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.
Female sex and age 18 years or older. [+5]
Breast reconstruction after cancer, prophylactic mastectomy, congenital deformit... [+5]