BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8059425 · Received November 12, 2018

    Report

    Report Number
    2951250-2018-04655
    Event Type
    Injury
    Date Received
    November 12, 2018
    Report Date
    December 3, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE DESCRIBES THE OCCURRENCE OF NICKEL SENSITIVITY (NICKEL ALLERGY) IN A FEMALE PATIENT WHO RECEIVED ESSURE FOR FEMALE STERILIZATION. THIS CASE DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ("NICKEL ALLERGY"). LITERATURE REFERENCE: RAISON-PEYRON N, DU-THANH A, COMPAN C, PERROCHIA H, FRANCINI S, DUFLOS C, CROCHET P, NICKEL ALLERGY AND ADVERSE-EVENTS ATTRIBUTED TO ESSURE SYSTEM: IS THERE A LINK?, CONTACT DERMATITIS - CONGRESS OF THE EUROPEAN SOCIETY OF CONTACT DERMATITIS, 2018, 79:SUPPLEMENT 1 (36). ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ECZEMA. THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY). ESSURE WAS REMOVED. THE REPORTER CONSIDERED ALLERGY TO METALS TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ALLERGY TEST - ON AN UNKNOWN DATE: RESULTS: POSITIVE FOR NICKEL. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. ABSTRACT BACKGROUND: THE ESSURE SYSTEM OFFERS AN EFFECTIVE METHOD FOR HYSTEROSCOPIC STERILIZATION. HOWEVER, IN RECENT YEARS, SEVERAL COMPLAINTS HAVE BEEN FORWARDED TO PUBLIC HEALTH AGENCIES IN SEVERAL COUNTRIES, INCLUDING FRANCE, REGARDING THE ADVERSE EFFECTS OF USING THIS METHOD. OBJECTIVES: TO DETERMINE WHETHER THERE IS A RELATIONSHIP BETWEEN THE ADVERSE EVENTS ATTRIBUTED TO ESSURE IMPLANTATION AND PROVEN NICKEL ALLERGY. PATIENT AND METHODS: FEMALE PATIENTS SEEN BY GYNECOLOGISTS FOR ALLEGED ADVERSE-REACTIONS TO THE ESSURE DEVICE WERE REFERRED FOR A NICKEL PATCH TEST BEFORE SURGICAL REMOVAL. DIMETHYLGLIOXIME SPOT TESTS (DMG) TO STUDY NICKEL RELEASE WERE PERFORMED ON ESSURE DEVICE AT THE END OF EACH SURGICAL PROCEDURE. DATA REGARDING PAST HISTORY OF NICKEL ALLERGY, PREVIOUS ALLERGOLOGICAL TESTS RESULTS, CUTANEOUS AND EXTRACUTANEOUS SYMPTOMS AFTER ESSURE IMPLANTATION, DURATION OF ESSURE IMPLANTATION, AND THE HISTOPATHOLOGY RESULTS OF SALPINGECTOMY WERE COLLECTED. PATIENTS WITH SKIN-ALLERGY RELATED SYMPTOMS WERE REEXAMINED 3 MONTHS AFTER ESSURE REMOVAL. RESULTS: ALL THE 39 PATIENTS HAD GYNAECOLOGIC AND/OR EXTRAGYNAECOLOGIC SYMPTOMS, INCLUDING SKIN-ALLERGY RELATED SYMPTOMS (ECZEMA) THAT WAS OBSERVED IN TWO PATIENTS. NINETEEN OF THE 39 SUBJECTS HAD A HISTORY OF NICKEL CONTACT DERMATITIS; HOWEVER, NONE HAD BEEN PATCH TESTED BEFORE ESSURE IMPLANTATION. TOTAL 15 OF THE 39 PATIENTS HAD POSITIVE REACTIONS TO NICKEL. THIRTEEN OF THE 19 PATIENTS WITH A HISTORY OF NICKEL HYPERSENSITIVITY HAD POSITIVE PATCH TESTS FOR SULFATE NICKEL. PAST RELEVANCE OF POSITIVE PATCH TESTS TO NICKEL WAS ESTABLISHED IN 13 OF THE 15 PATIENTS. CURRENT RELEVANCE WAS POSSIBLE FOR ONE ECZEMA PATIENT WHO HAD A POSITIVE NICKEL PATCH TEST. WITH RESPECT TO EXTRACUTANEOUS COMPLAINTS, NO SIGNIFICANT DIFFERENCE WAS FOUND IN PATIENTS WITH POSITIVE NICKEL PATCH TESTS AND THOSE WITH NEGATIVE RESULTS. NONE OF THE DMG SPOT TESTS PERFORMED ON THE 39 PATIENTS DETECTED A NICKEL RELEASE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-NOV-2018: QUALITY-SAFETY EVALUATION OF PTC. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 1

    THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ("NICKEL ALLERGY") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. LITERATURE REFERENCE: RAISON-PEYRON N, DU-THANH A, COMPAN C, PERROCHIA H, FRANCINI S, DUFLOS C, CROCHET P. NICKEL ALLERGY AND ADVERSE-EVENTS ATTRIBUTED TO ESSURE SYSTEM: IS THERE A LINK? CONTACT DERMATITIS - CONGRESS OF THE EUROPEAN SOCIETY OF CONTACT DERMATITIS, 2018, 79: SUPPLEMENT 1 (36). ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ECZEMA. THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY). ESSURE WAS REMOVED. THE REPORTER CONSIDERED ALLERGY TO METALS TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ALLERGY TEST - ON AN UNKNOWN DATE: POSITIVE FOR NICKEL. ABSTRACT BACKGROUND: THE ESSURE SYSTEM OFFERS AN EFFECTIVE METHOD FOR HYSTEROSCOPIC STERILIZATION. HOWEVER, IN RECENT YEARS, SEVERAL COMPLAINTS HAVE BEEN FORWARDED TO PUBLIC HEALTH AGENCIES IN SEVERAL COUNTRIES, INCLUDING FRANCE, REGARDING THE ADVERSE EFFECTS OF USING THIS METHOD. OBJECTIVES: TO DETERMINE WHETHER THERE IS A RELATIONSHIP BETWEEN THE ADVERSE EVENTS ATTRIBUTED TO ESSURE IMPLANTATION AND PROVEN NICKEL ALLERGY. PATIENT AND METHODS: FEMALE PATIENTS SEEN BY GYNAECOLOGISTS FOR ALLEGED ADVERSE-REACTIONS TO THE ESSURE DEVICE WERE REFERRED FOR A NICKEL PATCH TEST BEFORE SURGICAL REMOVAL. DIMETHYLGLIOXIME SPOT TESTS (DMG) TO STUDY NICKEL RELEASE WERE PERFORMED ON ESSURE DEVICE AT THE END OF EACH SURGICAL PROCEDURE. DATA REGARDING PAST HISTORY OF NICKEL ALLERGY, PREVIOUS ALLERGOLOGICAL TEST RESULTS, CUTANEOUS AND EXTRACUTANEOUS SYMPTOMS AFTER ESSURE IMPLANTATION, DURATION OF ESSURE IMPLANTATION, AND THE HISTOPATHOLOGY RESULTS OF SALPINGECTOMY WERE COLLECTED. PATIENTS WITH SKIN-ALLERGY RELATED SYMPTOMS WERE REEXAMINED 3 MONTHS AFTER ESSURE REMOVAL. RESULTS: ALL THE 39 PATIENTS HAD GYNAECOLOGIC AND/OR EXTRAGYNAECOLOGIC SYMPTOMS, INCLUDING SKIN-ALLERGY RELATED SYMPTOMS (ECZEMA) THAT WAS OBSERVED IN TWO PATIENTS. NINETEEN OF THE 39 SUBJECTS HAD A HISTORY OF NICKEL CONTACT DERMATITIS; HOWEVER, NONE HAD BEEN PATCH TESTED BEFORE ESSURE IMPLANTATION. TOTAL 15 OF THE 39 PATIENTS HAD POSITIVE REACTIONS TO NICKEL. THIRTEEN OF THE 19 PATIENTS WITH A HISTORY OF NICKEL HYPERSENSITIVITY HAD POSITIVE PATCH TESTS FOR SULFATE NICKEL. PAST RELEVANCE OF POSITIVE PATCH TESTS TO NICKEL WAS ESTABLISHED IN 13 OF THE 15 PATIENTS. CURRENT RELEVANCE WAS POSSIBLE FOR ONE ECZEMA PATIENT WHO HAD A POSITIVE NICKEL PATCH TEST. WITH RESPECT TO EXTRACUTANEOUS COMPLAINTS, NO SIGNIFICANT DIFFERENCE WAS FOUND IN PATIENTS WITH POSITIVE NICKEL PATCH TESTS AND THOSE WITH NEGATIVE RESULTS. NONE OF THE DMG SPOT TESTS PERFORMED ON THE 39 PATIENTS DETECTED A NICKEL RELEASE. INCIDENT: NO 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899443 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R