKING POINT ON THIS EXAMINATION. CYSTOSCOPY - ON (B)(6) 2019: MEATUS AT THE LEVEL OF THE APEX -LEFT; LEFT URETHRAL CATHETER IS REMOVED. GYNAECOLOGICAL EXAMINATION - ON (B)(6) 2012: NORMAL EXTERNAL GENITALIA. CERVIX: MACROSCOPICALLY HEALTHY, NO BLEEDING, NO LEUCORRHOEA. UTERUS IN MOBILE ANTEVERSION, NO PAIN ON MOBILIZATION. SOFT AND NON-TENDER ABDOMEN; ON (B)(6) 2019: HEALTHY LOOKING EXTERNAL GENITALIA. WHEN INTRODUCING A SPECULUM, CLEAR FLUID SEEN TO COME OUT THROUGH VAGINA. VAGINAL CAVITY WITHOUT BLOOD REMAINS OR ACTIVE BLEEDING AT THE PRESENT TIME. COMPRESS PLACED INSIDE THE VAGINA. BLADDER CATHETERIZATION PERFORMED. METHYLENE BLUE IS INJECTED THROUGH THE URETHRA. THE COMPRESS INSERTED IN VAGINA IS NOW METHYLENE BLUE STAINED. CASE DISCUSSED WITH UROLOGY SERVICE WHO REQUESTS COMPUTERISED TOMOGRAPHY UROGRAM, CYSTOGRAPHY AND THEN CONTROL IN UROLOGY, NEED FOR PERMANENT BLADDER CATHETERIZATION FOR 2 MONTHS AND EVALUATION OF RESULTS; ON (B)(6) 2019: SPECULUM: AFTER INSERTING A PROBE, CLEAR FLUID AND LIGHT BLEEDING FLOW. TISSUE IN VAGINAL APEX. HAEMOGLOBIN (G/DL) - ON (B)(6) 2019: 13.4 G/DL; ON (B)(6) 2019: 12.4 G/DL. HYSTEROSCOPY - ON (B)(6) 2012: SATISFACTORY PROCEDURE. PATENT CERVIX. TYPE II CAVITY. ATROPHIC ENDOMETRIUM. OSTIA DISPLAYED. GOOD TOLERANCE. ESSURE INSERTION IS PERFORMED WITHOUT ANY DIFFICULTIES. RIGHT OSTIUM: 4 COILS IN CAVITY. LEFT OSTIUM: 4 COILS IN CAVITY. TIME: 5 MINUTES. LAPAROTOMY - ON (B)(6) 2019: EXPLORATORY: CLOSURE OF LEFT URETEROVAGINAL FISTULA WITH URETHRAL REIMPLANTATION WITH RICARD-TYPE ANTIREFLUX TECHNIQUE INTUBATED WITH DOUBLE J URETHRAL CATHETER. DIAGNOSIS: LEFT URETEROVAGINAL FISTULA. LEFT DOUBLE J CATHETER. PATHOLOGY TEST - ON (B)(6) 2019: MACROSCOPIC: HYSTERECTOMY PIECE WEIGHT 110 GRAMS MEASURES 9 X 6.5 X 2.5 CM. SMOOTH SEROUS SURFACE. EXTERNAL CERVICAL ORIFICE IS TORN, EXOCERVIX WHITISH SHOWS FOCAL REDDISH AREAS. AFTER OPENING, ENDOCERVICAL CANAL FREE, AS IS THE ENDOMETRIAL CAVITY. ENDOMETRIUM 2 MM THICK, MYOMETRIUM 20 MM THICK. ON THE SEROUS SURFACE, AT LEVEL OF ONE OF THE UTERINE HORNS, RAISED AREA OF 8 X 5 MM OBSERVED, WHITISH COLOUR, ARRANGED IN SERIES AND INCLUDED IN ITS ENTIRETY. THE CONTRALATERAL ZONE, THE SURFACE OF THE OTHER UTERINE HORN, DOES NOT PRESENT MACROSCOPIC ALTERATIONS, IT IS ALSO ARRANGED IN SERIES AND INCLUDED IN ITS ENTIRETY. NO METALLIC DEVICE HAS BEEN OBSERVED. MICROSCOPIC: HISTOLOGY: AT LEVEL OF ONE OF THE UTERINE HORNS, WHERE RAISED AND WHITISH AREA OF 8 X 5 MM IS MACROSCOPICALLY