ESSURE
Report
- Report Number
- 2951250-2019-03251
- Event Type
- Injury
- Date Received
- July 3, 2019
- Date of Event
- November 1, 2010
- Report Date
- July 9, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN/PELVIC PAIN') AND MENORRHAGIA ('MENORRHAGIA') IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 50512941,(740663,740853)-INV) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED LOW GRADE SQUAMOUS INTRAEPITHELIAL LESION, PARITY 3, IRON DEFICIENCY ANEMIA, ASTHMA, RUPTURED INTERVERTEBRAL DISC, MULTIGRAVIDA, DYSPAREUNIA, VITAMIN D DEFICIENCY, OVARIAN CYST, NABOTHIAN CYST, VAGINAL DELIVERY (3) AND WEIGHT GAIN. CONCURRENT CONDITIONS INCLUDED CONSTIPATION, FIBROCYSTIC BREAST, HYPOVITAMINOSIS, MENORRHAGIA, CONDYLOMA, DYSFUNCTIONAL UTERINE BLEEDING, ABDOMINAL DISTENSION, LOWER ABDOMINAL PAIN, NECK PAIN, PAIN IN HIP, BACK PAIN, CERVICAL DYSPLASIA, VAGINAL BLEEDING, MENSTRUAL DISORDER NOS, MENSES IRREGULAR, PELVIC DISCOMFORT, BLEEDING BREAKTHROUGH, MOOD ALTERED, HEADACHE, DIARRHEA, DISTRESS GASTROINTESTINAL, DYSURIA, GAS, GROIN PAIN, ENDOMETRIAL HYPERPLASIA, INSOMNIA, PROCEDURAL PAIN (WITH MIRENA INSERTION), PROCEDURAL BLEEDING (WITH MIRENA INSERTION), DYSPNOEA, HEART RATE HIGH, DROWSINESS, DYSMENORRHOEA AND IUD EXPELLED. FAMILY HISTORY INCLUDED BREAST CANCER (TWO MATERNAL FIRST COUSINS). CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) SINCE (B)(6) 2017 FOR MENORRHAGIA AS WELL AS COPPER SULFATE;FERROUS SULFATE;MANGANESE SULFATE (FERROUS SULPHATE CO), IBUPROFEN, MEDROXYPROGESTERONE ACETATE (PROVERA) AND ORAL CONTRACEPTIVE NOS. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 24 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON 1-JAN-2012, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("MENTAL ANGUISH") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND TOTAL VAGINAL HYSTERECTOMY BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE MENORRHAGIA, VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAIL: THE LEFT FALLOPIAN TUBE WAS CANNULATED USING THE ESSURE DEVICE ALL THE WAY UP TO THE BLACK POSITIONING MARKER, THEN STABILIZED. APPROXIMATELY 4 COILS WERE VISIBLE AT THE TUBAL OSTIA. AFTER,A MONTH, ONCE SHE HAS A MENSTRUAL PERIOD, WE WILL GET HER IN RIGHT AFTER HER MENSTRUAL PERIOD. ON (B)(6) 2010-SECOND ATTEMPT AT ESSURE PROCEDURE TO CANALIZE THE-RIGHT FALLOPIAN TUBE. ON (B)(6) 2018, PATHOLOGY REPORT REVEALED SECTIONING THROUGH THE RIGHT AND LEFT CORNU OF THE UTERUS REVEALS BILATERAL POSSIBLY INCOMPLETE METALLIC ESSURE COILS MEASURING UP TO 1.2 CM. SECTIONING THROUGH THE SEPARATE FIMBRIATED AND NON-FIMBRIATED FALLOPIAN TUBE SEGMENTS REVEALS UNREMARKABLE CUT SURFACES. THE FIMBRIA ARE SECTIONED AT 0.2-0.3 CM INTERVALS AND ENTIRELY SUBMITTED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. PATHOLOGY TEST - ON (B)(6) 2018: DIAGNOSIS: A. UTERUS, CERVIX. BILATERAL FALLOPIAN TUBES; HYSTERECTOMY AND BILATERAL SALPINGECTOMY: CERVIX: CHRONIC CERVICITIS AND SQUAMOUS METAPLASIA, NEGATIVE FOR SQUAMOUS INTRAEPITHELIAL