Women With Breast Implants With and Without Self-reported Systemic SymptomsBIINCT04255810
Systemic Symptoms: Biospecimen Analysis Study
An observational study of Women With Breast Implants With and Without Self-reported Systemic Symptoms and Women Undergoing an Elective Mastopexy (Breast Lift) or Small Reduction, run by Glicksman, Caroline, M.D. at 1 site in United States.
Trial summary
An increasing number of women are reporting a collection of non-specific systemic symptoms thought to be caused by their breast implants. There is no current pathophysiologic explanation or diagnostic test for BII; it is not a recognized medical disease at this time. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Women With Breast Implants With and Without Self-reported Systemic Symptoms, Women Undergoing an Elective Mastopexy (Breast Lift) or Small Reduction
- What is being tested?
- Surgical collection of biospecimens
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 30 to 65 years
- Women only
- Adult, Older adult
Study population: Genetic females between the ages of 30 and 65 who fall into one of the three cohorts.
Who may be able to join
- Consecutive patients who present to investigator surgeon for:
- Self-reported BII requesting explantation;
- Patient who presents for breast implant exchange or explantation without self-reported symptoms of BII;
- Patient who presents for a mastopexy or small reduction less than 200grams (without implants or soft tissue support);
- Willingness to follow study requirements including 3-6 week and 6 month follow-up exams; and
- Genetic Female.
Who cannot join
- Subject lives more than three hours away from the investigator surgeon;
- Previous breast reconstruction for cancer;
- Active malignancy anywhere else in the body;
- Has been implanted with any silicone implant other than a breast implant anywhere else in the body;
- History of radiation to the breast;
- Currently on anti-estrogen therapy; or
- HIV positive.
Trial locations and contacts
1 site in 1 country.
United States1 site
Glicksman Plastic Surgery
Sea Girt, New Jersey, 08750
About this study
An increasing number of women are reporting a collection of non-specific systemic symptoms thought to be caused by their breast implants. There is no current pathophysiologic explanation or diagnostic test for BII; it is not a recognized medical disease at this time. This study aims to address the questions asked by patients, physicians, and the FDA with regard to the scientific validity of BII.
Read the detailed description
An increasing number of women are reporting a collection of non-specific systemic symptoms thought to be caused by their breast implants. The term Breast Implant Illness or "BII" originated with several social media groups. There is no current pathophysiologic explanation or diagnostic test for BII; it is not a recognized medical disease at this time. Recently several studies have been designed and funded to study the role of psychological and social behavioral factors. This study has been designed to scientifically analyze biospecimens from three cohorts of age matched women in the United States. This study aims to address the questions asked by patients, physicians, and the FDA with regard to the scientific validity of BII.
- Conditions
- Women With Breast Implants With and Without Self-reported Systemic Symptoms, Women Undergoing an Elective Mastopexy (Breast Lift) or Small Reduction
- Being tested
- Surgical collection of biospecimens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical collection of biospecimensProcedure or surgery
Systemic blood and implant capsule tissue will be collected from two cohorts with breast implants, systemic blood only will be collected from Mastopexy cohort
| Study group | Role | What they receive |
|---|---|---|
| Women with breast implants and self-reported symptoms of BII | Women undergoing elective breast implant removal without replacement who self-report systemic symptons associated with BII Receives: Procedure: Surgical collection of biospecimens | |
| Women with breast implants and no self-reported BII | Women undergoing elective breast implant exchange or removal without self-reported symptoms of BII Receives: Procedure: Surgical collection of biospecimens | |
| Women undergoing elective mastopexy (breast lift) | Women undergoing an elective mastopexy (breast lift) without breast implants or soft tissue support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported systemic symptoms
Change in self-reported symptoms on PROMIS (NIH) questionnaires
Measured: 3-6 weeks and 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Nov 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women With Breast Implants With and Without Self-reported Systemic SymptomsStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glicksman, Caroline, M.D.
