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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
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
3000
Start Date
2014-01-12
Completion Date
2026-12-15
Last Updated
2026-09-09
Healthy Volunteers
No
Interventions
Silicone 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.
Standardized 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.
Locations (1)
IQ interquirofanos
Medellín, Colombia