LESION. ENDOMETRIUM: INACTIVE ENDOMETRIUM WITH FEATURES SUGGESTIVE OF EXOGENOUS HORMONE EFFECT, NEGATIVE FOR ATYPICAL HYPERPLASIA AND CARCINOMA. MYOMETRIUM: ADENOMYOSIS. SMALL LEIOMYOMAS. UTERINE SEROSA: FIBROVASCULAR ADHESIONS. BILATERAL FALLOPIAN TUBES: HISTOLOGICALLY UNREMARKABLE; BENIGN PARATUBAL CYSTS; ESSURE COILS IN SITU. B. SKIN TAG, LEFT THIGH; EXCISION: FIBROEPITHELIAL POLYP. CLINICAL INFORMATION: DYSMENORRHEA, ABNORMAL UTERINE BLEEDING, CHRONIC IRON DEFICIENCY ANEMIA SECONDARY TO BLOOD LOSS. PREGNANCY TEST - ON (B)(6) 2017: NEGATIVE. ULTRASOUND SCAN - ON (B)(6) 2017: IMPRESSION: DOMINANT SIMPLE APPEARING LEFT OVARIAN FOLLICLE. 2. LOW POSITIONING OF IUD WITHIN THE LOWER UTERINE SEGMENT/ENDOCERVICAL CANAL. 3. OTHERWISE UNREMARKABLE PELVIC ULTRASOUND.; ON (B)(6) 2017: RESOLUTION OF PREVIOUSLY NOTED INCREASED ENDOMETRIAL STRIPE (NOW MEASURES 3.2 MM INSTEAD OF PRIOR 18 MM). IUD WAS NOTED TO BE IN LUS AND CERVIX RATHER THAN IN FUNDUS. NO OTHER UNUSUAL FINDINGS. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS MEDICAL RECORD: PELVIC PAIN." 740663, 740853 ARE INVALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-JUL-2019: QUALITY SAFETY EVALUATION OF PTC(PRODUCT TECHNICAL COMPLAINT). 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 DEVICE BREAKAGE ('FRACTURE'), PELVIC PAIN ('PHYSICAL PAIN/PELVIC PAIN') AND MENORRHAGIA ('MENORRHAGIA') IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 50512941,(740663,740853)-INV) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED LOW GRADE SQUAMOUS INTRAEPITHELIAL LESION, PARITY 3, IRON DEFICIENCY ANEMIA, ASTHMA, RUPTURED INTERVERTEBRAL DISC, MULTIGRAVIDA, DYSPAREUNIA, VITAMIN D DEFICIENCY, OVARIAN CYST, NABOTHIAN CYST, VAGINAL DELIVERY (3) AND WEIGHT GAIN. CONCURRENT CONDITIONS INCLUDED CONSTIPATION, FIBROCYSTIC BREAST, HYPOVITAMINOSIS, MENORRHAGIA, CONDYLOMA, DYSFUNCTIONAL UTERINE BLEEDING, ABDOMINAL DISTENSION, LOWER ABDOMINAL PAIN, NECK PAIN, PAIN IN HIP, BACK PAIN, CERVICAL DYSPLASIA, VAGINAL BLEEDING, MENSTRUAL DISORDER NOS, MENSES IRREGULAR, PELVIC DISCOMFORT, BLEEDING BREAKTHROUGH, MOOD ALTERED, HEADACHE, DIARRHEA, DISTRESS GASTROINTESTINAL, DYSURIA, GAS, GROIN PAIN, ENDOMETRIAL HYPERPLASIA, INSOMNIA, PROCEDURAL PAIN (WITH MIRENA INSERTION), PROCEDURAL BLEEDING (WITH MIRENA INSERTION), DYSPNOEA, HEART RATE HIGH, DROWSINESS, DYSMENORRHOEA AND IUD EXPELLED. FAMILY HISTORY INCLUDED BREAST CANCER (TWO MATERNAL FIRST COUSINS). CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) SINCE (B)(6) 2017 FOR MENORRHAGIA AS WELL AS COPPER SULFATE;FERROUS SULFATE;MANGANESE SULFATE (FERROUS SULPHATE CO), IBUPROFEN, MEDROXYPROGESTERONE ACETATE (PROVERA) AND ORAL CONTRACEPTIVE NOS. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 24 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("MENTAL ANGUISH") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ABLATION, HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND TOTAL VAGINAL HYSTERECTOMY BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEPRESSION, ANXIETY AND DYSMENORRHOEA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DEVICE BREAKAGE, DYSMENORRHOEA, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAIL: THE LEFT FALLOPIAN TUBE WAS CANNULATED USING THE ESSURE DEVICE ALL THE WAY UP TO THE BLACK POSITIONING MARKER, THEN STABILIZED. APPROXIMATELY 4 COILS WERE VISIBLE AT THE TUBAL OSTIA. AFTER,A MONTH, ONCE SHE HAS A MENSTRUAL PERIOD, WE WILL GET HER IN RIGHT AFTER HER MENSTRUAL PERIOD. ON (B)(6) 2010-SECOND ATTEMPT AT ESSURE PROCEDURE TO CANALIZE THE-RIGHT FALLOPIAN TUBE. ON (B)(6) 2018, PATHOLOGY REPORT REVEALED SECTIONING THROUGH THE RIGHT AND LEFT CORNU OF THE UTERUS REVEALS BILATERAL POSSIBLY INCOMPLETE METALLIC ESSURE COILS MEASURING UP TO 1.2 CM. SECTIONING THROUGH THE SEPARATE FIMBRIATED AND NON-FIMBRIATED FALLOPIAN TUBE SEGMENTS REVEALS UNREMARKABLE CUT SURFACES. THE FIMBRIA ARE SECTIONED AT 0.2-0.3 CM INTERVALS AND ENTIRELY SUBMITTED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) -2011: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. PATHOLOGY TEST - ON (B)(6) 2018: DIAGNOSIS: UTERUS, CERVIX. BILATERAL FALLOPIAN TUBES; HYSTERECTOMY AND BILATERAL SALPINGECTOMY: CERVIX: CHRONIC CERVICITIS AND SQUAMOUS METAPLASIA, NEGATIVE FOR SQUAMOUS INTRAEPITHELIAL LESION. ENDOMETRIUM: INACTIVE ENDOMETRIUM WITH FEATURES SUGGESTIVE OF EXOGENOUS HORMONE EFFECT, NEGATIVE FOR ATYPICAL HYPERPLASIA AND CARCINOMA. MYOMETRIUM: ADENOMYOSIS. SMALL LEIOMYOMAS. UTERINE SEROSA: FIBROVASCULAR ADHESIONS. BILATERAL FALLOPIAN TUBES: HISTOLOGICALLY UNREMARKABLE; BENIGN PARATUBAL CYSTS; ESSURE COILS. B. SKIN TAG, LEFT THIGH; EXCISION: FIBROEPITHELIAL POLYP. CLINICAL INFORMATION: DYSMENORRHEA, ABNORMAL UTERINE BLEEDING, CHRONIC IRON DEFICIENCY ANEMIA SECONDARY TO BLOOD LOSS. PREGNANCY TEST - ON (B)(6) 2017: NEGATIVE. ULTRASOUND SCAN - ON (B)(6) 2017: IMPRESSION: DOMINANT SIMPLE APPEARING LEFT OVARIAN FOLLICLE. LOW POSITIONING OF IUD WITHIN THE LOWER UTERINE SEGMENT/ENDOCERVICAL CANAL. OTHERWISE UNREMARKABLE PELVIC ULTRASOUND.; ON (B)(6) 2017: RESOLUTION OF PREVIOUSLY NOTED INCREASED ENDOMETRIAL STRIPE (NOW MEASURES 3.2 MM INSTEAD OF PRIOR 18 MM). IUD WAS NOTED TO BE IN LUS AND CERVIX RATHER THAN IN FUNDUS. NO OTHER UNUSUAL FINDINGS. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS MEDICAL RECORD: PELVIC PAIN.". LOT NUMBER: 50512941. MANUFACTURING DATE: 2010-06. EXPIRATION DATE: 2013-06 740663, 740853 ARE NOT VALID. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('FRACTURE'), PELVIC PAIN ('PHYSICAL PAIN/PELVIC PAIN') AND MENORRHAGIA ('MENORRHAGIA') IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 50512941,(740663,740853)-INV) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED LOW GRADE SQUAMOUS INTRAEPITHELIAL LESION, PARITY 3, IRON DEFICIENCY ANEMIA, ASTHMA, RUPTURED INTERVERTEBRAL DISC, MULTIGRAVIDA, DYSPAREUNIA, VITAMIN D DEFICIENCY, OVARIAN CYST, NABOTHIAN CYST, VAGINAL DELIVERY (3) AND WEIGHT GAIN. CONCURRENT CONDITIONS INCLUDED CONSTIPATION, FIBROCYSTIC