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

Research Inc3,000 enrolled

Overview

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.

Women with new or existing aesthetic silicone breast implants will enter the cohort only after baseline assessment confirms that the analyzed implant is intact. Implant and operative characteristics will be verified from device cards and operative records whenever possible. Annual high-resolution ultrasound will screen for integrity loss, with MRI or surgery used for confirmation under a standardized algorithm. Implant age will serve as the survival time scale, and prevalent implants will enter at their age on enrollment. The study will estimate rupture-free survival, symptomatic and silent rupture rates, adjusted predictor effects, and management after detection.

Study Type

OBSERVATIONAL

Enrollment

3,000

Conditions

Breast Implant Rupture

Interventions

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.

Prospective Breast Implant Surveillance ImagingDIAGNOSTIC_TEST

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.

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 implants. * Known implantation date or sufficiently precise implantation year, pocket plane, incision route, surface texture, and implant volume. * Both implants or the analyzed implant documented as intact at baseline by the study imaging algorithm. * Ability to complete annual surveillance for up to five years. * Written informed consent. Exclusion Criteria: * Reconstructive implantation after mastectomy, congenital deformity, or major trauma. * Tissue expander or nonpermanent device. * Confirmed rupture at cohort entry for the implant under analysis. * PIP implant or another recalled device if the final protocol elects to exclude it from etiologic modeling. * Missing core implant characteristics or implantation date. * Planned immediate explantation or exchange at enrollment for a reason unrelated to surveillance.

Outcomes

Primary Outcomes

Time to First Confirmed Breast Implant Rupture

Implant-level time from cohort entry to the first MRI- or surgically confirmed full-thickness implant shell rupture. Implant age is used as the survival time scale with delayed entry at age on enrollment. Contralateral implants are accounted for by patient-level clustering.

Time frame: From cohort entry through years of prospective follow-up. 10 TO 12 YEARS

Secondary Outcomes

Rupture-Free Survival by Implant Age

Kaplan-Meier or model-based probability of remaining free of confirmed rupture at prespecified implant ages, using delayed-entry methods.

Time frame: 12 YEARS