ESSURE
Report
- Report Number
- 2951250-2017-06212
- Event Type
- Injury
- Date Received
- November 3, 2017
- Report Date
- August 9, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF THE FIRST EPISODE OF DEVICE DISLOCATION ("NO ESSURE DEVICE WAS IDENTIFIED ON THE LEFT SIDE/ X-RAY SHOWED A BROKEN ESSURE COIL IN PELVIC AREA/ MIGRATION OF ESSURE DEVICE ¿ MIGRATION OF ESSURE MICRO-INSERT FURTHER UP LEFT TUBE"), DEVICE BREAKAGE ("ESSURE DEVICE WAS IDENTIFIED ON THE LEFT SIDE/ X-RAY SHOWED A BROKEN ESSURE COIL IN PELVIC AREA/ DEVICE BROKEN ON LEFT SIDE"), THE SECOND EPISODE OF DEVICE DISLOCATION ("THE RIGHT ESSURE COIL HAD MIGRATED"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING") AND CUSHING'S SYNDROME ("CUSHING¿S") IN A 47-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 624840) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED KIDNEY STONE, HYPERTENSION, OVARIAN CYST, GASTROESOPHAGEAL REFLUX, ANXIETY, BLADDER SUSPENSION, OSTEOARTHRITIS AND CHEST PAIN. CONCURRENT CONDITIONS INCLUDED URINARY INCONTINENCE, UTERINE BLEEDING, ENDOMETRIOSIS AND CYSTITIS INTERSTITIAL. CONCOMITANT PRODUCTS INCLUDED FROVATRIPTAN SUCCINATE MONOHYDRATE (FROVA) AND NAPROXEN (NAPROSYN). ON (B)(6) 2007, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 6 YEARS 1 MONTH AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED SKIN DISORDER ("SKIN CHANGES") AND HAIR DISORDER ("SKIN CHANGES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED THE FIRST EPISODE OF DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE SECOND EPISODE OF DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), CUSHING'S SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN/ PAIN"), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN/ DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("PROLONGED CYCLES"), ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN / CRAMPING"), DYSPAREUNIA ("PAIN DURING INTERCOURSE/ DYSPAREUNIA"), FATIGUE ("FATIGUE"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION"), DEPRESSION ("DEPRESSION"), ARTHRALGIA ("JOINT PAIN"), MYALGIA ("MUSCLE PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), FIBROMYALGIA ("FIBROMYALGIA"), BLADDER DISORDER ("BLADDER PROBLEM"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), HYPERTENSION ("HIGH BLOOD PRESSURE"), THE FIRST EPISODE OF PALPITATIONS ("HEART PALPITATIONS"), TOOTH DISORDER ("DENTAL PROBLEM"), ABDOMINAL DISTENSION ("BLOATING"), GASTRIC DISORDER ("STOMACH ISSUES"), ANAL INCONTINENCE ("FECAL INCONTINENCE"), ALOPECIA ("HAIR LOSS"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), HAEMATURIA ("MICROSCOPIC HEMATURIA"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), FEELING ABNORMAL ("BRAIN FOG"), AMNESIA ("MEMORY LOSS"), ANXIETY ("ANXIETY"), UTERINE LEIOMYOMA ("FIBROIDS IN UTERUS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VISUAL IMPAIRMENT ("VISION CHANGES"), WEIGHT INCREASED ("WEIGHT GAIN"), INSOMNIA ("INSOMNIA"), DIZZINESS ("DIZZY SPELLS"), VERTIGO ("VERTIGO"), VITAMIN D DEFICIENCY ("VITAMIN D DEFICIENCY"), BACK PAIN ("BACK PAIN"), BREAST PAIN ("BREAST PAIN"), THE SECOND EPISODE OF