ESSURE
Report
- Report Number
- 2951250-2018-02361
- Event Type
- Injury
- Date Received
- May 23, 2018
- Date of Event
- January 1, 2011
- Report Date
- November 26, 2024
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("NOT NEGLIGIBLE PELVIC PAIN") AND ASCITES ("LAYER OF INTRAPERITONEAL EFFUSION") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852008) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED RUPTURED ECTOPIC PREGNANCY, CERVICAL CONISATION (TWO SUCCESSIVE CONISATIONS), CERVICAL DYSPLASIA, ACUTE PERICARDITIS IN 1995, CHRONIC GASTRITIS IN 2011, RECURRENT URINARY TRACT INFECTION AND TOBACCO USER. IN 2011, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA WITH HEMORRHAGIC EPISODES / HEMORRHAGIC MENSTRUATIONS / MENORRHAGIA +++"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED UTERINE LEIOMYOMA ("SMALL FIBROMAS/MYOMAS IN UTERUS"). IN (B)(6) 2017, THE PATIENT EXPERIENCED SENSORIMOTOR DISORDER ("LEFT FOOT SENSORY DISORDERS WITH INTERMITTENT MOTOR DISCOMFORT OF RIGHT HAND"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ASCITES (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE POLYP ("ONE SMALL INTRACAVITARY POLYP MEASURING 5 MM"), ADENOMYOSIS ("ADENOMYOSIS"), TENDONITIS ("TENDONITIS OF GLUTEUS MEDIUS MUSCLE / THICKENING OF RIGHT TENDON OF GLUTEUS MEDIUS MUSCLE AND OF RIGHT ILIOTIBIAL TRACT SUGGESTING TENDINITIS OF GLUTEUS MEDIUS MUSCLE"), PAIN ("CHRONIC PAIN"), INTERVERTEBRAL DISC PROTRUSION ("MODERATE PROTUSIVE DISCOPATHY IN L2-L3 AND L3-L4"), INTERVERTEBRAL DISC DISORDER ("CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6"), VERTEBRAL FORAMINAL STENOSIS ("CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6"), MUSCULOSKELETAL PAIN ("MUSCLE AND JOINT PAIN"), UTERINE CERVIX STENOSIS ("CERVICAL STENOSIS"), ABDOMINAL PAIN ("STRONG ABDOMINAL PAIN"), THE FIRST EPISODE OF FATIGUE ("VERY STRONG FATIGABILITY"), FALLOPIAN TUBE DISORDER ("SMALL INFLAMMATORY REMODELLING IN LEFT TUBE"), THE SECOND EPISODE OF FATIGUE ("VERY STRONG FATIGUE") AND DIZZINESS ("DIZZINESS"). THE PATIENT WAS TREATED WITH SURGERY (VAGINAL HYSTERECTOMY AND LEFT SALPINGECTOMY VIA LAPAROSCOPY WERE PERFORMED ON (B)(6) 2018). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ASCITES, MENORRHAGIA, UTERINE POLYP, ADENOMYOSIS, TENDONITIS, PAIN, INTERVERTEBRAL DISC PROTRUSION, SENSORIMOTOR DISORDER, INTERVERTEBRAL DISC DISORDER, VERTEBRAL FORAMINAL STENOSIS, MUSCULOSKELETAL PAIN, UTERINE CERVIX STENOSIS, ABDOMINAL PAIN, UTERINE LEIOMYOMA, FALLOPIAN TUBE DISORDER, THE LAST EPISODE OF FATIGUE AND DIZZINESS OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN, ADENOMYOSIS, ASCITES, DIZZINESS, FALLOPIAN TUBE DISORDER, INTERVERTEBRAL DISC DISORDER, INTERVERTEBRAL DISC PROTRUSION, MENORRHAGIA, MUSCULOSKELETAL PAIN, PAIN, PELVIC PAIN, SENSORIMOTOR DISORDER, TENDONITIS, UTERINE CERVIX STENOSIS, UTERINE LEIOMYOMA, UTERINE POLYP, VERTEBRAL FORAMINAL STENOSIS, THE FIRST EPISODE OF FATIGUE AND THE SECOND EPISODE OF FATIGUE WITH ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION HAD BEEN PERFORMED IN ONE TUBE. WORK UP TO INVESTIGATION POTENTIAL SENSITIVITY TO NICKEL, TITANIUM AND STEEL WAS REQUESTED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): GYNAECOLOGICAL EXAMINATION - ON AN UNKNOWN DATE: CERVICAL STENOSIS ULTRASOUND SCAN - ON (B)(6) 2012: ONE SMALL INTRACAVITARY POLYP MEASURING 5 MM PELVIS MRI PERFORMED ON (B)(6) 2016 SHOWED DIFFUSE ADENOMYOSIS AND LAYER OF INTRAPERITONEAL EFFUSION. ULTRASOUND PERFORMED ON (B)(6) 2016 SHOWED THICKENING OF RIGHT TENDON OF GLUTEUS MEDIUS MUSCLE AND OF RIGHT ILIOTIBIAL TRACT SUGGESTING TENDINITIS OF GLUTEUS MEDIUS MUSCLE. SACROILIAC AND LUMBOSACRAL SPINE MRI SHOWED MODERATE PROTUSIVE DISCOPATHY IN L2-L3 AND L3-L4 AND INTEGRITY OF SACROILIAC JOINTS. BRAIN AND MEDULLAR MRI TO INVESTIGATE LEFT FOOT SENSORY DISORDERS PROGRESSING SINCE MID-MAY WITH INTERMITTENT MOTOR DISCOMFORT OF RIGHT HAND SHOWED NO VISIBLE ABNORMALITY IN MEDULLAR AND CEREBRAL REGIONS. CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6. RHEUMATOID FACTORS: ON (B)(6) 2017, HUMAN IGM ANTI-IGG AT 29 IU/ML (NORM: POSITIVE IF UPPER THAN 20 IU/ML). SERUM PROTEINS ELECTROPHORESIS FOUND HYPOGAMMAGLOBULINEMIA. THE LIST OF SIMILAR CASES CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS WITH SIMILAR EVENTS CODED IN MEDDRA. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON (B)(6) 2018 FOR THE FOLLOWING MEDDRA PREFERRED TERM: PELVIC PAIN. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 11.492 CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THIS MEDDRA PT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-JUN-2018: ATTORNEY¿S REPORT ¿ NEW ADVERSE EVENTS (VERY STRONG FATIGUE AND DIZZINESS) INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("NOT NEGLIGIBLE PELVIC PAIN") AND ASCITES ("LAYER OF INTRAPERITONEAL EFFUSION") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852008) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED RUPTURED ECTOPIC PREGNANCY, CERVICAL CONISATION (TWO SUCCESSIVE CONISATIONS), CERVICAL DYSPLASIA, ACUTE PERICARDITIS IN 1995, CHRONIC GASTRITIS IN 2011, RECURRENT URINARY TRACT INFECTION AND TOBACCO USER. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA WITH HEMORRHAGIC EPISODES / HEMORRHAGIC MENSTRUATIONS / MENORRHAGIA +++"). IN 2013, THE PATIENT EXPERIENCED UTERINE LEIOMYOMA ("SMALL FIBROMAS/MYOMAS IN UTERUS"). IN (B)(6) 2017, THE PATIENT EXPERIENCED SENSORIMOTOR DISORDER ("LEFT FOOT SENSORY DISORDERS WITH INTERMITTENT MOTOR DISCOMFORT OF RIGHT HAND"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ASCITES (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE POLYP ("ONE SMALL INTRACAVITARY POLYP MEASURING 5 MM"), ADENOMYOSIS ("ADENOMYOSIS"), TENDONITIS ("TENDONITIS OF GLUTEUS MEDIUS MUSCLE / THICKENING OF RIGHT TENDON OF GLUTEUS MEDIUS MUSCLE AND OF RIGHT ILIOTIBIAL TRACT SUGGESTING TENDINITIS OF GLUTEUS MEDIUS MUSCLE"), PAIN ("CHRONIC PAIN"), INTERVERTEBRAL DISC PROTRUSION ("MODERATE PROTUSIVE DISCOPATHY IN L2-L3 AND L3-L4"), INTERVERTEBRAL DISC DISORDER ("CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6"), VERTEBRAL FORAMINAL STENOSIS ("CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6"), MUSCULOSKELETAL PAIN ("MUSCLE AND JOINT PAIN"), UTERINE CERVIX STENOSIS ("CERVICAL STENOSIS"), ABDOMINAL PAIN ("STRONG ABDOMINAL PAIN"), THE FIRST EPISODE OF FATIGUE ("VERY STRONG FATIGABILITY"), FALLOPIAN TUBE DISORDER ("SMALL INFLAMMATORY REMODELLING IN LEFT TUBE"), THE SECOND EPISODE OF FATIGUE ("VERY STRONG FATIGUE") AND DIZZINESS ("DIZZINESS"). THE PATIENT WAS TREATED WITH SURGERY (VAGINAL HYSTERECTOMY AND LEFT SALPINGECTOMY VIA LAPAROSCOPY WERE PERFORMED ON (B)(6) 2018). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ASCITES, MENORRHAGIA, UTERINE POLYP, ADENOMYOSIS, TENDONITIS, PAIN, INTERVERTEBRAL DISC PROTRUSION, SENSORIMOTOR DISORDER, INTERVERTEBRAL DISC DISORDER, VERTEBRAL FORAMINAL STENOSIS, MUSCULOSKELETAL PAIN, UTERINE CERVIX STENOSIS, ABDOMINAL PAIN, UTERINE LEIOMYOMA, FALLOPIAN TUBE DISORDER, THE LAST EPISODE OF FATIGUE AND DIZZINESS OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN, ADENOMYOSIS, ASCITES, DIZZINESS, FALLOPIAN TUBE DISORDER, INTERVERTEBRAL DISC DISORDER, INTERVERTEBRAL DISC PROTRUSION, MENORRHAGIA, MUSCULOSKELETAL PAIN, PAIN, PELVIC PAIN, SENSORIMOTOR DISORDER, TENDONITIS, UTERINE CERVIX STENOSIS, UTERINE LEIOMYOMA, UTERINE POLYP, VERTEBRAL FORAMINAL STENOSIS, THE FIRST EPISODE OF FATIGUE AND THE SECOND EPISODE OF FATIGUE WITH ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION HAD BEEN PERFORMED IN ONE TUBE. WORK UP TO INVESTIGATE POTENTIAL SENSITIVITY TO NICKEL, TITANIUM AND STEEL WAS REQUESTED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): GYNAECOLOGICAL EXAMINATION - ON AN UNKNOWN DATE: CERVICAL STENOSIS ULTRASOUND SCAN - ON (B)(6) 2012: ONE SMALL INTRACAVITARY POLYP MEASURING 5 MM PELVIS MRI PERFORMED ON (B)(6) 2016 SHOWED DIFFUSE ADENOMYOSIS AND LAYER OF INTRAPERITONEAL EFFUSION. ULTRASOUND PERFORMED ON (B)(6) 2016 SHOWED THICKENING OF RIGHT TENDON OF GLUTEUS MEDIUS MUSCLE AND OF RIGHT ILIOTIBIAL TRACT SUGGESTING TENDINITIS OF GLUTEUS MEDIUS MUSCLE. SACROILIAC AND LUMBOSACRAL SPINE MRI SHOWED MODERATE PROTUSIVE DISCOPATHY IN L2-L3 AND L3-L4 AND INTEGRITY OF SACROILIAC JOINTS. BRAIN AND MEDULLAR MRI TO INVESTIGATE LEFT FOOT SENSORY DISORDERS PROGRESSING SINCE MID-MAY WITH INTERMITTENT MOTOR DISCOMFORT OF RIGHT HAND SHOWED NO VISIBLE ABNORMALITY IN MEDULLAR AND CEREBRAL REGIONS. CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6. RHEUMATOID FACTORS: ON (B)(6) 2017, HUMAN IGM ANTI-IGG AT 29 IU/ML (NORM: POSITIVE IF UPPER THAN 20 IU/ML). SERUM PROTEINS ELECTROPHORESIS FOUND HYPOGAMMAGLOBULINEMIA. THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS CODED WITH THE SAME MEDDRA PREFERRED TERM (PT). IN THIS PARTICULAR CASE A SEARCH IN THE GLOBAL SAFETY DATABASE WAS PERFORMED ON (B)(6) 2018 FOR THE FOLLOWING MEDDRA PT (EXCLUDING THIS CASE): PELVIC PAIN: 11603 CASES WERE IDENTIFIED. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THIS MEDDRA PT. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-JUN-2018: QUALITY-SAFETY EVALUATION OF PTC. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("NOT NEGLIGIBLE PELVIC PAIN"), ASCITES ("LAYER OF INTRAPERITONEAL EFFUSION") AND MENOMETRORRHAGIA ("MENORRHAGIA WITH HEMORRHAGIC EPISODES / HEMORRHAGIC MENSTRUATIONS / MENORRHAGIA +++/ FUNCTIONAL MENOMETRORRHAGIA") IN A 44-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852008) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CERVICAL CONISATION (TWO SUCCESSIVE CONISATIONS), CERVICAL DYSPLASIA, ACUTE PERICARDITIS IN 1995, CHRONIC GASTRITIS IN 2011, RECURRENT URINARY TRACT INFECTION, TOBACCO USER, RUPTURED ECTOPIC PREGNANCY IN 1996, DELIVERY IN 1999, DELIVERY IN 1990, MENOMETRORRHAGIA IN 2009, ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE IN 2008, CERVIX LESION, DYSPLASIA, HYSTERECTOMY IN 2008, BACK INJURY IN (B)(6) 2011, CHLAMYDIAL INFECTION IN 2009 AND RETROBULBAR NEURITIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: (B)(6). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED MENOMETRORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2013, THE PATIENT WAS FOUND TO HAVE UTERINE LEIOMYOMA ("SMALL FIBROMAS/MYOMAS IN UTERUS/ INTERSTITIAL FIBROMA MEASURING 20 MM"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ASTHENIA ("ASTHENIA") AND BALANCE DISORDER ("BALANCE DISORDERS"). ON (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("WHITISH LEUKORRHEA") AND DYSURIA ("BURNING SENSATION DURING URINATION"), 3 YEARS AFTER INSERTION OF ESSURE. IN 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("ACUTE DYSMENORRHEA") AND VAGINAL HAEMORRHAGE ("SPOTTING"). IN (B)(6) 2017, THE PATIENT EXPERIENCED SENSORIMOTOR DISORDER ("LEFT FOOT SENSORY DISORDERS WITH INTERMITTENT MOTOR DISCOMFORT OF RIGHT HAND"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ASCITES (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE POLYP ("ONE SMALL INTRACAVITARY POLYP MEASURING 5 MM"), THE FIRST EPISODE OF ADENOMYOSIS ("ADENOMYOSIS"), TENDONITIS ("TENDONITIS OF GLUTEUS MEDIUS MUSCLE / THICKENING OF RIGHT TENDON OF GLUTEUS MEDIUS MUSCLE AND OF RIGHT ILIOTIBIAL TRACT SUGGESTING TENDINITIS OF GLUTEUS MEDIUS MUSCLE"), PAIN ("CHRONIC PAIN"), INTERVERTEBRAL DISC PROTRUSION ("MODERATE PROTUSIVE DISCOPATHY IN L2-L3 AND L3-L4"), INTERVERTEBRAL DISC DISORDER ("CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6"), VERTEBRAL FORAMINAL STENOSIS ("CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6"), MUSCULOSKELETAL PAIN ("MUSCLE AND JOINT PAIN"), UTERINE CERVIX STENOSIS ("CERVICAL STENOSIS"), ABDOMINAL PAIN ("STRONG ABDOMINAL PAIN"), THE FIRST EPISODE OF FATIGUE ("VERY STRONG FATIGABILITY"), FALLOPIAN TUBE DISORDER ("SMALL INFLAMMATORY REMODELLING IN LEFT TUBE"), THE SECOND EPISODE OF FATIGUE ("VERY STRONG FATIGUE"), DIZZINESS ("DIZZINESS"), VULVOVAGINAL MYCOTIC INFECTION ("VAGINAL MYCOSIS"), PAPILLOMA VIRAL INFECTION ("HIGH-RISK PAPILLOMAVIRUS"), PHLEBOLITH ("PHLEBOLITHS") AND THE SECOND EPISODE OF ADENOMYOSIS ("DIFFUSE ADENOMYOSIS"). THE PATIENT WAS TREATED CURETTAGE, ENDOMETRIAL THERMOCOAGULATION, CHLORMADINONE ACETATE (LUTERAN), FOSFOMYCIN TROMETAMOL (MONURIL), MICONAZOLE NITRATE (GYNO-DAKTARIN) AND, ON (B)(6) 2018, ESSURE WAS REMOVED BY VAGINAL HYSTERECTOMY AND LEFT SALPINGECTOMY VIA LAPAROSCOPY WERE ALSO PERFORMED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ASCITES, MENOMETRORRHAGIA, UTERINE POLYP, TENDONITIS, PAIN, INTERVERTEBRAL DISC PROTRUSION, SENSORIMOTOR DISORDER, INTERVERTEBRAL DISC DISORDER, VERTEBRAL FORAMINAL STENOSIS, MUSCULOSKELETAL PAIN, UTERINE CERVIX STENOSIS, ABDOMINAL PAIN, UTERINE LEIOMYOMA, FALLOPIAN TUBE DISORDER, THE LAST EPISODE OF FATIGUE, DIZZINESS, VULVOVAGINAL MYCOTIC INFECTION, PAPILLOMA VIRAL INFECTION, PHLEBOLITH, ASTHENIA, BALANCE DISORDER, VAGINAL DISCHARGE, DYSURIA, DYSMENORRHOEA, VAGINAL HAEMORRHAGE AND THE LAST EPISODE OF ADENOMYOSIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ASCITES, ASTHENIA, BALANCE DISORDER, DIZZINESS, DYSMENORRHOEA, DYSURIA, FALLOPIAN TUBE DISORDER, INTERVERTEBRAL DISC DISORDER, INTERVERTEBRAL DISC PROTRUSION, MENOMETRORRHAGIA, MUSCULOSKELETAL PAIN, PAIN, PAPILLOMA VIRAL INFECTION, PELVIC PAIN, PHLEBOLITH, SENSORIMOTOR DISORDER, TENDONITIS, UTERINE CERVIX STENOSIS, UTERINE LEIOMYOMA, UTERINE POLYP, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VERTEBRAL FORAMINAL STENOSIS, VULVOVAGINAL MYCOTIC INFECTION, THE FIRST EPISODE OF ADENOMYOSIS, THE FIRST EPISODE OF FATIGUE, THE SECOND EPISODE OF ADENOMYOSIS AND THE SECOND EPISODE OF FATIGUE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION WAS PERFORMED ON (B)(6) 2011: IDENTIFICATION OF THE OSTIA WHICH WERE VISIBLE AND ACCESSIBLE. PLACEMENT OF AN ESSURE IMPLANT WITHOUT INCIDENT USING THE STANDARD PROCEDURE, 4 TRAILING COILS ON THE LEFT. DURATION OF THE PROCEDURE WAS OF 3 MINUTES. IT WAS VERY WELL TOLERATED. WORK UP TO INVESTIGATE POTENTIAL SENSITIVITY TO NICKEL, TITANIUM AND STEEL WAS REQUESTED. ON UNSPECIFIED DATE, SERUM PROTEINS ELECTROPHORESIS FOUND HYPOGAMMAGLOBULINEMIA. CONISATION WAS PERFORMED ON (B)(6) 2014 FOR LOW-GRADE INTRA-EPITHELIAL LESION CONFIRMED BY BIOPSY, PERSISTENT, WITH AN AREA AT THE SCJ. PATIENT CAME BACK FOR CONSULTATION THREE DAYS AFTER CONISATION BECAUSE OF ASTHENIA AND BALANCE DISORDERS DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BLOOD IMMUNOGLOBULIN M - ON (B)(6) 2017: 29 IU/ML (NORM: POSITIVE IF UPPER THAN 20 IU/ML).. COMPUTERISED TOMOGRAM HEAD - ON AN UNKNOWN DATE: WITHOUT CONTRAST SHOWED NOTHING REMARKABLE. GYNAECOLOGICAL EXAMINATION - ON AN UNKNOWN DATE: RESULTS: CERVICAL STENOSIS. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: PHLEBOLITHS WAS VISIBLE. THE LEFT IMPLANT IS WELL POSITIONED, WITH NO CONTRAST MEDIUM. LEFT TUBE WAS CORRECTLY OBSTRUCTED.. HYSTEROSCOPY - ON (B)(6) 2012: VISUALIZATION OF THREE POLYPS MEASURING ABOUT 55 MM ABOVE THE ISTHMUS, MID-CAVITY AND BELOW THE INTERSTITIAL PORTION OF THE RIGHT FALLOPIAN TUBE. INDICATION FOR HYSTEROSCOPY AND CURETTAGE.. NUCLEAR MAGNETIC RESONANCE IMAGING ABDOMINAL - ON AN UNKNOWN DATE: MODERATE PROTUSIVE DISCOPATHY IN L2-L3 AND L3-L4 AND INTEGRITY OF SACROILIAC JOINTS.; ON (B)(6) 2012: CONFIRMED PRESENCE OF A SMALL POLYP MEASURING 5 MM IN THE POSTERIOR WALL. PRESENCE OF AN INTERSTITIAL FIBROMA MEASURING 20 MM WITH A SUBMUCOUS COMPONENT IN THE POSTERIOR WALL. NO OTHER VISIBLE ABNORMALITIES.; ON (B)(6) 2016: RESULTS: DIFFUSE ADENOMYOSIS AND LAYER OF INTRAPERITONEAL EFFUSION.; ON (B)(6) 2016: DIFFUSE ADENOMYOSIS. NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN - ON AN UNKNOWN DATE: RESULTS: NO VISIBLE ABNORMALITY IN MEDULLAR AND CEREBRAL. CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6. PATHOLOGY TEST - ON (B)(6) 2012: FOUND DIFFUSE ENDOMETRIAL HYPERPLASIA.; ON (B)(6) 2014: LOW-GRADE SQUAMOUS INTRAEPITHELIAL LESIONS AT THE SCJ AND IN MULTIPLE LOCATIONS. NO HIGH-GRADE DYSPLASTIC LESIONS.. SMEAR CERVIX - ON (B)(6) 2013: ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE.. ULTRASOUND SCAN - ON (B)(6) 2012: RESULTS: ONE SMALL INTRACAVITARY POLYP MEASURING 5 MM. VIRAL TEST - ON (B)(6) 2013: PRESENCE OF HIGH-RISK PAPILLOMAVIRUS WAS FOUND. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-FEB-2019: INFORMATION RECEIVED FROM AN ATTORNEY VIA LEGAL DEPARTMENT. REPORTER¿S AND PATIENT¿S DETAILS WERE UPDATED. ESSURE INSERTION WAS PERFORMED ON (B)(6) 2011: IDENTIFICATION OF THE OSTIA WHICH WERE VISIBLE AND ACCESSIBLE. PLACEMENT OF AN ESSURE IMPLANT WITHOUT INCIDENT USING THE STANDARD PROCEDURE, 4 TRAILING COILS ON THE LEFT. DURATION OF THE PROCEDURE WAS OF 3 MINUTES. IT WAS VERY WELL TOLERATED. ON (B)(6) 2011, HSG WAS PERFORMED FOR CONTROL AFTER PLACEMENT OF IMPLANTS IN THE LEFT FALLOPIAN TUBE. PHLEBOLITHS WAS VISIBLE. THE LEFT IMPLANT IS WELL POSITIONED, WITH NO CONTRAST MEDIUM. LEFT TUBE WAS CORRECTLY OBSTRUCTED. HYSTEROSCOPY PERFORMED ON (B)(6) 2012: VISUALIZATION OF THREE POLYPS MEASURING ABOUT 55 MM ABOVE THE ISTHMUS, MID-CAVITY AND BELOW THE INTERSTITIAL PORTION OF THE RIGHT FALLOPIAN TUBE. PELVIS MRI PERFORMED ON(B)(6) 2012: CONFIRMED PRESENCE OF A SMALL POLYP MEASURING 5 MM IN THE POSTERIOR WALL. PRESENCE OF AN INTERSTITIAL FIBROMA MEASURING 20 MM WITH A SUBMUCOUS COMPONENT IN THE POSTERIOR WALL. NO OTHER VISIBLE ABNORMALITIES. ON (B)(6) 2012, HYSTEROSCOPY AND CURETTAGE, ENDOMETRIAL THERMOCOAGULATION WERE PERFORMED FOR FUNCTIONAL MENOMETRORRHAGIA. PATHOLOGICAL ANATOMY EXAMINATION ON (B)(6) 2012 FOUND DIFFUSE ENDOMETRIAL HYPERPLASIA. ASCUS SMEAR ON (B)(6) 2013: ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE. PRESENCE OF HIGH-RISK PAPILLOMAVIRUS WAS FOUND ON (B)(6) 2013 FOLLOWING VIRAL TYPING. CONISATION WAS PERFORMED ON (B)(6) 2014 FOR LOW-GRADE INTRA-EPITHELIAL LESION CONFIRMED BY BIOPSY, PERSISTENT, WITH AN AREA AT THE SCJ. PATIENT CAME BACK FOR CONSULTATION THREE DAYS AFTER CONISATION BECAUSE OF ASTHENIA AND BALANCE DISORDERS. BRAIN CT SCAN WITHOUT CONTRAST SHOWED NOTHING REMARKABLE. RECOMMENDATIONS WERE REST AND PRESCRIPTION OF TANGANIL. IN MEDICAL RECORD, DOCTOR REPORTED THE FOLLOWING: THE PATIENT EXPERIENCED JOINT PAIN DIFFICULT TO RELATE TO ESSURE, HOWEVER THE PATIENT EXPERIENCED NOT NEGLIGIBLE PELVIC PAIN. WE RECEIVED A LOT NUMBER/RETURNED SAMPLE IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("NOT NEGLIGIBLE PELVIC PAIN"), ASCITES ("LAYER OF INTRAPERITONEAL EFFUSION"), MENOMETRORRHAGIA ("MENORRHAGIA WITH HEMORRHAGIC EPISODES / HEMORRHAGIC MENSTRUATIONS / MENORRHAGIA +++/ FUNCTIONAL MENOMETRORRHAGIA"), GENITAL HAEMORRHAGE ("SIGNIFICANT BLEEDING"), SUICIDAL IDEATION ("SUICIDAL THOUGHTS") AND URINARY TRACT INFECTION ("URINARY TRACT INFECTIONS") IN A 44-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852008) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CERVICAL CONISATION (TWO SUCCESSIVE CONISATIONS), CERVICAL DYSPLASIA, ACUTE PERICARDITIS IN 1995, CHRONIC GASTRITIS IN 2011, RECURRENT URINARY TRACT INFECTION, TOBACCO USER, RUPTURED ECTOPIC PREGNANCY IN 1996, PARITY IN 1999, PARITY IN 1990, MENOMETRORRHAGIA IN 2009, ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE IN 2008, CERVIX LESION, DYSPLASIA, HYSTERECTOMY IN 2008, BACK INJURY IN (B)(6) 2011, CHLAMYDIAL INFECTION IN 2009, RETROBULBAR NEURITIS, VIRAL TEST POSITIVE IN 2008, IRREGULAR MENSTRUATION IN 2005 AND SHORT MENSTRUATION IN 2007. THE CONSUMER HAS AN ANTEVERTED UTERUS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: JASMINE. CONCURRENT CONDITIONS INCLUDED PREMENOPAUSE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED MENOMETRORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2013, THE PATIENT WAS FOUND TO HAVE UTERINE LEIOMYOMA ("SMALL FIBROMAS/MYOMAS IN UTERUS/ INTERSTITIAL FIBROMA MEASURING 20 MM"). IN (B)(6)2014, THE PATIENT EXPERIENCED ASTHENIA ("ASTHENIA") AND BALANCE DISORDER ("BALANCE DISORDERS"). ON (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("WHITISH LEUKORRHEA") AND DYSURIA ("BURNING SENSATION DURING URINATION"), 3 YEARS AFTER INSERTION OF ESSURE. IN 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("ACUTE DYSMENORRHEA") AND VAGINAL HAEMORRHAGE ("SPOTTING"). IN (B)(6) 2017, THE PATIENT EXPERIENCED SENSORIMOTOR DISORDER ("LEFT FOOT SENSORY DISORDERS WITH INTERMITTENT MOTOR DISCOMFORT OF RIGHT HAND"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ASCITES (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SUICIDAL IDEATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), URINARY TRACT INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE POLYP ("ONE SMALL INTRACAVITARY POLYP MEASURING 5 MM"), ADENOMYOSIS ("ADENOMYOSIS / DIFFUSE ADENOMYOSIS"), TENDONITIS ("TENDONITIS OF GLUTEUS MEDIUS MUSCLE / THICKENING OF RIGHT TENDON OF GLUTEUS MEDIUS MUSCLE AND OF RIGHT ILIOTIBIAL TRACT SUGGESTING TENDINITIS OF GLUTEUS MEDIUS MUSCLE / TENDONITIS IN WRISTS, ANKLES AND SHOULDERS"), PAIN ("CHRONIC PAIN / PAIN AT NIGHT"), INTERVERTEBRAL DISC PROTRUSION ("MODERATE PROTUSIVE DISCOPATHY IN L2-L3 AND L3-L4"), INTERVERTEBRAL DISC DISORDER ("CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6"), VERTEBRAL FORAMINAL STENOSIS ("CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6"), MUSCULOSKELETAL PAIN ("MUSCLE AND JOINT PAIN"), UTERINE CERVIX STENOSIS ("CERVICAL STENOSIS"), ABDOMINAL PAIN ("STRONG ABDOMINAL PAIN"), FATIGUE ("VERY STRONG FATIGABILITY / VERY STRONG FATIGUE"), FALLOPIAN TUBE DISORDER ("SMALL INFLAMMATORY REMODELLING IN LEFT TUBE"), VULVOVAGINAL MYCOTIC INFECTION ("VAGINAL MYCOSIS"), PAPILLOMA VIRAL INFECTION ("HIGH-RISK PAPILLOMAVIRUS"), PHLEBOLITH ("PHLEBOLITHS"), DIZZINESS ("DIZZINESS WHICH CAUSE A FALL IN STAIRS"), FALL ("DIZZINESS WHICH CAUSE A FALL IN STAIRS"), ABDOMINAL PAIN LOWER ("CRAMPS"), HOT FLUSH ("HOT FLUSHES"), UTERINE INFLAMMATION ("UTERINE INFLAMMATION"), NIGHT SWEATS ("SWEATS AT NIGHT"), LOSS OF LIBIDO ("LOSS OF LIBIDO"), MUSCLE SPASMS ("MUSCLE SPASMS/ ABDOMINAL SPASMS"), VISION BLURRED ("BLURRED VISION"), DRY EYE ("DRY EYES"), BACK PAIN ("PAIN IN BACK"), PAIN IN EXTREMITY ("PAIN IN LEGS"), ARTHRALGIA ("PAIN IN WRISTS"), GASTROINTESTINAL PAIN ("GASTROINTESTINAL PAIN"), DYSPEPSIA ("STOMACH BURNS"), NERVOUS SYSTEM DISORDER ("NEUROLOGICAL DISORDERS"), HYPOAESTHESIA ("NUMBNESS OF UPPER LIMBS"), DEPRESSED MOOD ("SADNESS"), AMNESIA ("IMMEDIATE MEMORY LOSS"), INSOMNIA ("INSOMNIA"), MIGRAINE ("MIGRAINES") AND DYSSTASIA ("DIFFICULTY STANDING"). THE PATIENT WAS TREATED WITH CHLORMADINONE ACETATE (LUTERAN), FOSFOMYCIN TROMETAMOL (MONURIL), MICONAZOLE NITRATE (GYNO-DAKTARIN) AND SURGERY (ON (B)(6) 2012, HYSTEROSCOPY AND CURETTAGE, ENDOMETRIAL THERMOCOAGULATION WERE PERFORMED AND VAGINAL HYSTERECTOMY AND LEFT SALPINGECTOMY VIA LAPAROSCOPY WERE PERFORMED ON (B)(6) 2018). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ASCITES, MENOMETRORRHAGIA, GENITAL HAEMORRHAGE, SUICIDAL IDEATION, URINARY TRACT INFECTION, UTERINE POLYP, ADENOMYOSIS, TENDONITIS, PAIN, INTERVERTEBRAL DISC PROTRUSION, SENSORIMOTOR DISORDER, INTERVERTEBRAL DISC DISORDER, VERTEBRAL FORAMINAL STENOSIS, MUSCULOSKELETAL PAIN, UTERINE CERVIX STENOSIS, ABDOMINAL PAIN, FATIGUE, UTERINE LEIOMYOMA, FALLOPIAN TUBE DISORDER, VULVOVAGINAL MYCOTIC INFECTION, PAPILLOMA VIRAL INFECTION, PHLEBOLITH, ASTHENIA, BALANCE DISORDER, DYSMENORRHOEA, VAGINAL HAEMORRHAGE, DIZZINESS, FALL, ABDOMINAL PAIN LOWER, HOT FLUSH, UTERINE INFLAMMATION, NIGHT SWEATS, LOSS OF LIBIDO, MUSCLE SPASMS, VISION BLURRED, DRY EYE, BACK PAIN, PAIN IN EXTREMITY, ARTHRALGIA, GASTROINTESTINAL PAIN, DYSPEPSIA, NERVOUS SYSTEM DISORDER, HYPOAESTHESIA, DEPRESSED MOOD, AMNESIA, INSOMNIA, MIGRAINE, DYSSTASIA, VAGINAL DISCHARGE AND DYSURIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ADENOMYOSIS, AMNESIA, ARTHRALGIA, ASCITES, ASTHENIA, BACK PAIN, BALANCE DISORDER, DEPRESSED MOOD, DIZZINESS, DRY EYE, DYSMENORRHOEA, DYSPEPSIA, DYSSTASIA, DYSURIA, FALL, FALLOPIAN TUBE DISORDER, FATIGUE, GASTROINTESTINAL PAIN, GENITAL HAEMORRHAGE, HOT FLUSH, HYPOAESTHESIA, INSOMNIA, INTERVERTEBRAL DISC DISORDER, INTERVERTEBRAL DISC PROTRUSION, LOSS OF LIBIDO, MENOMETRORRHAGIA, MIGRAINE, MUSCLE SPASMS, MUSCULOSKELETAL PAIN, NERVOUS SYSTEM DISORDER, NIGHT SWEATS, PAIN, PAIN IN EXTREMITY, PAPILLOMA VIRAL INFECTION, PELVIC PAIN, PHLEBOLITH, SENSORIMOTOR DISORDER, SUICIDAL IDEATION, TENDONITIS, URINARY TRACT INFECTION, UTERINE CERVIX STENOSIS, UTERINE INFLAMMATION, UTERINE LEIOMYOMA, UTERINE POLYP, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VERTEBRAL FORAMINAL STENOSIS, VISION BLURRED AND VULVOVAGINAL MYCOTIC INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION WAS PERFORMED ON (B)(6) 2011: IDENTIFICATION OF THE OSTIA WHICH WERE VISIBLE AND ACCESSIBLE. PLACEMENT OF AN ESSURE IMPLANT WITHOUT INCIDENT USING THE STANDARD PROCEDURE, 4 TRAILING COILS ON THE LEFT. DURATION OF THE PROCEDURE WAS OF 3 MINUTES. IT WAS VERY WELL TOLERATED. WORK UP TO INVESTIGATE POTENTIAL SENSITIVITY TO NICKEL, TITANIUM AND STEEL WAS REQUESTED. ON UNSPECIFIED DATE, SERUM PROTEINS ELECTROPHORESIS FOUND HYPOGAMMAGLOBULINEMIA. CONISATION WAS PERFORMED ON (B)(6) 2014 FOR LOW-GRADE INTRA-EPITHELIAL LESION CONFIRMED BY BIOPSY, PERSISTENT, WITH AN AREA AT THE SCJ. PATIENT CAME BACK FOR CONSULTATION THREE DAYS AFTER CONISATION BECAUSE OF ASTHENIA AND BALANCE DISORDERS. ANTIDEPRESSANT DRUG WAS PRESCRIBED TO THE PATIENT. THE EXPERT CONSIDERED THAT ALL THE EVENTS WERE RELATED TO GYNAECOLOGICAL DISEASE AND PRE-MENOPAUSE OF THE PATIENT. MEDICAL EXAMINATION OF THE PATIENT BY THE EXPERT FOUND NOTHING REMARKABLE. FOLLOWING VARIOUS QUESTIONS, THE EXPERT REQUESTED SOME EXHIBITS INCLUDING LAB TESTS, AND REPORTED FOR THE SECOND TIME THAT THE EVENTS WERE RELATED TO PRE-MENOPAUSE STATE OF THE PATIENT AS WELL AS SOME DISCLOSED UTERINE DISEASES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BLOOD IMMUNOGLOBULIN M - ON (B)(6) 2017: 29 IU/ML (NORM: POSITIVE IF UPPER THAN 20 IU/ML).. COMPUTERISED TOMOGRAM HEAD - ON AN UNKNOWN DATE: WITHOUT CONTRAST SHOWED NOTHING REMARKABLE. GYNAECOLOGICAL EXAMINATION - ON AN UNKNOWN DATE: RESULTS: CERVICAL STENOSIS. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: PHLEBOLITHS WAS VISIBLE. THE LEFT IMPLANT IS WELL POSITIONED, WITH NO CONTRAST MEDIUM. LEFT TUBE WAS CORRECTLY OBSTRUCTED.. HYSTEROSCOPY - ON (B)(6) 2012: VISUALIZATION OF THREE POLYPS MEASURING ABOUT 55 MM ABOVE THE ISTHMUS, MID-CAVITY AND BELOW THE INTERSTITIAL PORTION OF THE RIGHT FALLOPIAN TUBE. INDICATION FOR HYSTEROSCOPY AND CURETTAGE. NUCLEAR MAGNETIC RESONANCE IMAGING ABDOMINAL - ON AN UNKNOWN DATE: MODERATE PROTUSIVE DISCOPATHY IN L2-L3 AND L3-L4 AND INTEGRITY OF SACROILIAC JOINTS.; ON (B)(6) 2012: CONFIRMED PRESENCE OF A SMALL POLYP MEASURING 5 MM IN THE POSTERIOR WALL. PRESENCE OF AN INTERSTITIAL FIBROMA MEASURING 20 MM WITH A SUBMUCOUS COMPONENT IN THE POSTERIOR WALL. NO OTHER VISIBLE ABNORMALITIES.; ON (B)(6) 2016: RESULTS: DIFFUSE ADENOMYOSIS AND LAYER OF INTRAPERITONEAL EFFUSION.; ON (B)(6) 2016: DIFFUSE ADENOMYOSIS. NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN - ON AN UNKNOWN DATE: RESULTS: NO VISIBLE ABNORMALITY IN MEDULLAR AND CEREBRAL. CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6. PATHOLOGY TEST - ON (B)(6) 2012: FOUND DIFFUSE ENDOMETRIAL HYPERPLASIA.; ON (B)(6) 2014: LOW-GRADE SQUAMOUS INTRAEPITHELIAL LESIONS AT THE SCJ AND IN MULTIPLE LOCATIONS. NO HIGH-GRADE DYSPLASTIC LESIONS. SMEAR CERVIX - ON (B)(6) 2013: ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE.. ULTRASOUND SCAN - ON (B)(6) 2012: RESULTS: ONE SMALL INTRACAVITARY POLYP MEASURING 5 MM; ON (B)(6) 2016: RESULTS: THICKENING OF RIGHT TENDON OF GLUTEUS MEDIUS MUSCLE AND OF RIGHT ILIOTIBIAL TRACT SUGGESTING TENDINITIS OF GLUTEUS MEDIUS MUSCLE. VIRAL TEST - ON (B)(6) 2013: PRESENCE OF HIGH-RISK PAPILLOMAVIRUS WAS FOUND. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-FEB-2019: INFORMATION RECEIVED FROM ATTORNEY VIA LEGAL DEPARTMENT. OTHER RELEVANT HISTORY INCLUDE: ANTEVERTED UTERUS, ASCUS SMEAR WITH A POSITIVE VIRAL TEST IN 2008, IRREGULAR MENSTRUATIONS FOR SHORT TIME (24 HOURS) IN 2005, NOT MUCH ABUNDANT MENSTRUATIONS IN 2007 AND PRE-MENOPAUSE STATE OF THE PATIENT AS CONCOMITANT CONDITION. PATIENT ALSO EXPERIENCED DIZZINESS WHICH CAUSE A FALL IN STAIRS, CRAMPS, HOT FLUSHES, UTERINE INFLAMMATION, URINARY TRACT INFECTIONS, SIGNIFICANT BLEEDING, SWEARS AT NIGHT, LOSS OF LIBIDO, MUSCLE SPASMS, BLURRED VISION, DRY EYES, ABDOMINAL SPASM, PAIN IN BACK, PAIN IN LEGS, PAIN IN WRISTS, GASTROINTESTINAL PAIN, STOMACH BURNS, NEUROLOGICAL DISORDERS, NUMBNESS OF UPPER LIMBS, SADNESS, SUICIDAL THOUGHTS, IMMEDIATE MEMORY LOSS, INSOMNIA, PAIN AT NIGHT, MIGRAINES, TENDONITIS IN WRISTS, ANKLES AND SHOULDERS AND DIFFICULTY STANDING. ANTIDEPRESSANT DRUG WAS PRESCRIBED TO THE PATIENT. THE EXPERT CONSIDERED THAT ALL THE EVENTS WERE RELATED TO GYNECOLOGICAL DISEASE AND PRE-MENOPAUSE OF THE PATIENT. MEDICAL EXAMINATION OF THE PATIENT BY THE EXPERT FOUND NOTHING REMARKABLE. FOLLOWING VARIOUS QUESTIONS, THE EXPERT REQUESTED SOME EXHIBITS INCLUDING LAB TESTS, AND REPORTED FOR THE SECOND TIME THAT THE EVENTS WERE RELATED TO PRE-MENOPAUSE STATE OF THE PATIENT AS WELL AS SOME DISCLOSED UTERINE DISEASES. 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 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 ('NOT NEGLIGIBLE PELVIC PAIN'), MENOMETRORRHAGIA ('MENORRHAGIA WITH HEMORRHAGIC EPISODES / HEMORRHAGIC MENSTRUATIONS / MENORRHAGIA +++/ FUNCTIONAL MENOMETRORRHAGIA'), HEAVY MENSTRUAL BLEEDING ('SIGNIFICANT BLEEDING, HEAVY MENSTRUAL BLEEDING'), SUICIDAL IDEATION ('SUICIDAL THOUGHTS'), URINARY TRACT INFECTION ('URINARY TRACT INFECTIONS') AND ASCITES ('LAYER OF INTRAPERITONEAL EFFUSION') IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852008) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: COMPLICATION OF DEVICE INSERTION "ONLY ONE ESSURE PLACED DUE TO RIGHT SALPINGECTOMY IN 1996" ON (B)(6) 2011 AND DEVICE MATERIAL ISSUE "EXPONENTIAL RATE OF TIN IN THE PATIENT¿S TISSUES" (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT'S MEDICAL HISTORY INCLUDED BACK INJURY IN (B)(6) 2011, CHRONIC GASTRITIS IN 2011, MENOMETRORRHAGIA IN 2009, CHLAMYDIAL INFECTION IN 2009, LOOP ELECTROSURGICAL EXCISION PROCEDURE IN 2008, FEMALE GENITAL OPERATION IN 2008, VIRAL TEST POSITIVE IN 2008, PAPILLOMA VIRAL INFECTION (2008MILD DYSPLASIA AND LOOP RESECTION.) IN 2008, ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE IN 2008, SHORT MENSTRUATION IN 2007, IRREGULAR MENSTRUATION IN 2005, PARITY IN 1999, MISCARRIAGE (AFTER 2 MONTHS OF PREGNANCY, NO INTERVENTION) IN 1998, SALPINGECTOMY (RIGHT SIDE) IN 1996, RUPTURED ECTOPIC PREGNANCY (RIGHT-SIDED SALPINGECTOMY) IN 1996, ACUTE PERICARDITIS IN 1995, PARITY IN 1990, CERVICAL CONISATION (TWO SUCCESSIVE CONISATIONS), CERVICAL DYSPLASIA, RECURRENT URINARY TRACT INFECTION, TOBACCO USER (10 TO 15 CIGARETTES/DAY, WEANED FOR 20 YEARS), CERVIX LESION, DYSPLASIA, RETROBULBAR NEURITIS, ECTOPIC PREGNANCY AND CHLAMYDIA TRACHOMATIS INFECTION (PRIOR TO 1996, IGG POSITIVE AND IGA POSITIVE). NO KNOWN ALLERGIES, NO INTOLERANCE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: (B)(6) IN 2011. CONCURRENT CONDITIONS INCLUDED PREMENOPAUSE. IN 2011, THE PATIENT EXPERIENCED MENOMETRORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED INTERMENSTRUAL BLEEDING ("METRORRHAGIA TWICE A MONTH, AN INCREASE IN THE VOLUME OF THE PERIODS, RECURRENT"). IN 2012, THE PATIENT WAS FOUND TO HAVE UTERINE LEIOMYOMA ("SMALL FIBROMAS/MYOMAS IN UTERUS/ INTERSTITIAL FIBROMA MEASURING 20 MM / FIBROMATOUS MYOMETRIUM") AND EXPERIENCED DYSMENORRHOEA ("ACUTE DYSMENORRHEA / DYSMENORRHOEA THAT LASTS 48 HOURS IN EACH CYCLE, RECURRENT"). ON (B)(6) 2013, THE PATIENT EXPERIENCED PAPILLOMA VIRAL INFECTION ("HIGH-RISK PAPILLOMAVIRUS / HIGH-GRADE PAPILLOMAVIRUS"). IN 2014, THE PATIENT EXPERIENCED DIZZINESS ("PSEUDO DIZZY SENSATION OF A FEW SECONDS / DIZZINESS WHICH CAUSE A FALL IN STAIRS") AND VERTIGO ("PSEUDO VERTIGO"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ASTHENIA ("ASTHENIA") AND BALANCE DISORDER ("BALANCE DISORDERS"). ON (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("WHITISH