Natural History of Injectable Permanent Synthetic Filler Disease

NCT07867353 | Recruiting

• 1 other identifier: 026
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

Injectable permanent synthetic filler disease is characterized by heterogeneous local and systemic manifestations that may emerge years after filler injection. Although inflammatory reactions, migration, foreign-body granulomas, adipose tissue injury, fat necrosis, and fibrosis have been individually described, the temporal clinicopathologic evolution of the disease remains poorly characterized. This prospective observational cohort study aims to characterize the natural history of disease associated with injectable permanent synthetic fillers by integrating time since injection, clinical manifestations, magnetic resonance imaging findings, and histopathologic tissue features. Participants with a history of gluteal injection of permanent synthetic fillers who undergo clinical evaluation, magnetic resonance imaging, and clinically indicated surgical removal of affected tissue will be evaluated. Histopathologic findings will be systematically assessed for adipose tissue injury, acute and chronic inflammation, foreign-body granulomatous reaction, fat necrosis, fibrosis, characteristics of the exogenous material, and vascular or lymphatic involvement. The primary objective is to determine how histopathologic disease patterns vary according to time since injection. Secondary objectives include evaluating temporal associations with clinical symptoms, extent of migration on magnetic resonance imaging, fibrosis, granulomatous inflammation, and evidence of superimposed inflammatory reactivation.

Conditions

Complications of Injectable Permanent Synthetic Fillers

Keywords

Injectable permanent synthetic fillers; Biopolymers; Foreign-body granuloma; Chronic inflammation; Iatrogenic allogenosis

Outcome Measures

Primary Outcomes (1)

• Temporal Pattern of Histopathologic Tissue Injury

  Predefined histopathologic features will be assessed according to the time elapsed since filler injection. Features will include adipose tissue injury, acute inflammatory activity, chronic inflammation, foreign-body giant-cell and granulomatous reaction, fat necrosis, and fibrosis. The primary analysis will evaluate the association between disease duration, modeled primarily as a continuous variable, and the distribution and severity of these histopathologic findings.

  At surgical tissue sampling; disease duration measured from filler injection to surgical tissue collection. 1 week

Secondary Outcomes (4)

• Clinical Symptom Burden According to Disease Duration

  1 year

• Foreign-Body Granulomatous Inflammation

  At surgical tissue sampling. 1 week

• Severity and Pattern of Fibrosis

  At surgical tissue sampling. 1 week

• Histopathologic Evidence of Superimposed Inflammatory Reactivation

  At surgical tissue sampling; 1 week

Study Arms (1)

Injectable Permanent Synthetic Filler Disease Cohort

Consecutive participants with a documented history of gluteal injection of permanent synthetic fillers who undergo prospective clinical assessment, magnetic resonance imaging, and clinically indicated surgical removal of affected tissue with subsequent histopathologic evaluation. Participants are not assigned to an intervention by the investigators.

Eligibility Criteria

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

Study Population

The study population consists of consecutive adult patients evaluated at a tertiary referral center for complications associated with prior gluteal injection of permanent synthetic fillers. Participants undergo prospective clinical evaluation and magnetic resonance imaging as part of their clinical assessment and subsequently undergo clinically indicated surgical removal of affected tissue, allowing histopathologic characterization of the disease.

You may qualify if:

• Adults with a documented history of injection of permanent synthetic or modeling substances into the gluteal region.
• Available date or sufficiently reliable estimated date of filler injection to determine disease duration.
• Prospective clinical assessment documenting local and/or systemic manifestations.
• Available magnetic resonance imaging of the affected anatomical region performed as part of clinical evaluation.
• Clinically indicated surgical removal of affected tissue. Histopathologic tissue specimen available and of sufficient quality for standardized review.
• Availability of the core clinical, radiologic, and histopathologic variables required for the primary analysis.
• Written informed consent when required by the approved research protocol.

You may not qualify if:

• Exposure exclusively to temporary or resorbable fillers without evidence of permanent synthetic filler exposure.
• Inability to determine the approximate date of filler injection. Histopathologic specimens insufficient for standardized evaluation. Magnetic resonance imaging unavailable or technically inadequate for assessment of disease distribution.
• Incomplete core clinical data preventing evaluation of the prespecified study outcomes.
• Previous complete surgical removal of the injected material before the index clinical and imaging assessment, when this prevents reconstruction of the untreated disease state.

Sponsors & Collaborators

• Research Inc: lead

Study Sites (1)

Clinica Bioforma

Medellín, Antioquia, Colombia

RECRUITING

Related Publications (4)

• Pachon Suarez JE, Salazar MC, Rizo VZ. Classification for Staging and Managing Patients with Biopolymer-induced Human Adjuvant Disease. Plast Reconstr Surg Glob Open. 2022 Feb 24;10(2):e4137. doi: 10.1097/GOX.0000000000004137. eCollection 2022 Feb.

  PMID: 35233337 BACKGROUND

• Novo RC, Salgado CJ, Yim E, Sinha V, Chim HW, Romanelli P. A staging system for gluteal foreign body reaction to injectables. J Plast Reconstr Aesthet Surg. 2016 Aug;69(8):e174-9. doi: 10.1016/j.bjps.2016.05.007. Epub 2016 Jun 2.

  PMID: 27325516 BACKGROUND

• Kushida-Contreras BH, Gomez-Calva B, Gaxiola-Garcia MA. Cosmetic Injection of Illicit Foreign Materials: Imaging Features and Patterns of Migration in 413 Cases. Aesthet Surg J. 2024 Jan 16;44(2):183-191. doi: 10.1093/asj/sjad336.

  PMID: 37863473 BACKGROUND

• Osorio E, Ramirez B, Herrera O, Suarez C, Ciro C, Varela A. Three-flap Technique: Comprehensive Approach for Biopolymer Removal in the Gluteal and Lumbar Regions. Plast Reconstr Surg Glob Open. 2026 Jul 23;14(7):e7870. doi: 10.1097/GOX.0000000000007870. eCollection 2026 Jul.

  PMID: 42495057 BACKGROUND

MeSH Terms

Conditions

Granuloma, Foreign-Body

Condition Hierarchy (Ancestors)

Granuloma; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Foreign-Body Reaction; Foreign Bodies; Wounds and Injuries

Central Study Contacts

Edison Osorio, MD, Plastic surgeon

CONTACT

+573226140611; info@edisonosorio.com

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: October 5, 2026
• First Posted: October 9, 2026
• Study Start: January 22, 2020
• Primary Completion: October 2, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)