Breast Implant MalpositionNCT07810270
Prospective Two-Year Cohort Study of Surgical and Implant Predictors of Breast Implant Displacement and Rotation After Aesthetic Augmentation
An observational study of Breast Implant Malposition and Breast Implant Rotation, run by Research Inc at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Implant Malposition, Breast Implant Rotation
- What is being tested?
- Aesthetic Breast Implantation and Standardized Implant Position Assessment
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 1 siteColombia
- Study dates
- 12 Jan 2014to 15 Dec 2026
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult women undergoing primary or revision aesthetic breast implantation with complete operative and device documentation.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
IQ interquirofanos
Medellín
juan Velez, MD, Plastic surgeon, +57 321 8119802, direccion.medica@iqinterquirofanos.com
About this study
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.
Read the 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.
- Being tested
- Aesthetic Breast Implantation, Standardized Implant Position Assessment
- Keywords
- Breast Implant Displacement, Malposition, Implant Rotation, Pocket Plane, Incision, Texture, Implant Volume, Aesthetic Augmentation
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aesthetic Breast ImplantationProcedure or surgery
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.
Standardized Implant Position AssessmentDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Aesthetic Implant Position Cohort | Women are enrolled at implantation and followed prospectively. Implant characteristics and operative technique are exposures rather than assigned groups. Receives: Procedure: Aesthetic Breast Implantation; Diagnostic Test: Standardized Implant Position Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (1)
Incidence by Direction and Type of Malposition
Proportion of implants with inferior, superior, medial, lateral, or rotational malposition, reported separately and per 100 implant-years.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start12 Jan 2014
- Primary completion1 Jan 2026
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast Implant MalpositionStudies of the same condition, open and under way.
- More trials run by Research IncThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Research Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- juan velez, MD, plastic surgery, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810270
- Sponsor's protocol ID
- 023
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 40790387Elmorsi 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.
PubMed 41649883Kuruoglu 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.
PubMed 35370117Khanna 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.
PubMed 41826051
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Two-Year Cohort Study of Surgical and Implant Predictors of Breast Implant Displacement and Rotation After Aesthetic Augmentation
- ClinicalTrials.gov ID
- NCT07810270
- Acronym / sponsor ID
- 023
- Keywords
- Breast Implant Displacement, Malposition, Implant Rotation, Pocket Plane, Incision, Texture, Implant Volume, Aesthetic Augmentation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Research IncIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2014 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aesthetic Implant Position Cohort | – | Procedure: Aesthetic Breast Implantation, Diagnostic Test: Standardized Implant Position AssessmentWomen are enrolled at implantation and followed prospectively. Implant characteristics and operative technique are exposures rather than assigned groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women undergoing primary or revision aesthetic breast implantation with complete operative and device documentation.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aesthetic Breast ImplantationPrimary 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. | Procedure or surgery | Aesthetic Implant Position Cohort |
| Standardized Implant Position AssessmentBilateral 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. | Diagnostic test | Aesthetic Implant Position Cohort |
Primary outcome
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.
1 secondary outcome
Incidence by Direction and Type of Malposition
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 40790387Kretsis 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.
- Background: PubMed 41649883Elmorsi 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.
- Background: PubMed 35370117Kuruoglu 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.
- Background: PubMed 41826051Khanna 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
juan velez, MD, plastic surgery principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Implant Malposition and Breast Implant Rotation, run by Research Inc at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Velez, MD, Plastic surgeon (+57 3054511588, info@velezlara.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Clinically Significant Implant Displacement or Rotation (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07810270, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.