ESSURE
Report
- Report Number
- 2951250-2017-01205
- Event Type
- Injury
- Date Received
- April 6, 2017
- Date of Event
- January 1, 2010
- Report Date
- April 16, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
THIS CASE WAS REPORTED VIA REGULATORY AUTHORITY ANSM (REFERENCE NUMBER: (B)(4) ON (B)(6) 2017 AND FROM LAWYER ON (B)(6) 2017. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") AND CHOLECYSTITIS ("I HAVE HAD MY GALLBLADDER REMOVED AS IT WAS HIGHLY INFLAMED") IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 624275) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED NECK PAIN (NECK PAIN WITH PERIOD. PAINFUL BUT NOT UNBEARABLE, STRESS INCONTINENCE, FEMALE (MINOR URINARY LEAKS ON EFFORT). NO TREATMENT AND PREGNANCY. SHE STATED SHE COULD HAVE MOVED MOUNTAINS BEFORE CONSTANT SUFFERING STARTED. ON (B)(6) 2008, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2010, 1 YEAR 11 MONTHS AFTER INSERTION OF ESSURE (ESS205), THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), CHOLECYSTITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PAIN ("OVER THE YEARS, PROBLEMS HAVE PROGRESSIVELY SET IN ALL OVER MY BODY, NEW ACHES AND PAINFUL AREAS REGULARLY APPEAR, I WENT FROM WORKING FULL DAYS TO 4-HOUR HALF DAYS"), DYSMENORRHOEA ("VERY PAINFUL MENSTRUAL PERIODS"), MENORRHAGIA ("MORE OR LESS HAEMORRHAGIC PERIODS"), AMENORRHOEA ("SOMETIMES NO MENSTRUAL PERIOD"), NECK PAIN ("TERRIBLE NECK PAIN"), TACHYCARDIA ("TACHYCARDIA"), OESOPHAGEAL SPASM ("SPASMS OF OESOPHAGUS"), TENDONITIS ("TENDONITIS AND TENOSYNOVITIS HAVE PROGRESSIVELY SET IN, AFFECTING MY ELBOWS AND HIPS (GLUTEUS MEDIUS, TROCHANTER)"), TENOSYNOVITIS ("TENDONITIS AND TENOSYNOVITIS HAVE PROGRESSIVELY SET IN, AFFECTING MY ELBOWS AND HIPS (GLUTEUS MEDIUS, TROCHANTER)"), ARTHRALGIA ("JOINT PAIN IN THE HANDS, FINGERS, SHOULDERS, BACK, THIGHS, KNEES AND HEELS"), MYALGIA ("MUSCLE PAIN IN THE HANDS, FINGERS, SHOULDERS, BACK, THIGHS, KNEES AND HEELS"), NEURALGIA ("NERVE PAIN IN THE HANDS, FINGERS, SHOULDERS, BACK, THIGHS, KNEES AND HEELS"), HEADACHE ("HEADACHES"), DIZZINESS ("DIZZY SPELLS SOMETIMES VERY VIOLENT (LIKE LAST SUMMER, WITH THE FEELING THAT EVERYTHING IS MOVING INSIDE MY HEAD)"), DEPRESSED MOOD ("AFFECTS MORALE, LOSS OF MORALE, A MORE OR LESS DEPRESSIVE STATE SETS IN"), INSOMNIA ("INSOMNIA"), ASTHENIA ("LACK OF STRENGTH AND RESISTANCE TO EFFORT"), FATIGUE ("CHRONIC FATIGUE"), ALOPECIA ("HAIR LOSS"), TRICHORRHEXIS ("HAIR SOFT AND BREAKABLE"), ONYCHOCLASIS ("NAILS SOFT AND BREAKABLE") AND CYST ("CYST THAT COMES AND GOES IN ONE EAR"). IN 2016, THE PATIENT EXPERIENCED VERTIGO ("DIZZY SPELLS SOMETIMES VERY VIOLENT (LIKE LAST SUMMER, WITH THE FEELING THAT EVERYTHING IS MOVING INSIDE MY HEAD)"). ON (B)(6) 2017, THE PATIENT EXPERIENCED BOWEL MOVEMENT IRREGULARITY ("MY BOWEL MOVEMENTS ARE TOPSY-TURVY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSPEPSIA ("FURTHER GASTRO-OESOPHAGEAL PROBLEMS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FIBROMYALGIA ("FIBROMYALGIA"), SPONDYLITIS ("SPONDYLOARTHRITIS"), SERUM FERRITIN INCREASED ("INCREASED BLOOD FERRITIN"), EYE DISORDER ("OPHTHALMOLOGICAL DISORDERS"), NERVOUS SYSTEM DISORDER ("NEUROLOGICAL DISORDERS"), EAR DISORDER ("ENT DISORDERS"), NASAL DISCOMFORT ("ENT DISORDERS"), OROPHARYNGEAL DISCOMFORT ("ENT DISORDERS"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL DISORDERS"), CARDIAC DISORDER ("CARDIOLOGICAL DISORDERS"), RHEUMATIC DISORDER ("RHEUMATOLOGICAL DISORDERS"), REPRODUCTIVE TRACT DISORDER ("GYNAECOLOGICAL DISORDERS") AND GENERAL PHYSICAL HEALTH DETERIORATION ("HEALTH STATUS PROGRESSIVELY DETERIORATED"). THE PATIENT WAS TREATED WITH IBUPROFEN, ANTIINFLAMMATORY/ANTIRHEUMATIC PRODUCTS, SURGERY (SALPINGECTOMY AND/OR HYSTERECTOMY) AND SURGERY (GALLBLADDER WAS REMOVED). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, CHOLECYSTITIS, PAIN, DYSMENORRHOEA, MENORRHAGIA, AMENORRHOEA, NECK PAIN, TACHYCARDIA, OESOPHAGEAL SPASM, TENDONITIS, TENOSYNOVITIS, ARTHRALGIA, MYALGIA, NEURALGIA, BOWEL MOVEMENT IRREGULARITY, HEADACHE, VERTIGO, DIZZINESS, DEPRESSED MOOD, INSOMNIA, ASTHENIA, FATIGUE, ALOPECIA, TRICHORRHEXIS, ONYCHOCLASIS, DYSPEPSIA, CYST, FIBROMYALGIA, SPONDYLITIS, SERUM FERRITIN INCREASED, EYE DISORDER, NERVOUS SYSTEM DISORDER, EAR DISORDER, NASAL DISCOMFORT, OROPHARYNGEAL DISCOMFORT, GASTROINTESTINAL DISORDER, CARDIAC DISORDER, RHEUMATIC DISORDER, REPRODUCTIVE TRACT DISORDER AND GENERAL PHYSICAL HEALTH DETERIORATION OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ALOPECIA, AMENORRHOEA, ASTHENIA, BOWEL MOVEMENT IRREGULARITY, CHOLECYSTITIS, CYST, DEPRESSED MOOD, DIZZINESS, DYSMENORRHOEA, DYSPEPSIA, FATIGUE, FIBROMYALGIA, HEADACHE, INSOMNIA, MENORRHAGIA, MYALGIA, NECK PAIN, NEURALGIA, OESOPHAGEAL SPASM, ONYCHOCLASIS, PAIN, PELVIC PAIN, SPONDYLITIS, TACHYCARDIA, TENDONITIS, TENOSYNOVITIS, TRICHORRHEXIS AND VERTIGO WITH ESSURE (ESS205). THE REPORTER CONSIDERED ARTHRALGIA, CARDIAC DISORDER, EAR DISORDER, EYE DISORDER, GASTROINTESTINAL DISORDER, GENERAL PHYSICAL HEALTH DETERIORATION, NASAL DISCOMFORT, NERVOUS SYSTEM DISORDER, OROPHARYNGEAL DISCOMFORT, REPRODUCTIVE TRACT DISORDER, RHEUMATIC DISORDER AND SERUM FERRITIN INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: ALL OF THE BLOOD TESTS, X-RAYS, ULTRASOUND AND MRI FOUND ABSOLUTELY NOTHING, EXCEPT FOR THE PRESENCE OF TENDONITIS. NATURALLY, PEOPLE THINK I AM A HYPOCHONDRIAC, BUT BECAUSE MY BODY RESPONDS VERY WELL TO ANTIINFLAMMATORIES, I WAS DIAGNOSED WITH SPONDYLOARTHRITIS, AND THEN WITH FIBROMYALGIA..FOR A VERY LONG TIME I TOOK ANTI-INFLAMMATORIES, WHICH LED TO FURTHER GASTRO-OESOPHAGEAL PROBLEMS. OBVIOUSLY, CONSTANT SUFFERING IN SOMEONE WHO COULD HAVE MOVED MOUNTAINS BEFORE AFFECTS MORALE AND A MORE OR LESS DEPRESSIVE STATE SETS IN. OF COURSE ALL OF THIS HAS HAD REPERCUSSIONS ON MY PROFESSIONAL ACTIVITY AND THEREFORE ON MY SALARY. I WORK IN RETAIL SO I AM ALWAYS ON MY FEET. I WENT FROM WORKING FULL DAYS TO 4-HOUR HALF DAYS (NO FURTHER INFORMATION EXPECTED). DIAGNOSTIC RESULTS: BLOOD OR URINE TESTS, CONSULTATIONS WITH SPECIALISTS, XRAY, CT SCAN, MRI, FOR MONTHS OR YEARS, WITHOUT FINDING ANY ETIOLOGY. ALL OF THE BLOOD TESTS, X-RAYS, ULTRASOUND AND MRI: ABSOLUTELY NOTHING, EXCEPT FOR THE PRESENCE OF TENDONITIS. THE LIST OF DEVICE SIMILAR INCIDENTS 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 10.828 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. QUALITY-SAFETY EVALUATION OF PTC: LOT#: 624275 - PRODUCTION DATE: APR-2007 - EXPIRATION DATE: MAR-2009. SAMPLE NOT AVAILABLE. WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO SIMILAR AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO THE REPORTED BATCH. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-APR-2018: (B)(4) WAS IDENTIFIED AS DUPLICATE OF THIS CASE. ALL THE INFORMATION OF CASE (B)(4) WAS TRANSFERRED TO THIS CASE: THE PATIENT IS PART OF THE CLASS ACTION OF THE RESIST ASSOCIATION. NEW REPORTER WAS ADDED; HEALTH STATUS PROGRESSIVELY DETERIORATED WAS ADDED AS EVENT. 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 CASE WAS REPORTED VIA REGULATORY AUTHORITY ANSM (REFERENCE NUMBER: (B)(4)) ON (B)(6)2017. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") AND CHOLECYSTITIS ("I HAVE HAD MY GALLBLADDER REMOVED AS IT WAS HIGHLY INFLAMED") IN A FEMALE PATIENT WHO RECEIVED ESSURE (ESS205) (BATCH NO. (B)(4)). THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED NECK PAIN (NECK PAIN WITH PERIOD. PAINFUL BUT NOT UNBEARABLE.), BLADDER INCONTINENCE (MINOR URINARY LEAKS ON EFFORT. NO TREATMENT.) AND PREGNANCY. SHE STATED SHE COULD HAVE MOVED MOUNTAINS BEFORE CONSTANT SUFFERING STARTED. ON (B)(6) 2008, THE PATIENT STARTED ESSURE (ESS205). ON (B)(6) 2010, 716 DAYS AFTER STARTING ESSURE (ESS205), THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED), CHOLECYSTITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PAIN ("OVER THE YEARS, PROBLEMS HAVE PROGRESSIVELY SET IN ALL OVER MY BODY, NEW ACHES AND PAINFUL AREAS REGULARLY APPEAR, I WENT FROM WORKING FULL DAYS TO 4-HOUR HALF DAYS"), DYSMENORRHOEA ("VERY PAINFUL MENSTRUAL PERIODS"), MENORRHAGIA ("MORE OR LESS HAEMORRHAGIC PERIODS"), OLIGOMENORRHOEA ("SOMETIMES NO MENSTRUAL PERIOD"), NECK PAIN ("TERRIBLE NECK PAIN"), TACHYCARDIA ("TACHYCARDIA"), OESOPHAGEAL SPASM ("SPASMS OF OESOPHAGUS"), TENDONITIS ("TENDONITIS AND TENOSYNOVITIS HAVE PROGRESSIVELY SET IN, AFFECTING MY ELBOWS AND HIPS (GLUTEUS MEDIUS, TROCHANTER)"), TENOSYNOVITIS ("TENDONITIS AND TENOSYNOVITIS HAVE PROGRESSIVELY SET IN, AFFECTING MY ELBOWS AND HIPS (GLUTEUS MEDIUS, TROCHANTER)"), SPONDYLITIS ("SPONDYLARTHRITIS"), ARTHRALGIA ("JOINT PAIN IN THE HANDS, FINGERS, SHOULDERS, BACK, THIGHS, KNEES AND HEELS"), MYALGIA ("MUSCLE PAIN IN THE HANDS, FINGERS, SHOULDERS, BACK, THIGHS, KNEES AND HEELS"), FIBROMYALGIA ("FIBROMYALGIA"), NEURALGIA ("NERVE PAIN IN THE HANDS, FINGERS, SHOULDERS, BACK, THIGHS, KNEES AND HEELS"), HEADACHE ("HEADACHES"), DIZZINESS ("DIZZY SPELLS SOMETIMES VERY VIOLENT (LIKE LAST SUMMER, WITH THE FEELING THAT EVERYTHING IS MOVING INSIDE MY HEAD)"), DEPRESSED MOOD ("AFFECTS MORALE, LOSS OF MORALE, A MORE OR LESS DEPRESSIVE STATE SETS IN"), INSOMNIA ("INSOMNIA"), ASTHENIA ("LACK OF STRENGTH AND RESISTANCE TO EFFORT"), FATIGUE ("CHRONIC FATIGUE"), ALOPECIA ("HAIR LOSS"), TRICHORRHEXIS ("HAIR SOFT AND BREAKABLE"), ONYCHOCLASIS ("NAILS SOFT AND BREAKABLE") AND CYST ("CYST THAT COMES AND GOES IN ONE EAR"). IN 2016, THE PATIENT EXPERIENCED VERTIGO ("DIZZY SPELLS SOMETIMES VERY VIOLENT (LIKE LAST SUMMER, WITH THE FEELING THAT EVERYTHING IS MOVING INSIDE MY HEAD)"). ON (B)(6) 2017, THE PATIENT EXPERIENCED BOWEL MOVEMENT IRREGULARITY ("MY BOWEL MOVEMENTS ARE TOPSY-TURVY"). THE PATIENT WAS TREATED WITH IBUPROFEN, ANTIINFLAMMATORIES FOR A VERY LONG TIME, SURGERY (GALLBLADDER WAS REMOVED) AND SURGERY (ON (B)(6) 2017, ESSURE WAS REMOVED). ON AN UNSPECIFIED DATE, SHE EXPERIENCED DYSPEPSIA ("FURTHER GASTRO-OESOPHAGEAL PROBLEMS "). AT THE TIME OF THE REPORT, THE PELVIC PAIN, CHOLECYSTITIS, PAIN, DYSMENORRHOEA, MENORRHAGIA, OLIGOMENORRHOEA, NECK PAIN, TACHYCARDIA, OESOPHAGEAL