Breast implants: predicting displacement and rotation after cosmetic augmentation
Official title: Prospective Two-Year Cohort Study of Surgical and Implant Predictors of Breast Implant Displacement and Rotation After Aesthetic Augmentation
Run by Research Inc · NCT07810270 · Data updated 2026-11-12
This study follows women who receive cosmetic breast implants to see when and why the implants move or rotate over time.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 3000 (estimated) |
| Sponsor | Research Inc Industry-sponsored |
| Locations | 1 site (Medellín) |
| Status | Recruiting |
| Started | January 12, 2014 |
| Main results expected | January 1, 2026 |
| Study ends | December 15, 2026 |
| Registry record updated | September 9, 2026 |
| Trial ID | NCT07810270 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 and older undergoing primary or revision aesthetic breast implantation with permanent implants and complete surgical documentation.
✕Probably not a fit
Patients with reconstructive implants after mastectomy or those with missing operative data may not benefit from the study findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective inception cohort tracks women undergoing primary or revision aesthetic breast implantation for ten years, collecting detailed pocket and implant characteristics and standardized clinical and photographic assessments. The primary outcome is time to clinically significant implant malposition or rotation, with analyses exploring early predictors and patient-reported outcomes. Time-to-event and mixed-effects models will account for bilateral implants and track position from post-op month 1 as the reference point after swelling resolves. The study records variables such as pocket plane, incision route, implant texture, shape, volume, and operative details to identify factors associated with displacement and rotation.
Why it matters
Potential benefit: If successful, the findings could help surgeons anticipate which patients are at higher risk for implant malposition or rotation and tailor techniques to reduce this risk.
How similar studies have gone: Prior research in related implant performance has shown associations between surgical technique and implant positioning, though this exact long-term, set-theory approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
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
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.