An observational study in Aesthetic Breast Surgery and Breast Implants, sponsored by Research Inc. Completed at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Research Inc · Observational
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.
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.
Research Inc is the lead sponsor of 24 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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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.
Exclusion Criteria
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.
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.
Procedure: Primary Aesthetic Breast Augmentation · Procedure: Breast Implant Replacement · Procedure: Definitive Breast Implant Removal
Placement of breast implants for aesthetic augmentation as part of routine clinical care. The procedure was not assigned by the investigators.
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.
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.
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.
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
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.
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
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.
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
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.
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
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.
Time frame: At the definitive breast implant removal surgical event; reported separately for calendar years 2012 through 2024. Yearly
Plan to share: No
Ran from Jan 2012 to primary completion in Dec 2024, 155 months.
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