Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Rupture

NCT07810205 | Recruiting

• 1 other identifier: 020
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breast Implant Rupture

Keywords

Breast Implants; Implant Rupture; Silicone; Implant Age; Pocket Plane; Incision; Surface Texture; Implant Volume; Survival Analysis

Outcome Measures

Primary Outcomes (1)

• 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.

  From cohort entry through years of prospective follow-up. 10 TO 12 YEARS

Secondary Outcomes (1)

• Rupture-Free Survival by Implant Age

  12 YEARS

Study Arms (1)

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.

Device: Silicone Breast Implant Exposure; Diagnostic Test: Prospective Breast Implant Surveillance Imaging

Interventions

Silicone Breast Implant Exposure DEVICE

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.

Aesthetic Breast Implant Surveillance Cohort

Prospective Breast Implant Surveillance Imaging DIAGNOSTIC_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.

Aesthetic Breast Implant Surveillance Cohort

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 women with aesthetic silicone breast implants documented as intact at cohort entry, including new implant recipients and prevalent implant carriers.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Inc: lead

Study Sites (1)

IQ interquirofanos

Medellín, Colombia

RECRUITING

Related Publications (4)

• 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.

  PMID: 37011442 BACKGROUND

• Paolini 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.

  PMID: 36229658 BACKGROUND

• Hadad 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.

  PMID: 30616906 BACKGROUND

• 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.

  PMID: 39054844 BACKGROUND

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• juan velez, MD, plastic surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Velez, MD, Plastic surgeon

CONTACT

+57 3054511588; info@velezlara.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 9, 2026
• Study Start: January 12, 2014
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)