An observational study in Systemic Symptoms, Breast Implant Illness and Breast Implant Complications, sponsored by Research Inc. Recruiting at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Research Inc · Observational
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.
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.
Research Inc is the lead sponsor of 24 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult women planning primary aesthetic breast surgery, enrolled before receiving silicone implants or before a nonimplant breast procedure such as mastopexy or reduction.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women who independently choose primary aesthetic augmentation with silicone implants after standard counseling.
Device: Silicone Breast Implant Exposure · Other: Standardized Systemic Symptom and Psychosocial Assessment
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.
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.
Time frame: 10 years
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.
Time frame: 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.
Time frame: 10 years
Plan to share: No — no contempled in the patient informed concent
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