ESSURE
Report
- Report Number
- 2951250-2019-05834
- Event Type
- Injury
- Date Received
- September 10, 2019
- Report Date
- February 21, 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 PAIN ('PELVIC PAIN'), IDIOPATHIC INTRACRANIAL HYPERTENSION ('TUMOR / TERATOMA / CANCER TYPE: PSEUDO TUMOR CEREBRI') AND CHOLELITHIASIS ('CHOLELITHIASIS WITH INFECTION AND SUSEQUENT CHOLECYSTECTOMY') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 664591) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PREGNANCY, DEGENERATIVE DISC DISEASE, RADICULOPATHY, NEUROPATHY, HSV INFECTION, DEPRESSION AND ANXIETY. (B)(6)2010: DYE TEST: RESULTS: TOTAL BILATERAL OCCLUSION. CONCURRENT CONDITIONS INCLUDED OVARIAN CYST, UTERINE ENLARGEMENT, LEFT LOWER QUADRANT PAIN, CHRONIC CERVICITIS, CYSTADENOFIBROMA OF FALLOPIAN TUBE AND FOLLICULAR CYST OF OVARY. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN SINCE 2010. ON (B)(6)2009, THE PATIENT HAD ESSURE INSERTED. IN 2010, THE PATIENT EXPERIENCED DRY EYE ("VISION PROBS/SJOGRENS-DRY EYE"). IN 2011, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE,"). IN 2018, THE PATIENT EXPERIENCED BLADDER DISORDER ("BLADDER/URINARY PROBLEMS ¿ BLADDER PROBS., URINARY PROBS/URINARY PROBLEMS OR CHANGES") AND URINARY TRACT DISORDER ("BLADDER/URINARY PROBLEMS ¿ BLADDER PROBS., URINARY PROBS/BLADDER OR URINARY PROBLEMS OR CHANGES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), RHEUMATOID ARTHRITIS ("AUTOIMMUNE: SJOGREN¿S AND RHEUMATOID ARTHRITIS"), SJOGREN'S SYNDROME ("AUTOIMMUNE: SJOGREN¿S AND RHEUMATOID ARTHRITIS/VISION/EYE PROBLEMS TYPE: SJOGRENS"), POLYCYSTIC OVARIES ("POLYCYSTIC OVARY SYNDROME"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENTAL DISORDER ("PSYCH INJURY"), DENTAL CARIES ("DENTAL PROBS/DENTAL DECAY, TOOTH LOSS, BONE LOSS IN JOW BONE"), ALOPECIA ("HAIR LOSS,"), ENDOMETRIOSIS ("ENDOMETRIOSIS,"), PELVIC ADHESIONS ("PELVIC ADHESIONS"), HERPES SIMPLEX ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: HSV II,"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION WORSENED"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), IDIOPATHIC INTRACRANIAL HYPERTENSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ADENOMYOSIS ("ADENOMYOSIS"), FALLOPIAN TUBE CYST ("FALLOPIAN CYSTS"), TOOTH LOSS ("DENTAL PROBS/DENTAL DECAY, TOOTH LOSS, BONE LOSS IN JOW BONE"), BACK PAIN ("PAIN CHRONIC BACK PAIN DUE TO RADIOCULOPATHY AND FIBROMYALGIA"), FIBROMYALGIA ("PAIN CHRONIC BACK PAIN DUE TO RADIOCULOPATHY AND FIBROMYALGIA"), CHOLELITHIASIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PAIN ("ENTIRE BODY PAIN"), MYALGIA ("MUSCLE PAIN"), ARTHRALGIA ("JOINTS PAIN"), ARTHRITIS ("ARTHRITIS"), GENITAL HAEMORRHAGE ("WORSENING BLEEDING"), BONE LOSS ("JAW BONE LOSS") AND OVARIAN DISORDER ("HAD TO REMOVE BOTH OVARIES DUE TO PRECANCEROUS LESIONS"). THE PATIENT WAS TREATED WITH SURGERY (CHOLECYSTECTOMY AND HYST. (PARTIAL), OOPHORECTOMY BILATERAL), SALPINGECTOMY (BILATERAL)) AND TEETH REMOVAL. ESSURE WAS REMOVED ON 