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Prospective Two-Year Cohort Study of Surgical and Implant Predictors of Breast Implant Displacement and Rotation After Aesthetic Augmentation

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 inception cohort will follow women for ten years after primary or revision aesthetic breast implantation. Pocket plane, incision route, implant texture, shape, volume, and operative pocket variables will be recorded. Standardized clinical and photographic assessments will identify displacement and rotation. The primary outcome is time to clinically significant implant malposition or rotation; direction, reoperation, patient-reported outcomes, and early postoperative predictors will also be analyzed.

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. * Primary or revision aesthetic breast implantation with a permanent implant. * Complete documentation of pocket plane, incision route, texture, shape, volume, laterality, and operative pocket measurements. * Standardized early postoperative baseline photography and clinical position assessment. * Ability to complete follow-up through 24 months. * Written informed consent. Exclusion Criteria: * Reconstructive implantation after mastectomy or major trauma. * Tissue expander. * Immediate major postoperative complication requiring implant removal before the position baseline can be established; these cases remain in safety reporting but not the position-risk cohort. * Missing operative or device variables. * Inability to obtain standardized photographs or position measurements. * Planned pregnancy during the first 12 months if the final protocol elects to exclude it.
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What it tests

  • Aesthetic Breast Implantation
  • Standardized Implant Position Assessment
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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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