Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Rupture

Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Rupture

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.

Women with new or existing aesthetic silicone breast implants will enter the cohort only after baseline assessment confirms that the analyzed implant is intact. Implant and operative characteristics will be verified from device cards and operative records whenever possible. Annual high-resolution ultrasound will screen for integrity loss, with MRI or surgery used for confirmation under a standardized algorithm. Implant age will serve as the survival time scale, and prevalent implants will enter at their age on enrollment. The study will estimate rupture-free survival, symptomatic and silent rupture rates, adjusted predictor effects, and management after detection.

Inclusion Criteria:

• 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.
• Ability to complete annual surveillance for up to five years.
• Written informed consent.

Exclusion Criteria:

• 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.
• Missing core implant characteristics or implantation date.
• Planned immediate explantation or exchange at enrollment for a reason unrelated to surveillance.