NCT05736354

Molecular Mechanisms Associated With Breast Implant Complications

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Breast Implant; Complications
• Infection or Inflammation

Timeline

• Start date: 2021-01-03
• Primary completion: 2028-06-30
• Completion: 2028-06-30
• First posted: 2023-02-21
• Last updated: 2025-04-10

Locations

3 sites across 1 country: United States