Restylane: Q&A
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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?
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16 Doctor Answers |
Asked by
iggy
in St John, VI 00831
+2
Legal questions and Restylane
Thanks for the 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...
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Counterfeit Restylane should not be used
I would not recommend using counterfeit Restylane, as it may contain contaminants or may not even be hyaluronic acid. Be suspect if someone is offering a product that is much cheaper than anyone else in your area (keep in mind all the economic scandals lately like Bernie Madoff ["if it is too good to be true, it probably is!"]).
Be sure to go with a trained, medically qualified practitioner such as a Plastic Surgeon or Dermatologist. This is in contrast to off-label use of...
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Generic fillers are not safe
Restylane is a FDA approved hyaluronic acid filler that restores volume and fullness to the skin to correct moderate to severe facial wrinkles and folds, such as the lines from your nose to the corners of your mouth. I am not sure or never heard of a generic form of Restylane.
Mesotherapy is not FDA approved for the use of fat reduction to areas of the body but the medicine or some of the medicine that is used is FDA approved for other uses.
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Restylane should only be injected by board-certified MDs
Restylane is a very popular and effective hyaluronic acid-base dermal filler. It has been used widely throughout the face for the correction of deep lines and wrinkles. Although you may see offers to purchase Restylane online and may be tempted to do it yourself, keep in mind that you can cause harm if the injection is not placed at the crack level or with an improper technique. For this reason, your best results will be obtained if you work with a board-certified plastic surgeon who has...
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Use only real Restylane or Juvederm.
Hi.
Safety is the only issue, and you really want to be sure you know exactly what is being injected into your face. So stick with brand name Restylane or Juvederm.
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Counterfeit Restylane
I am not exactly sure what counterfeit Restylane is and that is the problem. Is it something that is a substitute for Restylane or is it the same basic product (a generic)?
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Generic Hyaluronic Acid?
The benefit of using a brand name, FDA approved product (like Juvederm and Restylane) is that there are established standards that the product must, by definition, live up to. Hyaluronidase acid has many uses in Medicine (Dermal filler, Ophthalmology, etc), but it is always better to use the product for the indication it was designed for.
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There is no generic Restylane or Juvederm
There is NO GENERIC Restylane or Juvederm. In other words, the patent has not yet expired and no other companies are legally allowed to produce the SAME EXACT compound.
Restylane in the US can come from:
- Legitimate source - MEDICIS - the Restylane distributor for QMed, the Swedish producer of Restylane
- Gray Market such as Canadian or other overseas sources - you COULD be getting real Restylane or God knows what packaged to look like it. Either way, you have no idea how the...
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Use of counterfeit injectables is off label
You are incorrect in thinking Mesotherapy injections are FULLY legal here in Florida! They are OFF LABEL USE or buyer beware.
Just as if you use imported Restylane or Botox, or any injectables, they are "OFF LABEL USE". This is because the doctor did not purchase the product through US resellers but obtained them from out of the US sources.
Is it the same parent company? I hope so but who knows? Just be careful out there.
Regards
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Is there a generic Restylane?
We're not sure what you mean by the term "generic Restylane" as their is no generic Restylane at this time. If your injector is offering discount injection products that are "generic", we would run far and fast.
While it's possible that the physician is just ordering product from overseas and getting it cheaper, he could also be substituting a substandard or unrelated product. In Los Angeles we have met with patients that have back room "Restylane"...
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Safety is the issue with counterfeit Restylane
Whether counterfeit Restylane is legal or not, the more important issue is the matter of safety. When you open a container of Restylane from Medicis, or a bottle of Botox from Allergan, along with the additional cost, is the assurance that these products have been tested and deemed safe for medical use. No reputable practitioner I know would consider injecting counterfeit Restylane. It simply is not worth the risk.
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Generic fillers are not proven to be safe.
Whenever a product is used that is approved by the FDA for medical purposes but used in a different method or area, the patient should be informed. Generic "Restylane" and mesotherapy are not FDA tested or approved so the patient should be clearly told that the procedure is experimental and the patient would have to consent to the treatment. It might not be illegal but an ethical practitioner will inform the patient properly.
All of the soft tissue fillers and Botox are...
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Selling something does not make it "legal"
Dear Iggy,
Core physicians which include Dermatologist, Facial Plastic Surgeons, General Plastic Surgeons, and Eye Plastic Surgeons are concerned with patient safety as well as getting the best aesthetic results.
Less ethical practioners may illegally import unapproved substances in order to make a quick profit. This practice has proven dangerous to the public and is not legal. Yet we are all aware that criminal activity goes on. Generally, state agencies that license physicians are also...
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Do not use "generic" or "counterfeit" Restylane!
There is no generic Restylane. It simply does not exist. I am not sure what your provider is referring to, but whatever it is, it is not safe. I would strongly advise you to stay away from that office, not matter how attractive is their pricing.
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Stay away from counterfeit fillers!
You should make sure your surgeon uses safe, FDA approved, medical brand name injectable fillers. This is the safest way to insure what you are having injected is the "real thing."
Be suspicious of any physician who is advertising discounted injectable fillers that are not brand name products.
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Generic Restylane
When using products that are not made by the manufacturer you run the risk of subquality products. I do not use these products on my patients. I do not know if it is legal or not. I think it is safer to use the one manufactured by the original company. Mesotherapy is not legal anywhere in the US. The products used are not FDA approved in humans.
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