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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Article info
Publication history
Published online: July 22, 2020
Accepted:
July 21,
2020
Received in revised form:
July 20,
2020
Received:
June 17,
2020
Identification
Copyright
© 2020 Elsevier B.V. All rights reserved.
