RecruitingNCT05736354

Molecular Mechanisms Associated With Breast Implant Complications


Sponsor

Indiana University

Enrollment

1,000 participants

Start Date

Jan 3, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

Bacterial biofilms cause implant failures, chronic inflammation, and immune polarization. The study investigates the possible role of bacterial biofilm as a factor in the etiology of Breast Implant Illness. Three patient cohorts will be studied (A) Subjects with breast implant with BII manifestations (B) Subjects with breast implants without BII manifestations (C) Subjects without breast implants who underwent breast surgery procedure. Blood, surgically discarded tissue, implants, and associated capsules will be collected through this protocol.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates the biological and molecular mechanisms behind complications related to breast implants, including a rare cancer called Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), as well as more common issues like capsular contracture (hardening of scar tissue around the implant). Researchers will collect tissue samples from women having implants removed or undergoing other breast surgeries to study the immune and cellular processes that may drive these complications. Women aged 18 and older who are scheduled for breast implant removal, or who are having another type of breast surgery, are eligible. Women who cannot give informed consent, are pregnant, have HIV/AIDS or severe immune deficiency, are on immunosuppressive medications, or are incarcerated are excluded. Participants simply provide a tissue sample that is collected during their already-planned surgical procedure — no additional operation is needed. The study is observational and does not involve any experimental treatment. This research is important because understanding the immune triggers behind implant-related complications could lead to better implant designs, earlier detection of BIA-ALCL, and safer outcomes for the hundreds of thousands of women who receive breast implants each year.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(3)

IU Health North Hospital

Carmel, Indiana, United States

Meridian Plastic Surgeons

Carmel, Indiana, United States

IU Health Methodist Hospital

Indianapolis, Indiana, United States

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NCT05736354


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