BREAST, HYPOVITAMINOSIS, MENORRHAGIA, CONDYLOMA, DYSFUNCTIONAL UTERINE BLEEDING, ABDOMINAL DISTENSION, LOWER ABDOMINAL PAIN, NECK PAIN, PAIN IN HIP, BACK PAIN, CERVICAL DYSPLASIA, VAGINAL BLEEDING, MENSTRUAL DISORDER NOS, MENSES IRREGULAR, PELVIC DISCOMFORT, BLEEDING BREAKTHROUGH, MOOD ALTERED, HEADACHE, DIARRHEA, DISTRESS GASTROINTESTINAL, DYSURIA, GAS, GROIN PAIN, ENDOMETRIAL HYPERPLASIA, INSOMNIA, PROCEDURAL PAIN (WITH MIRENA INSERTION), PROCEDURAL BLEEDING (WITH MIRENA INSERTION), DYSPNOEA, HEART RATE HIGH, DROWSINESS, DYSMENORRHOEA AND IUD EXPELLED. FAMILY HISTORY INCLUDED BREAST CANCER (TWO MATERNAL FIRST COUSINS). CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) SINCE (B)(6) 2017 FOR MENORRHAGIA AS WELL AS COPPER SULFATE;FERROUS SULFATE;MANGANESE SULFATE (FERROUS SULPHATE CO), IBUPROFEN, MEDROXYPROGESTERONE ACETATE (PROVERA) AND ORAL CONTRACEPTIVE NOS. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 24 DAYS AFTER INSERTION OF ESSURE. ON(B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("MENTAL ANGUISH") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ABLATION, HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND TOTAL VAGINAL HYSTERECTOMY BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEPRESSION, ANXIETY AND DYSMENORRHOEA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DEVICE BREAKAGE, DYSMENORRHOEA, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAIL: THE LEFT FALLOPIAN TUBE WAS CANNULATED USING THE ESSURE DEVICE ALL THE WAY UP TO THE BLACK POSITIONING MARKER, THEN STABILIZED. APPROXIMATELY 4 COILS WERE VISIBLE AT THE TUBAL OSTIA. AFTER,A MONTH, ONCE SHE HAS A MENSTRUAL PERIOD, WE WILL GET HER IN RIGHT AFTER HER MENSTRUAL PERIOD. ON (B)(6) 2010-SECOND ATTEMPT AT ESSURE PROCEDURE TO CANALIZE THE-RIGHT FALLOPIAN TUBE. ON (B)(6) 2018, PATHOLOGY REPORT REVEALED SECTIONING THROUGH THE RIGHT AND LEFT CORNU OF THE UTERUS REVEALS BILATERAL POSSIBLY INCOMPLETE METALLIC ESSURE COILS MEASURING UP TO 1.2 CM. SECTIONING THROUGH THE SEPARATE FIMBRIATED AND NON-FIMBRIATED FALLOPIAN TUBE SEGMENTS REVEALS UNREMARKABLE CUT SURFACES. THE FIMBRIA ARE SECTIONED AT 0.2-0.3 CM INTERVALS AND ENTIRELY SUBMITTED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. PATHOLOGY TEST - ON (B)(6) 2018: DIAGNOSIS: A. UTERUS, CERVIX. BILATERAL FALLOPIAN TUBES; HYSTERECTOMY AND BILATERAL SALPINGECTOMY: - CERVIX: CHRONIC CERVICITIS AND SQUAMOUS METAPLASIA, NEGATIVE FOR SQUAMOUS INTRAEPITHELIAL LESION -ENDOMETRIUM: INACTIVE ENDOMETRIUM WITH FEATURES SUGGESTIVE OF EXOGENOUS HORMONE EFFECT, NEGATIVE FOR ATYPICAL HYPERPLASIA AND CARCINOMA -MYOMETRIUM: ADENOMYOSIS. SMALL LEIOMYOMAS -UTERINE SEROSA: FIBROVASCULAR ADHESIONS -BILATERAL FALLOPIAN TUBES: HISTOLOGICALLY UNREMARKABLE; BENIGN PARATUBAL CYSTS; ESSURE COILS IN SITU B. SKIN TAG, LEFT THIGH; EXCISION: -FIBROEPITHELIAL POLYP CLINICAL INFORMATION: DYSMENORRHEA, ABNORMAL UTERINE BLEEDING, CHRONIC IRON DEFICIENCY ANEMIA SECONDARY TO BLOOD LOSS. PREGNANCY TEST - ON (B)(6) 2017: NEGATIVE. ULTRASOUND SCAN - ON (B)(6) 2017: IMPRESSION: DOMINANT SIMPLE APPEARING LEFT OVARIAN FOLLICLE. 