Molecular Mechanisms Associated With Breast Implant Complications

Recruiting now

Conditions studied: Breast Implant; Complications, Infection or Inflammation

In brief

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.

Key facts

Study ID

NCT05736354

Run by

Indiana University

People needed

1000

Starts

2021-01-03

Expected to finish

2028-06-30

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• IU Health North Hospital — Carmel, Indiana, United States (enrolling)
• Meridian Plastic Surgeons — Carmel, Indiana, United States (enrolling)
• IU Health Methodist Hospital — Indianapolis, Indiana, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.