This prospective inception cohort will follow women for ten years after primary or revision aesthetic breast implantation. Pocket plane, incision route, implant texture, shape, volume, and operative pocket variables will be recorded. Standardized clinical and photographic assessments will identify displacement and rotation. The primary outcome is time to clinically significant implant malposition or rotation; direction, reoperation, patient-reported outcomes, and early postoperative predictors will also be analyzed.
Female sex and age 18 years or older.
Primary or revision aesthetic breast implantation with a permanent implant.
Complete documentation of pocket plane, incision route, texture, shape, volume, laterality, and operative pocket measurements.
Standardized early postoperative baseline photography and clinical position assessment.
Reconstructive implantation after mastectomy or major trauma.
Tissue expander.
Immediate major postoperative complication requiring implant removal before the position baseline can be established; these cases remain in safety reporting but not the position-risk cohort.
Missing operative or device variables.
Adult women undergoing primary or revision aesthetic breast implantation with complete operative and device documentation.
Cohort
Prospective
Aesthetic Breast Implantation
Procedure/SurgeryPrimary or revision aesthetic implantation is performed according to independent clinical care. The study records incision route, pocket plane, pocket dimensions, implant texture, shape, volume, fixation or internal support, mastopexy, and postoperative support. Linked arm/group(s): Aesthetic Implant Position Cohort.
Standardized Implant Position Assessment
Diagnostic testBilateral photographs, surface landmark measurements, clinical examination, and ultrasound when indicated will assess implant center, inframammary fold relationship, medial/lateral displacement, vertical position, and orientation. Rotation assessment is prespecified for shaped implants. Linked arm/group(s): Aesthetic Implant Position Cohort.
Time to Clinically Significant Implant Displacement or Rotation
Time from implantation to the first confirmed inferior, superior, medial, or lateral malposition or clinically significant rotation that is visible, symptomatic, requires treatment, or meets the locked landmark-based threshold. Rotation is evaluated only for shaped implants unless a validated orientation marker is available.
Incidence by Direction and Type of Malposition
Proportion of implants with inferior, superior, medial, lateral, or rotational malposition, reported separately and per 100 implant-years.
Click on the lead sponsor to view all of their trials.
