Liquid silicone injections involve placing liquid silicone oil (dimethylpolysiloxane fluid) directly into the body’s soft tissues for volume enhancement or contouring, often using large volumes in areas like the buttocks, breasts, or hips. Liquid silicone used for cosmetic body contouring is generally considered unsafe and is not approved by major regulatory bodies for this purpose. The material used is often non-medical or industrial-grade silicone, which significantly increases the risk of severe and permanent health consequences. This practice is frequently performed illegally by unlicensed individuals in non-clinical settings, presenting a serious public health danger.
Regulatory Status of Liquid Silicone Injections
The legal standing of injectable liquid silicone for body augmentation in the United States is clear: it is not approved by the Food and Drug Administration (FDA) for this use. The FDA has issued multiple warnings about the serious health risks associated with injecting liquid silicone for body contouring. This unapproved status applies specifically to the injectable liquid form used for soft tissue augmentation.
It is important to differentiate this liquid substance from solid silicone medical devices, such as silicone breast implants. Approved implants are structured devices with a silicone shell that contains the material, preventing it from migrating into surrounding tissues. In contrast, the liquid silicone oil is injected freely into the tissue, allowing it to spread. The only FDA-approved use for injectable silicone oil is for a specific intraocular ophthalmic (inside the eye) procedure.
The majority of liquid silicone injections performed for cosmetic purposes involve unpurified or industrial-grade silicone, which contains impurities and adulterants. These non-medical substances are often sourced illegally and administered in non-sterile environments, compounding the danger. The use of unapproved substances by unlicensed practitioners is a criminal matter due to the significant risk of injury and death.
Acute and Chronic Health Complications
The immediate health risks following liquid silicone injection can be severe and life-threatening due to the body’s reaction to the foreign substance and the possibility of material entering the bloodstream. Acute complications include infection, intense inflammation, and localized pain at the injection site. Inflammation can sometimes lead to tissue necrosis, which is the death of the surrounding tissue.
A particularly dangerous acute complication is vascular embolization, which occurs when liquid silicone enters a blood vessel. Once in the bloodstream, the silicone can travel to the lungs, heart, or brain, causing a blockage. This can result in a pulmonary embolism, stroke, or organ damage, all medical emergencies that can lead to death. Symptoms like difficulty breathing or chest pain require immediate medical attention.
Beyond the immediate dangers, liquid silicone causes significant long-term, or chronic, complications because the substance is permanent and non-biodegradable. A common chronic issue is silicone migration, where the liquid moves from the initial injection site to distant parts of the body. This movement can cause uneven contours and disfigurement far from the intended augmentation.
The body’s long-term immune reaction to the foreign material often leads to the formation of granulomas—hard, painful lumps or nodules of inflamed tissue. These granulomas can cause chronic pain, severe disfigurement, and permanent changes to skin texture and color. These chronic complications may not appear until months or even years after the initial injection, making delayed adverse effects a significant concern.
Managing and Removing Silicone Complications
Treating complications from injectable liquid silicone is a complex and often incomplete process because the substance integrates deeply within the body’s soft tissue. Since silicone is permanent and non-biodegradable, complete removal is usually impossible. The goal of treatment shifts to managing symptoms and reducing the silicone burden, which is often prolonged and results in significant financial and emotional burdens for the patient.
Initial management for inflammation and early-stage complications often involves medical therapies such as anti-inflammatory medications, antibiotics, and systemic or intralesional steroid injections. Steroids are used to reduce the size and pain of granulomas by calming the localized immune response. However, medical management is often only successful for temporary symptom relief and does not address the underlying foreign material.
For more advanced complications, including large granulomas, tissue necrosis, or severe disfigurement, surgical intervention is necessary. This surgery, known as debulking or excisional surgery, involves removing as much of the silicone-infiltrated tissue as possible. Because the silicone is not encapsulated and has spread, these complex procedures often require multiple operations and may not fully restore the area to its pre-injection state.
The surgical removal itself carries risks, including significant scarring, deep contour abnormalities, and the possibility of infection, especially in areas like the buttocks. Surgeons must limit resection to avoid extensive tissue damage. This means some residual silicone often remains, leaving the patient susceptible to recurrent complications over time. The difficulty of removal highlights the permanent and invasive nature of the damage caused by the initial injection.
FDA-Approved Alternatives for Augmentation
For individuals seeking safe and regulated options for soft tissue augmentation, there are several FDA-approved alternatives that provide volume and contour enhancement. Hyaluronic acid (HA) dermal fillers are a popular temporary option, consisting of a substance naturally found in the body that can be dissolved if necessary. These fillers are typically used for smaller areas, such as the face and lips, and provide immediate results lasting from six months to over a year.
Another regulated option is poly-L-lactic acid (PLLA), a biodegradable, bio-stimulatory filler that works differently than HA. PLLA gradually stimulates the body to produce its own collagen over several months, with results lasting up to two years. While FDA-approved for facial concerns, it is also used off-label by licensed professionals for larger areas like gluteal enhancement.
Autologous fat grafting is a surgical procedure that uses the patient’s own body fat to enhance volume. Fat is harvested via liposuction, minimally processed, and then re-injected, reducing the risk of allergic or foreign body reactions since the material is the patient’s own tissue. This option is widely accepted for reconstructing and restoring volume and is a regulated procedure when performed by a licensed surgeon.