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Hello, my name is Dr. Philip Miller, a specialist in facial plastic surgery and my practice is here in Manhattan. Many people are interested in injectables that would be material that is injected into the face like botox or radiesse or restylane. And they should be and probably are concerned about the words FDA approved or FDA approval. Now the FDA is the federal drug administration and they are the federal government’s agency that overseas the safety of medications that are used here in the United States. Now once they approve the safety of that drug it becomes FDA approved. The important thing to understand is that most medications or most drugs that are submitted to the FDA for approval are done so with what’s called the particular indication that means for example. Penicillin was submitted to the FDA for treatment of pneumonia, well once it treated pneumonia, doctors were able to apply it to other diseases but in so doing they were treating the patients what is called off label. The drug was approved by the FDA but if you will it was approved for pneumonia. The FDA does give physicians some credit in their wisdom and knowledge and allows them to use those FDA drugs elsewhere in the body for different reasons. That is called using a drug off label.  Now let’s take a look at botox for example. Botox was actually approved by the FDA in the location right here on the forehead and yet surgeons decided to use that drug elsewhere on the face what is called off label. It is still an FDA approved drug but it’s being used off label which is completely safe. That is opposed to medication or a drug that is off, not FDA approved, those are dangerous and we don’t use those here in the United States. Now one thing to realize is that injections or medications or drugs that are used in Europe and used in Canada may have a long safety record but until such time that the FDA approves them here in the United States they can not be used. In fact it’s illegal to use those drugs here in the United States. So be careful what is injected into your face, make sure that it is a medication or drug that is in fact FDA approved. I’ve seen many patients who have come into my office who have had lumps and bumps and irregularities and in fact deformities because something was injected into their face that they don’t even know what it was, particular at injection parties performed by individuals that are not even physicians. And they are quite unhappy about that, so be careful, be careful about what is being injected into your face and make sure it is FDA approved. Thank you.

 

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Dr. Philip Miller, MD, FACS, New York plastic surgeon
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