Breast Implant ComplicationNCT07810257
Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Shell Fissure
An observational study of Breast Implant Complication and Breast Implant Shell Defect, run by Research Inc at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Implant Complication, Breast Implant Shell Defect
- What is being tested?
- Breast Implant Exposure and Structured Implant Shell Imaging
- Type of treatment
- Medical device
- 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 with aesthetic breast implants that are intact and without a documented shell fissure at baseline.
Who may be able to join
- 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.
Who cannot join
- 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.
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 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.
Read the 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.
- Being tested
- Breast Implant Exposure, Structured Implant Shell Imaging
- Keywords
- Breast Implant Fissure, Shell Integrity, Implant Age, Pocket Plane, Incision, Volume
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Implant Shell Integrity Surveillance Cohort | Women with no baseline shell defect are followed prospectively. Implant and surgical characteristics are modeled as exposures. Receives: Device: Breast Implant Exposure; Diagnostic Test: Structured Implant Shell Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From cohort entry through years of prospective follow-up. 10 years
Secondary outcomes (1)
Fissure-Free Survival by Implant Age
Probability of remaining free of confirmed fissure at prespecified implant ages using delayed-entry survival methods.
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 (2)Papers the sponsor has linked to this study.
- Other trials for Breast Implant ComplicationStudies 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
- NCT07810257
- Sponsor's protocol ID
- 022
- 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
- Individual data sharing
- No: not considered in the patient informed consent
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.
PubMed 39054844Hadad 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.
PubMed 30616906
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 Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Shell Fissure
- ClinicalTrials.gov ID
- NCT07810257
- Acronym / sponsor ID
- 022
- Keywords
- Breast Implant Fissure, Shell Integrity, Implant Age, Pocket Plane, Incision, Volume
- 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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implant Shell Integrity Surveillance Cohort | – | Device: Breast Implant Exposure, Diagnostic Test: Structured Implant Shell ImagingWomen with no baseline shell defect are followed prospectively. Implant and surgical characteristics are modeled as exposures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women with aesthetic breast implants that are intact and without a documented shell fissure at baseline.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Breast Implant ExposureRecorded 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. | Device | Implant Shell Integrity Surveillance Cohort |
| Structured Implant Shell ImagingAnnual 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. | Diagnostic test | Implant Shell Integrity Surveillance Cohort |
Primary outcome
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.
1 secondary outcome
Fissure-Free Survival by Implant Age
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 39054844Glener 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.
- Background: PubMed 30616906Hadad 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.
- Individual participant dataSharing planned: No. not considered in the patient informed consent
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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 Complication and Breast Implant Shell Defect, 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 5 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 First Confirmed Breast Implant Shell Fissure (time frame: From cohort entry through years of prospective follow-up. 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 NCT07810257, which also lists 2 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.