Molecular Mechanisms Associated With Breast Implant Complications
Trial Parameters
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.
Eligibility Criteria
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