Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Clinically Significant Capsular Contracture

Research Inc3,000 enrolled

Overview

This prospective breast implant surveillance cohort will evaluate whether implant age, pocket plane, incision route, surface texture, and volume predict clinically significant capsular contracture. Women with Baker grade I or II aesthetic implants at enrollment will undergo standardized annual assessments for up to five years. The primary outcome is time to incident Baker grade III or IV contracture. Progression, pain, imaging, treatment, and patient-reported outcomes will also be described.

Women with aesthetic breast implants and no clinically significant contracture at cohort entry will be enrolled into a dynamic surveillance cohort. Operative and device information will be verified from records. Trained assessors will apply a locked Baker grading protocol annually, supported by photographs, symptom assessment, and imaging. Suspected incident Baker III/IV contracture will undergo independent confirmation and operative verification when available. Delayed-entry survival models will estimate the independent effects of implant age, plane, incision, texture, and volume while accounting for bilateral implants and competing implant removal.

Study Type

OBSERVATIONAL

Enrollment

3,000

Conditions

Capsular Contracture of Breast Implant

Interventions

Standardized Capsular Contracture AssessmentDIAGNOSTIC_TEST

Two trained assessors will apply a standardized Baker grading protocol, with breast firmness, distortion, pain, and imaging recorded. Suspected grade III/IV events will undergo central review or operative confirmation when surgery occurs. Linked arm/group(s): Breast Implant Capsule Surveillance Cohort.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female sex and age 18 years or older. * Aesthetic breast augmentation with permanent silicone or saline implants under the final protocol. * Baker grade I or II in the analyzed breast at cohort entry, confirmed by standardized examination. * Known implantation date or year and known pocket plane, incision route, surface texture, and volume. * Ability to complete annual clinical assessment for up to five years. * Written informed consent. Exclusion Criteria: * Baker grade III or IV contracture at cohort entry in the analyzed breast. * Reconstructive implantation after mastectomy or major trauma. * Tissue expander. * Active breast infection or open wound at enrollment. * Planned immediate implant exchange or explantation. * Missing core implant or operative data.

Outcomes

Primary Outcomes

Time to Incident Baker Grade III or IV Capsular Contracture

Implant-level time from cohort entry to the first confirmed clinically significant contracture. Grade III is visible distortion/firmness and grade IV includes pain under the locked examination manual. Bilateral implants will be clustered by participant.

Time frame: From cohort entry through years of prospective follow-up. 10 years

Secondary Outcomes

Capsular Contracture-Free Survival by Implant Age

Probability of remaining free of Baker grade III/IV contracture at prespecified implant ages, estimated with delayed-entry survival methods when prevalent implants are included.

Time frame: Prospective follow-up through 10 years