Molecular Mechanisms Associated With Breast Implant Complications

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorIndiana University

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

1,000 Participants
are grouped into 3 trial groups

Sponsors and collaborators

Indiana University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator