Liquid silicone injections used for the augmentation of soft tissues remains a hotly debated and very controversial topic. Although silicone breast implants were approved by the FDA in 2006 and the newest form stable silicone breast implants are in clinical trials, the use of injectable liquid silicone is a very different and real concern.
Liquid Silicone as injectable filler: the problem
Once injected liquid silicone is permanent and it cannot be altered or removed. Many reports of complications have been published, including severe complications from liquid silicone used for breast enlargement as long ago as the 1950s. I have performed several breast reconstructions on women who had liquid silicone injected into their breasts for augmentation in the 1960’s, who developed disastrous complications and required total mastectomies decades later. Almost all of the problems noted were never seen by the injecting physician as they tend to arise years after injection. Among complications cited were:
- Migration of silicone to other parts of the body
- Inflammation and discoloration of surrounding tissue
- Formation of masses of chronically inflamed tissue called silicone granulomas
The FDA and Liquid Silicone
“Although the FDA has approved certain forms of silicone for cosmetic use, it continues to prohibit the injection of liquid silicone or silicone gel to fill wrinkles or augment tissues anywhere in the body for public and health safety reasons. Tissue augmentation using injectable fillers such as silicone has resulted in death and serious injuries in both the United States and abroad, especially when injections are performed by unlicensed practitioners and outside a clinical setting. Risks associated with such injections include permanent lumps within the skin, infection, skin ulceration, and potentially fatal pulmonary blood clots.”
The FDA has NOT approved injectable wrinkle fillers to:
- Augment (increase volume of) or alter the shape of facial features such as lips, cheeks, and nose
- Increase breast size (breast augmentation)
- Increase size of the buttocks
- Rejuvenate the hands or feet
- Implant into bone, tendon, ligament, or muscle
The position of the of the
Plastic Surgery Societies:
The current position of the American Society for Aesthetic Plastic Surgeons (ASAPS) position states:
- Alternative treatments for wrinkles or acne scars are available and may be discussed with an aesthetic plastic surgeon certified by the American Board of Plastic Surgery.
- Liquid silicone should never be injected into the breasts.
The most serious risks are associated with the injection of liquid silicone are:
- The results are permanent and can only be altered by the surgical removal of the liquid silicone
- Liquid silicone can migrate in the tissues with time and the body will develop a foreign body reaction to the gel called silicone granulomas
- Infection and long term deformities are a lifetime risk
- Brand names such as AdatoSil and Silikon 1000 are FDA approved only for the treatment of retinal detachment. A doctor may offer them for cosmetic purposes, but this is considered an “off label use”. They also cannot legally advertise its use, and they should obtain informed consent for the “off label” use of the product.
There are those who claim that liquid silicone can be safe and effective if administered by skilled physicians via a specific technique called microdroplet injection, which uses only pure, FDA-approved, medical grade silicone. The most tragic results are often caused by the injection of large volumes of industrial (i.e., non-medical grade) silicone in the hands of unskilled injectors.
- Until liquid injectable silicone is approved by the FDA for cosmetic use, the American Society for Aesthetic Plastic Surgery and the American Society of Plastic Surgeons both warn patients against its use.
- Patients should be aware of exactly what products their physician offers and ask to read the patient labeling for the product that the doctor plans to use. Patient labeling is only available for FDA approved wrinkle fillers.