OBSERVED, A FOREIGN BODY TYPE GRANULOMA CONSISTING OF PALISADED HISTIOCYTES, CHRONIC INFLAMMATION AND PIGMENT IRON DEPOSIT IDENTIFIED. FIBRIN OBSERVED INSIDE THE GRANULOMA. NO FOREIGN BODY CONTAINED. IN THE OTHER CORNUAL AREA OF THE PIECE, NO HISTOLOGICAL LESIONS IDENTIFIED. DIAGNOSIS: FOREIGN BODY GRANULOMA IN THE UTERINE HORN REGION (SEE MACROSCOPIC AND MICROSCOPIC DESCRIPTION). PROLIFERATIVE ENDOMETRIUM. CHRONIC CERVICITIS; ON (B)(6) 2019: LEFT DISTAL UROTHELIUM: CHRONIC INFLAMMATION AND FRAGMENTS OF FISTULOUS TRACT COMPATIBLE WITH CLINICAL DIAGNOSIS (URETEROVAGINAL FISTULA). ABSENCE OF EPITHELIAL DYSPLASIA. CYSTIC OVARIAN LESION: SIMPLE CYST. PLATELET COUNT (GIGA/L) - ON (B)(6) 2019: 366.0 GIGA/L; ON (B)(6) 2019: 468.0 GIGA/L. SKIN TEST - ON (B)(6) 2018: POSITIVE FOR NICKEL +++. NEGATIVE FOR THE REMAINDER OF THE TRUE TEST: CADMIUM, ALUMINIUM, ZINC, COPPER, TITANIUM, VANADIUM, IRON, ZIRCONIUM, MOLYBDENUM, TUNGSTEN, MANGANESE AND NIOBIUM. DIAGNOSIS: NICKEL ALLERGY. ULTRASOUND SCAN - ON (B)(6) 2012: UTERUS IN REGULAR ANTEVERSION POSITION, EMPTY, WITH MEDIAN LINING OF MM. NORMAL ANNEXES. FREE DOUGLAS; ON (B)(6) 2018: UTERUS IN ANTEVERTED POSITION. LENGTH: 89.0 . ANTEROPOSTERIOR DIAMETER: 42.0. TRANSVERSE DIAMETER: 48.0. INTRAMYOMETRIAL IN RIGHT HORN, HYPER REFRINGENT IMAGING THAT SUGGEST 8 MM. ENDOMETRIUM: THICKNESS: 12. RIGHT OVARY DIAMETER: 27 X 17. LEFT OVARY DIAMETER: 24 X 14 DIAGNOSIS: SUGGESTING REMAINS OF ESSURE IN RIGHT UTERINE HORN.. URINE ANALYSIS - ON (B)(6) 2019: RED BLOOD CELLS (HAEMOGLOBIN): LEUKOCYTES (ESTERASE): TRACES . NITRITES: NEGATIVE. URINARY SEDIMENT: AUTOMATED RED BLOOD CELLS PER FIELD: 5 . YEASTS: MODERATE CULTURE. CULTURE IN URINARY CATHETER: STERILE.; ON (B)(6) 2019: PH URINE ISOLATED SAMPLE 6.5 (5.0 - 6.5), GLUCOSE: NEGATIVE (), KETONE BODIES: NEGATIVE (), BILIRUBIN: NEGATIVE (), UROBILINOGEN: 0.2 EU/DL (0.0 - 1.0), PROTEINS: NEGATIVE (), NITRITES: NEGATIVE (); ON (B)(6) 2019: STERILE URINE CULTURE. UROGRAM - ON (B)(6) 2019: CT: LEFT URETEROVAGINAL FISTULA AND RETROVESICAL FLUID COLLECTION CONNECTED TO THE FISTULA; ON (B)(6) 2019: CT WITH SINGLE PHASE INTRAVENOUS CONTRAST: KIDNEYS OF NORMAL SIZE, MORPHOLOGY AND PARENCHYMA, WITH AN ADEQUATE NEPHROGRAM, WITH NO EVIDENCE OF SIGNIFICANT DILATION OF EXCRETORY TRACT. LEFT RENAL DOUBLE J CATHETER, WITHOUT LITHIASIC IMAGES OR DILATION OF EXCRETORY SYSTEM. OTHER FINDINGS: GALLBLADDER WITH SMALL LITHIASIS AND A NODULE IN THE FUNDUS OF ABOUT 17 MM. TO ASSESS POSSIBLE ADENOMYOMATOSIS