ESSURE
Report
- Report Number
- 2951250-2017-03319
- Event Type
- Injury
- Date Received
- September 1, 2017
- Report Date
- March 14, 2019
- 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 INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM, REFERENCE NUMBER: (B)(4)) ON (B)(6) 2017. THE MOST RECENT INFORMATION WAS RECEIVED ON 08-MAR-2019. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN ESPECIALLY ON RIGHT, FEELING OF UTERINE PROLAPSE"), DEVICE DISLOCATION ("ESSURE IN DISTAL POSITION ON THE RIGHT SIDE AND IN MORE DISTAL POSITION ON THE LEFT SIDE"), MAJOR DEPRESSION ("MAJOR DEPRESSION WITH PSYCHOLOGICAL FOLLOW-UP SINCE (B)(6) 2012 AND TREATMENT"), ANXIETY ("MAJOR ANXIETY DEPRESSIVE SYNDROME"), ROTATOR CUFF SYNDROME ("CHRONIC TENDINITIS IN SHOULDERS") AND ARTHRALGIA ("INTENSE JOINT PAIN ALL OVER, ESPECIALLY THE ANKLES, WRISTS AND FINGERS/INCAPACITATING JOINT PAIN") IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882192) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ANXIETY DEPRESSION, ARTHROMYALGIA (JOINT AND MUSCLE PAIN, BUT MUCH LESS INTENSE THAN NOW), FIBROMYALGIA, PARITY 2 AND ALLERGY TO METALS. SHE STATED SHE HAD AN EXCELLENT MEMORY. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("I HAD THE PROCEDURE WITHOUT ANAESTHETIC AND SUFFERED TERRIBLY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MAJOR DEPRESSION (SERIOUSNESS CRITERION DISABILITY). IN 2012, THE PATIENT EXPERIENCED DIZZINESS ("DIZZINESS, ON THE VERGE OF COLLAPSE SINCE EARLY 2012") AND PAIN IN JAW ("JAW PAIN, FITTED WITH BITE GUARD AT NIGHT SINCE 2012"). IN (B)(6) 2013, THE PATIENT EXPERIENCED FIBROMYALGIA ("FIBROMYALGIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ANXIETY (SERIOUSNESS CRITERION DISABILITY), ROTATOR CUFF SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ARTHRALGIA (SERIOUSNESS CRITERION DISABILITY), FEELING ABNORMAL ("LOWER ABDOMINAL PAIN ESPECIALLY ON RIGHT, FEELING OF UTERINE PROLAPSE"), MOOD ALTERED ("MOOD DISTURBANCE"), IRRITABILITY ("IRRITABILITY"), INSOMNIA ("INSOMNIA"), FATIGUE ("CHRONIC FATIGUE - THE SLIGHTEST PHYSICAL EFFORT IS EXHAUSTING"), HEADACHE ("HEADACHE"), HYPOTENSION ("LOW BLOOD PRESSURE"), MEMORY IMPAIRMENT ("DISTURBANCES OF MEMORY, ATTENTION AND CONCENTRATION"), DISTURBANCE IN ATTENTION ("DISTURBANCES OF MEMORY, ATTENTION AND CONCENTRATION"), TINNITUS ("TINNITUS"), SINUSITIS ("SINUSITIS"), VISUAL ACUITY REDUCED ("INCREASING REDUCTION IN VISION"), SKIN WARM ("INTENSE HEAT IN LEGS AT NIGHT"), ABDOMINAL DISTENSION ("ABDOMEN VERY SWOLLEN, ALMOST LIKE A PREGNANT WOMAN."), MENSTRUATION IRREGULAR ("VERY RANDOM MENSTRUAL PERIODS ALTERNATING WITH UNFORESEEABLE HAEMORRHAGIC BLEEDS, ALMOST DAILY"), MENORRHAGIA ("VERY RANDOM MENSTRUAL PERIODS ALTERNATING WITH UNFORESEEABLE HAEMORRHAGIC BLEEDS, ALMOST DAILY."), LOSS OF LIBIDO ("LOSS OF LIBIDO"), DYSPAREUNIA ("PAIN DURING SEXUAL INTERCOURSE"), STRESS URINARY INCONTINENCE ("URINARY LEAKAGE WHEN WALKING AND DURING SEXUAL INTERCOURSE"), MICTURITION URGENCY ("FREQUENT URGE TO URINATE"), MUSCULOSKELETAL