PALPITATIONS ("HEART PALPITATION"), UBIQUINONE DECREASED ("COQ10 DEFICIENT"), NAUSEA ("NAUSEA"), GINGIVAL RECESSION ("RECEDING GUMS"), C-REACTIVE PROTEIN INCREASED ("CRP EXTREMELY HIGH"), URINARY INCONTINENCE ("URINARY INCONTINENCE"), NEURALGIA ("NERVE PAIN"), PAIN ("BODY PAIN ") AND UTERINE PAIN ("UTERINE PAIN"). THE PATIENT WAS TREATED WITH LORAZEPAM, OXYCODONE, LORAZEPAM (ATIVAN), ESTRADIOL (ESTRACE), ONDANSETRON, COLECALCIFEROL (VITAMIN D), SURGERY (TOTAL HYSTERECTOMY AND SALPINGECTOMY TO REMOVE THE SECOND, BROKEN DEVICE) AND SURGERY (UNDERWENT AN OPERATIVE HYSTEROSCOPY ON 26-FEB-2009 AND RIGHT DEVICE WAS SUBSEQUENTLY REMOVED). ESSURE WAS REMOVED ON 26-FEB-2009. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, THE LAST EPISODE OF DEVICE DISLOCATION, GENITAL HAEMORRHAGE, CUSHING'S SYNDROME, PELVIC PAIN, DYSMENORRHOEA, MENORRHAGIA, ABDOMINAL PAIN LOWER, DYSPAREUNIA, FATIGUE, WEIGHT FLUCTUATION, DEPRESSION, ARTHRALGIA, MYALGIA, VAGINAL HAEMORRHAGE, HYPERSENSITIVITY, FEMALE SEXUAL DYSFUNCTION, FIBROMYALGIA, BLADDER DISORDER, URINARY TRACT DISORDER, HYPERTENSION, TOOTH DISORDER, ABDOMINAL DISTENSION, GASTRIC DISORDER, ANAL INCONTINENCE, ALOPECIA, SKIN DISORDER, HAIR DISORDER, URINARY TRACT INFECTION, HAEMATURIA, MIGRAINE, HEADACHE, FEELING ABNORMAL, AMNESIA, ANXIETY, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, VISUAL IMPAIRMENT, WEIGHT INCREASED, INSOMNIA, VERTIGO, VITAMIN D DEFICIENCY, THE LAST EPISODE OF PALPITATIONS, UBIQUINONE DECREASED, NAUSEA, GINGIVAL RECESSION, C-REACTIVE PROTEIN INCREASED, NEURALGIA AND PAIN OUTCOME WAS UNKNOWN, THE DIZZINESS AND URINARY INCONTINENCE WAS RESOLVING AND THE UTERINE PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALOPECIA, AMNESIA, ANAL INCONTINENCE, ANXIETY, ARTHRALGIA, BACK PAIN, BLADDER DISORDER, BREAST PAIN, C-REACTIVE PROTEIN INCREASED, CUSHING'S SYNDROME, DEPRESSION, DEVICE BREAKAGE, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FEMALE SEXUAL DYSFUNCTION, FIBROMYALGIA, GASTRIC DISORDER, GENITAL HAEMORRHAGE, GINGIVAL RECESSION, HAEMATURIA, HAIR DISORDER, HEADACHE, HYPERSENSITIVITY, HYPERTENSION, INSOMNIA, MENORRHAGIA, MIGRAINE, MYALGIA, NAUSEA, NEURALGIA, PAIN, PELVIC PAIN, SKIN DISORDER, TOOTH DISORDER, UBIQUINONE DECREASED, URINARY INCONTINENCE, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE LEIOMYOMA, UTERINE PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VERTIGO, VISUAL IMPAIRMENT, VITAMIN D DEFICIENCY, WEIGHT FLUCTUATION, WEIGHT INCREASED, THE FIRST EPISODE OF DEVICE DISLOCATION, THE FIRST EPISODE OF PALPITATIONS, THE SECOND EPISODE OF DEVICE DISLOCATION AND THE SECOND EPISODE OF PALPITATIONS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: IT WAS REPORTED THAT SHE HAD 2 SURGERIES: (B)(6) 2009 (REMOVAL OF UTERINE FOREIGN BODY) AND ON (B)(6) 2017 (LAPAROSCOPIC TOTAL HYSTERECTOMY AND SALPINGECTOMY). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.4 KG/SQM. X-RAY - ON (B)(6) 2015: REVEALED A BROKEN ESSURE COIL IN PELVIC AREA ON (B)(6) 2009 PLAINTIFF UNDERWENT AN OPERATIVE HYSTEROSCOPY NO ESSURE DEVICE WAS IDENTIFIED ON THE LEFT SIDE, HOWEVER, SUGGESTING MIGRATION OF THE LEFT COIL AS WELL. SHE DIDN¿T UNDERGO AN ESSURE CONFIRMATION TEST. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-JUN-2018: PFS RECEIVED. NEW EVENTS ADDED: NAUSEA, RECEDING GUMS, CRP EXTREMELY HIGH, URINARY INCONTINENCE, NERVE PAIN, BODY PAIN AND UTERINE PAIN. TREATMENT DRUGS ADDED. 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF THE FIRST EPISODE OF DEVICE DISLOCATION ("NO ESSURE DEVICE WAS IDENTIFIED ON THE LEFT SIDE/ X-RAY SHOWED A BROKEN ESSURE COIL IN PELVIC AREA/ MIGRATION OF ESSURE DEVICE ¿ MIGRATION OF ESSURE MICRO-INSERT FURTHER UP LEFT TUBE"), DEVICE BREAKAGE ("ESSURE DEVICE WAS IDENTIFIED ON THE LEFT SIDE/ X-RAY SHOWED A BROKEN ESSURE COIL IN PELVIC AREA/ DEVICE BROKEN ON LEFT SIDE"), THE SECOND EPISODE OF DEVICE DISLOCATION ("THE RIGHT ESSURE COIL HAD MIGRATED"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING") AND CUSHING'S SYNDROME ("CUSHING¿S") IN A 47-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 624840) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED KIDNEY STONE, HYPERTENSION, OVARIAN CYST, GASTROESOPHAGEAL REFLUX, ANXIETY, BLADDER SUSPENSION, OSTEOARTHRITIS AND CHEST PAIN. CONCURRENT CONDITIONS INCLUDED URINARY INCONTINENCE, UTERINE BLEEDING, ENDOMETRIOSIS AND CYSTITIS INTERSTITIAL. CONCOMITANT PRODUCTS INCLUDED FROVATRIPTAN SUCCINATE MONOHYDRATE (FROVA) AND NAPROXEN (NAPROSYN). ON (B)(6) 2007, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 6 YEARS 1 MONTH AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED SKIN DISORDER ("SKIN CHANGES") AND HAIR DISORDER ("SKIN CHANGES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED THE FIRST EPISODE OF DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE SECOND EPISODE OF DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), CUSHING'S SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN/ PAIN"), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN/ DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("PROLONGED CYCLES"), ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN / CRAMPING"), DYSPAREUNIA ("PAIN DURING INTERCOURSE/ DYSPAREUNIA"), FATIGUE ("FATIGUE"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION"), DEPRESSION ("DEPRESSION"), ARTHRALGIA ("JOINT PAIN"), MYALGIA ("MUSCLE PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), FIBROMYALGIA ("FIBROMYALGIA"), BLADDER DISORDER ("BLADDER PROBLEM"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), HYPERTENSION ("HIGH BLOOD PRESSURE"), THE FIRST EPISODE OF PALPITATIONS ("HEART PALPITATIONS"), TOOTH DISORDER ("DENTAL PROBLEM"), ABDOMINAL DISTENSION ("BLOATING"), GASTRIC DISORDER ("STOMACH ISSUES"), ANAL INCONTINENCE ("FECAL INCONTINENCE"), ALOPECIA ("HAIR LOSS"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), HAEMATURIA ("MICROSCOPIC HEMATURIA"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), FEELING ABNORMAL ("BRAIN FOG"), AMNESIA ("MEMORY LOSS"), ANXIETY ("ANXIETY"), UTERINE LEIOMYOMA ("FIBROIDS IN UTERUS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VISUAL IMPAIRMENT ("VISION CHANGES"), WEIGHT INCREASED ("WEIGHT GAIN"), INSOMNIA ("INSOMNIA"), DIZZINESS ("DIZZY