BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5225645 · Received November 16, 2015

    Report

    Report Number
    2951250-2015-01458
    Event Type
    Injury
    Date Received
    November 16, 2015
    Date of Event
    June 1, 2005
    Report Date
    January 20, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.

    Additional Manufacturer Narrative · 1

    FOLLOW UP ON INFORMATION RECEIVED ON 25-FEB-2016: NO NEW INFORMATION WAS PROVIDED. FOLLOW-UP INFORMATION RECEIVED ON 14-JUN-2016: DESPITE FOLLOW-UP ATTEMPTS, NO RESPONSE WAS GIVEN TO DATE. THE LIST OF SIMILAR CASES CONTAINS ESSURE REPORTS RECEIVED BY BAYER WITH SIMILAR EVENTS CODED IN MEDDRA. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 14-JUN-2016 FOR THE FOLLOWING MEDDRA PREFERRED TERM: ECTOPIC 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 AN ECTOPIC PREGNANCY 7 MONTHS AFTER ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTION. ACCORDING TO HER, ONE OF THE DEVICES HAD FAILED DURING HER PERIOD, BUT THE OTHER WAS STILL IN PLACE. THESE EVENTS ARE LISTED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. PREGNANCIES (INCLUDING ECTOPIC PREGNANCIES) HAVE BEEN REPORTED AMONG WOMEN WITH ESSURE MICRO-INSERTS IN PLACE. SOME OF THESE PREGNANCIES WERE DUE TO PATIENT NON-COMPLIANCE WHICH INCLUDED FAILURE TO RETURN FOR THE 3-MONTH ESSURE CONFIRMATION TEST (HSG). WHEN PREGNANCY DOES OCCUR AFTER ESSURE PLACEMENT, THE RELATIVE RISK THAT IT WILL BE AN ECTOPIC PREGNANCY IS HIGHER THAN FOR WOMEN WHO DO NOT HAVE ESSURE IN PLACE. IN THIS PARTICULAR CASE, NO INFORMATION WAS GIVEN ABOUT HSG. THE CONSUMER STATED ONE DEVICE FAILED AND THE OTHER WAS IN PLACE; HOWEVER IT IS UNCLEAR IF SHE WAS REFERRING TO A DEVICE EXPULSION INTO THE UTERUS OR IF ESSURE WAS DISLOCATED. THIS DEVICE MOVEMENT COULD HAVE BEEN A CONTRIBUTORY ROLE IN THE REPORTED PREGNANCY. NEVERTHELESS, CONSIDERING THE EXACT ONSET OF THIS EVENT IS UNKNOWN AND SINCE PREGNANCY OCCURRED MORE THAN 3 MONTHS AFTER ESSURE INSERTION; A CAUSAL RELATIONSHIP WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. THIS CASE WAS REGARDED AS INCIDENT, DUE TO SERIOUS INJURY (ECTOPIC PREGNANCY, WHICH USUALLY REQUIRES MEDICAL INTERVENTION). BASED ON THE AVAILABLE INFORMATION NO PRODUCT QUALITY DEFECT WAS CONFIRMED, THEREFORE THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS, THE REPORTED LACK OF EFFICACY AND A QUALITY DEFECT. DESPITE FOLLOW-UP ATTEMPTS, NO FURTHER INFORMATION WAS OBTAINED.

