ESSURE
Report
- Report Number
- 2951250-2017-09227
- Event Type
- Injury
- Date Received
- November 28, 2017
- Report Date
- April 26, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- 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 PELVIC INFECTION ("INFECTION:(BLADDER/ URINARY TRACT/VAGINAL) TYPE: PELVIC:PELVIC INFECTION"), DEVICE BREAKAGE ("FRACTURING OF THE IMPLANT/ TWO OF THE ESSURE COLI WERE LEFT IN ENDOMETRIAL CANAL."), FALLOPIAN TUBE PERFORATION ("PERFORATION OF ORGANS") AND DEVICE EXPULSION ("ULTRASOUND SHOWED ONE WAS IN THE INCORRECT PLACE/ ULTRASOUND IN THE OFFICE SHOWED POSSIBLYDISPLACED ESSURE COILS IN FUNDUS OF UTERUS") IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627744) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: TREATMENT NONCOMPLIANCE "NO HSG TEST DONE". THE PATIENT'S MEDICAL HISTORY INCLUDED LOW GRADE SQUAMOUS INTRAEPITHELIAL LESION, DYSPLASIA, HUMAN PAPILLOMA VIRUS INFECTION, VAGINAL FLORA IMBALANCE AND LAPAROSCOPY. DATE NOT PROVIDED: ULTRASOUND - ONE WAS IN THE INCORRECT PLACE. CONCURRENT CONDITIONS INCLUDED PAP SMEAR ABNORMAL, CERVICAL DYSPLASIA, OVARIAN CYST, CERVICAL INTRAEPITHELIAL NEOPLASIA II, ECCHYMOSIS, MENSTRUATION ABNORMAL, DYSFUNCTIONAL UTERINE BLEEDING, FITZ-HUGH-CURTIS SYNDROME, ANESTHESIA AND BODY MASS INDEX NORMAL. ON (B)(4)2009, THE PATIENT HAD ESSURE INSERTED. IN (B)(4), THE PATIENT EXPERIENCED ANXIETY ("ANXIETY"), DEPRESSION ("DEPRESSION"), RASH ("RASHES"), DRY SKIN ("DRY SKIN"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), DENTAL CARIES ("TOOTH DECAY"), DENTAL RESTORATION FAILURE ("FALLEN TEETH"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), FATIGUE ("FATIGUE"), ABDOMINAL DISTENSION ("BLOATING"), ARTHRITIS ("ARTHRITIS"), BACK DISORDER ("BACK ISSUE") AND NEPHROLITHIASIS ("KIDNEY STONE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(4)2011, THE PATIENT EXPERIENCED THE FIRST EPISODE OF BACK PAIN ("SEVERE BACK PAIN"), 1 YEAR 11 MONTHS AFTER INSERTION OF ESSURE. ON (B)(4)2012, THE PATIENT EXPERIENCED MENORRHAGIA ("HEAVY PERIODS/HEAVY BLEEDING/PERIODS ARE WORSE") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(4)2012, THE PATIENT EXPERIENCED MOOD SWINGS ("MOOD SWINGS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFECTION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, THE SECOND EPISODE OF BACK PAIN ("BACK PAIN"), PAIN ("IT HURTS TO WALK/PAIN ALL THE TIME"), INFLAMMATION ("INFLAMMATION"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND SCAR ("EXCESSIVE SCAR TISSUE"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),HYSTEROSCOPY, N (B)(4)2012: SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),HYSTEROSCOPY, ON (B)(4)2012: SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),HYSTEROSCOPY AND ON (B)(4)2012 SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),HYSTEROSCOPY). ESSURE WAS REMOVED ON (B)(4)2012. AT THE TIME OF THE REPORT, THE PELVIC INFECTION, DEVICE BREAKAGE, FALLOPIAN TUBE PERFORATION, THE LAST EPISODE OF BACK PAIN, PAIN, ANXIETY, MOOD SWINGS, DEPRESSION, RASH, DRY SKIN, MIGRAINE, DYSMENORRHOEA, FATIGUE, WEIGHT INCREASED, ARTHRITIS, BACK DISORDER, NEPHROLITHIASIS, ABDOMINAL PAIN AND SCAR OUTCOME WAS UNKNOWN, THE DEVICE EXPULSION HAD NOT RESOLVED, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, DENTAL CARIES AND DENTAL RESTORATION FAILURE HAD RESOLVED AND THE INFLAMMATION, HEADACHE AND ABDOMINAL DISTENSION WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ANXIETY, ARTHRITIS, BACK DISORDER, DENTAL CARIES, DENTAL RESTORATION FAILURE, DEPRESSION, DEVICE BREAKAGE, DEVICE EXPULSION, DRY SKIN, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, FATIGUE, HEADACHE, INFLAMMATION, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NEPHROLITHIASIS, PAIN, PELVIC INFECTION, RASH, SCAR, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, THE FIRST EPISODE OF BACK PAIN AND THE SECOND EPISODE OF BACK PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED AS PER PFS: DATE OF INSERTION OF ESSURE DEVICE: (B)(4)2009. DISCREPANCY NOTED AS PER PFS: DATE OF REMOVAL OF ESSURE DEVICE: (B)(4)2011(AS PER MR). CURRENT WEIGHT AS OF (B)(4)2019: 100 LBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 117 LBS. THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 5.THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 3. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 18.9 KG/SQM. COMPUTERISED TOMOGRAM - ON AN UNKNOWN DATE: ESSURE COILS ARE IN FALLOPIAN TUBES BILATERALLY.. HYSTEROSALPINGOGRAM - ON (B)(4)2011: BILATERAL ESSURE COILS IN CORRECT POSITION. TUBES ARE BLOCKED. PATHOLOGY TEST - ON (B)(4)2009: INTERPRETATION (1 ) UTERINE CERVIX, CONIZATION: FOCAL SEVERE SQUAMOUS EPITHELIAL DYSPLASIA (CIN III) . MULTIFOCAL LOW GRADE SQUAMOUS EPITHELIAL DYSPLASIA (CIN I) WITH HUMAN PAPILLOMA VIRUS INDUCED CELLULAR CHANGES 2: CHRONIC CERVICITIS WITH SQUAMOUS METAPLASIA. NABOTHIAN CYST FORMATION. ECTO AND ENDOCERVICAL EXCISION MARGINS NEGATIVE FOR SQUAM DUS OR GLANDULAR EPITHELIAL DYSPLASIA. UTERINE TISSUE, CURETTAGE: SMALL FRAGMENTS OF RESTING ENDOMETRIUM. NEGATIVE FOR DYSPLASIA, HYPERPLASIA, OR MALIGNANCY.. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORD: : PELVIC PAIN, VAGINAL HEMORRHAGE, ABDOMINAL PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(4)2019: PLAINTIFF FACT SHEET AND MEDICAL RECORD RECEIVED. EVENT ADDED: MOOD SWINGS, ABNORMAL BLEEDING (VAGINAL), INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: PELVIC, DEPRESSION, RASHES, DRY SKIN, MIGRAINES, HEADACHES, DYSMENORRHEA (CRAMPING), FATIGUE, WEIGHT GAIN, BLOATING, ARTHRITIS, BACK ISSUE, EXCESSIVE SCAR TISSUE, SEVERE BACK PAIN, TOOTH DECAY, FALLEN TEETH, KIDNEY STONE, ABDOMINAL PAIN. PT FOR THE EVENT: ULTRASOUND SHOWED ONE WAS IN THE INCORRECT PLACE WAS UPDATED TO ULTRASOUND IN THE OFFICE SHOWED POSSIBLY DISPLACED ESSURE COILS IN FUNDUS OF UTERUS. EVENT OUTCOME WAS UPDATED FOR THE EVENT: TOOTH DECAY, FALLEN TEETH, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), HEADACHES, BLOATING, INFLAMMATION. CONCOMITANT AND HISTORICAL CONDITIONS WERE ADDED. LOT NO. WAS ADDED. LAB DATA WAS ADDED. REPORTER INFORMATION WAS ADDED. INCIDENT WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("FRACTURING OF THE IMPLANT/ TWO OF THE ESSURE COLI WERE LEFT IN ENDOMETRIAL CANAL."), PELVIC INFECTION ("INFECTION:(BLADDER/ URINARY TRACT/VAGINAL) TYPE: PELVIC:PELVIC INFECTION"), FALLOPIAN TUBE PERFORATION ("PERFORATION OF ORGANS"), DEVICE EXPULSION ("ULTRASOUND SHOWED ONE WAS IN THE INCORRECT PLACE/ ULTRASOUND IN THE OFFICE SHOWED POSSIBLY DISPLACED ESSURE COILS IN FUNDUS OF UTERUS") AND NEPHROLITHIASIS ("KIDNEY STONE") IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 627744) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "NO HSG TEST DONE". THE PATIENT'S MEDICAL HISTORY INCLUDED LOW GRADE SQUAMOUS INTRAEPITHELIAL LESION, DYSPLASIA, HUMAN PAPILLOMA VIRUS INFECTION, VAGINAL FLORA IMBALANCE AND LAPAROSCOPY. DATE NOT PROVIDED: ULTRASOUND: ONE WAS IN THE INCORRECT PLACE. CONCURRENT CONDITIONS INCLUDED PAP SMEAR ABNORMAL, CERVICAL DYSPLASIA, OVARIAN CYST, CERVICAL INTRAEPITHELIAL NEOPLASIA II, ECCHYMOSIS, MENSTRUATION ABNORMAL, DYSFUNCTIONAL UTERINE BLEEDING, FITZ-HUGH-CURTIS SYNDROME, ANESTHESIA AND BODY MASS INDEX NORMAL. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN 2010, THE PATIENT EXPERIENCED NEPHROLITHIASIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ANXIETY ("ANXIETY"), DEPRESSION ("DEPRESSION"), RASH ("RASHES"), DRY SKIN ("DRY SKIN"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), DENTAL CARIES ("TOOTH DECAY"), TOOTH LOSS ("FALLEN TEETH"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), FATIGUE ("FATIGUE"), ABDOMINAL DISTENSION ("BLOATING"), ARTHRITIS ("ARTHRITIS") AND BACK DISORDER ("BACK ISSUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2011, THE PATIENT EXPERIENCED THE FIRST EPISODE OF BACK PAIN ("SEVERE BACK PAIN"), 1 YEAR 11 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("HEAVY PERIODS/HEAVY BLEEDING/PERIODS ARE WORSE") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MOOD SWINGS ("MOOD SWINGS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC INFECTION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, THE SECOND EPISODE OF BACK PAIN ("BACK PAIN"), PAIN ("IT HURTS TO WALK/PAIN ALL THE TIME"), INFLAMMATION ("INFLAMMATION"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND SCAR ("EXCESSIVE SCAR TISSUE"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), HYSTEROSCOPY, ON (B)(6) 2012: SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), HYSTEROSCOPY, ON (B)(6) 2012: SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), HYSTEROSCOPY AND ON (B)(6) 2012 SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), HYSTEROSCOPY). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, PELVIC INFECTION, FALLOPIAN TUBE PERFORATION, NEPHROLITHIASIS, THE LAST EPISODE OF BACK PAIN, PAIN, ANXIETY, MOOD SWINGS, DEPRESSION, RASH, DRY SKIN, MIGRAINE, DYSMENORRHOEA, FATIGUE, WEIGHT INCREASED, ARTHRITIS, BACK DISORDER, ABDOMINAL PAIN AND SCAR OUTCOME WAS UNKNOWN, THE DEVICE EXPULSION HAD NOT RESOLVED, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, DENTAL CARIES AND TOOTH LOSS HAD RESOLVED AND THE INFLAMMATION, HEADACHE AND ABDOMINAL DISTENSION WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ANXIETY, ARTHRITIS, BACK DISORDER, DENTAL CARIES, DEPRESSION, DEVICE BREAKAGE, DEVICE EXPULSION, DRY SKIN, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, FATIGUE, HEADACHE, INFLAMMATION, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NEPHROLITHIASIS, PAIN, PELVIC INFECTION, RASH, SCAR, TOOTH LOSS, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, THE FIRST EPISODE OF BACK PAIN AND THE SECOND EPISODE OF BACK PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED AS PER PFS: DATE OF INSERTION OF ESSURE DEVICE: ON (B)(6) 2009. DISCREPANCY NOTED AS PER PFS: DATE OF REMOVAL OF ESSURE DEVICE: ON (B)(6) 2011 (AS PER MR). CURRENT WEIGHT AS OF ON (B)(6) 2019: 100 LBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 117 LBS. THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 5. THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 3. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 18.9 KG/SQM. COMPUTERISED TOMOGRAM: ON AN UNKNOWN DATE: ESSURE COILS ARE IN FALLOPIAN TUBES BILATERALLY. HYSTEROSALPINGOGRAM: ON (B)(6) 2011: BILATERAL ESSURE COILS IN CORRECT POSITION. TUBES ARE BLOCKED. PATHOLOGY TEST: ON (B)(6) 2009: INTERPRETATION. (1 ) UTERINE CERVIX, CONIZATION: FOCAL SEVERE SQUAMOUS EPITHELIAL DYSPLASIA (CIN III) . MULTIFOCAL LOW GRADE SQUAMOUS EPITHELIAL DYSPLASIA (CIN I) WITH HUMAN PAPILLOMA VIRUS INDUCED CELLULAR CHANGES 2: CHRONIC CERVICITIS WITH SQUAMOUS METAPLASIA. NABOTHIAN CYST FORMATION. ECTO AND ENDOCERVICAL EXCISION MARGINS NEGATIVE FOR SQUAM DUS OR GLANDULAR EPITHELIAL DYSPLASIA. UTERINE TISSUE, CURETTAGE: SMALL FRAGMENTS OF RESTING ENDOMETRIUM. NEGATIVE FOR DYSPLASIA, HYPERPLASIA, OR MALIGNANCY. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORD: PELVIC PAIN, VAGINAL HEMORRHAGE, ABDOMINAL PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-APR-2019: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. EVENT TREATMENT NONCOMPLIANCE UPDATED TO DEVICE MONITORING PROCEDURE NOT PERFORMED. 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 ("FRACTURING OF THE IMPLANT"), PERFORATION ("PERFORATION OF ORGANS") AND DEVICE DISLOCATION ("ULTRASOUND SHOWED ONE WAS IN THE INCORRECT PLACE") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. 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 DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, MENORRHAGIA ("HEAVY PERIODS/HEAVY BLEEDING/PERIODS ARE WORSE"), BACK PAIN ("BACK PAIN"), TREATMENT NONCOMPLIANCE ("NO HSG TEST DONE"), PAIN ("IT HURTS TO WALK/PAIN ALL THE TIME"), INFLAMMATION ("INFLAMMATION") AND ANXIETY ("ANXIETY"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE IMPLANT), SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE IMPLANT) AND SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, PERFORATION, MENORRHAGIA, BACK PAIN, PAIN, INFLAMMATION AND ANXIETY OUTCOME WAS UNKNOWN AND THE DEVICE DISLOCATION AND TREATMENT NONCOMPLIANCE HAD NOT RESOLVED. THE REPORTER CONSIDERED ANXIETY, BACK PAIN, DEVICE BREAKAGE, DEVICE DISLOCATION, INFLAMMATION, MENORRHAGIA, PAIN AND PERFORATION TO BE RELATED TO ESSURE. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR TREATMENT NONCOMPLIANCE WITH ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2017: THIS CASE WAS CONVERTED FROM THE CONCEPTUS DATABASE INTO ARGUS ON (B)(6) 2013 AND WAS INITIALLY REPORTED BY A CONSUMER. FURTHER INFORMATION WAS RECEIVED ON (B)(6) 2017 AND QUALIFIES THIS PREVIOUS CONCEPTUS CASE AS REPORTABLE CASE BY BAYER. NEW INFORMATION ADDED: NEW REPORTERS, PRODUCT START, STOP DATE UPDATED AND NEW EVENTS FRACTURING OF THE IMPLANT, PERFORATION OF ORGANS, INFLAMMATION, HEAVY PERIODS, BACK, PAIN, ANXIETY WERE ADDED. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE,(B)(4) TO BAYER (B)(4), AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY. INCIDENT NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 841860 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 627744 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Other| R |