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

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

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.

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.