Predictors of capsular contracture after breast implants
Official title: Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Clinically Significant Capsular Contracture
Run by Research Inc · NCT07810231 · Data updated 2026-11-12
This study watches women with cosmetic breast implants to see if factors like implant age, placement plane, incision, surface, and size can predict when painful, hardening scar tissue develops.
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 | NCT07810231 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women 18 years or older with aesthetically implanted silicone or saline breast implants, Baker grade I or II in the analyzed breast at enrollment, and complete implant/device data.
✕Probably not a fit
Individuals with Baker III/IV contracture at enrollment, reconstructive implants, tissue expanders, or incomplete device 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, observational cohort follows women with aesthetic breast implants who have Baker grade I or II implants at enrollment for up to five years. Trained assessors apply a standardized Baker grading protocol annually, with photographs, symptoms, and imaging to monitor for progression to Baker grade III or IV contracture. The study uses delayed-entry survival analysis to estimate how implant age, pocket plane, incision route, surface texture, and volume relate to the risk of clinically significant capsular contracture, while accounting for bilateral implants and potential implant removal. Independent confirmation and operative verification will be sought for suspected Baker III/IV cases. Device information will be verified from records to support accurate exposure assessment.
Why it matters
Potential benefit: If successful, the findings could help clinicians and patients understand which implant factors are linked to higher risk of capsular contracture.
How similar studies have gone: Previous observational work in breast implant surveillance has identified risk factors for capsular contracture, but this study prospectively links multiple device and surgical factors in a single cohort.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female sex and age 18 years or older. * Aesthetic breast augmentation with permanent silicone or saline implants under the final protocol. * Baker grade I or II in the analyzed breast at cohort entry, confirmed by standardized examination. * Known implantation date or year and known pocket plane, incision route, surface texture, and volume. * Ability to complete annual clinical assessment for up to five years. * Written informed consent. Exclusion Criteria: * Baker grade III or IV contracture at cohort entry in the analyzed breast. * Reconstructive implantation after mastectomy or major trauma. * Tissue expander. * Active breast infection or open wound at enrollment. * Planned immediate implant exchange or explantation. * Missing core implant or operative data.
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.