Systemic SymptomsNCT07810803
Prospective Controlled Cohort Study of the Incidence, Trajectory, and Clinical Correlates of Persistent Systemic Symptoms in Women With and Without Silicone Breast Implants
An observational study of Systemic Symptoms and Breast Implant Illness, run by Research Inc at 1 site in Colombia.
Trial summary
This prospective controlled cohort will enroll women before primary aesthetic breast surgery. Women receiving silicone implants will be compared with women undergoing nonimplant mastopexy or reduction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Symptoms, Breast Implant Illness, Breast Implant Complications
- What is being tested?
- Silicone Breast Implant Exposure and Standardized Systemic Symptom and Psychosocial Assessment
- Type of treatment
- Medical device
- How many people
- 3,000 participants
- Where
- 1 siteColombia
- Study dates
- 12 Jan 2014to 15 Dec 2026
- How long will I take part?
- 10 Years
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult women planning primary aesthetic breast surgery, enrolled before receiving silicone implants or before a nonimplant breast procedure such as mastopexy or reduction.
Who may be able to join
- Female sex and age 18 years or older.
- Planning primary aesthetic breast augmentation with silicone implants or planning nonimplant aesthetic breast surgery such as mastopexy or reduction.
- No prior permanent breast implant.
- Completion of the full baseline systemic-symptom and psychosocial assessment before surgery.
- Ability to participate in annual follow-up for five years.
- Written informed consent.
Who cannot join
- Breast reconstruction after cancer, prophylactic mastectomy, congenital deformity, or major trauma.
- Known active autoimmune, inflammatory, neurologic, endocrine, infectious, or malignant condition expected to cause major systemic symptom change, unless the final protocol intentionally includes and stratifies these conditions.
- Current pregnancy or breastfeeding.
- Prior permanent breast implant or tissue expander.
- Inability to complete validated questionnaires in the authorized language.
- Planned simultaneous major surgery expected to dominate systemic recovery beyond the prespecified postoperative window.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
IQ interquirofanos
Medellín
juan Velez, MD, Plastic surgeon, +57 321 8119802, direccion.medica@iqinterquirofanos.com
About this study
This prospective controlled cohort will enroll women before primary aesthetic breast surgery. Women receiving silicone implants will be compared with women undergoing nonimplant mastopexy or reduction. Standardized systemic symptom, psychosocial, quality-of-life, and local breast assessments will be collected before surgery and through five years. The primary outcome is the incidence of a prespecified, adjudicated persistent new-onset multisystem symptom phenotype. Revision, explantation, local implant complications, and symptom changes after implant removal will also be evaluated.
Read the detailed description
The study addresses limitations of revision-only registry analyses by measuring symptoms before any implant exposure, including a contemporaneous nonimplant surgical control group, and applying a prespecified research phenotype rather than relying only on surgeon judgment or participant-requested BII labeling. Both cohorts will complete the same validated symptom and psychosocial battery at baseline, during early recovery, and annually through five years. Persistent cases will undergo multidisciplinary adjudication and clinically appropriate evaluation for alternative diagnoses. Implant complications, revision indications, and device characteristics will be recorded. A nested subcohort will measure symptom trajectories before and after explantation or exchange.
- Being tested
- Silicone Breast Implant Exposure, Standardized Systemic Symptom and Psychosocial Assessment
- Keywords
- Breast Implant Illness, Silicone Breast Implants, Persistent Systemic Symptoms, Explantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicone Breast Implant ExposureDevice
Implant characteristics include manufacturer/lot when available, texture, shape, volume, pocket plane, incision route, and laterality. Exposure is chosen as clinical care before enrollment and is not assigned by the study. Linked arm/group(s): Silicone Breast Implant Cohort.
Standardized Systemic Symptom and Psychosocial AssessmentOther
A locked battery will include validated measures of fatigue, pain interference, cognitive function, physical function, anxiety, depression, global health, and breast/body satisfaction. Proposed instruments include PROMIS short forms and BREAST-Q scales, subject to final licensing and language validation. Linked arm/group(s): Silicone Breast Implant Cohort, Nonimplant Breast Surgery Control Cohort.
| Study group | Role | What they receive |
|---|---|---|
| Silicone Breast Implant Cohort | Women who independently choose primary aesthetic augmentation with silicone implants after standard counseling. Receives: Device: Silicone Breast Implant Exposure; Other: Standardized Systemic Symptom and Psychosocial Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of an Adjudicated Persistent New-Onset Multisystem Symptom Phenotype
Proportion of participants who develop new or clinically meaningful worsening in at least two prespecified systemic symptom domains, persisting for at least 6 months, beginning after the initial 3-month postoperative recovery window, and not better explained by an alternative diagnosis after blinded adjudication. The final domain list and thresholds will be locked before enrollment.
