ESSURE
Report
- Report Number
- 2951250-2017-05831
- Event Type
- Injury
- Date Received
- October 31, 2017
- Date of Event
- July 1, 2017
- Report Date
- November 25, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION"), DEVICE BREAKAGE ("DEVICE BREAKAGE") AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST NOT PERFORMED". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED HASHIMOTO'S THYROIDITIS FROM 2009 TO 2010. PLAINTIFF HAD NO HISTORY OF SUFFERING MIGRAINE PRIOR TO UNDERGOING THE IMPLANTATION OF ESSURE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CYTOMEL IN 2008. CONCURRENT CONDITIONS INCLUDED HYPOTHYROIDISM SINCE 1996, CUSHING'S SYNDROME, GERD SINCE 2011 AND ADHD SINCE 2017. CONCOMITANT PRODUCTS INCLUDED COLECALCIFEROL (VITAMIN D), IBUPROFEN SINCE 2011, LORATADINE (CLARITIN) SINCE 2011, SELENIUM SINCE 2014, TOPIRAMATE (TOPAMAX) SINCE 2012 AND VITAMIN B SINCE 2014. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/ INTERCOURSE ISSUES"), FATIGUE ("EXTREME FATIGUE"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN (B)(6) 2011, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS (CONDITION: DEPRESSION)"), MEMORY IMPAIRMENT ("NEUROLOGICAL CONDITIONS OR PROBLEMS : MEMORY DISTURBANCE"), CONFUSIONAL STATE ("NEUROLOGICAL CONDITIONS OR PROBLEMS :CONFUSION") AND WEIGHT INCREASED ("WEIGHT GAIN"). IN 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("ABNORMAL BLEEDING: MENORRHAGIA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING : VAGINAL"), BACK PAIN ("BACK PAIN") AND ARTHRALGIA ("JOINT PAIN"). IN 2014, THE PATIENT EXPERIENCED PREMENSTRUAL SYNDROME ("HORMONAL CHANGES (DESCRIBE: SEVERE PMS)") AND THE FIRST EPISODE OF POLYCYSTIC OVARIES ("OTHER INJURY(IES) OR COMPLICATION (S) (PLEASE DESCRIBE: PCOS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED GLUCOSE TOLERANCE IMPAIRED ("ALLERGIC OR HYPERSENSITIVITY REACTION (TYPE: GLUCOSE INTOLERANT)"). IN 2015, THE PATIENT EXPERIENCED ALLERGY TO METALS ("ALLERGY TO NICKEL / METAL ALLERGY"). IN 2016, THE PATIENT EXPERIENCED URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES-LEAKS") AND VISION BLURRED ("VISION/EYE PROBLEMS (TYPE: BLURRED VISION)"). IN (B)(6) 2017, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), THE SECOND EPISODE OF POLYCYSTIC OVARIES ("POLYCYSTIC OVARY SYNDROME"), INFLAMMATION ("INFLAMMATION"), NAUSEA ("NAUSEA") AND DYSFUNCTIONAL UTERINE BLEEDING ("OTHER INJURY(IES) OR COMPLICATION (S) (PLEASE DESCRIBE: DUB"). THE PATIENT WAS TREATED WITH METFORMIN, OMEPRAZOLE, OBETROL (ADDERALL), SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY) AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DEVICE BREAKAGE, UTERINE HAEMORRHAGE, ALLERGY TO METALS, MENORRHAGIA, ALOPECIA, MIGRAINE, THE LAST EPISODE OF POLYCYSTIC OVARIES, HEADACHE, INFLAMMATION, PREMENSTRUAL SYNDROME, VAGINAL HAEMORRHAGE, GLUCOSE TOLERANCE IMPAIRED, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, MEMORY IMPAIRMENT, CONFUSIONAL STATE, VISION BLURRED, WEIGHT INCREASED AND DYSFUNCTIONAL UTERINE BLEEDING OUTCOME WAS UNKNOWN, THE DYSPAREUNIA, DYSMENORRHOEA, URINARY INCONTINENCE, BACK PAIN AND ARTHRALGIA HAD RESOLVED AND THE FATIGUE AND NAUSEA WAS RESOLVING. THE REPORTER CONSIDERED ALLERGY TO