Injectable silicone is a synthetic polymer that can exist in liquid, gel, or solid forms. The controversy surrounding it stems from the distinction between highly purified, medical-grade liquid silicone (LIS) and the non-medical, industrial forms frequently misused as a cosmetic filler. While refined LIS has limited, specific medical uses, the product is widely known for its unapproved and dangerous application as a bulk filler for body enhancement. This permanent and non-degradable material is the subject of ongoing public health warnings due to its inherent risks when injected for cosmetic purposes.
Regulatory Status of Injectable Silicone
The regulatory standing of injectable liquid silicone is clear: the U.S. Food and Drug Administration (FDA) has not approved it for cosmetic use as a dermal or bulk filler. Despite this, unlicensed practitioners often mislead consumers by falsely claiming the product is FDA-approved for body modification. The FDA has warned that using injectable silicone for large-scale body contouring or wrinkle treatment is unsafe and illegal.
The only FDA-approved use for specific, highly purified silicone oil products, such as Silikon-1000 and Adatosil-5000, is for specialized ophthalmic procedures. These products are used inside the eye to treat complex retinal detachments, where the oil holds the retina in place. This approval for a medical device in a small, contained environment does not extend to its use in large volumes for aesthetic purposes.
The general use of injectable liquid silicone for cosmetic augmentation was largely banned in the United States in the 1990s due to safety concerns. Unlike silicone contained within an approved breast implant shell, the free-flowing liquid cannot be contained and may migrate throughout the body. Liquid silicone is permanent and non-absorbable, differing significantly from approved, temporary, and biodegradable fillers.
Applications in Non-Surgical Body Contouring
Despite regulatory warnings, an illicit market persists where unapproved liquid silicone is used for non-surgical body contouring. These procedures involve large-volume injections that far exceed the minute amounts used in approved medical settings. Treatments are often sought for dramatic size increases in areas including buttock augmentation, breast enhancement, and hip widening.
The primary appeal is the promise of permanent results at a significantly lower cost than conventional, approved surgical options. These procedures are frequently performed by unlicensed or unqualified individuals in non-clinical settings, such as private homes or hotels.
The substance used in these illegal injections is often industrial-grade material, not medical-grade silicone, and may contain dangerous contaminants. Unscrupulous providers have been known to inject substances like tire sealant, mineral oil, or materials used in caulking, falsely marketing them as safe fillers.
Understanding the Health Complications
Local Complications
The injection of unapproved liquid silicone carries severe risks, beginning with complications at the injection site. One common issue is the formation of granulomas, which are hard, inflammatory nodules the body creates to wall off the foreign substance. These granulomas can appear months or years after the injection, resulting in a painful, hard texture beneath the skin.
Chronic inflammation and infection are frequent occurrences as the body continuously reacts to the permanent foreign material. This persistent inflammatory state can lead to skin discoloration, ulceration, and tissue death (necrosis) at and around the injection site. Because liquid silicone is free-flowing and not encapsulated, it can easily migrate from the original injection site, traveling to unintended areas such as the limbs.
The movement of the substance can cause significant disfigurement and pain far from the initial treatment area, complicating surgical removal. Removal is often challenging because the silicone infiltrates and mixes with the body’s natural tissues. The long-term presence of free-flowing liquid silicone creates a permanent site of vulnerability.
Systemic Complications
Beyond local issues, the improper injection of silicone poses life-threatening systemic risks. When silicone is injected into areas rich in blood vessels, especially large-volume injections into the buttocks, the substance can enter the bloodstream. Once in the circulatory system, the liquid silicone can travel through the body and become lodged in distant organs.
The most immediate and dangerous systemic complication is a pulmonary embolism, which occurs when silicone blocks blood vessels in the lungs, leading to severe difficulty breathing and potentially death. Silicone particles can also travel to the brain, causing a stroke, or to the heart, resulting in a heart attack. These events can happen immediately after the injection or in the days and weeks that follow.
Infection at the injection site can quickly spread throughout the body, causing systemic sepsis, a life-threatening complication that damages tissues and organs. These severe complications are directly linked to the unapproved nature of the substance and the large volumes administered, which overwhelms the body’s natural defenses.