Measured: 10 years
Secondary outcomes (2)
Incidence of Revision or Explantation Attributed to Systemic Symptoms
Proportion undergoing implant exchange or explantation for participant-reported systemic symptoms or clinician-recorded BII/ASIA indication, reported separately from local complications and elective aesthetic reasons.
Measured: 10 years
Change in Systemic Symptom Burden After Explantation or Exchange
Within-person change in the prespecified symptom and PROM scores from the pre-revision assessment to 3, 6, and 12 months after explantation or exchange.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start12 Jan 2014
- Primary completion1 Jan 2026
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Systemic SymptomsStudies of the same condition, open and under way.
- More trials run by Research IncThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Research Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- juan velez, MD, plastic surgery, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810803
- Sponsor's protocol ID
- 024
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no contempled in the patient informed concent
Publications
Ribeiro PDC, Sato EI. Autoimmune/autoinflammatory syndrome induced by adjuvants: a focus on silicone. Clin Rheumatol. 2022 Nov;41(11):3275-3283. doi: 10.1007/s10067-022-06274-0. Epub 2022 Jul 7.
PubMed 35798923Ferreira S, Barros AS, Marques M. Breast Implant Illness: Symptoms, Outcomes with Explantation and Potential Etiologies-A Systematic Review and Meta-analysis. Aesthetic Plast Surg. 2025 Dec;49(23):6600-6620. doi: 10.1007/s00266-025-05142-x. Epub 2025 Aug 11.
PubMed 40788544Spit KA, Scharff M, de Blok CJ, Niessen FB, Bachour Y, Nanayakkara PW. Patient-reported systemic symptoms in women with silicone breast implants: a descriptive cohort study. BMJ Open. 2022 Jun 9;12(6):e057159. doi: 10.1136/bmjopen-2021-057159.
PubMed 35680258Tervaert JWC, Shoenfeld Y, Cruciani C, Scarpa C, Bassetto F. Breast implant illness: Is it causally related to breast implants? Autoimmun Rev. 2024 Jan;23(1):103448. doi: 10.1016/j.autrev.2023.103448. Epub 2023 Sep 13.
PubMed 37714420Shivarov V, Yordanov A, Ivanova M, Tsoneva E. Breast Implant Illness and Autoimmune/Inflammatory Syndrome Induced by Adjuvants: Mechanistic Rationale and a Practical Multidisciplinary Diagnostic Algorithm. J Clin Med. 2026 Jul 21;15(14):5721. doi: 10.3390/jcm15145721.
PubMed 42513634
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Controlled Cohort Study of the Incidence, Trajectory, and Clinical Correlates of Persistent Systemic Symptoms in Women With and Without Silicone Breast Implants
- ClinicalTrials.gov ID
- NCT07810803
- Acronym / sponsor ID
- 024
- Keywords
- Breast Implant Illness, Silicone Breast Implants, Persistent Systemic Symptoms, Explantation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Research IncIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2014 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 9 Sep 2026 (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.
This prospective controlled cohort will enroll women before primary aesthetic breast surgery. Women receiving silicone implants will be compared with women undergoing nonimplant mastopexy or reduction. Standardized systemic symptom, psychosocial, quality-of-life, and local breast assessments will be collected before surgery and through five years. The primary outcome is the incidence of a prespecified, adjudicated persistent new-onset multisystem symptom phenotype. Revision, explantation, local implant complications, and symptom changes after implant removal will also be evaluated.
Detailed description
The study addresses limitations of revision-only registry analyses by measuring symptoms before any implant exposure, including a contemporaneous nonimplant surgical control group, and applying a prespecified research phenotype rather than relying only on surgeon judgment or participant-requested BII labeling. Both cohorts will complete the same validated symptom and psychosocial battery at baseline, during early recovery, and annually through five years. Persistent cases will undergo multidisciplinary adjudication and clinically appropriate evaluation for alternative diagnoses. Implant complications, revision indications, and device characteristics will be recorded. A nested subcohort will measure symptom trajectories before and after explantation or exchange.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Silicone Breast Implant Cohort | – | Device: Silicone Breast Implant Exposure, Other: Standardized Systemic Symptom and Psychosocial AssessmentWomen who independently choose primary aesthetic augmentation with silicone implants after standard counseling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women planning primary aesthetic breast surgery, enrolled before receiving silicone implants or before a nonimplant breast procedure such as mastopexy or reduction.
