BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5073035 · Received September 12, 2015

    Report

    Report Number
    2951250-2015-00803
    Event Type
    Injury
    Date Received
    September 12, 2015
    Report Date
    January 20, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATA CORRECTION: THE PRODUCT CODE KNH WAS REPLACED WITH HHS.

    Additional Manufacturer Narrative · 1

    PTC INVESTIGATION RESULT WAS RECEIVED ON 08-SEP-2015. 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: SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. 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: NO PRODUCT QUALITY DEFECT WAS CONFIRMED THEREFORE A RELATIONSHIP TO THE REPORTED MEDICAL EVENTS IS EXCLUDED. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS AND A QUALITY DEFECT. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS AND NON-MEDICALLY CONFIRMED CASE REPORT REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND WAS EXPERIENCING TWO HEAVY PERIODS A MONTH AND HAD AN ENDOMETRIAL ABLATION. SHE ALSO WAS SO DEPRESSED THAT SHE TRIED TO END HER LIFE. THESE EVENTS, SEEN AS POLYMENORRHOEA AND SUICIDE ATTEMPT, ARE SERIOUS DUE REQUIRED INTERVENTION AND LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. SOME DEPRESSIVE FEELINGS AND EMOTIONAL DISTURBANCES REGARDING THE DEFINITIVE CONTRACEPTION WITH ESSURE HAVE BEEN REPORTED, HOWEVER; NEITHER MAJOR DEPRESSIVE, NOR SUICIDAL ATTEMPTS ARE EXPECTED. THUS, CAUSAL RELATIONSHIP BETWEEN SUICIDE ATTEMPT AND ESSURE USE IS VERY UNLIKELY. ALSO, ABNORMAL GENITAL BLEEDING AND MENSES PATTERN CHANGES MAY OCCUR DURING ESSURE USE. THEREFORE, GIVEN EVENT'S NATURE AND IMPLIED TEMPORAL RELATIONSHIP POLYMENORRHOEA IS ASSESSED AS RELATED TO ESSURE USE. IN ADDITION SOME DEPRESSIVE FEELINGS AND EMOTIONAL DISTURBANCES REGARDING THE DEFINITIVE CONTRACEPTION WITH ESSURE HAVE BEEN REPORTED, HOWEVER; NEITHER MAJOR DEPRESSIVE, NOR SUICIDAL ATTEMPTS ARE EXPECTED. THUS, CAUSAL RELATIONSHIP BETWEEN SUICIDE ATTEMPT AND ESSURE USE IS VERY UNLIKELY. SINCE THIS EVENT LED TO REQUIRED INTERVENTION (ABLATION), THIS CASE IS REGARDED AS INCIDENT. SINCE NO PRODUCT WAS PROVIDED AND NO BATCH NUMBER WAS PROVIDED A QUALITY DEFECT CANNOT BE CONFIRMED. BASED ON AVAILABLE INFORMATION, THERE IS NO REASON TO SUSPECT THAT THE EVENTS WERE CAUSED BY A POTENTIAL QUALITY DEFECT. NO ACTIVE FOLLOW-UP WILL BE PURSUED, AS THIS CASE WAS IDENTIFIED DURING HEALTH AUTHORITY WEBSITE MONITORING.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP RECEIVED ON 04-NOV-2015: THIS FOLLOW-UP WAS IDENTIFIED DURING MONITORING OF POSTINGS ON AN FDA HOSTED DOCKET WEBSITE, WHICH HAS BEEN ESTABLISHED IN PREPARATION OF A PUBLIC FDA ADVISORY COMMITTEE MEETING, WHICH TOOK PLACE IN SEPTEMBER 2015 (FDA-2014-N-0736-2288): THE CONSUMER REPORTED RASH, AUTOIMMUNE ISSUES, MUSCLE SPASMS, CHRONIC NAUSEA, AND MIGRATION OF COIL AS PHYSICAL SYMPTOMS. HER EMOTIONAL IMPACT INCLUDED ANXIETY, AND DEPRESSION WITH SUICIDAL THOUGHTS. THE CONSEQUENCES WERE THE LOSS OF HER MARRIAGE AND CUSTODY OF CHILDREN AND TWO DAYS IN A COMA. SHE STATED THAT ESSURE RUINED HER LIFE. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS NON-MEDICALLY CONFIRMED CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND WAS EXPERIENCING TWO HEAVY PERIODS A MONTH AND HAD AN ENDOMETRIAL ABLATION. SHE REPORTED MIGRATION OF COIL AND AUTOIMMUNE ISSUES. SHE ALSO HAD DEPRESSION WITH SUICIDAL THOUGHTS, TRIED TO END HER LIFE AND WAS TWO DAYS IN A COMA. EVENTS TWO HEAVY PERIODS A MONTH AND MIGRATION OF COIL ARE LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE, THE OTHER EVENTS ARE UNLISTED. SOME DEPRESSIVE FEELINGS AND EMOTIONAL DISTURBANCES REGARDING THE DEFINITIVE CONTRACEPTION WITH ESSURE HAVE BEEN REPORTED, HOWEVER NEITHER MAJOR DEPRESSION, NOR SUICIDAL ATTEMPTS ARE EXPECTED. DEPRESSION IS A HIGHLY PREVALENT DISORDER AND ITS PATHOGENESIS INVOLVES GENETIC, SOCIAL AND PSYCHOLOGIC FACTORS. CONSIDERING THE PATHOPHYSIOLOGY OF THE EVENTS DEPRESSION WITH SUICIDAL THOUGHTS, TRIED TO END HER LIFE AND THE LOCAL EFFECT OF ESSURE IN THE FALLOPIAN TUBES, CAUSALITY WAS ASSESSED AS UNRELATED. THE EXACT REASON FOR THE COMA WAS NOT SPECIFIED, BUT IT WAS LIKELY RELATED TO THE SUICIDAL ATTEMPT, THEREFORE COMA WAS ALSO ASSESSED AS UNRELATED TO ESSURE. ABNORMAL GENITAL BLEEDING AND MENSES PATTERN CHANGES MAY OCCUR DURING ESSURE USE. ALSO, DURING ESSURE THERAPY THERE IS A RISK THAT THE DEVICE COULD MOVE OUT OF FALLOPIAN TUBES. THEREFORE, GIVEN THE NATURE OF THE EVENTS TWO HEAVY PERIODS A MONTH AND MIGRATION OF COIL CAUSALITY WITH ESSURE CANNOT BE EXCLUDED. EVENT AUTOIMMUNE ISSUES WAS ASSESSED AS UNRELATED TO ESSURE, GIVEN ITS PATHOPHYSIOLOGY AND CONSIDERING THE LOCAL EFFECT OF ESSURE IN THE FALLOPIAN TUBES. THIS CASE WAS REGARDED AS INCIDENT SINCE A MEDICAL INTERVENTION WAS PERFORMED (ABLATION). BASED ON AVAILABLE INFORMATION, THERE IS NO REASON TO SUSPECT THAT THE EVENTS WERE CAUSED BY A POTENTIAL QUALITY DEFECT. NO ACTIVE FOLLOW-UP WILL BE PURSUED, AS THIS CASE WAS IDENTIFIED DURING HEALTH AUTHORITY WEBSITE MONITORING.

