Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Clinically Significant Capsular Contracture

NCT07810231 | Recruiting

• 1 other identifier: 021
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Capsular Contracture of Breast Implant

Keywords

Capsular Contracture; Baker Grade; Breast Implant; Pocket Plane; Incision; Surface Texture; Implant Volume; Time-to-Event

Outcome Measures

Primary Outcomes (1)

• Time to Incident Baker Grade III or IV Capsular Contracture

  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 Outcomes (1)

• Capsular Contracture-Free Survival by Implant Age

  Prospective follow-up through 10 years

Study Arms (1)

Breast Implant Capsule Surveillance Cohort

Women with Baker grade I or II implants are followed prospectively. Implant and operative characteristics are modeled as exposures.

Device: Breast Implant Exposure; Diagnostic Test: Standardized Capsular Contracture Assessment

Interventions

Breast Implant Exposure DEVICE

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.

Breast Implant Capsule Surveillance Cohort

Standardized Capsular Contracture Assessment DIAGNOSTIC_TEST

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.

Breast Implant Capsule Surveillance Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult women with aesthetic breast implants and no clinically significant capsular contracture at cohort entry.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Inc: lead

Study Sites (1)

IQ interquirofanos

Medellín, Colombia

RECRUITING

Related Publications (5)

• 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.

  PMID: 29980456 BACKGROUND

• 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.

  PMID: 29595715 BACKGROUND

• 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.

  PMID: 39244792 BACKGROUND

• 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.

  PMID: 24056498 BACKGROUND

• 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.

  PMID: 25680100 BACKGROUND

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• juan velez, MD, plastic surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Velez, MD, Plastic surgeon

CONTACT

+57 3054511588; info@velezlara.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 9, 2026
• Study Start: January 12, 2014
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)