We are leaders in cosmetic surgery, facial aesthetics, and medically supervised weight loss, serving the entire San Francisco Bay area. Whether you live in the Bay Area or are coming in from out of town, we’re happy to answer any questions you may have on your path to your new self. Book your cosmetic surgery intro call or Med Spa consultation today and take the first step towards realizing the look you’ve always wanted for yourself.
Restylane
Is Using Counterfeit Restylane on a Patient Legal?
Using counterfeit Restylane is illegal. The FDA regulates dermal fillers as medical devices, and importing or injecting unapproved or counterfeit versions violates federal law, regardless of whether the patient consents. Counterfeit product also carries real medical risk: no verified sterility, no lot tracking if a recall or adverse reaction occurs, and no guarantee the syringe even contains what the label says. This is different from legitimate off-label use, where an FDA-approved filler like Juvederm is used in an area outside its labeled indication (hands, for example). That's legal as long as your provider discloses it and discusses the specific risks and benefits with you. Reputable board-certified plastic surgeons and dermatologists purchase directly from the manufacturer for this reason. If you suspect a provider is using counterfeit or diverted product, that's a red flag worth walking away from, and worth reporting.
Clinical Context
Counterfeit filler often reaches providers through unauthorized import channels instead of coming directly from the manufacturer. Without proper handling and storage, there's no way to confirm the product's sterility or that the syringe contains what the label says. If a problem occurs, there's also no manufacturer lot record to trace it. Patients can protect themselves by asking their provider where the filler is sourced and confirming it comes directly from the manufacturer.
Related Questions
