About this trial
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
Qualifiers
Age greater than or equal to 18 years
Undergoing removal of breast implant
Willing and able to comply with protocol instructions
Age greater than or equal to 18 years
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Indiana University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator