Home › NCT05736354

Molecular Mechanisms Associated With Breast Implant Complications

Who can join

Ages 18 and older · Women

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

About the study

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.

Sponsor: Indiana University · Participants: 1,000 · Started: Jan 3, 2021

Contact the study team

• Mithun Sinha, PhD. · Phone: 3172782713
• Bryce Hockman · Phone: 3172782715

Official record on ClinicalTrials.gov — NCT05736354

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.