RecruitingNCT07810803

Prospective Controlled Cohort Study of the Incidence, Trajectory, and Clinical Correlates of Persistent Systemic Symptoms in Women With and Without Silicone Breast Implants

Sponsor

Research Inc

Enrollment

3,000 participants

Start Date

Jan 12, 2014

Study Type

OBSERVATIONAL

Conditions

Breast Implant; Complications Systemic Symptoms Breast Implant Illness

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. 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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Silicone Breast Implant Exposure and Standardized Systemic Symptom and Psychosocial Assessment for people with breast implant illness, breast implant; complications, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESilicone Breast Implant Exposure

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.

OTHERStandardized Systemic Symptom and Psychosocial Assessment

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.