Breast Implant; ComplicationsMMABICNCT05736354
Molecular Mechanisms Associated With Breast Implant Complications
An observational study of Breast Implant; Complications and Infection or Inflammation, run by Indiana University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Implant; Complications, Infection or Inflammation
- How many people
- 1,000 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Jan 2021to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
IU Health North Hospital
Carmel, Indiana, 46032
Jason VonDerHaar, MD
- Recruiting
Meridian Plastic Surgeons
Carmel, Indiana, 46290
Christine Kelley-Patteson, MD
- Recruiting
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
Mary Lester, melester@iupui.edu
Bryce Hockman, 3172782715, bbhockma@iu.edu
About this study
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.
Read the 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.
- Medical subject headings
- Infections, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Biofilm in Breast Tissue
During a clinically scheduled breast surgery, breast tissue specimens will be taken from surgically discarded tissue. The specimens from both breast implant subjects and control subjects (those undergoing breast surgery for a reason other than implant removal) will be analyzed to determine the presence of bacterial biofilm.
Measured: Through study completion, an average of 1 year
Analysis of host-biofilm interaction mediated oxylipins from blood
Prior to a clinically scheduled breast surgery, 20 milliliters of blood will be collected during the pre-operative surgical preparations. The blood samples from both breast implant subjects and control subjects (those undergoing breast surgery for a reason other than implant removal) will be analyzed for host-biofilm interaction mediated oxylipins.
Measured: Through study completion, an average of 1 year
Cytokine analysis will be performed on breast tissue
During a clinically scheduled breast surgery, breast tissue specimens will be taken from surgically discarded tissue. The specimens from both breast implant subjects and control subjects (those undergoing breast surgery for a reason other than implant removal) will undergo cytokine analysis.
Measured: Through study completion, an average of 1 year
Analysis of host-biofilm interaction mediated oxylipins from breast tissue
During a clinically scheduled breast surgery, breast tissue specimens will be taken from surgically discarded tissue. The specimens from both breast implant subjects and control subjects (those undergoing breast surgery for a reason other than implant removal) will undergo oxylipin analysis.
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
CD4+ Immunological Activation due to Host Implant Interaction
Determining activation of CD4+ immune cells
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start3 Jan 2021
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Implant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Mithun Sinha, Indiana University
- Investigators
- Mithun Sinha, PhD., Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736354
- Sponsor's protocol ID
- 2003674175
- Other IDs
- R21AI171932, R01AI165958
- Acronym
- MMABIC
- Status last verified
- May 2026
- First submitted
- 17 Jan 2023
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Mechanisms Associated With Breast Implant Complications
- ClinicalTrials.gov ID
- NCT05736354
- Acronym / sponsor ID
- MMABIC / 2003674175
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of Biofilm in Breast Tissue
Time frame: Through study completion, an average of 1 year
During a clinically scheduled breast surgery, breast tissue specimens will be taken from surgically discarded tissue. The specimens from both breast implant subjects and control subjects (those undergoing breast surgery for a reason other than implant removal) will be analyzed to determine the presence of bacterial biofilm.
Analysis of host-biofilm interaction mediated oxylipins from blood
Time frame: Through study completion, an average of 1 year
Prior to a clinically scheduled breast surgery, 20 milliliters of blood will be collected during the pre-operative surgical preparations. The blood samples from both breast implant subjects and control subjects (those undergoing breast surgery for a reason other than implant removal) will be analyzed for host-biofilm interaction mediated oxylipins.
Cytokine analysis will be performed on breast tissue
Time frame: Through study completion, an average of 1 year
During a clinically scheduled breast surgery, breast tissue specimens will be taken from surgically discarded tissue. The specimens from both breast implant subjects and control subjects (those undergoing breast surgery for a reason other than implant removal) will undergo cytokine analysis.
Analysis of host-biofilm interaction mediated oxylipins from breast tissue
Time frame: Through study completion, an average of 1 year
During a clinically scheduled breast surgery, breast tissue specimens will be taken from surgically discarded tissue. The specimens from both breast implant subjects and control subjects (those undergoing breast surgery for a reason other than implant removal) will undergo oxylipin analysis.
1 secondary outcome
CD4+ Immunological Activation due to Host Implant Interaction
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mithun Sinha, PhD. principal investigator
Indiana University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Implant; Complications and Infection or Inflammation, run by Indiana University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mithun Sinha, PhD. (3172782713, mitsinha@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Biofilm in Breast Tissue (time frame: Through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.