2. LOW POSITIONING OF IUD WITHIN THE LOWER UTERINE SEGMENT/ENDOCERVICAL CANAL. 3. OTHERWISE UNREMARKABLE PELVIC ULTRASOUND.; ON (B)(6) 2017: RESOLUTION OF PREVIOUSLY NOTED INCREASED ENDOMETRIAL STRIPE (NOW MEASURES 3.2 MM INSTEAD OF PRIOR 18 MM). IUD WAS NOTED TO BE IN LUS AND CERVIX RATHER THAN IN FUNDUS. NO OTHER UNUSUAL FINDINGS. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS MEDICAL RECORD: PELVIC PAIN." 740663, 740853 ARE NOT VALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED: EVENT ADDED- DEVICE BREAKAGE-FRACTURE, OUTCOME FOR EVENT PAIN UPDATED FROM RECOVERING RESOLVING TO RECOVERED RESOLVED. AND FOR BLEEDING FROM UNKNOWN TO RECOVERED RESOLVED. 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 ('PHYSICAL PAIN/PELVIC PAIN') AND MENORRHAGIA ('MENORRHAGIA') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 50512941 LEFT, 740663 RIGHT, 740853) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED LOW GRADE SQUAMOUS INTRAEPITHELIAL LESION, PARITY 3, IRON DEFICIENCY ANEMIA, ASTHMA, RUPTURED INTERVERTEBRAL DISC, MULTIGRAVIDA, DYSPAREUNIA, VITAMIN D DEFICIENCY, OVARIAN CYST, NABOTHIAN CYST, VAGINAL DELIVERY (3) AND WEIGHT GAIN. CONCURRENT CONDITIONS INCLUDED CONSTIPATION, FIBROCYSTIC BREAST, HYPOVITAMINOSIS, MENORRHAGIA, CONDYLOMA, DYSFUNCTIONAL UTERINE BLEEDING, ABDOMINAL DISTENSION, LOWER ABDOMINAL PAIN, NECK PAIN, PAIN IN HIP, BACK PAIN, CERVICAL DYSPLASIA, VAGINAL BLEEDING, MENSTRUAL DISORDER NOS, MENSES IRREGULAR, PELVIC DISCOMFORT, BLEEDING BREAKTHROUGH, MOOD ALTERED, HEADACHE, DIARRHEA, DISTRESS GASTROINTESTINAL, DYSURIA, GAS, GROIN PAIN, ENDOMETRIAL HYPERPLASIA, INSOMNIA, PROCEDURAL PAIN (WITH MIRENA INSERTION), PROCEDURAL BLEEDING (WITH MIRENA INSERTION), DYSPNOEA, HEART RATE HIGH, DROWSINESS, DYSMENORRHOEA AND IUD EXPELLED. FAMILY HISTORY INCLUDED BREAST CANCER (TWO MATERNAL FIRST COUSINS). CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) SINCE (B)(6) 2017 FOR MENORRHAGIA AS WELL AS COPPER SULFATE;FERROUS SULFATE;MANGANESE SULFATE (FERROUS SULPHATE CO), IBUPROFEN, MEDROXYPROGESTERONE ACETATE (PROVERA) AND ORAL CONTRACEPTIVE NOS. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 24 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("MENTAL ANGUISH") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND TOTAL VAGINAL HYSTERECTOMY BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE MENORRHAGIA, VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAIL: THE LEFT FALLOPIAN TUBE WAS CANNULATED USING THE ESSURE DEVICE ALL THE WAY UP TO THE BLACK POSITIONING MARKER, THEN STABILIZED. APPROXIMATELY 4 COILS WERE VISIBLE AT THE TUBAL OSTIA. AFTER,A MONTH, ONCE SHE HAS A MENSTRUAL PERIOD, WE WILL GET HER IN RIGHT AFTER HER MENSTRUAL PERIOD. ON (B)(6) 2010- SECOND ATTEMPT AT ESSURE PROCEDURE TO CANALIZE THE-RIGHT FALLOPIAN TUBE. ON (B)(6) 2018, PATHOLOGY REPORT REVEALED SECTIONING THROUGH THE RIGHT AND LEFT CORNU OF THE UTERUS REVEALS BILATERAL POSSIBLY INCOMPLETE METALLIC ESSURE COILS MEASURING UP TO 1.2 CM. SECTIONING THROUGH THE SEPARATE FIMBRIATED AND NON-FIMBRIATED FALLOPIAN TUBE SEGMENTS REVEALS UNREMARKABLE CUT SURFACES. THE FIMBRIA ARE SECTIONED AT 0.2-0.3 CM INTERVALS AND ENTIRELY SUBMITTED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. PATHOLOGY TEST - ON (B)(6) 2018: DIAGNOSIS: UTERUS, CERVIX. BILATERAL FALLOPIAN TUBES; HYSTERECTOMY AND BILATERAL SALPINGECTOMY: CERVIX: CHRONIC CERVICITIS AND SQUAMOUS METAPLASIA, NEGATIVE FOR SQUAMOUS INTRAEPITHELIAL LESION. ENDOMETRIUM: INACTIVE ENDOMETRIUM WITH FEATURES SUGGESTIVE OF EXOGENOUS HORMONE EFFECT, NEGATIVE FOR ATYPICAL HYPERPLASIA AND CARCINOMA. MYOMETRIUM: ADENOMYOSIS. SMALL LEIOMYOMAS. UTERINE SEROSA: FIBROVASCULAR ADHESIONS. BILATERAL FALLOPIAN TUBES: HISTOLOGICALLY UNREMARKABLE; BENIGN PARATUBAL CYSTS; ESSURE COILS. IN SITU- SKIN TAG, LEFT THIGH; EXCISION: FIBROEPITHELIAL POLYP. CLINICAL INFORMATION: DYSMENORRHEA, ABNORMAL UTERINE BLEEDING, CHRONIC IRON DEFICIENCY ANEMIA SECONDARY TO BLOOD LOSS. PREGNANCY TEST - ON (B)(6) 2017: NEGATIVE. ULTRASOUND SCAN - ON (B)(6) 2017: IMPRESSION: DOMINANT SIMPLE APPEARING LEFT OVARIAN FOLLICLE. LOW POSITIONING OF IUD WITHIN THE LOWER UTERINE SEGMENT/ENDOCERVICAL CANAL. OTHERWISE UNREMARKABLE PELVIC ULTRASOUND. ON (B)(6) 2017: RESOLUTION OF PREVIOUSLY NOTED INCREASED ENDOMETRIAL STRIPE (NOW MEASURES 3.2 MM INSTEAD OF PRIOR 18 MM). IUD WAS NOTED TO BE IN LUS AND CERVIX RATHER THAN IN FUNDUS. NO OTHER UNUSUAL FINDINGS. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS MEDICAL RECORD: PELVIC PAIN." MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-JUN-2019: FU(2) AND FU(3) PROCESSED TOGETHER. MEDICAL RECORD WAS RECEIVED. THIS IS INCIDENT CASE. ESSURE LOT NUMBER AND CONCOMITANT MEDICATION WAS ADDED. REPORTER, MEDICAL HISTORY, CONCURRENT CONDITION AND LAB DATA WAS ADDED. PRODUCT INDICATION UPDATED. SURGERY ADDED FOR EVENT PELVIC PAIN. CASE BECOME INCIDENT. AS FU(2) AND FU(3) PROCESSED TOGETHER ABLATION CAPTURED AS SURGERY FOR EVENT MENORRHAGIA WHICH WAS EXTRACTED FROM 3RD FOLLOW UP. ON 24-JUN-2019: FU(2) AND FU(3) PROCESSED TOGETHER. PLAINTIFF FACT SHEET RECEIVED. FOLLOWING EVENTS WERE ADDED: ABNORMAL BLEEDING (VAGINAL), MENORRHAGIA, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION, MENTAL ANGUISH, DYSMENORRHEA (CRAMPING) AND SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST. EVENT OUTCOME ADDED FOR: PHYSICAL PAIN/PELVIC PAIN. 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 |
|---|---|---|---|---|---|---|---|
| 554112 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 50512941,(740663,740853)-INV | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Other| R | FERROUS SULPHATE CO| FERROUS SULPHATE CO| FERROUS SULPHATE CO| FERROUS SULPHATE CO| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| MIRENA| MIRENA| MIRENA| MIRENA| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| PROVERA| PROVERA| PROVERA| PROVERA| FERROUS SULPHATE CO| IBUPROFEN| MIRENA| ORAL CONTRACEPTIVE NOS| PROVERA |