SPELLS"), VERTIGO ("VERTIGO"), VITAMIN D DEFICIENCY ("VITAMIN D DEFICIENCY"), BACK PAIN ("BACK PAIN"), BREAST PAIN ("BREAST PAIN"), THE SECOND EPISODE OF PALPITATIONS ("HEART PALPITATION"), UBIQUINONE DECREASED ("COQ10 DEFICIENT"), NAUSEA ("NAUSEA"), GINGIVAL RECESSION ("RECEDING GUMS"), C-REACTIVE PROTEIN INCREASED ("CRP EXTREMELY HIGH"), URINARY INCONTINENCE ("URINARY INCONTINENCE"), NEURALGIA ("NERVE PAIN"), PAIN ("BODY PAIN") AND UTERINE PAIN ("UTERINE PAIN"). THE PATIENT WAS TREATED WITH LORAZEPAM, OXYCODONE, LORAZEPAM (ATIVAN), ESTRADIOL (ESTRACE), ONDANSETRON, COLECALCIFEROL (VITAMIN D), SURGERY (TOTAL HYSTERECTOMY AND SALPINGECTOMY TO REMOVE THE SECOND, BROKEN DEVICE), SURGERY (OTAL HYSTERECTOMY AND SALPINGECTOMY TO REMOVE THE SECOND, BROKEN DEVICE) AND SURGERY (UNDERWENT AN OPERATIVE HYSTEROSCOPY ON (B)(6) 2009 AND RIGHT DEVICE WAS SUBSEQUENTLY REMOVED). ESSURE WAS REMOVED ON (B)(6) 2009. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, THE LAST EPISODE OF DEVICE DISLOCATION, GENITAL HAEMORRHAGE, CUSHING'S SYNDROME, PELVIC PAIN, DYSMENORRHOEA, MENORRHAGIA, ABDOMINAL PAIN LOWER, DYSPAREUNIA, FATIGUE, WEIGHT FLUCTUATION, DEPRESSION, ARTHRALGIA, MYALGIA, VAGINAL HAEMORRHAGE, HYPERSENSITIVITY, FEMALE SEXUAL DYSFUNCTION, FIBROMYALGIA, BLADDER DISORDER, URINARY TRACT DISORDER, HYPERTENSION, TOOTH DISORDER, ABDOMINAL DISTENSION, GASTRIC DISORDER, ANAL INCONTINENCE, ALOPECIA, SKIN DISORDER, HAIR DISORDER, URINARY TRACT INFECTION, HAEMATURIA, MIGRAINE, HEADACHE, FEELING ABNORMAL, AMNESIA, ANXIETY, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, VISUAL IMPAIRMENT, WEIGHT INCREASED, INSOMNIA, VERTIGO, VITAMIN D DEFICIENCY, THE LAST EPISODE OF PALPITATIONS, UBIQUINONE DECREASED, NAUSEA, GINGIVAL RECESSION, C-REACTIVE PROTEIN INCREASED, NEURALGIA AND PAIN OUTCOME WAS UNKNOWN, THE DIZZINESS AND URINARY INCONTINENCE WAS RESOLVING AND THE UTERINE PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALOPECIA, AMNESIA, ANAL INCONTINENCE, ANXIETY, ARTHRALGIA, BACK PAIN, BLADDER DISORDER, BREAST PAIN, C-REACTIVE PROTEIN INCREASED, CUSHING'S SYNDROME, DEPRESSION, DEVICE BREAKAGE, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FEMALE SEXUAL DYSFUNCTION, FIBROMYALGIA, GASTRIC DISORDER, GENITAL HAEMORRHAGE, GINGIVAL RECESSION, HAEMATURIA, HAIR DISORDER, HEADACHE, HYPERSENSITIVITY, HYPERTENSION, INSOMNIA, MENORRHAGIA, MIGRAINE, MYALGIA, NAUSEA, NEURALGIA, PAIN, PELVIC PAIN, SKIN DISORDER, TOOTH DISORDER, UBIQUINONE DECREASED, URINARY INCONTINENCE, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE LEIOMYOMA, UTERINE PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VERTIGO, VISUAL IMPAIRMENT, VITAMIN D DEFICIENCY, WEIGHT FLUCTUATION, WEIGHT INCREASED, THE FIRST EPISODE OF DEVICE DISLOCATION, THE FIRST EPISODE OF PALPITATIONS, THE SECOND EPISODE OF DEVICE DISLOCATION AND THE SECOND EPISODE OF PALPITATIONS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: IT WAS REPORTED THAT SHE HAD 2 SURGERIES: (B)(6) 2009 (REMOVAL OF UTERINE FOREIGN BODY) AND ON (B)(6) 2017 (LAPAROSCOPIC TOTAL HYSTERECTOMY AND SALPINGECTOMY). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.4 KG/SQM. X-RAY - ON (B)(6) 2015: REVEALED A BROKEN ESSURE COIL IN PELVIC AREA ON (B)(6) 2009 PLAINTIFF UNDERWENT AN OPERATIVE HYSTEROSCOPY NO ESSURE DEVICE WAS IDENTIFIED ON THE LEFT SIDE, HOWEVER, SUGGESTING MIGRATION OF THE LEFT COIL AS WELL. SHE DIDN¿T UNDERGO AN ESSURE CONFIRMATION TEST QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 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 THE FIRST EPISODE OF DEVICE DISLOCATION ("NO ESSURE DEVICE WAS IDENTIFIED ON THE LEFT SIDE/ X-RAY SHOWED A BROKEN ESSURE COIL IN PELVIC AREA/ MIGRATION OF ESSURE DEVICE ¿ MIGRATION OF ESSURE MICRO-INSERT FURTHER UP LEFT TUBE"), DEVICE BREAKAGE ("ESSURE DEVICE WAS IDENTIFIED ON THE LEFT SIDE/ X-RAY SHOWED A BROKEN ESSURE COIL IN PELVIC AREA/ DEVICE BROKEN ON LEFT SIDE"), THE SECOND EPISODE OF DEVICE DISLOCATION ("THE RIGHT ESSURE COIL HAD MIGRATED") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN A 47-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 624840) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED KIDNEY STONE, HYPERTENSION, OVARIAN CYST, GASTROESOPHAGEAL REFLUX, ANXIETY, BLADDER SUSPENSION, OSTEOARTHRITIS AND CHEST PAIN. CONCURRENT CONDITIONS INCLUDED URINARY INCONTINENCE, UTERINE BLEEDING, ENDOMETRIOSIS AND CYSTITIS INTERSTITIAL. CONCOMITANT PRODUCTS INCLUDED FROVATRIPTAN SUCCINATE MONOHYDRATE (FROVA) AND NAPROXEN (NAPROSYN). IN 2008, THE PATIENT EXPERIENCED MENORRHAGIA ("PROLONGED CYCLES") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN JULY 2008, THE PATIENT EXPERIENCED ARTHRALGIA ("JOINT PAIN"), MYALGIA ("MUSCLE PAIN"), BACK PAIN ("BACK PAIN") AND BREAST PAIN ("BREAST PAIN"). IN 2009, THE PATIENT EXPERIENCED INSOMNIA ("INSOMNIA"). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 6 YEARS 1 MONTH AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED SKIN DISORDER ("SKIN CHANGES") AND HAIR DISORDER ("SKIN CHANGES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED THE FIRST EPISODE OF DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE SECOND EPISODE OF DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN/ PAIN"), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN/ DYSMENORRHEA (CRAMPING)"), ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN / CRAMPING"), DYSPAREUNIA ("PAIN DURING INTERCOURSE/ DYSPAREUNIA"), FATIGUE ("FATIGUE"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION"), DEPRESSION ("DEPRESSION"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), CUSHING'S SYNDROME ("CUSHING¿S"), FIBROMYALGIA ("FIBROMYALGIA"), BLADDER DISORDER ("BLADDER PROBLEM"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), HYPERTENSION ("HIGH BLOOD PRESSURE"), THE FIRST EPISODE OF PALPITATIONS ("HEART PALPITATIONS"), TOOTH DISORDER ("DENTAL PROBLEM"), ABDOMINAL DISTENSION ("BLOATING"), GASTRIC DISORDER ("STOMACH ISSUES"), ANAL INCONTINENCE ("FECAL INCONTINENCE"), ALOPECIA ("HAIR LOSS"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), HAEMATURIA ("MICROSCOPIC HEMATURIA"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), FEELING ABNORMAL ("BRAIN FOG"), AMNESIA ("MEMORY LOSS"), ANXIETY ("ANXIETY"), UTERINE