OR TUMOUR. POSSIBLY FUNCTIONAL RIGHT OVARIAN CYST OF 33 MM. SMALL HEPATIC SIMPLE CYST; ON (B)(6) 2019: INTRAVENOUS CONTRAST MEDIUM: KIDNEYS LOCATED IN IPSILATERAL RENAL FOSSAE, NORMAL SIZE AND MORPHOLOGY. BILATERAL, SYMMETRIC NEPHROGRAM WITH CONTRAST UPTAKE AND REMOVAL BY BOTH KIDNEYS. NORMAL COLLECTING SYSTEMS AND URETERS. REPLENISHED BLADDER, OBSERVING ALTERATION OF THE MORPHOLOGY AT LEVEL OF LEFT VESICOURETERAL MEATUS, PROBABLY SECONDARY TO PREVIOUS SURGERY. NO INTRAVENOUS CONTRAST EXTRAVASATIONS IDENTIFIED. DIAGNOSTIC JUDGEMENT: ALTERATION OF MORPHOLOGY AT LEVEL OF LEFT VESICOURETERAL MEATUS, PROBABLY SECONDARY TO PREVIOUS SURGERY. NO INTRAVENOUS CONTRAST EXTRAVASATIONS IDENTIFIED. WHITE BLOOD CELL COUNT (GIGA/L) - ON (B)(6) 2019: 8.80 GIGA/L; ON (B)(6) 2019: 12.40 GIGA/L. LOT NUMBER: 810877 MANUFACTURING DATE: 2010/12 EXPIRATION DATE: 2013/12. 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 22-MAR-2021: 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 ('PELVIC PAIN'), DEVICE BREAKAGE ('REMAINS OF ESSURE IN RIGHT UTERINE HORN'), EMBEDDED DEVICE ('ON ULTRASOUND ESSURE INTRAMYOMETRIAL IN RIGHT HORN') AND POST PROCEDURAL FISTULA ('LEFT URETEROVAGINAL FISTULA/ POSTOPERATIVE FISTULA') IN A (B)(6) YEAR OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810877) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CAESAREAN SECTION (1) IN 2005, GRAVIDA II, PARITY 2, VAGINAL DELIVERY (1), BREAST FEEDING, CONTRACEPTION (BARRIER METHOD), DRUG INTOLERANCE, CONTACT DERMATITIS (YEARS AGO), POLLEN ALLERGY (RHINOCONJUNCTIVITIS TREATED SUCCESSFULLY WITH ANTIHISTAMINES IN ADOLESCENCE) AND APPENDECTOMY (AGE 18). NO PROBLEMS WITH HAIR DYES OR MAKE-UP. NO PROBLEMS WITH LATEX. FAMILY HISTORY WITHOUT RELEVANCE. NORMAL MENSTRUAL CYCLE. DATE OF LAST PERIOD BEFORE ESSURE INSERTION STARTED ON (B)(6) 2012. UTERUS ANTEVERTED. CONCURRENT CONDITIONS INCLUDED VON WILLEBRAND'S DISEASE SINCE 2011. FAMILY HISTORY INCLUDED ACUTE MYOCARDIAL INFARCTION (IN FATHER). CONCOMITANT PRODUCTS INCLUDED DESOGESTREL (CERAZETTE) SINCE (B)(6) 2012 FOR ORAL CONTRACEPTION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED HEADACHE ("PERMANENT HEADACHE, SEVERE HEADACHE"), METAL POISONING ("METALLOSIS"), FATIGUE ("TIREDNESS / CHRONIC FATIGUE") AND ARTHRALGIA ("JOINT PAIN (KNEES, SHOULDERS, WRISTS, FINGERS)"). ON (B)(6) 2018, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), EMBEDDED DEVICE (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED) AND COMPLICATION