Molecular Mechanisms Associated With Breast Implant Complications

Recruiting

• Conditions: Breast Implant; Complications; Infection or Inflammation

• Registration Number: NCT05736354
• Lead Sponsor: Indiana University

Brief 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.

Detailed Description

Breast implants were first introduced in 1962. It is estimated that 10 million women worldwide, including three million Americans have breast implants. There has been increased identification of patients experiencing a constellation of symptoms related to their implants. For breast implants, these symptoms are often associated with autoimmune and connective tissue disorders (CTD) and have been referred to as Breast Implant Illness (BII). A growing number of patients 30,000 annually are seeking to have their breast implants removed. In view of the implant associated complications, the US Food and Drug Administration (FDA) has placed a black box warning on breast implants. Limited research has resulted in a void in the prognosis of this surgical problem. Bacterial biofilms are becoming a major concern for medical device implants. 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 BII.

This research studies oxilidized lipids (oxylipins). These are metabolities formed as a result of host-biofilm interaction. The presence of oxylipins will be studied in peri-prosthetic tissue post-biofilm infection and in systemic circulation. Oxylipins are immunogenic. Hence, the investigators will also study the abundance of immune cells T cells and macrophages (types and subtypes) and associated cytokines.

Study Timeline

• Study Start: 2021-01-03
• Study First Submitted: 2023-01-17
• Study First Submitted QC: 2023-02-16
• Study First Posted: 2023-02-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-10
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

• Individuals who are deemed unable to understand the procedures, risks, and benefits of the study, (i.e., unable to provide informed consent)
• Pregnant females
• Immunodeficiency (HIV/AIDS, SCID)
• Currently on immunosuppressive medications
• Prisoners

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of Biofilm in Breast Tissue	Through study completion, an average of 1 year	During a clinically scheduled breast surgery, breast tissue specimens will be taken from surgically discarded tissue. The specimens from both breast implant subjects and control subjects (those undergoing breast surgery for a reason other than implant removal) will be analyzed to determine the presence of bacterial biofilm.
Analysis of host-biofilm interaction mediated oxylipins from blood	Through study completion, an average of 1 year	Prior to a clinically scheduled breast surgery, 20 milliliters of blood will be collected during the pre-operative surgical preparations. The blood samples from both breast implant subjects and control subjects (those undergoing breast surgery for a reason other than implant removal) will be analyzed for host-biofilm interaction mediated oxylipins.
Cytokine analysis will be performed on breast tissue	Through study completion, an average of 1 year	During a clinically scheduled breast surgery, breast tissue specimens will be taken from surgically discarded tissue. The specimens from both breast implant subjects and control subjects (those undergoing breast surgery for a reason other than implant removal) will undergo cytokine analysis.
Analysis of host-biofilm interaction mediated oxylipins from breast tissue	Through study completion, an average of 1 year	During a clinically scheduled breast surgery, breast tissue specimens will be taken from surgically discarded tissue. The specimens from both breast implant subjects and control subjects (those undergoing breast surgery for a reason other than implant removal) will undergo oxylipin analysis.

Secondary Outcome Measures

Name	Time	Method
CD4+ Immunological Activation due to Host Implant Interaction	Through study completion, an average of 1 year	Determining activation of CD4+ immune cells

Trial Locations

Locations (3)

IU Health North Hospital; 🇺🇸 Carmel, Indiana, United States

IU Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States

Meridian Plastic Surgeons; 🇺🇸 Carmel, Indiana, United States