Sculptra Safety Screening

Ran Y. Rubinstein, MD answers: EU screening regulations for Sculptra?

I would like to know more about the screening regulations which cosmetic treatments, particularly Sculptra, have to go through. There is alot of information about FDA regualtions and U.S lisencing laws on this site. I was wondering if you could offer any information on the screenings in place for Europe? I know that Sculptra [the NewFill] had been available here in Europe since 1999. What lisencing screens did it have to pass? Do these then allow access to all markets within the EU, or do each of member states have their own regulations? Thanks


Ran Y. Rubinstein, MD
26 days ago
By Ran Y. Rubinstein, MD - New York City Facial Plastic Surgeon

Peggy,

I am not sure about what screenings are done by the EU. The FDA has more stringent criteria than that in the EU which is why many of the new cosmetic products and medications appear in the EU before the US. I think you should feel more secure knowing the FDA has given Sculptra official approval. Based on my extensive experience with Sculptra and the FDA approval both in 2004 for HIV patients and in 2009 for aesthetic use, I would advise you to proceed with your Sculptra treatments.   One word of caution. In the US, only plastic surgeons and dermatologists are trained and provide Sculptra injections. In the EU that is not the case. Please make sure your injector is qualified and experienced.

Good luck!

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