PAIN ("BEFORE THE PROCEDURE, I HAD JOINT AND MUSCLE PAIN, BUT MUCH LESS INTENSE THAN NOW"), NECK PAIN ("CHRONIC NECK PAIN"), MYALGIA ("GENERALISED MUSCLE PAIN"), PAIN OF SKIN ("SORE SPOT IN BACK THAT DESCENDS ALONG THE BACK OF MY LEG TO THE KNEE") AND SOMATIC SYMPTOM DISORDER ("MULTIPLE SOMATIC SYMPTOMS"). THE PATIENT WAS TREATED WITH SURGERY (IN (B)(6) 2014, OPERATION DUE TO CHRONIC TENDINITIS IN SHOULDERS AND NON CONSERVATIVE TOTAL HYSTERECTOMY FOR ESSURE REMOVAL ON (B)(6) 2017) AND FITTED WITH BITE GUARD AT NIGHT SINCE 2012. ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, DEVICE DISLOCATION, MAJOR DEPRESSION, ANXIETY, ROTATOR CUFF SYNDROME, FEELING ABNORMAL, MOOD ALTERED, IRRITABILITY, INSOMNIA, FATIGUE, HEADACHE, DIZZINESS, HYPOTENSION, MEMORY IMPAIRMENT, DISTURBANCE IN ATTENTION, TINNITUS, SINUSITIS, VISUAL ACUITY REDUCED, SKIN WARM, ABDOMINAL DISTENSION, MENSTRUATION IRREGULAR, MENORRHAGIA, LOSS OF LIBIDO, DYSPAREUNIA, STRESS URINARY INCONTINENCE, MICTURITION URGENCY, PROCEDURAL PAIN, NECK PAIN, PAIN IN JAW, PAIN OF SKIN AND SOMATIC SYMPTOM DISORDER OUTCOME WAS UNKNOWN AND THE ARTHRALGIA, MUSCULOSKELETAL PAIN, FIBROMYALGIA AND MYALGIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ANXIETY, ARTHRALGIA, DEVICE DISLOCATION, DISTURBANCE IN ATTENTION, DIZZINESS, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FIBROMYALGIA, HEADACHE, HYPOTENSION, INSOMNIA, IRRITABILITY, LOSS OF LIBIDO, MAJOR DEPRESSION, MEMORY IMPAIRMENT, MENORRHAGIA, MENSTRUATION IRREGULAR, MICTURITION URGENCY, MOOD ALTERED, MUSCULOSKELETAL PAIN, MYALGIA, NECK PAIN, PAIN IN JAW, PAIN OF SKIN, PROCEDURAL PAIN, ROTATOR CUFF SYNDROME, SINUSITIS, SKIN WARM, SOMATIC SYMPTOM DISORDER, STRESS URINARY INCONTINENCE, TINNITUS AND VISUAL ACUITY REDUCED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BEFORE THE PROCEDURE, SHE HAD JOINT AND MUSCLE PAIN, BUT MUCH LESS INTENSE THAN NOW. SHE ALSO HAD A BACKGROUND OF ANXIETY-DEPRESSION. ON THE VERGE OF COLLAPSE SINCE EARLY 2012 BECAUSE THE PROBLEMS THAT WERE ALREADY PRESENT HAVE BECOME WORSE AND NEW PROBLEMS HAVE APPEARED. SHE ENDED UP CONSULTING A PSYCHIATRIST IN (B)(6) 2012, WHO FOLLOWED HER UNTIL RECENTLY. SHE HAS MOVED HOUSE SINCE THEN. EVERYTHING HAPPENED VERY QUICKLY WITH HEALTH PROBLEMS AS SOON AS THE INSERTS WERE PLACED. ON UNKNOWN DATE: TESTS BY RHEUMATOLOGIST BEFORE ESSURE: NEGATIVE. SO HAVING RULED OUT OTHER CONDITIONS, IN (B)(6) 2013, HE THOUGHT IT MIGHT BE FIBROMYALGIA ON UNKNOWN DATE: URODYNAMIC STUDIES: URINARY LEAKAGE WHEN WALKING AND DURING SEXUAL INTERCOURSE SURGERY REPORT ON (B)(6) 207: NON CONSERVATIVE TOTAL HYSTERECTOMY FOR ESSURE REMOVAL FOLLOWING SIGNIFICANT DETERIORATION OF HER STATE OF HEALTH. SHE WAS ON SICK LEAVE FOR MAJOR ANXIETY DEPRESSIVE SYNDROME AND JOINT PAIN FOR LONG DURATION ((B)(6) 2013, (B)(6) 2013; (B)(6) 2013, (B)(6) 2014, (B)(6) 2014,(B)(6) 2014 AND (B)(6) 2015). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN - ON (B)(6) 2017: UTERUS OF NORMAL SIZE AND STRUCTURE EXCEPT THE PRESENCE OF ADENOMYOSIS; ABSENCE OF HYPERTROPHY OF ENDOMETRIUM AND ANNEX ANOMALY. LOCATION OF ESSURE: DISTAL ON THE RIGHT, VERY DISTAL ON THE LEFT. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-MAR-2019: INFORMATION RECEIVED VIA LEGAL TEAM. PATIENT'S MEDICAL HISTORY INCLUDED PARA II. TUBAL STERILIZATION WITH ESSURE, REPORT DATED (B)(6) 2011. INDICATION: REQUEST FROM THE PATIENT FOR TUBAL STERILIZATION. SURGERY REPORT ON (B)(6) 2017: NON CONSERVATIVE TOTAL HYSTERECTOMY FOR ESSURE REMOVAL.ALLERGY WITH MERCURY AND TIN. NO ALLERGY WITH NICKEL.SHE WAS ON SICK LEAVE FOR MAJOR ANXIETY DEPRESSIVE SYNDROME AND JOINT PAIN FOR LONG DURATION ((B)(6) 2013, (B)(6) 2013; (B)(6) 2013, (B)(6) 2014, (B)(6) 2014,(B)(6) 2014 AND (B)(6) 2015).PELVIC ULTRASOUND PERFORMED ON (B)(6) 2017. CONCLUSION: UTERUS OF NORMAL SIZE AND STRUCTURE EXCEPT THE PRESENCE OF ADENOMYOSIS; ABSENCE OF HYPERTROPHY OF ENDOMETRIUM AND ANNEX ANOMALY. LOCATION OF ESSURE: DISTAL ON THE RIGHT, VERY DISTAL ON THE LEFT. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM, REFERENCE NUMBER: R1704027) ON 24-MAR-2017. THE MOST RECENT INFORMATION WAS RECEIVED ON 31-JAN-2019. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN ESPECIALLY ON RIGHT, FEELING OF UTERINE PROLAPSE"), DEVICE DISLOCATION ("ESSURE IN DISTAL POSITION ON THE RIGHT SIDE AND IN MORE DISTAL POSITION ON THE LEFT SIDE"), ARTHRALGIA ("INTENSE JOINT PAIN ALL OVER, ESPECIALLY THE ANKLES, WRISTS AND FINGERS/INCAPACITATING JOINT PAIN"), MAJOR DEPRESSION ("MAJOR DEPRESSION WITH PSYCHOLOGICAL FOLLOW-UP SINCE (B)(6)2012 AND TREATMENT") AND ROTATOR CUFF SYNDROME ("CHRONIC TENDINITIS IN SHOULDERS") IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882192) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ANXIETY DEPRESSION, ARTHROMYALGIA (JOINT AND MUSCLE PAIN, BUT MUCH LESS INTENSE THAN NOW) AND FIBROMYALGIA. SHE STATED SHE HAD AN EXCELLENT MEMORY. ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2011, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("I HAD THE PROCEDURE WITHOUT ANAESTHETIC AND SUFFERED TERRIBLY"). IN (B)(6)2012, THE PATIENT EXPERIENCED MAJOR DEPRESSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2012, THE PATIENT EXPERIENCED DIZZINESS ("DIZZINESS, ON THE VERGE OF COLLAPSE SINCE EARLY 2012") AND PAIN IN JAW ("JAW PAIN, FITTED WITH BITE GUARD AT NIGHT SINCE 2012"). IN (B)(6)2013, THE PATIENT EXPERIENCED FIBROMYALGIA ("FIBROMYALGIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ARTHRALGIA (SERIOUSNESS CRITERION DISABILITY), ROTATOR CUFF SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FEELING ABNORMAL ("LOWER ABDOMINAL PAIN ESPECIALLY ON RIGHT, FEELING OF UTERINE PROLAPSE"), MOOD ALTERED ("MOOD DISTURBANCE"), IRRITABILITY ("IRRITABILITY"), INSOMNIA ("INSOMNIA"), FATIGUE ("CHRONIC FATIGUE - THE SLIGHTEST PHYSICAL EFFORT IS EXHAUSTING"), HEADACHE ("HEADACHE"), HYPOTENSION ("LOW BLOOD PRESSURE"), MEMORY IMPAIRMENT ("DISTURBANCES OF MEMORY, ATTENTION AND CONCENTRATION"), DISTURBANCE IN ATTENTION ("DISTURBANCES OF MEMORY, ATTENTION AND