Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Shell Fissure
September 2, 2026 updated by: Research Inc
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
A locked radiologic and operative definition will distinguish focal shell fissure from complete rupture, deformation, porosity, and leakage.
Eligible women will enter only after baseline imaging shows no shell defect.
Annual ultrasound and confirmatory MRI will prospectively identify incident events, which will undergo central blinded review and surgical confirmation when available.
Delayed-entry time-to-event models will evaluate implant and surgical predictors and will account for bilateral implants and competing removal.
A multi-state analysis will explore progression from intact implant to fissure and rupture if the event count is adequate.
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: +57 321 8119802
- 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 that are intact and without a documented shell fissure at baseline.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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 |
|---|---|
|
Implant Shell Integrity Surveillance Cohort
Women with no baseline shell defect are followed prospectively.
Implant and surgical characteristics are modeled as exposures.
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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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to First Confirmed Breast Implant Shell Fissure
Time Frame: From cohort entry through years of prospective follow-up. 10 years
|
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.
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From cohort entry through years of prospective follow-up. 10 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fissure-Free Survival by Implant Age
Time Frame: 10 years
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Probability of remaining free of confirmed fissure at prespecified implant ages using delayed-entry survival methods.
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10 years
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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
- 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.
- 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.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 022 (ITCC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
not considered 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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