12-MAR-2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, RHEUMATOID ARTHRITIS, SJOGREN'S SYNDROME, POLYCYSTIC OVARIES, ABDOMINAL PAIN, MENTAL DISORDER, BLADDER DISORDER, URINARY TRACT DISORDER, DENTAL CARIES, FATIGUE, DRY EYE, ALOPECIA, ENDOMETRIOSIS, PELVIC ADHESIONS, HERPES SIMPLEX, DEPRESSION, ANXIETY, IDIOPATHIC INTRACRANIAL HYPERTENSION, ADENOMYOSIS, FALLOPIAN TUBE CYST, TOOTH LOSS, BACK PAIN, FIBROMYALGIA, CHOLELITHIASIS, PAIN, MYALGIA, ARTHRALGIA, ARTHRITIS, GENITAL HAEMORRHAGE, BONE LOSS AND OVARIAN DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADENOMYOSIS, ALOPECIA, ANXIETY, ARTHRALGIA, ARTHRITIS, BACK PAIN, BLADDER DISORDER, BONE LOSS, CHOLELITHIASIS, DENTAL CARIES, DEPRESSION, DRY EYE, ENDOMETRIOSIS, FALLOPIAN TUBE CYST, FATIGUE, FIBROMYALGIA, GENITAL HAEMORRHAGE, HERPES SIMPLEX, IDIOPATHIC INTRACRANIAL HYPERTENSION, MENTAL DISORDER, MYALGIA, OVARIAN DISORDER, PAIN, PELVIC ADHESIONS, PELVIC PAIN, POLYCYSTIC OVARIES, RHEUMATOID ARTHRITIS, SJOGREN'S SYNDROME, TOOTH LOSS AND URINARY TRACT DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE(S) OF INSERTION: (B)(6)2009. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6)2010: ESSURE CONFIRMATION TEST(S) CONDUCTED - DYE AND X RAY - BILATERAL OCCLUSION, TOTAL BILATERAL OCCLUSION.. ULTRASOUND SCAN - ON (B)(6)2012: SHOWS ENLARGED UTERUS, PAIN IN LEFT LOWER QUADRANT. SUSPECT ADENOMYOSIS, ENDOMETRIOSIS, ADHESIONS(AS WRITTEN). X-RAY - IN (B)(6)2010: RESULTS: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ENDOMETRIOSIS, PELVIC ADHESIONS, PELVIC PAIN, DYSPAREUNIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-JAN-2020: PFS RECEIVED. LOT NUMBER ADDED. ONSET DATES FOR EVENTS WERE ADDED. MEDICAL HISTORY AND CONCOMITANT DRUG ADDED. LAB DATA ADDED. 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 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 PAIN ('PELVIC PAIN'), IDIOPATHIC INTRACRANIAL HYPERTENSION ('TUMOR / TERATOMA / CANCER TYPE: PSEUDO TUMOR CEREBRI') AND CHOLELITHIASIS ('CHOLELITHIASIS WITH INFECTION AND SUBSEQUENT CHOLECYSTECTOMY') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 664591) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PREGNANCY, DEGENERATIVE DISC DISEASE, RADICULOPATHY, NEUROPATHY, HSV INFECTION, DEPRESSION AND ANXIETY. (B)(6)2010: DYE TEST: RESULTS: TOTAL BILATERAL OCCLUSION. CONCURRENT CONDITIONS INCLUDED OVARIAN CYST, UTERINE ENLARGEMENT, LEFT LOWER QUADRANT PAIN, CHRONIC CERVICITIS, CYSTADENOFIBROMA OF FALLOPIAN TUBE AND FOLLICULAR CYST OF OVARY. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN SINCE 2010. ON (B)(6)2009, THE PATIENT HAD ESSURE INSERTED. IN 2010, THE PATIENT EXPERIENCED DRY EYE ("VISION PROBS/SJOGRENS-DRY EYE"). IN 2011, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE,"). IN 2018, THE PATIENT EXPERIENCED BLADDER DISORDER ("BLADDER/URINARY PROBLEMS ¿ BLADDER PROBS., URINARY PROBS/URINARY PROBLEMS OR CHANGES") AND URINARY TRACT DISORDER ("BLADDER/URINARY PROBLEMS ¿ BLADDER PROBS., URINARY PROBS/BLADDER OR URINARY PROBLEMS