Aesthetic Breast SurgeryNCT07765953
Thirteen-Year Trends in Aesthetic Breast Implant Surgery
An observational study of Aesthetic Breast Surgery and Breast Implants, run by Research Inc at 1 site in Colombia.
Trial summary
This prospective observational cohort study evaluated temporal trends in primary aesthetic breast augmentation, breast implant replacement, and definitive breast implant removal at IQ Interquirofanos in Medellín, Colombia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aesthetic Breast Surgery, Breast Implants
- What is being tested?
- Primary Aesthetic Breast Augmentation, Breast Implant Replacement and Definitive Breast Implant Removal
- Type of treatment
- Surgery or procedure
- How many people
- 22,642 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jan 2012to 31 Dec 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 participants undergoing primary aesthetic breast implant placement, breast implant replacement, or definitive breast implant removal at IQ Interquirofanos in Medellín, Colombia, between January 1, 2012, and December 31, 2024. Each participant contributed one unique surgical event.
Who may be able to join
- Participants aged 18 years or older. Participants undergoing primary aesthetic breast implant placement, breast implant replacement, or definitive breast implant removal.
- Procedure performed at IQ Interquirofanos. Complete clinical and surgical records for the eligible procedure. Documented postoperative follow-up in the institutional record.
Who cannot join
- Breast surgery performed for reconstructive indications, including postmastectomy reconstruction, congenital deformity, or trauma.
- Mixed reconstructive and aesthetic indications. Missing core clinical or surgical variables. Absence of documented postoperative follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thirteen-Year Trends in Primary Aesthetic Breast Augmentation, Implant Replacement, and Explantation: A Prospective Observational Cohort Study
This prospective observational cohort study evaluated temporal trends in primary aesthetic breast augmentation, breast implant replacement, and definitive breast implant removal at IQ Interquirofanos in Medellín, Colombia. Clinical and surgical information was prospectively collected at the time of surgery in an institutional registry from January 1, 2012, through December 31, 2024.
The cohort included 22,642 unique adult participants, each of whom contributed one eligible surgical event and was classified into one of three mutually exclusive groups: primary implant placement, implant replacement, or implant removal. The primary outcome was the annual and overall distribution of these procedure categories. Secondary outcomes included breast implant volume, duration of prior implant use, indications for replacement and removal, and the relationships between participant age, implant volume, and implant duration.
Surgical procedures were selected as part of routine clinical care and were not assigned by the investigators for research purposes.
Read the detailed description
An institutional prospective observational registry was established at IQ Interquirofanos to collect standardized clinical and surgical information and evaluate temporal trends in aesthetic breast surgery. Data included in this analysis were prospectively recorded at the time of surgery between January 1, 2012, and December 31, 2024.
The analytical cohort consisted of 22,642 unique adult participants. No participant contributed more than one surgical event. Each participant was assigned to one of three mutually exclusive procedural groups: primary aesthetic breast implant placement, breast implant replacement, or definitive breast implant removal without replacement.
Data collected included age, sex, calendar year of surgery, procedure category, right- and left-sided breast implant volumes, duration of prior implant use, and the primary recorded indication for implant replacement or removal. For replacement procedures, both prior and newly placed implant volumes were evaluated. For removal procedures, prior implant volumes were recorded.
When implant duration coexisted with another clinical or aesthetic indication for secondary surgery, the specific clinical or aesthetic indication was prioritized. "Time with implants" was recorded as the primary indication only when another specific indication was not present.
The primary outcome was the annual number and proportion of primary implant placements, implant replacements, and implant removals. Secondary outcomes included implant volumes by calendar year and procedural group, duration of prior implant use, indications for replacement and removal, and associations between age, implant volume, and implant duration.
Continuous variables were summarized using means and standard deviations. Categorical variables were reported using absolute frequencies and percentages. Differences in implant volume across calendar years were evaluated using Welch's one-way analysis of variance. Pearson correlation coefficients, 95% confidence intervals, and p-values were used to evaluate associations between age and new implant volume and between age and implant duration.
