This prospective biospecimen cohort will collect and analyze tissue from adults undergoing clinically indicated surgery for gluteal permanent synthetic filler disease. Two blinded pathologists will score foreign material burden, inflammation, fibrosis, necrosis, vascular and lymphatic injury, and deep-tissue involvement. Histopathologic severity will be compared across clinical-radiologic stages and time since injection. The study will propose a cross-sectional disease-evolution framework and assess the reproducibility of the scoring system.
Prior gluteal injection of a permanent or unknown nonresorbable filler.
Clinically indicated biopsy or surgical excision yielding tissue suitable for histopathologic evaluation.
Available history of approximate injection date and standardized preoperative clinical staging.
Written consent for tissue analysis and optional future use of deidentified specimens.
Specimen composed only of scar or skin without tissue from the filler-affected region.
Insufficient tissue quality for routine histology.
Acute bacterial infection that precludes distinction of the underlying chronic tissue response unless infection is itself a prespecified advanced-stage feature.
Prior oncologic radiation to the sampled gluteal region.
Adults undergoing biopsy or surgical removal of gluteal tissue affected by permanent synthetic filler, spanning early exposure through advanced disease with ulceration or necrosis.
Cohort
Prospective
Standardized Tissue Sampling During Clinically Indicated Surgery
Procedure/SurgerySamples will be obtained from predefined superficial, interface, deep, and visibly abnormal regions without extending the clinically indicated excision. Each sample will be oriented and linked to an MRI/operative map. Linked arm/group(s): Prospective Histopathology Cohort.
Blinded Histopathologic Scoring
Other interventionTwo pathologists will independently grade foreign material burden, granulomatous inflammation, fibrosis, fat necrosis, vascular injury, lymphatic involvement, muscle injury, and skin necrosis on 0-to-3 ordinal scales. The proposed composite ranges from 0 to 24; the manual will be locked before the first analytic read. Linked arm/group(s): Prospective Histopathology Cohort.
Composite Histopathologic Severity Score by Clinical-Radiologic Stage
Sum of eight prespecified 0-to-3 domain scores: foreign material burden, granulomatous inflammation, fibrosis, fat necrosis, vascular injury, lymphatic involvement, muscle injury, and skin necrosis. Total score ranges from 0 to 24; higher scores indicate more severe tissue injury.
Prevalence of Individual Histopathologic Features
Proportion of participants with each prespecified feature and distribution of each 0-to-3 domain grade.
Histopathologic Phenotype Classification
Data-driven clusters or latent classes based on the eight domains, integrated with clinical and MRI stage to generate a proposed disease-evolution framework.
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