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Illegal Injectable Silicone for Cosmetic Augmentation – Diagnosis and Management

Injectable silicone has had a controversial history for decades, and despite regulations, continues to be used illegally for cosmetic enhancement. Unlike standard FDA-approved fillers such as hyaluronic acid, liquid silicone is permanent, causes severe fibrosis, scarring, and is highly susceptible to migration, which can lead to unpredictable systemic reactions.1 Management regarding complications associated with injectable silicone ranges from conservative (medical) management to surgical (invasive) approaches. The goal of the surgical approach is to perform a subtotal debulking procedure, with the goal of removing as much silicone as possible with an attempt to significantly decrease (and sometimes permanently) eliminate symptoms. In contradistinction, medical management, albeit a more conservative approach, is simply palliative and the goal is to decrease the severity of symptoms.2

If it is used in breast implants, why is illegal liquid silicone dangerous for cosmetic enhancement?

Silicone is one of the most used polymers, specifically polydimethylsiloxane (PDMS). This adjuvant can be beneficial when used appropriately, as demonstrated in breast implants. However, breast implant silicone is safe and is FDA-approved for cosmetic implantation. In fact, the 6th generation cohesive gel implants have a very stable and predictable safety profile. However, injecting liquid silicone poses significant safety risks and is totally unrelated to the safe silicone in breast implants.3 Liquid (illegal) silicone is commonly administered by unqualified personnel in unregulated settings to increase soft tissue volume at a lower cost. These are often unlicensed practitioners, sometimes with clinical background from foreign countries, but sometimes with no formal medical training at all. Since these individuals have no concept of sterile technique and are injecting non-medical grade liquid silicone (sometimes out of a Fiji water bottle!), it shouldn’t be a surprise that bacterial contamination is commonplace.

Complications of Liquid Silicone Injection

Very often, the patient has a low-grade infection trapped within the silicone or has bacterial biofilm on the outside of the silicone droplets. Beyond the infectious risks, additional complications arise when silicone migrates from the original injection site, commonly via lymphatic and subcutaneous migration of silicone in up to 59% of patients.3 For example, in our practice, we have seen liquid silicone migrate from the buttocks into the lymphatics to the perineum, vagina, and rectum, as well as down the thighs, around the knees, and even as far as the ankles. Studies have reported a range of dermatologic complications, including: inflammation (50%), varicose veins (39%), post-inflammatory pigmentation (20%), infection (14%) and abscesses (4%). Other studies have associated liquid silicone with devastating and irreversible kidney injury. Complications from silicone injections can occur almost immediately but can also present decades later. For example, growth of new blood vessels leads to increased vascular permeability, potentially allowing silicone to enter the bloodstream.3 This widespread involvement increases the risk of chronic immune stimulation. In addition, immune system stimulation is common, leading to progressive infiltration and accumulation of silicone within lymphatic channels.3 Furthermore, despite silicone’s prior classification as biologically inert, the material is now recognized as an immune adjuvant supported by the documentation of symptoms 15 years post-inoculation.3 Subsequently, the surgical removal of silicone is deemed the gold standard of treatment.

What are the autoimmune-related complications of illegal liquid silicone injections?

Historically, the common myth was that the human body would have a tissue response to the injectable silicone, classified as a localized foreign body granulomatous reaction (FBG).3 However, recent data on post-silicone injection reflect elevated immune cell infiltration rates in addition to pro-inflammatory cytokines, such as IL-1, IL-12, and TNF-α.3 Hyperactive immune response is detrimental for the human body on a long-term basis.

In 2011, the concept of Autoimmune/Inflammatory Syndrome Induced by Adjuvants, aka ASIA, was introduced by Shoenfeld et al.4 ASIA involves genetic and environmental factors and produces a wide range of manifestations, including 72% of patients reporting subsequent (mental) depression.3 PLEASE SEE OUR BLOG ON ASIA SYNDROME.

Clinical Presentation and Diagnosis

An accurate diagnosis relies on a thorough history, physical examination, and appropriate imaging.1 Many factors influence these outcomes, such as patient naivety regarding the history of prior cosmetic procedures including nonconsensual injection of liquid silicone. We have had multiple patients in our clinic who reported having a history of “BBL” or “fat transfer” but the MRI with contrast demonstrates very clearly that there is silicone, based on the silicone suppression protocol (that we have developed in conjunction with our radiology colleagues).
Complications can vary based on duration from injection to presentation at the clinic, volume of silicone administered, how many sessions of silicone injections performed, and whether the silicone was injected into the subcutaneous plane (or into the intramuscular plane, which is much more dangerous, and has more complications).1 Commonly, patients present with complications associated with injectable silicone including: skin hyperpigmentation (90.9%), skin induration (63.6%), chronic fatigue (63.6%), and ulcers (36.4%).1 Fortunately, preop magnetic resonance imaging is beneficial to evaluate the presence and extent of silicone infiltration and thus guide the management.1

