Prospective Two-Year Cohort Study of Surgical and Implant Predictors of Breast Implant Displacement and Rotation After Aesthetic Augmentation
September 2, 2026 updated by: Research Inc
This prospective inception cohort will follow women for ten years after primary or revision aesthetic breast implantation.
Pocket plane, incision route, implant texture, shape, volume, and operative pocket variables will be recorded.
Standardized clinical and photographic assessments will identify displacement and rotation.
The primary outcome is time to clinically significant implant malposition or rotation; direction, reoperation, patient-reported outcomes, and early postoperative predictors will also be analyzed.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
Participants will be enrolled before aesthetic breast implantation.
A standardized preoperative anatomic assessment and detailed operative record will establish implant and pocket characteristics.
Postoperative month 1 will serve as the reference position after early swelling decreases, and assessments will be repeated through years.
A locked landmark-based definition will distinguish clinically significant inferior, superior, medial, and lateral displacement and rotation.
Time-to-event and mixed-effects models will evaluate implant, surgical, and patient predictors while accounting for bilateral implants.
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 undergoing primary or revision aesthetic breast implantation with complete operative and device documentation.
Description
Inclusion Criteria:
- Female sex and age 18 years or older.
- Primary or revision aesthetic breast implantation with a permanent implant.
- Complete documentation of pocket plane, incision route, texture, shape, volume, laterality, and operative pocket measurements.
- Standardized early postoperative baseline photography and clinical position assessment.
- Ability to complete follow-up through 24 months.
- Written informed consent.
Exclusion Criteria:
- Reconstructive implantation after mastectomy or major trauma.
- Tissue expander.
- Immediate major postoperative complication requiring implant removal before the position baseline can be established; these cases remain in safety reporting but not the position-risk cohort.
- Missing operative or device variables.
- Inability to obtain standardized photographs or position measurements.
- Planned pregnancy during the first 12 months if the final protocol elects to exclude it.
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 |
|---|---|
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Aesthetic Implant Position Cohort
Women are enrolled at implantation and followed prospectively.
Implant characteristics and operative technique are exposures rather than assigned groups.
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Primary or revision aesthetic implantation is performed according to independent clinical care.
The study records incision route, pocket plane, pocket dimensions, implant texture, shape, volume, fixation or internal support, mastopexy, and postoperative support.
Linked arm/group(s): Aesthetic Implant Position Cohort.
Bilateral photographs, surface landmark measurements, clinical examination, and ultrasound when indicated will assess implant center, inframammary fold relationship, medial/lateral displacement, vertical position, and orientation.
Rotation assessment is prespecified for shaped implants.
Linked arm/group(s): Aesthetic Implant Position Cohort.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to Clinically Significant Implant Displacement or Rotation
Time Frame: 10 years
|
Time from implantation to the first confirmed inferior, superior, medial, or lateral malposition or clinically significant rotation that is visible, symptomatic, requires treatment, or meets the locked landmark-based threshold.
Rotation is evaluated only for shaped implants unless a validated orientation marker is available.
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence by Direction and Type of Malposition
Time Frame: 10 years
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Proportion of implants with inferior, superior, medial, lateral, or rotational malposition, reported separately and per 100 implant-years.
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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
- Kretsis V, Loizou CE, Kretsis K. Evaluation of a Technique to Minimize Complications in Breast Augmentation Surgery with Anatomical Implants: A Single Surgeon's, 10-Year Experience. Aesthetic Plast Surg. 2026 Jan;50(2):657-666. doi: 10.1007/s00266-025-05094-2. Epub 2025 Aug 11.
- Elmorsi R, Babu A, Shay PL, Barrera JE, Olenczak JBE, Clemens MW, Largo RD, Mericli AF. The Tipping Point: Predictors of Implant Flipping in Staged Breast Reconstruction. Plast Reconstr Surg. 2026 Feb 6. doi: 10.1097/PRS.0000000000012882. Online ahead of print.
- Kuruoglu D, Harless CA, Tran NV, Yan M, Martinez-Jorge J, Nguyen MT. Implant Malposition in Prepectoral Breast Reconstruction: Experience with Natrelle(R) Cohesive Implants over 6.5 Years. J Plast Reconstr Aesthet Surg. 2022 Aug;75(8):2561-2568. doi: 10.1016/j.bjps.2022.02.072. Epub 2022 Mar 6.
- Khanna J, Incze T. Breast Implant Malposition: Prevention, Assessment, and Treatment. Clin Plast Surg. 2026 Apr;53(2):307-319. doi: 10.1016/j.cps.2025.11.012. Epub 2025 Dec 5.
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
- 023
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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