Prospective Controlled Cohort Study of the Incidence, Trajectory, and Clinical Correlates of Persistent Systemic Symptoms in Women With and Without Silicone Breast Implants
September 3, 2026 updated by: Research Inc
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
3000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Juan Velez, MD, Plastic surgeon
- Phone Number: +57 301 6918526
- Email: info@velezlara.com
Study Locations
-
-
-
Medellín, Colombia
- Recruiting
- IQ interquirofanos
-
Contact:
- juan Velez, MD, Plastic surgeon
- Phone Number: +57 321 8119802
- Email: direccion.medica@iqinterquirofanos.com
-
-
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.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Silicone Breast Implant Cohort
Women who independently choose primary aesthetic augmentation with silicone implants after standard counseling.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Revision or Explantation Attributed to Systemic Symptoms
Time Frame: 10 years
|
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.
|
10 years
|
|
Change in Systemic Symptom Burden After Explantation or Exchange
Time Frame: 10 years
|
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.
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: juan velez, MD, plastic surgery
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Ferreira 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.
- Spit 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.
- Tervaert 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.
- Shivarov 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 12, 2014
Primary Completion (Actual)
January 1, 2026
Study Completion (Estimated)
December 15, 2026
Study Registration Dates
First Submitted
September 3, 2026
First Submitted That Met QC Criteria
September 3, 2026
First Posted (Actual)
September 9, 2026
Study Record Updates
Last Update Posted (Actual)
September 9, 2026
Last Update Submitted That Met QC Criteria
September 3, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
no contempled in the patient informed concent
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.