Predictors of Breast Implant Shell Fissure in Aesthetic Implants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, observational cohort tracks women with cosmetic breast implants who have no shell fissure at baseline. Participants undergo annual clinical exams and imaging (ultrasound and MRI as needed) for up to five years to identify incident shell fissures and track progression to rupture. The study examines implant age, pocket plane, incision route, surface texture, and volume as potential predictors, using time-to-event analyses and central blinded reviews. Bilateral implants and competing risks are accounted for, with a multi-state model to explore progression from intact to fissure and rupture if data allow. A predefined radiologic and operative definition distinguishes focal fissures from other implant defects.

Why it matters

Who can join: the full rules

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.

Where it's running

• IQ interquirofanos
  Medellín, Colombia Recruiting

Study contacts

• Principal investigator: juan velez, MD, plastic surgery
• Study coordinator: Juan Velez, MD, Plastic surgeon
• Email: info@velezlara.com
• Phone: +57 3054511588

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.