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

Research Inc3,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

3,000

Conditions

Breast Implant Malposition Breast Implant Rotation

Interventions

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 AssessmentDIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 10 years

Secondary Outcomes

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.