BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3872108 · Received June 7, 2014

    Report

    Report Number
    2951250-2014-00204
    Event Type
    Injury
    Date Received
    June 7, 2014
    Report Date
    January 30, 2024
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PRODUCT TECHNICAL COMPLAINT INVESTIGATION AND FINAL ASSESSMENT WERE RECEIVED ON (B)(4) 2014: (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 CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR AND INSPECT THE DEVICE 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 AT THIS TIME. MEDICAL ASSESSMENT: THE REPORTED MEDICAL EVENT IS A POSSIBLE UNDESIRABLE EVENT WITH THE USE OF ESSURE AND IS NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. NO BATCH NUMBER WAS REPORTED. NEITHER A TECHNICAL BATCH INVESTIGATION NOR A BATCH CLUSTER REVIEW IN THE (B)(4) DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE WITHOUT A BATCH NUMBER. AT THE TIME OF THIS MEDICAL ASSESSMENT THE TECHNICAL INVESTIGATION CONCLUDED "UNCONFIRMED QUALITY DEFECT". BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT. THE LIST OF SIMILAR CASES CONTAINS REPORTS WITH SIMILAR EVENTS CODED IN (B)(4). IT INCLUDES RECENT CASES RECEIVED BY BAYER (B)(4) AND OLDER CASES RECEIVED FROM THE PREVIOUS OWNER OF THE ESSURE PRODUCT (CONCEPTUS). THESE LEGACY REPORTS HAVE BEEN RE-CODED ACCORDING TO BAYER (B)(4) STANDARDS. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE, THIS INCLUDES CONSIDERATION OF THE LEGACY CASES IN SAFETY ANALYSES. THE CUMULATIVE REVIEW OF THE RE-CODED LEGACY REPORTS HAS NOT YIELDED ANY NEW SAFETY SIGNAL. COMPANY CAUSALITY COMMENT: THIS CASE REPORT WAS DERIVED FROM MEDICAL LITERATURE AND REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND SHORTLY AFTER THE PROCEDURE PRESENTED WITH POPULAR URTICARIA AND ERYTHEMA, REPORTED AS ALLERGY TO NICKEL. SYMPTOMS DISAPPEARED AFTER THE SUBSEQUENT REMOVAL OF BOTH MICRO-INSERTS. NO OTHER DETAILS WERE PROVIDED. ALLERGY TO NICKEL, SERIOUS DUE TO MEDICAL IMPORTANCE, IS LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE (FALLOPIAN TUBE OCCLUSION INSERT). THIS CASE WAS REGARDED AS INCIDENT, SINCE IT WAS REPORTED THAT BOTH MICRO-INSERTS WERE REMOVED AND A SURGICAL INTERVENTION CAN BE ASSUMED. THE ESSURE MICRO-INSERT INCLUDES NICKEL-TITANIUM ALLOY, WHICH IS GENERALLY CONSIDERED SAFE. HOWEVER, IN VITRO TESTING HAS DEMONSTRATED THAT NICKEL IS RELEASED FROM THIS DEVICE. PATIENTS WHO ARE ALLERGIC TO NICKEL MAY HAVE AN ALLERGIC REACTION TO THIS DEVICE, ESPECIALLY THOSE WITH A HISTORY OF METAL ALLERGIES. IN ADDITION, SOME PATIENTS MAY DEVELOP AN ALLERGY TO NICKEL IF THIS DEVICE IS IMPLANTED. TYPICAL ALLERGY SYMPTOMS INCLUDE RASH, PRURITUS, AND HIVES. AS TEMPORAL RELATIONSHIP BETWEEN REPORTED EVENT AND ESSURE USE IS POSITIVE, CAUSALITY IS ASSESSED AS RELATED. A PRODUCT TECHNICAL COMPLAINT (PTC) ANALYSIS WAS PERFORMED AND CONCLUDED THAT BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT OF THE PRODUCT.

    Description of Event or Problem · 1

    THIS CASE REPORT FROM UNITED STATES WAS DERIVED FROM MEDICAL LITERATURE ON MAY 07, 2014, ARTICLE ENTITLED "MANAGEMENT OF COMPLICATIONS ENCOUNTERED WITH ESSURE HYSTEROSCOPIC STERILIZATION: A SYSTEMATIC REVIEW." IT REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE WHO HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED FOR HYSTEROSCOPIC STERILIZATION AND EXPERIENCED ALLERGY TO NICKEL (URTICARIA AND ERYTHEMA). THE TRADE NAME WAS REPORTED TO BE ESSURE. CASE REPORT: FEMALE PATIENT HAVING UNDERGONE SUCCESSFUL MICRO-INSERT PLACEMENT, ALLERGY TO NICKEL WAS NOTED. PATIENT EXPERIENCING URTICARIA AND ERYTHEMA SHORTLY AFTER THE PROCEDURE. SYMPTOMS RESOLVED AFTER REMOVAL OF DEVICES. ABSTRACT: ESSURE HYSTEROSCOPIC STERILIZATION HAS BEEN FDA APPROVED IN THE UNITED STATES SINCE 2002. COMPLICATIONS ASSOCIATED WITH ESSURE INCLUDE IMPROPER PLACEMENT (MALPOSITIONING), UNINTENDED PREGNANCY, PAIN, INFECTION, AND NICKEL ALLERGY. THE RARITY OF COMPLICATIONS, COMPOUNDED BY UNDERREPORTING, MAKES IT DIFFICULT TO DETERMINE BEST PRACTICES WITH REGARDS TO MANAGEMENT. THIS SYSTEMATIC REVIEW SYNTHESIZES THE NATION AND GLOBAL EXPERIENCE WITH MANAGEMENT OF ESSURE-RELATED COMPLICATIONS, AND SUGGESTS TREATMENT OPTIONS WHERE DATA ALLOW. FOLLOW UP RECEIVED ON MAY 14, 2014. FULL TEXT RECEIVED, TITLED COMPLICATIONS OF HYSTEROSCOPIC ESSURE STERILISATION: REPORT ON 4306 PROCEDURES PERFORMED IN A SINGLE CENTRE. CASE REPORT: A WOMAN WITH A HISTORY OF ATOPY, WHO PRESENTED SHORTLY AFTER THE PROCEDURE WITH PAPULAR URTICARIA AND ERYTHEMA, AND IN WHOM THE SYMPTOMS DISAPPEARED AFTER THE SUBSEQUENT REMOVAL OF DEVICES. CORRECTION ON MAY 14, 2014: FOLLOWING COMPANY INTERNAL REVIEW THE COUNTRY OF CASE ORIGIN WAS AMENDED TO SPAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333517 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051
    333546 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other| R