LEUKORRHEA") AND DYSURIA ("BURNING SENSATION DURING URINATION"). IN 2015, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("SPOTTING") AND FALL ("DIZZINESS WHICH CAUSE A FALL IN STAIRS WITHOUT LOSS OF CONSCIOUSNESS ATTRIBUTED TO A MECHANICAL CAUSE"). IN 2016, THE PATIENT EXPERIENCED DEPRESSED MOOD ("SADNESS, DARK THOUGHTS, RECURRENT"). IN (B)(6) 2016, THE PATIENT EXPERIENCED TENDONITIS ("TENDONITIS OF GLUTEUS MEDIUS MUSCLE / THICKENING OF RIGHT TENDON OF GLUTEUS MEDIUS MUSCLE AND OF RIGHT ILIOTIBIAL TRACT SUGGESTING TENDINITIS OF GLUTEUS MEDIUS MUSCLE / TENDONITIS IN WRISTS, ANKLES AND SHOULDERS"). IN (B)(6) 2017, THE PATIENT EXPERIENCED SENSORIMOTOR DISORDER ("LEFT FOOT SENSORY DISORDERS WITH INTERMITTENT MOTOR DISCOMFORT OF RIGHT HAND"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SUICIDAL IDEATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), URINARY TRACT INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ASCITES (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE POLYP ("ONE SMALL INTRACAVITARY POLYP MEASURING 5 MM"), ADENOMYOSIS ("ADENOMYOSIS / DIFFUSE ADENOMYOSIS"), PAIN ("CHRONIC PAIN / PAIN AT NIGHT"), INTERVERTEBRAL DISC PROTRUSION ("MODERATE PROTUSIVE DISCOPATHY IN L2-L3 AND L3-L4"), INTERVERTEBRAL DISC DISORDER ("CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6"), VERTEBRAL FORAMINAL STENOSIS ("CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6"), MUSCULOSKELETAL PAIN ("MUSCLE AND JOINT PAIN"), UTERINE CERVIX STENOSIS ("CERVICAL STENOSIS"), ABDOMINAL PAIN ("STRONG ABDOMINAL PAIN"), FATIGUE ("VERY STRONG FATIGABILITY / VERY STRONG FATIGUE"), FALLOPIAN TUBE DISORDER ("SMALL INFLAMMATORY REMODELLING IN LEFT TUBE"), VULVOVAGINAL MYCOTIC INFECTION ("VAGINAL MYCOSIS"), PHLEBOLITH ("PHLEBOLITHS"), ABDOMINAL PAIN LOWER ("CRAMPS"), HOT FLUSH ("HOT FLUSHES"), UTERINE INFLAMMATION ("UTERINE INFLAMMATION"), NIGHT SWEATS ("SWEATS AT NIGHT"), LOSS OF LIBIDO ("LOSS OF LIBIDO"), MUSCLE SPASMS ("MUSCLE SPASMS/ ABDOMINAL SPASMS"), VISION BLURRED ("BLURRED VISION"), DRY EYE ("DRY EYES"), BACK PAIN ("PAIN IN BACK"), PAIN IN EXTREMITY ("PAIN IN LEGS"), ARTHRALGIA ("PAIN IN WRISTS, JOINT PAIN, ANKLES, KNEES,"), GASTROINTESTINAL PAIN ("GASTROINTESTINAL PAIN"), DYSPEPSIA ("STOMACH BURNS"), NERVOUS SYSTEM DISORDER ("NEUROLOGICAL DISORDERS"), HYPOAESTHESIA ("NUMBNESS OF UPPER LIMBS"), AMNESIA ("IMMEDIATE MEMORY LOSS / LOSS OF MEMORY"), INSOMNIA ("INSOMNIA"), MIGRAINE ("MIGRAINES"), DYSSTASIA ("DIFFICULTY STANDING"), PALPITATIONS ("HEART PALPITATIONS"), ENDOMETRIAL HYPERPLASIA ("DIAGNOSIS OF SIMPLE ATYPICAL HYPERPLASIA WAS CONFIRMED"), ALLERGY TO METALS ("SKIN REACTION TO EAR JEWELRY - ALLERGY TO NICKEL"), SPINAL OSTEOARTHRITIS ("C5/C6 ON CERVICAL OSTEOARTHRITIS"), MYALGIA ("MUSCLE PAIN"), BURNOUT SYNDROME ("PHYSICAL AND PSYCHOLOGICAL EXHAUSTION"), MENOPAUSE ("PREMENOPAUSAL"), ABDOMINAL PAIN UPPER ("STOMACH PAIN"), MYOSITIS ("RANDOM MUSCLE INFLAMMATION"), NEUROPATHY PERIPHERAL ("NEUROLOGI PROBLEMS WITH LOSS OF ABILITY TO USE OF LEFT HAND"), UTERINE PAIN ("UTERUS SENSITIVE TO TOUCH, UTERINE PAIN"), MALAISE ("MALAISE"), IRRITABILITY ("IRRITABILITY"), HEADACHE ("HEADACHES") AND GAIT DISTURBANCE ("DIFFICULTY WALKING"). THE PATIENT WAS TREATED WITH CHLORMADINONE ACETATE (LUTERAN), FOSFOMYCIN TROMETAMOL (MONURIL), MICONAZOLE NITRATE (GYNO-DAKTARIN), SURGERY (ON (B)(6) 2012, HYSTEROSCOPY AND CURETTAGE, ENDOMETRIAL THERMOCOAGULATION WERE PERFORMED AND VAGINAL HYSTERECTOMY AND LEFT SALPINGECTOMY VIA LAPAROSCOPY WERE PERFORMED ON (B)(6) 2018) AND CONIZATION FOR EXTENSIVE MILD JUNCTIONAL HPV DYSPLASIA ON (B)(6) 2014. ESSURE WAS REMOVED ON (B)(6) 2018. IN 2017, THE DIZZINESS AND VERTIGO WAS RESOLVING. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENOMETRORRHAGIA, HEAVY MENSTRUAL BLEEDING, SUICIDAL IDEATION, URINARY TRACT INFECTION, ASCITES, UTERINE POLYP, ADENOMYOSIS, TENDONITIS, PAIN, INTERVERTEBRAL DISC PROTRUSION, SENSORIMOTOR DISORDER, INTERVERTEBRAL DISC DISORDER, VERTEBRAL FORAMINAL STENOSIS, MUSCULOSKELETAL PAIN, UTERINE CERVIX STENOSIS, ABDOMINAL PAIN, FATIGUE, UTERINE LEIOMYOMA, FALLOPIAN TUBE DISORDER, VULVOVAGINAL MYCOTIC INFECTION, PAPILLOMA VIRAL INFECTION, PHLEBOLITH, ASTHENIA, BALANCE DISORDER, DYSMENORRHOEA, VAGINAL HAEMORRHAGE, FALL, ABDOMINAL PAIN LOWER, HOT FLUSH, UTERINE INFLAMMATION, NIGHT SWEATS, LOSS OF LIBIDO, MUSCLE SPASMS, VISION BLURRED, DRY EYE, BACK PAIN, PAIN IN EXTREMITY, ARTHRALGIA, GASTROINTESTINAL PAIN, DYSPEPSIA, NERVOUS SYSTEM DISORDER, HYPOAESTHESIA, DEPRESSED MOOD, AMNESIA, INSOMNIA, MIGRAINE, DYSSTASIA, VAGINAL DISCHARGE, DYSURIA AND PALPITATIONS WAS RESOLVING AND THE ENDOMETRIAL HYPERPLASIA, INTERMENSTRUAL BLEEDING, ALLERGY TO METALS, SPINAL OSTEOARTHRITIS, MYALGIA, BURNOUT SYNDROME, MENOPAUSE, ABDOMINAL PAIN UPPER, MYOSITIS, NEUROPATHY PERIPHERAL, UTERINE PAIN, MALAISE, IRRITABILITY, HEADACHE AND GAIT DISTURBANCE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ADENOMYOSIS, AMNESIA, ARTHRALGIA, ASCITES, ASTHENIA, BACK PAIN, BALANCE DISORDER, DEPRESSED MOOD, DIZZINESS, DRY EYE, DYSMENORRHOEA, DYSPEPSIA, DYSSTASIA, DYSURIA, FALL, FALLOPIAN TUBE DISORDER, FATIGUE, GASTROINTESTINAL PAIN, HEAVY MENSTRUAL BLEEDING, HOT FLUSH, HYPOAESTHESIA, INSOMNIA, INTERVERTEBRAL DISC DISORDER, INTERVERTEBRAL DISC PROTRUSION, LOSS OF LIBIDO, MENOMETRORRHAGIA, MIGRAINE, MUSCLE SPASMS, MUSCULOSKELETAL PAIN, NERVOUS SYSTEM DISORDER, NIGHT SWEATS, PAIN, PAIN IN EXTREMITY, PALPITATIONS, PAPILLOMA VIRAL INFECTION, PELVIC PAIN, PHLEBOLITH, SENSORIMOTOR DISORDER, SUICIDAL IDEATION, TENDONITIS, URINARY TRACT INFECTION, UTERINE CERVIX STENOSIS, UTERINE INFLAMMATION, UTERINE LEIOMYOMA, UTERINE POLYP, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VERTEBRAL FORAMINAL STENOSIS, VISION BLURRED AND VULVOVAGINAL MYCOTIC INFECTION TO BE UNRELATED TO ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN UPPER, ALLERGY TO METALS, BURNOUT SYNDROME, ENDOMETRIAL HYPERPLASIA, GAIT DISTURBANCE, HEADACHE, INTERMENSTRUAL BLEEDING, IRRITABILITY, MALAISE, MENOPAUSE, MYALGIA, MYOSITIS, NEUROPATHY PERIPHERAL, SPINAL OSTEOARTHRITIS, UTERINE PAIN AND VERTIGO TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION IN LEFT TUBE, OSTIA VISIBLE AND ACCESSIBLE. PLACEMENT WITHOUT INCIDENT ON STANDARD PROCEDURE, 4 TRAILING COILS ON THE LEFT. DURATION 3 MINUTES, VERY WELL TOLERATED. WORK UP TO INVESTIGATE POTENTIAL SENSITIVITY TO NICKEL, TITANIUM AND STEEL WAS REQUESTED. ON UNSPECIFIED DATE, SERUM PROTEINS ELECTROPHORESIS FOUND HYPOGAMMAGLOBULINEMIA. LAB DATA ADDED: ON (B)(6) 2012, FSH OF 8,4 IU/L (MENOPAUSE: FROM 26 TO 135),LH OF 6,4 IU/L (MENOPAUSE FROM 7,7 TO 58,5), ESTRADIOL OF 1203 PMOL/L (MENOPAUSE: <505 PMOL/L). FULL BLOOD COUNT ON (B)(6) 2012, (B)(6) 2013 AND ON (B)(6) 2014 WAS NORMAL. CONISATION WAS PERFORMED ON (B)(6) 2014 FOR LOW-GRADE INTRA-EPITHELIAL LESION CONFIRMED BY BIOPSY, PERSISTENT, WITH AN AREA AT THE SCJ. PATIENT CAME BACK FOR CONSULTATION THREE DAYS AFTER CONISATION BECAUSE OF ASTHENIA AND BALANCE DISORDERS. ANTIDEPRESSANT DRUG WAS PRESCRIBED TO THE PATIENT. MEDICAL EXAMINATION OF TPATIENT BY EXPERT FOUND NOTHING REMARKABLE. FOLLOWING VARIOUS QUESTIONS, EXPERT REQUESTED SOME EXHIBITS INCLUDING LAB TESTS, AND REPORTED FOR SECOND TIME THE EVENTS WERE RELATED TO PRE-MENOPAUSE STATE OF PATIENT AS WELL AS SOME DISCLOSED UTERINE DISEASES. NO CAUSAL RELATIONSHIP BETWEEN THE GENERAL SYMPTOMS AND THE GYNECOLOGICAL SYMPTOMS REPORTED BY THE PATIENT AND THE ESSURE. IMPROVEMENT OF THE GENERAL SYMPTOMS IMMEDIATELY AFTER REMOVAL OF ESSURE WAS NOT DIRECTLY RELATED TO ESSURE REMOVAL ACCORDING TO THE EXPERT. PSYCHOLOGICAL REJECTION OF ESSURE STARTED IMMEDIATELY AFTER SEEKING DOCUMENTATION ON INTERNET. THE QUICK IMPROVEMENT OF THE GENERAL SYMPTOMS AFTER REMOVAL EVOKED A NOCEBO EFFECT. IMPROVEMENT OF MENORRHAGIA AND DYSMENORRHEA WAS DIRECTLY RELATED TO THE HYSTERECTOMY. GYNECOLOGICAL DISORDERS WHICH HAD CERTAIN AND DIRECT CAUSAL RELATIONSHIP WITH PRE-MENOPAUSE. ANTEVERTED UTERUS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BLOOD FOLLICLE STIMULATING HORMONE (IU/L) - ON (B)(6) 2012: 8.4 IU/L. BLOOD IMMUNOGLOBULIN M - ON (B)(6) 2017: 29 IU/ML (NORM: POSITIVE IF UPPER THAN 20 IU/ML).. BLOOD LUTEINISING HORMONE (IU/L) - ON (B)(6) -2012: 6.4 IU/L. COMPUTERISED TOMOGRAM HEAD - ON AN UNKNOWN DATE: WITHOUT CONTRAST SHOWED NOTHING REMARKABLE. GYNAECOLOGICAL EXAMINATION - ON AN UNKNOWN DATE: RESULTS: CERVICAL STENOSIS. HAEMOGLOBIN (G/DL) - ON (B)(6) 2012: 14.1 G/DL. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: PHLEBOLITHS WAS VISIBLE. THE LEFT IMPLANT IS WELL POSITIONED, WITH NO CONTRAST MEDIUM. LEFT TUBE WAS CORRECTLY OBSTRUCTED.. HYSTEROSCOPY - ON (B)(6) 2012: VISUALIZATION OF THREE POLYPS MEASURING ABOUT 55 MM ABOVE THE ISTHMUS, MID-CAVITY AND BELOW THE INTERSTITIAL PORTION OF THE RIGHT FALLOPIAN TUBE. INDICATION FOR HYSTEROSCOPY AND CURETTAGE.. MAGNETIC RESONANCE IMAGING - ON AN UNKNOWN DATE: MILD PROTRUSIVE DISC DISEASE OF L2/L3 AND L3/L4; IN (B)(6) 2016: GLUTEUS MEDIUS TENDONITIS. MAGNETIC RESONANCE IMAGING ABDOMINAL - ON AN UNKNOWN DATE: MODERATE PROTUSIVE DISCOPATHY IN L2-L3 AND L3-L4 AND INTEGRITY OF SACROILIAC JOINTS.; ON (B)(6) 2012: CONFIRMED PRESENCE OF A SMALL POLYP MEASURING 5 MM IN THE POSTERIOR WALL. PRESENCE OF AN INTERSTITIAL FIBROMA MEASURING 20 MM WITH A SUBMUCOUS COMPONENT IN THE POSTERIOR WALL. NO OTHER VISIBLE ABNORMALITIES.; ON (B)(6) 2016: RESULTS: DIFFUSE ADENOMYOSIS AND LAYER OF INTRAPERITONEAL EFFUSION.; ON (B)(6) 2016: DIFFUSE ADENOMYOSIS. MAGNETIC RESONANCE IMAGING HEAD - ON (B)(6) 2017: RESULTS: NO VISIBLE ABNORMALITY IN MEDULLAR AND CEREBRAL. CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6, CERVICAL OSTEOARTHRITIS. MEAN CELL VOLUME (FL) - ON (B)(6) 2012: 102 FL. OESTRADIOL (PMOL/L) - ON (B)(6) 2012: 1203 PMOL/L. PATHOLOGY TEST - ON (B)(6) 2012: HISTOLOGICAL ANALYSIS OF THE MUCOSA CONCLUDES TO A HYPERPLASIA OF THE UTERINE PSEUDOPOLYPOID SECRETORY MUCOSA; ON (B)(6) 2012: FOUND DIFFUSE ENDOMETRIAL HYPERPLASIA.; ON (B)(6) 2013: DIAGNOSIS OF SIMPLE ATYPICAL HYPERPLASIA WAS CONFIRMED; ON (B)(6) 2014: SUSPECTED ABNORMALITIES OF MALIGNANCY OF THE CERVIX (PAPILLOMAVIRUS INFECTION); ON (B)(6) 2014: LOW-GRADE SQUAMOUS INTRAEPITHELIAL LESIONS AT THE SCJ AND IN MULTIPLE LOCATIONS. NO HIGH-GRADE DYSPLASTIC LESIONS. SMEAR CERVIX - ON (B)(6) 2013: ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE. ULTRASOUND SCAN - ON (B)(6) 2012: RESULTS: ONE SMALL INTRACAVITARY POLYP MEASURING 5 MM; ON (B)(6) 2012: UTERINE POLYP AND A 20 MM INTRAMURAL MYOMATOUS NODULE; IN (B)(6) 2015: ENDO-VAGINAL PELVIC ULTRASOUND FOUND FIBROMATOUS UTERUS; ON (B)(6) 2016: RESULTS: THICKENING OF RIGHT TENDON OF GLUTEUS MEDIUS MUSCLE AND OF RIGHT ILIOTIBIAL TRACT SUGGESTING TENDINITIS OF GLUTEUS MEDIUS MUSCLE.. VIRAL TEST - ON (B)(6) 2013: PRESENCE OF HIGH-RISK PAPILLOMAVIRUS WAS FOUND. LOT NUMBER: 852008 MANUFACTURING DATE: 2011-04 EXPIRATION DATE: 2014-04. 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 5-MAY-2022: 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 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 ('NOT NEGLIGIBLE PELVIC PAIN'), MENOMETRORRHAGIA ('MENORRHAGIA WITH HEMORRHAGIC EPISODES / HEMORRHAGIC MENSTRUATIONS / MENORRHAGIA +++/ FUNCTIONAL MENOMETRORRHAGIA'), ASCITES ('LAYER OF INTRAPERITONEAL EFFUSION'), GENITAL HAEMORRHAGE ('SIGNIFICANT BLEEDING'), SUICIDAL IDEATION ('SUICIDAL THOUGHTS') AND URINARY TRACT INFECTION ('URINARY TRACT INFECTIONS') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852008) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BACK INJURY IN SEPTEMBER 2011, CHRONIC GASTRITIS IN 2011, MENOMETRORRHAGIA IN 2009, CHLAMYDIAL INFECTION IN 2009, FEMALE GENITAL OPERATION IN 2008, VIRAL TEST POSITIVE IN 2008, ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE IN 2008, SHORT MENSTRUATION IN 2007, IRREGULAR MENSTRUATION IN 2005, PARITY IN 1999, RUPTURED ECTOPIC PREGNANCY IN 1996, ACUTE PERICARDITIS IN 1995, PARITY IN 1990, CERVICAL CONISATION (TWO SUCCESSIVE CONISATIONS), CERVICAL DYSPLASIA, RECURRENT URINARY TRACT INFECTION, TOBACCO USER, CERVIX LESION, DYSPLASIA, RETROBULBAR NEURITIS AND ECTOPIC PREGNANCY. NO KNOWN ALLERGIES, NO INTOLERANCE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: (B)(6). CONCURRENT CONDITIONS INCLUDED PREMENOPAUSE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED MENOMETRORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2013, THE PATIENT EXPERIENCED PAPILLOMA VIRAL INFECTION ("HIGH-RISK PAPILLOMAVIRUS"), 1 YEAR 5 MONTHS AFTER INSERTION OF ESSURE. IN 2013, THE PATIENT WAS FOUND TO HAVE UTERINE LEIOMYOMA ("SMALL FIBROMAS/MYOMAS IN UTERUS/ INTERSTITIAL FIBROMA MEASURING 20 MM"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ASTHENIA ("ASTHENIA") AND BALANCE DISORDER ("BALANCE DISORDERS"). ON (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("WHITISH LEUKORRHEA") AND DYSURIA ("BURNING SENSATION DURING URINATION"). IN 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("ACUTE DYSMENORRHEA") AND VAGINAL HAEMORRHAGE ("SPOTTING"). IN (B)(6) 2017, THE PATIENT EXPERIENCED SENSORIMOTOR DISORDER ("LEFT FOOT SENSORY DISORDERS WITH INTERMITTENT MOTOR DISCOMFORT OF RIGHT HAND"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ASCITES (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SUICIDAL IDEATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), URINARY TRACT INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE POLYP ("ONE SMALL INTRACAVITARY POLYP MEASURING 5 MM"), ADENOMYOSIS ("ADENOMYOSIS / DIFFUSE ADENOMYOSIS"), TENDONITIS ("TENDONITIS OF GLUTEUS MEDIUS MUSCLE / THICKENING OF RIGHT TENDON OF GLUTEUS MEDIUS MUSCLE AND OF RIGHT ILIOTIBIAL TRACT SUGGESTING TENDINITIS OF GLUTEUS MEDIUS MUSCLE / TENDONITIS IN WRISTS, ANKLES AND SHOULDERS"), PAIN ("CHRONIC PAIN / PAIN AT NIGHT"), INTERVERTEBRAL DISC PROTRUSION ("MODERATE PROTUSIVE DISCOPATHY IN L2-L3 AND L3-L4"), INTERVERTEBRAL DISC DISORDER ("CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6"), VERTEBRAL FORAMINAL STENOSIS ("CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6"), MUSCULOSKELETAL PAIN ("MUSCLE AND JOINT PAIN"), UTERINE CERVIX STENOSIS ("CERVICAL STENOSIS"), ABDOMINAL PAIN ("STRONG ABDOMINAL PAIN"), FATIGUE ("VERY STRONG FATIGABILITY / VERY STRONG FATIGUE"), FALLOPIAN TUBE DISORDER ("SMALL INFLAMMATORY REMODELLING IN LEFT TUBE"), VULVOVAGINAL MYCOTIC INFECTION ("VAGINAL MYCOSIS"), PHLEBOLITH ("PHLEBOLITHS"), DIZZINESS ("DIZZINESS WHICH CAUSE A FALL IN STAIRS"), FALL ("DIZZINESS WHICH CAUSE A FALL IN STAIRS"), ABDOMINAL PAIN LOWER ("CRAMPS"), HOT FLUSH ("HOT FLUSHES"), UTERINE INFLAMMATION ("UTERINE INFLAMMATION"), NIGHT SWEATS ("SWEATS AT NIGHT"), LOSS OF LIBIDO ("LOSS OF LIBIDO"), MUSCLE SPASMS ("MUSCLE SPASMS/ ABDOMINAL SPASMS"), VISION BLURRED ("BLURRED VISION"), DRY EYE ("DRY EYES"), BACK PAIN ("PAIN IN BACK"), PAIN IN EXTREMITY ("PAIN IN LEGS"), ARTHRALGIA ("PAIN IN WRISTS"), GASTROINTESTINAL PAIN ("GASTROINTESTINAL PAIN"), DYSPEPSIA ("STOMACH BURNS"), NERVOUS SYSTEM DISORDER ("NEUROLOGICAL DISORDERS"), HYPOAESTHESIA ("NUMBNESS OF UPPER LIMBS"), DEPRESSED MOOD ("SADNESS"), AMNESIA ("IMMEDIATE MEMORY LOSS"), INSOMNIA ("INSOMNIA"), MIGRAINE ("MIGRAINES"), DYSSTASIA ("DIFFICULTY STANDING"), PALPITATIONS ("HEART PALPITATIONS") AND ENDOMETRIAL HYPERPLASIA ("DIAGNOSIS OF SIMPLE ATYPICAL HYPERPLASIA WAS CONFIRMED"). THE PATIENT WAS TREATED WITH CHLORMADINONE ACETATE (LUTERAN), FOSFOMYCIN TROMETAMOL (MONURIL), MICONAZOLE NITRATE (GYNO-DAKTARIN) AND SURGERY (ON (B)(6) 2012, HYSTEROSCOPY AND CURETTAGE, ENDOMETRIAL THERMOCOAGULATION WERE PERFORMED AND VAGINAL HYSTERECTOMY AND LEFT SALPINGECTOMY VIA LAPAROSCOPY WERE PERFORMED ON (B)(6) 2018). