Analysis of explanted Essure® devices

Area of Science:

• Biomaterials Science
• Medical Device Analysis
• Toxicology

Background:

• Essure® is a permanent female sterilization device.
• Understanding the in-vivo behavior of medical implants is crucial for patient safety.
• Previous studies have raised concerns regarding Essure® complications.

Purpose of the Study:

• To investigate the atomic composition and structural changes of explanted Essure® devices.
• To correlate elemental findings with macroscopic and microscopic observations.
• To explore the potential role of device components in adverse patient symptoms.

Main Methods:

• Analysis of 50 explanted Essure® devices using microscopy and spectral analysis.
• Elemental analysis of device components divided into inner, main, and outer coils.
• X-ray Faxitron imaging to assess structural integrity.

Main Results:

• Explanted devices exhibited significant stretching and deformation.
• Calcification and biological tissue encapsulation were observed.
• Tin was a predominant element across all analyzed zones, alongside other metals; calcium was also detected.

Conclusions:

• The presence and distribution of tin in Essure® devices suggest its potential involvement in adverse symptom development.
• Further research is recommended to elucidate the role of tin in the pathogenesis of patient complications.
• Findings underscore the importance of material analysis in understanding medical device-related health issues.