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.
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.
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.
Adult women planning primary aesthetic breast surgery, enrolled before receiving silicone implants or before a nonimplant breast procedure such as mastopexy or reduction.
Cohort
Prospective
Silicone Breast Implant Exposure
DeviceImplant 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
Other interventionA 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.
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.
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.
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