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Bacteria on breast implants: the hidden culprit behind chronic illness?

NCT ID NCT05736354

Knowledge-focused Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether bacterial biofilms (sticky layers of bacteria) on breast implants can lead to complications like chronic inflammation or Breast Implant Illness. Researchers will collect blood and discarded tissue from 1000 women—some with implants and symptoms, some with implants but no symptoms, and some without implants. The goal is to understand the role of bacteria in implant-related health problems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could clarify why some people get sick from breast implants and point toward better prevention or treatment.
What could go wrong
This is an observational study, not a treatment trial. It may not find a clear link, and results may take years to translate into practical changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2021

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population focuses on females, ages 18 years or older, that are either undergoing removal of breast implants or undergoing breast surgery. Participants must be willing to comply with protocol instructions and possess the mental capabilities to understand the procedures, risks, and benefits of the study. Additionally, participants that are pregnant will not be eligible for participation. Lastly, participants that are deemed immunodeficient or currently taking immunosuppressive medications will be ineligible for participation.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast implant illness Infections Inflammation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast implant complications Infection or inflammation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IU Health Methodist Hospital

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • IU Health North Hospital

    RECRUITING

    Carmel, Indiana, 46032, United States

  • Meridian Plastic Surgeons

    RECRUITING

    Carmel, Indiana, 46290, United States

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