Prospective Two-Year Cohort Study of Surgical and Implant Predictors of Breast Implant Displacement and Rotation After Aesthetic Augmentation

NCT07810270 | Recruiting

• 1 other identifier: 023
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Implant Malposition; Breast Implant Rotation

Keywords

Breast Implant Displacement; Malposition; Implant Rotation; Pocket Plane; Incision; Texture; Implant Volume; Aesthetic Augmentation

Outcome Measures

Primary Outcomes (1)

• Time to Clinically Significant Implant Displacement or Rotation

  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 Outcomes (1)

• Incidence by Direction and Type of Malposition

  10 years

Study Arms (1)

Aesthetic Implant Position Cohort

Women are enrolled at implantation and followed prospectively. Implant characteristics and operative technique are exposures rather than assigned groups.

Procedure: Aesthetic Breast Implantation; Diagnostic Test: Standardized Implant Position Assessment

Interventions

Aesthetic Breast Implantation PROCEDURE

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.

Aesthetic Implant Position Cohort

Standardized Implant Position Assessment DIAGNOSTIC_TEST

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.

Aesthetic Implant Position 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 undergoing primary or revision aesthetic breast implantation with complete operative and device documentation.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Inc: lead

Study Sites (1)

IQ interquirofanos

Medellín, Colombia

RECRUITING

Related Publications (4)

• 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.

  PMID: 40790387 BACKGROUND

• 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.

  PMID: 41649883 BACKGROUND

• 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.

  PMID: 35370117 BACKGROUND

• 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.

  PMID: 41826051 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

Locations

CO (1)