NCT07810257

Brief Summary

This prospective implant-surveillance cohort will evaluate predictors of breast implant shell fissure. Women with aesthetic implants without baseline fissure or rupture will undergo annual clinical and imaging assessment for up to five years. Implant age, pocket plane, incision route, surface texture, and volume will be evaluated as predictors. The primary outcome is time to first confirmed focal shell fissure; progression to complete rupture, symptoms, inter-reader agreement, and revision will also be assessed.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Jan 2014Dec 2026

Study Start

First participant enrolled

January 12, 2014

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Expected
Last Updated

September 9, 2026

Status Verified

September 1, 2026

Enrollment Period

12 years

First QC Date

September 2, 2026

Last Update Submit

September 2, 2026

Conditions

Breast Implant ComplicationBreast Implant Shell Defect

Keywords

Breast Implant FissureShell IntegrityImplant AgePocket PlaneIncisionVolume

Outcome Measures

Primary Outcomes (1)

  • Time to First Confirmed Breast Implant Shell Fissure

    Implant-level time from cohort entry to the first focal partial-thickness or noncomplete shell discontinuity meeting the locked MRI, ultrasound, or operative criteria and not meeting the definition of complete rupture.

    From cohort entry through years of prospective follow-up. 10 years

Secondary Outcomes (1)

  • Fissure-Free Survival by Implant Age

    10 years

Study Arms (1)

Implant Shell Integrity Surveillance Cohort

Women with no baseline shell defect are followed prospectively. Implant and surgical characteristics are modeled as exposures.

Device: Breast Implant ExposureDiagnostic Test: Structured Implant Shell Imaging

Interventions

Breast Implant ExposureDEVICE

Recorded characteristics include implant age, material, surface texture, shape, volume, pocket plane, incision route, manufacturer/lot when available, primary or revision placement, and laterality. Linked arm/group(s): Implant Shell Integrity Surveillance Cohort.

Implant Shell Integrity Surveillance Cohort
Structured Implant Shell ImagingDIAGNOSTIC_TEST

Annual high-resolution ultrasound and confirmatory MRI will apply a locked definition of focal shell fissure, complete rupture, deformation, porosity, and silicone leakage. Event images will undergo blinded central review. Linked arm/group(s): Implant Shell Integrity Surveillance Cohort.

Implant Shell Integrity Surveillance Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult women with aesthetic breast implants that are intact and without a documented shell fissure at baseline.

You may qualify if:

  • Female sex and age 18 years or older.
  • Aesthetic breast implant with known implantation date or year and known pocket plane, incision route, surface texture, and volume.
  • No fissure or rupture identified by the baseline imaging algorithm.
  • Ability to undergo annual ultrasound and confirmatory MRI when indicated.
  • Written informed consent.

You may not qualify if:

  • Confirmed fissure or rupture at cohort entry.
  • Reconstructive breast implantation or tissue expander.
  • Immediate planned implant removal or exchange.
  • Missing core implant characteristics.
  • MRI contraindication when MRI is required to adjudicate a suspected event.
  • Recalled/PIP implant if excluded by the final analytic plan.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IQ interquirofanos

Medellín, Colombia

RECRUITING

Related Publications (2)

  • Glener AD, Sergesketter AR, Adams WP Jr. Outcomes of In-Office, High Resolution Ultrasound Silicone Breast Implant Surveillance by Plastic Surgeons. Aesthet Surg J. 2024 Dec 12;45(1):48-55. doi: 10.1093/asj/sjae165.

    PMID: 39054844BACKGROUND

  • Hadad E, Klein D, Seligman Y, Wiser I, Heller L. Sub-muscular plane for augmentation mammoplasty patients increases silicone gel implant rupture rate. J Plast Reconstr Aesthet Surg. 2019 Mar;72(3):419-423. doi: 10.1016/j.bjps.2018.11.009. Epub 2018 Nov 22.

    PMID: 30616906BACKGROUND

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 3054511588info@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

not considered in the patient informed consent

Locations

CO(1)