Liquid Silicone: Buyer Beware

Reviewed by Yael Halaas, MD

Liquid silicone injections are among the most controversial topics in facial plastic surgery (not to mention plastic surgery in general).

The use of silicone breast implants was also mired in controversy for a while, but the Food and Drug Administration (FDA) gave these implants a clean bill of health in November 2006. Liquid silicone injections are another story altogether, and for good reason.

Liquid Silicone and Your Face: Past, Present and Future

In the 1960s and 1970s, injecting liquid silicone was all the rage due to the introduction of a medical grade silicone by Dow Corning. The FDA has regulated liquid silicone as a device since 1976 because it is technically an implant intended to affect the structure of the body. Before that, it was regulated as a drug.

There were several clinical trials from 1978 to 1988 that looked at using liquid silicone injections to correct certain facial deformities. And while it did have some positive effects, there were also complications, particularly when a large volume of silicone was needed to correct the deformity.

Liquid silicone injections are not FDA approved for cosmetic use, and the FDA explicitly prohibits manufacturers or doctors from marketing or promoting liquid silicone for cosmetic use. Put another way: liquid silicone injections are illegal. That said, they tend to be highly sought after on the black market, largely for non-facial uses such as more voluptuous breasts and buttocks, more shapely thighs, penis enlargement and for feminization of the face and body among members of the transgender community. In addition, two injectable silicone products — AdatoSil and Silikon 1000 — are FDA approved to treat a retinal detachment that is most typically associated with AIDS. Doctors can, and do, use both products for off-label cosmetic purposes as well

So what is it about these injections that have regulators and a cadre of doctors urging extreme caution, and consumers clamoring for a fix?

The vocal liquid silicone advocates say the filler is safe, affordable (around $1,000 per treatment) and can produce stellar, permanent results if administered by skilled physicians via a specific technique called microdroplet injection, which uses only pure, FDA-approved, medical grade silicone. Many of the highly-publicized problems with liquid silicone involved the use of industrial (i.e., non-medical grade) silicone in the hands of unskilled injectors.

Liquid Silicone Injections: First Do No Harm?

What can go wrong with liquid silicone injections? Lots, depending on who you ask.

For starters, the results are highly unpredictable, and there have been numerous reports of allergic reactions. Additionally, the results of liquid silicone injections — like those of another soft tissue filler, Bellafill — are permanent. The only way to remove silicone once injected is to cut out the affected tissue.

What's more, the silicone can move or migrate to other parts of your body, resulting in inflammation, discoloration of the surrounding tissues, and the formation of lumps or bumps of inflamed tissue (granulomas). Infection is another risk associated with liquid silicone injections. These problems do not necessarily develop right away, so even if things go well initially, you are not in the clear.

Liquid Silicone Injections and Your Face: Is There a Role?

When treating certain nasal irregularities following primary rhinoplasty, some facial plastic surgeons may choose to forego complicated revision rhinoplasty and instead inject microdroplets of liquid silicone just under the nasal skin. Other potential uses include lip augmentation and minimizing deep acne scars. Currently, the FDA is reviewing data on the use of a liquid silicone product called SilSkin for the treatment of wrinkles and skin depressions.

Until liquid injectable silicone is approved by the FDA, the American Society for Aesthetic Plastic Surgery warns against its use for cosmetic purposes. Unless and until the FDA gives a nod to the use of liquid silicone for cosmetic use, it's strictly buyer beware.

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