OF DEVICE REMOVAL ("ESSURE REMOVAL INCOMPLETE"). ON (B)(6) 2019, THE PATIENT EXPERIENCED CERVICITIS ("CHRONIC CERVICITIS"). IN (B)(6) 2019, THE PATIENT EXPERIENCED POST PROCEDURAL HAEMORRHAGE ("VAGINAL BLEEDING GREATER THAN HER PERIODS AFTER HYSTERECTOMY, METRORRHAGIA"). ON (B)(6) 2019, THE PATIENT EXPERIENCED POST PROCEDURAL FISTULA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH POST PROCEDURAL URINE LEAK AND MICTURITION URGENCY. ON (B)(6) 2019, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAIN AFTER LAPAROTOMY 6 DAYS AGO"). ON (B)(6) 2019, THE PATIENT EXPERIENCED URINARY TRACT DISORDER ("URINARY SPASMS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), ALLERGY TO METALS ("NICKEL ALLERGY") AND SWELLING ("SWELLING"). THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2018 TO (B)(6) 2018 AND THEN FROM (B)(6) 2019 TO (B)(6) 2019. THE PATIENT WAS TREATED WITH CEFUROXIME, HYOSCINE BUTYLBROMIDE (BUSCOPAN), METAMIZOLE MAGNESIUM (NOLOTIL), PARACETAMOL, TRANEXAMIC ACID (AMCHAFIBRIN) AND SURGERY (BILATERAL SALPINGECTOMY ON (B)(6) 2018, CATHETER ON (B)(6) 2019, CLOSURE OF LEFT FISTULA (B)(6) 2019, DOUBLE J URETHRAL CATHETER UNTIL (B)(6) 2019 AND LAPAROSCOPIC TOTAL HYSTERECTOMY ON (B)(6) 2019 WITH VAGINAL PIECE REMOVED TO EXTRACT ESSURE REMAINS). ESSURE WAS REMOVED ON (B)(6) 2019. IN (B)(6) 2019, THE POST PROCEDURAL HAEMORRHAGE HAD RESOLVED. ON (B)(6) 2019, THE POST PROCEDURAL FISTULA HAD RESOLVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, EMBEDDED DEVICE, PROCEDURAL PAIN AND URINARY TRACT DISORDER HAD RESOLVED, THE DEVICE BREAKAGE, METAL POISONING, SWELLING, COMPLICATION OF DEVICE REMOVAL AND CERVICITIS OUTCOME WAS UNKNOWN AND THE ALLERGY TO METALS, HEADACHE, FATIGUE AND ARTHRALGIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ALLERGY TO METALS, ARTHRALGIA, CERVICITIS, COMPLICATION OF DEVICE REMOVAL, DEVICE BREAKAGE, EMBEDDED DEVICE, FATIGUE, HEADACHE, METAL POISONING, PELVIC PAIN, POST PROCEDURAL FISTULA, POST PROCEDURAL HAEMORRHAGE, PROCEDURAL PAIN, SWELLING AND URINARY TRACT DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION WITHOUT DIFFICULTY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BLOOD GLUCOSE ON (B)(6) 2019: ABNORMAL: 107. BLOOD TEST IN 2011: FACTOR VIII COAGULANT 75%, VON WILLEBRAND FACTOR 39%, RISTOCETIN COFACTOR 41.9%. PLATELET FUNCTION ANALYSER EPINEPHRINE 156, PLATELET FUNCTION ANALYSER ADENOSINE DIPHOSPHATE 120, WITH OPTIMAL RESPONSE FROM DESMOPRESSIN (FACTOR VIII COAGULANT 230, VON