Is Using Counterfeit Restylane on a Patient Legal?

I'm confused, because Mesotherapy is not FDA approved but it is legal to use in Florida. So is using a "generic" Restylane legal because the ingredients are supposedly the same as Restylane?

Legal questions and Restylane

Thanks for your question. I'm not a lawyer so would not venture to offer legal advice however, most board certified plastic surgeons, facial plastic surgeons and dermatologists will not use generic Restylane or European botox, etc. These products may not have the same assurance, quality and product tracking with name brand products. Our patient safety and the efficacy of our treatments aren't worth the few dollars saved. A physician may use a product that is not FDA approved in an "off label" application, but you should be certain that the doctor communicates with you that the treatment you're receiving is not FDA approved for the indication being treated. (This would include Juvederm in the hands for example). In these cases particular attention should be paid to possible risks and benefits of this off label treatment. Mesotherapy is a whole other can of worms. Mesotherapy involves injecting quantities of something, which can include natural extracts, homeopathic agents, pharmaceuticals and vitamins into the skin. There is no agent that I am aware of that is FDA approved to treat the claims that Mesotherapy covers (cellulite, fat, loose skin). It typically is viewed in a negative light by board certified plastic surgeon or dermatologist. I would never administer or recommend it to any of my patients. I hope this helps.


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