SPASM, TENDONITIS, TENOSYNOVITIS, SPONDYLITIS, ARTHRALGIA, MYALGIA, FIBROMYALGIA, NEURALGIA, BOWEL MOVEMENT IRREGULARITY, HEADACHE, VERTIGO, DIZZINESS, DEPRESSED MOOD, INSOMNIA, ASTHENIA, FATIGUE, ALOPECIA, TRICHORRHEXIS, ONYCHOCLASIS, DYSPEPSIA AND CYST OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR PELVIC PAIN, CHOLECYSTITIS, PAIN, DYSMENORRHOEA, MENORRHAGIA, OLIGOMENORRHOEA, NECK PAIN, TACHYCARDIA, OESOPHAGEAL SPASM, TENDONITIS, TENOSYNOVITIS, SPONDYLITIS, ARTHRALGIA, MYALGIA, FIBROMYALGIA, NEURALGIA, BOWEL MOVEMENT IRREGULARITY, HEADACHE, VERTIGO, DIZZINESS, DEPRESSED MOOD, INSOMNIA, ASTHENIA, FATIGUE, ALOPECIA, TRICHORRHEXIS, ONYCHOCLASIS, DYSPEPSIA AND CYST WITH ESSURE (ESS205). THE REPORTER COMMENTED: ALL OF THE BLOOD TESTS, X-RAYS, ULTRASOUND AND MRI FOUND ABSOLUTELY NOTHING, EXCEPT FOR THE PRESENCE OF TENDONITIS. NATURALLY, PEOPLE THINK I AM A HYPOCHONDRIAC, BUT BECAUSE MY BODY RESPONDS VERY WELL TO ANTIINFLAMMATORIES, I WAS DIAGNOSED WITH SPONDYLOARTHRITIS, AND THEN WITH FIBROMYALGIA. FOR A VERY LONG TIME I TOOK ANTI-INFLAMMATORIES, WHICH LED TO FURTHER GASTRO-OESOPHAGEAL PROBLEMS. OBVIOUSLY, CONSTANT SUFFERING IN SOMEONE WHO COULD HAVE MOVED MOUNTAINS BEFORE AFFECTS MORALE AND A MORE OR LESS DEPRESSIVE STATE SETS IN. OF COURSE ALL OF THIS HAS HAD REPERCUSSIONS ON MY PROFESSIONAL ACTIVITY AND THEREFORE ON MY SALARY. I WORK IN RETAIL SO I AM ALWAYS ON MY FEET. I WENT FROM WORKING FULL DAYS TO 4-HOUR HALF DAYS. DIAGNOSTIC RESULTS: ALL OF THE BLOOD TESTS, X-RAYS, ULTRASOUND AND MRI: ABSOLUTELY NOTHING, EXCEPT FOR THE PRESENCE OF TENDONITIS. THE LIST OF DEVICE SIMILAR INCIDENTS 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) 2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: PELVIC PAIN. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED (B)(4) 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. QUALITY-SAFETY EVALUATION OF PTC: LOT#: 624275 - PRODUCTION DATE: (B)(6) 2007 - EXPIRATION DATE: MAR-2009. SAMPLE NOT AVAILABLE. WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO SIMILAR AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO THE REPORTED BATCH. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2017: QUALITY SAFETY EVALUATION OF PTC. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT RECEIVED VIA REGULATORY AUTHORITY REFERS TO A CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND SHE PRESENTED PELVIC PAIN AND HAD HER GALLBLADDER REMOVED AS IT WAS HIGHLY INFLAMED (SEEN AS CHOLECYSTITIS). CONSUMER HAD ESSURE REMOVED APPROXIMATELY 9 YEARS AFTER INSERTION. THE REPORTED EVENTS ARE SERIOUS DUE TO MEDICAL IMPORTANCE. CHOLECYSTITIS IS UNANTICIPATED WHILE OTHER EVENT IS ANTICIPATED IN ESSURE'S REFERENCE SAFETY INFORMATION. AFTER ESSURE INSERTION, PELVIC, BACK AND UNCHARACTERIZED PAIN MAY OCCUR. IN THIS CASE, THE EVENT STARTED AFTER ESSURE INSERTION. CONSIDERING POSITIVE TEMPORAL RELATIONSHIP AND EVENT'S NATURE, CAUSALITY WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. REGARDING CHOLECYSTITIS, CONSIDERING ESSURE'S LOCAL ACTION IN FALLOPIAN TUBES AND EVENT'S PATHOPHYSIOLOGY CAUSALITY CAN BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED. ACCORDING TO THE PRODUCT TECHNICAL ANALYSIS, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. NO FURTHER INFORMATION WILL BE AVAILABLE, BECAUSE HEALTH AUTHORITY DOES NOT ALLOW ACTIVE FOLLOW-UP.
