Analysis of explanted Essure® devices

Objective: The objective of this study was to understand the behavior of explanted Essure® devices in humans, focusing on the atomic composition of the device in different areas. Methods: We collected 50 explanted Essure® devices (Bayer, Switzerland), in 29 patients. The following systematic investigations were performed on each devices: eye-nacked and optical microscopy, X-ray Faxitron, spectral analysis, elemental analysis of the metallic structure to accurately define the metallic composition of the spire and correlate these findings with macroscopic and microscopic observations. As part of the elemental analysis, the explant was subdivided into three zones: the inner coil (zone 1), the main coil (zone 2), and the outer coil (zone 3). Results: The metal structures of the devices were significantly stretched and deformed due to the explantation procedure. The observed mass around the weld was encapsulated by a layer of biological tissue on one explant. The analysis reveals the presence of 11% calcium and 17% tin, which means that the sample taken is a calcification and suggests the possibility that the tin from the metallic structure is present in the patient's biological tissues. The elemental analysis of each area showed that tin is predominantly present in each zone on the 48 explants, along with platinum, titanium, iron, chromium and nickel. Conclusion: These findings highlight the potential role of tin in the pathogenesis of adverse symptoms, and further research into its involvement is strongly recommended.