WILLEBRAND FACTOR ANTIGEN 111, RISTOCETIN COFACTOR 102, PLATELET FUNCTION ANALYSER EPINEPHRINE 55). C-REACTIVE PROTEIN - ON (B)(6) 2019: ABNORMAL: 13.3. CYSTOGRAM ON (B)(6) 2019: CT INTRODUCED THROUGH BLADDER CATHETER, OBSERVING ADEQUATE FILLING OF BLADDER WITH THICKENING AND IRREGULARITY OF ITS LEFT POSTEROSUPERIOR WALL, AND RAPID EXTRAVASATION OF CONTRAST WITH DIRECT PASSAGE TO VAGINA BUT WITHOUT IDENTIFYING LEAKING POINT ON THIS EXAMINATION. CYSTOSCOPY ON (B)(6) 2019: MEATUS AT THE LEVEL OF THE APEX -LEFT; LEFT URETHRAL CATHETER IS REMOVED. GYNAECOLOGICAL EXAMINATION ON (B)(6) 2012: NORMAL EXTERNAL GENITALIA. CERVIX: MACROSCOPICALLY HEALTHY, NO BLEEDING, NO LEUCORRHOEA. UTERUS IN MOBILE ANTEVERSION, NO PAIN ON MOBILIZATION. SOFT AND NON-TENDER ABDOMEN; ON (B)(6) 2019: HEALTHY LOOKING EXTERNAL GENITALIA. WHEN INTRODUCING A SPECULUM, CLEAR FLUID SEEN TO COME OUT THROUGH VAGINA. VAGINAL CAVITY WITHOUT BLOOD REMAINS OR ACTIVE BLEEDING AT THE PRESENT TIME. COMPRESS PLACED INSIDE THE VAGINA. BLADDER CATHETERIZATION PERFORMED. METHYLENE BLUE IS INJECTED THROUGH THE URETHRA. THE COMPRESS INSERTED IN VAGINA IS NOW METHYLENE BLUE STAINED. CASE DISCUSSED WITH UROLOGY SERVICE WHO REQUESTS COMPUTERISED TOMOGRAPHY UROGRAM, CYSTOGRAPHY AND THEN CONTROL IN UROLOGY, NEED FOR PERMANENT BLADDER CATHETERIZATION FOR 2 MONTHS AND EVALUATION OF RESULTS; ON (B)(6) 2019: SPECULUM: AFTER INSERTING A PROBE, CLEAR FLUID AND LIGHT BLEEDING FLOW. TISSUE IN VAGINAL APEX. HAEMOGLOBIN (G/DL) ON (B)(6) 2019: 13.4 G/DL; ON (B)(6) 2019: 12.4 G/DL. HYSTEROSCOPY ON (B)(6) 2012: SATISFACTORY PROCEDURE. PATENT CERVIX. TYPE II CAVITY. ATROPHIC ENDOMETRIUM. OSTIA DISPLAYED. GOOD TOLERANCE. ESSURE INSERTION IS PERFORMED WITHOUT ANY DIFFICULTIES. RIGHT OSTIUM: 4 COILS IN CAVITY. LEFT OSTIUM: 4 COILS IN CAVITY. TIME: 5 MINUTES. LAPAROTOMY ON (B)(6) 2019: EXPLORATORY: CLOSURE OF LEFT URETEROVAGINAL FISTULA WITH URETHRAL REIMPLANTATION WITH RICARD-TYPE ANTIREFLUX TECHNIQUE INTUBATED WITH DOUBLE J URETHRAL CATHETER. DIAGNOSIS: LEFT URETEROVAGINAL FISTULA. LEFT DOUBLE J CATHETER. PATHOLOGY TEST ON (B)(6) 2019: MACROSCOPIC: HYSTERECTOMY PIECE WEIGHT 110 GRAMS MEASURES 9 X 6.5 X 2.5 CM. SMOOTH SEROUS SURFACE. EXTERNAL CERVICAL ORIFICE IS TORN, EXOCERVIX WHITISH SHOWS FOCAL REDDISH AREAS. AFTER OPENING, ENDOCERVICAL CANAL FREE, AS IS THE ENDOMETRIAL CAVITY. ENDOMETRIUM 2 MM THICK, MYOMETRIUM 20 MM THICK. ON THE SEROUS SURFACE, AT LEVEL OF ONE OF THE UTERINE HORNS, RAISED AREA OF 8 X 5 MM