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Bioalcamid, aquamid European CE certification
Jun 7, 2004

Dear Doc,

Being from a European country you may have a better sense about this. Would you trust a CE certificate issued by the Italian regulating agency? [PLEASE answer without political considerations, considerations such as hurting your Italian colleagues' feelings...etc] If you yourself had a bad case of lipoatrophy, would you have bioalcamid injected in your face at this time? How about aquamid? It has a CE certificate from the Danish regulating agency. Would you think a product with CE mark from Denmark is more guaranteed to be safe vs a CE mark from Italy? When I contacted Polymekon, maker of bioalcamid, to obtain the toxicity and safety studies, I was told these are provided to the doctors. Maybe you could request these for us and make them available (can worry about the Italian translation later). When I contacted Contura, the maker of aquamid, I got back no response at all. Doesnt help build confidence either. Txx for your opinion and help!

eb

Response from Dr. Moyle

These substances are regulated by the European licensing authorities and should be as scruitinised as something approved by the FDA. The FDA is shotly to recieve an approach from Polymekon regarding approval in the US. The substance is widely used in Europe and Mexico and I have seen good responses. It may be especially good for deeper 'holes' that are hard to fill with Newfill/Sculptura. Companies are restricted on providing information to patients by a code of conduct in Europe which restricts promotion to patients. There are several polymekon sites (see link) which provide information on the use of Bioaclamid

regards

Graeme Moyle


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