LAM FACIAL PLASTICS

I was told by another doctor, that silicone is illegal & therefore i could not have it in my lips. Is that true? How come other doctors use it in the face & lips?

Excellent, excellent question. Silicone is absolutely absolutely NOT illegal. I would never do anything illegal.

Silicone is what is called "off label". You must fully understand what off label means to have your silicone performed. Silicone is currently approved for use in the human eyeball for retinal detachments. Because it is currently approved for use in the human body, a physician can use silicone legally in the human body so long as he or she provides a detailed explanation of the risks, benefits, and limitations of the product.

Silicone has been around for about 40 plus years so in my opinion it has the longest safety record out there for a permanent filler. That is why I do not use Artefill since I think the time frame of safety is too short. In fact, there have been a lot of reported problems in Europe when it was Artecoll formulation.

Was silicone ever illegal? Yes, in the early 90s there was a time that the FDA did not have silicone cleared for any use in the human body but since that time with approval for use, it is now legal but just considered off label, as explained above. So for a short time in the 90s, silicone use in the human body anywhere was illegal.

Okay, let's explore what off label means further and go through other examples. Botox is FDA cleared for use for the glabellar frown lines only meaning that if you use Botox in the forehead and the area around the eyes the physician is using botox off label. Restylane is permitted only in the smile lines (nasolabial folds) and not anywhere else in the face. I use Restylane all over the face for the patient in an off label way. Now, let me make a distinction here to be fair in every respect. First, Botox and Restylane are cleared for cosmetic purposes so the off label nature of these treatments is much closer than say silicone is since it is used in the eyeball and I am using it in lips and for facial repair and enhancement.

Another example of a product that I have used off label for the past 4 years is Radiesse (formerly Radiance). It only received cosmetic indications for the smile lines last December. Before that time, it was FDA cleared only for vocal cord paralyses and as a soft-tissue marker. However, as stated, I was using Radiesse much longer for cosmetic purposes, as most physicians have been doing.

One more point, the term "FDA approved" is also a misleading one. I prefer "FDA cleared". Remember that the FDA does not regulate how effective a product is but only that it has met certain minimum criteria for patient safety. Just wanted to make that clear as well.

Hope this answer helps clarify this important matter. If you need more clarification, please respond with any more pertinent questions.

Best,
SML