ESSURE
Report
- Report Number
- 2951250-2016-02720
- Event Type
- Injury
- Date Received
- December 14, 2016
- Report Date
- October 31, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
CUTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("ESSURE HAD MIGRATED OUT OF HER FALLOPIAN TUBE"), PELVIC INFLAMMATORY DISEASE ("PELVIC INFLAMMATORY DISEASE"), ABDOMINAL PAIN ("CHRONIC AND SEVERE ABDOMINAL PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 962114 INVALID) INSERTED FOR TUBAL LIGATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 ((B)(6) 1989, (B)(6) 1995,(B)(6) 2000), SHORTNESS OF BREATH, DYSPNEA, CHEST PAIN, HYPERCALCEMIA AND ANEMIA. PATIENT IS NON-ALCOHOLIC. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVES FROM 2007 TO (B)(6) 2012. CONCURRENT CONDITIONS INCLUDED CONDOM, BODY MASS INDEX NORMAL, BREAST MASS, NON-SMOKER, PASSIVE SMOKING, DUODENAL ULCER, UTERINE BLEEDING, PLEURISY, PAP SMEAR ABNORMAL, CONSTIPATION, SEXUALLY TRANSMITTED DISEASE, NAUSEA, VOMITING, HYPOKALEMIA, OVARIAN CYST AND VAGINAL ODOR. FAMILY HISTORY INCLUDED KIDNEY CANCER (FATHER), DIABETES (MATERNAL AUNT) AND HYPERTENSION (MOTHER). CONCOMITANT PRODUCTS INCLUDED ANAESTHETICS (ANESTHESIA), KETOROLAC TROMETHAMINE (TORADOL), METRONIDAZOLE AND NAPROXEN SODIUM (ALEVE). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED ARTHRALGIA ("SEVERE JOINT PAIN / HIP PAIN(CONSTANT, SEVERE)"), VAGINAL INFECTION ("VAGINAL INFECTIONS / VAGINITIS"), RASH PRURITIC ("ITCHING SKIN RASH") AND WEIGHT DECREASED ("WEIGHT LOSS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAIN DURING INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING") AND MENORRHAGIA ("MENORRHAGIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ANAEMIA ("ANEMIA"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY,DILATION &CURETTAGE,) AND SURGERY (LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC INFLAMMATORY DISEASE, ABDOMINAL PAIN, ARTHRALGIA, ANAEMIA, VAGINAL HAEMORRHAGE, MENORRHAGIA AND RASH PRURITIC OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, DYSPAREUNIA, VAGINAL INFECTION, DYSMENORRHOEA, VAGINAL DISCHARGE, FATIGUE, WEIGHT DECREASED AND ALOPECIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANAEMIA, ARTHRALGIA, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC INFLAMMATORY DISEASE, RASH PRURITIC, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT TOLERATED THE PROCEDURE WELL DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 19.4 KG/SQM. ULTRASOUND SCAN VAGINA - IN (B)(6) 2012: TOTAL BILATERAL OCCLUSION ON (B)(6) 2015 PATIENT HAD TRANSVAGINAL AND TRANSABDOMINAL PELVIC ULTRASOUND EXAMINATION WAS RESULTED IN ANTEVERTED UTERUS: ENDOMETRIAL THICKNESS IS 8MM. THERE IS A SMALL CYST PRESENT IN THE ENDOMETRIUM MEASURING ABOUT 8.7 CM X 6.1 CM X 5.4CM. FURTHER FOLLOW-UP EXAMINATION IS SUGGESTED IN THAT REGARD. THERE ARE SMALL LINEAR ECHO NOTED LATERAL ASPECTS OF THE UTERUS THESE ARE TUBES INSERTED IN THE FALLOPIAN TUBES. BILATERAL OVARIES ARE FAIRLY WELL SEEN. VASCULAR COLOR FLOW NOTED. THERE ARE OVARIAN FOLLICLES PRESENT BILATERALLY. LARGEST ONE FOLLICLE HAS SOME ECHOES INSIDE AND IS COMPLEX CYST MEASURING 20 MM X 14 MM X 11 CM RIGHT SIDE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS:PELVIC INFLAMMATORY DISEASE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED. EVENT:VAGINAL DISCHARGE, WEIGHT GAIN OUTCOME WERE UPDATED. HISTORICAL CONDITION, CONCOMITANT DRUGS WERE ADDED. INCIDENT: NO VALID 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("CHRONIC AND SEVERE ABDOMINAL PAIN"), PELVIC INFLAMMATORY DISEASE ("PELVIC INFLAMMATORY DISEASE"), DEVICE DISLOCATION ("ESSURE HAD MIGRATED OUT OF HER FALLOPIAN TUBE") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 962114) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 3 ((B)(6)1989, (B)(6)1995, (B)(6) 200), SHORTNESS OF BREATH, DYSPNEA, CHEST PAIN AND HYPERCALCEMIA. PATIENT IS NON-ALCOHOLIC. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVES FROM 2007 TO (B)(6) 2012. CONCURRENT CONDITIONS INCLUDED CONDOM, BODY MASS INDEX NORMAL, BREAST MASS, NON-SMOKER, PASSIVE SMOKING, DUODENAL ULCER, UTERINE BLEEDING, PLEURISY, PAP SMEAR ABNORMAL, CONSTIPATION, SEXUALLY TRANSMITTED DISEASE, NAUSEA, VOMITING, HYPOKALEMIA, OVARIAN CYST AND VAGINAL ODOR. FAMILY HISTORY INCLUDED KIDNEY CANCER (FATHER), DIABETES (MATERNAL AUNT) AND HYPERTENSION (MOTHER). CONCOMITANT PRODUCTS INCLUDED ANAESTHETICS (ANESTHESIA) AND KETOROLAC TROMETHAMINE (TORADOL). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED ARTHRALGIA ("SEVERE JOINT PAIN / HIP PAIN(CONSTANT, SEVERE)"), VAGINAL INFECTION ("VAGINAL INFECTIONS / VAGINITIS"), RASH PRURITIC ("ITCHING SKIN RASH") AND WEIGHT DECREASED ("WEIGHT LOSS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAIN DURING INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING") AND MENORRHAGIA ("MENORRHAGIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ANAEMIA ("ANEMIA"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY ON (B)(6) 2016) AND SURGERY (ROBOTIC ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY,DILATION &CURETTAGE,). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, PELVIC INFLAMMATORY DISEASE, DEVICE DISLOCATION, ARTHRALGIA, ANAEMIA, VAGINAL INFECTION, VAGINAL HAEMORRHAGE, MENORRHAGIA, RASH PRURITIC, VAGINAL DISCHARGE AND WEIGHT DECREASED OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, DYSPAREUNIA, DYSMENORRHOEA, FATIGUE AND ALOPECIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANAEMIA, ARTHRALGIA, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC INFLAMMATORY DISEASE, RASH PRURITIC, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT TOLERATED THE PROCEDURE WELL DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 19.4 KG/SQM. ULTRASOUND SCAN VAGINA - IN (B)(6) 2012: TOTAL BILATERAL OCCLUSION ON (B)(6) 2015 PATEINT HAD TRANSVAGINAL AND TRANSABDOMINAL PELVIC ULTRASOUND EXAMINATION WAS RESULTED IN ANTEVERTED UTERUS: ENDOMETRIAL THICKNESS IS 8MM. THERE IS A SMALL CYST PRESENT IN THE ENDOMETRIUM MEASURING ABOUT 8.7 CM X 6.1 CM X 5.4CM. FURTHER FOLLOW-UP EXAMINATION IS SUGGESTED IN THAT REGARD. THERE ARE SMALL LINEAR ECHO NOTED LATERAL ASPECTS OF THE UTERUS THESE ARE TUBES INSERTED IN THE FALLOPIAN TUBES. BILATERAL OVARIES ARE FAIRLY WELL SEEN. VASCULAR COLOR FLOW NOTED. THERE ARE OVARIAN FOLLICLES PRESENT BILATERALLY. LARGEST ONE FOLLICLE HAS SOME ECHOES INSIDE AND IS COMPLEX CYST MEASURING 20 MM X 14 MM X 11 CM RIGHT SIDE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS:PELVIC INFLAMMATORY DISEASE. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-JAN-2018: PFS RECEIVED-LOT NUMBER RECEIVED. PATIENT DEMOGRAPHICS ADDED, PATIENT CONCOMITANT AND HISTORICAL CONDITION AND CONCOMITANT DRUG ADDED, EVENT ADDED AS FOLLOWS:ESSURE HAD MIGRATED OUT OF HER FALLOPIAN TUBE, GENITAL HEMORRHAGE, VAGINAL HEMORRHAGE, MENORRHAGIA, RASH PRURITIC, DYSMENORRHEA, VAGINAL DISCHARGE, FATIGUE, WEIGHT DECREASED, ALOPECIA, PELVIC INFLAMMATORY DISEASE. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, (B)(4) TO BAYER PHARMA (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: AT THE TIME OF REPORTING, 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("CHRONIC AND SEVERE ABDOMINAL PAIN"), PELVIC INFLAMMATORY DISEASE ("PELVIC INFLAMMATORY DISEASE"), DEVICE DISLOCATION ("ESSURE HAD MIGRATED OUT OF HER FALLOPIAN TUBE") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 962114 INVALID) INSERTED FOR TUBAL LIGATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 ((B)(6) 1989, (B)(6) 1995, (B)(6) 200), SHORTNESS OF BREATH, DYSPNEA, CHEST PAIN AND HYPERCALCEMIA. PATIENT IS NON-ALCOHOLIC. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVES FROM 2007 TO (B)(6) 2012. CONCURRENT CONDITIONS INCLUDED CONDOM, BODY MASS INDEX NORMAL, BREAST MASS, NON-SMOKER, PASSIVE SMOKING, DUODENAL ULCER, UTERINE BLEEDING, PLEURISY, PAP SMEAR ABNORMAL, CONSTIPATION, SEXUALLY TRANSMITTED DISEASE, NAUSEA, VOMITING, HYPOKALEMIA, OVARIAN CYST AND VAGINAL ODOR. FAMILY HISTORY INCLUDED KIDNEY CANCER (FATHER), DIABETES (MATERNAL AUNT) AND HYPERTENSION (MOTHER). CONCOMITANT PRODUCTS INCLUDED ANAESTHETICS (ANESTHESIA) AND KETOROLAC TROMETHAMINE (TORADOL). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED ARTHRALGIA ("SEVERE JOINT PAIN / HIP PAIN(CONSTANT, SEVERE)"), VAGINAL INFECTION ("VAGINAL INFECTIONS / VAGINITIS"), RASH PRURITIC ("ITCHING SKIN RASH") AND WEIGHT DECREASED ("WEIGHT LOSS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAIN DURING INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING") AND MENORRHAGIA ("MENORRHAGIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ANAEMIA ("ANEMIA"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY ON (B)(6) 2016) AND SURGERY (ROBOTIC ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY,DILATION &CURETTAGE,). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, PELVIC INFLAMMATORY DISEASE, DEVICE DISLOCATION, ARTHRALGIA, ANAEMIA, VAGINAL INFECTION, VAGINAL HAEMORRHAGE, MENORRHAGIA, RASH PRURITIC, VAGINAL DISCHARGE AND WEIGHT DECREASED OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, DYSPAREUNIA, DYSMENORRHOEA, FATIGUE AND ALOPECIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANAEMIA, ARTHRALGIA, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC INFLAMMATORY DISEASE, RASH PRURITIC, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT TOLERATED THE PROCEDURE WELL DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 19.4 KG/SQM. ULTRASOUND SCAN VAGINA - IN (B)(6) 2012: TOTAL BILATERAL OCCLUSION . ON (B)(6) 2015 PATEINT HAD TRANSVAGINAL AND TRANSABDOMINAL PELVIC ULTRASOUND EXAMINATION WAS RESULTED IN ANTEVERTED UTERUS: ENDOMETRIAL THICKNESS IS 8MM. THERE IS A SMALL CYST PRESENT IN THE ENDOMETRIUM MEASURING ABOUT 8.7 CM X 6.1. CM X 5.4CM. FURTHER FOLLOW-UP EXAMINATION IS SUGGESTED IN THAT REGARD. THERE ARE SMALL LINEAR ECHO NOTED LATERAL ASPECTS OF THE UTERUS THESE ARE TUBES INSERTED IN THE FALLOPIAN TUBES. BILATERAL OVARIES ARE FAIRLY WELL SEEN. VASCULAR COLOR FLOW NOTED. THERE ARE OVARIAN FOLLICLES PRESENT BILATERALLY. LARGEST ONE FOLLICLE HAS SOME ECHOES INSIDE AND IS COMPLEX CYST MEASURING 20 MM X 14 MM X 11 CM RIGHT SIDE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS:PELVIC INFLAMMATORY DISEASE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-FEB-2018: THE LOT NUMBER REPORTED (LOT #962114) IS INVALID. INCIDENT: AT THE TIME OF REPORTING, 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.
QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-DEC-2016: PTC INVESTIGATION RESULT. COMPANY CAUSALITY COMMENT: A FEMALE PLAINTIFF HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED ABDOMINAL PAIN. SHE UNDERWENT HYSTERECTOMY AND BILATERAL SALPINGECTOMY FOUR YEARS AFTER PLACEMENT PROCEDURE. THIS EVENT IS ANTICIPATED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. CONSIDERING THE IMPLIED TEMPORAL RELATIONSHIP AND THE ABSENCE OF ALTERNATIVE EXPLANATION, CAUSAL RELATIONSHIP WITH ESSURE DEVICE CANNOT BE EXCLUDED. SINCE A SURGICAL INTERVENTION WAS REQUIRED, THIS CASE IS REGARDED AS INCIDENT. A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. FURTHER INFORMATION WILL BE OBTAINED THROUGH LITIGATION PROCESS.
THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A LAWYER IN THE UNITED STATES, ON BEHALF OF A PLAINTIFF IN UNITED STATES ON 18-NOV-2016 WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2012 FOR PERMANENT CONTRACEPTION. SOMETIME AFTER IMPLANT OF THE ESSURE DEVICE SHE BEGAN TO EXPERIENCE ONE OR MORE OF THE FOLLOWING SYMPTOMS INCLUDING BUT NOT LIMITED TO SEVERE ABNORMAL MENSTRUAL PAIN, ABNORMAL MENSTRUAL CYCLE, EXCESSIVE BLEEDING, SEVERE PELVIC PAIN, BACK PAIN, ABDOMINAL PAIN, PAIN DURING INTERCOURSE, HEADACHES, ALLERGIC REACTION, MOOD SWINGS, MIGRATION OF THE DEVICE, UNWANTED PREGNANCY AND FATIGUE. SHE REPORTED TO HER HEALTHCARE PROVIDER THAT SHE WAS EXPERIENCING CHRONIC AND SEVERE ABDOMINAL PAIN, PAIN DURING INTERCOURSE, SEVERE JOINT PAIN, ANEMIA AND VAGINAL INFECTIONS. ON (B)(6) 2016, LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY WERE PERFORMED. COMPANY CAUSALITY COMMENT: A FEMALE PLAINTIFF HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED ABDOMINAL PAIN. SHE UNDERWENT HYSTERECTOMY AND BILATERAL SALPINGECTOMY FOUR YEARS AFTER PLACEMENT PROCEDURE. THIS EVENT IS ANTICIPATED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. CONSIDERING THE IMPLIED TEMPORAL RELATIONSHIP AND THE ABSENCE OF ALTERNATIVE EXPLANATION, CAUSAL RELATIONSHIP WITH ESSURE DEVICE CANNOT BE EXCLUDED. SINCE A SURGICAL INTERVENTION WAS REQUIRED, THIS CASE IS REGARDED AS INCIDENT. TECHNICAL ANALYSIS HAS BEEN REQUESTED. FURTHER INFORMATION WILL BE OBTAINED THROUGH LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 823798 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 962114 INVALID |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | ALEVE| ANESTHESIA| ANESTHESIA| ANESTHESIA| METRONIDAZOLE| TORADOL| TORADOL| TORADOL |