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.
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.
Confirmed fissure or rupture at cohort entry.
Reconstructive breast implantation or tissue expander.
Immediate planned implant removal or exchange.
Missing core implant characteristics.
Adult women with aesthetic breast implants that are intact and without a documented shell fissure at baseline.
Cohort
Prospective
Breast Implant Exposure
DeviceRecorded characteristics include implant age, material, surface texture, shape, volume, pocket plane, incision route, manufacturer/lot when available, primary or revision placement, and laterality. Linked arm/group(s): Implant Shell Integrity Surveillance Cohort.
Structured Implant Shell Imaging
Diagnostic testAnnual high-resolution ultrasound and confirmatory MRI will apply a locked definition of focal shell fissure, complete rupture, deformation, porosity, and silicone leakage. Event images will undergo blinded central review. Linked arm/group(s): Implant Shell Integrity Surveillance Cohort.
Time to First Confirmed Breast Implant Shell Fissure
Implant-level time from cohort entry to the first focal partial-thickness or noncomplete shell discontinuity meeting the locked MRI, ultrasound, or operative criteria and not meeting the definition of complete rupture.
Fissure-Free Survival by Implant Age
Probability of remaining free of confirmed fissure at prespecified implant ages using delayed-entry survival methods.
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