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENOMETRORRHAGIA, ASCITES, GENITAL HAEMORRHAGE, SUICIDAL IDEATION, URINARY TRACT INFECTION, UTERINE POLYP, ADENOMYOSIS, TENDONITIS, PAIN, INTERVERTEBRAL DISC PROTRUSION, SENSORIMOTOR DISORDER, INTERVERTEBRAL DISC DISORDER, VERTEBRAL FORAMINAL STENOSIS, MUSCULOSKELETAL PAIN, UTERINE CERVIX STENOSIS, ABDOMINAL PAIN, FATIGUE, UTERINE LEIOMYOMA, FALLOPIAN TUBE DISORDER, VULVOVAGINAL MYCOTIC INFECTION, PAPILLOMA VIRAL INFECTION, PHLEBOLITH, ASTHENIA, BALANCE DISORDER, DYSMENORRHOEA, VAGINAL HAEMORRHAGE, DIZZINESS, FALL, ABDOMINAL PAIN LOWER, HOT FLUSH, UTERINE INFLAMMATION, NIGHT SWEATS, LOSS OF LIBIDO, MUSCLE SPASMS, VISION BLURRED, DRY EYE, BACK PAIN, PAIN IN EXTREMITY, ARTHRALGIA, GASTROINTESTINAL PAIN, DYSPEPSIA, NERVOUS SYSTEM DISORDER, HYPOAESTHESIA, DEPRESSED MOOD, AMNESIA, INSOMNIA, MIGRAINE, DYSSTASIA, VAGINAL DISCHARGE, DYSURIA AND PALPITATIONS WAS RESOLVING AND THE ENDOMETRIAL HYPERPLASIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ADENOMYOSIS, AMNESIA, ARTHRALGIA, ASCITES, ASTHENIA, BACK PAIN, BALANCE DISORDER, DEPRESSED MOOD, DIZZINESS, DRY EYE, DYSMENORRHOEA, DYSPEPSIA, DYSSTASIA, DYSURIA, FALL, FALLOPIAN TUBE DISORDER, FATIGUE, GASTROINTESTINAL PAIN, GENITAL HAEMORRHAGE, HOT FLUSH, HYPOAESTHESIA, INSOMNIA, INTERVERTEBRAL DISC DISORDER, INTERVERTEBRAL DISC PROTRUSION, LOSS OF LIBIDO, MENOMETRORRHAGIA, MIGRAINE, MUSCLE SPASMS, MUSCULOSKELETAL PAIN, NERVOUS SYSTEM DISORDER, NIGHT SWEATS, PAIN, PAIN IN EXTREMITY, PALPITATIONS, PAPILLOMA VIRAL INFECTION, PELVIC PAIN, PHLEBOLITH, SENSORIMOTOR DISORDER, SUICIDAL IDEATION, TENDONITIS, URINARY TRACT INFECTION, UTERINE CERVIX STENOSIS, UTERINE INFLAMMATION, UTERINE LEIOMYOMA, UTERINE POLYP, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VERTEBRAL FORAMINAL STENOSIS, VISION BLURRED AND VULVOVAGINAL MYCOTIC INFECTION TO BE UNRELATED TO ESSURE. THE REPORTER CONSIDERED ENDOMETRIAL HYPERPLASIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DURING ESSURE INSERTION, THE OSTIA WERE VISIBLE AND ACCESSIBLE. PLACEMENT OF ESSURE WITHOUT INCIDENT USING THE STANDARD PROCEDURE, 4 TRAILING COILS ON THE LEFT. DURATION OF THE PROCEDURE WAS OF 3 MINUTES. IT WAS VERY WELL TOLERATED. WORK UP TO INVESTIGATE POTENTIAL SENSITIVITY TO NICKEL, TITANIUM AND STEEL WAS REQUESTED. ON UNSPECIFIED DATE, SERUM PROTEINS ELECTROPHORESIS FOUND HYPOGAMMAGLOBULINEMIA. LAB DATA ADDED: ON (B)(6) 2012, FSH OF 8,4 IU/L (MENOPAUSE: FROM 26 TO 135),LH OF 6,4 IU/L (MENOPAUSE FROM 7,7 TO 58,5), ESTRADIOL OF 1203 PMOL/L (MENOPAUSE: <505 PMOL/L). FULL BLOOD COUNT ON (B)(6) 2012, (B)(6) 2013 AND ON (B)(6) 2014 WAS NORMAL. CONISATION WAS PERFORMED ON (B)(6) 2014 FOR LOW-GRADE INTRA-EPITHELIAL LESION CONFIRMED BY BIOPSY, PERSISTENT, WITH AN AREA AT THE SCJ. PATIENT CAME BACK FOR CONSULTATION THREE DAYS AFTER CONISATION BECAUSE OF ASTHENIA AND BALANCE DISORDERS. ANTIDEPRESSANT DRUG WAS PRESCRIBED TO THE PATIENT. MEDICAL EXAMINATION OF THE PATIENT BY THE EXPERT FOUND NOTHING REMARKABLE. FOLLOWING VARIOUS QUESTIONS, THE EXPERT REQUESTED SOME EXHIBITS INCLUDING LAB TESTS, AND REPORTED FOR THE SECOND TIME THAT THE EVENTS WERE RELATED TO PRE-MENOPAUSE STATE OF THE PATIENT AS WELL AS SOME DISCLOSED UTERINE DISEASES. THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE GENERAL SYMPTOMS AND THE GYNECOLOGICAL SYMPTOMS REPORTED BY THE PATIENT AND ESSURE. IMPROVEMENT OF THE GENERAL SYMPTOMS IMMEDIATELY AFTER REMOVAL OF ESSURE WAS NOT DIRECTLY RELATED TO ESSURE REMOVAL ACCORDING TO THE EXPERT. PSYCHOLOGICAL REJECTION OF ESSURE STARTED IMMEDIATELY AFTER SEEKING DOCUMENTATION ON INTERNET. THE QUICK IMPROVEMENT OF THE GENERAL SYMPTOMS AFTER REMOVAL EVOKED A NOCEBO EFFECT. IMPROVEMENT OF MENORRHAGIA AND DYSMENORRHEA WAS DIRECTLY RELATED TO THE HYSTERECTOMY. THE PATIENT EXPERIENCED GYNECOLOGICAL DISORDERS WHICH HAD CERTAIN AND DIRECT CAUSAL RELATIONSHIP WITH PRE-MENOPAUSE. THE CONSUMER HAS AN ANTEVERTED UTERUS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BLOOD FOLLICLE STIMULATING HORMONE (IU/L) - ON (B)(6) 2012: 8.4 IU/L. BLOOD IMMUNOGLOBULIN M - ON (B)(6) 2017: 29 IU/ML (NORM: POSITIVE IF UPPER THAN 20 IU/ML).. BLOOD LUTEINISING HORMONE (IU/L) - ON (B)(6) 2012: 6.4 IU/L. COMPUTERISED TOMOGRAM HEAD - ON AN UNKNOWN DATE: WITHOUT CONTRAST SHOWED NOTHING REMARKABLE. GYNAECOLOGICAL EXAMINATION - ON AN UNKNOWN DATE: RESULTS: CERVICAL STENOSIS. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: PHLEBOLITHS WAS VISIBLE. THE LEFT IMPLANT IS WELL POSITIONED, WITH NO CONTRAST MEDIUM. LEFT TUBE WAS CORRECTLY OBSTRUCTED.. HYSTEROSCOPY - ON (B)(6) 2012: VISUALIZATION OF THREE POLYPS MEASURING ABOUT 55 MM ABOVE THE ISTHMUS, MID-CAVITY AND BELOW THE INTERSTITIAL PORTION OF THE RIGHT FALLOPIAN TUBE. INDICATION FOR HYSTEROSCOPY AND CURETTAGE.. MAGNETIC RESONANCE IMAGING ABDOMINAL - ON AN UNKNOWN DATE: MODERATE PROTUSIVE DISCOPATHY IN L2-L3 AND L3-L4 AND INTEGRITY OF SACROILIAC JOINTS.; ON (B)(6) 2012: CONFIRMED PRESENCE OF A SMALL POLYP MEASURING 5 MM IN THE POSTERIOR WALL. PRESENCE OF AN INTERSTITIAL FIBROMA MEASURING 20 MM WITH A SUBMUCOUS COMPONENT IN THE POSTERIOR WALL. NO OTHER VISIBLE ABNORMALITIES.; ON (B)(6) 2016: RESULTS: DIFFUSE ADENOMYOSIS AND LAYER OF INTRAPERITONEAL EFFUSION.; ON (B)(6) 2016: DIFFUSE ADENOMYOSIS. MAGNETIC RESONANCE IMAGING HEAD - ON AN UNKNOWN DATE: RESULTS: NO VISIBLE ABNORMALITY IN MEDULLAR AND CEREBRAL. CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6.. OESTRADIOL (PMOL/L) - ON (B)(6) 2012: 1203 PMOL/L. PATHOLOGY TEST - ON (B)(6) 2012: FOUND DIFFUSE ENDOMETRIAL HYPERPLASIA.; ON (B)(6) 2013: DIAGNOSIS OF SIMPLE ATYPICAL HYPERPLASIA WAS CONFIRMED; ON (B)(6) 2014: LOW-GRADE SQUAMOUS INTRAEPITHELIAL LESIONS AT THE SCJ AND IN MULTIPLE LOCATIONS. NO HIGH-GRADE DYSPLASTIC LESIONS.. SMEAR CERVIX - ON (B)(6) 2013: ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE.. ULTRASOUND SCAN - ON (B)(6) 2012: RESULTS: ONE SMALL INTRACAVITARY POLYP MEASURING 5 MM; IN (B)(6) 2015: ENDO-VAGINAL PELVIC ULTRASOUND FOUND FIBROMATOUS UTERUS; ON (B)(6) 2016: RESULTS: THICKENING OF RIGHT TENDON OF GLUTEUS MEDIUS MUSCLE AND OF RIGHT ILIOTIBIAL TRACT SUGGESTING TENDINITIS OF GLUTEUS MEDIUS MUSCLE.. VIRAL TEST - ON (B)(6) 2013: PRESENCE OF HIGH-RISK PAPILLOMAVIRUS WAS FOUND. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021: EVENT PAPILLOMA VIRAL INFECTION ¿ONSET DATE¿ ADDED. NEW PATIENT LAB DATA ¿ULTRASOUND SCAN ((B)(6) 2015)¿ AND ¿PATHOLOGY TEST ((B)(6) 2013)¿ ADDED. NEW EVENT "DIAGNOSIS OF SIMPLE ATYPICAL HYPERPLASIA WAS CONFIRMED" WAS ALSO ADDED WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW AND A REVIEW OF COMPLAINT RECORDS AND OTHER 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 ('NOT NEGLIGIBLE PELVIC PAIN'), MENOMETRORRHAGIA ('MENORRHAGIA WITH HEMORRHAGIC EPISODES / HEMORRHAGIC MENSTRUATIONS / MENORRHAGIA +++/ FUNCTIONAL MENOMETRORRHAGIA'), ASCITES ('LAYER OF INTRAPERITONEAL EFFUSION'), GENITAL HAEMORRHAGE ('SIGNIFICANT BLEEDING'), SUICIDAL IDEATION ('SUICIDAL THOUGHTS') AND URINARY TRACT INFECTION ('URINARY TRACT INFECTIONS') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852008) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BACK INJURY IN (B)(6) 2011, CHRONIC GASTRITIS IN 2011, MENOMETRORRHAGIA IN 2009, CHLAMYDIAL INFECTION IN 2009, FEMALE GENITAL OPERATION IN 2008, VIRAL TEST POSITIVE IN 2008, ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE IN 2008, SHORT MENSTRUATION IN 2007, IRREGULAR MENSTRUATION IN 2005, PARITY IN 1999, RUPTURED ECTOPIC PREGNANCY IN 1996, ACUTE PERICARDITIS IN 1995, PARITY IN 1990, CERVICAL CONISATION (TWO SUCCESSIVE CONISATIONS), CERVICAL DYSPLASIA, RECURRENT URINARY TRACT INFECTION, TOBACCO USER, CERVIX LESION, DYSPLASIA, RETROBULBAR NEURITIS AND ECTOPIC PREGNANCY. NO KNOWN ALLERGIES, NO INTOLERANCE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: (B)(6). CONCURRENT CONDITIONS INCLUDED PREMENOPAUSE. IN 2011, THE PATIENT EXPERIENCED MENOMETRORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED PAPILLOMA VIRAL INFECTION ("HIGH-RISK PAPILLOMAVIRUS"), 1 YEAR 5 MONTHS AFTER INSERTION OF ESSURE. IN 2013, THE PATIENT WAS FOUND TO HAVE UTERINE LEIOMYOMA ("SMALL FIBROMAS/MYOMAS IN UTERUS/ INTERSTITIAL FIBROMA MEASURING 20 MM"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ASTHENIA ("ASTHENIA") AND BALANCE DISORDER ("BALANCE DISORDERS"). ON (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("WHITISH LEUKORRHEA") AND DYSURIA ("BURNING SENSATION DURING URINATION"). IN 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("ACUTE DYSMENORRHEA") AND VAGINAL HAEMORRHAGE ("SPOTTING"). IN (B)(6) 2017, THE PATIENT EXPERIENCED SENSORIMOTOR DISORDER ("LEFT FOOT SENSORY DISORDERS WITH INTERMITTENT MOTOR DISCOMFORT OF RIGHT HAND"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ASCITES (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SUICIDAL IDEATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), URINARY TRACT INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE POLYP ("ONE SMALL INTRACAVITARY POLYP MEASURING 5 MM"), ADENOMYOSIS ("ADENOMYOSIS / DIFFUSE ADENOMYOSIS"), TENDONITIS ("TENDONITIS OF GLUTEUS MEDIUS MUSCLE / THICKENING OF RIGHT TENDON OF GLUTEUS MEDIUS MUSCLE AND OF RIGHT ILIOTIBIAL TRACT SUGGESTING TENDINITIS OF GLUTEUS MEDIUS MUSCLE / TENDONITIS IN WRISTS, ANKLES AND SHOULDERS"), PAIN ("CHRONIC PAIN / PAIN AT NIGHT"), INTERVERTEBRAL DISC PROTRUSION ("MODERATE PROTUSIVE DISCOPATHY IN L2-L3 AND L3-L4"), INTERVERTEBRAL DISC DISORDER ("CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6"), VERTEBRAL FORAMINAL STENOSIS ("CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6"), MUSCULOSKELETAL PAIN ("MUSCLE AND JOINT PAIN"), UTERINE CERVIX STENOSIS ("CERVICAL STENOSIS"), ABDOMINAL PAIN ("STRONG ABDOMINAL PAIN"), FATIGUE ("VERY STRONG FATIGABILITY / VERY STRONG FATIGUE"), FALLOPIAN TUBE DISORDER ("SMALL INFLAMMATORY REMODELLING IN LEFT TUBE"), VULVOVAGINAL MYCOTIC INFECTION ("VAGINAL MYCOSIS"), PHLEBOLITH ("PHLEBOLITHS"), DIZZINESS ("DIZZINESS WHICH CAUSE A FALL IN STAIRS"), FALL ("DIZZINESS WHICH CAUSE A FALL IN STAIRS"), ABDOMINAL PAIN LOWER ("CRAMPS"), HOT FLUSH ("HOT FLUSHES"), UTERINE INFLAMMATION ("UTERINE INFLAMMATION"), NIGHT SWEATS ("SWEATS AT NIGHT"), LOSS OF LIBIDO ("LOSS OF LIBIDO"), MUSCLE SPASMS ("MUSCLE SPASMS/ ABDOMINAL SPASMS"), VISION BLURRED ("BLURRED VISION"), DRY EYE ("DRY EYES"), BACK PAIN ("PAIN IN BACK"), PAIN IN EXTREMITY ("PAIN IN LEGS"), ARTHRALGIA ("PAIN IN WRISTS"), GASTROINTESTINAL PAIN ("GASTROINTESTINAL PAIN"), DYSPEPSIA ("STOMACH BURNS"), NERVOUS SYSTEM DISORDER ("NEUROLOGICAL DISORDERS"), HYPOAESTHESIA ("NUMBNESS OF UPPER LIMBS"), DEPRESSED MOOD ("SADNESS"), AMNESIA ("IMMEDIATE MEMORY LOSS"), INSOMNIA ("INSOMNIA"), MIGRAINE ("MIGRAINES"), DYSSTASIA ("DIFFICULTY STANDING"), PALPITATIONS ("HEART PALPITATIONS") AND ENDOMETRIAL HYPERPLASIA ("DIAGNOSIS OF SIMPLE ATYPICAL HYPERPLASIA WAS CONFIRMED"). THE PATIENT WAS TREATED WITH CHLORMADINONE ACETATE (LUTERAN), FOSFOMYCIN TROMETAMOL (MONURIL), MICONAZOLE NITRATE (GYNO-DAKTARIN) AND SURGERY (ON (B)(6) 2012, HYSTEROSCOPY AND CURETTAGE, ENDOMETRIAL THERMOCOAGULATION WERE PERFORMED AND VAGINAL HYSTERECTOMY AND LEFT SALPINGECTOMY VIA LAPAROSCOPY WERE PERFORMED ON (B)(6) 2018). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENOMETRORRHAGIA, ASCITES, GENITAL HAEMORRHAGE, SUICIDAL IDEATION, URINARY TRACT INFECTION, UTERINE POLYP, ADENOMYOSIS, TENDONITIS, PAIN, INTERVERTEBRAL DISC PROTRUSION, SENSORIMOTOR DISORDER, INTERVERTEBRAL DISC DISORDER, VERTEBRAL FORAMINAL STENOSIS, MUSCULOSKELETAL PAIN, UTERINE CERVIX STENOSIS, ABDOMINAL PAIN, FATIGUE, UTERINE LEIOMYOMA, FALLOPIAN TUBE DISORDER, VULVOVAGINAL MYCOTIC INFECTION, PAPILLOMA VIRAL INFECTION, PHLEBOLITH, ASTHENIA, BALANCE DISORDER, DYSMENORRHOEA, VAGINAL HAEMORRHAGE, DIZZINESS, FALL, ABDOMINAL PAIN LOWER, HOT FLUSH, UTERINE INFLAMMATION, NIGHT SWEATS, LOSS OF LIBIDO, MUSCLE SPASMS, VISION BLURRED, DRY EYE, BACK PAIN, PAIN IN EXTREMITY, ARTHRALGIA, GASTROINTESTINAL PAIN, DYSPEPSIA, NERVOUS SYSTEM DISORDER, HYPOAESTHESIA, DEPRESSED MOOD, AMNESIA, INSOMNIA, MIGRAINE, DYSSTASIA, VAGINAL DISCHARGE, DYSURIA AND PALPITATIONS WAS RESOLVING AND THE ENDOMETRIAL HYPERPLASIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ADENOMYOSIS, AMNESIA, ARTHRALGIA, ASCITES, ASTHENIA, BACK PAIN, BALANCE DISORDER, DEPRESSED MOOD, DIZZINESS, DRY EYE, DYSMENORRHOEA, DYSPEPSIA, DYSSTASIA, DYSURIA, FALL, FALLOPIAN TUBE DISORDER, FATIGUE, GASTROINTESTINAL PAIN, GENITAL HAEMORRHAGE, HOT FLUSH, HYPOAESTHESIA, INSOMNIA, INTERVERTEBRAL DISC DISORDER, INTERVERTEBRAL DISC PROTRUSION, LOSS OF LIBIDO, MENOMETRORRHAGIA, MIGRAINE, MUSCLE SPASMS, MUSCULOSKELETAL PAIN, NERVOUS SYSTEM DISORDER, NIGHT SWEATS, PAIN, PAIN IN EXTREMITY, PALPITATIONS, PAPILLOMA VIRAL INFECTION, PELVIC PAIN, PHLEBOLITH, SENSORIMOTOR DISORDER, SUICIDAL IDEATION, TENDONITIS, URINARY TRACT INFECTION, UTERINE CERVIX STENOSIS, UTERINE INFLAMMATION, UTERINE LEIOMYOMA, UTERINE POLYP, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VERTEBRAL FORAMINAL STENOSIS, VISION BLURRED AND VULVOVAGINAL MYCOTIC INFECTION TO BE UNRELATED TO ESSURE. THE REPORTER CONSIDERED ENDOMETRIAL HYPERPLASIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DURING ESSURE INSERTION, THE OSTIA WERE VISIBLE AND ACCESSIBLE. PLACEMENT OF ESSURE WITHOUT INCIDENT USING THE STANDARD PROCEDURE, 4 TRAILING COILS ON THE LEFT. DURATION OF THE PROCEDURE WAS OF 3 MINUTES. IT WAS VERY WELL TOLERATED. WORK UP TO INVESTIGATE POTENTIAL SENSITIVITY TO NICKEL, TITANIUM AND STEEL WAS REQUESTED. ON UNSPECIFIED DATE, SERUM PROTEINS ELECTROPHORESIS FOUND HYPOGAMMAGLOBULINEMIA. LAB DATA ADDED: ON (B)(6) 2012, FSH OF 8,4 IU/L (MENOPAUSE: FROM 26 TO 135),LH OF 6,4 IU/L (MENOPAUSE FROM 7,7 TO 58,5), ESTRADIOL OF 1203 PMOL/L (MENOPAUSE: <505 PMOL/L). FULL BLOOD COUNT ON (B)(6) 2012, (B)(6) 2013 AND ON (B)(6) 2014 WAS NORMAL. CONISATION WAS PERFORMED ON (B)(6) 2014 FOR LOW-GRADE INTRA-EPITHELIAL LESION CONFIRMED BY BIOPSY, PERSISTENT, WITH AN AREA AT THE SCJ. PATIENT CAME BACK FOR CONSULTATION THREE DAYS AFTER CONISATION BECAUSE OF ASTHENIA AND BALANCE DISORDERS. ANTIDEPRESSANT DRUG WAS PRESCRIBED TO THE PATIENT. MEDICAL EXAMINATION OF THE PATIENT BY THE EXPERT FOUND NOTHING REMARKABLE. FOLLOWING VARIOUS QUESTIONS, THE EXPERT REQUESTED SOME EXHIBITS INCLUDING LAB TESTS, AND REPORTED FOR THE SECOND TIME THAT THE EVENTS WERE RELATED TO PRE-MENOPAUSE STATE OF THE PATIENT AS WELL AS SOME DISCLOSED UTERINE DISEASES. THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE GENERAL SYMPTOMS AND THE GYNECOLOGICAL SYMPTOMS REPORTED BY THE PATIENT AND ESSURE. IMPROVEMENT OF THE GENERAL SYMPTOMS IMMEDIATELY AFTER REMOVAL OF ESSURE WAS NOT DIRECTLY RELATED TO ESSURE REMOVAL ACCORDING TO THE EXPERT. PSYCHOLOGICAL REJECTION OF ESSURE STARTED IMMEDIATELY AFTER SEEKING DOCUMENTATION ON INTERNET. THE QUICK IMPROVEMENT OF THE GENERAL SYMPTOMS AFTER REMOVAL EVOKED A NOCEBO EFFECT. IMPROVEMENT OF MENORRHAGIA AND DYSMENORRHEA WAS DIRECTLY RELATED TO THE HYSTERECTOMY. THE PATIENT EXPERIENCED GYNECOLOGICAL DISORDERS WHICH HAD CERTAIN AND DIRECT CAUSAL RELATIONSHIP WITH PRE-MENOPAUSE. THE CONSUMER HAS AN ANTEVERTED UTERUS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BLOOD FOLLICLE STIMULATING HORMONE (IU/L) - ON (B)(6) 2012: 8.4 IU/L. BLOOD IMMUNOGLOBULIN M - ON (B)(6) 2017: 29 IU/ML (NORM: POSITIVE IF UPPER THAN 20 IU/ML).. BLOOD LUTEINISING HORMONE (IU/L) - ON (B)(6) 2012: 6.4 IU/L. COMPUTERISED TOMOGRAM HEAD - ON AN UNKNOWN DATE: WITHOUT CONTRAST SHOWED NOTHING REMARKABLE. GYNAECOLOGICAL EXAMINATION - ON AN UNKNOWN DATE: RESULTS: CERVICAL STENOSIS. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: PHLEBOLITHS WAS VISIBLE. THE LEFT IMPLANT IS WELL POSITIONED, WITH NO CONTRAST MEDIUM. LEFT TUBE WAS CORRECTLY OBSTRUCTED.. HYSTEROSCOPY - ON (B)(6) 2012: VISUALIZATION OF THREE POLYPS MEASURING ABOUT 55 MM ABOVE THE ISTHMUS, MID-CAVITY AND BELOW THE INTERSTITIAL PORTION OF THE RIGHT FALLOPIAN TUBE. INDICATION FOR HYSTEROSCOPY AND CURETTAGE.. MAGNETIC RESONANCE IMAGING ABDOMINAL - ON AN UNKNOWN DATE: MODERATE PROTUSIVE DISCOPATHY IN L2-L3 AND L3-L4 AND INTEGRITY OF SACROILIAC JOINTS.; ON (B)(6) 2012: CONFIRMED PRESENCE OF A SMALL POLYP MEASURING 5 MM IN THE POSTERIOR WALL. PRESENCE OF AN INTERSTITIAL FIBROMA MEASURING 20 MM WITH A SUBMUCOUS COMPONENT IN THE POSTERIOR WALL. NO OTHER VISIBLE ABNORMALITIES.; ON (B)(6) 2016: RESULTS: DIFFUSE ADENOMYOSIS AND LAYER OF INTRAPERITONEAL EFFUSION.; ON (B)(6) 2016: DIFFUSE ADENOMYOSIS. MAGNETIC RESONANCE IMAGING HEAD - ON AN UNKNOWN DATE: RESULTS: NO VISIBLE ABNORMALITY IN MEDULLAR AND CEREBRAL. CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6.. OESTRADIOL (PMOL/L) - ON (B)(6) 2012: 1203 PMOL/L. PATHOLOGY TEST - ON (B)(6) 2012: FOUND DIFFUSE ENDOMETRIAL HYPERPLASIA.; ON (B)(6) 2013: DIAGNOSIS OF SIMPLE ATYPICAL HYPERPLASIA WAS CONFIRMED; ON (B)(6) 2014: LOW-GRADE SQUAMOUS INTRAEPITHELIAL LESIONS AT THE SCJ AND IN MULTIPLE LOCATIONS. NO HIGH-GRADE DYSPLASTIC LESIONS. SMEAR CERVIX - ON (B)(6) 2013: ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE.. ULTRASOUND SCAN - ON (B)(6) 2012: RESULTS: ONE SMALL INTRACAVITARY POLYP MEASURING 5 MM; IN (B)(6) 2015: ENDO-VAGINAL PELVIC ULTRASOUND FOUND FIBROMATOUS UTERUS; ON (B)(6) 2016: RESULTS: THICKENING OF RIGHT TENDON OF GLUTEUS MEDIUS MUSCLE AND OF RIGHT ILIOTIBIAL TRACT SUGGESTING TENDINITIS OF GLUTEUS MEDIUS MUSCLE. VIRAL TEST - ON (B)(6) 2013: PRESENCE OF HIGH-RISK PAPILLOMAVIRUS WAS FOUND. LOT NUMBER: 852008 MANUFACTURING DATE: 2011-04 EXPIRATION DATE: 2014-04. 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 19-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 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 ('NOT NEGLIGIBLE PELVIC PAIN'), MENOMETRORRHAGIA ('MENORRHAGIA WITH HEMORRHAGIC EPISODES / HEMORRHAGIC MENSTRUATIONS / MENORRHAGIA +++/ FUNCTIONAL MENOMETRORRHAGIA'), GENITAL HAEMORRHAGE ('SIGNIFICANT BLEEDING'), SUICIDAL IDEATION ('SUICIDAL THOUGHTS'), URINARY TRACT INFECTION ('URINARY TRACT INFECTIONS') AND ASCITES ('LAYER OF INTRAPERITONEAL EFFUSION') IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852008) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BACK INJURY IN (B)(6) 2011, CHRONIC GASTRITIS IN 2011, MENOMETRORRHAGIA IN 2009, CHLAMYDIAL INFECTION IN 2009, LOOP ELECTROSURGICAL EXCISION PROCEDURE IN 2008, FEMALE GENITAL OPERATION IN 2008, VIRAL TEST POSITIVE IN 2008, PAPILLOMA VIRAL INFECTION (2008MILD DYSPLASIA AND LOOP RESECTION.) IN 2008, ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE IN 2008, SHORT MENSTRUATION IN 2007, IRREGULAR MENSTRUATION IN 2005, PARITY IN 1999, MISCARRIAGE (AFTER 2 MONTHS OF PREGNANCY, NO INTERVENTION) IN 1998, RUPTURED ECTOPIC PREGNANCY IN 1996, SALPINGECTOMY IN 1996, ACUTE PERICARDITIS IN 1995, PARITY IN 1990, CERVICAL CONISATION (TWO SUCCESSIVE CONISATIONS), CERVICAL DYSPLASIA, RECURRENT URINARY TRACT INFECTION, TOBACCO USER (10 TO 15 CIGARETTES/DAY, WEANED FOR 20 YEARS), CERVIX LESION, DYSPLASIA, RETROBULBAR NEURITIS, ECTOPIC PREGNANCY AND CHLAMYDIA TRACHOMATIS INFECTION (PRIOR TO 1996, IGG POSITIVE AND IGA POSITIVE). NO KNOWN ALLERGIES, NO INTOLERANCE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: (B)(6) IN 2011. CONCURRENT CONDITIONS INCLUDED PREMENOPAUSE. IN 2011, THE PATIENT EXPERIENCED MENOMETRORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED COMPLICATION OF DEVICE INSERTION ("ONLY ONE ESSURE PLACED DUE TO RIGHT SALPINGECTOMY IN 1996"). IN (B)(6) 2012, THE PATIENT EXPERIENCED INTERMENSTRUAL BLEEDING ("METRORRHAGIA TWICE A MONTH, AN INCREASE IN THE VOLUME OF THE PERIODS, RECURRENT"). IN 2012, THE PATIENT WAS FOUND TO HAVE UTERINE LEIOMYOMA ("SMALL FIBROMAS/MYOMAS IN UTERUS/ INTERSTITIAL FIBROMA MEASURING 20 MM / FIBROMATOUS MYOMETRIUM") AND EXPERIENCED DYSMENORRHOEA ("ACUTE DYSMENORRHEA / DYSMENORRHOEA THAT LASTS 48 HOURS IN EACH CYCLE, RECURRENT"). ON (B)(6) 2013, THE PATIENT EXPERIENCED PAPILLOMA VIRAL INFECTION ("HIGH-RISK PAPILLOMAVIRUS / HIGH-GRADE PAPILLOMAVIRUS"). IN 2014, THE PATIENT EXPERIENCED DIZZINESS ("PSEUDO DIZZY SENSATION OF A FEW SECONDS / DIZZINESS WHICH CAUSE A FALL IN STAIRS") AND VERTIGO ("PSEUDO VERTIGO"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ASTHENIA ("ASTHENIA") AND BALANCE DISORDER ("BALANCE DISORDERS"). ON (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("WHITISH LEUKORRHEA") AND DYSURIA ("BURNING SENSATION DURING URINATION"). IN 2015, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("SPOTTING") AND FALL ("DIZZINESS WHICH CAUSE A FALL IN STAIRS WITHOUT LOSS OF CONSCIOUSNESS ATTRIBUTED TO A MECHANICAL CAUSE"). IN 2016, THE PATIENT EXPERIENCED DEPRESSED MOOD ("SADNESS, DARK THOUGHTS, RECURRENT"). IN (B)(6) 2016, THE PATIENT EXPERIENCED TENDONITIS ("TENDONITIS OF GLUTEUS MEDIUS MUSCLE / THICKENING OF RIGHT TENDON OF GLUTEUS MEDIUS MUSCLE AND OF RIGHT ILIOTIBIAL TRACT SUGGESTING TENDINITIS OF GLUTEUS MEDIUS MUSCLE / TENDONITIS IN WRISTS, ANKLES AND SHOULDERS"). IN (B)(6) 2017, THE PATIENT EXPERIENCED SENSORIMOTOR DISORDER ("LEFT FOOT SENSORY DISORDERS WITH INTERMITTENT MOTOR DISCOMFORT OF RIGHT HAND"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SUICIDAL IDEATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), URINARY TRACT INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ASCITES (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE POLYP ("ONE SMALL INTRACAVITARY POLYP MEASURING 5 MM"), ADENOMYOSIS ("ADENOMYOSIS / DIFFUSE ADENOMYOSIS"), PAIN ("CHRONIC PAIN / PAIN AT NIGHT"), INTERVERTEBRAL DISC PROTRUSION ("MODERATE PROTUSIVE DISCOPATHY IN L2-L3 AND L3-L4"), INTERVERTEBRAL DISC DISORDER ("CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6"), VERTEBRAL FORAMINAL STENOSIS ("CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6"), MUSCULOSKELETAL PAIN ("MUSCLE AND JOINT PAIN"), UTERINE CERVIX STENOSIS ("CERVICAL STENOSIS"), ABDOMINAL PAIN ("STRONG ABDOMINAL PAIN"), FATIGUE ("VERY STRONG FATIGABILITY / VERY STRONG FATIGUE"), FALLOPIAN TUBE DISORDER ("SMALL INFLAMMATORY REMODELLING IN LEFT TUBE"), VULVOVAGINAL MYCOTIC INFECTION ("VAGINAL MYCOSIS"), PHLEBOLITH ("PHLEBOLITHS"), ABDOMINAL PAIN LOWER ("CRAMPS"), HOT FLUSH ("HOT FLUSHES"), UTERINE INFLAMMATION ("UTERINE INFLAMMATION"), NIGHT SWEATS ("SWEATS AT NIGHT"), LOSS OF LIBIDO ("LOSS OF LIBIDO"), MUSCLE SPASMS ("MUSCLE SPASMS/ ABDOMINAL SPASMS"), VISION BLURRED ("BLURRED VISION"), DRY EYE ("DRY EYES"), BACK PAIN ("PAIN IN BACK"), PAIN IN EXTREMITY ("PAIN IN LEGS"), ARTHRALGIA ("PAIN IN WRISTS, JOINT PAIN, ANKLES, KNEES,"), GASTROINTESTINAL PAIN ("GASTROINTESTINAL PAIN"), DYSPEPSIA ("STOMACH BURNS"), NERVOUS SYSTEM DISORDER ("NEUROLOGICAL DISORDERS"), HYPOAESTHESIA ("NUMBNESS OF UPPER LIMBS"), AMNESIA ("IMMEDIATE MEMORY LOSS / LOSS OF MEMORY"), INSOMNIA ("INSOMNIA"), MIGRAINE ("MIGRAINES"), DYSSTASIA ("DIFFICULTY STANDING"), PALPITATIONS ("HEART PALPITATIONS"), ENDOMETRIAL HYPERPLASIA ("DIAGNOSIS OF SIMPLE ATYPICAL HYPERPLASIA WAS CONFIRMED"), ALLERGY TO METALS ("SKIN REACTION TO EAR JEWELRY - ALLERGY TO NICKEL"), SPINAL OSTEOARTHRITIS ("C5/C6 ON CERVICAL OSTEOARTHRITIS"), MYALGIA ("MUSCLE PAIN"), BURNOUT SYNDROME ("PHYSICAL AND PSYCHOLOGICAL EXHAUSTION") AND MENOPAUSE ("PREMENOPAUSAL"). THE PATIENT WAS TREATED WITH CHLORMADINONE ACETATE (LUTERAN), FOSFOMYCIN TROMETAMOL (MONURIL), MICONAZOLE NITRATE (GYNO-DAKTARIN), SURGERY (ON (B)(6)2012, HYSTEROSCOPY AND CURETTAGE, ENDOMETRIAL THERMOCOAGULATION WERE PERFORMED AND VAGINAL HYSTERECTOMY AND LEFT SALPINGECTOMY VIA LAPAROSCOPY WERE PERFORMED ON (B)(6)2018) AND CONIZATION FOR EXTENSIVE MILD JUNCTIONAL HPV DYSPLASIA ON (B)(6) 2014. ESSURE WAS REMOVED ON (B)(6) 2018. IN 2017, THE DIZZINESS AND VERTIGO WAS RESOLVING. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENOMETRORRHAGIA, GENITAL HAEMORRHAGE, SUICIDAL IDEATION, URINARY TRACT INFECTION, ASCITES, UTERINE POLYP, ADENOMYOSIS, TENDONITIS, PAIN, INTERVERTEBRAL DISC PROTRUSION, SENSORIMOTOR DISORDER, INTERVERTEBRAL DISC DISORDER, VERTEBRAL FORAMINAL STENOSIS, MUSCULOSKELETAL PAIN, UTERINE CERVIX STENOSIS, ABDOMINAL PAIN, FATIGUE, UTERINE LEIOMYOMA, FALLOPIAN TUBE DISORDER, VULVOVAGINAL MYCOTIC INFECTION, PAPILLOMA VIRAL INFECTION, PHLEBOLITH, ASTHENIA, BALANCE DISORDER, DYSMENORRHOEA, VAGINAL HAEMORRHAGE, FALL, ABDOMINAL PAIN LOWER, HOT FLUSH, UTERINE INFLAMMATION, NIGHT SWEATS, LOSS OF LIBIDO, MUSCLE SPASMS, VISION BLURRED, DRY EYE, BACK PAIN, PAIN IN EXTREMITY, ARTHRALGIA, GASTROINTESTINAL PAIN, DYSPEPSIA, NERVOUS SYSTEM DISORDER, HYPOAESTHESIA, DEPRESSED MOOD, AMNESIA, INSOMNIA, MIGRAINE, DYSSTASIA, VAGINAL DISCHARGE, DYSURIA AND PALPITATIONS WAS RESOLVING AND THE ENDOMETRIAL HYPERPLASIA, INTERMENSTRUAL BLEEDING, ALLERGY TO METALS, SPINAL OSTEOARTHRITIS, MYALGIA, BURNOUT SYNDROME, MENOPAUSE AND COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ADENOMYOSIS, AMNESIA, ARTHRALGIA, ASCITES, ASTHENIA, BACK PAIN, BALANCE DISORDER, DEPRESSED MOOD, DIZZINESS, DRY EYE, DYSMENORRHOEA, DYSPEPSIA, DYSSTASIA, DYSURIA, FALL, FALLOPIAN TUBE DISORDER, FATIGUE, GASTROINTESTINAL PAIN, GENITAL HAEMORRHAGE, HOT FLUSH, HYPOAESTHESIA, INSOMNIA, INTERVERTEBRAL DISC DISORDER, INTERVERTEBRAL DISC PROTRUSION, LOSS OF LIBIDO, MENOMETRORRHAGIA, MIGRAINE, MUSCLE SPASMS, MUSCULOSKELETAL PAIN, NERVOUS SYSTEM DISORDER, NIGHT SWEATS, PAIN, PAIN IN EXTREMITY, PALPITATIONS, PAPILLOMA VIRAL INFECTION, PELVIC PAIN, PHLEBOLITH, SENSORIMOTOR DISORDER, SUICIDAL IDEATION, TENDONITIS, URINARY TRACT INFECTION, UTERINE CERVIX STENOSIS, UTERINE INFLAMMATION, UTERINE LEIOMYOMA, UTERINE POLYP, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VERTEBRAL FORAMINAL STENOSIS, VISION BLURRED AND VULVOVAGINAL MYCOTIC INFECTION TO BE UNRELATED TO ESSURE. THE REPORTER CONSIDERED ALLERGY TO METALS, BURNOUT SYNDROME, COMPLICATION OF DEVICE INSERTION, ENDOMETRIAL HYPERPLASIA, INTERMENSTRUAL BLEEDING, MENOPAUSE, MYALGIA, SPINAL OSTEOARTHRITIS AND VERTIGO TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DURING ESSURE INSERTION, THE OSTIA WERE VISIBLE AND ACCESSIBLE. PLACEMENT OF ESSURE WITHOUT INCIDENT USING THE STANDARD PROCEDURE, 4 TRAILING COILS ON THE LEFT. DURATION OF THE PROCEDURE WAS OF 3 MINUTES. IT WAS VERY WELL TOLERATED. WORK UP TO INVESTIGATE POTENTIAL SENSITIVITY TO NICKEL, TITANIUM AND STEEL WAS REQUESTED. ON UNSPECIFIED DATE, SERUM PROTEINS ELECTROPHORESIS FOUND HYPOGAMMAGLOBULINEMIA. LAB DATA ADDED: ON (B)(6) 2012, FSH OF 8,4 IU/L (MENOPAUSE: FROM 26 TO 135),LH OF 6,4 IU/L (MENOPAUSE FROM 7,7 TO 58,5), ESTRADIOL OF 1203 PMOL/L (MENOPAUSE: <505 PMOL/L). FULL BLOOD COUNT ON (B)(6) 2012, (B)(6) 2013 AND ON (B)(6) 2014 WAS NORMAL. CONISATION WAS PERFORMED ON (B)(6) 2014 FOR LOW-GRADE INTRA-EPITHELIAL LESION CONFIRMED BY BIOPSY, PERSISTENT, WITH AN AREA AT THE SCJ. PATIENT CAME BACK FOR CONSULTATION THREE DAYS AFTER CONISATION BECAUSE OF ASTHENIA AND BALANCE DISORDERS. ANTIDEPRESSANT DRUG WAS PRESCRIBED TO THE PATIENT. MEDICAL EXAMINATION OF THE PATIENT BY THE EXPERT FOUND NOTHING REMARKABLE. FOLLOWING VARIOUS QUESTIONS, THE EXPERT REQUESTED SOME EXHIBITS INCLUDING LAB TESTS, AND REPORTED FOR THE SECOND TIME THAT THE EVENTS WERE RELATED TO PRE-MENOPAUSE STATE OF THE PATIENT AS WELL AS SOME DISCLOSED UTERINE DISEASES. THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE GENERAL SYMPTOMS AND THE GYNECOLOGICAL SYMPTOMS REPORTED BY THE PATIENT AND ESSURE. IMPROVEMENT OF THE GENERAL SYMPTOMS IMMEDIATELY AFTER REMOVAL OF ESSURE WAS NOT DIRECTLY RELATED TO ESSURE REMOVAL ACCORDING TO THE EXPERT. PSYCHOLOGICAL REJECTION OF ESSURE STARTED IMMEDIATELY AFTER SEEKING DOCUMENTATION ON INTERNET. THE QUICK IMPROVEMENT OF THE GENERAL SYMPTOMS AFTER REMOVAL EVOKED A NOCEBO EFFECT. IMPROVEMENT OF MENORRHAGIA AND DYSMENORRHEA WAS DIRECTLY RELATED TO THE HYSTERECTOMY. THE PATIENT EXPERIENCED GYNECOLOGICAL DISORDERS WHICH HAD CERTAIN AND DIRECT CAUSAL RELATIONSHIP WITH PRE-MENOPAUSE. THE CONSUMER HAS AN ANTEVERTED UTERUS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BLOOD FOLLICLE STIMULATING HORMONE (IU/L) - ON (B)(6) 2012: 8.4 IU/L. BLOOD IMMUNOGLOBULIN M - ON (B)(6) 2017: 29 IU/ML (NORM: POSITIVE IF UPPER THAN 20 IU/ML).. BLOOD LUTEINISING HORMONE (IU/L) - ON (B)(6) 2012: 6.4 IU/L. COMPUTERISED TOMOGRAM HEAD - ON AN UNKNOWN DATE: WITHOUT CONTRAST SHOWED NOTHING REMARKABLE. GYNAECOLOGICAL EXAMINATION - ON AN UNKNOWN DATE: RESULTS: CERVICAL STENOSIS. HAEMOGLOBIN (G/DL) - ON (B)(6) 2012: 14.1 G/DL. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: PHLEBOLITHS WAS VISIBLE. THE LEFT IMPLANT IS WELL POSITIONED, WITH NO CONTRAST MEDIUM. LEFT TUBE WAS CORRECTLY OBSTRUCTED.. HYSTEROSCOPY - ON (B)(6) 2012: VISUALIZATION OF THREE POLYPS MEASURING ABOUT 55 MM ABOVE THE ISTHMUS, MID-CAVITY AND BELOW THE INTERSTITIAL PORTION OF THE RIGHT FALLOPIAN TUBE. INDICATION FOR HYSTEROSCOPY AND CURETTAGE.. MAGNETIC RESONANCE IMAGING - ON AN UNKNOWN DATE: MILD PROTRUSIVE DISC DISEASE OF L2/L3 AND L3/L4; IN (B)(6) 2016: GLUTEUS MEDIUS TENDONITIS. MAGNETIC RESONANCE IMAGING ABDOMINAL - ON AN UNKNOWN DATE: MODERATE PROTUSIVE DISCOPATHY IN L2-L3 AND L3-L4 AND INTEGRITY OF SACROILIAC JOINTS.; ON (B)(6) 2012: CONFIRMED PRESENCE OF A SMALL POLYP MEASURING 5 MM IN THE POSTERIOR WALL. PRESENCE OF AN INTERSTITIAL FIBROMA MEASURING 20 MM WITH A SUBMUCOUS COMPONENT IN THE POSTERIOR WALL. NO OTHER VISIBLE ABNORMALITIES.; ON (B)(6) 2016: RESULTS: DIFFUSE ADENOMYOSIS AND LAYER OF INTRAPERITONEAL EFFUSION.; ON (B)(6) 2016: DIFFUSE ADENOMYOSIS. MAGNETIC RESONANCE IMAGING HEAD - ON (B)(6) 2017: RESULTS: NO VISIBLE ABNORMALITY IN MEDULLAR AND CEREBRAL. CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6, CERVICAL OSTEOARTHRITIS. MEAN CELL VOLUME (FL) - ON (B)(6) 2012: 102 FL. OESTRADIOL (PMOL/L) - ON (B)(6) 2012: 1203 PMOL/L. PATHOLOGY TEST - ON(B)(6) 2012: HISTOLOGICAL ANALYSIS OF THE MUCOSA CONCLUDES TO A HYPERPLASIA OF THE UTERINE PSEUDOPOLYPOID SECRETORY MUCOSA; ON (B)(6) 2012: FOUND DIFFUSE ENDOMETRIAL HYPERPLASIA.; ON (B)(6) 2013: DIAGNOSIS OF SIMPLE ATYPICAL HYPERPLASIA WAS CONFIRMED; ON (B)(6) 2014: LOW-GRADE SQUAMOUS INTRAEPITHELIAL LESIONS AT THE SCJ AND IN MULTIPLE LOCATIONS. NO HIGH-GRADE DYSPLASTIC LESIONS; ON (B)(6) 2014: SUSPECTED ABNORMALITIES OF MALIGNANCY OF THE CERVIX (PAPILLOMAVIRUS INFECTION). SMEAR CERVIX - ON (B)(6) 2013: ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE.. ULTRASOUND SCAN - ON (B)(6) 2012: RESULTS: ONE SMALL INTRACAVITARY POLYP MEASURING 5 MM; IN (B)(6) 2015: ENDO-VAGINAL PELVIC ULTRASOUND FOUND FIBROMATOUS UTERUS; ON (B)(6) 2016: RESULTS: THICKENING OF RIGHT TENDON OF GLUTEUS MEDIUS MUSCLE AND OF RIGHT ILIOTIBIAL TRACT SUGGESTING TENDINITIS OF GLUTEUS MEDIUS MUSCLE.; ON (B)(6) 2012: UTERINE POLYP AND A 20 MM INTRAMURAL MYOMATOUS NODULE. VIRAL TEST - ON (B)(6) 2013: PRESENCE OF HIGH-RISK PAPILLOMAVIRUS WAS FOUND. LOT NUMBER: 852008 MANUFACTURING DATE: 2011-04 EXPIRATION DATE: 2014-04. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-JAN-2022: THE FOLLOW INFORMATION WERE INCLUDE LAWYER'S REPORTER, MEDICAL HISTORY, LAB DATA, METRORRHAGIA , NICKEL SENSITIVITY, OSTEOARTHRITIS OF CERVICAL SPINE, MUSCLE PAIN, VERTIGO, BURN-OUT SYNDROME, PREMENOPAUSE , NO-DRUG TREATMENT RECEIVED ADDED TO PAPILLOMA VIRAL INFECTION, COMPLICATION OF DEVICE INSERTION (10064538) , ONSET DATE ADDED TO TENDONITIS, FALL, DEPRESSED MOOD, ONSET DATE AND STOP DATE ADDED TO DIZZINESS, ONSET DATE DYSMENORRHOEA UPDATED FROM 2015 TO 2012, ONSET DATE UTERINE FIBROMYOMA UPDATED FROM 2013 TO 2012. 