OBSERVED, WHITISH COLOUR, ARRANGED IN SERIES AND INCLUDED IN ITS ENTIRETY. THE CONTRALATERAL ZONE, THE SURFACE OF THE OTHER UTERINE HORN, DOES NOT PRESENT MACROSCOPIC ALTERATIONS, IT IS ALSO ARRANGED IN SERIES AND INCLUDED IN ITS ENTIRETY. NO METALLIC DEVICE HAS BEEN OBSERVED. MICROSCOPIC: HISTOLOGY: AT LEVEL OF ONE OF THE UTERINE HORNS, WHERE RAISED AND WHITISH AREA OF 8 X 5 MM IS MACROSCOPICALLY OBSERVED, A FOREIGN BODY TYPE GRANULOMA CONSISTING OF PALISADED HISTIOCYTES, CHRONIC INFLAMMATION AND PIGMENT IRON DEPOSIT IDENTIFIED. FIBRIN OBSERVED INSIDE THE GRANULOMA. NO FOREIGN BODY CONTAINED. IN THE OTHER CORNUAL AREA OF THE PIECE, NO HISTOLOGICAL LESIONS IDENTIFIED. DIAGNOSIS: FOREIGN BODY GRANULOMA IN THE UTERINE HORN REGION (SEE MACROSCOPIC AND MICROSCOPIC DESCRIPTION). PROLIFERATIVE ENDOMETRIUM. CHRONIC CERVICITIS; ON (B)(6) 2019: LEFT DISTAL UROTHELIUM: CHRONIC INFLAMMATION AND FRAGMENTS OF FISTULOUS TRACT COMPATIBLE WITH CLINICAL DIAGNOSIS (URETEROVAGINAL FISTULA). ABSENCE OF EPITHELIAL DYSPLASIA. CYSTIC OVARIAN LESION: SIMPLE CYST. PLATELET COUNT (GIGA/L) ON (B)(6) 2019: 366.0 GIGA/L; ON (B)(6) 2019: 468.0 GIGA/L. SKIN TEST ON (B)(6) 2018: POSITIVE FOR NICKEL +++. NEGATIVE FOR THE REMAINDER OF THE TRUE TEST: CADMIUM, ALUMINIUM, ZINC, COPPER, TITANIUM, VANADIUM, IRON, ZIRCONIUM, MOLYBDENUM, TUNGSTEN, MANGANESE AND NIOBIUM. DIAGNOSIS: NICKEL ALLERGY. ULTRASOUND SCAN ON (B)(6) 2012: UTERUS IN REGULAR ANTEVERSION POSITION, EMPTY, WITH MEDIAN LINING OF MM. NORMAL ANNEXES. FREE DOUGLAS; ON (B)(6) 2018: UTERUS IN ANTEVERTED POSITION. LENGTH: 89.0 . ANTEROPOSTERIOR DIAMETER: 42.0. TRANSVERSE DIAMETER: 48.0. INTRAMYOMETRIAL IN RIGHT HORN, HYPER REFRINGENT IMAGING THAT SUGGEST 8 MM. ENDOMETRIUM: THICKNESS: 12. RIGHT OVARY DIAMETER: 27 X 17. LEFT OVARY DIAMETER: 24 X 14 DIAGNOSIS: SUGGESTING REMAINS OF ESSURE IN RIGHT UTERINE HORN. URINE ANALYSIS ON (B)(6) 2019: RED BLOOD CELLS (HAEMOGLOBIN): LEUKOCYTES (ESTERASE): TRACES. NITRITES: NEGATIVE. URINARY SEDIMENT: AUTOMATED RED BLOOD CELLS PER FIELD: 5 . YEASTS: MODERATE CULTURE. CULTURE IN URINARY CATHETER: STERILE.; ON (B)(6) 2019: PH URINE ISOLATED SAMPLE 6.5 (5.0 - 6.5), GLUCOSE: NEGATIVE (), KETONE BODIES: NEGATIVE (), BILIRUBIN: NEGATIVE (), UROBILINOGEN: 0.2 EU/DL (0.0 - 1.0), PROTEINS: NEGATIVE (), NITRITES: NEGATIVE (); ON (B)(6) 2019: STERILE URINE CULTURE. UROGRAM ON (B)(6) 2019: CT: LEFT URETEROVAGINAL FISTULA AND RETROVESICAL FLUID COLLECTION CONNECTED TO THE FISTULA; ON (B)(6) 2019: CT WITH SINGLE PHASE INTRAVENOUS CONTRAST: KIDNEYS OF NORMAL SIZE, MORPHOLOGY AND PARENCHYMA, WITH AN ADEQUATE NEPHROGRAM, WITH NO EVIDENCE OF SIGNIFICANT DILATION OF EXCRETORY TRACT. LEFT RENAL DOUBLE J CATHETER, WITHOUT LITHIASIC IMAGES OR DILATION OF EXCRETORY SYSTEM. OTHER FINDINGS: GALLBLADDER WITH SMALL LITHIASIS AND A NODULE IN THE FUNDUS OF ABOUT 17 MM. TO ASSESS POSSIBLE ADENOMYOMATOSIS OR TUMOUR. POSSIBLY FUNCTIONAL RIGHT OVARIAN CYST OF 33 MM. SMALL HEPATIC SIMPLE CYST; ON (B)(6) 2019: INTRAVENOUS CONTRAST MEDIUM: KIDNEYS LOCATED IN IPSILATERAL RENAL FOSSAE, NORMAL SIZE AND MORPHOLOGY. BILATERAL, SYMMETRIC NEPHROGRAM WITH CONTRAST UPTAKE AND REMOVAL BY BOTH KIDNEYS. NORMAL COLLECTING SYSTEMS AND URETERS. REPLENISHED BLADDER, OBSERVING ALTERATION OF THE MORPHOLOGY AT LEVEL OF LEFT VESICOURETERAL MEATUS, PROBABLY SECONDARY TO PREVIOUS SURGERY. NO INTRAVENOUS CONTRAST EXTRAVASATIONS IDENTIFIED. DIAGNOSTIC JUDGEMENT: ALTERATION OF MORPHOLOGY AT LEVEL OF LEFT VESICOURETERAL MEATUS, PROBABLY SECONDARY TO PREVIOUS SURGERY. NO INTRAVENOUS CONTRAST EXTRAVASATIONS IDENTIFIED. WHITE BLOOD CELL COUNT (GIGA/L) ON (B)(6) 2019: 8.80 GIGA/L; ON (B)(6) 2019: 12.40 GIGA/L. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-FEB-2020: REPORT WAS RECEIVED FROM LAWYER: ADDITION OF PLAINTIFF INITIALS, MEDICAL RECORDS (MEDICALLY CONFIRMED), MEDICAL HISTORY, ESSURE (LOT # 810877) TREATMENT DATES (REMOVED VIA SALPINGECTOMY - UPGRADE OF EVENTS TO SERIOUS INCIDENT, TOTAL REMOVAL VIA HYSTERECTOMY), INDICATION, NEW EVENTS ADDED: PELVIC PAIN, DEVICE BREAKAGE, COMPLICATION OF DEVICE REMOVAL, UROGENITAL FISTULA (POSTOPERATIVE FISTULA) WITH SYMPTOMS URINARY INCONTINENCE, URINARY URGE, SWELLING, CERVICITIS, BLADDER SPASM, ENDOMETRIAL DISORDER, POST PROCEDURAL HEMORRHAGE, POSTPROCEDURAL PAIN, METALLOSIS, NICKEL ALLERGY, TEST RESULTS. ALL EVENTS WERE CONSIDERED AS RELATED TO ESSURE BY REPORTER WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW AND REVIEW OF COMPLAINT RECORDS AND RECORDS OF NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 836472 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 810877 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Hospitalization| O| R | CERAZETTE [DESOGESTREL]| CERAZETTE [DESOGESTREL]| CERAZETTE [DESOGESTREL]| CERAZETTE [DESOGESTREL]| CERAZETTE [DESOGESTREL]| CERAZETTE [DESOGESTREL]| CERAZETTE [DESOGESTREL]| FLU VACCINE VII| FLU VACCINE VII| FLU VACCINE VII| FLU VACCINE VII| FLU VACCINE VII| FLU VACCINE VII |