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ID05736354

Study of Molecular Mechanisms and Biofilm Role in Breast Implant Complications and Illness

Led by Indiana University · Updated on 2026-06-11

1000

Participants Needed

3

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating the role of bacterial biofilms in breast implant complications, particularly focusing on Breast Implant Illness BII. This condition is linked to symptoms resembling autoimmune and connective tissue disorders, which have led to an increasing number of implant removals. The study examines how bacterial biofilms may contribute to implant failures, chronic inflammation, and immune changes associated with BII. It also explores oxylipinsmolecules produced during host-biofilm interactionin breast tissue and blood, along with immune cell responses. The study involves three groups women with breast implants showing BII symptoms, women with implants but no BII symptoms, and women without implants undergoing breast surgery. Researchers will collect blood samples, discarded tissue, implants, and surrounding capsules from participants. By analyzing these samples, the study aims to identify the presence of bacterial biofilms, oxylipins, immune cells like T cells and macrophages, and related cytokines in breast tissue and circulation. Participants will be involved throughout the study period, lasting about one year on average. During this time, researchers will assess biofilm presence, oxylipins, and immune markers in breast tissue and blood. The study includes detailed analysis of cytokines and immune activation markers such as CD4 cells. This comprehensive evaluation seeks to better understand the biological mechanisms behind breast implant complications and BII, contributing to improved knowledge of this condition.

CONDITIONS

Brief Title

Molecular Mechanisms Associated With Breast Implant Complications

Research Team

M

Mithun Sinha, PhD.

B

Bryce Hockman

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