Molecular Mechanisms Associated With Breast Implant Complications

Last updated: April 8, 2025
Sponsor: Indiana University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Inflammation

Treatment

N/A

Clinical Study ID

NCT05736354
2003674175
R21AI171932
R01AI165958
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Individuals who are deemed unable to understand the procedures, risks, and benefitsof the study, (i.e., unable to provide informed consent)

  • Pregnant females

  • Immunodeficiency (HIV/AIDS, SCID)

  • Currently on immunosuppressive medications

  • Prisoners

Study Design

Total Participants: 1000
Study Start date:
January 03, 2021
Estimated Completion Date:
June 30, 2028

Study Description

Breast implants were first introduced in 1962. It is estimated that 10 million women worldwide, including three million Americans have breast implants. There has been increased identification of patients experiencing a constellation of symptoms related to their implants. For breast implants, these symptoms are often associated with autoimmune and connective tissue disorders (CTD) and have been referred to as Breast Implant Illness (BII). A growing number of patients 30,000 annually are seeking to have their breast implants removed. In view of the implant associated complications, the US Food and Drug Administration (FDA) has placed a black box warning on breast implants. Limited research has resulted in a void in the prognosis of this surgical problem. Bacterial biofilms are becoming a major concern for medical device implants. 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 BII.

This research studies oxilidized lipids (oxylipins). These are metabolities formed as a result of host-biofilm interaction. The presence of oxylipins will be studied in peri-prosthetic tissue post-biofilm infection and in systemic circulation. Oxylipins are immunogenic. Hence, the investigators will also study the abundance of immune cells T cells and macrophages (types and subtypes) and associated cytokines.

Connect with a study center

  • IU Health North Hospital

    Carmel, Indiana 46032
    United States

    Active - Recruiting

  • Meridian Plastic Surgeons

    Carmel, Indiana 46290
    United States

    Active - Recruiting

  • IU Health Methodist Hospital

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

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