Molecular Mechanisms Associated With Breast Implant Complications

Description

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 Overview

Study Details

Study overview

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.

Molecular Mechanisms Associated With Breast Implant Complications

Molecular Mechanisms Associated With Breast Implant Complications

Condition
Breast Implant; Complications
Intervention / Treatment

-

Contacts and Locations

Carmel

IU Health North Hospital, Carmel, Indiana, United States, 46032

Carmel

Meridian Plastic Surgeons, Carmel, Indiana, United States, 46290

Indianapolis

IU Health Methodist Hospital, Indianapolis, Indiana, United States, 46202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Indiana University,

Mithun Sinha, PhD., PRINCIPAL_INVESTIGATOR, Indiana University School of Medicine

Study Record Dates

2028-06-30