Recruiting

Breast Implant Complications

Sponsor:

Indiana University

Code:

NCT05736354

Conditions

Breast Implant; Complications

Infection or Inflammation

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Breast Implant; Complications

Infection or Inflammation

Study ID

NCT05736354

Start date

Jan 3, 2021

Status verified date

May, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

BII Subjects

Subjects with breast implants having BII manifestations.

Non-BII Subjects

Subjects with breast implants with no reported BII symptoms.

Subjects without Breast Implants

Subjects without breast implants.

Primary outcome measure

  • Presence of Biofilm in Breast Tissue [ Time Frame: Through study completion, an average of 1 year ]
  • Analysis of host-biofilm interaction mediated oxylipins from blood [ Time Frame: Through study completion, an average of 1 year ]
  • Cytokine analysis will be performed on breast tissue [ Time Frame: Through study completion, an average of 1 year ]
  • Analysis of host-biofilm interaction mediated oxylipins from breast tissue [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Mithun Sinha, PhD.

3172782713mitsinha@iu.edu

Bryce Hockman

3172782715bbhockma@iu.edu

Locations

IU Health North Hospital

Recruiting

Carmel, Indiana, United States, 46032

Meridian Plastic Surgeons

Recruiting

Carmel, Indiana, United States, 46290

IU Health Methodist Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Mary Lester

melester@iupui.edu

Bryce Hockman

3172782715bbhockma@iu.edu

More Information

Sponsor

Indiana University

Last update posted

Jun 11, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-06-11.