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Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Clinically Significant Capsular Contracture
Sponsor: Research Inc
Summary
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.
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
Conditions
Interventions
Breast Implant Exposure
Implant-level data include age, laterality, material, surface texture, shape, volume, pocket plane, incision route, primary or revision placement, manufacturer/lot when available, and concomitant mastopexy or fat grafting. Linked arm/group(s): Breast Implant Capsule Surveillance Cohort.
Standardized Capsular Contracture Assessment
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.
Locations (1)
IQ interquirofanos
Medellín, Colombia