METALS, ALOPECIA, ARTHRALGIA, BACK PAIN, CONFUSIONAL STATE, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSFUNCTIONAL UTERINE BLEEDING, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GLUCOSE TOLERANCE IMPAIRED, HEADACHE, INFLAMMATION, MEMORY IMPAIRMENT, MENORRHAGIA, MIGRAINE, NAUSEA, PREMENSTRUAL SYNDROME, URINARY INCONTINENCE, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE, VISION BLURRED, WEIGHT INCREASED, THE FIRST EPISODE OF POLYCYSTIC OVARIES AND THE SECOND EPISODE OF POLYCYSTIC OVARIES TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 33.1 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-SEP-2018: PLAINTIFF FACT SHEET RECEIVED - REPORTER INFORMATION WAS ADDED. PATIENT¿S INFORMATION UPDATED. NEW EVENTS PREMENSTRUAL SYNDROME, DEVICE BREAKAGE, VAGINAL BLEEDING, MENORRHAGIA, GLUCOSE INTOLERANCE, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, BLADDER PROBLEMS/ URINARY TRACT DISORDER-LEAKS, NAUSEA, MEMORY DISTURBANCE, CONFUSION, DYSMENORRHEA, BLURRED VISION, WEIGHT GAIN, BACK PAIN, JOINT PAIN, POLYCYSTIC OVARY, DYSFUNCTIONAL UTERINE BLEEDING, DEVICE MONITORING PROCEDURE NOT PERFORMED WERE ADDED. HISTORICAL AND CONCOMITANT DISEASE WERE ADDED. HISTORICAL, CONCOMITANT AND TREATMENT DRUGS WERE ADDED. 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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION"), DEVICE BREAKAGE ("DEVICE BREAKAGE") AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST NOT PERFORMED". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED HASHIMOTO'S THYROIDITIS FROM 2009 TO 2010. PLAINTIFF HAD NO HISTORY OF SUFFERING MIGRAINE PRIOR TO UNDERGOING THE IMPLANTATION OF ESSURE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CYTOMEL IN 2008. CONCURRENT CONDITIONS INCLUDED HYPOTHYROIDISM SINCE 1996, CUSHING'S SYNDROME, GERD SINCE 2011 AND ADHD SINCE 2017. CONCOMITANT PRODUCTS INCLUDED COLECALCIFEROL (VITAMIN D), IBUPROFEN SINCE 2011, LORATADINE (CLARITIN) SINCE 2011, SELENIUM SINCE 2014, TOPIRAMATE (TOPAMAX) SINCE 2012 AND VITAMIN B SINCE 2014. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/ INTERCOURSE ISSUES"), FATIGUE ("EXTREME FATIGUE"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN (B)(6) 2011, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS (CONDITION: DEPRESSION)"), MEMORY IMPAIRMENT ("NEUROLOGICAL CONDITIONS OR PROBLEMS : MEMORY DISTURBANCE"), CONFUSIONAL STATE ("NEUROLOGICAL CONDITIONS OR PROBLEMS :CONFUSION") AND WEIGHT INCREASED ("WEIGHT GAIN"). IN 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("ABNORMAL BLEEDING: MENORRHAGIA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING : VAGINAL"), BACK PAIN ("BACK PAIN") AND ARTHRALGIA ("JOINT PAIN"). IN 2014, THE PATIENT EXPERIENCED PREMENSTRUAL SYNDROME ("HORMONAL CHANGES (DESCRIBE: SEVERE PMS)") AND THE FIRST EPISODE OF POLYCYSTIC OVARIES ("OTHER INJURY(IES) OR COMPLICATION (S) (PLEASE DESCRIBE: PCOS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED GLUCOSE TOLERANCE IMPAIRED ("ALLERGIC OR HYPERSENSITIVITY REACTION (TYPE: GLUCOSE INTOLERANT)"). IN 2015, THE PATIENT EXPERIENCED ALLERGY TO METALS ("ALLERGY TO NICKEL / METAL ALLERGY"). IN 2016, THE PATIENT EXPERIENCED URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES-LEAKS") AND