    Additional Manufacturer Narrative · 1

    PTC INVESTIGATION RESULT WAS RECEIVED ON 07-JAN-2016. THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: PTC GLOBAL NUMBER (B)(4). FINAL ASSESSMENT: LOT 223833 IS INVALID. IN THIS CASE, NO PRODUCT SAMPLE WAS RETURNED. 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. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. MEDICAL ASSESSMENT: BASED ON THE AVAILABLE INFORMATION NO PRODUCT QUALITY DEFECT WAS CONFIRMED, THEREFORE THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS, THE REPORTED LACK OF EFFICACY AND A QUALITY DEFECT. THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO VALID 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 AN ECTOPIC PREGNANCY 7 MONTHS AFTER ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTION. ACCORDING TO HER, ONE OF THE DEVICES HAD FAILED DURING HER PERIOD, BUT THE OTHER WAS STILL IN PLACE. THESE EVENTS ARE LISTED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. PREGNANCIES (INCLUDING ECTOPIC PREGNANCIES) HAVE BEEN REPORTED AMONG WOMEN WITH ESSURE MICRO-INSERTS IN PLACE. SOME OF THESE PREGNANCIES WERE DUE TO PATIENT NON-COMPLIANCE WHICH INCLUDED FAILURE TO RETURN FOR THE 3-MONTH ESSURE CONFIRMATION TEST (HSG). WHEN PREGNANCY DOES OCCUR AFTER ESSURE PLACEMENT, THE RELATIVE RISK THAT IT WILL BE AN ECTOPIC PREGNANCY IS HIGHER THAN FOR WOMEN WHO DO NOT HAVE ESSURE IN PLACE. IN THIS PARTICULAR CASE, NO INFORMATION WAS GIVEN ABOUT HSG. THE CONSUMER STATED ONE DEVICE FAILED AND THE OTHER WAS IN PLACE; HOWEVER IT IS UNCLEAR IF SHE WAS REFERRING TO A DEVICE EXPULSION INTO THE UTERUS OR IF ESSURE WAS DISLOCATED. THIS DEVICE MOVEMENT COULD HAVE BEEN A CONTRIBUTORY ROLE IN THE REPORTED PREGNANCY. NEVERTHELESS, CONSIDERING THE EXACT ONSET OF THIS EVENT IS UNKNOWN AND SINCE PREGNANCY OCCURRED MORE THAN 3 MONTHS AFTER ESSURE INSERTION; A CAUSAL RELATIONSHIP WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. THIS CASE WAS REGARDED AS INCIDENT, DUE TO SERIOUS INJURY (ECTOPIC PREGNANCY, WHICH USUALLY REQUIRES MEDICAL INTERVENTION). BASED ON THE AVAILABLE INFORMATION NO PRODUCT QUALITY DEFECT WAS CONFIRMED, THEREFORE THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS, THE REPORTED LACK OF EFFICACY AND A QUALITY DEFECT. FOLLOW-UP INFORMATION IS BEING SOUGHT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A FEMALE CONSUMER OF UNSPECIFIED AGE VIA REGULATORY AUTHORITY (CASE# (B)(4)) IN (B)(4) ON 19-OCT-2015 WHO HAD ESSURE (ESS205) (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED IN (B)(6) 2004 WITH LOT NUMBER 223833. SEVEN MONTHS ((B)(6) 2005) AFTER HAVING IT PUT IN, CONSUMER BECAME PREGNANT, RESULTING IN AN ECTOPIC PREGNANCY THAT SHE WAS TOLD SHE COULD NOT CONTINUE WITH. THE HOSPITAL DID NOT TREAT HER, SHE WAS SENT TO ANOTHER SITE. SHE WAS TOLD THAT ONE OF THE DEVICES HAD FAILED DURING HER PERIOD BUT THE OTHER WAS STILL IN PLACE. AFTER ELEVEN YEARS IT HAS NOT BEEN REMOVED. SHE HAS MUSCLE PAIN, CRAMPS IN PELVIS AND LEGS, FATIGUE, ANXIETY, SWELLING IN ABDOMEN, MYOMAS IN UTERUS, SADNESS AND ALLERGIES. ALL OF THIS BECAUSE OF ESSURE. COMPANY CAUSALITY COMMENT THIS NON-MEDICALLY CONFIRMED; SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD AN ECTOPIC PREGNANCY 7 MONTHS AFTER ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTION. ACCORDING TO HER, ONE OF THE DEVICES HAD FAILED DURING HER PERIOD, BUT THE OTHER WAS STILL IN PLACE. THESE EVENTS ARE LISTED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. PREGNANCIES (INCLUDING ECTOPIC PREGNANCIES) HAVE BEEN REPORTED AMONG WOMEN WITH ESSURE MICRO-INSERTS IN PLACE. SOME OF THESE PREGNANCIES WERE DUE TO PATIENT NON-COMPLIANCE WHICH INCLUDED FAILURE TO RETURN FOR THE 3-MONTH ESSURE CONFIRMATION TEST (HSG). WHEN PREGNANCY DOES OCCUR AFTER ESSURE PLACEMENT, THE RELATIVE RISK THAT IT WILL BE AN ECTOPIC PREGNANCY IS HIGHER THAN FOR WOMEN WHO DO NOT HAVE ESSURE IN PLACE. IN THIS PARTICULAR CASE, NO INFORMATION WAS GIVEN ABOUT HSG. THE CONSUMER STATED ONE DEVICE FAILED AND THE OTHER WAS IN PLACE; HOWEVER IT IS UNCLEAR IF SHE WAS REFERRING TO A DEVICE EXPULSION INTO THE UTERUS OR IF ESSURE WAS DISLOCATED. THIS DEVICE MOVEMENT COULD HAVE BEEN A CONTRIBUTORY ROLE IN THE REPORTED PREGNANCY. NEVERTHELESS, CONSIDERING THE EXACT ONSET OF THIS EVENT IS UNKNOWN AND SINCE PREGNANCY OCCURRED MORE THAN 3 MONTHS AFTER ESSURE INSERTION; A CAUSAL RELATIONSHIP WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. THIS CASE WAS REGARDED AS INCIDENT, DUE TO SERIOUS INJURY (ECTOPIC PREGNANCY, WHICH USUALLY REQUIRES MEDICAL INTERVENTION). A PRODUCT TECHNICAL ANALYSIS AND FOLLOW-UP INFORMATION ARE BEING SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756022 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS205 223833

    Patients

    Seq Age Sex Outcome Treatment
    1 Other