Prospective Two-Year Cohort Study of Surgical and Implant Predictors of Breast Implant Displacement and Rotation After Aesthetic Augmentation

Prospective Two-Year Cohort Study of Surgical and Implant Predictors of Breast Implant Displacement and Rotation After Aesthetic Augmentation

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.

Participants will be enrolled before aesthetic breast implantation. A standardized preoperative anatomic assessment and detailed operative record will establish implant and pocket characteristics. Postoperative month 1 will serve as the reference position after early swelling decreases, and assessments will be repeated through years. A locked landmark-based definition will distinguish clinically significant inferior, superior, medial, and lateral displacement and rotation. Time-to-event and mixed-effects models will evaluate implant, surgical, and patient predictors while accounting for bilateral implants.

Inclusion Criteria:

• 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.
• Ability to complete follow-up through 24 months.
• Written informed consent.

Exclusion Criteria:

• 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.
• Inability to obtain standardized photographs or position measurements.
• Planned pregnancy during the first 12 months if the final protocol elects to exclude it.