Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Clinically Significant Capsular Contracture
September 2, 2026 updated by: Research Inc
This prospective breast implant surveillance cohort will evaluate whether implant age, pocket plane, incision route, surface texture, and volume predict clinically significant capsular contracture.
Women with Baker grade I or II aesthetic implants at enrollment will undergo standardized annual assessments for up to five years.
The primary outcome is time to incident Baker grade III or IV contracture.
Progression, pain, imaging, treatment, and patient-reported outcomes will also be described.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Women with aesthetic breast implants and no clinically significant contracture at cohort entry will be enrolled into a dynamic surveillance cohort.
Operative and device information will be verified from records.
Trained assessors will apply a locked Baker grading protocol annually, supported by photographs, symptom assessment, and imaging.
Suspected incident Baker III/IV contracture will undergo independent confirmation and operative verification when available.
Delayed-entry survival models will estimate the independent effects of implant age, plane, incision, texture, and volume while accounting for bilateral implants and competing implant removal.
Study Type
Observational
Enrollment (Estimated)
3000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Juan Velez, MD, Plastic surgeon
- Phone Number: +57 3054511588
- Email: info@velezlara.com
Study Locations
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-
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Medellín, Colombia
- Recruiting
- IQ interquirofanos
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Contact:
- juan Velez, MD, Plastic surgeon
- Phone Number: +573054511588
- Email: direccion.medica@iqinterquirofanos.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult women with aesthetic breast implants and no clinically significant capsular contracture at cohort entry.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Breast Implant Capsule Surveillance Cohort
Women with Baker grade I or II implants are followed prospectively.
Implant and operative characteristics are modeled as exposures.
|
Implant-level data include age, laterality, material, surface texture, shape, volume, pocket plane, incision route, primary or revision placement, manufacturer/lot when available, and concomitant mastopexy or fat grafting.
Linked arm/group(s): Breast Implant Capsule Surveillance Cohort.
Two trained assessors will apply a standardized Baker grading protocol, with breast firmness, distortion, pain, and imaging recorded.
Suspected grade III/IV events will undergo central review or operative confirmation when surgery occurs.
Linked arm/group(s): Breast Implant Capsule Surveillance Cohort.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to Incident Baker Grade III or IV Capsular Contracture
Time Frame: From cohort entry through years of prospective follow-up. 10 years
|
Implant-level time from cohort entry to the first confirmed clinically significant contracture.
Grade III is visible distortion/firmness and grade IV includes pain under the locked examination manual.
Bilateral implants will be clustered by participant.
|
From cohort entry through years of prospective follow-up. 10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Capsular Contracture-Free Survival by Implant Age
Time Frame: Prospective follow-up through 10 years
|
Probability of remaining free of Baker grade III/IV contracture at prespecified implant ages, estimated with delayed-entry survival methods when prevalent implants are included.
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Prospective follow-up through 10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: juan velez, MD, plastic surgery
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bachour Y, Bargon CA, de Blok CJM, Ket JCF, Ritt MJPF, Niessen FB. Risk factors for developing capsular contracture in women after breast implant surgery: A systematic review of the literature. J Plast Reconstr Aesthet Surg. 2018 Sep;71(9):e29-e48. doi: 10.1016/j.bjps.2018.05.022. Epub 2018 Jun 9.
- Calobrace MB, Stevens WG, Capizzi PJ, Cohen R, Godinez T, Beckstrand M. Risk Factor Analysis for Capsular Contracture: A 10-Year Sientra Study Using Round, Smooth, and Textured Implants for Breast Augmentation. Plast Reconstr Surg. 2018 Apr;141(4S Sientra Shaped and Round Cohesive Gel Implants):20S-28S. doi: 10.1097/PRS.0000000000004351.
- Christodoulou N, Secanho M, Kokosis G, Malgor RD, Winocour J, Yu JW, Mathes DW, Kaoutzanis C. Capsular contracture in breast reconstruction: A systematic review and meta-analysis. J Plast Reconstr Aesthet Surg. 2024 Nov;98:131-143. doi: 10.1016/j.bjps.2024.08.057. Epub 2024 Aug 17.
- Stevens WG, Nahabedian MY, Calobrace MB, Harrington JL, Capizzi PJ, Cohen R, d'Incelli RC, Beckstrand M. Risk factor analysis for capsular contracture: a 5-year Sientra study analysis using round, smooth, and textured implants for breast augmentation. Plast Reconstr Surg. 2013 Nov;132(5):1115-1123. doi: 10.1097/01.prs.0000435317.76381.68.
- Liu X, Zhou L, Pan F, Gao Y, Yuan X, Fan D. Comparison of the postoperative incidence rate of capsular contracture among different breast implants: a cumulative meta-analysis. PLoS One. 2015 Feb 13;10(2):e0116071. doi: 10.1371/journal.pone.0116071. eCollection 2015.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 12, 2014
Primary Completion (Actual)
January 1, 2026
Study Completion (Estimated)
December 15, 2026
Study Registration Dates
First Submitted
September 2, 2026
First Submitted That Met QC Criteria
September 2, 2026
First Posted (Actual)
September 9, 2026
Study Record Updates
Last Update Posted (Actual)
September 9, 2026
Last Update Submitted That Met QC Criteria
September 2, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
not contempled in the patient informed consent
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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