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RECRUITING
NCT07810205

Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Rupture

Sponsor: Research Inc

View on ClinicalTrials.gov

Summary

This prospective dynamic cohort will follow women with intact aesthetic silicone breast implants to evaluate predictors of rupture. Implant age, pocket plane, incision route, surface texture, and volume will be recorded, and participants will undergo annual clinical and imaging surveillance for up to five years. Confirmed rupture will require MRI or operative evidence. Delayed-entry survival models will estimate the independent association of implant and surgical characteristics with rupture risk.

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

DEVICE

Silicone Breast Implant Exposure

Implant-level exposure data include implantation date, laterality, pocket plane, incision route, surface texture, shape, volume, manufacturer/lot when available, primary versus revision placement, and concomitant mastopexy or fat grafting. Linked arm/group(s): Intact Aesthetic Breast Implant Surveillance Cohort.

DIAGNOSTIC_TEST

Prospective Breast Implant Surveillance Imaging

Baseline and annual high-resolution ultrasound will assess implant integrity. Suspicious or indeterminate findings will undergo MRI according to the locked diagnostic algorithm. Rupture is confirmed by MRI, operative inspection, or both. Linked arm/group(s): Intact Aesthetic Breast Implant Surveillance Cohort.

Locations (1)

IQ interquirofanos

Medellín, Colombia