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 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 ('NOT NEGLIGIBLE PELVIC PAIN'), DEVICE MATERIAL ISSUE ('EXPONENTIAL RATE OF TIN IN THE PATIENT¿S TISSUES'), MENOMETRORRHAGIA ('MENORRHAGIA WITH HEMORRHAGIC EPISODES / HEMORRHAGIC MENSTRUATIONS / MENORRHAGIA +++/ FUNCTIONAL MENOMETRORRHAGIA'), GENITAL HAEMORRHAGE ('SIGNIFICANT BLEEDING'), SUICIDAL IDEATION ('SUICIDAL THOUGHTS'), URINARY TRACT INFECTION ('URINARY TRACT INFECTIONS') AND ASCITES ('LAYER OF INTRAPERITONEAL EFFUSION') IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852008) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BACK INJURY IN (B)(6) 2011, CHRONIC GASTRITIS IN 2011, MENOMETRORRHAGIA IN 2009, CHLAMYDIAL INFECTION IN 2009, LOOP ELECTROSURGICAL EXCISION PROCEDURE IN 2008, FEMALE GENITAL OPERATION IN 2008, VIRAL TEST POSITIVE IN 2008, PAPILLOMA VIRAL INFECTION (2008MILD DYSPLASIA AND LOOP RESECTION.) IN 2008, ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE IN 2008, SHORT MENSTRUATION IN 2007, IRREGULAR MENSTRUATION IN 2005, PARITY IN 1999, MISCARRIAGE (AFTER 2 MONTHS OF PREGNANCY, NO INTERVENTION) IN 1998, RUPTURED ECTOPIC PREGNANCY IN 1996, SALPINGECTOMY IN 1996, ACUTE PERICARDITIS IN 1995, PARITY IN 1990, CERVICAL CONISATION (TWO SUCCESSIVE CONISATIONS), CERVICAL DYSPLASIA, RECURRENT URINARY TRACT INFECTION, TOBACCO USER (10 TO 15 CIGARETTES/DAY, WEANED FOR 20 YEARS), CERVIX LESION, DYSPLASIA, RETROBULBAR NEURITIS, ECTOPIC PREGNANCY AND CHLAMYDIA TRACHOMATIS INFECTION (PRIOR TO 1996, IGG POSITIVE AND IGA POSITIVE). NO KNOWN ALLERGIES, NO INTOLERANCE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: (B)(6) IN 2011. CONCURRENT CONDITIONS INCLUDED PREMENOPAUSE. ON (B)(6) 2011, THE PATIENT EXPERIENCED MENOMETRORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED COMPLICATION OF DEVICE INSERTION ("ONLY ONE ESSURE PLACED DUE TO RIGHT SALPINGECTOMY IN 1996"). IN (B)(6) 2012, THE PATIENT EXPERIENCED INTERMENSTRUAL BLEEDING ("METRORRHAGIA TWICE A MONTH, AN INCREASE IN THE VOLUME OF THE PERIODS, RECURRENT"). IN 2012, THE PATIENT WAS FOUND TO HAVE UTERINE LEIOMYOMA ("SMALL FIBROMAS/MYOMAS IN UTERUS/ INTERSTITIAL FIBROMA MEASURING 20 MM / FIBROMATOUS MYOMETRIUM") AND EXPERIENCED DYSMENORRHOEA ("ACUTE DYSMENORRHEA / DYSMENORRHOEA THAT LASTS 48 HOURS IN EACH CYCLE, RECURRENT"). ON (B)(6) 2013, THE PATIENT EXPERIENCED PAPILLOMA VIRAL INFECTION ("HIGH-RISK PAPILLOMAVIRUS / HIGH-GRADE PAPILLOMAVIRUS"). IN 2014, THE PATIENT EXPERIENCED DIZZINESS ("PSEUDO DIZZY SENSATION OF A FEW SECONDS / DIZZINESS WHICH CAUSE A FALL IN STAIRS") AND VERTIGO ("PSEUDO VERTIGO"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ASTHENIA ("ASTHENIA") AND BALANCE DISORDER ("BALANCE DISORDERS"). ON (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("WHITISH LEUKORRHEA") AND DYSURIA ("BURNING SENSATION DURING URINATION"). IN 2015, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("SPOTTING") AND FALL ("DIZZINESS WHICH CAUSE A FALL IN STAIRS WITHOUT LOSS OF CONSCIOUSNESS ATTRIBUTED TO A MECHANICAL CAUSE"). IN 2016, THE PATIENT EXPERIENCED DEPRESSED MOOD ("SADNESS, DARK THOUGHTS, RECURRENT"). IN (B)(6) 2016, THE PATIENT EXPERIENCED TENDONITIS ("TENDONITIS OF GLUTEUS MEDIUS MUSCLE / THICKENING OF RIGHT TENDON OF GLUTEUS MEDIUS MUSCLE AND OF RIGHT ILIOTIBIAL TRACT SUGGESTING TENDINITIS OF GLUTEUS MEDIUS MUSCLE / TENDONITIS IN WRISTS, ANKLES AND SHOULDERS"). IN (B)(6) 2017, THE PATIENT EXPERIENCED SENSORIMOTOR DISORDER ("LEFT FOOT SENSORY DISORDERS WITH INTERMITTENT MOTOR DISCOMFORT OF RIGHT HAND"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SUICIDAL IDEATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), URINARY TRACT INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN UPPER (STOMACH PAIN), MYOSITIS (MYOSITIS), NEUROPATHY PERIPHERAL (NEUROPATHY PERIPHERAL), UTERUS PAIN (UTERUS PAIN), MALAISE (MALAISE), DEVICE MATERIAL ISSUE (SERIOUSNESS CRITERION INTERVENTION REQUIRED), IRRITABILITY (IRRITABILITY), HEADACHE (HEADACHES), GAIT DISTURBANCE (GAIT DISTURBANCE), ASCITES (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE POLYP ("ONE SMALL INTRACAVITARY POLYP MEASURING 5 MM"), ADENOMYOSIS ("ADENOMYOSIS / DIFFUSE ADENOMYOSIS"), PAIN ("CHRONIC PAIN / PAIN AT NIGHT"), INTERVERTEBRAL DISC PROTRUSION ("MODERATE PROTUSIVE DISCOPATHY IN L2-L3 AND L3-L4"), INTERVERTEBRAL DISC DISORDER ("CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6"), VERTEBRAL FORAMINAL STENOSIS ("CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6"), MUSCULOSKELETAL PAIN ("MUSCLE AND JOINT PAIN"), UTERINE CERVIX STENOSIS ("CERVICAL STENOSIS"), ABDOMINAL PAIN ("STRONG ABDOMINAL PAIN"), FATIGUE ("VERY STRONG FATIGABILITY / VERY STRONG FATIGUE"), FALLOPIAN TUBE DISORDER ("SMALL INFLAMMATORY REMODELLING IN LEFT TUBE"), VULVOVAGINAL MYCOTIC INFECTION ("VAGINAL MYCOSIS"), PHLEBOLITH ("PHLEBOLITHS"), ABDOMINAL PAIN LOWER ("CRAMPS"), HOT FLUSH ("HOT FLUSHES"), UTERINE INFLAMMATION ("UTERINE INFLAMMATION"), NIGHT SWEATS ("SWEATS AT NIGHT"), LOSS OF LIBIDO ("LOSS OF LIBIDO"), MUSCLE SPASMS ("MUSCLE SPASMS/ ABDOMINAL SPASMS"), VISION BLURRED ("BLURRED VISION"), DRY EYE ("DRY EYES"), BACK PAIN ("PAIN IN BACK"), PAIN IN EXTREMITY ("PAIN IN LEGS"), ARTHRALGIA ("PAIN IN WRISTS, JOINT PAIN, ANKLES, KNEES,"), GASTROINTESTINAL PAIN ("GASTROINTESTINAL PAIN"), DYSPEPSIA ("STOMACH BURNS"), NERVOUS SYSTEM DISORDER ("NEUROLOGICAL DISORDERS"), HYPOAESTHESIA ("NUMBNESS OF UPPER LIMBS"), AMNESIA ("IMMEDIATE MEMORY LOSS / LOSS OF MEMORY"), INSOMNIA ("INSOMNIA"), MIGRAINE ("MIGRAINES"), DYSSTASIA ("DIFFICULTY STANDING"), PALPITATIONS ("HEART PALPITATIONS"), ENDOMETRIAL HYPERPLASIA ("DIAGNOSIS OF SIMPLE ATYPICAL HYPERPLASIA WAS CONFIRMED"), ALLERGY TO METALS ("SKIN REACTION TO EAR JEWELRY - ALLERGY TO NICKEL"), SPINAL OSTEOARTHRITIS ("C5/C6 ON CERVICAL OSTEOARTHRITIS"), MYALGIA ("MUSCLE PAIN"), BURNOUT SYNDROME ("PHYSICAL AND PSYCHOLOGICAL EXHAUSTION") AND MENOPAUSE ("PREMENOPAUSAL"). THE PATIENT WAS TREATED WITH CHLORMADINONE ACETATE (LUTERAN), FOSFOMYCIN TROMETAMOL (MONURIL), MICONAZOLE NITRATE (GYNO-DAKTARIN), SURGERY (ON (B)(6) 2012, HYSTEROSCOPY AND CURETTAGE, ENDOMETRIAL THERMOCOAGULATION WERE PERFORMED AND VAGINAL HYSTERECTOMY AND LEFT SALPINGECTOMY VIA LAPAROSCOPY WERE PERFORMED ON (B)(6) 2018) AND CONIZATION FOR EXTENSIVE MILD JUNCTIONAL HPV DYSPLASIA ON (B)(6) 2014. ESSURE WAS REMOVED ON (B)(6)2018. IN 2017, THE DIZZINESS AND VERTIGO WAS RESOLVING. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENOMETRORRHAGIA, GENITAL HAEMORRHAGE, SUICIDAL IDEATION, URINARY TRACT INFECTION, ASCITES, UTERINE POLYP, ADENOMYOSIS, TENDONITIS, PAIN, INTERVERTEBRAL DISC PROTRUSION, SENSORIMOTOR DISORDER, INTERVERTEBRAL DISC DISORDER, VERTEBRAL FORAMINAL STENOSIS, MUSCULOSKELETAL PAIN, UTERINE CERVIX STENOSIS, ABDOMINAL PAIN, FATIGUE, UTERINE LEIOMYOMA, FALLOPIAN TUBE DISORDER, VULVOVAGINAL MYCOTIC INFECTION, PAPILLOMA VIRAL INFECTION, PHLEBOLITH, ASTHENIA, BALANCE DISORDER, DYSMENORRHOEA, VAGINAL HAEMORRHAGE, FALL, ABDOMINAL PAIN LOWER, HOT FLUSH, UTERINE INFLAMMATION, NIGHT SWEATS, LOSS OF LIBIDO, MUSCLE SPASMS, VISION BLURRED, DRY EYE, BACK PAIN, PAIN IN EXTREMITY, ARTHRALGIA, GASTROINTESTINAL PAIN, DYSPEPSIA, NERVOUS SYSTEM DISORDER, HYPOAESTHESIA, DEPRESSED MOOD, AMNESIA, INSOMNIA, MIGRAINE, DYSSTASIA, VAGINAL DISCHARGE, DYSURIA AND PALPITATIONS WAS RESOLVING AND THE ENDOMETRIAL HYPERPLASIA, INTERMENSTRUAL BLEEDING, ALLERGY TO METALS, SPINAL OSTEOARTHRITIS, MYALGIA, BURNOUT SYNDROME, MENOPAUSE, ABDOMINAL PAIN UPPER, MYOSITIS, NEUROPATHY PERIPHERAL, UTERUS PAIN MALAISE, DEVICE MATERIAL ISSUE, IRRITABILITY, HEADACHE , GAIT DISTURBANCE AND COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ADENOMYOSIS, AMNESIA, ARTHRALGIA, ASCITES, ASTHENIA, BACK PAIN, BALANCE DISORDER, DEPRESSED MOOD, DIZZINESS, DRY EYE, DYSMENORRHOEA, DYSPEPSIA, DYSSTASIA, DYSURIA, FALL, FALLOPIAN TUBE DISORDER, FATIGUE, GASTROINTESTINAL PAIN, GENITAL HAEMORRHAGE, HOT FLUSH, HYPOAESTHESIA, INSOMNIA, INTERVERTEBRAL DISC DISORDER, INTERVERTEBRAL DISC PROTRUSION, LOSS OF LIBIDO, MENOMETRORRHAGIA, MIGRAINE, MUSCLE SPASMS, MUSCULOSKELETAL PAIN, NERVOUS SYSTEM DISORDER, NIGHT SWEATS, PAIN, PAIN IN EXTREMITY, PALPITATIONS, PAPILLOMA VIRAL INFECTION, PELVIC PAIN, PHLEBOLITH, SENSORIMOTOR DISORDER, SUICIDAL IDEATION, TENDONITIS, URINARY TRACT INFECTION, UTERINE CERVIX STENOSIS, UTERINE INFLAMMATION, UTERINE LEIOMYOMA, UTERINE POLYP, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VERTEBRAL FORAMINAL STENOSIS, VISION BLURRED AND VULVOVAGINAL MYCOTIC INFECTION TO BE UNRELATED TO ESSURE. THE REPORTER CONSIDERED ALLERGY TO METALS, BURNOUT SYNDROME, ABDOMINAL PAIN UPPER, MYOSITIS, NEUROPATHY PERIPHERAL, UTERUS PAIN MALAISE, DEVICE MATERIAL ISSUE, IRRITABILITY, HEADACHE , GAIT DISTURBANCE , COMPLICATION OF DEVICE INSERTION, ENDOMETRIAL HYPERPLASIA, INTERMENSTRUAL BLEEDING, MENOPAUSE, MYALGIA, SPINAL OSTEOARTHRITIS AND VERTIGO TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DURING ESSURE INSERTION, THE OSTIA WERE VISIBLE AND ACCESSIBLE. PLACEMENT OF ESSURE WITHOUT INCIDENT USING THE STANDARD PROCEDURE, 4 TRAILING COILS ON THE LEFT. DURATION OF THE PROCEDURE WAS OF 3 MINUTES. IT WAS VERY WELL TOLERATED. WORK UP TO INVESTIGATE POTENTIAL SENSITIVITY TO NICKEL, TITANIUM AND STEEL WAS REQUESTED. ON UNSPECIFIED DATE, SERUM PROTEINS ELECTROPHORESIS FOUND HYPOGAMMAGLOBULINEMIA. LAB DATA ADDED: ON (B)(6) 2012, FSH OF 8,4 IU/L (MENOPAUSE: FROM 26 TO 135),LH OF 6,4 IU/L (MENOPAUSE FROM 7,7 TO 58,5), ESTRADIOL OF 1203 PMOL/L (MENOPAUSE: <505 PMOL/L). FULL BLOOD COUNT ON (B)(6) 2012, (B)(6) 2013 AND ON (B)(6) 2014 WAS NORMAL. CONISATION WAS PERFORMED ON (B)(6) 2014 FOR LOW-GRADE INTRA-EPITHELIAL LESION CONFIRMED BY BIOPSY, PERSISTENT, WITH AN AREA AT THE SCJ. PATIENT CAME BACK FOR CONSULTATION THREE DAYS AFTER CONISATION BECAUSE OF ASTHENIA AND BALANCE DISORDERS. ANTIDEPRESSANT DRUG WAS PRESCRIBED TO THE PATIENT. MEDICAL EXAMINATION OF THE PATIENT BY THE EXPERT FOUND NOTHING REMARKABLE. FOLLOWING VARIOUS QUESTIONS, THE EXPERT REQUESTED SOME EXHIBITS INCLUDING LAB TESTS, AND REPORTED FOR THE SECOND TIME THAT THE EVENTS WERE RELATED TO PRE-MENOPAUSE STATE OF THE PATIENT AS WELL AS SOME DISCLOSED UTERINE DISEASES. THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE GENERAL SYMPTOMS AND THE GYNECOLOGICAL SYMPTOMS REPORTED BY THE PATIENT AND ESSURE. IMPROVEMENT OF THE GENERAL SYMPTOMS IMMEDIATELY AFTER REMOVAL OF ESSURE WAS NOT DIRECTLY RELATED TO ESSURE REMOVAL ACCORDING TO THE EXPERT. PSYCHOLOGICAL REJECTION OF ESSURE STARTED IMMEDIATELY AFTER SEEKING DOCUMENTATION ON INTERNET. THE QUICK IMPROVEMENT OF THE GENERAL SYMPTOMS AFTER REMOVAL EVOKED A NOCEBO EFFECT. IMPROVEMENT OF MENORRHAGIA AND DYSMENORRHEA WAS DIRECTLY RELATED TO THE HYSTERECTOMY. THE PATIENT EXPERIENCED GYNECOLOGICAL DISORDERS WHICH HAD CERTAIN AND DIRECT CAUSAL RELATIONSHIP WITH PRE-MENOPAUSE. THE CONSUMER HAS AN ANTEVERTED UTERUS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BLOOD FOLLICLE STIMULATING HORMONE (IU/L) - ON (B)(6) 2012: 8.4 IU/L. BLOOD IMMUNOGLOBULIN M - ON (B)(6) 2017: 29 IU/ML (NORM: POSITIVE IF UPPER THAN 20 IU/ML).. BLOOD LUTEINISING HORMONE (IU/L) - ON (B)(6) 2012: 6.4 IU/L. COMPUTERISED TOMOGRAM HEAD - ON AN UNKNOWN DATE: WITHOUT CONTRAST SHOWED NOTHING REMARKABLE. GYNAECOLOGICAL EXAMINATION - ON AN UNKNOWN DATE: RESULTS: CERVICAL STENOSIS. HAEMOGLOBIN (G/DL) - ON (B)(6) 2012: 14.1 G/DL. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: PHLEBOLITHS WAS VISIBLE. THE LEFT IMPLANT IS WELL POSITIONED, WITH NO CONTRAST MEDIUM. LEFT TUBE WAS CORRECTLY OBSTRUCTED.. HYSTEROSCOPY - ON (B)(6) 2012: VISUALIZATION OF THREE POLYPS MEASURING ABOUT 55 MM ABOVE THE ISTHMUS, MID-CAVITY AND BELOW THE INTERSTITIAL PORTION OF THE RIGHT FALLOPIAN TUBE. INDICATION FOR HYSTEROSCOPY AND CURETTAGE.. MAGNETIC RESONANCE IMAGING - ON AN UNKNOWN DATE: MILD PROTRUSIVE DISC DISEASE OF L2/L3 AND L3/L4; IN (B)(6) 2016: GLUTEUS MEDIUS TENDONITIS. MAGNETIC RESONANCE IMAGING ABDOMINAL - ON AN UNKNOWN DATE: MODERATE PROTUSIVE DISCOPATHY IN L2-L3 AND L3-L4 AND INTEGRITY OF SACROILIAC JOINTS.; ON (B)(6) 2012: CONFIRMED PRESENCE OF A SMALL POLYP MEASURING 5 MM IN THE POSTERIOR WALL. PRESENCE OF AN INTERSTITIAL FIBROMA MEASURING 20 MM WITH A SUBMUCOUS COMPONENT IN THE POSTERIOR WALL. NO OTHER VISIBLE ABNORMALITIES.; ON (B)(6) 2016: RESULTS: DIFFUSE ADENOMYOSIS AND LAYER OF INTRAPERITONEAL EFFUSION.; ON (B)(6) 2016: DIFFUSE ADENOMYOSIS. MAGNETIC RESONANCE IMAGING HEAD - ON (B)(6) 2017: RESULTS: NO VISIBLE ABNORMALITY IN MEDULLAR AND CEREBRAL. CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6, CERVICAL OSTEOARTHRITIS. MEAN CELL VOLUME (FL) - ON (B)(6) 2012: 102 FL. OESTRADIOL (PMOL/L) - ON (B)(6) 2012: 1203 PMOL/L. PATHOLOGY TEST - ON (B)(6) 2012: HISTOLOGICAL ANALYSIS OF THE MUCOSA CONCLUDES TO A HYPERPLASIA OF THE UTERINE PSEUDOPOLYPOID SECRETORY MUCOSA; ON (B)(6) 2012: FOUND DIFFUSE ENDOMETRIAL HYPERPLASIA.; ON (B)(6) 2013: DIAGNOSIS OF SIMPLE ATYPICAL HYPERPLASIA WAS CONFIRMED; ON (B)(6) 2014: LOW-GRADE SQUAMOUS INTRAEPITHELIAL LESIONS AT THE SCJ AND IN MULTIPLE LOCATIONS. NO HIGH-GRADE DYSPLASTIC LESIONS; ON (B)(6) 2014: SUSPECTED ABNORMALITIES OF MALIGNANCY OF THE CERVIX (PAPILLOMAVIRUS INFECTION). SMEAR CERVIX - ON (B)(6) 2013: ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE.. ULTRASOUND SCAN - ON (B)(6) 2012: RESULTS: ONE SMALL INTRACAVITARY POLYP MEASURING 5 MM; IN (B)(6) 2015: ENDO-VAGINAL PELVIC ULTRASOUND FOUND FIBROMATOUS UTERUS; ON (B)(6) 2016: RESULTS: THICKENING OF RIGHT TENDON OF GLUTEUS MEDIUS MUSCLE AND OF RIGHT ILIOTIBIAL TRACT SUGGESTING TENDINITIS OF GLUTEUS MEDIUS MUSCLE.; ON (B)(6) 2012: UTERINE POLYP AND A 20 MM INTRAMURAL MYOMATOUS NODULE. VIRAL TEST - ON (B)(6) 2013: PRESENCE OF HIGH-RISK PAPILLOMAVIRUS WAS FOUND. LOT NUMBER: 852008 MANUFACTURING DATE: 2011-04 EXPIRATION DATE: 2014-04. 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 29-APR-2022: FOLLOW UP INFORMATION WAS RECEIVED VIA LAWYER: ESSURE INDICATION ADDED: PERMANENT CONTRACEPTION. THE EVENT GENITAL BLEEDING WAS SPECIFIED TO HEAVY MENSTRUAL BLEEDING. EVENT ADDED: STOMACH PAIN, MYOSITIS, NEUROPATHY PERIPHERAL, UTERUS PAIN, MALAISE, DEVICE MATERIAL ISSUE (EXPONENTIAL RATE OF TIN IN THE PATIENT¿S TISSUES), IRRITABILITY, HEADACHES, GAIT DISTURBANCE. 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 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 ('NOT NEGLIGIBLE PELVIC PAIN'), MENOMETRORRHAGIA ('MENORRHAGIA WITH HEMORRHAGIC EPISODES / HEMORRHAGIC MENSTRUATIONS / MENORRHAGIA / FUNCTIONAL MENOMETRORRHAGIA'), ASCITES ('LAYER OF INTRAPERITONEAL EFFUSION'), GENITAL HAEMORRHAGE ('SIGNIFICANT BLEEDING'), SUICIDAL IDEATION ('SUICIDAL THOUGHTS') AND URINARY TRACT INFECTION ('URINARY TRACT INFECTIONS') IN A 44-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852008) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BACK INJURY IN (B)(6) 2011, CHRONIC GASTRITIS IN 2011, MENOMETRORRHAGIA IN 2009, CHLAMYDIAL INFECTION IN 2009, HYSTERECTOMY IN 2008, VIRAL TEST POSITIVE IN 2008, ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE IN 2008, SHORT MENSTRUATION IN 2007, IRREGULAR MENSTRUATION IN 2005, PARITY IN 1999, RUPTURED ECTOPIC PREGNANCY IN 1996, ACUTE PERICARDITIS IN 1995, PARITY IN 1990, CERVICAL CONISATION (TWO SUCCESSIVE CONISATIONS), CERVICAL DYSPLASIA, RECURRENT URINARY TRACT INFECTION, TOBACCO USER, CERVIX LESION, DYSPLASIA AND RETROBULBAR NEURITIS. THE CONSUMER HAS AN ANTEVERTED UTERUS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: JASMINE. CONCURRENT CONDITIONS INCLUDED PREMENOPAUSE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED MENOMETRORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2013, THE PATIENT WAS FOUND TO HAVE UTERINE LEIOMYOMA ("SMALL FIBROMAS/MYOMAS IN UTERUS/ INTERSTITIAL FIBROMA MEASURING 20 MM"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ASTHENIA ("ASTHENIA") AND BALANCE DISORDER ("BALANCE DISORDERS"). ON (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("WHITISH LEUKORRHEA") AND DYSURIA ("BURNING SENSATION DURING URINATION"), 3 YEARS AFTER INSERTION OF ESSURE. IN 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("ACUTE DYSMENORRHEA") AND VAGINAL HAEMORRHAGE ("SPOTTING"). IN (B)(6) 2017, THE PATIENT EXPERIENCED SENSORIMOTOR DISORDER ("LEFT FOOT SENSORY DISORDERS WITH INTERMITTENT MOTOR DISCOMFORT OF RIGHT HAND"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ASCITES (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SUICIDAL IDEATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), URINARY TRACT INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE POLYP ("ONE SMALL INTRACAVITARY POLYP MEASURING 5 MM"), ADENOMYOSIS ("ADENOMYOSIS / DIFFUSE ADENOMYOSIS"), TENDONITIS ("TENDONITIS OF GLUTEUS MEDIUS MUSCLE / THICKENING OF RIGHT TENDON OF GLUTEUS MEDIUS MUSCLE AND OF RIGHT ILIOTIBIAL TRACT SUGGESTING TENDINITIS OF GLUTEUS MEDIUS MUSCLE / TENDONITIS IN WRISTS, ANKLES AND SHOULDERS"), PAIN ("CHRONIC PAIN / PAIN AT NIGHT"), INTERVERTEBRAL DISC PROTRUSION ("MODERATE PROTRUSIVE DISCOPATHY IN L2-L3 AND L3-L4"), INTERVERTEBRAL DISC DISORDER ("CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6"), VERTEBRAL FORAMINAL STENOSIS ("CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6"), MUSCULOSKELETAL PAIN ("MUSCLE AND JOINT PAIN"), UTERINE CERVIX STENOSIS ("CERVICAL STENOSIS"), ABDOMINAL PAIN ("STRONG ABDOMINAL PAIN"), FATIGUE ("VERY STRONG FATIGABILITY / VERY STRONG FATIGUE"), FALLOPIAN TUBE DISORDER ("SMALL INFLAMMATORY REMODELLING IN LEFT TUBE"), VULVOVAGINAL MYCOTIC INFECTION ("VAGINAL MYCOSIS"), PAPILLOMA VIRAL INFECTION ("HIGH-RISK PAPILLOMAVIRUS"), PHLEBOLITH ("PHLEBOLITHS"), DIZZINESS ("DIZZINESS WHICH CAUSE A FALL IN STAIRS"), FALL ("DIZZINESS WHICH CAUSE A FALL IN STAIRS"), ABDOMINAL PAIN LOWER ("CRAMPS"), HOT FLUSH ("HOT FLUSHES"), UTERINE INFLAMMATION ("UTERINE INFLAMMATION"), NIGHT SWEATS ("SWEATS AT NIGHT"), LOSS OF LIBIDO ("LOSS OF LIBIDO"), MUSCLE SPASMS ("MUSCLE SPASMS/ ABDOMINAL SPASMS"), VISION BLURRED ("BLURRED VISION"), DRY EYE ("DRY EYES"), BACK PAIN ("PAIN IN BACK"), PAIN IN EXTREMITY ("PAIN IN LEGS"), ARTHRALGIA ("PAIN IN WRISTS"), GASTROINTESTINAL PAIN ("GASTROINTESTINAL PAIN"), DYSPEPSIA ("STOMACH BURNS"), NERVOUS SYSTEM DISORDER ("NEUROLOGICAL DISORDERS"), HYPOAESTHESIA ("NUMBNESS OF UPPER LIMBS"), DEPRESSED MOOD ("SADNESS"), AMNESIA ("IMMEDIATE MEMORY LOSS"), INSOMNIA ("INSOMNIA"), MIGRAINE ("MIGRAINES"), DYSSTASIA ("DIFFICULTY STANDING") AND PALPITATIONS ("HEART PALPITATIONS"). THE PATIENT WAS TREATED WITH CHLORMADINONE ACETATE (LUTERAN), FOSFOMYCIN TROMETAMOL (MONURIL), MICONAZOLE NITRATE (GYNO-DAKTARIN) AND SURGERY (ON (B)(6) 2012, HYSTEROSCOPY AND CURETTAGE, ENDOMETRIAL THERMOCOAGULATION WERE PERFORMED AND VAGINAL HYSTERECTOMY AND LEFT SALPINGECTOMY VIA LAPAROSCOPY WERE PERFORMED ON (B)(6) 2018). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENOMETRORRHAGIA, ASCITES, GENITAL HAEMORRHAGE, SUICIDAL IDEATION, URINARY TRACT INFECTION, UTERINE POLYP, ADENOMYOSIS, TENDONITIS, PAIN, INTERVERTEBRAL DISC PROTRUSION, SENSORIMOTOR DISORDER, INTERVERTEBRAL DISC DISORDER, VERTEBRAL FORAMINAL STENOSIS, MUSCULOSKELETAL PAIN, UTERINE CERVIX STENOSIS, ABDOMINAL PAIN, FATIGUE, UTERINE LEIOMYOMA, FALLOPIAN TUBE DISORDER, VULVOVAGINAL MYCOTIC INFECTION, PAPILLOMA VIRAL INFECTION, PHLEBOLITH, ASTHENIA, BALANCE DISORDER, DYSMENORRHOEA, VAGINAL HAEMORRHAGE, DIZZINESS, FALL, ABDOMINAL PAIN LOWER, HOT FLUSH, UTERINE INFLAMMATION, NIGHT SWEATS, LOSS OF LIBIDO, MUSCLE SPASMS, VISION BLURRED, DRY EYE, BACK PAIN, PAIN IN EXTREMITY, ARTHRALGIA, GASTROINTESTINAL PAIN, DYSPEPSIA, NERVOUS SYSTEM DISORDER, HYPOAESTHESIA, DEPRESSED MOOD, AMNESIA, INSOMNIA, MIGRAINE, DYSSTASIA, VAGINAL DISCHARGE, DYSURIA AND PALPITATIONS WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ADENOMYOSIS, AMNESIA, ARTHRALGIA, ASCITES, ASTHENIA, BACK PAIN, BALANCE DISORDER, DEPRESSED MOOD, DIZZINESS, DRY EYE, DYSMENORRHOEA, DYSPEPSIA, DYSSTASIA, DYSURIA, FALL, FALLOPIAN TUBE DISORDER, FATIGUE, GASTROINTESTINAL PAIN, GENITAL HAEMORRHAGE, HOT FLUSH, HYPOAESTHESIA, INSOMNIA, INTERVERTEBRAL DISC DISORDER, INTERVERTEBRAL DISC PROTRUSION, LOSS OF LIBIDO, MENOMETRORRHAGIA, MIGRAINE, MUSCLE SPASMS, MUSCULOSKELETAL PAIN, NERVOUS SYSTEM DISORDER, NIGHT SWEATS, PAIN, PAIN IN EXTREMITY, PALPITATIONS, PAPILLOMA VIRAL INFECTION, PELVIC PAIN, PHLEBOLITH, SENSORIMOTOR DISORDER, SUICIDAL IDEATION, TENDONITIS, URINARY TRACT INFECTION, UTERINE CERVIX STENOSIS, UTERINE INFLAMMATION, UTERINE LEIOMYOMA, UTERINE POLYP, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VERTEBRAL FORAMINAL STENOSIS, VISION BLURRED AND VULVOVAGINAL MYCOTIC INFECTION TO BE UNRELATED TO ESSURE. THE REPORTER COMMENTED: DURING ESSURE INSERTION, THE OSTIA WERE VISIBLE AND ACCESSIBLE. PLACEMENT OF ESSURE WITHOUT INCIDENT USING THE STANDARD PROCEDURE, 4 TRAILING COILS ON THE LEFT. DURATION OF THE PROCEDURE WAS OF 3 MINUTES. IT WAS VERY WELL TOLERATED. WORK UP TO INVESTIGATE POTENTIAL SENSITIVITY TO NICKEL, TITANIUM AND STEEL WAS REQUESTED. ON UNSPECIFIED DATE, SERUM PROTEINS ELECTROPHORESIS FOUND HYPOGAMMAGLOBULINEMIA. LAB DATA ADDED: ON (B)(6) 2012, FSH OF 8,4 IU/L (MENOPAUSE: FROM 26 TO 135),LH OF 6,4 IU/L (MENOPAUSE FROM 7,7 TO 58,5), ESTRADIOL OF 1203 PMOL/L (MENOPAUSE: <505 PMOL/L). FULL BLOOD COUNT ON (B)(6) 2012, (B)(6) 2013 AND ON (B)(6) 2014 WAS NORMAL. CONISATION WAS PERFORMED ON (B)(6) 2014 FOR LOW-GRADE INTRA-EPITHELIAL LESION CONFIRMED BY BIOPSY, PERSISTENT, WITH AN AREA AT THE SCJ. PATIENT CAME BACK FOR CONSULTATION THREE DAYS AFTER CONISATION BECAUSE OF ASTHENIA AND BALANCE DISORDERS. ANTIDEPRESSANT DRUG WAS PRESCRIBED TO THE PATIENT. MEDICAL EXAMINATION OF THE PATIENT BY THE EXPERT FOUND NOTHING REMARKABLE. FOLLOWING VARIOUS QUESTIONS, THE EXPERT REQUESTED SOME EXHIBITS INCLUDING LAB TESTS, AND REPORTED FOR THE SECOND TIME THAT THE EVENTS WERE RELATED TO PRE-MENOPAUSE STATE OF THE PATIENT AS WELL AS SOME DISCLOSED UTERINE DISEASES. THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE GENERAL SYMPTOMS AND THE GYNECOLOGICAL SYMPTOMS REPORTED BY THE PATIENT AND ESSURE. IMPROVEMENT OF THE GENERAL SYMPTOMS IMMEDIATELY AFTER REMOVAL OF ESSURE WAS NOT DIRECTLY RELATED TO ESSURE REMOVAL ACCORDING TO THE EXPERT. PSYCHOLOGICAL REJECTION OF ESSURE STARTED IMMEDIATELY AFTER SEEKING DOCUMENTATION ON INTERNET. THE QUICK IMPROVEMENT OF THE GENERAL SYMPTOMS AFTER REMOVAL EVOKED A NOCEBO EFFECT. IMPROVEMENT OF MENORRHAGIA AND DYSMENORRHEA WAS DIRECTLY RELATED TO THE HYSTERECTOMY. THE PATIENT EXPERIENCED GYNECOLOGICAL DISORDERS WHICH HAD CERTAIN AND DIRECT CAUSAL RELATIONSHIP WITH PRE-MENOPAUSE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BLOOD FOLLICLE STIMULATING HORMONE (IU/L) - ON (B)(6) 2012: 8.4 IU/L. BLOOD IMMUNOGLOBULIN M - ON (B)(6) 2017: 29 IU/ML (NORM: POSITIVE IF UPPER THAN 20 IU/ML).. BLOOD LUTEINISING HORMONE (IU/L) - ON (B)(6) 2012: 6.4 IU/L. COMPUTERISED TOMOGRAM HEAD - ON AN UNKNOWN DATE: WITHOUT CONTRAST SHOWED NOTHING REMARKABLE. GYNAECOLOGICAL EXAMINATION - ON AN UNKNOWN DATE: RESULTS: CERVICAL STENOSIS. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: PHLEBOLITHS WAS VISIBLE. THE LEFT IMPLANT IS WELL POSITIONED, WITH NO CONTRAST MEDIUM. LEFT TUBE WAS CORRECTLY OBSTRUCTED.. HYSTEROSCOPY - ON (B)(6) 2012: VISUALIZATION OF THREE POLYPS MEASURING ABOUT 55 MM ABOVE THE ISTHMUS, MID-CAVITY AND BELOW THE INTERSTITIAL PORTION OF THE RIGHT FALLOPIAN TUBE. INDICATION FOR HYSTEROSCOPY AND CURETTAGE.. NUCLEAR MAGNETIC RESONANCE IMAGING ABDOMINAL - ON AN UNKNOWN DATE: MODERATE PROTRUSIVE DISCOPATHY IN L2-L3 AND L3-L4 AND INTEGRITY OF SACROILIAC JOINTS.; ON (B)(6) 2012: CONFIRMED PRESENCE OF A SMALL POLYP MEASURING 5 MM IN THE POSTERIOR WALL. PRESENCE OF AN INTERSTITIAL FIBROMA MEASURING 20 MM WITH A SUBMUCOUS COMPONENT IN THE POSTERIOR WALL. NO OTHER VISIBLE ABNORMALITIES.; ON (B)(6) 2016: RESULTS: DIFFUSE ADENOMYOSIS AND LAYER OF INTRAPERITONEAL EFFUSION.; ON (B)(6) 2016: DIFFUSE ADENOMYOSIS. NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN - ON AN UNKNOWN DATE: RESULTS: NO VISIBLE ABNORMALITY IN MEDULLAR AND CEREBRAL. CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6.. OESTRADIOL (PMOL/L) - ON (B)(6) 2012: 1203 PMOL/L. PATHOLOGY TEST - ON (B)(6) 2012: FOUND DIFFUSE ENDOMETRIAL HYPERPLASIA.; ON (B)(6) 2014: LOW-GRADE SQUAMOUS INTRAEPITHELIAL LESIONS AT THE SCJ AND IN MULTIPLE LOCATIONS. NO HIGH-GRADE DYSPLASTIC LESIONS.. SMEAR CERVIX - ON (B)(6) 2013: ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE.. ULTRASOUND SCAN - ON (B)(6) 2012: RESULTS: ONE SMALL INTRACAVITARY POLYP MEASURING 5 MM; ON (B)(6) 2016: RESULTS: THICKENING OF RIGHT TENDON OF GLUTEUS MEDIUS MUSCLE AND OF RIGHT ILIOTIBIAL TRACT SUGGESTING TENDINITIS OF GLUTEUS MEDIUS MUSCLE. VIRAL TEST - ON (B)(6) 2013: PRESENCE OF HIGH-RISK PAPILLOMAVIRUS WAS FOUND. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-JUN-2019: NEW ADVERSE EVENT (HEART PALPITATIONS); CAUSALITY ASSESSMENT BETWEEN THE EVENTS AND ESSURE (UNRELATED); AND OUTCOME OF EVENTS (IMPROVING). 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
BAYER CASE NUMBER: (B)(4) NOT NEGLIGIBLE PELVIC PAIN [PELVIC PAIN FEMALE], EXPONENTIAL RATE OF TIN IN THE PATIENT¿S TISSUES [DEVICE MATERIAL FRAGMENTATION], MENORRHAGIA WITH HEMORRHAGIC EPISODES / HEMORRHAGIC MENSTRUATIONS / MENORRHAGIA +++/ FUNCTIONAL MENOMETRORRHAGIA [MENOMETRORRHAGIA] , SIGNIFICANT BLEEDING, HEAVY MENSTRUAL BLEEDING [HEAVY MENSTRUAL BLEEDING] , SUICIDAL THOUGHTS [SUICIDAL IDEATION]. URINARY TRACT INFECTIONS [RECURRENT URINARY TRACT INFECTION]. LAYER OF INTRAPERITONEAL EFFUSION [PERITONEAL EFFUSION] . ONE SMALL INTRACAVITARY POLYP MEASURING 5 MM [UTERINE POLYP] . ADENOMYOSIS / DIFFUSE ADENOMYOSIS [ADENOMYOSIS] . TENDONITIS OF GLUTEUS MEDIUS MUSCLE / THICKENING OF RIGHT TENDON OF GLUTEUS MEDIUS MUSCLE AND OF RIGHT ILIOTIBIAL TRACT SUGGESTING TENDINITIS OF GLUTEUS MEDIUS MUSCLE / TENDONITIS IN WRISTS, ANKLES AND SHOULDERS [TENDONITIS] . CHRONIC PAIN / PAIN AT NIGHT [CHRONIC PAIN] . MODERATE PROTUSIVE DISCOPATHY IN L2-L3 AND L3-L4 [PROLAPSED LUMBAR DISC]. LEFT FOOT SENSORY DISORDERS WITH INTERMITTENT MOTOR DISCOMFORT OF RIGHT HAND [SENSORIMOTOR DISORDER] . CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6 [CERVICAL DISCOPATHY] . CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6 [CERVICAL FORAMINAL STENOSIS] . MUSCLE AND JOINT PAIN [ARTHROMYALGIA] . CERVICAL STENOSIS [UTERINE CERVIX STENOSIS] . STRONG ABDOMINAL PAIN [ABDOMINAL PAIN] . VERY STRONG FATIGABILITY / VERY STRONG FATIGUE [FATIGUE EXTREME] . SMALL FIBROMAS/MYOMAS IN UTERUS/ INTERSTITIAL FIBROMA MEASURING 20 MM / FIBROMATOUS MYOMETRIUM [UTERINE FIBROMYOMA] . SMALL INFLAMMATORY REMODELLING IN LEFT TUBE [FALLOPIAN TUBE DISORDER] . VAGINAL MYCOSIS [VAGINAL MYCOSIS]. HIGH-RISK PAPILLOMAVIRUS / HIGH-GRADE PAPILLOMAVIRUS [PAPILLOMA VIRAL INFECTION] . PHLEBOLITHS [PHLEBOLITH] . ASTHENIA [ASTHENIA] . BALANCE DISORDERS [BALANCE DISORDER] . ACUTE DYSMENORRHEA / DYSMENORRHOEA THAT LASTS 48 HOURS IN EACH CYCLE, RECURRENT [DYSMENORRHEA] . SPOTTING [PER VAGINAL BLEEDING] . PSEUDO DIZZY SENSATION OF A FEW SECONDS / DIZZINESS WHICH CAUSE A FALL IN STAIRS [DIZZINESS] DIZZINESS WHICH CAUSE A FALL IN STAIRS WITHOUT LOSS OF CONSCIOUSNESS ATTRIBUTED TO A MECHANICAL CAUSE [FALL] CRAMPS [CRAMP IN LOWER ABDOMEN] HOT FLUSHES [HOT FLUSHES] UTERINE INFLAMMATION [UTERINE INFLAMMATION] SWEATS AT NIGHT [NIGHT SWEAT] LOSS OF LIBIDO [LOSS OF LIBIDO] MUSCLE SPASMS/ ABDOMINAL SPASMS [MUSCLE SPASMS] BLURRED VISION [BLURRED VISION] DRY EYES [DRY EYES] PAIN IN BACK [BACK PAIN] PAIN IN LEGS [PAINS IN LEGS] PAIN IN WRISTS, JOINT PAIN, ANKLES, KNEES, [ARTHRALGIA MULTIPLE] GASTROINTESTINAL PAIN [GASTROINTESTINAL PAIN] STOMACH BURNS [STOMACH BURNING SENSATION OF] NEUROLOGICAL DISORDERS [NEUROLOGIC DISORDER NOS] NUMBNESS OF UPPER LIMBS [NUMBNESS OF UPPER EXTREMITIES] SADNESS, DARK THOUGHTS, RECURRENT [DEPRESSED MOOD] IMMEDIATE MEMORY LOSS / LOSS OF MEMORY [SHORT-TERM MEMORY LOSS] INSOMNIA [INSOMNIA] MIGRAINES [MIGRAINE] DIFFICULTY STANDING [DIFFICULTY IN STANDING] WHITISH LEUKORRHEA [LEUKORRHEA] BURNING SENSATION DURING URINATION [BURNING MICTURITION] HEART PALPITATIONS [PALPITATIONS] DIAGNOSIS OF SIMPLE ATYPICAL HYPERPLASIA WAS CONFIRMED [ATYPICAL HYPERPLASIA OF ENDOMETRIUM] METRORRHAGIA TWICE A MONTH, AN INCREASE IN THE VOLUME OF THE PERIODS, RECURRENT [METRORRHAGIA] SKIN REACTION TO EAR JEWELRY - ALLERGY TO NICKEL [NICKEL ALLERGY] C5/C6 ON CERVICAL OSTEOARTHRITIS [OSTEOARTHRITIS OF CERVICAL SPINE] MUSCLE PAIN [MUSCLE PAIN] PSEUDO VERTIGO [VERTIGO] PHYSICAL AND PSYCHOLOGICAL EXHAUSTION [BURN-OUT SYNDROME] PREMENOPAUSAL [PREMENOPAUSE] ONLY ONE ESSURE PLACED DUE TO RIGHT SALPINGECTOMY IN 1996 [DEVICE INSERTION FAILED] STOMACH PAIN [STOMACH PAIN] RANDOM MUSCLE INFLAMMATION [MUSCLE INFLAMMATION] NEUROLOGI PROBLEMS WITH LOSS OF ABILITY TO USE OF LEFT HAND [NEUROPATHY PERIPHERAL] UTERUS SENSITIVE TO TOUCH, UTERINE PAIN [UTERINE PAIN] MALAISE [MALAISE] IRRITABILITY [IRRITABILITY] HEADACHES [HEADACHE] DIFFICULTY WALKING [DIFFICULTY IN WALKING] MUSCULAR INFLAMMATION [MUSCLE INFLAMMATION] SHE HAD SICK LEAVE [SICK LEAVE] SHE PRESENTED UNTREATED DEPRESSIVE BEHAVIOR. [DEPRESSIVE DISORDER] CASE NARRATIVE: THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("NOT NEGLIGIBLE PELVIC PAIN"), MENOMETRORRHAGIA ("MENORRHAGIA WITH HEMORRHAGIC EPISODES / HEMORRHAGIC MENSTRUATIONS / MENORRHAGIA +++/ FUNCTIONAL MENOMETRORRHAGIA"), HEAVY MENSTRUAL BLEEDING ("SIGNIFICANT BLEEDING, HEAVY MENSTRUAL BLEEDING"), SUICIDAL IDEATION ("SUICIDAL THOUGHTS"), URINARY TRACT INFECTION ("URINARY TRACT INFECTIONS") AND ASCITES ("LAYER OF INTRAPERITONEAL EFFUSION") IN A 41 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 852008) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MATERIAL FRAGMENTATION ("EXPONENTIAL RATE OF TIN IN THE PATIENT¿S TISSUES") AND DEVICE INSERTION FAILED ("ONLY ONE ESSURE PLACED DUE TO RIGHT SALPINGECTOMY IN 1996" ON (B)(6) 2011). THE PATIENT HAD A MEDICAL HISTORY OF BACK INJURY AND CHRONIC GASTRITIS IN 2011, CHLAMYDIAL INFECTION AND MENOMETRORRHAGIA IN 2009, LOOP ELECTROSURGICAL EXCISION PROCEDURE, FEMALE GENITAL OPERATION, ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE, PAPILLOMA VIRAL INFECTION (2008 MILD DYSPLASIA AND LOOP RESECTION.) AND VIRAL TEST POSITIVE IN 2008, SHORT MENSTRUATION IN 2007, IRREGULAR MENSTRUATION IN 2005, PARITY IN 1999, MISCARRIAGE (AFTER 2 MONTHS OF PREGNANCY, NO INTERVENTION) IN 1998, RUPTURED ECTOPIC PREGNANCY (RIGHT-SIDED SALPINGECTOMY) AND SALPINGECTOMY (RIGHT SIDE) IN 1996, ACUTE PERICARDITIS IN 1995, PARITY IN 1990 AND CHLAMYDIA TRACHOMATIS INFECTION (PRIOR TO 1996, IGG POSITIVE AND IGA POSITIVE), ECTOPIC PREGNANCY, RETROBULBAR NEURITIS, DYSPLASIA, CERVIX LESION, CERVICAL DYSPLASIA, TOBACCO USER (10 TO 15 CIGARETTES/DAY, WEANED FOR 20 YEARS), RECURRENT URINARY TRACT INFECTION AND CERVICAL CONISATION (TWO SUCCESSIVE CONISATIONS). NO KNOWN ALLERGIES, NO INTOLERANCE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: JASMINE [AZELASTINE HYDROCHLORIDE]. CONCURRENT CONDITIONS WERE LISTED AS ADENOMYOSIS AND PREMENOPAUSE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011 SHE EXPERIENCED MENOMETRORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED). IN (B)(6) 2012 SHE EXPERIENCED INTERMENSTRUAL BLEEDING ("METRORRHAGIA TWICE A MONTH, AN INCREASE IN THE VOLUME OF THE PERIODS, RECURRENT"). IN 2012 SHE EXPERIENCED DYSMENORRHOEA ("ACUTE DYSMENORRHEA / DYSMENORRHOEA THAT LASTS 48 HOURS IN EACH CYCLE, RECURRENT") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("SMALL FIBROMAS/MYOMAS IN UTERUS/ INTERSTITIAL FIBROMA MEASURING 20 MM / FIBROMATOUS MYOMETRIUM"). ON (B)(6) 2013 SHE EXPERIENCED PAPILLOMA VIRAL INFECTION ("HIGH-RISK PAPILLOMAVIRUS / HIGH-GRADE PAPILLOMAVIRUS"). IN (B)(6) 2014 SHE EXPERIENCED ASTHENIA ("ASTHENIA") AND BALANCE DISORDER ("BALANCE DISORDERS"). ON (B)(6) 2014 SHE EXPERIENCED VAGINAL DISCHARGE ("WHITISH LEUKORRHEA") AND DYSURIA ("BURNING SENSATION DURING URINATION"). IN 2014 SHE EXPERIENCED DIZZINESS ("PSEUDO DIZZY SENSATION OF A FEW SECONDS / DIZZINESS WHICH CAUSE A FALL IN STAIRS") AND VERTIGO ("PSEUDO VERTIGO"). IN 2015 SHE EXPERIENCED VAGINAL HAEMORRHAGE ("SPOTTING") AND FALL ("DIZZINESS WHICH CAUSE A FALL IN STAIRS WITHOUT LOSS OF CONSCIOUSNESS ATTRIBUTED TO A MECHANICAL CAUSE"). IN (B)(6) 2016 SHE EXPERIENCED TENDONITIS ("TENDONITIS OF GLUTEUS MEDIUS MUSCLE / THICKENING OF RIGHT TENDON OF GLUTEUS MEDIUS MUSCLE AND OF RIGHT ILIOTIBIAL TRACT SUGGESTING TENDINITIS OF GLUTEUS MEDIUS MUSCLE / TENDONITIS IN WRISTS, ANKLES AND SHOULDERS"). IN 2016 SHE EXPERIENCED DEPRESSED MOOD ("SADNESS, DARK THOUGHTS, RECURRENT"). IN (B)(6) 2017 SHE EXPERIENCED SENSORIMOTOR DISORDER ("LEFT FOOT SENSORY DISORDERS WITH INTERMITTENT MOTOR DISCOMFORT OF RIGHT HAND"). ESSURE WAS REMOVED ON (B)(6) 2018. ON UNKNOWN DATE SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED), HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), SUICIDAL IDEATION (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), URINARY