- Collaborators
- The Aesthetic Surgery Education & Research Foundation
- Responsible party
- Principal investigator, Caroline Glicksman, MD and Patricia McGuire, MD, The Aesthetic Surgery Education & Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255810
- Sponsor's protocol ID
- ASERF-BII Study
- Acronym
- BII
- Status last verified
- Aug 2025
- First submitted
- 3 Feb 2020
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anticipated completion of biospecimen and qualitative data collection in 2022, with publication in the Aesthetic Surgery Journal. Four peer reviewed publications in Aesthetic Surgery Journal- ASERF Biospecimen Study.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Symptoms: Biospecimen Analysis Study
- ClinicalTrials.gov ID
- NCT04255810
- Acronym / sponsor ID
- BII / ASERF-BII Study
- Conditions
- Women With Breast Implants With and Without Self-reported Systemic Symptoms, Women Undergoing an Elective Mastopexy (Breast Lift) or Small Reduction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Glicksman, Caroline, M.D.
- Collaborators
- The Aesthetic Surgery Education & Research Foundation
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 5 Feb 2020 (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.
An increasing number of women are reporting a collection of non-specific systemic symptoms thought to be caused by their breast implants. There is no current pathophysiologic explanation or diagnostic test for BII; it is not a recognized medical disease at this time. This study aims to address the questions asked by patients, physicians, and the FDA with regard to the scientific validity of BII.
Detailed description
An increasing number of women are reporting a collection of non-specific systemic symptoms thought to be caused by their breast implants. The term Breast Implant Illness or "BII" originated with several social media groups. There is no current pathophysiologic explanation or diagnostic test for BII; it is not a recognized medical disease at this time. Recently several studies have been designed and funded to study the role of psychological and social behavioral factors. This study has been designed to scientifically analyze biospecimens from three cohorts of age matched women in the United States. This study aims to address the questions asked by patients, physicians, and the FDA with regard to the scientific validity of BII.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Women with breast implants and self-reported symptoms of BII | – | Procedure: Surgical collection of biospecimensWomen undergoing elective breast implant removal without replacement who self-report systemic symptons associated with BII |
| Women with breast implants and no self-reported BII | – | Procedure: Surgical collection of biospecimensWomen undergoing elective breast implant exchange or removal without self-reported symptoms of BII |
| Women undergoing elective mastopexy (breast lift) | – | –Women undergoing an elective mastopexy (breast lift) without breast implants or soft tissue support |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Genetic females between the ages of 30 and 65 who fall into one of the three cohorts.
Key inclusion criteria (6 listed)
- Self-reported BII requesting explantation;
- Patient who presents for breast implant exchange or explantation without self-reported symptoms of BII;
- Patient who presents for a mastopexy or small reduction less than 200grams (without implants or soft tissue support);
- Willingness to follow study requirements including 3-6 week and 6 month follow-up exams; and
- Genetic Female.
Key exclusion criteria (7 listed)
- Subject lives more than three hours away from the investigator surgeon;
- Previous breast reconstruction for cancer;
- Active malignancy anywhere else in the body;
- Has been implanted with any silicone implant other than a breast implant anywhere else in the body;
- History of radiation to the breast;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical collection of biospecimensSystemic blood and implant capsule tissue will be collected from two cohorts with breast implants, systemic blood only will be collected from Mastopexy cohort | Procedure or surgery | Women with breast implants and no self-reported BII, Women with breast implants and self-reported symptoms of BII |
Primary outcome
Change in self-reported systemic symptoms
Time frame: 3-6 weeks and 6 months and 1 year
Change in self-reported symptoms on PROMIS (NIH) questionnaires
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: Undecided. Anticipated completion of biospecimen and qualitative data collection in 2022, with publication in the Aesthetic Surgery Journal. Four peer reviewed publications in Aesthetic Surgery Journal- ASERF Biospecimen Study.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Women With Breast Implants With and Without Self-reported Systemic Symptoms and Women Undergoing an Elective Mastopexy (Breast Lift) or Small Reduction, run by Glicksman, Caroline, M.D. at 1 site 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported systemic symptoms (time frame: 3-6 weeks and 6 months and 1 year). 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 22 Aug 2025; AzTrials last refreshed its copy on 31 Oct 2026.