Management Options for the Complications of Liquid Silicone Injections

Initial conservative management is considered for patients with mild symptoms or for non-surgical candidates. A multidisciplinary approach, including plastic surgeons and other specialists involved in the management of complications, is crucial for successful management.1 Pharmacologic therapy may include corticosteroids to reduce symptoms such as inflammation and granulomatous reactions (FBG).2 Additionally, immunomodulatory agents are often included to decrease the severity of immune-mediated symptoms.2 Further, antibiotic therapy may be indicated if a secondary infection is suspected. Although conservative approaches may provide symptomatic relief, the risk of recurrence remains high due to residual silicone.3
Surgical management is considered for patients who have failed conservative therapy or for patients with moderate to severe clinical symptoms. Surgical intervention is considered the gold standard to safely remove the highest amount of silicone possible and to decrease the risk of progression or future relapses.1 Various approaches are utilized, including excision, debridement, liposuction via ultrasound, or reconstruction techniques with skin grafts or flaps.1 We will often perform a two-stage approach with silicone removal in the first stage, and reconstruction in the second stage. It should be noted, however, that 100% complete removal of silicone is difficult due to unpredictable issues that arise from the initial injections, such as diffuse migration.1 For example, in our clinic, we have seen patients with silicone migration into the sciatic foramen with nerve involvement; external compression of the large veins with persistent venous congestion and/or lymphedema; and silicone migration into the perirectal and even fistulas into the vagina. Thus, although invasive management is the gold standard, surgical risks should be considered, including scarring and infection. In contrast to conservative management, surgical management aims to provide subtotal silicone removal with the best chance to address the underlying cause of complications, providing more stable symptom relief and a better functional outcome.1

Why isn’t there more info in the mainstream media about illegal liquid silicone injections? Is there ample literature in the medical research arena?

Lopez-Mendoza et al.1 conducted a retrospective, consecutive case series study in 2021 comparing outcomes of multidisciplinary conservative versus invasive management, both aimed at reducing complications associated with injectable silicone.1 This involved cohort of 11 patients with histories of unregulated polymer injections and associated FBA or ASIA syndrome. An MRI with contrast confirmed the presence of silicone and the extent of infiltration. Diffuse silicone migration was observed in 36.4% of patients, requiring surgical management with ultrasound-assisted liposuction.1 The remaining 63.6% of patients underwent multidisciplinary conservative management with medications and laser treatments.1 All of the conservatively managed patients (63.6%) reported only minimal improvement, and ultimately proceeded with surgical management, described as open en-bloc excision.1 Further, second stage surgical reconstruction was required in 27.2% of cases, due to severe silicone infiltration. In this study, 82.6% of patients demonstrated significant relief of psychological and systemic symptoms.1 Mustin et al.2 published a systematic review in 2023 of 93 studies that compared 227 patient outcomes related to surgery vs conservative management of silicone granulomas (FBG). Respectively, 66.2% of participants underwent surgical management with various surgical approaches to remove silicone. Among these patients (66.2%), 48% reported a complete symptomatic response while 50% reported a partial response.2 In comparison, 10.2% of studied patients underwent conservative management with immunomodulators. Of those patients (10.2%), 20% reported a complete symptomatic response and 60% reported a partial response.2

The Bottom Line on Illegal Silicone Injections

Puerta et al.3 highlighted evidence supporting the link between the presence of foreign material and a higher prevalence of autoimmune / autoinflammatory diseases. The associated complications are unpredictable. Across the literature, the intention of surgical management remains consistent to sustain an improved quality of life. In contrast, conservative management prioritizes temporary symptomatic relief, with a greater potential for recurrence and a less chance of reducing symptoms long term.1 Due to the high failure rate associated with conservative management approaches, patients frequently require subsequent surgical management. According to the literature, surgical management also supported sustained symptomatic relief, psychological improvement, reduced progression of inflammation, and the correction of the causative pathology.1

Future Management Algorithm for Symptomatic Patients with History of Illegal Silicone Injections

Over the past several years, we have successfully treated dozens and dozens of patients with illegal silicone injections. Dr Arthur has developed a comprehensive management algorithm which will be published in late 2026 / early 2027.

The algorithm focuses on classifying types of silicone, the symptoms, and complication severity; this prioritizes the development of standardized, specific diagnostic criteria and thus management options. Clinicians must incorporate patients’ history, operative risk, symptom presentation, and imaging findings to formulate an appropriate management plan In essence, if patients were properly diagnosed and classified into severity categories, it would support standardizing the establishment of evidence-based treatment guidelines for complications related to injectable silicone.

Schedule a Consultation

If you have been noticing changes in your body after silicone injections and are ready to explore your options, we encourage you to schedule a consultation. Surgical silicone removal and reconstruction is highly individualized, and the right approach depends on a careful evaluation of your anatomy, the degree of silicone present, and your personal goals. We take the time to understand what matters most to you and to recommend an approach that aligns with your anatomy and your vision for the results.

To learn more about silicone removal and reconstruction in Miami, contact our office today, schedule a consultation or call 305-403-2922, or email us at concierge@ArthurMD.com.

[1] Lopez-Mendoza J, Vargas-Flores E, Mouneu-Ornelas N, Altamirano-Arcos C. Disease presentation and surgical treatment of patients with foreign-body granulomas and ASIA syndrome: case series. Arch Plast Surg. 2021;48(4):366-372. doi:10.5999/aps.2020.02152

[2] Mustin DE, Barrett DL, Gangal A, White MS, Yeung H. Management of silicone granuloma: A systematic review. JAAD Int. 2023;11:41-42. Published 2023 Jan 21. doi:10.1016/j.jdin.2022.12.006

[3] Puerta Sarmiento GE, Modragón I, Echeverri A, Sua LF, Bonilla-Abadía F, Aguirre-Valencia D. Autoimmune/inflammatory syndrome induced by adjuvants (ASIA), medical treatment of severe systemic compromise: case report. Colomb Med (Cali). 2023;54(1):e5004625. Published 2023 Mar 30. doi:10.25100/cm.v54i1.4625

[4] Cohen Tervaert JW, Martinez-Lavin M, Jara LJ, Halpert G, Watad A, Amital H, Shoenfeld Y. Autoimmune/inflammatory syndrome induced by adjuvants (ASIA) in 2023. Autoimmun Rev. 2023 May;22(5):103287. doi: 10.1016/j.autrev.2023.103287. Epub 2023 Feb 3. PMID: 36738954.

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