THIS CASE WAS REPORTED VIA REGULATORY AUTHORITY ANSM (REFERENCE NUMBER: (B)(4)) ON 09-MAR-2017 AND FROM LAWYER ON 15-MAY-2017. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") AND CHOLECYSTITIS ("I HAVE HAD MY GALLBLADDER REMOVED AS IT WAS HIGHLY INFLAMED") IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 624275) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED NECK PAIN (NECK PAIN WITH PERIOD. PAINFUL BUT NOT UNBEARABLE.), STRESS INCONTINENCE, FEMALE (MINOR URINARY LEAKS ON EFFORT. NO TREATMENT.) AND PREGNANCY. SHE STATED SHE COULD HAVE MOVED MOUNTAINS BEFORE CONSTANT SUFFERING STARTED. ON (B)(6) 2008, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2010, 1 YEAR 11 MONTHS AFTER INSERTION OF ESSURE (ESS205), THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), CHOLECYSTITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PAIN ("OVER THE YEARS, PROBLEMS HAVE PROGRESSIVELY SET IN ALL OVER MY BODY, NEW ACHES AND PAINFUL AREAS REGULARLY APPEAR, I WENT FROM WORKING FULL DAYS TO 4-HOUR HALF DAYS"), DYSMENORRHOEA ("VERY PAINFUL MENSTRUAL PERIODS"), MENORRHAGIA ("MORE OR LESS HAEMORRHAGIC PERIODS"), AMENORRHOEA ("SOMETIMES NO MENSTRUAL PERIOD"), NECK PAIN ("TERRIBLE NECK PAIN"), TACHYCARDIA ("TACHYCARDIA"), OESOPHAGEAL SPASM ("SPASMS OF OESOPHAGUS"), TENDONITIS ("TENDONITIS AND TENOSYNOVITIS HAVE PROGRESSIVELY SET IN, AFFECTING MY ELBOWS AND HIPS (GLUTEUS MEDIUS, TROCHANTER)"), TENOSYNOVITIS ("TENDONITIS AND TENOSYNOVITIS HAVE PROGRESSIVELY SET IN, AFFECTING MY ELBOWS AND HIPS (GLUTEUS MEDIUS, TROCHANTER)"), ARTHRALGIA ("JOINT PAIN IN THE HANDS, FINGERS, SHOULDERS, BACK, THIGHS, KNEES AND HEELS"), MYALGIA ("MUSCLE PAIN IN THE HANDS, FINGERS, SHOULDERS, BACK, THIGHS, KNEES AND HEELS"), NEURALGIA ("NERVE PAIN IN THE HANDS, FINGERS, SHOULDERS, BACK, THIGHS, KNEES AND HEELS"), HEADACHE ("HEADACHES"), DIZZINESS ("DIZZY SPELLS SOMETIMES VERY VIOLENT (LIKE LAST SUMMER, WITH THE FEELING THAT EVERYTHING IS MOVING INSIDE MY HEAD)"), DEPRESSED MOOD ("AFFECTS MORALE, LOSS OF MORALE, A MORE OR LESS DEPRESSIVE STATE SETS IN"), INSOMNIA ("INSOMNIA"), ASTHENIA ("LACK OF STRENGTH AND RESISTANCE TO EFFORT"), FATIGUE ("CHRONIC FATIGUE"), ALOPECIA ("HAIR LOSS"), TRICHORRHEXIS ("HAIR SOFT AND BREAKABLE"), ONYCHOCLASIS ("NAILS SOFT AND BREAKABLE") AND CYST ("CYST THAT COMES AND GOES IN ONE EAR"). IN 2016, THE PATIENT EXPERIENCED VERTIGO ("DIZZY SPELLS SOMETIMES VERY VIOLENT (LIKE LAST SUMMER, WITH THE FEELING THAT EVERYTHING IS MOVING INSIDE MY HEAD)"). ON (B)(6) 2017, THE PATIENT EXPERIENCED BOWEL MOVEMENT IRREGULARITY ("MY BOWEL MOVEMENTS ARE TOPSY-TURVY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSPEPSIA ("FURTHER GASTRO-OESOPHAGEAL PROBLEMS"), FIBROMYALGIA ("FIBROMYALGIA"), SPONDYLITIS ("SPONDYLOARTHRITIS"), SERUM FERRITIN INCREASED ("INCREASED BLOOD FERRITIN"), EYE DISORDER ("OPHTHALMOLOGICAL DISORDERS"), NERVOUS SYSTEM DISORDER ("NEUROLOGICAL DISORDERS"), EAR DISORDER ("ENT DISORDERS"), NASAL DISCOMFORT ("ENT DISORDERS"), OROPHARYNGEAL DISCOMFORT ("ENT DISORDERS"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL DISORDERS"), CARDIAC DISORDER ("CARDIOLOGICAL DISORDERS"), RHEUMATIC DISORDER ("RHEUMATOLOGICAL DISORDERS") AND GENITAL DISORDER FEMALE ("GYNAECOLOGICAL DISORDERS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSPEPSIA ("FURTHER GASTRO-OESOPHAGEAL PROBLEMS"), FIBROMYALGIA ("FIBROMYALGIA"), SPONDYLITIS ("SPONDYLOARTHRITIS"), SERUM FERRITIN INCREASED ("INCREASED BLOOD FERRITIN"), EYE DISORDER ("OPHTHALMOLOGICAL DISORDERS"), NERVOUS SYSTEM DISORDER ("NEUROLOGICAL DISORDERS"), EAR DISORDER ("ENT DISORDERS"), NASAL DISCOMFORT ("ENT DISORDERS"), OROPHARYNGEAL DISCOMFORT ("ENT DISORDERS"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL DISORDERS"), CARDIAC DISORDER ("CARDIOLOGICAL DISORDERS"), RHEUMATIC DISORDER ("RHEUMATOLOGICAL DISORDERS") AND GENITAL DISORDER FEMALE ("GYNAECOLOGICAL DISORDERS"). THE PATIENT WAS TREATED WITH IBUPROFEN, ANTIINFLAMMATORY/ANTIRHEUMATIC PRODUCTS, SURGERY (ON (B)(6) 2017, ESSURE WAS REMOVED.) AND SURGERY (GALLBLADDER WAS REMOVED). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, CHOLECYSTITIS, PAIN, DYSMENORRHOEA, MENORRHAGIA, AMENORRHOEA, NECK PAIN, TACHYCARDIA, OESOPHAGEAL SPASM, TENDONITIS, TENOSYNOVITIS, ARTHRALGIA, MYALGIA, NEURALGIA, BOWEL MOVEMENT IRREGULARITY, HEADACHE, VERTIGO, DIZZINESS, DEPRESSED MOOD, INSOMNIA, ASTHENIA, FATIGUE, ALOPECIA, TRICHORRHEXIS, ONYCHOCLASIS, DYSPEPSIA, CYST, FIBROMYALGIA, SPONDYLITIS, SERUM FERRITIN INCREASED, EYE DISORDER, NERVOUS SYSTEM DISORDER, EAR DISORDER, NASAL DISCOMFORT, OROPHARYNGEAL DISCOMFORT, GASTROINTESTINAL DISORDER, CARDIAC DISORDER, RHEUMATIC DISORDER AND GENITAL DISORDER FEMALE OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ALOPECIA, AMENORRHOEA, ASTHENIA, BOWEL MOVEMENT IRREGULARITY, CHOLECYSTITIS, CYST, DEPRESSED MOOD, DIZZINESS, DYSMENORRHOEA, DYSPEPSIA, FATIGUE, FIBROMYALGIA, HEADACHE, INSOMNIA, MENORRHAGIA, MYALGIA, NECK PAIN, NEURALGIA, OESOPHAGEAL SPASM, ONYCHOCLASIS, PAIN, PELVIC PAIN, SPONDYLITIS, TACHYCARDIA, TENDONITIS, TENOSYNOVITIS, TRICHORRHEXIS AND VERTIGO WITH ESSURE (ESS205). THE REPORTER CONSIDERED ARTHRALGIA, CARDIAC DISORDER, EAR DISORDER, EYE DISORDER, GASTROINTESTINAL DISORDER, GENITAL DISORDER FEMALE, NASAL DISCOMFORT, NERVOUS SYSTEM DISORDER, OROPHARYNGEAL DISCOMFORT, RHEUMATIC DISORDER AND SERUM FERRITIN INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: ALL OF THE BLOOD TESTS, X-RAYS, ULTRASOUND AND MRI FOUND ABSOLUTELY NOTHING, EXCEPT FOR THE PRESENCE OF TENDONITIS. NATURALLY, PEOPLE THINK I AM A HYPOCHONDRIAC, BUT BECAUSE MY BODY RESPONDS VERY WELL TO ANTIINFLAMMATORIES, I WAS DIAGNOSED WITH SPONDYLOARTHRITIS, AND THEN WITH FIBROMYALGIA..FOR A VERY LONG TIME I TOOK ANTI-INFLAMMATORIES, WHICH LED TO FURTHER GASTRO-OESOPHAGEAL PROBLEMS. OBVIOUSLY, CONSTANT SUFFERING IN SOMEONE WHO COULD HAVE MOVED MOUNTAINS BEFORE AFFECTS MORALE AND A MORE OR LESS DEPRESSIVE STATE SETS IN. OF COURSE ALL OF THIS HAS HAD REPERCUSSIONS ON MY PROFESSIONAL ACTIVITY AND THEREFORE ON MY SALARY. I WORK IN RETAIL SO I AM ALWAYS ON MY FEET. I WENT FROM WORKING FULL DAYS TO 4-HOUR HALF DAYS (NO FURTHER INFORMATION EXPECTED). DIAGNOSTIC RESULTS: ALL OF THE BLOOD TESTS, X-RAYS, ULTRASOUND AND MRI: ABSOLUTELY NOTHING, EXCEPT FOR THE PRESENCE OF TENDONITIS. THE LIST OF DEVICE SIMILAR INCIDENTS 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 18-MAY-2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: PELVIC PAIN. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 2785 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. QUALITY-SAFETY EVALUATION OF PTC: LOT#: 624275 - PRODUCTION DATE: APR-2007 - EXPIRATION DATE: MAR-2009. SAMPLE NOT AVAILABLE. WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO SIMILAR AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO THE REPORTED BATCH. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-MAY-2017: INFORMATION WAS RECEIVED FROM LAWYER: SOME TIME AFTER PLACEMENT OF THE SAID DEVICE, SHE DEVELOPED VERY NUMEROUS PROBLEMS, INCLUDING INCREASED BLOOD FERRITIN, OPHTHALMOLOGICAL DISORDERS, PAIN IN THE KNEES, GASTROINTESTINAL DISORDERS, NEUROLOGICAL DISORDERS, ENT DISORDERS, CARDIOLOGICAL DISORDERS, RHEUMATOLOGICAL DISORDERS AND GYNAECOLOGICAL DISORDERS, WHICH LED HER TO HAVE THE INSERTS REMOVED ON (B)(6) 2017. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT RECEIVED VIA REGULATORY AUTHORITY REFERS TO A CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND SHE PRESENTED PELVIC PAIN AND HAD HER GALLBLADDER REMOVED AS IT WAS HIGHLY INFLAMED (SEEN AS CHOLECYSTITIS). CONSUMER HAD ESSURE REMOVED APPROXIMATELY 9 YEARS AFTER INSERTION. THE REPORTED EVENTS ARE SERIOUS DUE TO MEDICAL IMPORTANCE. CHOLECYSTITIS IS UNANTICIPATED WHILE OTHER EVENT IS ANTICIPATED IN ESSURE'S REFERENCE SAFETY INFORMATION. AFTER ESSURE INSERTION, PELVIC, BACK AND UNCHARACTERIZED PAIN MAY OCCUR. IN THIS CASE, THE EVENT STARTED AFTER ESSURE INSERTION. CONSIDERING POSITIVE TEMPORAL RELATIONSHIP AND EVENT'S NATURE, CAUSALITY WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. REGARDING CHOLECYSTITIS, CONSIDERING ESSURE'S LOCAL ACTION IN FALLOPIAN TUBES AND EVENT'S PATHOPHYSIOLOGY CAUSALITY CAN BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED. ACCORDING TO THE PRODUCT TECHNICAL ANALYSIS, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. NO FURTHER INFORMATION WILL BE AVAILABLE, BECAUSE HEALTH AUTHORITY DOES NOT ALLOW ACTIVE FOLLOW-UP.
