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Prospective Two-Year Cohort Study of Surgical and Implant Predictors of Breast Implant Displacement and Rotation After Aesthetic Augmentation
Sponsor: Research Inc
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
3000
Start Date
2014-01-12
Completion Date
2026-12-15
Last Updated
2026-09-09
Healthy Volunteers
No
Interventions
Aesthetic Breast Implantation
Primary 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
Bilateral 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.
Locations (1)
IQ interquirofanos
Medellín, Colombia