ESSURE
Report
- Report Number
- 2951250-2019-04952
- Event Type
- Injury
- Date Received
- August 20, 2019
- Date of Event
- February 14, 2014
- Report Date
- April 1, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFLAMMATORY DISEASE ('PELVIC INFLAMMATION'), UTERINE INFLAMMATION ('UTERINE INFLAMMATION'), ENDOMETRIAL ABLATION ('ABLATION'), RHEUMATOID ARTHRITIS ('AUTOIMMUNE DISORDER:RHEUMATOID ARTHRITIS/ JOINT INFLAMMATION') AND IMMUNODEFICIENCY ('IMMUNE SYSTEME DEFICIENCY / IMMUNE SYSTEM COMPROMISED') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940969) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MENOMETRORRHAGIA ON (B)(6) 2012, MENORRHAGIA ON (B)(6) 2012 AND URINARY INCONTINENCE. CONCURRENT CONDITIONS INCLUDED ENDOMETRIAL POLYP SINCE (B)(6) 2012, MULTINODULAR GOITER, STRESS INCONTINENCE AND AUTOIMMUNE DISORDER. CONCOMITANT PRODUCTS INCLUDED BETAMETHASONE FROM 2018 TO 2019, CLOTRIMAZOLE FROM 2018 TO 2019, COLECALCIFEROL (VITAMIN D3) FROM 2015 TO 2018, FOLIC ACID FROM 2015 TO 2017, IBUPROFEN (MOTRIN) FROM 2014 TO 2019, NAPROXEN SODIUM (ALEVE) FROM 2014 TO 2019, TRAMADOL FROM 2014 TO 2015 AND VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) FROM 2015 TO 2019. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED RHEUMATOID ARTHRITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH MUSCULOSKELETAL STIFFNESS AND MOBILITY DECREASED, RASH ("RASHES OR SKIN CONDITIONS - RASHES ON MY BODY"), HEADACHE ("MIGRAINES / HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), ARTHRALGIA ("PAIN/JOINT PAIN"), IMMUNODEFICIENCY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND PELVIC PAIN ("PELVIC PAIN/CHRONIC PAIN/PELVIC CRAMPING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2014, THE PATIENT UNDERWENT ENDOMETRIAL ABLATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2015, THE PATIENT WAS FOUND TO HAVE WHITE BLOOD CELL COUNT INCREASED ("ELEVATED WHITE BLOOD CELLS"). IN (B)(6) 2017, THE PATIENT WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES - TESTS SHOWED HORMONE IMBALANCE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE INFLAMMATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PAIN IN EXTREMITY ("FEET PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MYALGIA ("MUSCLE PAIN"), CARDIAC DISORDER ("HEART PROBLEMS"), ANAEMIA ("ANEMIA"), VITAMIN D DEFICIENCY ("VITAMIN D DEFICIENCY"), HYPOTHYROIDISM ("THYROID DEFICIENCY") AND MIGRAINE ("MIGRAINE") AND WAS FOUND TO HAVE QUALITY OF LIFE DECREASED ("AFFECTING QUALITY OF LIFE"). THE PATIENT WAS TREATED WITH GOLIMUMAB, INFLIXIMAB, LEFLUNOMIDE, METHOTREXATE, PREDNISONE, SULFASALAZINE (SULFASALASIN), SURGERY (HYSTERECTOMY (FULL)/SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)) AND HORMONE REPLACEMENT. ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, UTERINE INFLAMMATION, ENDOMETRIAL ABLATION, RHEUMATOID ARTHRITIS, HORMONE LEVEL ABNORMAL, RASH, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, WEIGHT INCREASED, FATIGUE, ALOPECIA, IMMUNODEFICIENCY, QUALITY OF LIFE DECREASED, CARDIAC DISORDER, ANAEMIA, VITAMIN D DEFICIENCY, HYPOTHYROIDISM, WHITE BLOOD CELL COUNT INCREASED AND MIGRAINE OUTCOME WAS UNKNOWN, THE HEADACHE, PELVIC PAIN AND ABDOMINAL PAIN HAD RESOLVED AND THE ARTHRALGIA, PAIN IN EXTREMITY AND MYALGIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, ANAEMIA, ARTHRALGIA, CARDIAC DISORDER, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIAL ABLATION, FATIGUE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPOTHYROIDISM, IMMUNODEFICIENCY, MIGRAINE, MYALGIA, PAIN IN EXTREMITY, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, QUALITY OF LIFE DECREASED, RASH, RHEUMATOID ARTHRITIS, UTERINE INFLAMMATION, VITAMIN D DEFICIENCY, WEIGHT INCREASED AND WHITE BLOOD CELL COUNT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY TO BE NOTED IN ESSURE INSERTION DATE AS: (B)(6) 2014 AND (B)(6) 2012 CURRENT WEIGHT 155.6LBS. PLAINTIFF RECEIVED TREATMENT FOR DYSPAREUNIA , DYEMENORRHOEA, NICKEL ALLERGY , RASH, RHEUMATOID ARTHRITIS , IMMUNE SYSTEM DEFICIENCY , FATIGUE, HAIR LOSS, HORMONAL CHANGE, WEIGHT GAIN . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.5 KG/SQM. BLOOD TEST - ON AN UNKNOWN DATE: POSITIVE FOR INFLAMMATION ON BODY. ULTRASOUND SCAN VAGINA - ON (B)(6) 2012: THE ESSURE WAS IN PLACE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-NOV-2019: PFS RECEIVED. EVENTS: MIGRAINE WERE ADDED. INCIDENT: WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFLAMMATORY DISEASE ('PELVIC INFLAMMATION'), UTERINE INFLAMMATION ('UTERINE INFLAMMATION'), ENDOMETRIAL ABLATION ('ABLATION'), RHEUMATOID ARTHRITIS ('AUTOIMMUNE DISORDER:RHEUMATOID ARTHRITIS/ JOINT INFLAMMATION') AND IMMUNODEFICIENCY ('IMMUNE SYSTEME DEFICIENCY / IMMUNE SYSTEM COMPROMISED') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940969) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MENOMETRORRHAGIA ON (B)(6) 2012, MENORRHAGIA ON (B)(6) 2012 AND URINARY INCONTINENCE. CONCURRENT CONDITIONS INCLUDED ENDOMETRIAL POLYP SINCE (B)(6) 2012, MULTINODULAR GOITER, STRESS INCONTINENCE AND AUTOIMMUNE DISORDER. CONCOMITANT PRODUCTS INCLUDED BETAMETHASONE FROM 2018 TO 2019, CLOTRIMAZOLE FROM 2018 TO 2019, COLECALCIFEROL (VITAMIN D3) FROM 2015 TO 2018, FOLIC ACID FROM 2015 TO 2017, IBUPROFEN (MOTRIN) FROM 2014 TO 2019, NAPROXEN SODIUM (ALEVE) FROM 2014 TO 2019, TRAMADOL FROM 2014 TO 2015 AND VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) FROM 2015 TO 2019. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED RHEUMATOID ARTHRITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH MUSCULOSKELETAL STIFFNESS AND MOBILITY DECREASED, RASH ("RASHES OR SKIN CONDITIONS - RASHES ON MY BODY/SLING RASHES"), HEADACHE ("MIGRAINES / HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), ARTHRALGIA ("PAIN/JOINT PAIN/PAIN ON MY JOINTS"), IMMUNODEFICIENCY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND PELVIC PAIN ("PELVIC PAIN/CHRONIC PAIN/PELVIC CRAMPING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2014, THE PATIENT UNDERWENT ENDOMETRIAL ABLATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2015, THE PATIENT WAS FOUND TO HAVE WHITE BLOOD CELL COUNT INCREASED ("ELEVATED WHITE BLOOD CELLS"). IN (B)(6) 2017, THE PATIENT WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES - TESTS SHOWED HORMONE IMBALANCE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE INFLAMMATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PAIN IN EXTREMITY ("FEET PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MYALGIA ("MUSCLE PAIN"), CARDIAC DISORDER ("HEART PROBLEMS"), ANAEMIA ("ANEMIA"), VITAMIN D DEFICIENCY ("VITAMIN D DEFICIENCY"), HYPOTHYROIDISM ("THYROID DEFICIENCY"), MIGRAINE ("MIGRAINE"), IMMUNE SYSTEM DISORDER ("PROBLEM WITH MY IMMUNE SYSTEM/MY IMMUNE SYSTEM WAS OUT OF CONTROL"), PAIN ("MY BODY WAS IN SO MUCH PAIN") AND ASTHENIA ("NO ENERGY") AND WAS FOUND TO HAVE QUALITY OF LIFE DECREASED ("AFFECTING QUALITY OF LIFE"). THE PATIENT WAS TREATED WITH GOLIMUMAB, INFLIXIMAB, LEFLUNOMIDE, METHOTREXATE, PREDNISONE, SULFASALAZINE (SULFASALASIN), SURGERY (HYSTERECTOMY (FULL)/SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)) AND HORMONE REPLACEMENT. ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, UTERINE INFLAMMATION, ENDOMETRIAL ABLATION, RHEUMATOID ARTHRITIS, HORMONE LEVEL ABNORMAL, RASH, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, ALOPECIA, IMMUNODEFICIENCY, QUALITY OF LIFE DECREASED, CARDIAC DISORDER, ANAEMIA, VITAMIN D DEFICIENCY, HYPOTHYROIDISM, WHITE BLOOD CELL COUNT INCREASED, MIGRAINE AND IMMUNE SYSTEM DISORDER OUTCOME WAS UNKNOWN, THE HEADACHE, PELVIC PAIN, ABDOMINAL PAIN, PAIN AND ASTHENIA HAD RESOLVED, THE WEIGHT INCREASED HAD NOT RESOLVED AND THE ARTHRALGIA, PAIN IN EXTREMITY AND MYALGIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, ANAEMIA, ARTHRALGIA, ASTHENIA, CARDIAC DISORDER, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIAL ABLATION, FATIGUE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPOTHYROIDISM, IMMUNE SYSTEM DISORDER, IMMUNODEFICIENCY, MIGRAINE, MYALGIA, PAIN, PAIN IN EXTREMITY, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, QUALITY OF LIFE DECREASED, RASH, RHEUMATOID ARTHRITIS, UTERINE INFLAMMATION, VITAMIN D DEFICIENCY, WEIGHT INCREASED AND WHITE BLOOD CELL COUNT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY TO BE NOTED IN ESSURE INSERTION DATE AS: (B)(6) 2014 AND (B)(6) 2012 CURRENT WEIGHT 155.6LBS. PLAINTIFF RECEIVED TREATMENT FOR DYSPAREUNIA , DYEMENORRHOEA, NICKEL ALLERGY , RASH, RHEUMATOID ARTHRITIS , IMMUNE SYSTEM DEFICIENCY , FATIGUE, HAIR LOSS, HORMONAL CHANGE, WEIGHT GAIN . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.5 KG/SQM. BLOOD TEST - ON AN UNKNOWN DATE: POSITIVE FOR INFLAMMATION ON BODY. ULTRASOUND SCAN VAGINA - ON (B)(6) 2012: THE ESSURE WAS IN PLACE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-MAR-2020: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT 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 PELVIC INFLAMMATORY DISEASE ('PELVIC INFLAMMATION'), UTERINE INFLAMMATION ('UTERINE INFLAMMATION'), ENDOMETRIAL ABLATION ('ABLATION'), RHEUMATOID ARTHRITIS ('AUTOIMMUNE DISORDER:RHEUMATOID ARTHRITIS/ JOINT INFLAMMATION') AND IMMUNODEFICIENCY ('IMMUNE SYSTEME DEFICIENCY / IMMUNE SYSTEM COMPROMISED') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940969) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MENOMETRORRHAGIA ON (B)(6) 2012, MENORRHAGIA ON (B)(6) 2012 AND URINARY INCONTINENCE. CONCURRENT CONDITIONS INCLUDED ENDOMETRIAL POLYP SINCE (B)(6) 2012, MULTINODULAR GOITER, STRESS INCONTINENCE AND AUTOIMMUNE DISORDER. CONCOMITANT PRODUCTS INCLUDED BETAMETHASONE FROM 2018 TO 2019, CLOTRIMAZOLE FROM 2018 TO 2019, COLECALCIFEROL (VITAMIN D3) FROM 2015 TO 2018, FOLIC ACID FROM 2015 TO 2017, IBUPROFEN (MOTRIN) FROM 2014 TO 2019, NAPROXEN SODIUM (ALEVE) FROM 2014 TO 2019, TRAMADOL FROM 2014 TO 2015 AND VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) FROM 2015 TO 2019. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED RHEUMATOID ARTHRITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH MUSCULOSKELETAL STIFFNESS AND MOBILITY DECREASED, RASH ("RASHES OR SKIN CONDITIONS - RASHES ON MY BODY/SLING RASHES"), HEADACHE ("MIGRAINES / HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), ARTHRALGIA ("PAIN/JOINT PAIN/PAIN ON MY JOINTS"), IMMUNODEFICIENCY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND PELVIC PAIN ("PELVIC PAIN/CHRONIC PAIN/PELVIC CRAMPING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2014, THE PATIENT UNDERWENT ENDOMETRIAL ABLATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2015, THE PATIENT WAS FOUND TO HAVE WHITE BLOOD CELL COUNT INCREASED ("ELEVATED WHITE BLOOD CELLS"). IN (B)(6) 2017, THE PATIENT WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES - TESTS SHOWED HORMONE IMBALANCE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE INFLAMMATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PAIN IN EXTREMITY ("FEET PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MYALGIA ("MUSCLE PAIN"), CARDIAC DISORDER ("HEART PROBLEMS"), ANAEMIA ("ANEMIA"), VITAMIN D DEFICIENCY ("VITAMIN D DEFICIENCY"), HYPOTHYROIDISM ("THYROID DEFICIENCY"), MIGRAINE ("MIGRAINE"), IMMUNE SYSTEM DISORDER ("PROBLEM WITH MY IMMUNE SYSTEM/MY IMMUNE SYSTEM WAS OUT OF CONTROL"), PAIN ("MY BODY WAS IN SO MUCH PAIN") AND ASTHENIA ("NO ENERGY") AND WAS FOUND TO HAVE QUALITY OF LIFE DECREASED ("AFFECTING QUALITY OF LIFE"). THE PATIENT WAS TREATED WITH GOLIMUMAB, INFLIXIMAB, LEFLUNOMIDE, METHOTREXATE, PREDNISONE, SULFASALAZINE (SULFASALASIN), SURGERY (HYSTERECTOMY (FULL)/SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)) AND HORMONE REPLACEMENT. ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, UTERINE INFLAMMATION, ENDOMETRIAL ABLATION, RHEUMATOID ARTHRITIS, HORMONE LEVEL ABNORMAL, RASH, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, ALOPECIA, IMMUNODEFICIENCY, QUALITY OF LIFE DECREASED, CARDIAC DISORDER, ANAEMIA, VITAMIN D DEFICIENCY, HYPOTHYROIDISM, WHITE BLOOD CELL COUNT INCREASED, MIGRAINE AND IMMUNE SYSTEM DISORDER OUTCOME WAS UNKNOWN, THE HEADACHE, PELVIC PAIN, ABDOMINAL PAIN, PAIN AND ASTHENIA HAD RESOLVED, THE WEIGHT INCREASED HAD NOT RESOLVED AND THE ARTHRALGIA, PAIN IN EXTREMITY AND MYALGIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, ANAEMIA, ARTHRALGIA, ASTHENIA, CARDIAC DISORDER, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIAL ABLATION, FATIGUE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPOTHYROIDISM, IMMUNE SYSTEM DISORDER, IMMUNODEFICIENCY, MIGRAINE, MYALGIA, PAIN, PAIN IN EXTREMITY, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, QUALITY OF LIFE DECREASED, RASH, RHEUMATOID ARTHRITIS, UTERINE INFLAMMATION, VITAMIN D DEFICIENCY, WEIGHT INCREASED AND WHITE BLOOD CELL COUNT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY TO BE NOTED IN ESSURE INSERTION DATE AS: (B)(6) 2014 AND (B)(6) 2012 CURRENT WEIGHT 155.6LBS. PLAINTIFF RECEIVED TREATMENT FOR DYSPAREUNIA , DYEMENORRHOEA, NICKEL ALLERGY , RASH, RHEUMATOID ARTHRITIS , IMMUNE SYSTEM DEFICIENCY , FATIGUE, HAIR LOSS, HORMONAL CHANGE, WEIGHT GAIN . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.5 KG/SQM. BLOOD TEST - ON AN UNKNOWN DATE: POSITIVE FOR INFLAMMATION ON BODY. ULTRASOUND SCAN VAGINA - ON (B)(6) 2012: THE ESSURE WAS IN PLACE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-FEB-2020: CONTENT FROM SOCIAL MEDIA RECEIVED. NEW EVENTS: PROBLEM WITH MY IMMUNE SYSTEM/MY IMMUNE SYSTEM WAS OUT OF CONTROL, MY BODY WAS IN SO MUCH OF PAIN, NO ENERGY WERE ADDED. OUTCOME OF THE EVENTS WERE UPDATED. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT 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 PELVIC INFLAMMATORY DISEASE ('PELVIC INFLAMMATION'), ENDOMETRIAL ABLATION ('ABLATION'), UTERINE INFLAMMATION ('UTERINE INFLAMMATION'), RHEUMATOID ARTHRITIS ('AUTOIMMUNE DISORDER: RHEUMATOID ARTHRITIS/ JOINT INFLAMMATION') AND IMMUNODEFICIENCY ('IMMUNE SYSTEME DEFICIENCY / IMMUNE SYSTEM COMPROMISED') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940969) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MENOMETRORRHAGIA ON (B)(6) 2012, MENORRHAGIA ON (B)(6) 2012 AND URINARY INCONTINENCE. CONCURRENT CONDITIONS INCLUDED ENDOMETRIAL POLYP SINCE (B)(6) 2012 AND MULTINODULAR GOITER. CONCOMITANT PRODUCTS INCLUDED BETAMETHASONE FROM 2018 TO 2019, CLOTRIMAZOLE FROM 2018 TO 2019, COLECALCIFEROL (VITAMIN D3) FROM 2015 TO 2018, FOLIC ACID FROM 2015 TO 2017, IBUPROFEN (MOTRIN) FROM 2014 TO 2019, NAPROXEN SODIUM (ALEVE) FROM 2014 TO 2019, TRAMADOL FROM 2014 TO 2015 AND VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) FROM 2015 TO 2019. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED RHEUMATOID ARTHRITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH MUSCULOSKELETAL STIFFNESS AND MOBILITY DECREASED, RASH GENERALISED ("RASHES OR SKIN CONDITIONS - RASHES ON MY BODY"), HEADACHE ("MIGRAINES / HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), ARTHRALGIA ("PAIN/JOINT PAIN"), IMMUNODEFICIENCY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND PELVIC PAIN ("PELVIC PAIN/CHRONIC PAIN/PELVIC CRAMPING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2014, THE PATIENT UNDERWENT ENDOMETRIAL ABLATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2015, THE PATIENT WAS FOUND TO HAVE WHITE BLOOD CELL COUNT INCREASED ("ELEVATED WHITE BLOOD CELLS"). IN (B)(6) 2017, THE PATIENT WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES - TESTS SHOWED HORMONE IMBALANCE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE INFLAMMATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PAIN IN EXTREMITY ("FEET PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MYALGIA ("MUSCLE PAIN"), IMPAIRED QUALITY OF LIFE ("AFFECTING QUALITY OF LIFE"), CARDIAC DISORDER ("HEART PROBLEMS"), ANAEMIA ("ANEMIA"), VITAMIN D DEFICIENCY ("VITAMIN D DEFICIENCY") AND HYPOTHYROIDISM ("THYROID DEFICIENCY"). THE PATIENT WAS TREATED WITH GOLIMUMAB, INFLIXIMAB, LEFLUNOMIDE, METHOTREXATE, PREDNISONE, SULFASALAZINE (SULFASALASIN), SURGERY (HYSTERECTOMY (FULL)/SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)) AND HORMONE REPLACEMENT. ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, ENDOMETRIAL ABLATION, UTERINE INFLAMMATION, RHEUMATOID ARTHRITIS, HORMONE LEVEL ABNORMAL, RASH GENERALISED, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, WEIGHT INCREASED, ALOPECIA, IMMUNODEFICIENCY, IMPAIRED QUALITY OF LIFE, CARDIAC DISORDER, ANAEMIA, VITAMIN D DEFICIENCY, HYPOTHYROIDISM AND WHITE BLOOD CELL COUNT INCREASED OUTCOME WAS UNKNOWN, THE HEADACHE, PELVIC PAIN AND ABDOMINAL PAIN HAD RESOLVED AND THE ARTHRALGIA, PAIN IN EXTREMITY AND MYALGIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, ANAEMIA, ARTHRALGIA, CARDIAC DISORDER, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIAL ABLATION, FATIGUE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPOTHYROIDISM, IMMUNODEFICIENCY, IMPAIRED QUALITY OF LIFE, MYALGIA, PAIN IN EXTREMITY, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, RASH GENERALISED, RHEUMATOID ARTHRITIS, UTERINE INFLAMMATION, VITAMIN D DEFICIENCY, WEIGHT INCREASED AND WHITE BLOOD CELL COUNT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY TO BE NOTED IN ESSURE INSERTION DATE AS: (B)(6) 2014 AND (B)(6) 2012. CURRENT WEIGHT (B)(6). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS (B)(6). BLOOD TEST - ON AN UNKNOWN DATE: POSITIVE FOR INFLAMMATION ON BODY. ULTRASOUND SCAN VAGINA - IN (B)(6) 2012: THE ESSURE WAS IN PLACE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-AUG-2019: PFS AND MR RECEIVED: PREVIOUSLY REPORTED EVENT ¿INJURY¿ WAS DELETED AND UPDATED TO NEW EVENTS ABLATION, AUTOIMMUNE DISORDER: RHEUMATOID ARTHRITIS, PELVIC INFLAMMATION, HORMONAL CHANGES - TESTS SHOWED HORMONE IMBALANCE, RASHES OR SKIN CONDITIONS - RASHES ON MY BODY, MIGRAINES / HEADACHES, NICKEL ALLERGY, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), WEIGHT GAIN, FATIGUE, HAIR LOSS, PAIN/JOINT PAIN, IMMUNE SYSTEME DEFICIENCY, UTERINE INFLAMMATION, FEET PAIN, PELVIC PAIN/CHRONIC PAIN/PELVIC CRAMPING, ABDOMINAL PAIN, MUSCLE PAIN, AFFECTING QUALITY OF LIFE, HEART PROBLEMS, ANEMIA, VITAMIN D DEFICIENCY, THYROID DEFICIENCY, STIFFNESS, DECREASE MOBILITY,ELEVATED WHITE BLOOD CELLS, INFLAMMATION ON MY BODY, LOT NUMBER ADDED, REPORTER AND PATIENT DEMOGRAPHICS ,MEDICAL HISTORY, CONCOMITANT MEDICATION, CONDITION WERE ADDED AND UPDATED SUSPECT DRUG INDICATION. INCIDENT 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 703468 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 940969 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Other| R | ALEVE| ALEVE| ALEVE| ALEVE| BETAMETHASONE| BETAMETHASONE| BETAMETHASONE| BETAMETHASONE| CLOTRIMAZOLE| CLOTRIMAZOLE| CLOTRIMAZOLE| CLOTRIMAZOLE| FOLIC ACID| FOLIC ACID| FOLIC ACID| FOLIC ACID| MOTRIN [IBUPROFEN]| MOTRIN [IBUPROFEN]| MOTRIN [IBUPROFEN]| MOTRIN [IBUPROFEN]| TRAMADOL| TRAMADOL| TRAMADOL| TRAMADOL| VALACYCLOVIR HCL| VALACYCLOVIR HCL| VALACYCLOVIR HCL| VALACYCLOVIR HCL| VITAMIN D3| VITAMIN D3| VITAMIN D3| VITAMIN D3 |