OR CHANGES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), RHEUMATOID ARTHRITIS ("AUTOIMMUNE: SJOGREN¿S AND RHEUMATOID ARTHRITIS"), SJOGREN'S SYNDROME ("AUTOIMMUNE: SJOGREN¿S AND RHEUMATOID ARTHRITIS/VISION/EYE PROBLEMS TYPE: SJOGRENS"), POLYCYSTIC OVARIES ("POLYCYSTIC OVARY SYNDROME"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENTAL DISORDER ("PSYCH INJURY"), DENTAL CARIES ("DENTAL PROBS/DENTAL DECAY, TOOTH LOSS, BONE LOSS IN JOW BONE"), ALOPECIA ("HAIR LOSS,"), ENDOMETRIOSIS ("ENDOMETRIOSIS,"), PELVIC ADHESIONS ("PELVIC ADHESIONS"), HERPES SIMPLEX ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: HSV II,"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION WORSENED"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), IDIOPATHIC INTRACRANIAL HYPERTENSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ADENOMYOSIS ("ADENOMYOSIS"), FALLOPIAN TUBE CYST ("FALLOPIAN CYSTS"), TOOTH LOSS ("DENTAL PROBS/DENTAL DECAY, TOOTH LOSS, BONE LOSS IN JOW BONE"), BACK PAIN ("PAIN CHRONIC BACK PAIN DUE TO RADICULOPATHY AND FIBROMYALGIA"), FIBROMYALGIA ("PAIN CHRONIC BACK PAIN DUE TO RADICULOPATHY AND FIBROMYALGIA"), CHOLELITHIASIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PAIN ("ENTIRE BODY PAIN"), MYALGIA ("MUSCLE PAIN"), ARTHRALGIA ("JOINTS PAIN"), ARTHRITIS ("ARTHRITIS"), GENITAL HAEMORRHAGE ("WORSENING BLEEDING"), BONE LOSS ("JAW BONE LOSS") AND OVARIAN DISORDER ("HAD TO REMOVE BOTH OVARIES DUE TO PRECANCEROUS LESIONS"). THE PATIENT WAS TREATED WITH SURGERY (CHOLECYSTECTOMY AND HYST. (PARTIAL), OOPHORECTOMY BILATERAL), SALPINGECTOMY (BILATERAL)) AND TEETH REMOVAL. ESSURE WAS REMOVED ON (B)(6)2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, RHEUMATOID ARTHRITIS, SJOGREN'S SYNDROME, POLYCYSTIC OVARIES, ABDOMINAL PAIN, MENTAL DISORDER, BLADDER DISORDER, URINARY TRACT DISORDER, DENTAL CARIES, FATIGUE, DRY EYE, ALOPECIA, ENDOMETRIOSIS, PELVIC ADHESIONS, HERPES SIMPLEX, DEPRESSION, ANXIETY, IDIOPATHIC INTRACRANIAL HYPERTENSION, ADENOMYOSIS, FALLOPIAN TUBE CYST, TOOTH LOSS, BACK PAIN, FIBROMYALGIA, CHOLELITHIASIS, PAIN, MYALGIA, ARTHRALGIA, ARTHRITIS, GENITAL HAEMORRHAGE, BONE LOSS AND OVARIAN DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADENOMYOSIS, ALOPECIA, ANXIETY, ARTHRALGIA, ARTHRITIS, BACK PAIN, BLADDER DISORDER, BONE LOSS, CHOLELITHIASIS, DENTAL CARIES, DEPRESSION, DRY EYE, ENDOMETRIOSIS, FALLOPIAN TUBE CYST, FATIGUE, FIBROMYALGIA, GENITAL HAEMORRHAGE, HERPES SIMPLEX, IDIOPATHIC INTRACRANIAL HYPERTENSION, MENTAL DISORDER, MYALGIA, OVARIAN DISORDER, PAIN, PELVIC ADHESIONS, PELVIC PAIN, POLYCYSTIC OVARIES, RHEUMATOID ARTHRITIS, SJOGREN'S SYNDROME, TOOTH LOSS AND URINARY TRACT DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE(S) OF INSERTION: (B)(6)2009. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6)2010: ESSURE CONFIRMATION TEST(S) CONDUCTED - DYE AND X RAY - BILATERAL OCCLUSION, TOTAL BILATERAL OCCLUSION.. ULTRASOUND SCAN - ON (B)(6)2012: SHOWS ENLARGED UTERUS, PAIN IN LEFT LOWER QUADRANT. SUSPECT ADENOMYOSIS, ENDOMETRIOSIS, ADHESIONS(AS WRITTEN). X-RAY - IN (B)(6)2010: RESULTS: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ENDOMETRIOSIS, PELVIC ADHESIONS, PELVIC PAIN, DYSPAREUNIA. LOT NUMBER: 664591 MANUFACTURE DATE: 2009-08 EXPIRATION DATE: 2012-08. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-FEB-2020: QUALITY SAFETY EVALUATION OF PTC. 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 PAIN ('PELVIC PAIN'), RHEUMATOID ARTHRITIS ('AUTOIMMUNE: SJOGREN¿S AND RHEUMATOID ARTHRITIS'), SJOGREN'S SYNDROME ('AUTOIMMUNE: SJOGREN¿S AND RHEUMATOID ARTHRITIS/VISION/EYE PROBLEMS TYPE: SJOGRENS'), IDIOPATHIC INTRACRANIAL HYPERTENSION ('TUMOR / TERATOMA / CANCER TYPE: PSEUDO TUMOR CEREBRI'), CHOLELITHIASIS ('CHOLELITHIASIS WITH INFECTION AND SUSEQUENT CHOLECYSTECTOMY') AND GENITAL HAEMORRHAGE ('WORSENING BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PREGNANCY, DEGENERATIVE DISC DISEASE, RADICULOPATHY AND NEUROPATHY. CONCURRENT CONDITIONS INCLUDED OVARIAN CYST, UTERINE ENLARGEMENT, LEFT LOWER QUADRANT PAIN, CHRONIC CERVICITIS, CYSTADENOFIBROMA OF FALLOPIAN TUBE AND FOLLICULAR CYST OF OVARY. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), RHEUMATOID ARTHRITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SJOGREN'S SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), POLYCYSTIC OVARIES ("POLYCYSTIC OVARY SYNDROME"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENTAL DISORDER ("PSYCH INJURY"), BLADDER DISORDER ("BLADDER/URINARY PROBLEMS ¿ BLADDER PROBS., URINARY PROBS/URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER/URINARY PROBLEMS ¿ BLADDER PROBS., URINARY PROBS/BLADDER OR URINARY PROBLEMS OR CHANGES"), DENTAL CARIES ("DENTAL PROBS/DENTAL DECAY, TOOTH LOSS, BONE LOSS IN JOW BONE"), FATIGUE ("FATIGUE,"), DRY EYE ("VISION PROBS/SJOGRENS-DRY EYE"), ALOPECIA ("HAIR LOSS,"), ENDOMETRIOSIS ("ENDOMETRIOSIS,"), PELVIC ADHESIONS ("PELVIC ADHESIONS"), HERPES SIMPLEX ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: HSV II,"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION WORSENED"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), IDIOPATHIC INTRACRANIAL HYPERTENSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ADENOMYOSIS ("ADENOMYOSIS"), FALLOPIAN TUBE CYST ("FALLOPIAN CYSTS"), TOOTH LOSS ("DENTAL PROBS/DENTAL DECAY, TOOTH LOSS, BONE LOSS IN JOW BONE"), BACK PAIN ("PAIN CHRONIC BACK PAIN DUE TO RADIOCULOPATHY AND FIBROMYALGIA"), FIBROMYALGIA ("PAIN CHRONIC BACK PAIN DUE TO RADIOCULOPATHY AND FIBROMYALGIA"), CHOLELITHIASIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PAIN ("ENTIRE BODY PAIN"), MYALGIA ("MUSCLE PAIN"), ARTHRALGIA ("JOINTS PAIN"), ARTHRITIS ("ARTHRITIS"), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BONE LOSS ("JAW BONE LOSS") AND OVARIAN DISORDER ("HAD TO REMOVE BOTH OVARIES DUE TO PRECANCEROUS LESIONS"). THE PATIENT WAS TREATED WITH SURGERY (CHOLECYSTECTOMY AND HYST. (PARTIAL), OOPHORECTOMY BILATERAL)) AND TEETH REMOVAL. ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, RHEUMATOID ARTHRITIS, SJOGREN'S SYNDROME, POLYCYSTIC OVARIES, ABDOMINAL PAIN, MENTAL DISORDER, BLADDER DISORDER, URINARY TRACT DISORDER, DENTAL CARIES, FATIGUE, DRY EYE, ALOPECIA, ENDOMETRIOSIS, PELVIC ADHESIONS, HERPES SIMPLEX, DEPRESSION, ANXIETY, IDIOPATHIC INTRACRANIAL HYPERTENSION, ADENOMYOSIS, FALLOPIAN TUBE CYST, TOOTH LOSS, BACK PAIN, FIBROMYALGIA, CHOLELITHIASIS, PAIN, MYALGIA, ARTHRALGIA, ARTHRITIS, GENITAL HAEMORRHAGE, BONE LOSS AND OVARIAN DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADENOMYOSIS, ALOPECIA, ANXIETY, ARTHRALGIA, ARTHRITIS, BACK PAIN, BLADDER DISORDER, BONE LOSS, CHOLELITHIASIS, DENTAL CARIES, DEPRESSION, DRY EYE, ENDOMETRIOSIS, FALLOPIAN TUBE CYST, FATIGUE, FIBROMYALGIA, GENITAL HAEMORRHAGE, HERPES SIMPLEX, IDIOPATHIC INTRACRANIAL HYPERTENSION, MENTAL DISORDER, MYALGIA, OVARIAN DISORDER, PAIN, PELVIC ADHESIONS, PELVIC PAIN, POLYCYSTIC OVARIES, RHEUMATOID ARTHRITIS, SJOGREN'S SYNDROME, TOOTH LOSS AND URINARY TRACT DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE(S) OF INSERTION: (B)(6) 2009. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2010: ESSURE CONFIRMATION TEST(S) CONDUCTED - DYE AND X RAY - BILATERAL OCCLUSION, TOTAL BILATERAL OCCLUSION. ULTRASOUND SCAN - ON (B)(6) 2012: SHOWS ENLARGED UTERUS, PAIN IN LEFT LOWER QUADRANT. SUSPECT ADENOMYOSIS, ENDOMETRIOSIS, ADHESIONS(AS WRITTEN). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ENDOMETRIOSIS, PELVIC ADHESIONS, PELVIC PAIN, DYSPAREUNIA. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: SIGNIFICANT AMENDMENT - PT OF PREVIOUSLY REPORTED EVENT TUMOR / TERATOMA / CANCER TYPE: PSEUDO TUMOR CEREBRI; WAS UPDATED TO IDIOPATHIC INTRACRANIAL HYPERTENSION FROM BRAIN NEOPLASM. EVENT ADDED FROM PREVIOUS DISTRIBUTED VERSION FRD (B)(6) 2019 HAD TO REMOVE BOTH OVARIES DUE TO PRECANCEROUS LESIONS AND JAW BONE LOSS. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. 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 PELVIC PAIN ('PELVIC PAIN'), RHEUMATOID ARTHRITIS ('AUTOIMMUNE: SJOGREN¿S AND RHEUMATOID ARTHRITIS'), SJOGREN'S SYNDROME ('AUTOIMMUNE: SJOGREN¿S AND RHEUMATOID ARTHRITIS/VISION/EYE PROBLEMS TYPE: SJOGRENS'), BRAIN NEOPLASM ('TUMOR / TERATOMA / CANCER TYPE: PSEUDO TUMOR CEREBRI'), CHOLELITHIASIS ('CHOLELITHIASIS WITH INFECTION AND SUBSEQUENT CHOLECYSTECTOMY') AND GENITAL HAEMORRHAGE ('WORSENING BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PREGNANCY, DEGENERATIVE DISC DISEASE, RADICULOPATHY AND NEUROPATHY. CONCURRENT CONDITIONS INCLUDED OVARIAN CYST, UTERINE ENLARGEMENT, LEFT LOWER QUADRANT PAIN, CHRONIC CERVICITIS, CYSTADENOFIBROMA OF FALLOPIAN TUBE AND FOLLICULAR CYST OF OVARY. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), RHEUMATOID ARTHRITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SJOGREN'S SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), POLYCYSTIC OVARIES ("POLYCYSTIC OVARY SYNDROME"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENTAL DISORDER ("PSYCH INJURY"), BLADDER DISORDER ("BLADDER/URINARY PROBLEMS ¿ BLADDER PROBS., URINARY PROBS/URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER/URINARY PROBLEMS ¿ BLADDER PROBS., URINARY PROBS/BLADDER OR URINARY PROBLEMS OR CHANGES"), DENTAL CARIES ("DENTAL PROBS/DENTAL DECAY, TOOTH LOSS, BONE LOSS IN JAW BONE"), FATIGUE ("FATIGUE,"), DRY EYE ("VISION PROBS/SJOGRENS-DRY EYE"), ALOPECIA ("HAIR LOSS,"), ENDOMETRIOSIS ("ENDOMETRIOSIS,"), PELVIC ADHESIONS ("PELVIC ADHESIONS"), HERPES SIMPLEX ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: HSV II,"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION WORSENED"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), ADENOMYOSIS ("ADENOMYOSIS"), FALLOPIAN TUBE CYST ("FALLOPIAN CYSTS"), TOOTH LOSS ("DENTAL PROBS/DENTAL DECAY, TOOTH LOSS, BONE LOSS IN JAW BONE"), BACK PAIN ("PAIN CHRONIC BACK PAIN DUE TO RADICULOPATHY AND FIBROMYALGIA"), FIBROMYALGIA ("PAIN CHRONIC BACK PAIN DUE TO RADICULOPATHY AND FIBROMYALGIA"), CHOLELITHIASIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PAIN ("ENTIRE BODY PAIN"), MYALGIA ("MUSCLE PAIN"), ARTHRALGIA ("JOINTS PAIN"), ARTHRITIS ("ARTHRITIS") AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE BRAIN NEOPLASM (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (CHOLECYSTECTOMY AND HYST. (PARTIAL), OOPHORECTOMY BILATERAL)) AND TEETH REMOVAL. ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, RHEUMATOID ARTHRITIS, SJOGREN'S SYNDROME, POLYCYSTIC OVARIES, ABDOMINAL PAIN, MENTAL DISORDER, BLADDER DISORDER, URINARY TRACT DISORDER, DENTAL CARIES, FATIGUE, DRY EYE, ALOPECIA, ENDOMETRIOSIS, PELVIC ADHESIONS, HERPES SIMPLEX, DEPRESSION, ANXIETY, BRAIN NEOPLASM, ADENOMYOSIS, FALLOPIAN TUBE CYST, TOOTH LOSS, BACK PAIN, FIBROMYALGIA, CHOLELITHIASIS, PAIN, MYALGIA, ARTHRALGIA, ARTHRITIS AND GENITAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADENOMYOSIS, ALOPECIA, ANXIETY, ARTHRALGIA, ARTHRITIS, BACK PAIN, BLADDER DISORDER, BRAIN NEOPLASM, CHOLELITHIASIS, DENTAL CARIES, DEPRESSION, DRY EYE, ENDOMETRIOSIS, FALLOPIAN TUBE CYST, FATIGUE, FIBROMYALGIA, GENITAL HAEMORRHAGE, HERPES SIMPLEX, MENTAL DISORDER, MYALGIA, PAIN, PELVIC ADHESIONS, PELVIC PAIN, POLYCYSTIC OVARIES, RHEUMATOID ARTHRITIS, SJOGREN'S SYNDROME, TOOTH LOSS AND URINARY TRACT DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE(S) OF INSERTION: ON (B)(6) 2009. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2010: ESSURE CONFIRMATION TEST(S) CONDUCTED - DYE AND X RAY - BILATERAL OCCLUSION, TOTAL BILATERAL OCCLUSION. ULTRASOUND SCAN - ON (B)(6) 2012: SHOWS ENLARGED UTERUS, PAIN IN LEFT LOWER QUADRANT. SUSPECT ADENOMYOSIS, ENDOMETRIOSIS, ADHESIONS(AS WRITTEN). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ENDOMETRIOSIS, PELVIC ADHESIONS, PELVIC PAIN, DYSPAREUNIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-SEP-2019: PFS RECEIVED ¿ EVENTS UPDATED DENTAL CARIES FROM TOOTH DISORDER AND DRY EYE FROM VISION IMPAIRMENT. NEW EVENTS INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: HSV II, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION WORSENED, ANXIETY, TUMOR / TERATOMA / CANCER TYPE: PSEUDO TUMOR CEREBRI, ADENOMYOSIS, FALLOPIAN CYSTS, DENTAL PROBS/DENTAL DECAY, TOOTH LOSS, BONE LOSS IN JAW BONE, PAIN CHRONIC BACK PAIN DUE TO RADICULOPATHY AND FIBROMYALGIA, CHOLELITHIASIS WITH INFECTION AND SUBSEQUENT CHOLECYSTECTOMY, ENTIRE BODY PAIN, MUSCLE PAIN, JOINTS PAIN, ARTHRITIS AND WORSENING BLEEDING WERE ADDED. PATIENT DATE OF BIRTH, HEIGHT AND WEIGHT WERE ADDED. NEW REPORTER WERE ADDED. MEDICAL HISTORY AND LAB DATA WERE ADDED. NO LOT NUMBER 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-CONFORMANT 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 PAIN ('PELVIC PAIN'), RHEUMATOID ARTHRITIS ('AUTOIMMUNE: SJOGREN¿S AND RHEUMATOID ARTHRITIS') AND SJOGREN'S SYNDROME ('AUTOIMMUNE: SJOGREN¿S AND RHEUMATOID ARTHRITIS') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), RHEUMATOID ARTHRITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SJOGREN'S SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), POLYCYSTIC OVARIES ("POLYCYSTIC OVARY SYNDROME"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENTAL DISORDER ("PSYCH INJURY"), BLADDER DISORDER ("BLADDER/URINARY PROBLEMS ¿ BLADDER PROBS., URINARY PROBS"), URINARY TRACT DISORDER ("BLADDER/URINARY PROBLEMS ¿ BLADDER PROBS., URINARY PROBS"), TOOTH DISORDER ("DENTAL PROBS"), FATIGUE ("FATIGUE,"), VISUAL IMPAIRMENT ("VISION PROBS"), ALOPECIA ("HAIR LOSS,"), ENDOMETRIOSIS ("ENDOMETRIOSIS,") AND PELVIC ADHESIONS ("PELVIC ADHESIONS"). THE PATIENT WAS TREATED WITH SURGERY (HYST. (PARTIAL), OOPHORECTOMY BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, RHEUMATOID ARTHRITIS, SJOGREN'S SYNDROME, POLYCYSTIC OVARIES, ABDOMINAL PAIN, MENTAL DISORDER, BLADDER DISORDER, URINARY TRACT DISORDER, TOOTH DISORDER, FATIGUE, VISUAL IMPAIRMENT, ALOPECIA, ENDOMETRIOSIS AND PELVIC ADHESIONS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BLADDER DISORDER, ENDOMETRIOSIS, FATIGUE, MENTAL DISORDER, PELVIC ADHESIONS, PELVIC PAIN, POLYCYSTIC OVARIES, RHEUMATOID ARTHRITIS, SJOGREN'S SYNDROME, TOOTH DISORDER, URINARY TRACT DISORDER AND VISUAL IMPAIRMENT TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE(S) OF INSERTION: (B)(6) 2009. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2010: BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-AUG-2019: PFS RECEIVED: CASE BECOME INCIDENT. UNSPECIFIED EVENT "INJURY TO HERSELF" WAS UPDATED TO MORE SPECIFIC EVENTS: PELVIC PAIN, ABDOMINAL PAIN, SJOGREN¿S AND RHEUMATOID ARTHRITIS, MENTAL DISORDER, BLADDER DISORDER, URINARY TRACT DISORDER, DENTAL PROBS., FATIGUE, VISION PROBLEMS, HAIR LOSS, ENDOMETRIOSIS, PELVIC ADHESIONS, POLYCYSTIC OVARY SYNDROME. REPORTER ADDED, PATIENT DEMOGRAPHIC ADDED, ESSURE REMOVAL DATE ADDED, PRODUCT INDICATION UPDATED. LAB DATA ADDED. NO LOT NUMBER 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 772674 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 664591 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | IBUPROFEN| IBUPROFEN |