Thirteen-Year Trends in Aesthetic Breast Implant Surgery

NCT07765953 | Completed

• 1 other identifier: 004
• Study Type: observational
• Target: 22,642
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  At the definitive breast implant removal surgical event; reported separately for calendar years 2012 through 2024. Yearly

Study Arms (1)

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.

Procedure: Primary Aesthetic Breast Augmentation; Procedure: Breast Implant Replacement; Procedure: Definitive Breast Implant Removal

Interventions

Primary Aesthetic Breast Augmentation PROCEDURE

Placement of breast implants for aesthetic augmentation as part of routine clinical care. The procedure was not assigned by the investigators.

Aesthetic Breast Implant Placement

Breast Implant Replacement PROCEDURE

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.

Aesthetic Breast Implant Placement

Definitive Breast Implant Removal PROCEDURE

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.

Aesthetic Breast Implant Placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Inc: lead

Study Sites (1)

IQ interquirofanos

Medellín, Antioquia, 050022, Colombia

Location

Related Publications (5)

• 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.

  PMID: 36205992 BACKGROUND

• Ramalho 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.

  PMID: 40565910 BACKGROUND

• Zhang 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.

  PMID: 37204467 BACKGROUND

• Chen 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.

  PMID: 40670655 BACKGROUND

• Calobrace 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.

  PMID: 37563756 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Aerospace medicine, MSc, PhD(c)

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 14, 2026
• Study Start: January 1, 2012
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)