TRACT INFECTION (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), ASCITES (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), UTERINE POLYP ("ONE SMALL INTRACAVITARY POLYP MEASURING 5 MM"), ADENOMYOSIS ("ADENOMYOSIS / DIFFUSE ADENOMYOSIS"), PAIN ("CHRONIC PAIN / PAIN AT NIGHT"), INTERVERTEBRAL DISC PROTRUSION ("MODERATE PROTUSIVE DISCOPATHY IN L2-L3 AND L3-L4"), INTERVERTEBRAL DISC DISORDER ("CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6"), VERTEBRAL FORAMINAL STENOSIS ("CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6"), ARTHROMYALGIA ("MUSCLE AND JOINT PAIN"), UTERINE CERVIX STENOSIS ("CERVICAL STENOSIS"), ABDOMINAL PAIN ("STRONG ABDOMINAL PAIN"), FATIGUE ("VERY STRONG FATIGABILITY / VERY STRONG FATIGUE"), FALLOPIAN TUBE DISORDER ("SMALL INFLAMMATORY REMODELLING IN LEFT TUBE"), VULVOVAGINAL MYCOTIC INFECTION ("VAGINAL MYCOSIS"), PHLEBOLITH ("PHLEBOLITHS"), ABDOMINAL PAIN LOWER ("CRAMPS"), HOT FLUSH ("HOT FLUSHES"), UTERINE INFLAMMATION ("UTERINE INFLAMMATION"), NIGHT SWEATS ("SWEATS AT NIGHT"), LOSS OF LIBIDO ("LOSS OF LIBIDO"), MUSCLE SPASMS ("MUSCLE SPASMS/ ABDOMINAL SPASMS"), VISION BLURRED ("BLURRED VISION"), DRY EYE ("DRY EYES"), BACK PAIN ("PAIN IN BACK"), PAIN IN EXTREMITY ("PAIN IN LEGS"), ARTHRALGIA MULTIPLE ("PAIN IN WRISTS, JOINT PAIN, ANKLES, KNEES,"), GASTROINTESTINAL PAIN ("GASTROINTESTINAL PAIN"), DYSPEPSIA ("STOMACH BURNS"), NERVOUS SYSTEM DISORDER ("NEUROLOGICAL DISORDERS"), HYPOAESTHESIA ("NUMBNESS OF UPPER LIMBS"), AMNESIA ("IMMEDIATE MEMORY LOSS / LOSS OF MEMORY"), INSOMNIA ("INSOMNIA"), MIGRAINE ("MIGRAINES"), DYSSTASIA ("DIFFICULTY STANDING"), PALPITATIONS ("HEART PALPITATIONS"), ENDOMETRIAL HYPERPLASIA WITH CELLULAR ATYPIA ("DIAGNOSIS OF SIMPLE ATYPICAL HYPERPLASIA WAS CONFIRMED"), ALLERGY TO METALS ("SKIN REACTION TO EAR JEWELRY - ALLERGY TO NICKEL"), SPINAL OSTEOARTHRITIS ("C5/C6 ON CERVICAL OSTEOARTHRITIS"), MYALGIA ("MUSCLE PAIN"), BURNOUT SYNDROME ("PHYSICAL AND PSYCHOLOGICAL EXHAUSTION"), MENOPAUSE ("PREMENOPAUSAL"), ABDOMINAL PAIN UPPER ("STOMACH PAIN"), A FIRST EPISODE OF MYOSITIS ("RANDOM MUSCLE INFLAMMATION"), NEUROPATHY PERIPHERAL ("NEUROLOGI PROBLEMS WITH LOSS OF ABILITY TO USE OF LEFT HAND"), UTERINE PAIN ("UTERUS SENSITIVE TO TOUCH, UTERINE PAIN"), MALAISE ("MALAISE"), IRRITABILITY ("IRRITABILITY"), HEADACHE ("HEADACHES"), GAIT DISTURBANCE ("DIFFICULTY WALKING"), A SECOND EPISODE OF MYOSITIS ("MUSCULAR INFLAMMATION"), SICK LEAVE ("SHE HAD SICK LEAVE") AND DEPRESSION ("SHE PRESENTED UNTREATED DEPRESSIVE BEHAVIOR."). THE PATIENT WAS TREATED WITH MONURIL (FOSFOMYCIN TROMETAMOL), GYNO-DAKTARIN (MICONAZOLE NITRATE) AND LUTERAN (CHLORMADINONE ACETATE) AS WELL AS SURGERY (VAGINAL HYSTERECTOMY AND LEFT SALPINGECTOMY VIA LAPAROSCOPY WERE PERFORMED ON (B)(6) 2018 AND ON (B)(6 )2012, HYSTEROSCOPY AND CURETTAGE, ENDOMETRIAL THERMOCOAGULATION WERE PERFORMED) AND NON-DRUG THERAPY (CONIZATION FOR EXTENSIVE MILD JUNCTIONAL HPV DYSPLASIA ON (B)(6) 2014). IN 2017, THE DIZZINESS WAS RESOLVING AND THE VERTIGO HAD RESOLVED. AT THE TIME OF THE REPORT, THE MENOMETRORRHAGIA, ASCITES, UTERINE POLYP, ADENOMYOSIS, TENDONITIS, PAIN, INTERVERTEBRAL DISC PROTRUSION, SENSORIMOTOR DISORDER, INTERVERTEBRAL DISC DISORDER, VERTEBRAL FORAMINAL STENOSIS, ARTHROMYALGIA, UTERINE CERVIX STENOSIS, ABDOMINAL PAIN, UTERINE LEIOMYOMA, FALLOPIAN TUBE DISORDER, VULVOVAGINAL MYCOTIC INFECTION, PAPILLOMA VIRAL INFECTION, PHLEBOLITH, ASTHENIA, BALANCE DISORDER, DYSMENORRHOEA, VAGINAL HAEMORRHAGE, FALL, ABDOMINAL PAIN LOWER, HOT FLUSH, UTERINE INFLAMMATION, NIGHT SWEATS, LOSS OF LIBIDO, MUSCLE SPASMS, VISION BLURRED, DRY EYE, GASTROINTESTINAL PAIN, DYSPEPSIA, HYPOAESTHESIA, DEPRESSED MOOD, INSOMNIA, MIGRAINE, DYSSTASIA, VAGINAL DISCHARGE AND DYSURIA WERE RESOLVING AND THE PELVIC PAIN, HEAVY MENSTRUAL BLEEDING, SUICIDAL IDEATION, URINARY TRACT INFECTION, FATIGUE, BACK PAIN, PAIN IN EXTREMITY, ARTHRALGIA MULTIPLE, NERVOUS SYSTEM DISORDER, AMNESIA, PALPITATIONS AND LATEST EPISODE OF MYOSITIS HAD RESOLVED. THE OUTCOMES FOR ENDOMETRIAL HYPERPLASIA WITH CELLULAR ATYPIA, INTERMENSTRUAL BLEEDING, ALLERGY TO METALS, SPINAL OSTEOARTHRITIS, MYALGIA, BURNOUT SYNDROME, MENOPAUSE, ABDOMINAL PAIN UPPER, NEUROPATHY PERIPHERAL, UTERINE PAIN, MALAISE, IRRITABILITY, HEADACHE, GAIT DISTURBANCE, SICK LEAVE AND DEPRESSION WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN UPPER, ALLERGY TO METALS, BURNOUT SYNDROME, DEPRESSION, ENDOMETRIAL HYPERPLASIA WITH CELLULAR ATYPIA, GAIT DISTURBANCE, HEADACHE, INTERMENSTRUAL BLEEDING, IRRITABILITY, MALAISE, MENOPAUSE, MYALGIA, THE FIRST EPISODE OF MYOSITIS, THE SECOND EPISODE OF MYOSITIS, NEUROPATHY PERIPHERAL, SICK LEAVE, SPINAL OSTEOARTHRITIS, UTERINE PAIN AND VERTIGO TO BE RELATED TO ESSURE ADMINISTRATION BUT SAW NO CAUSAL RELATIONSHIP BETWEEN MENOMETRORRHAGIA, UTERINE POLYP, ASCITES, ADENOMYOSIS, TENDONITIS, PAIN, INTERVERTEBRAL DISC PROTRUSION, SENSORIMOTOR DISORDER, INTERVERTEBRAL DISC DISORDER, ARTHROMYALGIA, PELVIC PAIN, UTERINE CERVIX STENOSIS, ABDOMINAL PAIN, FATIGUE, UTERINE LEIOMYOMA, FALLOPIAN TUBE DISORDER, VERTEBRAL FORAMINAL STENOSIS, FALL, VULVOVAGINAL MYCOTIC INFECTION, PAPILLOMA VIRAL INFECTION, PHLEBOLITH, ASTHENIA, BALANCE DISORDER, VAGINAL DISCHARGE, DYSURIA, DYSMENORRHOEA, VAGINAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, HOT FLUSH, UTERINE INFLAMMATION, URINARY TRACT INFECTION, HEAVY MENSTRUAL BLEEDING, NIGHT SWEATS, LOSS OF LIBIDO, MUSCLE SPASMS, VISION BLURRED, DRY EYE, BACK PAIN, PAIN IN EXTREMITY, ARTHRALGIA MULTIPLE, GASTROINTESTINAL PAIN, DYSPEPSIA, NERVOUS SYSTEM DISORDER, HYPOAESTHESIA, DEPRESSED MOOD, SUICIDAL IDEATION, AMNESIA, INSOMNIA, MIGRAINE, DYSSTASIA, DIZZINESS OR PALPITATIONS AND ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION IN LEFT TUBE, OSTIA VISIBLE AND ACCESSIBLE. PLACEMENT WITHOUT INCIDENT ON STANDARD PROCEDURE, 4 TRAILING COILS ON THE LEFT. DURATION 3 MINUTES, VERY WELL TOLERATED. WORK UP TO INVESTIGATE POTENTIAL SENSITIVITY TO NICKEL, TITANIUM AND STEEL WAS REQUESTED. ON UNSPECIFIED DATE, SERUM PROTEINS ELECTROPHORESIS FOUND HYPOGAMMAGLOBULINEMIA. LAB DATA ADDED: ON (B)(6) 2012, FSH OF 8,4 IU/L (MENOPAUSE: FROM 26 TO 135),LH OF 6,4 IU/L (MENOPAUSE FROM 7,7 TO 58,5), ESTRADIOL OF 1203 PMOL/L (MENOPAUSE: <505 PMOL/L). FULL BLOOD COUNT ON (B)(6) 2012, (B)(6) 2013 AND ON (B)(6) 2014 WAS NORMAL. CONISATION WAS PERFORMED ON (B)(6) 2014 FOR LOW-GRADE INTRA-EPITHELIAL LESION CONFIRMED BY BIOPSY, PERSISTENT, WITH AN AREA AT THE SCJ. PATIENT CAME BACK FOR CONSULTATION THREE DAYS AFTER CONISATION BECAUSE OF ASTHENIA AND BALANCE DISORDERS. ANTIDEPRESSANT DRUG WAS PRESCRIBED TO THE PATIENT. MEDICAL EXAMINATION OF PATIENT BY EXPERT FOUND NOTHING REMARKABLE. FOLLOWING VARIOUS QUESTIONS, EXPERT REQUESTED SOME EXHIBITS INCLUDING LAB TESTS, AND REPORTED FOR SECOND TIME THE EVENTS WERE RELATED TO PRE-MENOPAUSE STATE OF PATIENT AS WELL AS SOME DISCLOSED UTERINE DISEASES. NO CAUSAL RELATIONSHIP BETWEEN THE GENERAL SYMPTOMS AND THE GYNECOLOGICAL SYMPTOMS REPORTED BY THE PATIENT AND THE ESSURE. IMPROVEMENT OF THE GENERAL SYMPTOMS IMMEDIATELY AFTER REMOVAL OF ESSURE WAS NOT DIRECTLY RELATED TO ESSURE REMOVAL ACCORDING TO THE EXPERT. PSYCHOLOGICAL REJECTION OF ESSURE STARTED IMMEDIATELY AFTER SEEKING DOCUMENTATION ON INTERNET. THE QUICK IMPROVEMENT OF THE GENERAL SYMPTOMS AFTER REMOVAL EVOKED A NOCEBO EFFECT. IMPROVEMENT OF MENORRHAGIA AND DYSMENORRHEA WAS DIRECTLY RELATED TO THE HYSTERECTOMY. GYNECOLOGICAL DISORDERS WHICH HAD CERTAIN AND DIRECT CAUSAL RELATIONSHIP WITH PRE-MENOPAUSE. ANTEVERTED UTERUS. ESSURE INSERTION IN 2011. COMPLICATIONS APPEARED SHORTLY AFTER, AND THEY BECAME INCREASINGLY SERIOUS AND NUMEROUS, WITH THE IMPLANT REMOVED IN 2018. THE EXPERT CONSIDERED THAT THE SYMPTOMS REPORTED BY THE PATIENT CORRESPONDED TO DISABLING FUNCTIONAL DISORDERS OF PSYCHOGENIC ORIGIN, WITH DEPRESSIVE AND CONVERSION ELEMENTS. ACCORDING TO THE EXPERT, THE DAMAGES DIRECTLY RELATED TO ESSURE WERE NIL REGARDING THE ALLEGED GENERAL AND GYNECOLOGICAL SYMPTOMS ACCORDING TO THE EXPERT, THE DISAPPEARANCE OF SYMPTOMS AT THE TIME OF THE IMPLANT REMOVAL COULD NOT BE EXPLAINED BY THE SIMPLE REMOVAL OF THE IMPLANT BUT ONLY BY THE HYSTERECTOMY THAT PATIENT UNDERWENT IN (B)(6) 2018. SYMPTOMS WERE FAR FROM EXCLUSIVELY GYNECOLOGICAL BUT WOULD BE RELATED TO A POISONING OF THE BODY BY METAL RELEASES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [BLOOD FOLLICLE STIMULATING HORMONE] ON (B)(6)2012: 8.4 IU/L [BLOOD IMMUNOGLOBULIN M] ON (B)(6) 2017: 29 IU/ML (NORM: POSITIVE IF UPPER THAN 20 IU/ML). [BLOOD LUTEINISING HORMONE] ON (B)(6)2012: 6.4 IU/L [COMPUTERISED TOMOGRAM HEAD] (DATE UNKNOWN): WITHOUT CONTRAST SHOWED NOTHING REMARKABLE. [GYNAECOLOGICAL EXAMINATION] (DATE UNKNOWN): RESULTS: CERVICAL STENOSIS [HAEMOGLOBIN] ON (B)(6)2012: 14.1 G/DL. [HYSTEROSALPINGOGRAM] ON (B)(6) 2011: PHLEBOLITHS WAS VISIBLE. THE LEFT IMPLANT IS WELL POSITIONED, WITH NO CONTRAST MEDIUM. LEFT TUBE WAS CORRECTLY OBSTRUCTED. [HYSTEROSCOPY] ON (B)(6)2012: VISUALIZATION OF THREE POLYPS MEASURING ABOUT 55 MM ABOVE THE ISTHMUS, MID-CAVITY AND BELOW THE INTERSTITIAL PORTION OF THE RIGHT FALLOPIAN TUBE. INDICATION FOR HYSTEROSCOPY AND CURETTAGE. [MAGNETIC RESONANCE IMAGING] IN (B)(6) 2016: GLUTEUS MEDIUS TENDONITIS; (DATE UNKNOWN): MILD PROTRUSIVE DISC DISEASE OF L2/L3 AND L3/L4 [MAGNETIC RESONANCE IMAGING HEAD] ON (B)(6) 2017: RESULTS: NO VISIBLE ABNORMALITY IN MEDULLAR AND CEREBRAL. CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6, CERVICAL OSTEOARTHRITIS. [MAGNETIC RESONANCE IMAGING PELVIC] ON (B)(6) 2012: CONFIRMED PRESENCE OF A SMALL POLYP MEASURING 5 MM IN THE POSTERIOR WALL. PRESENCE OF AN INTERSTITIAL FIBROMA MEASURING 20 MM WITH A SUBMUCOUS COMPONENT IN THE POSTERIOR WALL. NO OTHER VISIBLE ABNORMALITIES.; ON (B)(6) 2016: RESULTS: DIFFUSE ADENOMYOSIS AND LAYER OF INTRAPERITONEAL EFFUSION.; ON (B)(6) 2016: DIFFUSE ADENOMYOSIS; (DATE UNKNOWN): MODERATE PROTUSIVE DISCOPATHY IN L2-L3 AND L3-L4 AND INTEGRITY OF SACROILIAC JOINTS. [MEAN CELL VOLUME] ON (B)(6)2012: 102 FL [OESTRADIOL] ON (B)(6) 2012: 1203 PMOL/L [PATHOLOGY TEST] ON (B)(6) 2012: HISTOLOGICAL ANALYSIS OF THE MUCOSA CONCLUDES TO A HYPERPLASIA OF THE UTERINE PSEUDOPOLYPOID SECRETORY MUCOSA; ON (B)(6)2012: FOUND DIFFUSE ENDOMETRIAL HYPERPLASIA.; ON (B)(6)2013: DIAGNOSIS OF SIMPLE ATYPICAL HYPERPLASIA WAS CONFIRMED; ON (B)(6) 2014: SUSPECTED ABNORMALITIES OF MALIGNANCY OF THE CERVIX (PAPILLOMAVIRUS INFECTION); ON (B)(6) 2014: LOW-GRADE SQUAMOUS INTRAEPITHELIAL LESIONS AT THE SCJ AND IN MULTIPLE LOCATIONS. NO HIGH-GRADE DYSPLASTIC LESIONS [SMEAR CERVIX] ON (B)(6) 2013: ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE. [ULTRASOUND SCAN] ON (B)(6) 2012: RESULTS: ONE SMALL INTRACAVITARY POLYP MEASURING 5 MM; ON (B)(6) 2012: UTERINE POLYP AND A 20 MM INTRAMURAL MYOMATOUS NODULE; IN (B)(6) 2015: ENDO-VAGINAL PELVIC ULTRASOUND FOUND FIBROMATOUS UTERUS; ON (B)(6) 2016: RESULTS: THICKENING OF RIGHT TENDON OF GLUTEUS MEDIUS MUSCLE AND OF RIGHT ILIOTIBIAL TRACT SUGGESTING TENDINITIS OF GLUTEUS MEDIUS MUSCLE. [VIRAL TEST] ON (B)(6) 2013: PRESENCE OF HIGH-RISK PAPILLOMAVIRUS WAS FOUND. LOT NUMBER: 852008 MANUFACTURING DATE: 2011-04 EXPIRATION DATE: 2014-04. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: 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. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 21-NOV-2024: MEDICAL RECORD RECEIVED. NEW EVENTS MYOSITIS, SICK LEAVE & DEPRESSIVE DISORDER WERE ADDED. MEDICAL HISTORY UPDATED. REPORTER CAUSALITY COMMENT ADDED. ANNEX E CODES ARE UPDATED FOR RELATED EVENTS. CASE COMMENTS: 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 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 ("NOT NEGLIGIBLE PELVIC PAIN") AND ASCITES ("LAYER OF INTRAPERITONEAL EFFUSION") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852008) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED RUPTURED ECTOPIC PREGNANCY, CERVICAL CONISATION (TWO SUCCESSIVE CONISATIONS), CERVICAL DYSPLASIA, ACUTE PERICARDITIS IN 1995, CHRONIC GASTRITIS IN 2011, RECURRENT URINARY TRACT INFECTION AND TOBACCO USER. IN 2011, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA WITH HEMORRHAGIC EPISODES / HEMORRHAGIC MENSTRUATIONS / MENORRHAGIA +++"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED UTERINE LEIOMYOMA ("SMALL FIBROMAS/MYOMAS IN UTERUS"). IN (B)(6) 2017, THE PATIENT EXPERIENCED SENSORIMOTOR DISORDER ("LEFT FOOT SENSORY DISORDERS WITH INTERMITTENT MOTOR DISCOMFORT OF RIGHT HAND"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE POLYP ("ONE SMALL INTRACAVITARY POLYP MEASURING 5 MM"), ASCITES (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ADENOMYOSIS ("ADENOMYOSIS"), TENDONITIS ("TENDONITIS OF GLUTEUS MEDIUS MUSCLE / THICKENING OF RIGHT TENDON OF GLUTEUS MEDIUS MUSCLE AND OF RIGHT ILIOTIBIAL TRACT SUGGESTING TENDINITIS OF GLUTEUS MEDIUS MUSCLE"), PAIN ("CHRONIC PAIN"), INTERVERTEBRAL DISC PROTRUSION ("MODERATE PROTUSIVE DISCOPATHY IN L2-L3 AND L3-L4"), INTERVERTEBRAL DISC DISORDER ("CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6"), VERTEBRAL FORAMINAL STENOSIS ("CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6"), MUSCULOSKELETAL PAIN ("MUSCLE AND JOINT PAIN"), UTERINE CERVIX STENOSIS ("CERVICAL STENOSIS"), ABDOMINAL PAIN ("STRONG ABDOMINAL PAIN"), FATIGUE ("VERY STRONG FATIGABILITY") AND FALLOPIAN TUBE DISORDER ("SMALL INFLAMMATORY REMODELLING IN LEFT TUBE"). THE PATIENT WAS TREATED WITH SURGERY (VAGINAL HYSTERECTOMY AND LEFT SALPINGECTOMY VIA LAPAROSCOPY WERE PERFORMED ON (B)(6) 2018). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, UTERINE POLYP, ASCITES, ADENOMYOSIS, TENDONITIS, PAIN, INTERVERTEBRAL DISC PROTRUSION, SENSORIMOTOR DISORDER, INTERVERTEBRAL DISC DISORDER, VERTEBRAL FORAMINAL STENOSIS, MUSCULOSKELETAL PAIN, UTERINE CERVIX STENOSIS, ABDOMINAL PAIN, FATIGUE, UTERINE LEIOMYOMA AND FALLOPIAN TUBE DISORDER OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN, ADENOMYOSIS, ASCITES, FALLOPIAN TUBE DISORDER, FATIGUE, INTERVERTEBRAL DISC DISORDER, INTERVERTEBRAL DISC PROTRUSION, MENORRHAGIA, MUSCULOSKELETAL PAIN, PAIN, PELVIC PAIN, SENSORIMOTOR DISORDER, TENDONITIS, UTERINE CERVIX STENOSIS, UTERINE LEIOMYOMA, UTERINE POLYP AND VERTEBRAL FORAMINAL STENOSIS WITH ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION HAD BEEN PERFORMED IN ONE TUBE. WORK UP TO INVESTIGATION POTENTIAL SENSITIVITY TO NICKEL, TITANIUM AND STEEL WAS REQUESTED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): GYNAECOLOGICAL EXAMINATION - ON AN UNKNOWN DATE: CERVICAL STENOSIS ULTRASOUND SCAN - ON (B)(6) 2012: ONE SMALL INTRACAVITARY POLYP MEASURING 5 MM PELVIS MRI PERFORMED ON (B)(6) 2016 SHOWED DIFFUSE ADENOMYOSIS AND LAYER OF INTRAPERITONEAL EFFUSION. ULTRASOUND PERFORMED ON (B)(6) 2016 SHOWED THICKENING OF RIGHT TENDON OF GLUTEUS MEDIUS MUSCLE AND OF RIGHT ILIOTIBIAL TRACT SUGGESTING TENDINITIS OF GLUTEUS MEDIUS MUSCLE. SACROILIAC AND LUMBOSACRAL SPINE MRI SHOWED MODERATE PROTUSIVE DISCOPATHY IN L2-L3 AND L3-L4 AND INTEGRITY OF SACROILIAC JOINTS. BRAIN AND MEDULLAR MRI TO INVESTIGATE LEFT FOOT SENSORY DISORDERS PROGRESSING SINCE MID-MAY WITH INTERMITTENT MOTOR DISCOMFORT OF RIGHT HAND SHOWED NO VISIBLE ABNORMALITY IN MEDULLAR AND CEREBRAL REGIONS. CERVICAL DISCOPATHY WITH LEFT FORAMINAL STENOSIS IN C5-C6. RHEUMATOID FACTORS: ON (B)(6) 2017, HUMAN IGM ANTI-IGG AT 29 IU/ML (NORM: POSITIVE IF UPPER THAN 20 IU/ML). SERUM PROTEINS ELECTROPHORESIS FOUND HYPOGAMMAGLOBULINEMIA. THE LIST OF SIMILAR CASES CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS WITH SIMILAR EVENTS CODED IN MEDDRA. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON (B)(6) 2018 FOR THE FOLLOWING MEDDRA PREFERRED TERMS: PELVIC PAIN ¿ ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 11.376 CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THESE MEDDRA PT. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 380524 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 852008 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Female | Required Intervention| O |