Participants without documented postoperative follow-up or with missing core variables were excluded. Postoperative complications and reinterventions occurring outside IQ Interquirofanos were not evaluated as study outcomes and could not be comprehensively ascertained from the institutional registry.
- Conditions
- Aesthetic Breast Surgery, Breast Implants
- Being tested
- Primary Aesthetic Breast Augmentation, Breast Implant Replacement, Definitive Breast Implant Removal
- Keywords
- Breast augmentation, Breast implants, Implant replacement, Breast implant removal, Explantation, Aesthetic breast surgery, Temporal trends, Prospective observational cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Aesthetic Breast AugmentationProcedure or surgery
Placement of breast implants for aesthetic augmentation as part of routine clinical care. The procedure was not assigned by the investigators.
Breast Implant ReplacementProcedure or surgery
Removal of previously placed breast implants followed by placement of new breast implants as part of routine clinical care. The procedure was not assigned by the investigators.
Definitive Breast Implant RemovalProcedure or surgery
Removal of previously placed breast implants without placement of replacement implants. The procedure was selected during routine clinical care and was not assigned by the investigators.
| Study group | Role | What they receive |
|---|---|---|
| Aesthetic Breast Implant Placement | Adult participants undergoing primary aesthetic breast surgery, removal of previously placed breast implants followed by placement of new breast implants or removal without placement of breast implants. Receives: Procedure: Primary Aesthetic Breast Augmentation; Procedure: Breast Implant Replacement; Procedure: Definitive Breast Implant Removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual and Overall Distribution of Aesthetic Breast Implant Procedure Categories
the number and percentage of eligible participants undergoing primary implant placement, implant replacement, or implant removal will be calculated for each calendar year. The numerator is the number of participants in each procedure category, and the denominator is the total number of eligible participants undergoing one of the three procedures during the corresponding calendar year. Overall counts and percentages will also be calculated across the complete observation interval. Each participant contributes one mutually exclusive surgical event.
Measured: yearly, each year the eligible surgical event; reported separately for calendar years 2012, 2013, 2014, 2015, 2016, 2017, 2018, 2019, 2020, 2021, 2022, 2023, and 2024
Secondary outcomes (4)
Right- and Left-Sided Breast Implant Volume by Calendar Year and Procedure Group
Right- and left-sided implant volumes were recorded at the surgical event. New implant volumes were evaluated in the primary-placement and replacement groups. Prior implant volumes were evaluated in the replacement and removal groups. Volumes will be summarized separately by side, implant status, procedure group, and calendar year using means and standard deviations.
Measured: yearly, At the eligible surgical event; reported separately for calendar years 2012, 2013, 2014, 2015, 2016, 2017, 2018, 2019, 2020, 2021, 2022, 2023, and 2024
Duration of Prior Breast Implant Use at Replacement or Removal
Duration of prior breast implant use, defined as the elapsed time from prior implant placement to the replacement or removal surgical event, measured in years and summarized separately for the replacement and removal groups.
Measured: At the breast implant replacement or removal surgical event; eligible events occurring from January 1, 2012, through December 31, 2024. we looked for events yearly, it could be 0 years up to 15 years
Distribution of Recorded Indications for Breast Implant Replacement
The number and percentage of replacement participants in each predefined indication category will be calculated overall and by calendar year. The denominator is the total number of participants undergoing implant replacement during the corresponding reporting period. One primary indication was recorded per participant. When implant duration coexisted with another clinical or aesthetic indication, the other specific indication was prioritized.
Measured: At the breast implant replacement surgical event; reported separately for calendar years 2012 through 2024. Yearly
Distribution of Recorded Indications for Definitive Breast Implant Removal
The number and percentage of removal participants in each predefined indication category will be calculated overall and by calendar year. The denominator is the total number of participants undergoing definitive implant removal during the corresponding reporting period. One primary indication was recorded per participant. When implant duration coexisted with another clinical or aesthetic indication, the other specific indication was prioritized.
Measured: At the definitive breast implant removal surgical event; reported separately for calendar years 2012 through 2024. Yearly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Jan 2012
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Aesthetic Breast SurgeryStudies 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
- 22,642 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Research Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Brian Ramirez, MD, MSc, Research Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765953
- Sponsor's protocol ID
- 004
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lieffering AS, Hommes JE, Ramerman L, Rakhorst HA, Mureau MAM, Verheij RA, van der Hulst RRWJ. Prevalence of Local Postoperative Complications and Breast Implant Illness in Women With Breast Implants. JAMA Netw Open. 2022 Oct 3;5(10):e2236519. doi: 10.1001/jamanetworkopen.2022.36519.
PubMed 36205992Ramalho AAL, Tavares AA, da Silva HN, Navarro RF, da Silva VAVC, Melchior SC, Vicente MG, Fook MVL, Silva SML. Safety and Performance of Postmarketing Breast Implants: An Integrated Review with Technovigilance Data. J Clin Med. 2025 Jun 12;14(12):4164. doi: 10.3390/jcm14124164.
PubMed 40565910Zhang Z, Qi J, Zhang X, Wang J, Li Z, Xin M. What Can We Learn from Breast Implant Explantation: a 28-Year, Multicenter Retrospective Study of 1004 Explantation Cases. Aesthetic Plast Surg. 2023 Oct;47(5):1743-1750. doi: 10.1007/s00266-023-03365-4. Epub 2023 May 18.
PubMed 37204467Chen Z, Sun Y, Weng H, Tong J, Yang J, Wang R, Sun J. A Long-Term Single-Center Study: Motivations and Strategies in Implant Management for Breast Augmentation Revision Surgery. Aesthetic Plast Surg. 2025 Dec;49(23):6543-6552. doi: 10.1007/s00266-025-05049-7. Epub 2025 Jul 16.
PubMed 40670655Calobrace MB, Schwartz MR, Kaufman DL, Gordon AE, Cohen R, Harrington J, Dajles D, Zeidler K. Safety and Efficacy of the Sientra Silicone Gel Round and Shaped Breast Implants: 6-Year Results of the U.S. Postapproval Study. Plast Reconstr Surg. 2024 Jul 1;154(1):44e-56e. doi: 10.1097/PRS.0000000000010953. Epub 2023 Aug 11.
PubMed 37563756
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thirteen-Year Trends in Primary Aesthetic Breast Augmentation, Implant Replacement, and Explantation: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07765953
- Acronym / sponsor ID
- 004
- Conditions
- Aesthetic Breast Surgery, Breast Implants
- Keywords
- Breast augmentation, Breast implants, Implant replacement, Breast implant removal, Explantation, Aesthetic breast surgery, Temporal trends, Prospective observational cohort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22,642 participants (actual)
- Lead sponsor
- Research IncIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 14 Aug 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 observational cohort study evaluated temporal trends in primary aesthetic breast augmentation, breast implant replacement, and definitive breast implant removal at IQ Interquirofanos in Medellín, Colombia. Clinical and surgical information was prospectively collected at the time of surgery in an institutional registry from January 1, 2012, through December 31, 2024.
The cohort included 22,642 unique adult participants, each of whom contributed one eligible surgical event and was classified into one of three mutually exclusive groups: primary implant placement, implant replacement, or implant removal. The primary outcome was the annual and overall distribution of these procedure categories. Secondary outcomes included breast implant volume, duration of prior implant use, indications for replacement and removal, and the relationships between participant age, implant volume, and implant duration.
Surgical procedures were selected as part of routine clinical care and were not assigned by the investigators for research purposes.
Detailed description
An institutional prospective observational registry was established at IQ Interquirofanos to collect standardized clinical and surgical information and evaluate temporal trends in aesthetic breast surgery. Data included in this analysis were prospectively recorded at the time of surgery between January 1, 2012, and December 31, 2024.
The analytical cohort consisted of 22,642 unique adult participants. No participant contributed more than one surgical event. Each participant was assigned to one of three mutually exclusive procedural groups: primary aesthetic breast implant placement, breast implant replacement, or definitive breast implant removal without replacement.
Data collected included age, sex, calendar year of surgery, procedure category, right- and left-sided breast implant volumes, duration of prior implant use, and the primary recorded indication for implant replacement or removal. For replacement procedures, both prior and newly placed implant volumes were evaluated. For removal procedures, prior implant volumes were recorded.
When implant duration coexisted with another clinical or aesthetic indication for secondary surgery, the specific clinical or aesthetic indication was prioritized. "Time with implants" was recorded as the primary indication only when another specific indication was not present.
The primary outcome was the annual number and proportion of primary implant placements, implant replacements, and implant removals. Secondary outcomes included implant volumes by calendar year and procedural group, duration of prior implant use, indications for replacement and removal, and associations between age, implant volume, and implant duration.
Continuous variables were summarized using means and standard deviations. Categorical variables were reported using absolute frequencies and percentages. Differences in implant volume across calendar years were evaluated using Welch's one-way analysis of variance. Pearson correlation coefficients, 95% confidence intervals, and p-values were used to evaluate associations between age and new implant volume and between age and implant duration.
Participants without documented postoperative follow-up or with missing core variables were excluded. Postoperative complications and reinterventions occurring outside IQ Interquirofanos were not evaluated as study outcomes and could not be comprehensively ascertained from the institutional registry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aesthetic Breast Implant Placement | – | Procedure: Primary Aesthetic Breast Augmentation, Procedure: Breast Implant Replacement, Procedure: Definitive Breast Implant RemovalAdult participants undergoing primary aesthetic breast surgery, removal of previously placed breast implants followed by placement of new breast implants or removal without placement of breast implants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants undergoing primary aesthetic breast implant placement, breast implant replacement, or definitive breast implant removal at IQ Interquirofanos in Medellín, Colombia, between January 1, 2012, and December 31, 2024. Each participant contributed one unique surgical event.
Key inclusion criteria (2 listed)
- Participants aged 18 years or older. Participants undergoing primary aesthetic breast implant placement, breast implant replacement, or definitive breast implant removal.
- Procedure performed at IQ Interquirofanos. Complete clinical and surgical records for the eligible procedure. Documented postoperative follow-up in the institutional record.
Key exclusion criteria (2 listed)
- Breast surgery performed for reconstructive indications, including postmastectomy reconstruction, congenital deformity, or trauma.
- Mixed reconstructive and aesthetic indications. Missing core clinical or surgical variables. Absence of documented postoperative follow-up.
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 |
|---|---|---|
| Primary Aesthetic Breast AugmentationPlacement of breast implants for aesthetic augmentation as part of routine clinical care. The procedure was not assigned by the investigators. | Procedure or surgery | Aesthetic Breast Implant Placement |
| Breast Implant ReplacementRemoval of previously placed breast implants followed by placement of new breast implants as part of routine clinical care. The procedure was not assigned by the investigators. | Procedure or surgery | Aesthetic Breast Implant Placement |
| Definitive Breast Implant RemovalRemoval of previously placed breast implants without placement of replacement implants. The procedure was selected during routine clinical care and was not assigned by the investigators. | Procedure or surgery | Aesthetic Breast Implant Placement |
Primary outcome
Annual and Overall Distribution of Aesthetic Breast Implant Procedure Categories
Time frame: yearly, each year the eligible surgical event; reported separately for calendar years 2012, 2013, 2014, 2015, 2016, 2017, 2018, 2019, 2020, 2021, 2022, 2023, and 2024
the number and percentage of eligible participants undergoing primary implant placement, implant replacement, or implant removal will be calculated for each calendar year. The numerator is the number of participants in each procedure category, and the denominator is the total number of eligible participants undergoing one of the three procedures during the corresponding calendar year. Overall counts and percentages will also be calculated across the complete observation interval. Each participant contributes one mutually exclusive surgical event.