THIS CASE WAS REPORTED VIA REGULATORY AUTHORITY (B)(4) ON 09-MAR-2017. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") AND CHOLECYSTITIS ("I HAVE HAD MY GALLBLADDER REMOVED AS IT WAS HIGHLY INFLAMED") IN A FEMALE PATIENT WHO RECEIVED ESSURE (ESS205) (BATCH NO. 624275). THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED NECK PAIN (NECK PAIN WITH PERIOD. PAINFUL BUT NOT UNBEARABLE.), BLADDER INCONTINENCE (MINOR URINARY LEAKS ON EFFORT. NO TREATMENT.) AND PREGNANCY. SHE STATED SHE COULD HAVE MOVED MOUNTAINS BEFORE CONSTANT SUFFERING STARTED. ON (B)(6) 2008, THE PATIENT STARTED ESSURE (ESS205). ON (B)(6) 2010, 716 DAYS AFTER STARTING ESSURE (ESS205), THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED), CHOLECYSTITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PAIN ("OVER THE YEARS, PROBLEMS HAVE PROGRESSIVELY SET IN ALL OVER MY BODY, NEW ACHES AND PAINFUL AREAS REGULARLY APPEAR, I WENT FROM WORKING FULL DAYS TO 4-HOUR HALF DAYS"), DYSMENORRHOEA ("VERY PAINFUL MENSTRUAL PERIODS"), MENORRHAGIA ("MORE OR LESS HAEMORRHAGIC PERIODS"), OLIGOMENORRHOEA ("SOMETIMES NO MENSTRUAL PERIOD"), NECK PAIN ("TERRIBLE NECK PAIN"), TACHYCARDIA ("TACHYCARDIA"), OESOPHAGEAL SPASM ("SPASMS OF OESOPHAGUS"), TENDONITIS ("TENDONITIS AND TENOSYNOVITIS HAVE PROGRESSIVELY SET IN, AFFECTING MY ELBOWS AND HIPS (GLUTEUS MEDIUS, TROCHANTER)"), TENOSYNOVITIS ("TENDONITIS AND TENOSYNOVITIS HAVE PROGRESSIVELY SET IN, AFFECTING MY ELBOWS AND HIPS (GLUTEUS MEDIUS, TROCHANTER)"), SPONDYLITIS ("SPONDYLARTHRITIS"), ARTHRALGIA ("JOINT PAIN IN THE HANDS, FINGERS, SHOULDERS, BACK, THIGHS, KNEES AND HEELS"), MYALGIA ("MUSCLE PAIN IN THE HANDS, FINGERS, SHOULDERS, BACK, THIGHS, KNEES AND HEELS"), FIBROMYALGIA ("FIBROMYALGIA"), NEURALGIA ("NERVE PAIN IN THE HANDS, FINGERS, SHOULDERS, BACK, THIGHS, KNEES AND HEELS"), HEADACHE ("HEADACHES"), DIZZINESS ("DIZZY SPELLS SOMETIMES VERY VIOLENT (LIKE LAST SUMMER, WITH THE FEELING THAT EVERYTHING IS MOVING INSIDE MY HEAD)"), DEPRESSED MOOD ("AFFECTS MORALE, LOSS OF MORALE, A MORE OR LESS DEPRESSIVE STATE SETS IN"), INSOMNIA ("INSOMNIA"), ASTHENIA ("LACK OF STRENGTH AND RESISTANCE TO EFFORT"), FATIGUE ("CHRONIC FATIGUE"), ALOPECIA ("HAIR LOSS"), TRICHORRHEXIS ("HAIR SOFT AND BREAKABLE"), ONYCHOCLASIS ("NAILS SOFT AND BREAKABLE") AND CYST ("CYST THAT COMES AND GOES IN ONE EAR"). IN 2016, THE PATIENT EXPERIENCED VERTIGO ("DIZZY SPELLS SOMETIMES VERY VIOLENT (LIKE LAST SUMMER, WITH THE FEELING THAT EVERYTHING IS MOVING INSIDE MY HEAD)"). ON (B)(6) 2017, THE PATIENT EXPERIENCED BOWEL MOVEMENT IRREGULARITY ("MY BOWEL MOVEMENTS ARE TOPSY-TURVY"). THE PATIENT WAS TREATED WITH IBUPROFEN, ANTIINFLAMMATORIES FOR A VERY LONG TIME, SURGERY (GALLBLADDER WAS REMOVED) AND SURGERY (ON (B)(6) 2017, ESSURE WAS REMOVED). ON AN UNSPECIFIED DATE, SHE EXPERIENCED DYSPEPSIA ("FURTHER GASTRO-OESOPHAGEAL PROBLEMS "). AT THE TIME OF THE REPORT, THE PELVIC