BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10372489 · Received August 6, 2020

    Report

    Report Number
    2951250-2020-12715
    Event Type
    Injury
    Date Received
    August 6, 2020
    Report Date
    August 11, 2020
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF DYSPAREUNIA ('DYSPAREUNIA') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. LITERATURE REFERENCE: PARANTA F, BOSTA M, NOHUZB N, PROSTA J, CERRUTOB E, MORET S, MAURIN J, GAUTIER C, POTENTIAL RELEASE OF TOXIC METAL ELEMENTS FROM ESSURE DEVICE IN SYMPTOMATIC PATIENTS: FIRST RESULTS OF THE FRENCH ABLIMCO COHORT, EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY 252, 2020. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSPAREUNIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC REMOVAL OF ESSURE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSPAREUNIA TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . OBJECTIVE: MANY PATIENTS WITH ESSURE DEVICES REQUEST THE REMOVAL OF THESE IMPLANTS DUE TO PERSISTENT ADVERSE EFFECTS. THE PATHOPHYSIOLOGY REMAINS UNKNOWN, BUT A CORROSION OF THE IMPLANTS IN THE IN-VIVO ENVIRONMENT LEADING TO METAL ION RELEASE MAY BE SUSPECTED. THE IMPLANTS CONSIST OF POLYESTER FIBERS, NICKEL-TITANIUM ALLOY AND OTHER METALS INCLUDING CHROMIUM. THE PURPOSE OF THIS STUDY IS TO DELIVER THE FIRST RESULTS ON THE CONCENTRATIONS OF NICKEL AND CHROMIUM (TWO POTENTIAL TOXIC METAL ELEMENTS) IN PERITONEAL FLUID AND IN THE FALLOPIAN TUBE TISSUE DURING LAPAROSCOPIC REMOVAL OF ESSURE. STUDY DESIGN: IN THIS PROSPECTIVE OBSERVATIONAL STUDY CONDUCTED IN A FRENCH ACADEMIC RESEARCH HOSPITAL, NICKEL AND CHROMIUM CONCENTRATIONS WERE DETERMINED IN THE FALLOPIAN TUBE TISSUE AND PERITONEAL LIQUID FROM SYMPTOMATIC PATIENTS WITH ESSURE BY INDUCTIVELY COUPLED PLASMA MASS SPECTROMETRY (ICP-MS) ANALYSIS IN A PERKINELMER NEXION 350. RESULTS: SIGNIFICANT METAL ELEMENT CONCENTRATIONS WERE SHOWED IN THE PERITONEAL FLUID. THERE WAS ALSO A DIFFERENTIAL CONCENTRATION IN THE FALLOPIAN TUBE TISSUE WITH HIGHER CONCENTRATION CLOSE TO THE IMPLANT THAN LOWER AT A DISTANCE FROM THIS IMPLANT. THERE WAS A CORRELATION BETWEEN THE CONCENTRATIONS OF THE TWO METALS. CONCLUSION: THE PRESENCE OF NICKEL AND CHROMIUM IN THE FALLOPIAN TUBE TISSUE AND THE PERITONEAL FLUID RAISES THE QUESTION OF A POSSIBLE RELATIONSHIP BETWEEN THE SYMPTOMS ATTRIBUTED TO ESSURE IMPLANTS AND THE DISSEMINATION OF POTENTIAL TOXIC METALS DUE TO GALVANIC CORROSION OF THE DEVICES. THIS REPORT REFERS TO A SINGLE PATIENT IN TABLE 1 WHO EXPERIENCED DYSPAREUNIA MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-AUG-2020: QUALITY-SAFETY EVALUATION OF PTC. ON 6-AUG-2020: HA NUMBER RECEIVED - R2011984. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 1

    THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF DYSPAREUNIA ('DYSPAREUNIA') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. LITERATURE REFERENCE: PARANTA F, BOSTA M, NOHUZB N, PROSTA J, CERRUTOB E, MORET S, MAURIN J, GAUTIER C, POTENTIAL RELEASE OF TOXIC METAL ELEMENTS FROM ESSURE DEVICE IN SYMPTOMATIC PATIENTS: FIRST RESULTS OF THE FRENCH ABLIMCO COHORT, EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY 252, 2020. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSPAREUNIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC REMOVAL OF ESSURE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSPAREUNIA TO BE RELATED TO ESSURE. OBJECTIVE: MANY PATIENTS WITH ESSURE DEVICES REQUEST THE REMOVAL OF THESE IMPLANTS DUE TO PERSISTENT ADVERSE EFFECTS. THE PATHOPHYSIOLOGY REMAINS UNKNOWN, BUT A CORROSION OF THE IMPLANTS IN THE IN-VIVO ENVIRONMENT LEADING TO METAL ION RELEASE MAY BE SUSPECTED. THE IMPLANTS CONSIST OF POLYESTER FIBERS, NICKEL-TITANIUM ALLOY AND OTHER METALS INCLUDING CHROMIUM. THE PURPOSE OF THIS STUDY IS TO DELIVER THE FIRST RESULTS ON THE CONCENTRATIONS OF NICKEL AND CHROMIUM (TWO POTENTIAL TOXIC METAL ELEMENTS) IN PERITONEAL FLUID AND IN THE FALLOPIAN TUBE TISSUE DURING LAPAROSCOPIC REMOVAL OF ESSURE. STUDY DESIGN: IN THIS PROSPECTIVE OBSERVATIONAL STUDY CONDUCTED IN A FRENCH ACADEMIC RESEARCH HOSPITAL, NICKEL AND CHROMIUM CONCENTRATIONS WERE DETERMINED IN THE FALLOPIAN TUBE TISSUE AND PERITONEAL LIQUID FROM SYMPTOMATIC PATIENTS WITH ESSURE BY INDUCTIVELY COUPLED PLASMA MASS SPECTROMETRY (ICP-MS) ANALYSIS IN A PERKINELMER NEXION 350. RESULTS: SIGNIFICANT METAL ELEMENT CONCENTRATIONS WERE SHOWED IN THE PERITONEAL FLUID. THERE WAS ALSO A DIFFERENTIAL CONCENTRATION IN THE FALLOPIAN TUBE TISSUE WITH HIGHER CONCENTRATION CLOSE TO THE IMPLANT THAN LOWER AT A DISTANCE FROM THIS IMPLANT. THERE WAS A CORRELATION BETWEEN THE CONCENTRATIONS OF THE TWO METALS. CONCLUSION: THE PRESENCE OF NICKEL AND CHROMIUM IN THE FALLOPIAN TUBE TISSUE AND THE PERITONEAL FLUID RAISES THE QUESTION OF A POSSIBLE RELATIONSHIP BETWEEN THE SYMPTOMS ATTRIBUTED TO ESSURE IMPLANTS AND THE DISSEMINATION OF POTENTIAL TOXIC METALS DUE TO GALVANIC CORROSION OF THE DEVICES. THIS REPORT REFERS TO A SINGLE PATIENT IN TABLE 1 WHO EXPERIENCED DYSPAREUNIA. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839858 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R