4 secondary outcomes
Right- and Left-Sided Breast Implant Volume by Calendar Year and Procedure Group
Time frame: yearly, At the eligible surgical event; reported separately for calendar years 2012, 2013, 2014, 2015, 2016, 2017, 2018, 2019, 2020, 2021, 2022, 2023, and 2024
Duration of Prior Breast Implant Use at Replacement or Removal
Time frame: At the breast implant replacement or removal surgical event; eligible events occurring from January 1, 2012, through December 31, 2024. we looked for events yearly, it could be 0 years up to 15 years
Distribution of Recorded Indications for Breast Implant Replacement
Time frame: At the breast implant replacement surgical event; reported separately for calendar years 2012 through 2024. Yearly
Distribution of Recorded Indications for Definitive Breast Implant Removal
Time frame: At the definitive breast implant removal surgical event; reported separately for calendar years 2012 through 2024. Yearly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Background: PubMed 36205992Lieffering AS, Hommes JE, Ramerman L, Rakhorst HA, Mureau MAM, Verheij RA, van der Hulst RRWJ. Prevalence of Local Postoperative Complications and Breast Implant Illness in Women With Breast Implants. JAMA Netw Open. 2022 Oct 3;5(10):e2236519. doi: 10.1001/jamanetworkopen.2022.36519.
- Background: PubMed 40565910Ramalho AAL, Tavares AA, da Silva HN, Navarro RF, da Silva VAVC, Melchior SC, Vicente MG, Fook MVL, Silva SML. Safety and Performance of Postmarketing Breast Implants: An Integrated Review with Technovigilance Data. J Clin Med. 2025 Jun 12;14(12):4164. doi: 10.3390/jcm14124164.
- Background: PubMed 37204467Zhang Z, Qi J, Zhang X, Wang J, Li Z, Xin M. What Can We Learn from Breast Implant Explantation: a 28-Year, Multicenter Retrospective Study of 1004 Explantation Cases. Aesthetic Plast Surg. 2023 Oct;47(5):1743-1750. doi: 10.1007/s00266-023-03365-4. Epub 2023 May 18.
- Background: PubMed 40670655Chen Z, Sun Y, Weng H, Tong J, Yang J, Wang R, Sun J. A Long-Term Single-Center Study: Motivations and Strategies in Implant Management for Breast Augmentation Revision Surgery. Aesthetic Plast Surg. 2025 Dec;49(23):6543-6552. doi: 10.1007/s00266-025-05049-7. Epub 2025 Jul 16.
- Background: PubMed 37563756Calobrace MB, Schwartz MR, Kaufman DL, Gordon AE, Cohen R, Harrington J, Dajles D, Zeidler K. Safety and Efficacy of the Sientra Silicone Gel Round and Shaped Breast Implants: 6-Year Results of the U.S. Postapproval Study. Plast Reconstr Surg. 2024 Jul 1;154(1):44e-56e. doi: 10.1097/PRS.0000000000010953. Epub 2023 Aug 11.
- Individual participant dataSharing planned: No
Related trials for Aesthetic Breast Surgery
Recruiting
Comparison of the Safety and Aesthetic Outcomes of a Novel Endoscopic-Assisted Breast-Conserving Surgery (SRRSHzb-EABCS) With Those of Conventional Breast-Conserving Surgery
Breast Cancer
Active, not recruiting
Comparing Decision on Aesthetics After Breast Cancer Locoregional Treatment.
Breast Cancer
RecruitingObservational study
Prospective Two-Year Cohort Study of Surgical and Implant Predictors of Breast Implant Displacement and Rotation After Aesthetic Augmentation
Breast Implant Malposition, Breast Implant Rotation
Recruiting
Motiva Implants® Post-Approval Study
Breast Implant
Active, not recruiting
Quality of Life, Aesthetic Result and Health Economy in Breast Reconstruction
Breast Cancer Female, Surgery--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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Aesthetic Breast Surgery and Breast Implants, 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 14 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual and Overall Distribution of Aesthetic Breast Implant Procedure Categories (time frame: yearly, each year the eligible surgical event; reported separately for calendar years 2012, 2013, 2014, 2015, 2016, 2017, 2018, 2019, 2020, 2021, 2022, 2023, and 2024). 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 NCT07765953, which also lists 5 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 14 Aug 2026.