LEIOMYOMA ("FIBROIDS IN UTERUS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VISUAL IMPAIRMENT ("VISION CHANGES"), WEIGHT INCREASED ("WEIGHT GAIN"), DIZZINESS ("DIZZY SPELLS"), VERTIGO ("VERTIGO"), VITAMIN D DEFICIENCY ("VITAMIN D DEFICIENCY"), THE SECOND EPISODE OF PALPITATIONS ("HEART PALPITATION") AND UBIQUINONE DECREASED ("COQ10 DEFICIENT"). THE PATIENT WAS TREATED WITH LORAZEPAM, SURGERY (UNDERWENT A HYSTERECTOMY TO REMOVE THE SECOND, BROKEN DEVICE), SURGERY (UNDERWENT A HYSTERECTOMY TO REMOVE THE SECOND, BROKEN DEVICE) AND SURGERY (UNDERWENT AN OPERATIVE HYSTEROSCOPY ON (B)(6) 2009 AND RIGHT DEVICE WAS SUBSEQUENTLY REMOVED). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, THE LAST EPISODE OF DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN, DYSMENORRHOEA, MENORRHAGIA, ABDOMINAL PAIN LOWER, DYSPAREUNIA, FATIGUE, WEIGHT FLUCTUATION, DEPRESSION, ARTHRALGIA, MYALGIA, VAGINAL HAEMORRHAGE, HYPERSENSITIVITY, FEMALE SEXUAL DYSFUNCTION, CUSHING'S SYNDROME, FIBROMYALGIA, BLADDER DISORDER, URINARY TRACT DISORDER, HYPERTENSION, TOOTH DISORDER, ABDOMINAL DISTENSION, GASTRIC DISORDER, ANAL INCONTINENCE, ALOPECIA, SKIN DISORDER, HAIR DISORDER, URINARY TRACT INFECTION, HAEMATURIA, MIGRAINE, HEADACHE, FEELING ABNORMAL, AMNESIA, ANXIETY, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, VISUAL IMPAIRMENT, WEIGHT INCREASED, INSOMNIA, DIZZINESS, VERTIGO, VITAMIN D DEFICIENCY, THE LAST EPISODE OF PALPITATIONS AND UBIQUINONE DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALOPECIA, AMNESIA, ANAL INCONTINENCE, ANXIETY, ARTHRALGIA, BACK PAIN, BLADDER DISORDER, BREAST PAIN, CUSHING'S SYNDROME, DEPRESSION, DEVICE BREAKAGE, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FEMALE SEXUAL DYSFUNCTION, FIBROMYALGIA, GASTRIC DISORDER, GENITAL HAEMORRHAGE, HAEMATURIA, HAIR DISORDER, HEADACHE, HYPERSENSITIVITY, HYPERTENSION, INSOMNIA, MENORRHAGIA, MIGRAINE, MYALGIA, PELVIC PAIN, SKIN DISORDER, TOOTH DISORDER, UBIQUINONE DECREASED, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VERTIGO, VISUAL IMPAIRMENT, VITAMIN D DEFICIENCY, WEIGHT FLUCTUATION, WEIGHT INCREASED, THE FIRST EPISODE OF DEVICE DISLOCATION, THE FIRST EPISODE OF PALPITATIONS, THE SECOND EPISODE OF DEVICE DISLOCATION AND THE SECOND EPISODE OF PALPITATIONS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SINCE HAVING THE SURGERY ON (B)(6) 2017, PLAINTIFF'S SYMPTOMS ARE MOSTLY RESOLVED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): X-RAY - ON (B)(6) 2015: REVEALED A BROKEN ESSURE COIL IN PELVIC AREA ON (B)(6) 2009 PLAINTIFF UNDERWENT AN OPERATIVE HYSTEROSCOPY NO ESSURE DEVICE WAS IDENTIFIED ON THE LEFT SIDE, HOWEVER, SUGGESTING MIGRATION OF THE LEFT COIL AS WELL. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-MAR-2018: PLAINTIFF FACT SHEET- ALL RELEVANT MEDICAL HISTORY, CONCURRENT CONDITION, CONCOMITANT MEDICATION AND LOT NUMBER ADDED.EVENTS ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), ALLERGIC OR HYPERSENSITIVITY REACTION, APAREUNIA, CURRENTLY BEING EVALUATED FOR CUSHING¿S AND FIBROMYALGIA, BLADDER OR URINARY PROBLEMS OR CHANGES, HIGH BLOOD PRESSURE, HEART PALPITATIONS; DENTAL PROBLEMS, DEVICE BREAKAGE, DYSMENORRHEA, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION ¿ BLOATING, STOMACH ISSUES, FECAL INCONTINENCE; HAIR LOSS, LACTATION, SKIN AND HAIR CHANGES; URINARY TRACT INFECTION/MICROSCOPIC HEMATURIA, MIGRAINES/HEADACHES, MIGRATION OF ESSURE DEVICE ¿ MIGRATION OF ESSURE MICRO-INSERT FURTHER UP LEFT TUBE, DEVICE BROKEN ON LEFT SIDE; BRAIN FOG, MEMORY LOSS; PAIN, ANXIETY, DEPRESSION; FIBROIDS IN UTERUS, VAGINAL DISCHARGE,VISION CHANGES, WEIGHT GAIN, INSOMNIA, DIZZY SPELLS, VERTIGO, VITAMIN D DEFICIENT, COQ10 DEFICIENT WERE ADDED. 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 THE FIRST EPISODE OF DEVICE DISLOCATION ("NO ESSURE DEVICE WAS IDENTIFIED ON THE LEFT SIDE/ X-RAY SHOWED A BROKEN ESSURE COIL IN PELVIC AREA"), DEVICE BREAKAGE ("ESSURE DEVICE WAS IDENTIFIED ON THE LEFT SIDE/ X-RAY SHOWED A BROKEN ESSURE COIL IN PELVIC AREA"), THE SECOND EPISODE OF DEVICE DISLOCATION ("THE RIGHT ESSURE COIL HAD MIGRATED") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED THE FIRST EPISODE OF DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE SECOND EPISODE OF DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN"), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), MENORRHAGIA ("PROLONGED CYCLES"), ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN / CRAMPING"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), FATIGUE ("FATIGUE"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION"), ANXIETY ("ANXIETY"), DEPRESSION ("DEPRESSION"), ABDOMINAL DISTENSION ("BLOATING"), ARTHRALGIA ("JOINT PAIN") AND MYALGIA ("MUSCLE PAIN"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A HYSTERECTOMY TO REMOVE THE SECOND, BROKEN DEVICE), SURGERY (UNDERWENT A HYSTERECTOMY TO REMOVE THE SECOND, BROKEN DEVICE) AND SURGERY (UNDERWENT AN OPERATIVE HYSTEROSCOPY ON (B)(6) 2009 AND RIGHT DEVICE WAS SUBSEQUENTLY REMOVED). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, THE LAST EPISODE OF DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN, DYSMENORRHOEA, MENORRHAGIA, ABDOMINAL PAIN LOWER, DYSPAREUNIA, FATIGUE, WEIGHT FLUCTUATION, ANXIETY, DEPRESSION, ABDOMINAL DISTENSION, ARTHRALGIA AND MYALGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ANXIETY, ARTHRALGIA, DEPRESSION, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, MYALGIA, PELVIC PAIN, WEIGHT FLUCTUATION, THE FIRST EPISODE OF DEVICE DISLOCATION AND THE SECOND EPISODE OF DEVICE DISLOCATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SINCE HAVING THE SURGERY ON (B)(6) 2017, PLAINTIFF'S SYMPTOMS ARE MOSTLY RESOLVED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): X-RAY - ON (B)(6) 2015: REVEALED A BROKEN ESSURE COIL IN PELVIC AREA. ON (B)(6) 2009 PLAINTIFF UNDERWENT AN OPERATIVE HYSTEROSCOPY NO ESSURE DEVICE WAS IDENTIFIED ON THE LEFT SIDE, HOWEVER, SUGGESTING MIGRATION OF THE LEFT COIL AS WELL. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 780125 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 624840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other| R | FROVA.| FROVA.| FROVA.| NAPROSYN.| NAPROSYN.| NAPROSYN. |