CONCENTRATION"), TINNITUS ("TINNITUS"), SINUSITIS ("SINUSITIS"), VISUAL ACUITY REDUCED ("INCREASING REDUCTION IN VISION"), SKIN WARM ("INTENSE HEAT IN LEGS AT NIGHT"), ABDOMINAL DISTENSION ("ABDOMEN VERY SWOLLEN, ALMOST LIKE A PREGNANT WOMAN."), MENSTRUATION IRREGULAR ("VERY RANDOM MENSTRUAL PERIODS ALTERNATING WITH UNFORESEEABLE HAEMORRHAGIC BLEEDS, ALMOST DAILY"), MENORRHAGIA ("VERY RANDOM MENSTRUAL PERIODS ALTERNATING WITH UNFORESEEABLE HAEMORRHAGIC BLEEDS, ALMOST DAILY."), LOSS OF LIBIDO ("LOSS OF LIBIDO"), DYSPAREUNIA ("PAIN DURING SEXUAL INTERCOURSE"), STRESS URINARY INCONTINENCE ("URINARY LEAKAGE WHEN WALKING AND DURING SEXUAL INTERCOURSE"), MICTURITION URGENCY ("FREQUENT URGE TO URINATE"), MUSCULOSKELETAL PAIN ("BEFORE THE PROCEDURE, I HAD JOINT AND MUSCLE PAIN, BUT MUCH LESS INTENSE THAN NOW"), NECK PAIN ("CHRONIC NECK PAIN"), MYALGIA ("GENERALISED MUSCLE PAIN"), PAIN OF SKIN ("SORE SPOT IN BACK THAT DESCENDS ALONG THE BACK OF MY LEG TO THE KNEE"), ANXIETY ("MAJOR DEPRESSIVE SYNDROME") AND SOMATIC SYMPTOM DISORDER ("MULTIPLE SOMATIC SYMPTOMS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL ON (B)(6)2017 AND IN (B)(6)2014, OPERATION DUE TO CHRONIC TENDINITIS IN SHOULDERS) AND FITTED WITH BITE GUARD AT NIGHT SINCE 2012. ESSURE WAS REMOVED ON (B)(6)2017. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, DEVICE DISLOCATION, MAJOR DEPRESSION, ROTATOR CUFF SYNDROME, FEELING ABNORMAL, MOOD ALTERED, IRRITABILITY, INSOMNIA, FATIGUE, HEADACHE, DIZZINESS, HYPOTENSION, MEMORY IMPAIRMENT, DISTURBANCE IN ATTENTION, TINNITUS, SINUSITIS, VISUAL ACUITY REDUCED, SKIN WARM, ABDOMINAL DISTENSION, MENSTRUATION IRREGULAR, MENORRHAGIA, LOSS OF LIBIDO, DYSPAREUNIA, STRESS URINARY INCONTINENCE, MICTURITION URGENCY, PROCEDURAL PAIN, NECK PAIN, PAIN IN JAW, PAIN OF SKIN, ANXIETY AND SOMATIC SYMPTOM DISORDER OUTCOME WAS UNKNOWN AND THE ARTHRALGIA, MUSCULOSKELETAL PAIN, FIBROMYALGIA AND MYALGIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ANXIETY, ARTHRALGIA, DEVICE DISLOCATION, DISTURBANCE IN ATTENTION, DIZZINESS, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FIBROMYALGIA, HEADACHE, HYPOTENSION, INSOMNIA, IRRITABILITY, LOSS OF LIBIDO, MAJOR DEPRESSION, MEMORY IMPAIRMENT, MENORRHAGIA, MENSTRUATION IRREGULAR, MICTURITION URGENCY, MOOD ALTERED, MUSCULOSKELETAL PAIN, MYALGIA, NECK PAIN, PAIN IN JAW, PAIN OF SKIN, PROCEDURAL PAIN, ROTATOR CUFF SYNDROME, SINUSITIS, SKIN WARM, SOMATIC SYMPTOM DISORDER, STRESS URINARY INCONTINENCE, TINNITUS AND VISUAL ACUITY REDUCED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BEFORE THE PROCEDURE, SHE HAD JOINT AND MUSCLE PAIN, BUT MUCH LESS INTENSE THAN NOW. SHE ALSO HAD A BACKGROUND OF ANXIETY-DEPRESSION. ON THE VERGE OF COLLAPSE SINCE EARLY 2012 BECAUSE THE PROBLEMS THAT WERE ALREADY PRESENT HAVE BECOME WORSE AND NEW PROBLEMS HAVE APPEARED. SHE ENDED UP CONSULTING A PSYCHIATRIST IN (B)(6)2012, WHO FOLLOWED HER UNTIL RECENTLY. SHE HAS MOVED HOUSE SINCE THEN. EVERYTHING HAPPENED VERY QUICKLY WITH HEALTH PROBLEMS AS SOON AS THE INSERTS WERE PLACED. STEPS UNDERWAY FOR REMOVAL. ON UNKNOWN DATE: TESTS BY RHEUMATOLOGIST BEFORE ESSURE: NEGATIVE. SO HAVING RULED OUT OTHER CONDITIONS, IN (B)(6)2013, HE THOUGHT IT MIGHT BE FIBROMYALGIA. ON UNKNOWN DATE: URODYNAMIC STUDIES: URINARY LEAKAGE WHEN WALKING AND DURING SEXUAL INTERCOURSE. THE PATIENT HAD 7 SICK LEAVES, ALL FOR DEPRESSION. ESSURE REMOVAL ON (B)(6)2017 FOLLOWING SIGNIFICANT DETERIORATION OF HER STATE OF HEALTH. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN - ON (B)(6)2017: DISTAL POSITION ON RIGHT AND LEFT SIDE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-JAN-2019: CASE BECOME LEGAL. DATE OF BIRTH AND ONSET DATE FOR ESSURE UPDATED. EVENTS ADDED : MAJOR DEPRESSIVE SYNDROME, MULTIPLE SOMATIC SYMPTOMS AND ESSURE IN DISTAL POSITION ON THE RIGHT SIDE AND IN MORE DISTAL POSITION ON THE LEFT SIDE. THE EVENT "INTENSE JOINT PAIN ALL OVER, ESPECIALLY THE ANKLES, WRISTS AND FINGERS" CHANGED TO "INTENSE JOINT PAIN ALL OVER, ESPECIALLY THE ANKLES, WRISTS AND FINGERS/INCAPACITATING JOINT PAIN WITH "DISABILITY" TICKED AS SERIOUS CRITERION. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (B)(6) (REFERENCE NUMBER: (B)(4)) ON 24-MAR-2017. THE MOST RECENT INFORMATION WAS RECEIVED ON 25-SEP-2017. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN ESPECIALLY ON RIGHT, FEELING OF UTERINE PROLAPSE"), MAJOR DEPRESSION ("MAJOR DEPRESSION WITH PSYCHOLOGICAL FOLLOW-UP SINCE (B)(6) 2012 AND TREATMENT") AND ROTATOR CUFF SYNDROME ("CHRONIC TENDINITIS IN SHOULDERS") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882192) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ANXIETY DEPRESSION, ARTHROMYALGIA (JOINT AND MUSCLE PAIN, BUT MUCH LESS INTENSE THAN NOW) AND FIBROMYALGIA. SHE STATED SHE HAD AN EXCELLENT MEMORY. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("I HAD THE PROCEDURE WITHOUT ANAESTHETIC AND SUFFERED TERRIBLY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MAJOR DEPRESSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2012, THE PATIENT EXPERIENCED DIZZINESS ("DIZZINESS, ON THE VERGE OF COLLAPSE SINCE EARLY 2012") AND PAIN IN JAW ("JAW PAIN, FITTED WITH BITE GUARD AT NIGHT SINCE 2012"). IN (B)(6) 2013, THE PATIENT EXPERIENCED FIBROMYALGIA ("FIBROMYALGIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ROTATOR CUFF SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FEELING ABNORMAL ("LOWER ABDOMINAL PAIN ESPECIALLY ON RIGHT, FEELING OF UTERINE PROLAPSE"), MOOD ALTERED ("MOOD DISTURBANCE"), IRRITABILITY ("IRRITABILITY"), INSOMNIA ("INSOMNIA"), FATIGUE ("CHRONIC FATIGUE - THE SLIGHTEST PHYSICAL EFFORT IS EXHAUSTING"), HEADACHE ("HEADACHE"), HYPOTENSION ("LOW BLOOD PRESSURE"), MEMORY IMPAIRMENT ("DISTURBANCES OF MEMORY, ATTENTION AND CONCENTRATION"), DISTURBANCE IN ATTENTION ("DISTURBANCES OF MEMORY, ATTENTION AND CONCENTRATION"), TINNITUS ("TINNITUS"), SINUSITIS ("SINUSITIS"), VISUAL ACUITY REDUCED ("INCREASING REDUCTION IN VISION"), SKIN WARM ("INTENSE HEAT IN LEGS AT NIGHT"), ABDOMINAL DISTENSION ("ABDOMEN VERY SWOLLEN, ALMOST LIKE A PREGNANT WOMAN."), MENSTRUATION IRREGULAR ("VERY RANDOM MENSTRUAL PERIODS ALTERNATING WITH UNFORESEEABLE HAEMORRHAGIC BLEEDS, ALMOST DAILY"), MENORRHAGIA ("VERY RANDOM MENSTRUAL PERIODS ALTERNATING WITH UNFORESEEABLE HAEMORRHAGIC BLEEDS, ALMOST DAILY."), LOSS OF LIBIDO ("LOSS OF LIBIDO"), DYSPAREUNIA ("PAIN DURING SEXUAL INTERCOURSE"), STRESS URINARY INCONTINENCE ("URINARY LEAKAGE WHEN WALKING AND DURING SEXUAL INTERCOURSE"), MICTURITION URGENCY ("FREQUENT URGE TO URINATE"), MUSCULOSKELETAL PAIN ("BEFORE THE PROCEDURE, I HAD JOINT AND MUSCLE PAIN, BUT MUCH LESS INTENSE THAN NOW"), ARTHRALGIA ("INTENSE JOINT PAIN ALL OVER, ESPECIALLY THE ANKLES, WRISTS AND FINGERS"), NECK PAIN ("CHRONIC NECK PAIN"), MYALGIA ("GENERALISED MUSCLE PAIN") AND PAIN OF SKIN ("SORE SPOT IN BACK THAT DESCENDS ALONG THE BACK OF MY LEG TO THE KNEE"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL ON (B)(6) 2017) AND SURGERY (IN (B)(6) 2014, OPERATION DUE TO CHRONIC TENDINITIS IN SHOULDERS). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, MAJOR DEPRESSION, ROTATOR CUFF SYNDROME, FEELING ABNORMAL, MOOD ALTERED, IRRITABILITY, INSOMNIA, FATIGUE, HEADACHE, DIZZINESS, HYPOTENSION, MEMORY IMPAIRMENT, DISTURBANCE IN ATTENTION, TINNITUS, SINUSITIS, VISUAL ACUITY REDUCED, SKIN WARM, ABDOMINAL DISTENSION, MENSTRUATION IRREGULAR, MENORRHAGIA, LOSS OF LIBIDO, DYSPAREUNIA, STRESS URINARY INCONTINENCE, MICTURITION URGENCY, PROCEDURAL PAIN, NECK PAIN, PAIN IN JAW AND PAIN OF SKIN OUTCOME WAS UNKNOWN AND THE MUSCULOSKELETAL PAIN, ARTHRALGIA, FIBROMYALGIA AND MYALGIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ARTHRALGIA, DISTURBANCE IN ATTENTION, DIZZINESS, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FIBROMYALGIA, HEADACHE, HYPOTENSION, INSOMNIA, IRRITABILITY, LOSS OF LIBIDO, MAJOR DEPRESSION, MEMORY IMPAIRMENT, MENORRHAGIA, MENSTRUATION IRREGULAR, MICTURITION URGENCY, MOOD ALTERED, MUSCULOSKELETAL PAIN, MYALGIA, NECK PAIN, PAIN IN JAW, PAIN OF SKIN, PROCEDURAL PAIN, ROTATOR CUFF SYNDROME, SINUSITIS, SKIN WARM, STRESS URINARY INCONTINENCE, TINNITUS AND VISUAL ACUITY REDUCED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BEFORE THE PROCEDURE, SHE HAD JOINT AND MUSCLE PAIN, BUT MUCH LESS INTENSE THAN NOW. SHE ALSO HAD A BACKGROUND OF ANXIETY-DEPRESSION. ON THE VERGE OF COLLAPSE SINCE EARLY 2012 BECAUSE THE PROBLEMS THAT WERE ALREADY PRESENT HAVE BECOME WORSE AND NEW PROBLEMS HAVE APPEARED. SHE ENDED UP CONSULTING A PSYCHIATRIST IN (B)(6) 2012, WHO FOLLOWED HER UNTIL RECENTLY. SHE HAS MOVED HOUSE SINCE THEN. EVERYTHING HAPPENED VERY QUICKLY WITH HEALTH PROBLEMS AS SOON AS THE INSERTS WERE PLACED. STEPS UNDERWAY FOR REMOVAL. ESSURE REMOVAL ON (B)(6) 2017 FOLLOWING SIGNIFICANT DETERIORATION OF HER STATE OF HEALTH. DIAGNOSTIC RESULTS: ON UNKNOWN DATE: TESTS BY RHEUMATOLOGIST BEFORE ESSURE: NEGATIVE. SO HAVING RULED OUT OTHER CONDITIONS, IN (B)(6) 2013, HE THOUGHT IT MIGHT BE FIBROMYALGIA. ON UNKNOWN DATE: URODYNAMIC STUDIES: URINARY LEAKAGE WHEN WALKING AND DURING SEXUAL INTERCOURSE. 