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Potential release of toxic metal elements from Essure® device in symptomatic patients: First results of the French Ablimco cohort

  • François Parant
    Affiliations
    Trace Element Analysis Laboratory, Biochemistry Department, CBAPS, Centre Hospitalier Lyon-Sud, Chemin du Grand-Revoyet, University Hospital of Lyon, 69495 Pierre-Bénite, France
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  • Muriel Bost
    Affiliations
    Trace Element Analysis Laboratory, Biochemistry Department, CBAPS, Centre Hospitalier Lyon-Sud, Chemin du Grand-Revoyet, University Hospital of Lyon, 69495 Pierre-Bénite, France
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  • Erdogan Nohuz
    Affiliations
    Department of Gynecology, Hôpital Femme Mère Enfant, HFME, 59 Boulevard Pinel, University Hospital of Lyon, 69500 Bron, France
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  • Julie Prost
    Affiliations
    Trace Element Analysis Laboratory, Biochemistry Department, CBAPS, Centre Hospitalier Lyon-Sud, Chemin du Grand-Revoyet, University Hospital of Lyon, 69495 Pierre-Bénite, France
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  • Emanuele Cerruto
    Affiliations
    Department of Gynecology, Hôpital Femme Mère Enfant, HFME, 59 Boulevard Pinel, University Hospital of Lyon, 69500 Bron, France
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  • Stephanie Moret
    Affiliations
    Department of Gynecology, Hôpital Femme Mère Enfant, HFME, 59 Boulevard Pinel, University Hospital of Lyon, 69500 Bron, France
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  • Julien Maurin
    Affiliations
    Trace Element Analysis Laboratory, Biochemistry Department, CBAPS, Centre Hospitalier Lyon-Sud, Chemin du Grand-Revoyet, University Hospital of Lyon, 69495 Pierre-Bénite, France
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  • Gautier Chene
    Correspondence
    Corresponding author at: Department of gynecology, Hôpital Femme Mère Enfant, HFME, 59 boulevard Pinel, University hospital of Lyon, 69500 Bron, France.
    Affiliations
    Department of Gynecology, Hôpital Femme Mère Enfant, HFME, 59 Boulevard Pinel, University Hospital of Lyon, 69500 Bron, France

    University Claude Bernard of Lyon 1, EMR 3738, 69000 Lyon, France
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      Highlights

      • Significant concentrations of Nickel and Chromium in the peritoneal fluid
      • Significant concentrations of Nickel and Chromium in the fallopian tube tissue
      • Dissemination of metal elements likely explained by galvanic corrosion

      Abstract

      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 (University hospital of Lyon), 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 then 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.

      Keywords

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