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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.
Botox (onabotulinumtoxinA) is an FDA-approved neuromodulator that temporarily relaxes targeted facial muscles to reduce the appearance of dynamic wrinkles. It works by blocking the release of acetylcholine at the neuromuscular junction. Results typically appear within 3–7 days and last 3–4 months, though some patients report longer duration with consistent treatment. Common treatment areas include the glabella (frown lines), forehead, and lateral canthal lines (crow’s feet). Dosing is measured in units and varies by treatment area and muscle mass.
When evaluating any cosmetic procedure, choosing a surgeon who operates in an accredited surgical facility is one of the most important safety decisions a patient can make.
