Breast Implant RuptureNCT07810205
Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Rupture
An observational study of Breast Implant Rupture, run by Research Inc at 1 site in Colombia.
Trial summary
This prospective dynamic cohort will follow women with intact aesthetic silicone breast implants to evaluate predictors of rupture. Implant age, pocket plane, incision route, surface texture, and volume will be recorded, and participants will undergo annual clinical and imaging surveillance 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 Rupture
- What is being tested?
- Silicone Breast Implant Exposure and Prospective Breast Implant Surveillance 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 silicone breast implants documented as intact at cohort entry, including new implant recipients and prevalent implant carriers.
Who may be able to join
- Female sex and age 18 years or older.
- Aesthetic breast augmentation with permanent silicone implants.
- Known implantation date or sufficiently precise implantation year, pocket plane, incision route, surface texture, and implant volume.
- Both implants or the analyzed implant documented as intact at baseline by the study imaging algorithm.
- Ability to complete annual surveillance for up to five years.
- Written informed consent.
Who cannot join
- Reconstructive implantation after mastectomy, congenital deformity, or major trauma.
- Tissue expander or nonpermanent device.
- Confirmed rupture at cohort entry for the implant under analysis.
- PIP implant or another recalled device if the final protocol elects to exclude it from etiologic modeling.
- Missing core implant characteristics or implantation date.
- Planned immediate explantation or exchange at enrollment for a reason unrelated to surveillance.
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 3054511588
About this study
This prospective dynamic cohort will follow women with intact aesthetic silicone breast implants to evaluate predictors of rupture. Implant age, pocket plane, incision route, surface texture, and volume will be recorded, and participants will undergo annual clinical and imaging surveillance for up to five years. Confirmed rupture will require MRI or operative evidence. Delayed-entry survival models will estimate the independent association of implant and surgical characteristics with rupture risk.
Read the detailed description
Women with new or existing aesthetic silicone breast implants will enter the cohort only after baseline assessment confirms that the analyzed implant is intact. Implant and operative characteristics will be verified from device cards and operative records whenever possible. Annual high-resolution ultrasound will screen for integrity loss, with MRI or surgery used for confirmation under a standardized algorithm. Implant age will serve as the survival time scale, and prevalent implants will enter at their age on enrollment. The study will estimate rupture-free survival, symptomatic and silent rupture rates, adjusted predictor effects, and management after detection.
- Conditions
- Breast Implant Rupture
- Being tested
- Silicone Breast Implant Exposure, Prospective Breast Implant Surveillance Imaging
- Keywords
- Breast Implants, Implant Rupture, Silicone, Implant Age, Pocket Plane, Incision, Surface Texture, Implant Volume, Survival Analysis
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicone Breast Implant ExposureDevice
Implant-level exposure data include implantation date, laterality, pocket plane, incision route, surface texture, shape, volume, manufacturer/lot when available, primary versus revision placement, and concomitant mastopexy or fat grafting. Linked arm/group(s): Intact Aesthetic Breast Implant Surveillance Cohort.
Prospective Breast Implant Surveillance ImagingDiagnostic test
Baseline and annual high-resolution ultrasound will assess implant integrity. Suspicious or indeterminate findings will undergo MRI according to the locked diagnostic algorithm. Rupture is confirmed by MRI, operative inspection, or both. Linked arm/group(s): Intact Aesthetic Breast Implant Surveillance Cohort.
| Study group | Role | What they receive |
|---|---|---|
| Aesthetic Breast Implant Surveillance Cohort | Women with intact silicone implants at enrollment are followed prospectively. Pocket plane, incision, texture, volume, and implant age are modeled as exposures rather than recruitment groups. Receives: Device: Silicone Breast Implant Exposure; Diagnostic Test: Prospective Breast Implant Surveillance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Confirmed Breast Implant Rupture
Implant-level time from cohort entry to the first MRI- or surgically confirmed full-thickness implant shell rupture. Implant age is used as the survival time scale with delayed entry at age on enrollment. Contralateral implants are accounted for by patient-level clustering.
Measured: From cohort entry through years of prospective follow-up. 10 TO 12 YEARS
Secondary outcomes (1)
Rupture-Free Survival by Implant Age
Kaplan-Meier or model-based probability of remaining free of confirmed rupture at prespecified implant ages, using delayed-entry methods.
Measured: 12 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 RuptureStudies 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
- NCT07810205
- Sponsor's protocol ID
- 020
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not contempled in the patient informed concent
Publications
Hadad E, Sualhi I, Legarda C, Seligman Y, Sorkin A, Dor O, Menashe S, Heller L, Wiser I. Silicone breast implant rupture is more prevalent in the dominant limb side: A retrospective cohort study. J Plast Reconstr Aesthet Surg. 2023 May;80:126-132. doi: 10.1016/j.bjps.2023.02.016. Epub 2023 Feb 20.
PubMed 37011442Paolini G, Firmani G, Briganti F, Macino M, Nigrelli S, Sorotos M, Santanelli di Pompeo F. Assessment of Risk Factors for Rupture in Breast Reconstruction Patients with Macrotextured Breast Implants. Aesthetic Plast Surg. 2023 Apr;47(2):517-530. doi: 10.1007/s00266-022-03118-9. Epub 2022 Oct 13.
