Molecular Mechanisms Associated With Breast Implant Complications

Study Overview
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Brief Summary
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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
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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.

Official Title
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Molecular Mechanisms Associated With Breast Implant Complications

Conditions
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Breast Implant; Complications, Infection or Inflammation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for breast implant subjects: Age greater than or equal to 18 years Undergoing removal of breast implant Willing and able to comply with protocol instructions Inclusion Criteria for subjects undergoing breast surgeries (other than implant removal) Age greater than or equal to 18 years Undergoing breast surgery Willing and able to comply with protocol instructions 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BII Subjects<br>Subjects with breast implants having BII manifestations. | |
| Non-BII Subjects<br>Subjects with breast implants with no reported BII symptoms. | |
| Subjects without Breast Implants<br>Subjects without breast implants. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Biofilm in Breast Tissue | 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. | Through study completion, an average of 1 year | 
| Analysis of host-biofilm interaction mediated oxylipins from blood | 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. | Through study completion, an average of 1 year | 
| Cytokine analysis will be performed on breast tissue | 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. | Through study completion, an average of 1 year | 
| Analysis of host-biofilm interaction mediated oxylipins from breast tissue | 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. | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4+ Immunological Activation due to Host Implant Interaction | Determining activation of CD4+ immune cells | Through study completion, an average of 1 year |