ESSURE
Report
- Report Number
- 2951250-2019-08001
- Event Type
- Injury
- Date Received
- September 24, 2019
- Date of Event
- July 21, 2015
- Report Date
- June 10, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION/ MIGRATION OF ESSURE DEVICE: LEFT DEVICE,') AND PELVIC PAIN ('PELVIC PAIN FEMALE / CHRONIC PAIN') IN A 45-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C222902-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MISCARRIAGE. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY, ASC-US, HUMAN PAPILLOMA VIRUS TEST POSITIVE AND ADENOMYOSIS. ON (B)(6)2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/DYSMENORRHEA (CRAMPING),"). ON (B)(6)2015, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), 15 DAYS AFTER INSERTION OF ESSURE. ON (B)(6)2015, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6)2015, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), METRORRHAGIA ("METRORRHAGIA (BLEEDING B/W PERIODS),"), GENITAL HAEMORRHAGE ("GEN. ABNORMAL. BLEED."), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), URINARY INCONTINENCE ("BLADDER / URINARY PROBLEMS: LEAKAGE"), MIGRAINE ("MIGRAINES / HEADACHES"), HYPERTENSION ("HIGH BLOOD PRESSURE"), TOOTH FRACTURE ("DENTAL PROBLEMS: WEAKNESS BREAKING OF TEETH"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), DYSPEPSIA ("HEART BURN") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY, SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6)2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION, URINARY INCONTINENCE, MIGRAINE, HYPERTENSION, TOOTH FRACTURE, DYSPAREUNIA, FATIGUE, WEIGHT INCREASED, DYSPEPSIA AND ALOPECIA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA, METRORRHAGIA AND GENITAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, DYSPEPSIA, FATIGUE, GENITAL HAEMORRHAGE, HYPERTENSION, MENORRHAGIA, METRORRHAGIA, MIGRAINE, PELVIC PAIN, TOOTH FRACTURE, URINARY INCONTINENCE, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR CHRONIC, DYSMENORRHEA (CRAMPING), PELVIC/ABDOMINAL, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), METRORRHAGIA (BLEEDING B/W PERIODS), GEN. ABNORMAL. BLEED., MIGRATION. LEFT APPROXIMATELY THREE TO FOUR COILS OUTSIDE OF THE OSTIA AND ON RIGHT APPROXIMATELY THREE TO FOUR COILS OUTSIDE OF THE OSTIA OF THE FALLOPIAN TUBE. DISCREPANCY ON DATE OF REMOVAL -IN PREVIOUS PFS IT IS GIVEN AS (B)(6)2018. DOCTOR HAD TROUBLE FINDING LEFT ESSURE DEVICE, WHICH WAS FOUND AND BOTH DEVICES REMOVED. UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED), MIGRATION OF ESSURE DEVICE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 37.5 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)2015: UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED),MIGRATION OF ESSURE DEVICE.. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-JAN-2020: UPDATE OF INFORMATION (BATCH IS NOT VALID). BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ('MIGRATION/ MIGRATION OF ESSURE DEVICE: LEFT DEVICE,LEFT DEVICE FOUND IN UTERUS') AND PELVIC PAIN ('PELVIC PAIN FEMALE / CHRONIC PAIN') IN A 45-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C222902-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MISCARRIAGE, CERVICAL INTRAEPITHELIAL NEOPLASIA I, PERINEAL PAIN, PARAKERATOSIS AND ADENOMYOSIS. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY, ASC-US, HUMAN PAPILLOMA VIRUS TEST POSITIVE AND ADENOMYOSIS. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/DYSMENORRHEA (CRAMPING),") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2015, THE PATIENT EXPERIENCED HEAVY MENSTRUAL BLEEDING ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), 15 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2015, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), INTERMENSTRUAL BLEEDING ("METRORRHAGIA (BLEEDING B/W PERIODS),"), GENITAL HAEMORRHAGE ("GEN. ABNORM. BLEED."), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), URINARY INCONTINENCE ("BLADDER / URINARY PROBLEMS: LEAKAGE"), MIGRAINE ("MIGRAINES / HEADACHES"), HYPERTENSION ("HIGH BLOOD PRESSURE"), TOOTH FRACTURE ("DENTAL PROBLEMS: WEAKNESS BREAKING OF TEETH"), FATIGUE ("FATIGUE"), DYSPEPSIA ("HEART BURN") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY, SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, URINARY TRACT INFECTION, URINARY INCONTINENCE, MIGRAINE, HYPERTENSION, TOOTH FRACTURE, FATIGUE, WEIGHT INCREASED, DYSPEPSIA AND ALOPECIA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, HEAVY MENSTRUAL BLEEDING, INTERMENSTRUAL BLEEDING, GENITAL HAEMORRHAGE AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, DYSPEPSIA, FATIGUE, GENITAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, HYPERTENSION, INTERMENSTRUAL BLEEDING, MIGRAINE, PELVIC PAIN, TOOTH FRACTURE, URINARY INCONTINENCE, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR CHRONIC, DYSMENORRHEA (CRAMPING), PELVIC/ABDOMINAL, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), METRORRHAGIA (BLEEDING B/W PERIODS), GEN. ABNORM. BLEED., MIGRATION. LEFT APPROXIMATELY THREE TO FOUR COILS OUTSIDE OF THE OSTIA AND ON RIGHT APPROXIMATELY THREE TO FOUR COILS OUTSIDE OF THE OSTIA OF THE FALLOPIAN TUBE. DISCREPANCY ON DATE OF REMOVAL -IN PREVIOUS PFS IT IS GIVEN AS (B)(6) 2018. DOCTOR HAD TROUBLE FINDING LEFT ESSURE DEVICE, WHICH WAS FOUND AND BOTH DEVICES REMOVED. UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED), MIGRATION OF ESSURE DEVICE. DISCREPANCY NOTED: CURRENT HEIGHT GIVEN IS 158.4 CM DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 37.5 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2015: UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED),MIGRATION OF ESSURE DEVICE. TOTAL BILATERAL OCCLUSION. PATHOLOGY TEST - ON (B)(6) 2016: A. UTERINE ENDOCERVICAL CURETTING: 1. A FEW ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE. 2. NO CARCINOMA OR DIAGNOSTIC DYSPLASIA IDENTIFIED. B. UTERINE CERVICAL BIOPSY AT 12 O'CLOCK: 1. FOCAL SQUAMOUS ATYPIA BORDERING ON LGSIL (CIN-1). 2. NO CARCINOMA OR HIGH-GRADE DYSPLASIA IDENTIFIED.. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-JUN-2021: MEDICAL RECORD RECEIVED- NEW REPORTER, LAB DATA, MEDICAL HISTORY AND REMOVAL DETAILS WERE ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION/ MIGRATION OF ESSURE DEVICE: LEFT DEVICE,'), PELVIC PAIN ('PELVIC PAIN FEMALE / CHRONIC PAIN') AND GENITAL HAEMORRHAGE ('GEN. ABNORM. BLEED.') IN A 45-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C222902) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MISCARRIAGE. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY, ASC-US, HUMAN PAPILLOMA VIRUS TEST POSITIVE AND ADENOMYOSIS. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN JUNE 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/DYSMENORRHEA (CRAMPING),"). ON (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), 15 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2015, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), METRORRHAGIA ("METRORRHAGIA (BLEEDING B/W PERIODS),"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), URINARY INCONTINENCE ("BLADDER / URINARY PROBLEMS: LEAKAGE"), MIGRAINE ("MIGRAINES / HEADACHES"), HYPERTENSION ("HIGH BLOOD PRESSURE"), TOOTH FRACTURE ("DENTAL PROBLEMS: WEAKNESS BREAKING OF TEETH"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), DYSPEPSIA ("HEART BURN") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY, SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION, URINARY INCONTINENCE, MIGRAINE, HYPERTENSION, TOOTH FRACTURE, DYSPAREUNIA, FATIGUE, WEIGHT INCREASED, DYSPEPSIA AND ALOPECIA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA AND METRORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, DYSPEPSIA, FATIGUE, GENITAL HAEMORRHAGE, HYPERTENSION, MENORRHAGIA, METRORRHAGIA, MIGRAINE, PELVIC PAIN, TOOTH FRACTURE, URINARY INCONTINENCE, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR CHRONIC, DYSMENORRHEA (CRAMPING), PELVIC/ABDOMINAL, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), METRORRHAGIA (BLEEDING B/W PERIODS), GEN. ABNORM. BLEED., MIGRATION. LEFT APPROXIMATELY THREE TO FOUR COILS OUTSIDE OF THE OSTIA AND ON RIGHT APPROXIMATELY THREE TO FOUR COILS OUTSIDE OF THE OSTIA OF THE FALLOPIAN TUBE. DISCREPANCY ON DATE OF REMOVAL -IN PREVIOUS PFS IT IS GIVEN AS (B)(6) 2018. DOCTOR HAD TROUBLE FINDING LEFT ESSURE DEVICE, WHICH WAS FOUND AND BOTH DEVICES REMOVED. UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED), MIGRATION OF ESSURE DEVICE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 37.5 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2015: UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED),MIGRATION OF ESSURE DEVICE.. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-DEC-2019: PLAINTIFF FACT SHEET AND MEDICAL RECORDS WERE RECEIVED. EVENTS PER PFS: ABNORMAL BLEEDING (VAGINAL), URINARY TRACT INFECTION, BLADDER / URINARY PROBLEMS: LEAKAGE, MIGRAINES / HEADACHES, HIGH BLOOD PRESSURE, DENTAL PROBLEMS: WEAKNESS BREAKING OF TEETH, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), FATIGUE, WEIGHT GAIN, HEART BURN AND HAIR LOSS. 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 DEVICE EXPULSION ('MIGRATION/ MIGRATION OF ESSURE DEVICE: LEFT DEVICE,LEFT DEVICE FOUND IN UTERUS') AND PELVIC PAIN ('PELVIC PAIN FEMALE / CHRONIC PAIN') IN A 45-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C222902-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MISCARRIAGE. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY, ASC-US, HUMAN PAPILLOMA VIRUS TEST POSITIVE AND ADENOMYOSIS. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/DYSMENORRHEA (CRAMPING),") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), 15 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2015, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), METRORRHAGIA ("METRORRHAGIA (BLEEDING B/W PERIODS),"), GENITAL HAEMORRHAGE ("GEN. ABNORMAL. BLEED."), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), URINARY INCONTINENCE ("BLADDER / URINARY PROBLEMS: LEAKAGE"), MIGRAINE ("MIGRAINES / HEADACHES"), HYPERTENSION ("HIGH BLOOD PRESSURE"), TOOTH FRACTURE ("DENTAL PROBLEMS: WEAKNESS BREAKING OF TEETH"), FATIGUE ("FATIGUE"), DYSPEPSIA ("HEART BURN") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY, SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, URINARY TRACT INFECTION, URINARY INCONTINENCE, MIGRAINE, HYPERTENSION, TOOTH FRACTURE, FATIGUE, WEIGHT INCREASED, DYSPEPSIA AND ALOPECIA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, METRORRHAGIA, GENITAL HAEMORRHAGE AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, DYSPEPSIA, FATIGUE, GENITAL HAEMORRHAGE, HYPERTENSION, MENORRHAGIA, METRORRHAGIA, MIGRAINE, PELVIC PAIN, TOOTH FRACTURE, URINARY INCONTINENCE, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR CHRONIC, DYSMENORRHEA (CRAMPING), PELVIC/ABDOMINAL, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), METRORRHAGIA (BLEEDING B/W PERIODS), GEN. ABNORM. BLEED., MIGRATION. LEFT APPROXIMATELY THREE TO FOUR COILS OUTSIDE OF THE OSTIA AND ON RIGHT APPROXIMATELY THREE TO FOUR COILS OUTSIDE OF THE OSTIA OF THE FALLOPIAN TUBE. DISCREPANCY ON DATE OF REMOVAL -IN PREVIOUS PFS IT IS GIVEN AS (B)(6) 2018. DOCTOR HAD TROUBLE FINDING LEFT ESSURE DEVICE, WHICH WAS FOUND AND BOTH DEVICES REMOVED. UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED), MIGRATION OF ESSURE DEVICE. DISCREPANCY NOTED: CURRENT HEIGHT GIVEN IS 158.4 CM DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 37.5 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2015: UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED),MIGRATION OF ESSURE DEVICE. TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-JAN-2021: QUALITY-SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ('MIGRATION/ MIGRATION OF ESSURE DEVICE: LEFT DEVICE,LEFT DEVICE FOUND IN UTERUS') AND PELVIC PAIN ('PELVIC PAIN FEMALE / CHRONIC PAIN') IN A 45-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C222902-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MISCARRIAGE. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY, ASC-US, HUMAN PAPILLOMA VIRUS TEST POSITIVE AND ADENOMYOSIS. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/DYSMENORRHEA (CRAMPING),") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), 15 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2015, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), METRORRHAGIA ("METRORRHAGIA (BLEEDING B/W PERIODS),"), GENITAL HAEMORRHAGE ("GEN. ABNORM. BLEED."), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), URINARY INCONTINENCE ("BLADDER / URINARY PROBLEMS: LEAKAGE"), MIGRAINE ("MIGRAINES / HEADACHES"), HYPERTENSION ("HIGH BLOOD PRESSURE"), TOOTH FRACTURE ("DENTAL PROBLEMS: WEAKNESS BREAKING OF TEETH"), FATIGUE ("FATIGUE"), DYSPEPSIA ("HEART BURN") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY, SALPINGECTOMY (BILATERAL) AND TOTAL HYSTERECTOMY, SALPINGECTOMY (BILATERAL)/HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, URINARY TRACT INFECTION, URINARY INCONTINENCE, MIGRAINE, HYPERTENSION, TOOTH FRACTURE, FATIGUE, WEIGHT INCREASED, DYSPEPSIA AND ALOPECIA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, METRORRHAGIA, GENITAL HAEMORRHAGE AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, DYSPEPSIA, FATIGUE, GENITAL HAEMORRHAGE, HYPERTENSION, MENORRHAGIA, METRORRHAGIA, MIGRAINE, PELVIC PAIN, TOOTH FRACTURE, URINARY INCONTINENCE, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR CHRONIC, DYSMENORRHEA (CRAMPING), PELVIC/ABDOMINAL, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), METRORRHAGIA (BLEEDING B/W PERIODS), GEN. ABNORM. BLEED., MIGRATION. LEFT APPROXIMATELY THREE TO FOUR COILS OUTSIDE OF THE OSTIA AND ON RIGHT APPROXIMATELY THREE TO FOUR COILS OUTSIDE OF THE OSTIA OF THE FALLOPIAN TUBE. DISCREPANCY ON DATE OF REMOVAL -IN PREVIOUS PFS IT IS GIVEN AS (B)(6) 2018. DOCTOR HAD TROUBLE FINDING LEFT ESSURE DEVICE, WHICH WAS FOUND AND BOTH DEVICES REMOVED. UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED), MIGRATION OF ESSURE DEVICE. DISCREPANCY NOTED: CURRENT HEIGHT GIVEN IS 158.4 CM DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 37.5 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2015: UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED),MIGRATION OF ESSURE DEVICE. TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-JAN-2021: PFS RECEIVED. EVENT DEVICE DISLOCATION WAS UPDATED AS MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT DEVICE FOUND IN UTERUS. OUTCOME OF EVENTS " DYSPAREUNIA AND VAGINAL BLEEDING" UPDATED AS RECOVERED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN FEMALE / CHRONIC PAIN'), DEVICE DISLOCATION ('MIGRATION') AND GENITAL HAEMORRHAGE ('GEN. ABNORM. BLEED.') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND METRORRHAGIA ("METRORRHAGIA (BLEEDING B/W PERIODS),"). THE PATIENT WAS TREATED WITH SURGERY (HYST. (FULL)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA AND METRORRHAGIA HAD RESOLVED AND THE DEVICE DISLOCATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, METRORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR CHRONIC, DYSMENORRHEA (CRAMPING), PELVIC/ABDOMINAL, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), METRORRHAGIA (BLEEDING B/W PERIODS), GEN. ABNORM. BLEED., MIGRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE ON AN UNKNOWN DATE: ESSURE CONFIRMATION TEST(S) (UNSPECIFIED): YES. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-SEP-2019: PFS RECEIVED: THIS CASE WAS BECOME INCIDENT. EVENT INJURY WAS UPDATED AS CHRONIC, DYSMENORRHEA (CRAMPING), PELVIC/ABDOMINAL, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), METRORRHAGIA (BLEEDING B/W PERIODS), GEN. ABNORM. BLEED., MIGRATION. PATIENT DATE OF BIRTH, LAB DATA, ESSURE REMOVAL DATE, REPORTER CAUSALITY COMMENT 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 907499 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | C222902-NOT VALID | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Other| R |