Key inclusion criteria (6 listed)
- Female sex and age 18 years or older.
- Planning primary aesthetic breast augmentation with silicone implants or planning nonimplant aesthetic breast surgery such as mastopexy or reduction.
- No prior permanent breast implant.
- Completion of the full baseline systemic-symptom and psychosocial assessment before surgery.
- Ability to participate in annual follow-up for five years.
Key exclusion criteria (6 listed)
- Breast reconstruction after cancer, prophylactic mastectomy, congenital deformity, or major trauma.
- Known active autoimmune, inflammatory, neurologic, endocrine, infectious, or malignant condition expected to cause major systemic symptom change, unless the final protocol intentionally includes and stratifies these conditions.
- Current pregnancy or breastfeeding.
- Prior permanent breast implant or tissue expander.
- Inability to complete validated questionnaires in the authorized language.
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 |
|---|---|---|
| Silicone Breast Implant ExposureImplant characteristics include manufacturer/lot when available, texture, shape, volume, pocket plane, incision route, and laterality. Exposure is chosen as clinical care before enrollment and is not assigned by the study. Linked arm/group(s): Silicone Breast Implant Cohort. | Device | Silicone Breast Implant Cohort |
| Standardized Systemic Symptom and Psychosocial AssessmentA locked battery will include validated measures of fatigue, pain interference, cognitive function, physical function, anxiety, depression, global health, and breast/body satisfaction. Proposed instruments include PROMIS short forms and BREAST-Q scales, subject to final licensing and language validation. Linked arm/group(s): Silicone Breast Implant Cohort, Nonimplant Breast Surgery Control Cohort. | Other | Silicone Breast Implant Cohort |
Primary outcome
Incidence of an Adjudicated Persistent New-Onset Multisystem Symptom Phenotype
Time frame: 10 years
Proportion of participants who develop new or clinically meaningful worsening in at least two prespecified systemic symptom domains, persisting for at least 6 months, beginning after the initial 3-month postoperative recovery window, and not better explained by an alternative diagnosis after blinded adjudication. The final domain list and thresholds will be locked before enrollment.
2 secondary outcomes
Incidence of Revision or Explantation Attributed to Systemic Symptoms
Time frame: 10 years
Change in Systemic Symptom Burden After Explantation or Exchange
Time frame: 10 years
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 9 Sep 2026.
- Background: PubMed 35798923Ribeiro PDC, Sato EI. Autoimmune/autoinflammatory syndrome induced by adjuvants: a focus on silicone. Clin Rheumatol. 2022 Nov;41(11):3275-3283. doi: 10.1007/s10067-022-06274-0. Epub 2022 Jul 7.
- Background: PubMed 40788544Ferreira S, Barros AS, Marques M. Breast Implant Illness: Symptoms, Outcomes with Explantation and Potential Etiologies-A Systematic Review and Meta-analysis. Aesthetic Plast Surg. 2025 Dec;49(23):6600-6620. doi: 10.1007/s00266-025-05142-x. Epub 2025 Aug 11.
- Background: PubMed 35680258Spit KA, Scharff M, de Blok CJ, Niessen FB, Bachour Y, Nanayakkara PW. Patient-reported systemic symptoms in women with silicone breast implants: a descriptive cohort study. BMJ Open. 2022 Jun 9;12(6):e057159. doi: 10.1136/bmjopen-2021-057159.
- Background: PubMed 37714420Tervaert JWC, Shoenfeld Y, Cruciani C, Scarpa C, Bassetto F. Breast implant illness: Is it causally related to breast implants? Autoimmun Rev. 2024 Jan;23(1):103448. doi: 10.1016/j.autrev.2023.103448. Epub 2023 Sep 13.
- Background: PubMed 42513634Shivarov V, Yordanov A, Ivanova M, Tsoneva E. Breast Implant Illness and Autoimmune/Inflammatory Syndrome Induced by Adjuvants: Mechanistic Rationale and a Practical Multidisciplinary Diagnostic Algorithm. J Clin Med. 2026 Jul 21;15(14):5721. doi: 10.3390/jcm15145721.
- Individual participant dataSharing planned: No. no contempled in the patient informed concent
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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.
juan velez, MD, plastic surgery principal investigator
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 Systemic Symptoms and Breast Implant Illness, run by Research Inc at 1 site in Colombia.
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 6 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 9 Sep 2026. 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 Colombia. 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 Juan Velez, MD, Plastic surgeon (+57 301 6918526, info@velezlara.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of an Adjudicated Persistent New-Onset Multisystem Symptom Phenotype (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07810803, which also lists 5 linked publications.
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 9 Sep 2026.