Clinical Research Directory
Browse clinical research sites, groups, and studies.
Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Shell Fissure
Sponsor: Research Inc
Summary
This prospective implant-surveillance cohort will evaluate predictors of breast implant shell fissure. Women with aesthetic implants without baseline fissure or rupture will undergo annual clinical and imaging assessment for up to five years. Implant age, pocket plane, incision route, surface texture, and volume will be evaluated as predictors. The primary outcome is time to first confirmed focal shell fissure; progression to complete rupture, symptoms, inter-reader agreement, and revision will also be assessed.
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
Breast Implant Exposure
Recorded characteristics include implant age, material, surface texture, shape, volume, pocket plane, incision route, manufacturer/lot when available, primary or revision placement, and laterality. Linked arm/group(s): Implant Shell Integrity Surveillance Cohort.
Structured Implant Shell Imaging
Annual high-resolution ultrasound and confirmatory MRI will apply a locked definition of focal shell fissure, complete rupture, deformation, porosity, and silicone leakage. Event images will undergo blinded central review. Linked arm/group(s): Implant Shell Integrity Surveillance Cohort.
Locations (1)
IQ interquirofanos
Medellín, Colombia