VISION BLURRED ("VISION/EYE PROBLEMS (TYPE: BLURRED VISION)"). IN (B)(6) 2017, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), THE SECOND EPISODE OF POLYCYSTIC OVARIES ("POLYCYSTIC OVARY SYNDROME"), INFLAMMATION ("INFLAMMATION"), NAUSEA ("NAUSEA") AND DYSFUNCTIONAL UTERINE BLEEDING ("OTHER INJURY(IES) OR COMPLICATION (S) (PLEASE DESCRIBE: DUB"). THE PATIENT WAS TREATED WITH METFORMIN, OMEPRAZOLE, OBETROL (ADDERALL), SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY) AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DEVICE BREAKAGE, UTERINE HAEMORRHAGE, ALLERGY TO METALS, MENORRHAGIA, ALOPECIA, MIGRAINE, THE LAST EPISODE OF POLYCYSTIC OVARIES, HEADACHE, INFLAMMATION, PREMENSTRUAL SYNDROME, VAGINAL HAEMORRHAGE, GLUCOSE TOLERANCE IMPAIRED, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, MEMORY IMPAIRMENT, CONFUSIONAL STATE, VISION BLURRED, WEIGHT INCREASED AND DYSFUNCTIONAL UTERINE BLEEDING OUTCOME WAS UNKNOWN, THE DYSPAREUNIA, DYSMENORRHOEA, URINARY INCONTINENCE, BACK PAIN AND ARTHRALGIA HAD RESOLVED AND THE FATIGUE AND NAUSEA WAS RESOLVING. THE REPORTER CONSIDERED ALLERGY TO METALS, ALOPECIA, ARTHRALGIA, BACK PAIN, CONFUSIONAL STATE, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSFUNCTIONAL UTERINE BLEEDING, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GLUCOSE TOLERANCE IMPAIRED, HEADACHE, INFLAMMATION, MEMORY IMPAIRMENT, MENORRHAGIA, MIGRAINE, NAUSEA, PREMENSTRUAL SYNDROME, URINARY INCONTINENCE, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE, VISION BLURRED, WEIGHT INCREASED, THE FIRST EPISODE OF POLYCYSTIC OVARIES AND THE SECOND EPISODE OF POLYCYSTIC OVARIES TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 33.1 KG/SQM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-OCT-2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('DEVICE BREAKAGE/ONE OF MINE WAS BROKEN IN HALF'), DEVICE EXPULSION ('MIGRATION/ONE HALF IN THE TUBE AND OANE HALF IN MY UTERUS'), AUTOIMMUNE THYROIDITIS ('I ALREADY HAD AN AUTOIMMUNE ISSUE- HASHIMOTO'S THYROIDITIS, SINCE MY IMPLANTATION IN 2011'), UTERINE HAEMORRHAGE ('ABNORMAL UTERINE BLEEDING'), GENITAL HAEMORRHAGE ('THEN I BLEED FOR 67 DAYS STARIGHT THE WORST BLOOD CLOTS ') AND PSORIATIC ARTHROPATHY ('PSORIATIC ARTHRITIS') IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST NOT PERFORMED". THE PATIENT'S MEDICAL HISTORY INCLUDED HASHIMOTO'S THYROIDITIS FROM 2009 TO 2010. PLAINTIFF HAD NO HISTORY OF SUFFERING MIGRAINE PRIOR TO UNDERGOING THE IMPLANTATION OF ESSURE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CYTOMEL. CONCURRENT CONDITIONS INCLUDED ADHD SINCE 2017, GERD SINCE 2011, HYPOTHYROIDISM SINCE 1996 AND CUSHING'S SYNDROME. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN SINCE 2011, LORATADINE (CLARITIN) SINCE 2011, SELENIUM SINCE 2014, TOPIRAMATE (TOPAMAX) SINCE 2012, VITAMIN B COMPLEX (VITAMIN B) SINCE 2014, VITAMIN D NOS (VITAMIN D) AND VITAMIN D NOS (VITAMIN D). IN 2011, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/ INTERCOURSE ISSUES"), FATIGUE ("EXTREME FATIGUE/ FATIGUE"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN (B)(6) 2011, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS (CONDITION: DEPRESSION)/ DEPRESSION FEELINGS"), MEMORY IMPAIRMENT ("NEUROLOGICAL CONDITIONS OR PROBLEMS : MEMORY DISTURBANCE") AND CONFUSIONAL STATE ("NEUROLOGICAL CONDITIONS OR PROBLEMS :CONFUSION") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("ABNORMAL BLEEDING: MENORRHAGIA/SEVERELY HEAVY BLEEDING"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING : VAGINAL"), BACK PAIN ("BACK PAIN"), ARTHRALGIA ("JOINT PAIN/HIP PAIN"), POLYCYSTIC OVARY ("OTHER INJURY(IES) OR COMPLICATION (S) (PLEASE DESCRIBE: PCOS") AND DYSFUNCTIONAL UTERINE BLEEDING ("OTHER INJURY(IES) OR COMPLICATION (S) (PLEASE DESCRIBE: DUB"). IN 2014, THE PATIENT EXPERIENCED PREMENSTRUAL SYNDROME ("HORMONAL CHANGES (DESCRIBE: SEVERE PMS)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED GLUCOSE TOLERANCE IMPAIRED ("ALLERGIC OR HYPERSENSITIVITY REACTION (TYPE: GLUCOSE INTOLERANT)"). IN 2015, THE PATIENT EXPERIENCED ALLERGY TO METALS ("ALLERGY TO NICKEL / METAL ALLERGY/ NICKEL ALLERGY"). IN 2016, THE PATIENT EXPERIENCED URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES-LEAKS") AND VISION BLURRED ("VISION/EYE PROBLEMS (TYPE: BLURRED VISION)"). IN (B)(6) 2017, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, AUTOIMMUNE THYROIDITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), POLYCYSTIC OVARIAN SYNDROME ("POLYCYSTIC OVARY SYNDROME"), INFLAMMATION ("INFLAMMATION"), MUSCULOSKELETAL STIFFNESS ("NECK STIFFNESS"), MENSTRUATION IRREGULAR ("IRREGULAR CYCLE"), MUSCULOSKELETAL CHEST PAIN ("MY HIPS AND BACK AND EVEN RIBS WOULD HURT AND JUST ACHE ALL OF THE TIME"), EYE SWELLING ("MY EYES FEEL SWOLLEN AND TWITCHY"), EYE MOVEMENT DISORDER ("MY EYES FEEL SWOLLEN AND TWITCHY"), MALAISE ("SICK"), HYPERHIDROSIS ("SWEATING"), ANAEMIA ("I WAS DEF ANEMIC FROM ALL THE BLEEDING"), MYALGIA ("MUSCLE PAIN"), MENSTRUATION DELAYED ("BACK END OF MARCH I SKIPPED MY PERIOD ABOUT 21/2 MONTHS"), METRORRHAGIA ("WHEN I FINALLY GOT IT WAS MORE LIKE JUST A TRACE FOR 2 DAYS"), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), CYST ("I HAVE FIBROIDS AND CYCTS CAUSED BY E-HELL"), CHILLS ("I HAVE CHILLS"), ABDOMINAL PAIN UPPER ("STOMACH ISSUE/STOMACH PAIN"), GOITRE ("I HAVE MULTINODULAR GOITER"), COUGH ("I M SO SICK OF COUGHING "), BRONCHITIS ("I HAVE HAD BRONCHITIS"), PRURITUS ("I HV HAD FULL BODY ITCHING"), SKIN EXFOLIATION ("SKIN PEELING"), PSORIATIC ARTHROPATHY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ADENOMYOSIS ("ADENOMYOSIS"), FLATULENCE ("GAS"), PHANTOM LIMB SYNDROME ("PHANTOM PAIN"), GASTROINTESTINAL DISORDER ("BOWEL ISSUES"), WEIGHT FLUCTUATION ("MY WEIGHT FLUCTUATES IN BUG SWINGS WHRN MY IMMUNE SYSTEM IS BEING JERK"), FEELING ABNORMAL ("MY BRAIN FOG IS CLEARING") AND INSOMNIA ("INSOMNIA") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("FIBROIDS"). THE PATIENT WAS TREATED WITH AMFETAMINE ASPARTATE;AMFETAMINE SULFATE;DEXAMFETAMINE SACCHARATE;DEXAMFETAMINE SULFATE (ADDERALL), METFORMIN, OMEPRAZOLE AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND HYSTERECTOMY (FULL) WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE EXPULSION, AUTOIMMUNE THYROIDITIS, UTERINE HAEMORRHAGE, ALLERGY TO METALS, MENORRHAGIA, ALOPECIA, MIGRAINE, POLYCYSTIC OVARIAN SYNDROME, HEADACHE, INFLAMMATION, PREMENSTRUAL SYNDROME, VAGINAL HAEMORRHAGE, GLUCOSE TOLERANCE IMPAIRED, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, MEMORY IMPAIRMENT, CONFUSIONAL STATE, VISION BLURRED, WEIGHT INCREASED, POLYCYSTIC OVARY, DYSFUNCTIONAL UTERINE BLEEDING, UTERINE LEIOMYOMA, MENSTRUATION IRREGULAR, EYE SWELLING, EYE MOVEMENT DISORDER, MALAISE, HYPERHIDROSIS, ANAEMIA, MYALGIA, MENSTRUATION DELAYED, METRORRHAGIA, CYST, CHILLS, ABDOMINAL PAIN UPPER, GOITRE, COUGH, BRONCHITIS, PRURITUS, SKIN EXFOLIATION, PSORIATIC ARTHROPATHY, ADENOMYOSIS, FLATULENCE, PHANTOM LIMB SYNDROME, GASTROINTESTINAL DISORDER, WEIGHT FLUCTUATION AND INSOMNIA OUTCOME WAS UNKNOWN, THE DYSPAREUNIA, DYSMENORRHOEA, URINARY INCONTINENCE, BACK PAIN, ARTHRALGIA AND MUSCULOSKELETAL STIFFNESS HAD RESOLVED AND THE FATIGUE, NAUSEA AND FEELING ABNORMAL WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN UPPER, ADENOMYOSIS, ALLERGY TO METALS, ALOPECIA, ANAEMIA, ARTHRALGIA, AUTOIMMUNE THYROIDITIS, BACK PAIN, BRONCHITIS, CHILLS, CONFUSIONAL STATE, COUGH, CYST, DEPRESSION, DEVICE BREAKAGE, DEVICE EXPULSION, DYSFUNCTIONAL UTERINE BLEEDING, DYSMENORRHOEA, DYSPAREUNIA, EYE MOVEMENT DISORDER, EYE SWELLING, FATIGUE, FEELING ABNORMAL, FEMALE SEXUAL DYSFUNCTION, FLATULENCE, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, GLUCOSE TOLERANCE IMPAIRED, GOITRE, HEADACHE, HYPERHIDROSIS, INFLAMMATION, INSOMNIA, MALAISE, MEMORY IMPAIRMENT, MENORRHAGIA, MENSTRUATION DELAYED, MENSTRUATION IRREGULAR, METRORRHAGIA, MIGRAINE, MUSCULOSKELETAL CHEST PAIN, MUSCULOSKELETAL STIFFNESS, MYALGIA, NAUSEA, PHANTOM LIMB SYNDROME, POLYCYSTIC OVARY, PREMENSTRUAL SYNDROME, PRURITUS, PSORIATIC ARTHROPATHY, SKIN EXFOLIATION, URINARY INCONTINENCE, UTERINE HAEMORRHAGE, UTERINE LEIOMYOMA, VAGINAL HAEMORRHAGE, VISION BLURRED, WEIGHT FLUCTUATION, WEIGHT INCREASED AND POLYCYSTIC OVARIAN SYNDROME TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 33.1 KG/SQM. X-RAY - ON AN UNKNOWN DATE: X-RAY THIS JULY IT WAS SEEN THAT THE RIGHT COIL WAS SNAPPED IN TWO PIECES- IN TUBE AND UPPER UTERUS.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE ADDED FROM SOCIAL MEDIA: MUSCULOSKELETAL STIFFNESS, AUTOIMMUNE THYROIDITIS, UTERINE LEIOMYOMA, MENSTRUATION IRREGULAR, MUSCULOSKELETAL CHEST PAIN, EYE SWELLING, EYE MOVEMENT DISORDER, MALAISE, HYPERHIDROSIS, ANEMIA, MYALGIA, MENSTRUATION DELAYED, METRORRHAGIA, GENITAL BLEEDING, CYST, CHILLS, GASTRIC DISORDER, ABDOMINAL PAIN UPPER, GOITER, COUGH, BRONCHITIS, PRURITUS, SKIN EXFOLIATION, PSORIATIC ARTHROPATHY, ADENOMYOSIS, FLATULENCE, PHANTOM LIMB SYNDROME, GASTROINTESTINAL DISORDER, WEIGHT FLUCTUATION, FEELING ABNORMAL, INSOMNIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-NOV-2019: SOCIAL MEDIA RECORD RECEIVED. EVENTS: NECK STIFFNESS, I ALREADY HAD AN AUTOIMMUNE ISSUE- HASHIMOTO'S THYROIDITIS, SINCE MY IMPLANTATION IN 2011, FIBROIDS, IRREGULAR CYCLE, MY HIPS AND BACK AND EVEN RIBS WOULD HURT AND JUST ACHE ALL OF THE TIME, MY EYES FEEL SWOLLEN AND TWITCHY, SICK, SWEATING, I WAS DEF. ANEMIC FROM ALL THE BLEEDING, MUSCLE PAIN, BACK END OF MARCH I SKIPPED MY PERIOD ABOUT 21/2 MONTHS, WHEN I FINALLY GOT IT WAS MORE LIKE JUST A TRACE FOR 2 DAYS, THEN I BLEED FOR 67 DAYS STRAIGHT THE WORST BLOOD CLOTS, I HAVE FIBROIDS AND CYCTS CAUSED BY E-HELL, I HAVE CHILLS, STOMACH ISSUE/STOMACH PAIN, I HAVE MULTINODULAR GOITER, I M SO SICK OF COUGHING, I HAVE HAD BRONCHITIS, I HAVE HAD FULL BODY ITCHING, SKIN PEELING, PSORIATIC ARTHRITIS, ADENOMYOSIS, GAS, PHANTOM PAIN, BOWEL ISSUES, MY WEIGHT FLUCTUATES IN BUG SWINGS WHEN MY IMMUNE SYSTEM IS BEING JERK, MY BRAIN FOG IS CLEARING, INSOMNIA WERE ADDED. EVENT OUTCOME WAS UPDATED FOR THE EVENTS: NECK STIFFNESS, FEELING ABNORMAL. EVENT PT WAS UPDATED FROM DEVICE DISLOCATION TO DEVICE EXPULSION. LAB DATA AND REPORTER'S INFORMATION WAS ADDED. INCIDENT NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION") AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: PLAINTIFF HAD NO HISTORY OF SUFFERING MIGRAINE PRIOR TO UNDERGOING THE IMPLANTATION OF ESSURE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FATIGUE ("EXTREME FATIGUE"), ALOPECIA ("HAIR LOSS"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), MIGRAINE ("MIGRAINES"), ALLERGY TO METALS ("ALLERGY TO NICKEL / METAL ALLERGY"), POLYCYSTIC OVARIES ("POLYCYSTIC OVARY SYNDROME"), HEADACHE ("HEADACHES") AND INFLAMMATION ("INFLAMMATION"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT HYSTERECTOMY TO REMOVE ESSURE). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, UTERINE HAEMORRHAGE, FATIGUE, ALOPECIA, DYSPAREUNIA, MIGRAINE, ALLERGY TO METALS, POLYCYSTIC OVARIES, HEADACHE AND INFLAMMATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALLERGY TO METALS, ALOPECIA, DEVICE DISLOCATION, DYSPAREUNIA, FATIGUE, HEADACHE, INFLAMMATION, MIGRAINE, POLYCYSTIC OVARIES AND UTERINE HAEMORRHAGE TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-NOV-2017: LAWYERS WERE ADDED AS REPORTERS. EVENTS MIGRATION, HEADACHES, INFLAMMATION AND PAIN (CLUBBED WITH PELVIC PAIN) WAS ADDED. PELVIC PAIN WAS MADE SYMPTOM FOR THE EVENT MIGRATION. DEVICE CATEGORY INCIDENT WAS REMOVED FROM THE EVENT PELVIC PAIN AND KEPT FOR THE EVENT DEVICE MIGRATION. 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("RIGHT SIDE PAIN") AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: PLAINTIFF HAD NO HISTORY OF SUFFERING MIGRAINE PRIOR TO UNDERGOING THE IMPLANTATION OF ESSURE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FATIGUE ("EXTREME FATIGUE"), ALOPECIA ("HAIR LOSS"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), MIGRAINE ("MIGRAINES"), ALLERGY TO METALS ("ALLERGY TO NICKEL") AND POLYCYSTIC OVARIES ("POLYCYSTIC OVARY SYNDROME"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT HYSTERECTOMY TO REMOVE ESSURE). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, UTERINE HAEMORRHAGE, FATIGUE, ALOPECIA, DYSPAREUNIA, MIGRAINE, ALLERGY TO METALS AND POLYCYSTIC OVARIES OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALLERGY TO METALS, ALOPECIA, DYSPAREUNIA, FATIGUE, MIGRAINE, PELVIC PAIN, POLYCYSTIC OVARIES AND UTERINE HAEMORRHAGE TO BE RELATED TO ESSURE. COMPANY CAUSALITY COMMENT: 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 |
|---|---|---|---|---|---|---|---|
| 769295 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Other| R | CLARITIN| CLARITIN| CLARITIN| IBUPROFEN| IBUPROFEN| IBUPROFEN| SELENIUM| SELENIUM| SELENIUM| TOPAMAX| TOPAMAX| TOPAMAX| VITAMIN B| VITAMIN B| VITAMIN B| VITAMIN D| VITAMIN D| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS] |