PubMed 36229658Hadad 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 30616906Glener 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 39054844
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 Rupture
- ClinicalTrials.gov ID
- NCT07810205
- Acronym / sponsor ID
- 020
- Conditions
- Breast Implant Rupture
- Keywords
- Breast Implants, Implant Rupture, Silicone, Implant Age, Pocket Plane, Incision, Surface Texture, Implant 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 dynamic cohort will follow women with intact aesthetic silicone breast implants to evaluate predictors of rupture. Implant age, pocket plane, incision route, surface texture, and volume will be recorded, and participants will undergo annual clinical and imaging surveillance for up to five years. Confirmed rupture will require MRI or operative evidence. Delayed-entry survival models will estimate the independent association of implant and surgical characteristics with rupture risk.
Detailed description
Women with new or existing aesthetic silicone breast implants will enter the cohort only after baseline assessment confirms that the analyzed implant is intact. Implant and operative characteristics will be verified from device cards and operative records whenever possible. Annual high-resolution ultrasound will screen for integrity loss, with MRI or surgery used for confirmation under a standardized algorithm. Implant age will serve as the survival time scale, and prevalent implants will enter at their age on enrollment. The study will estimate rupture-free survival, symptomatic and silent rupture rates, adjusted predictor effects, and management after detection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aesthetic Breast Implant Surveillance Cohort | – | Device: Silicone Breast Implant Exposure, Diagnostic Test: Prospective Breast Implant Surveillance ImagingWomen with intact silicone implants at enrollment are followed prospectively. Pocket plane, incision, texture, volume, and implant age are modeled as exposures rather than recruitment groups. |
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 silicone breast implants documented as intact at cohort entry, including new implant recipients and prevalent implant carriers.
Key inclusion criteria (6 listed)
- Female sex and age 18 years or older.
- Aesthetic breast augmentation with permanent silicone implants.
- Known implantation date or sufficiently precise implantation year, pocket plane, incision route, surface texture, and implant volume.
- Both implants or the analyzed implant documented as intact at baseline by the study imaging algorithm.
- Ability to complete annual surveillance for up to five years.
Key exclusion criteria (6 listed)
- Reconstructive implantation after mastectomy, congenital deformity, or major trauma.
- Tissue expander or nonpermanent device.
- Confirmed rupture at cohort entry for the implant under analysis.
- PIP implant or another recalled device if the final protocol elects to exclude it from etiologic modeling.
- Missing core implant characteristics or implantation date.
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 |
|---|---|---|
| Silicone Breast Implant ExposureImplant-level exposure data include implantation date, laterality, pocket plane, incision route, surface texture, shape, volume, manufacturer/lot when available, primary versus revision placement, and concomitant mastopexy or fat grafting. Linked arm/group(s): Intact Aesthetic Breast Implant Surveillance Cohort. | Device | Aesthetic Breast Implant Surveillance Cohort |
| Prospective Breast Implant Surveillance ImagingBaseline and annual high-resolution ultrasound will assess implant integrity. Suspicious or indeterminate findings will undergo MRI according to the locked diagnostic algorithm. Rupture is confirmed by MRI, operative inspection, or both. Linked arm/group(s): Intact Aesthetic Breast Implant Surveillance Cohort. | Diagnostic test | Aesthetic Breast Implant Surveillance Cohort |
Primary outcome
Time to First Confirmed Breast Implant Rupture
Time frame: From cohort entry through years of prospective follow-up. 10 TO 12 YEARS
Implant-level time from cohort entry to the first MRI- or surgically confirmed full-thickness implant shell rupture. Implant age is used as the survival time scale with delayed entry at age on enrollment. Contralateral implants are accounted for by patient-level clustering.
1 secondary outcome
Rupture-Free Survival by Implant Age
Time frame: 12 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 37011442Hadad E, Sualhi I, Legarda C, Seligman Y, Sorkin A, Dor O, Menashe S, Heller L, Wiser I. Silicone breast implant rupture is more prevalent in the dominant limb side: A retrospective cohort study. J Plast Reconstr Aesthet Surg. 2023 May;80:126-132. doi: 10.1016/j.bjps.2023.02.016. Epub 2023 Feb 20.
- Background: PubMed 36229658Paolini G, Firmani G, Briganti F, Macino M, Nigrelli S, Sorotos M, Santanelli di Pompeo F. Assessment of Risk Factors for Rupture in Breast Reconstruction Patients with Macrotextured Breast Implants. Aesthetic Plast Surg. 2023 Apr;47(2):517-530. doi: 10.1007/s00266-022-03118-9. Epub 2022 Oct 13.
- 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.
- 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.
- Individual participant dataSharing planned: No. not contempled in the patient informed concent
Related trials for Breast Implant Rupture
RecruitingObservational study
Prospective Observational Clinical Follow-up of Euromi Biosciences Pre-filled Silicone Gel Breast Implants
Breast Implant Rupture, Breast Implant; Complications
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 Rupture, 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 First Confirmed Breast Implant Rupture (time frame: From cohort entry through years of prospective follow-up. 10 TO 12 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 NCT07810205, 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.