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. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 25-SEP-2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: ABDOMINAL PAIN LOWER. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 504 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: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-SEP-2017: QUALITY SAFETY EVALUATION OF PTC. INCIDENT: NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS CASE WAS REPORTED VIA REGULATORY AUTHORITY ANSM ((B)(4)) ON (B)(6) 2017. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN ESPECIALLY ON RIGHT, FEELING OF UTERINE PROLAPSE"), MAJOR DEPRESSION ("MAJOR DEPRESSION WITH PSYCHOLOGICAL FOLLOW-UP SINCE (B)(6) 2012 AND TREATMENT") AND ROTATOR CUFF SYNDROME ("CHRONIC TENDINITIS IN SHOULDERS") IN A FEMALE PATIENT WHO HAD ESSURE (LOT NUMBER 882192) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ANXIETY DEPRESSION, MUSCULOSKELETAL DISORDER (JOINT AND MUSCLE PAIN, BUT MUCH LESS INTENSE THAN NOW) AND FIBROMYALGIA. SHE STATED SHE HAD AN EXCELLENT MEMORY. ON (B)(6) 2011, THE PATIENT STARTED ESSURE. ON (B)(6) 2011, THE SAME DAY AFTER STARTING ESSURE, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("I HAD THE PROCEDURE WITHOUT ANAESTHETIC AND SUFFERED TERRIBLY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MAJOR DEPRESSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2012, THE PATIENT EXPERIENCED DIZZINESS ("DIZZINESS, ON THE VERGE OF COLLAPSE SINCE EARLY 2012") AND PAIN IN JAW ("JAW PAIN, FITTED WITH BITE GUARD AT NIGHT SINCE 2012"). IN (B)(6) 2013, THE PATIENT EXPERIENCED FIBROMYALGIA ("FIBROMYALGIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ROTATOR CUFF SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FEELING ABNORMAL ("LOWER ABDOMINAL PAIN ESPECIALLY ON RIGHT, FEELING OF UTERINE PROLAPSE"), MOOD ALTERED ("MOOD DISTURBANCE"), IRRITABILITY ("IRRITABILITY"), INSOMNIA ("INSOMNIA"), FATIGUE ("CHRONIC FATIGUE - THE SLIGHTEST PHYSICAL EFFORT IS EXHAUSTING"), HEADACHE ("HEADACHE"), HYPOTENSION ("LOW BLOOD PRESSURE"), MEMORY IMPAIRMENT ("DISTURBANCES OF MEMORY, ATTENTION AND CONCENTRATION"), DISTURBANCE IN ATTENTION ("DISTURBANCES OF MEMORY, ATTENTION AND CONCENTRATION"), TINNITUS ("TINNITUS"), SINUSITIS ("SINUSITIS"), VISUAL ACUITY REDUCED ("INCREASING REDUCTION IN VISION"), SKIN WARM ("INTENSE HEAT IN LEGS AT NIGHT"), ABDOMINAL DISTENSION ("ABDOMEN VERY SWOLLEN, ALMOST LIKE A PREGNANT WOMAN."), MENSTRUATION IRREGULAR ("VERY RANDOM MENSTRUAL PERIODS ALTERNATING WITH UNFORESEEABLE HAEMORRHAGIC BLEEDS, ALMOST DAILY"), MENORRHAGIA ("VERY RANDOM MENSTRUAL PERIODS ALTERNATING WITH UNFORESEEABLE HAEMORRHAGIC BLEEDS, ALMOST DAILY."), LOSS OF LIBIDO ("LOSS OF LIBIDO"), DYSPAREUNIA ("PAIN DURING SEXUAL INTERCOURSE"), URINARY INCONTINENCE ("URINARY LEAKAGE WHEN WALKING AND DURING SEXUAL INTERCOURSE"), MICTURITION URGENCY ("FREQUENT URGE TO URINATE"), MUSCULOSKELETAL PAIN ("BEFORE THE PROCEDURE, I HAD JOINT AND MUSCLE PAIN, BUT MUCH LESS INTENSE THAN NOW"), ARTHRALGIA ("INTENSE JOINT PAIN ALL OVER, ESPECIALLY THE ANKLES, WRISTS AND FINGERS"), NECK PAIN ("CHRONIC NECK PAIN"), MYALGIA ("GENERALISED MUSCLE PAIN") AND PAIN OF SKIN ("SORE SPOT IN BACK THAT DESCENDS ALONG THE BACK OF MY LEG TO THE KNEE"). THE PATIENT WAS TREATED WITH SURGERY (IN (B)(6) 2014, OPERATION DUE TO CHRONIC TENDINITIS IN SHOULDERS) AND ESSURE REMOVAL WAS PERFORMED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, MAJOR DEPRESSION, ROTATOR CUFF SYNDROME, FEELING ABNORMAL, MOOD ALTERED, IRRITABILITY, INSOMNIA, FATIGUE, HEADACHE, DIZZINESS, HYPOTENSION, MEMORY IMPAIRMENT, DISTURBANCE IN ATTENTION, TINNITUS, SINUSITIS, VISUAL ACUITY REDUCED, SKIN WARM, ABDOMINAL DISTENSION, MENSTRUATION IRREGULAR, MENORRHAGIA, LOSS OF LIBIDO, DYSPAREUNIA, URINARY INCONTINENCE, MICTURITION URGENCY, PROCEDURAL PAIN, NECK PAIN, PAIN IN JAW AND PAIN OF SKIN OUTCOME WAS UNKNOWN AND THE MUSCULOSKELETAL PAIN, ARTHRALGIA, FIBROMYALGIA AND MYALGIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, MAJOR DEPRESSION, ROTATOR CUFF SYNDROME, FEELING ABNORMAL, MOOD ALTERED, IRRITABILITY, INSOMNIA, FATIGUE, HEADACHE, DIZZINESS, HYPOTENSION, MEMORY IMPAIRMENT, DISTURBANCE IN ATTENTION, TINNITUS, SINUSITIS, VISUAL ACUITY REDUCED, SKIN WARM, ABDOMINAL DISTENSION, MENSTRUATION IRREGULAR, MENORRHAGIA, LOSS OF LIBIDO, DYSPAREUNIA, URINARY INCONTINENCE, MICTURITION URGENCY, PROCEDURAL PAIN, MUSCULOSKELETAL PAIN, ARTHRALGIA, NECK PAIN, PAIN IN JAW, FIBROMYALGIA, MYALGIA AND PAIN OF SKIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BEFORE THE PROCEDURE, SHE HAD JOINT AND MUSCLE PAIN, BUT MUCH LESS INTENSE THAN NOW. SHE ALSO HAD A BACKGROUND OF ANXIETY-DEPRESSION. ON THE VERGE OF COLLAPSE SINCE EARLY 2012 BECAUSE THE PROBLEMS THAT WERE ALREADY PRESENT HAVE BECOME WORSE AND NEW PROBLEMS HAVE APPEARED. SHE ENDED UP CONSULTING A PSYCHIATRIST IN (B)(6) 2012, WHO FOLLOWED HER UNTIL RECENTLY. SHE HAS MOVED HOUSE SINCE THEN. EVERYTHING HAPPENED VERY QUICKLY WITH HEALTH PROBLEMS AS SOON AS THE INSERTS WERE PLACED. STEPS UNDERWAY FOR REMOVAL. ESSURE WAS REMOVED ON (B)(6) 2017 FOLLOWING SIGNIFICANT DETERIORATION OF HER STATE OF HEALTH. DIAGNOSTIC RESULTS: ON UNKNOWN DATE: TESTS BY RHEUMATOLOGIST BEFORE ESSURE: NEGATIVE. SO HAVING RULED OUT OTHER CONDITIONS, IN (B)(6) 2013, HE THOUGHT IT MIGHT BE FIBROMYALGIA. ON UNKNOWN DATE: URODYNAMIC STUDIES: URINARY LEAKAGE WHEN WALKING AND DURING SEXUAL INTERCOURSE. THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS CODED WITH THE SAME MEDDRA PREFERRED TERMS. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON (B)(6) 2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: ABDOMINAL PAIN LOWER: 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. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2017: ESSURE REMOVAL INFORMATION WAS REPORTED. 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 |
|---|---|---|---|---|---|---|---|
| 617391 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 882192 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Other| R |