Abstract

Injectable silicone has been used for body contouring and enhancement, particularly but not exclusively in transgender women. Large-volume silicone injections are often complicated by the development of silicone granulomas that form over months to years, resulting in pain and disfiguration. To our knowledge, no evidence-based guidelines exist for the treatment of silicone granulomas. This systematic review aimed to characterize treatments and associated outcomes for silicone granuloma. The review protocol was registered with PROSPERO (#CRD42021260380) and was reported in accordance with PRISMA guidelines. We searched PubMed/MEDLINE, Cochrane Library, EMBASE, and Web of Science on 6/4/2021 for observational studies or clinical trials published in English reporting treatment outcomes for silicone injected-based cosmetic foreign-body reactions. We included 98 studies (95 case reports/series, 3 cross-sectional), with 239 total patients (28.5% male, 67.4% female, and 4.2% unknown gender). Patients underwent surgical removal (n=148), systemic therapy (41), multiple modalities (37), laser (6), injection (5), and topical treatments (1). Surgical removal led to complete response in 57/148 (39%) and partial response in 87/148 (59%). Outcomes for systemic steroids led to complete response in 4/19 (21%), partial response in 10/19 (53%), and stable disease in 4/19 (21%). Intralesional triamcinolone or 5-fluorouracil injections led to partial response in 3/5 (60%). Multiple modalities, including combinations of systemic, surgical, and injection options, led to complete response in 9/37 (24%) and partial response in 22/37 (59%). Study limitations include nonuniform outcome definitions and lack of patient-reported outcomes. Current treatment strategies based on limited reported data largely resulted in partial response. There is a paucity of high-quality studies on treatment outcomes for silicone granuloma. Future studies should compare treatment efficacies through randomized controlled trials and outcomes should be followed using long-term cohort studies.

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