    Description of Event or Problem · 1

    THIS CASE HAS BEEN IDENTIFIED DURING MONITORING OF POSTINGS ON AN FDA HOSTED DOCKET WEBSITE, WHICH HAS BEEN ESTABLISHED IN PREPARATION OF A PUBLIC FDA ADVISORY COMMITTEE MEETING TAKING PLACE IN SEPTEMBER 2015 (CASE# FDA-2014-N-2780736-0062, AWARENESS DATE 13-AUG-2015). IT REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE IN UNITED STATES WHO HAD ESSURE INSERTED (FALLOPIAN TUBE OCCLUSION INSERT ) ON AN UNSPECIFIED DATE. CONSUMER REPORTED THAT ESSURE HAS MADE HER VERY SICK. AFTER GETTING ESSURE SHE HAS HAD PAINFUL SEX, PELVIC PAIN, STABBING PAINS IN ABDOMINAL CAVITY, STABBING PAINS IN UTERUS AND VAGINA. SHE STARTED HAVING TWO HEAVY PERIODS A MONTH AND WHEN THE DOCTOR REFUSED TO BELIEVE IT WAS BECAUSE OF THE ESSURE, HE CHOSE TO DO AN ABLATION. CONSUMER HAS PAIN EVERYWHERE, BONES, MUSCLES, JOINTS. A TERRIBLE METALLIC TASTE IN MOUTH, TEETH AND HAIR ARE BRITTLE, AND A CONSTANT RINGING IN EARS. TWICE A MONTH, INSTEAD OF BLEEDING, SHE STILL HAS THE HORMONAL ISSUES WITH HER PERIOD. HER STOMACH IS BLOATED AND SHE IS ONLY (B)(6). THERE IS NO REASON FOR HER TO LOOK PREGNANT. CONSUMER ALSO HAS A RASH ON STOMACH AND THIGHS. SHE WAS SO SICK AND SO DEPRESSED THAT SHE TRIED TO END HER LIFE. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS AND NON-MEDICALLY CONFIRMED CASE REPORT REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND WAS EXPERIENCING TWO HEAVY PERIODS A MONTH AND HAD AN ENDOMETRIAL ABLATION. SHE ALSO WAS SO DEPRESSED THAT SHE TRIED TO END HER LIFE. THESE EVENTS, SEEN AS POLYMENORRHOEA AND SUICIDE ATTEMPT, ARE SERIOUS DUE REQUIRED INTERVENTION AND LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. SOME DEPRESSIVE FEELINGS AND EMOTIONAL DISTURBANCES REGARDING THE DEFINITIVE CONTRACEPTION WITH ESSURE HAVE BEEN REPORTED, HOWEVER; NEITHER MAJOR DEPRESSIVE, NOR SUICIDAL ATTEMPTS ARE EXPECTED. THUS, CAUSAL RELATIONSHIP BETWEEN SUICIDE ATTEMPT AND ESSURE USE IS VERY UNLIKELY. ALSO, ABNORMAL GENITAL BLEEDING AND MENSES PATTERN CHANGES MAY OCCUR DURING ESSURE USE. THEREFORE, GIVEN EVENT'S NATURE AND IMPLIED TEMPORAL RELATIONSHIP POLYMENORRHOEA IS ASSESSED AS RELATED TO ESSURE USE. SINCE THIS EVENT LED TO REQUIRED INTERVENTION (ABLATION), THIS CASE IS REGARDED AS INCIDENT. IN ADDITION SOME DEPRESSIVE FEELINGS AND EMOTIONAL DISTURBANCES REGARDING THE DEFINITIVE CONTRACEPTION WITH ESSURE HAVE BEEN REPORTED, HOWEVER; NEITHER MAJOR DEPRESSIVE, NOR SUICIDAL ATTEMPTS ARE EXPECTED. THUS, CAUSAL RELATIONSHIP BETWEEN SUICIDE ATTEMPT AND ESSURE USE IS VERY UNLIKELY. NO ACTIVE FOLLOW-UP WILL BE PURSUED, AS THIS CASE WAS IDENTIFIED DURING HEALTH AUTHORITY WEBSITE MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604470 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R