ESSURE
Report
- Report Number
- 2951250-2019-06511
- Event Type
- Injury
- Date Received
- September 16, 2019
- Date of Event
- December 1, 2014
- Report Date
- May 28, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION : OTHER/ PERFORATION (FALLOPIAN TUBE(S))'), DEVICE EXPULSION ('MIGRATION/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS/UTERUS: ESSURE COIL SEEN'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL),'), MENORRHAGIA ('ABNORMAL BLEEDING ( MENORRHAGIA),'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY: BIRTH - NO COMPLICATION') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN A 24-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C96076) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED OVARIAN CYSTECTOMY IN 2011 AND OVARIAN CYST IN 2011. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, NAUSEA, VOMITING, URINE OUTPUT DECREASED, ADENOMA AND CORPUS LUTEUM CYST. CONCOMITANT PRODUCTS INCLUDED NORETHISTERONE (ORTHO MICRONOR) FROM (B)(6) 2016 TO (B)(6) 2016 FOR VAGINAL BLEEDING AS WELL AS ASCORBIC ACID;CALCIUM;CALCIUM LEVOMEFOLATE;COLECALCIFEROL;CYANOCOBALAMIN;DL-ALPHA TOCOPHERYL ACETATE;DOCOSAHEXAENOIC ACID;FERROUS FUMARATE;MAGNESIUM;PYRIDOXINE HYDROCHLORIDE (PNV DHA) FROM (B)(6) 2014 TO (B)(6) 2016, CLINDAMYCIN FROM (B)(6) 2016 TO (B)(6) 2016 AND MIDAZOLAM HYDROCHLORIDE (VERSED) FROM (B)(6) 2014 TO (B)(6) 2015. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN/ PELVIC"). IN (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEPRESSION ("PSYCH INJURY/ PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY AND MENTAL ANGUISH"). ON (B)(6) 2015, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2016, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARRY TRACT/VAGINAL)- TYPE : UTI"). ON (B)(6) 2017, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), VAGINAL INFECTION ("BLADDER/URINARY PROBLEMS : VAGINA INFECTION"), PROCEDURAL COMPLICATION ("COMPLICATIONS DURING REMOVAL SURGERY ? : REPEAT/MULTIPLE SURGERIES") AND MIGRAINE ("MIGRAINES / HEADACHES"). THE PATIENT WAS TREATED WITH CEFALEXIN (KEFLEX-C) AND SURGERY (BILATERAL SALPINGECTOMY, UNILATERAL OOPHERECTOMY - LEFT, SURGICAL REMOVAL OF COIL(S) - LAPAROSCOPIC AND ORTHO MICRONOR NOVASURE ABLATION, (B)(6) 2016.). AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE EXPULSION, VAGINAL HAEMORRHAGE, MENORRHAGIA, PREGNANCY WITH CONTRACEPTIVE DEVICE, DEPRESSION, PROCEDURAL COMPLICATION, ANXIETY, MIGRAINE AND URINARY TRACT INFECTION OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN AND VAGINAL INFECTION HAD RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DEVICE EXPULSION, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, PROCEDURAL COMPLICATION, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, GENITAL BLEEDING, PSYCH INJURY, MIGRATION, PERFORATION, VAGINAL INFECTION. TYPE OF ADDITIONAL SURGERIES : TUBAL LIGATION. CURRENT WEIGHT 165LBS. NUMBER OF PROXIMAL COILS 2 ON THE LEFT CORNUA AND 1 ON THE RIGHT CORNUA. THE COIL WAS THEN REMOVED AND THEN THE BASE OF THE TUBAL PORTION CAUTERIZED AND CUT RELEASING THE TUBE. THE ABDOMEN AND PELVIS WAS INSPECTED AND COIL FROM THE RIGHT WAS NOT IDENTIFIED. UTERUS: POSITION ANTEVERTED - COMMENT: ESSURE COILS STILL SEEN, RIGHT COILS APPEARED IN THE MYOMETRIUM WITH A CYSTIC AREA AROUND IT MEASURING 6X4 MM, PARTIAL COIL STILL SEEN. ENDOMETRIUM: TEXTURE: HYPERECHOIC , IRREGULAR , ILL-DEFINED. CERVIX: APPEARED NORMAL. OVARY: RIGHT FINDINGS: ENLARGED WITH THE COMPLEX CYSTIC AREA SEEN WITH PERIPHERAL BLOOD FLOW MEASURING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.3 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.; ON (B)(6) 2015: RIGHT OCCLUSION ONLY; ON (B)(6) 2015: UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED) OTHER (PLEASE DESCRIBE) RIGHT TUBE PATENT, SUSPICIOUS PERFORATION. PATHOLOGY TEST - ON AN UNKNOWN DATE: SECTIONS SHOW COMPLETE CROSS SECTIONS OF TWO FALLOPIAN TUBE SEGMENT EACH SHOWS CENTRAL LUMEN LINED BY CILIATED EPITHELIUM, SURROUNDED BY MUSCULAR WALL. ADDITIONAL TISSUE FRAGMENT SHOW DILATED MULTI CYSTIC OVARY. THE CYSTS ARE LINED BY FLATTENED TO CUBOIDAL EPITHELIUM WITH FOCAL MUCINOUS EPITHELIUM. NO EVIDENCE OF PAPILLATIONS, ATYPIA, OR MALIGNANCY IS NOTED. REMAINING OVARIAN TISSUE SHOWS CORPUS LUTEUM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, HEADACHE, DIZZINESS, VAGINAL BLEEDING. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-SEP-2019: PFS AND MEDICAL RECORD RECEIVED ¿ NEW EVENTS ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY AND MENTAL ANGUISH, MIGRAINES / HEADACHES, INFECTION (BLADDER/URINARRY TRACT/VAGINAL)- TYPE : UTI WAS ADDED. EVENT PERFORATION : OTHER UPDATED TO PERFORATION : OTHER/ PERFORATION (FALLOPIAN TUBE(S)), MIGRATION UPDATED TO MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS/UTERUS: ESSURE COIL SEEN AND PSYCH INJURY UPDATED TO DEPRESSION. ESSURE LOT NUMBER WAS ADDED. PATIENT WEIGHT AND HEIGHT WAS ADDED. NEW REPORTER WAS ADDED. CONCOMITANTS MEDICATION, MEDICAL HISTORY AND LAB DATA WAS 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 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 FALLOPIAN TUBE PERFORATION ('PERFORATION: OTHER/ PERFORATION (FALLOPIAN TUBE(S))'), DEVICE EXPULSION ('MIGRATION/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS/UTERUS: ESSURE COIL SEEN'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL),'), MENORRHAGIA ('ABNORMAL BLEEDING ( MENORRHAGIA),'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY: BIRTH - NO COMPLICATION') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN A 24-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C96076-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED OVARIAN CYSTECTOMY IN 2011 AND OVARIAN CYST IN 2011. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, NAUSEA, VOMITING, URINE OUTPUT DECREASED, ADENOMA BENIGN AND CORPUS LUTEUM CYST. CONCOMITANT PRODUCTS INCLUDED NORETHISTERONE (ORTHO MICRONOR) FROM (B)(6) 2016 TO (B)(6) 2016 FOR VAGINAL BLEEDING AS WELL AS ASCORBIC ACID; CALCIUM;CALCIUM LEVOMEFOLATE;COLECALCIFEROL; CYANOCOBALAMIN; DL-ALPHA TOCOPHERYL ACETATE;DOCOSAHEXAENOIC ACID; FERROUS FUMARATE;MAGNESIUM;PYRIDOXINE HYDROCHLORIDE (PNV DHA) FROM (B)(6) 2014 TO (B)(6) 2016, CLINDAMYCIN FROM (B)(6)APRIL 2016 TO (B)(6) 2016 AND MIDAZOLAM HYDROCHLORIDE (VERSED) FROM (B)(6) 2014 TO (B)(6) 2015. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN/ PELVIC"). IN (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEPRESSION ("PSYCH INJURY/ PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY AND MENTAL ANGUISH"). ON (B)(6) 2015, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2016, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARRY TRACT/VAGINAL) - TYPE : UTI"). ON (B)(6) 2017, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), VAGINAL INFECTION ("BLADDER/URINARY PROBLEMS : VAGINA INFECTION"), PROCEDURAL COMPLICATION ("COMPLICATIONS DURING REMOVAL SURGERY? : REPEAT/MULTIPLE SURGERIES") AND MIGRAINE ("MIGRAINES / HEADACHES"). THE PATIENT WAS TREATED WITH CEFALEXIN (KEFLEX-C) AND SURGERY (BILATERAL SALPINGECTOMY, UNILATERAL OOPHERECTOMY - LEFT, SURGICAL REMOVAL OF COIL(S) - LAPAROSCOPIC AND ORTHO MICRONOR NOVASURE ABLATION, (B)(6) 2016.). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE EXPULSION, VAGINAL HAEMORRHAGE, MENORRHAGIA, PREGNANCY WITH CONTRACEPTIVE DEVICE, DEPRESSION, PROCEDURAL COMPLICATION, ANXIETY, MIGRAINE AND URINARY TRACT INFECTION OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN AND VAGINAL INFECTION HAD RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DEVICE EXPULSION, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, PROCEDURAL COMPLICATION, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, GENITAL BLEEDING, PSYCH INJURY, MIGRATION, PERFORATION, VAGINAL INFECTION. TYPE OF ADDITIONAL SURGERIES : TUBAL LIGATION. CURRENT WEIGHT 165LBS. NUMBER OF PROXIMAL COILS 2 ON THE LEFT CORNUA AND 1 ON THE RIGHT CORNUA. THE COIL WAS THEN REMOVED AND THEN THE BASE OF THE TUBAL PORTION CAUTERIZED AND CUT RELEASING THE TUBE. THE ABDOMEN AND PELVIS WAS INSPECTED AND COIL FROM THE RIGHT WAS NOT IDENTIFIED. UTERUS: POSITION ANTEVERTED - COMMENT: ESSURE COILS STILL SEEN, RIGHT COILS APPEARED IN THE MYOMETRIUM WITH A CYSTIC AREA AROUND IT MEASURING 6X4 MM, PARTIAL COIL STILL SEEN. ENDOMETRIUM: TEXTURE: HYPERECHOIC , IRREGULAR , ILL-DEFINED. CERVIX: APPEARED NORMAL. OVARY: RIGHT FINDINGS: ENLARGED WITH THE COMPLEX CYSTIC AREA SEEN WITH PERIPHERAL BLOOD FLOW MEASURING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.3 KG/SQM. HYSTEROSALPINGOGRAM ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.; ON (B)(6) 2015: RIGHT OCCLUSION ONLY; ON (B)(6) 2015: UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED) OTHER (PLEASE DESCRIBE) RIGHT TUBE PATENT, SUSPICIOUS PERFORATION.. PATHOLOGY TEST ON AN UNKNOWN DATE: SECTIONS SHOW COMPLETE CROSS SECTIONS OF TWO FALLOPIAN TUBE SEGMENT EACH SHOWS CENTRAL LUMEN LINED BY CILIATED EPITHELIUM, SURROUNDED BY MUSCULAR WALL. ADDITIONAL TISSUE FRAGMENT SHOW DILATED MULTI CYSTIC OVARY. THE CYSTS ARE LINED BY FLATTENED TO CUBOIDAL EPITHELIUM WITH FOCAL MUCINOUS EPITHELIUM. NO EVIDENCE OF PAPILLATIONS, ATYPIA, OR MALIGNANCY IS NOTED. REMAINING OVARIAN TISSUE SHOWS CORPUS LUTEUM, CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, HEADACHE, DIZZINESS, VAGINAL BLEEDING. LOT NUMBER C96076 IS NOT VALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-SEP-2019: QUALITY SAFETY EVALUATION OF PTC. NO VALID LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. 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 FALLOPIAN TUBE PERFORATION ('PERFORATION : OTHER/ PERFORATION (FALLOPIAN TUBE(S))'), DEVICE EXPULSION ('MIGRATION/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS/UTERUS: ESSURE COIL SEEN'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL),') AND MENORRHAGIA ('ABNORMAL BLEEDING ( MENORRHAGIA),') IN A 24-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C96076-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED OVARIAN CYSTECTOMY IN 2011 AND OVARIAN CYST IN 2011. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, NAUSEA, VOMITING, URINE OUTPUT DECREASED, ADENOMA BENIGN AND CORPUS LUTEUM CYST. CONCOMITANT PRODUCTS INCLUDED NORETHISTERONE (ORTHO MICRONOR) FROM (B)(6) 2016 TO (B)(6) 2016 FOR VAGINAL BLEEDING AS WELL AS ASCORBIC ACID;CALCIUM;CALCIUM LEVOMEFOLATE;COLECALCIFEROL;CYANOCOBALAMIN;DL-ALPHA TOCOPHERYL ACETATE;DOCOSAHEXAENOIC ACID;FERROUS FUMARATE;MAGNESIUM;PYRIDOXINE HYDROCHLORIDE (PNV DHA) FROM (B)(6) 2014 TO (B)(6) 2016, CLINDAMYCIN FROM (B)(6) 2016 TO (B)(6) 2016 AND MIDAZOLAM HYDROCHLORIDE (VERSED) FROM (B)(6) 2014 TO (B)(6) 2015. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN/ PELVIC"). IN (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEPRESSION ("PSYCH INJURY/ PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY AND MENTAL ANGUISH"). ON (B)(6) 2015, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY: BIRTH - NO COMPLICATION"). IN (B)(6) 2016, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARRY TRACT/VAGINAL)- TYPE : UTI"). ON (B)(6) 2017, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), VAGINAL INFECTION ("BLADDER/URINARY PROBLEMS : VAGINA INFECTION"), PROCEDURAL COMPLICATION ("COMPLICATIONS DURING REMOVAL SURGERY ? : REPEAT/MULTIPLE SURGERIES") AND MIGRAINE ("MIGRAINES / HEADACHES"). THE PATIENT WAS TREATED WITH CEFALEXIN (KEFLEX-C) AND SURGERY (BILATERAL SALPINGECTOMY, UNILATERAL OOPHERECTOMY - LEFT, SURGICAL REMOVAL OF COIL(S) - LAPAROSCOPIC AND ORTHO MICRONOR NOVASURE ABLATION, (B)(6) 2016.). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE EXPULSION, PREGNANCY WITH CONTRACEPTIVE DEVICE, DEPRESSION, PROCEDURAL COMPLICATION, ANXIETY AND MIGRAINE OUTCOME WAS UNKNOWN AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, VAGINAL INFECTION AND URINARY TRACT INFECTION HAD RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DEVICE EXPULSION, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, PROCEDURAL COMPLICATION, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, GENITAL BLEEDING, PSYCH INJURY, MIGRATION, PERFORATION, VAGINAL INFECTION. TYPE OF ADDITIONAL SURGERIES : TUBAL LIGATION. CURRENT WEIGHT 165LBS. NUMBER OF PROXIMAL COILS 2 ON THE LEFT CORNUA AND 1 ON THE RIGHT CORNUA. THE COIL WAS THEN REMOVED AND THEN THE BASE OF THE TUBAL PORTION CAUTERIZED AND CUT RELEASING THE TUBE. THE ABDOMEN AND PELVIS WAS INSPECTED AND COIL FROM THE RIGHT WAS NOT IDENTIFIED. UTERUS: POSITION ANTEVERTED - COMMENT: ESSURE COILS STILL SEEN, RIGHT COILS APPEARED IN THE MYOMETRIUM WITH A CYSTIC AREA AROUND IT MEASURING 6X4 MM, PARTIAL COIL STILL SEEN. ENDOMETRIUM: TEXTURE: HYPERECHOIC , IRREGULAR , ILL-DEFINED. CERVIX: APPEARED NORMAL. OVARY: RIGHT FINDINGS: ENLARGED WITH THE COMPLEX CYSTIC AREA SEEN WITH PERIPHERAL BLOOD FLOW MEASURING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.3 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.; ON (B)(6) 2015: RIGHT OCCLUSION ONLY; ON (B)(6) 2015: UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED) OTHER (PLEASE DESCRIBE) RIGHT TUBE PATENT, SUSPICIOUS PERFORATION. PATHOLOGY TEST - ON AN UNKNOWN DATE: SECTIONS SHOW COMPLETE CROSS SECTIONS OF TWO FALLOPIAN TUBE SEGMENT EACH SHOWS CENTRAL LUMEN LINED BY CILIATED EPITHELIUM, SURROUNDED BY MUSCULAR WALL. ADDITIONAL TISSUE FRAGMENT SHOW DILATED MULTI CYSTIC OVARY. THE CYSTS ARE LINED BY FLATTENED TO CUBOIDAL EPITHELIUM WITH FOCAL MUCINOUS EPITHELIUM. NO EVIDENCE OF PAPILLATIONS, ATYPIA, OR MALIGNANCY IS NOTED. REMAINING OVARIAN TISSUE SHOWS CORPUS LUTEUM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, HEADACHE, DIZZINESS, VAGINAL BLEEDING. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED. OUTCOME OF EVENTS URINARY TRACT INFECTION, VAGINAL HEMORRHAGE AND MENORRHAGIA WERE UPDATED TO 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 PERFORATION ('PERFORATION : OTHER'), DEVICE DISLOCATION ('MIGRATION'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY: BIRTH - NO COMPLICATION') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PHYSICAL PAIN/ PELVIC"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), VAGINAL INFECTION ("BLADDER/URINARY PROBLEMS : VAGINA INFECTION") AND PROCEDURAL COMPLICATION ("COMPLICATIONS DURING REMOVAL SURGERY ? : REPEAT/MULTIPLE SURGERIES") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (UNILATERAL),TUBAL LIGATION). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PERFORATION, DEVICE DISLOCATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, PSYCHOLOGICAL TRAUMA AND PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN AND VAGINAL INFECTION HAD RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN, PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, PROCEDURAL COMPLICATION, PSYCHOLOGICAL TRAUMA AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, GENITAL BLEEDING, PSYCH INJURY, MIGRATION, PERFORATION, VAGINAL INFECTION. TYPE OF ADDITIONAL SURGERIES: TUBAL LIGATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED ON (B)(6) 2015: RIGHT OCCLUSION ONLY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-SEP-2019: PFS RECEIVED: NEW EVENTS- ABDOMINAL PAIN, BACK PAIN, GENERAL ABNORMAL BLEEDING, PSYCH INJURY, PREGNANCY: BIRTH - NO COMPLICATION, PERFORATION, VAGINAL INFECTION, COMPLICATIONS DURING REMOVAL SURGERY WERE ADDED. UPDATED OUTCOME OF EVENTS PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, GENITAL BLEEDING, VAGINAL INFECTION TO RECOVERED/RESOLVED. DATE OF REMOVAL, REPORTERS AND LAB DATA WERE ADDED. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. 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 |
|---|---|---|---|---|---|---|---|
| 863599 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | C96076-NOT VALID | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Other| R | CLINDAMYCIN| CLINDAMYCIN| CLINDAMYCIN| ORTHO MICRONOR| ORTHO MICRONOR| ORTHO MICRONOR| PNV DHA| PNV DHA| PNV DHA| VERSED| VERSED| VERSED |