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

Recruitingn/aAges 18 Years - anyAllResearch Inc
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Silicone Breast Implant Exposure
  • Prospective Breast Implant Surveillance Imaging
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Where

1 site
IQ interquirofanos
Medellรญn, Colombia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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