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

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

This prospective implant-surveillance cohort will evaluate predictors of breast implant shell fissure. Women with aesthetic implants without baseline fissure or rupture will undergo annual clinical and imaging assessment for up to five years. Implant age, pocket plane, incision route, surface texture, and volume will be evaluated as predictors. The primary outcome is time to first confirmed focal shell fissure; progression to complete rupture, symptoms, inter-reader agreement, and revision will also be assessed.

A locked radiologic and operative definition will distinguish focal shell fissure from complete rupture, deformation, porosity, and leakage. Eligible women will enter only after baseline imaging shows no shell defect. Annual ultrasound and confirmatory MRI will prospectively identify incident events, which will undergo central blinded review and surgical confirmation when available. Delayed-entry time-to-event models will evaluate implant and surgical predictors and will account for bilateral implants and competing removal. A multi-state analysis will explore progression from intact implant to fissure and rupture if the event count is adequate.

Inclusion Criteria:

• Female sex and age 18 years or older.
• Aesthetic breast implant with known implantation date or year and known pocket plane, incision route, surface texture, and volume.
• No fissure or rupture identified by the baseline imaging algorithm.
• Ability to undergo annual ultrasound and confirmatory MRI when indicated.
• Written informed consent.

Exclusion Criteria:

• Confirmed fissure or rupture at cohort entry.
• Reconstructive breast implantation or tissue expander.
• Immediate planned implant removal or exchange.
• Missing core implant characteristics.
• MRI contraindication when MRI is required to adjudicate a suspected event.
• Recalled/PIP implant if excluded by the final analytic plan.