This prospective dynamic cohort will follow women with intact aesthetic silicone breast implants to evaluate predictors of rupture. Implant age, pocket plane, incision route, surface texture, and volume will be recorded, and participants will undergo annual clinical and imaging surveillance for up to five years. Confirmed rupture will require MRI or operative evidence. Delayed-entry survival models will estimate the independent association of implant and surgical characteristics with rupture risk.
Female sex and age 18 years or older.
Aesthetic breast augmentation with permanent silicone implants.
Known implantation date or sufficiently precise implantation year, pocket plane, incision route, surface texture, and implant volume.
Both implants or the analyzed implant documented as intact at baseline by the study imaging algorithm.
Reconstructive implantation after mastectomy, congenital deformity, or major trauma.
Tissue expander or nonpermanent device.
Confirmed rupture at cohort entry for the implant under analysis.
PIP implant or another recalled device if the final protocol elects to exclude it from etiologic modeling.
Adult women with aesthetic silicone breast implants documented as intact at cohort entry, including new implant recipients and prevalent implant carriers.
Cohort
Prospective
Silicone Breast Implant Exposure
DeviceImplant-level exposure data include implantation date, laterality, pocket plane, incision route, surface texture, shape, volume, manufacturer/lot when available, primary versus revision placement, and concomitant mastopexy or fat grafting. Linked arm/group(s): Intact Aesthetic Breast Implant Surveillance Cohort.
Prospective Breast Implant Surveillance Imaging
Diagnostic testBaseline and annual high-resolution ultrasound will assess implant integrity. Suspicious or indeterminate findings will undergo MRI according to the locked diagnostic algorithm. Rupture is confirmed by MRI, operative inspection, or both. Linked arm/group(s): Intact Aesthetic Breast Implant Surveillance Cohort.
Time to First Confirmed Breast Implant Rupture
Implant-level time from cohort entry to the first MRI- or surgically confirmed full-thickness implant shell rupture. Implant age is used as the survival time scale with delayed entry at age on enrollment. Contralateral implants are accounted for by patient-level clustering.
Rupture-Free Survival by Implant Age
Kaplan-Meier or model-based probability of remaining free of confirmed rupture at prespecified implant ages, using delayed-entry methods.
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