Predictors of Breast Implant Rupture in Women with Aesthetic Silicone 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 cohort observes women with intact aesthetic silicone breast implants for up to five years, collecting data on implant age, pocket plane, incision route, surface texture, and volume. Annual high-resolution ultrasound screens for rupture, with MRI or surgery confirmation when rupture is suspected. Survival analysis will estimate rupture-free duration and how patient- and device-related factors relate to rupture risk, using baseline and time-updated variables. Eligibility requires confirmed intact implants at enrollment and commitment to five years of follow-up.

Why it matters

Who can join: the full rules

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.

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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Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.