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

Recruitingn/aAges 18 Years - anyAllResearch Inc
NCT07810257 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Female sex and age 18 years or older. * Aesthetic breast implant with known implantation date or year and known pocket plane, incision route, surface texture, and volume. * No fissure or rupture identified by the baseline imaging algorithm. * Ability to undergo annual ultrasound and confirmatory MRI when indicated. * Written informed consent. Exclusion Criteria: * Confirmed fissure or rupture at cohort entry. * Reconstructive breast implantation or tissue expander. * Immediate planned implant removal or exchange. * Missing core implant characteristics. * MRI contraindication when MRI is required to adjudicate a suspected event. * Recalled/PIP implant if excluded by the final analytic plan.
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What it tests

  • Breast Implant Exposure
  • Structured Implant Shell Imaging
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Where

1 site
IQ interquirofanos
Medellín, Colombia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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