PAIN, CHOLECYSTITIS, PAIN, DYSMENORRHOEA, MENORRHAGIA, OLIGOMENORRHOEA, NECK PAIN, TACHYCARDIA, OESOPHAGEAL SPASM, TENDONITIS, TENOSYNOVITIS, SPONDYLITIS, ARTHRALGIA, MYALGIA, FIBROMYALGIA, NEURALGIA, BOWEL MOVEMENT IRREGULARITY, HEADACHE, VERTIGO, DIZZINESS, DEPRESSED MOOD, INSOMNIA, ASTHENIA, FATIGUE, ALOPECIA, TRICHORRHEXIS, ONYCHOCLASIS, DYSPEPSIA AND CYST OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR PELVIC PAIN, CHOLECYSTITIS, PAIN, DYSMENORRHOEA, MENORRHAGIA, OLIGOMENORRHOEA, NECK PAIN, TACHYCARDIA, OESOPHAGEAL SPASM, TENDONITIS, TENOSYNOVITIS, SPONDYLITIS, ARTHRALGIA, MYALGIA, FIBROMYALGIA, NEURALGIA, BOWEL MOVEMENT IRREGULARITY, HEADACHE, VERTIGO, DIZZINESS, DEPRESSED MOOD, INSOMNIA, ASTHENIA, FATIGUE, ALOPECIA, TRICHORRHEXIS, ONYCHOCLASIS, DYSPEPSIA AND CYST WITH ESSURE (ESS205). THE REPORTER COMMENTED: ALL OF THE BLOOD TESTS, X-RAYS, ULTRASOUND AND MRI FOUND ABSOLUTELY NOTHING, EXCEPT FOR THE PRESENCE OF TENDONITIS. NATURALLY, PEOPLE THINK I AM A HYPOCHONDRIAC, BUT BECAUSE MY BODY RESPONDS VERY WELL TO ANTIINFLAMMATORIES, I WAS DIAGNOSED WITH SPONDYLOARTHRITIS, AND THEN WITH FIBROMYALGIA. FOR A VERY LONG TIME I TOOK ANTI-INFLAMMATORIES, WHICH LED TO FURTHER GASTRO-OESOPHAGEAL PROBLEMS. OBVIOUSLY, CONSTANT SUFFERING IN SOMEONE WHO COULD HAVE MOVED MOUNTAINS BEFORE AFFECTS MORALE AND A MORE OR LESS DEPRESSIVE STATE SETS IN. OF COURSE ALL OF THIS HAS HAD REPERCUSSIONS ON MY PROFESSIONAL ACTIVITY AND THEREFORE ON MY SALARY. I WORK IN RETAIL SO I AM ALWAYS ON MY FEET. I WENT FROM WORKING FULL DAYS TO 4-HOUR HALF DAYS. DIAGNOSTIC RESULTS: ALL OF THE BLOOD TESTS, X-RAYS, ULTRASOUND AND MRI: ABSOLUTELY NOTHING, EXCEPT FOR THE PRESENCE OF TENDONITIS. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT RECEIVED VIA REGULATORY AUTHORITY REFERS TO A CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND SHE PRESENTED PELVIC PAIN AND HAD HER GALLBLADDER REMOVED AS IT WAS HIGHLY INFLAMED (SEEN AS CHOLECYSTITIS). CONSUMER HAD ESSURE REMOVED APPROXIMATELY 9 YEARS AFTER INSERTION. THE REPORTED EVENTS ARE SERIOUS DUE TO MEDICAL IMPORTANCE. CHOLECYSTITIS IS UNANTICIPATED WHILE OTHER EVENT IS ANTICIPATED IN ESSURE'S REFERENCE SAFETY INFORMATION. AFTER ESSURE INSERTION, PELVIC, BACK AND UNCHARACTERIZED PAIN MAY OCCUR. IN THIS CASE, THE EVENT STARTED AFTER ESSURE INSERTION. CONSIDERING POSITIVE TEMPORAL RELATIONSHIP AND EVENT'S NATURE, CAUSALITY WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. REGARDING CHOLECYSTITIS, CONSIDERING ESSURE'S LOCAL ACTION IN FALLOPIAN TUBES AND EVENT'S PATHOPHYSIOLOGY CAUSALITY CAN BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED. THE PRODUCT TECHNICAL ANALYSIS HAS BEEN SOUGHT. NO FURTHER INFORMATION WILL BE AVAILABLE, BECAUSE HEALTH AUTHORITY DOES NOT ALLOW ACTIVE FOLLOW-UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 245419 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS205 | 624275 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |