ESSURE
Report
- Report Number
- 2951250-2016-02152
- Event Type
- Injury
- Date Received
- October 11, 2016
- Date of Event
- August 1, 2016
- Report Date
- March 27, 2017
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER
Narratives
FOLLOW UP INFORMATION RECEIVED ON 24-OCT-2016: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT (PTC). THIS ADVERSE EVENT REPORT IS RELATED TO A PTC AND THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS 2016-042919. NO SAMPLE AVAILABLE FOR THIS INVESTIGATION. 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. BASED ON THE AVAILABLE INFORMATION A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. BASED ON THE PROVIDED INFORMATION THE DEFECT TYPE CORRESPONDS TO THE FOLLOWING MEDDRA LLT: DEVICE INEFFECTIVE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS AND THE REPORTED LACK OF EFFICACY CANNOT BE TOTALLY EXCLUDED. A LACK OF EFFICACY AND 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. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND AFTER DIFFICULT INSERTION, ONE COIL SANK TOTALLY IN THE UTERINE TUBE. SHE HAD CONSTANT PAIN. ALTHOUGH THE HYSTEROSALPINGOGRAPHY SHOWED THAT FALLOPIAN TUBES WERE BLOCKED, SHE HAD A POSITIVE PREGNANCY TEST 8 MONTHS AFTER ESSURE INSERTION. SHE HAD A SPONTANEOUS ABORTION WHERE THE BLEEDING STARTED WHEN MENSTRUATION WAS LATE FOR 10 DAYS. ESSURE IMPLANTS WERE REMOVED LAPAROSCOPICALLY AND ONE OF THE IMPLANTS WAS LOCATED IN BOWEL´S FAT. PELVIC PAIN, DEVICE DISLOCATION INTO ABDOMINAL CAVITY AND PREGNANCY WITH DEVICE CONTRACEPTIVE ARE LISTED WHILE SPONTANEOUS ABORTION AND POST ABORTION HAEMORRHAGE ARE UNLISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. ALTHOUGH THE EXACT ONSET DATE AND MECHANISM OF DISLOCATION ARE UNKNOWN, GIVEN THE NATURE OF THE EVENT, A CAUSAL RELATIONSHIP WITH ESSURE INSERTS CANNOT BE EXCLUDED. SINCE ESSURE WAS NOT IN CORRECT LOCATION AND THERE IS NO ALTERNATIVE EXPLANATION, THE PELVIC PAIN IS ASSESSED AS RELATED TO ESSURE. IN THIS CASE, IT IS NOT CLEAR WHEN EXACTLY THE DISLOCATION OCCURRED AND THEREFORE IT IS NOT POSSIBLE TO EXCLUDE A CAUSAL RELATIONSHIP WITH ESSURE (DEVICE INEFFECTIVE) SINCE THE PREGNANCY OCCURRED 8 MONTHS AFTER ESSURE INSERTION. IN THIS CASE, THE ABORTION OCCURRED DURING EARLY PREGNANCY SINCE BLEEDING STARTED AFTER A 10-DAY DELAY. SINCE IN MOST OF THE EARLY PREGNANCIES, THE MISCARRIAGE IS DUE TO CHROMOSOME ABNORMALITIES OR GROSS MORPHOLOGICAL MALFORMATIONS, THIS MISCARRIAGE AND THE SUBSEQUENT BLEEDING ARE ASSESSED AS UNRELATED TO ESSURE INSERTS. THIS CASE IS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED. ACCORDING TO TECHNICAL ANALYSIS, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. FURTHER INFORMATION HAS BEEN REQUESTED.
MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2017: HCP RETURNED PERFORATION QUESTIONNAIRE: BIRTH DATE, (B)(6), NO PREVIOUS ECTOPICS, C-SECTIONS (PATIENT REPORTED OTHERWISE), SPONTANEOUS ABORTIONS, GYNECOLOGICAL INTERVENT. ESSURE INSERTED DURING FOLLICULAR PHASE (LMP BEFORE INSERTION ON (B)(6) 2015), UTERINE FINDINGS NORMAL. VISUALISATION OF TUBAL OS EASY, INSERTION DIFF.,TUBAL SPASMS, UTERINE CONTRACTIONS, FLUID LOSS ABOUT2000 CC, PROCEDURE ABOUT 30 MINUTES. PATIENT (ACCORD. TO RECORDS) DID NOT REPORT PAIN, FELT FINE DURING AND AFTER THE PROCEDURE. ON (B)(6) 2016, TRANS-SONOSALPINGOGRAPHY CONFIRMED TUBAL OCCLUSION, PATIENT INFORMED IT WAS NOT 100%. PATIENT PRESENTED WITH ABDOMINAL PAIN AND PREGNANCY OF ABOUT 5 WEEKS. ON (B)(6) 2016, LAPAROSCOPY FOUND UNILATERAL LEFT PERFORATION, NO ORGAN OR INTRA-ABDOMINAL STRUCTURE PERFORATED, THE COIL WAS ON TOP OF THE BOWEL (SIGMOID MESO), THE RIGHT COIL WAS IN CORRECT POSITION. ON (B)(6) 2016, LAPAROSCOPIC IN ORDER TO REMOVE ESSURE WAS PERFORMED (MEDICALLY NECESS.,PATIENT REQUEST), RECOVERED. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A (B)(6) FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND HAD CONSTANT PAIN (SEEN AS PELVIC PAIN). ALTHOUGH THE HYSTEROSALPINGOGRAPHY SHOWED THAT FALLOPIAN TUBES WERE BLOCKED, SHE HAD A POSITIVE PREGNANCY TEST 8 MONTHS AFTER ESSURE INSERTION. SHE HAD A SPONTANEOUS ABORTION WHERE THE BLEEDING STARTED WHEN MENSTRUATION WAS LATE FOR 10 DAYS. IT WAS REPORTED THAT UNILATERAL LEFT PERFORATION OCCURRED AND NO ORGAN OR INTRA-ABDOMINAL STRUCTURE WAS PERFORATED. THEREFORE, PREVIOUS EVENT ONE OF THE IMPLANTS WAS LOCATED IN BOWEL´S FAT WAS DELETED. ESSURE IMPLANTS WERE REMOVED LAPAROSCOPICALLY. PELVIC PAIN, FALLOPIAN TUBE PERFORATION (LEFT) AND PREGNANCY WITH DEVICE CONTRACEPTIVE ARE ANTICIPATED. SPONTANEOUS ABORTION AND POST ABORTION HAEMORRHAGE ARE UNANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. ALTHOUGH THE EXACT ONSET DATE AND MECHANISM OF FALLOPIAN TUBE PERFORATION ARE UNKNOWN, GIVEN THE NATURE OF THE EVENT, A CAUSAL RELATIONSHIP WITH ESSURE INSERTS CANNOT BE EXCLUDED. AS ESSURE WAS NOT IN CORRECT LOCATION AND THERE IS NO ALTERNATIVE EXPLANATION, THE PELVIC PAIN IS ASSESSED AS RELATED TO ESSURE. IN THIS CASE, IT IS NOT CLEAR WHEN EXACTLY THE FALLOPIAN TUBE PERFORATION OCCURRED AND THEREFORE IT IS NOT POSSIBLE TO EXCLUDE A CAUSAL RELATIONSHIP WITH ESSURE (DEVICE INEFFECTIVE) AS THE PREGNANCY OCCURRED 8 MONTHS AFTER ESSURE INSERTION. IN THIS CASE, THE ABORTION OCCURRED DURING EARLY PREGNANCY SINCE BLEEDING STARTED AFTER A 10-DAY DELAY. SINCE IN MOST OF THE EARLY PREGNANCIES, THE MISCARRIAGE IS DUE TO CHROMOSOME ABNORMALITIES OR GROSS MORPHOLOGICAL MALFORMATIONS, THIS MISCARRIAGE AND THE SUBSEQUENT BLEEDING ARE ASSESSED AS UNRELATED TO ESSURE INSERTS. THIS CASE IS REGARDED AS INCIDENT BECAUSE DEVICE REMOVAL WAS REQUIRED. ACCORDING TO TECHNICAL ANALYSIS, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. NO FURTHER INFORMATION IS EXPECTED.
FOLLOW-UP INFORMATION RECEIVED - QUALITY-SAFETY EVALUATION OF PTC (PTC GLOBAL NUMBER: (B)(4)) RECEIVED ON 09-DEC-2016: 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. BASED ON THE PROVIDED INFORMATION THE DEFECT TYPE CORRESPONDS TO THE FOLLOWING MEDDRA LLT: DEVICE INEFFECTIVE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICALS EVENT OR LACK OF EFFICACY CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE MEDICAL EVENTS AND LACK OF EFFICACY 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. NO FURTHER INFORMATION WAS PROVIDED. FOLLOW-UP ON 23-DEC-2016: NO FOLLOW-UP INFORMATION (ANSWER TO QUESTIONNAIRES) COULD BE OBTAINED FROM HEALTHCARE PROFESSIONAL. THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS WITH SIMILAR EVENTS CODED IN MEDDRA. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 26-DEC-2016 FOR THE FOLLOWING MEDDRA PREFERRED TERMS: PELVIC PAIN. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED (B)(4) CASES; DEVICE DISLOCATION. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED (B)(4) CASES; PREGNANCY WITH CONTRACEPTIVE DEVICE. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED (B)(4) CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THIS MEDDRA PT. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND AFTER DIFFICULT INSERTION, ONE COIL SANK TOTALLY IN THE UTERINE TUBE. SHE HAD CONSTANT PAIN. ALTHOUGH THE HYSTEROSALPINGOGRAPHY SHOWED THAT FALLOPIAN TUBES WERE BLOCKED, SHE HAD A POSITIVE PREGNANCY TEST 8 MONTHS AFTER ESSURE INSERTION. SHE HAD A SPONTANEOUS ABORTION WHERE THE BLEEDING STARTED WHEN MENSTRUATION WAS LATE FOR 10 DAYS. ESSURE IMPLANTS WERE REMOVED LAPAROSCOPICALLY AND ONE OF THE IMPLANTS WAS LOCATED IN BOWEL´S FAT. PELVIC PAIN, DEVICE DISLOCATION INTO ABDOMINAL CAVITY AND PREGNANCY WITH DEVICE CONTRACEPTIVE ARE LISTED WHILE SPONTANEOUS ABORTION AND POST ABORTION HAEMORRHAGE ARE UNLISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. ALTHOUGH THE EXACT ONSET DATE AND MECHANISM OF DISLOCATION ARE UNKNOWN, GIVEN THE NATURE OF THE EVENT, A CAUSAL RELATIONSHIP WITH ESSURE INSERTS CANNOT BE EXCLUDED. SINCE ESSURE WAS NOT IN CORRECT LOCATION AND THERE IS NO ALTERNATIVE EXPLANATION, THE PELVIC PAIN IS ASSESSED AS RELATED TO ESSURE. IN THIS CASE, IT IS NOT CLEAR WHEN EXACTLY THE DISLOCATION OCCURRED AND THEREFORE IT IS NOT POSSIBLE TO EXCLUDE A CAUSAL RELATIONSHIP WITH ESSURE (DEVICE INEFFECTIVE) SINCE THE PREGNANCY OCCURRED 8 MONTHS AFTER ESSURE INSERTION. IN THIS CASE, THE ABORTION OCCURRED DURING EARLY PREGNANCY SINCE BLEEDING STARTED AFTER A 10-DAY DELAY. SINCE IN MOST OF THE EARLY PREGNANCIES, THE MISCARRIAGE IS DUE TO CHROMOSOME ABNORMALITIES OR GROSS MORPHOLOGICAL MALFORMATIONS, THIS MISCARRIAGE AND THE SUBSEQUENT BLEEDING ARE ASSESSED AS UNRELATED TO ESSURE INSERTS. THIS CASE IS REGARDED AS INCIDENT BECAUSE DEVICE REMOVAL WAS REQUIRED. ACCORDING TO TECHNICAL ANALYSIS, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. NO FURTHER INFORMATION IS EXPECTED.
MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-MAR-2017: PATIENT REPORTED DURING THE ESSURE USE SHE HAD REPEATED URINARY TRACT INFECTIONS (EVENT TERM AMENDED), NEW EVENTS ADDED (PAIN DURING SEXUAL INTERCOURSE, DISTURBANCES OF MENSTRUAL CYCLE). SHE HAS ARTERIAL HYPERTENSION AS A CONCOMITANT DISEASE AND GESTATIONAL DIABETES DURING EARLIER PREGNANCY. SHE MADE A CLAIM FOR PATIENT INJURY INSURANCE AND RECEIVED NEGATIVE DECISION BACK. SHE IS GOING TO CLAIM ABOUT THE DECISION. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND HAD CONSTANT PAIN (SEEN AS PELVIC PAIN). ALTHOUGH THE HYSTEROSALPINGOGRAPHY SHOWED THAT FALLOPIAN TUBES WERE BLOCKED, SHE HAD A POSITIVE PREGNANCY TEST 8 MONTHS AFTER ESSURE INSERTION. SHE HAD A SPONTANEOUS ABORTION WHERE THE BLEEDING STARTED WHEN MENSTRUATION WAS LATE FOR (B)(6). IT WAS REPORTED THAT UNILATERAL LEFT PERFORATION OCCURRED AND NO ORGAN OR INTRA-ABDOMINAL STRUCTURE WAS PERFORATED. THEREFORE, PREVIOUS EVENT ONE OF THE IMPLANTS WAS LOCATED IN BOWEL´S FAT WAS DELETED. ESSURE IMPLANTS WERE REMOVED LAPAROSCOPICALLY. PELVIC PAIN, FALLOPIAN TUBE PERFORATION (LEFT) AND PREGNANCY WITH DEVICE CONTRACEPTIVE ARE ANTICIPATED. SPONTANEOUS ABORTION AND POST ABORTION HAEMORRHAGE ARE UNANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. ALTHOUGH THE EXACT ONSET DATE AND MECHANISM OF FALLOPIAN TUBE PERFORATION ARE UNKNOWN, GIVEN THE NATURE OF THE EVENT, A CAUSAL RELATIONSHIP WITH ESSURE INSERTS CANNOT BE EXCLUDED. AS ESSURE WAS NOT IN CORRECT LOCATION AND THERE IS NO ALTERNATIVE EXPLANATION, THE PELVIC PAIN IS ASSESSED AS RELATED TO ESSURE. IN THIS CASE, IT IS NOT CLEAR WHEN EXACTLY THE FALLOPIAN TUBE PERFORATION OCCURRED AND THEREFORE IT IS NOT POSSIBLE TO EXCLUDE A CAUSAL RELATIONSHIP WITH ESSURE (DEVICE INEFFECTIVE) AS THE PREGNANCY OCCURRED 8 MONTHS AFTER ESSURE INSERTION. IN THIS CASE, THE ABORTION OCCURRED DURING EARLY PREGNANCY SINCE BLEEDING STARTED AFTER A (B)(6). SINCE IN MOST OF THE EARLY PREGNANCIES, THE MISCARRIAGE IS DUE TO CHROMOSOME ABNORMALITIES OR GROSS MORPHOLOGICAL MALFORMATIONS, THIS MISCARRIAGE AND THE SUBSEQUENT BLEEDING ARE ASSESSED AS UNRELATED TO ESSURE INSERTS. THIS CASE IS REGARDED AS INCIDENT BECAUSE DEVICE REMOVAL WAS REQUIRED. ACCORDING TO TECHNICAL ANALYSIS, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. NO FURTHER INFORMATION IS EXPECTED.
THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A CONSUMER VIA INTERNET IN (B)(6) ON 01-SEP-2016 AND REFERS TO (B)(6) FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED. REPORTER STATED THAT THE FEMALE EXPERIENCED CONSTANT PAIN, EDEMA AND FINALLY BECAME PREGNANT DURING ESSURE. FOLLOW-UP RECEIVED ON 09-SEP-2016: INFORMATION RECEIVED FROM CONSUMER STATES THAT HOSPITAL HAD MADE A MALPRACTICE IN HER CASE. ACCORDING TO REPORTER, THE MANUFACTURER'S INSTRUCTIONS WERE NOT FOLLOWED; NEITHER IN INSERTION NOR IN THE CONFIRMATION TEST AFTER 3 MONTHS. FOLLOW-UP INFORMATION RECEIVED ON 12-SEP-2016 FROM THE CONSUMER (UPGRADED TO INCIDENT). ESSURE WAS INSERTED ON (B)(6) -2015. INSERTION WAS DIFFICULT AND PAINFUL. 10 COILS FROM ANOTHER IMPLANT REMAINED ON URETRAL SIDE, FROM THE OTHER 0 COILS, THAT IS IT SANK TOTALLY TO THE UTERINE TUBE. ESSURE CONFIRMATION TEST WAS PERFORMED 3 MONTHS AFTER INSERTION BY TSSG (SALPHINGOHYDROSONOGRAPHY). SHE WAS TOLD THAT BOTH TUBES WERE BLOCKED AND THERE WAS NO NEED FOR ADDITIONAL CONTRACEPTION. THE FEMALE CONSUMER USED CONDOM FOR THREE MONTHS AFTER INSERTION. CONSTANT PAIN AND EDEMA HAD BEEN PRESENT ALL THE TIME, URINARY TRACT INFECTIONS DURING SPRING 2016. URINE HOME PREGNANCY TEST WAS (B)(6) ON (B)(6) 2016, ON THE SAME DATE HCG WAS MEASURED IN HOSPITAL EMERGENCY, BEING 189. THE PREGNANCY TERMINATED SPONTANEOUSLY, BLEEDING STARTED WHEN THE MENSTRUATION WAS LATE FOR 10 DAYS. THE FEMALE HAS 4 EARLIER PREGNANCIES AND 4 CHILDREN; IN 1999, 2002, 2006 AND 2012. ALL PREGNANCIES HAVE INITIATED EASILY, NO MISCARRIAGES OR ECTOPIC PREGNANCIES. THE FIRST DELIVERY WAS CESAREAN SECTION DUE TO BREECH PRESENTATION. THE OTHER DELIVERIES WERE INDUCED DUE TO BEING POST TERM. THEY WERE FAST AND WITHOUT COMPLICATIONS. NO GYNECOLOGICAL DISEASES OR PROCEDURES. ESSURE IMPLANTS WERE REMOVED LAPAROSCOPICALLY ON (B)(6) 2016 IN DAY CARE SURGERY. AT THE SAME TIME BOTH TUBES WERE REMOVED. THE OTHER ESSURE IMPLANT WAS NOT ANYMORE IN TUBA, BUT WAS LOCATED IT BOWEL'S MESO FAT. THE EXACT LOCATION OF IMPLANTS HADN'T BEEN CONFIRMED AT ANY STAGE, THE FEMALE WAS ONLY TOLD THAT THE IMPLANTS ARE SOMEWHERE VERY DEEP. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND AFTER DIFFICULT INSERTION, ONE COIL SANK TOTALLY IN THE UTERINE TUBE. SHE HAD CONSTANT PAIN. ALTHOUGH THE HYSTEROSALPINGOGRAPHY SHOWED THAT FALLOPIAN TUBES WERE BLOCKED, SHE HAD A (B)(6) PREGNANCY TEST 8 MONTHS AFTER ESSURE INSERTION. SHE HAD A SPONTANEOUS ABORTION WHERE THE BLEEDING STARTED WHEN MENSTRUATION WAS LATE FOR 10 DAYS. ESSURE IMPLANTS WERE REMOVED LAPAROSCOPICALLY AND ONE OF THE IMPLANTS WAS LOCATED IN BOWEL'S FAT. PELVIC PAIN, DEVICE DISLOCATION INTO ABDOMINAL CAVITY AND PREGNANCY WITH DEVICE CONTRACEPTIVE ARE LISTED WHILE SPONTANEOUS ABORTION AND POST ABORTION HAEMORRHAGE ARE UNLISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. ALTHOUGH THE EXACT ONSET DATE AND MECHANISM OF DISLOCATION ARE UNKNOWN, GIVEN THE NATURE OF THE EVENT, A CAUSAL RELATIONSHIP WITH ESSURE INSERTS CANNOT BE EXCLUDED. SINCE ESSURE WAS NOT IN CORRECT LOCATION AND THERE IS NO ALTERNATIVE EXPLANATION, THE PELVIC PAIN IS ASSESSED AS RELATED TO ESSURE. IN THIS CASE, IT IS NOT CLEAR WHEN EXACTLY THE DISLOCATION OCCURRED AND THEREFORE IT IS NOT POSSIBLE TO EXCLUDE A CAUSAL RELATIONSHIP WITH ESSURE (DEVICE INEFFECTIVE) SINCE THE PREGNANCY OCCURRED 8 MONTHS AFTER ESSURE INSERTION. IN THIS CASE, THE ABORTION OCCURRED DURING EARLY PREGNANCY SINCE BLEEDING STARTED AFTER A 10-DAY DELAY. SINCE IN MOST OF THE EARLY PREGNANCIES, THE MISCARRIAGE IS DUE TO CHROMOSOME ABNORMALITIES OR GROSS MORPHOLOGICAL MALFORMATIONS, THIS MISCARRIAGE AND THE SUBSEQUENT BLEEDING ARE ASSESSED AS UNRELATED TO ESSURE INSERTS. THIS CASE IS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED. A PRODUCT TECHNICAL COMPLAINT ANALYSIS IS BEING SOUGHT. FURTHER INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 668481 | ESSURE | INSERT, TUBAL OCCLUSION | HHS | BAYER PHARMA AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other| R |