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?
Is Using Counterfeit Restylane on a Patient Legal?
Doctor Answers 16
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 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.
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 products such as Botox (which is FDA approved for use in the glabella), but is often used by qualified practitioners around the eyes and forehead. Please be careful of what you have injected!
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 a great till of experience in facial rejuvenation and in using dermal fillers. They will be able to assess your skin, and provide the technique and correct dermal filler to meet your goals.
Use only real Restylane or Juvederm.
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.
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)?
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.
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 "Restylane" was stored or handled. (Did it sit on a warm dock for hours or was it always kept at the temperature suggested by the manufacturer?)
- Black Market - God knows where it came from and what the hell this really is. The Chinese sell knock off fillers. Others may re-package them to look like Restylane.
The injection of Restylane, an FDA approved filler, under the "supervision of a physician" (can drive a fleet of trucks through this loop hole since some spas are "supervised" by doctors from across town...) is legal. If it is injected in areas OTHER than those approved, it is an "off label" use, but is still legal.
The injection of ANY filler that is NOT FDA approved, is illegal as is the importation of the filler. it does not make a difference if the doctor imported to unapproved filler or the patient brought it to the doctor to inject.
Since there is NO GENERIC Restylane, I suspect you are being injected with a fake (from the black market, who knows what's in it) filler. Anyone who would do it to you is KNOWINGLY breaking US Federal law and is risking their medical license. If someone is willing to lose their license, do you REALLY think they much care what happens to you?
I would get online and alert the FDA and other law enforcement agencies this is taking place. You could be helping a lot, less intelligent people by doing so.
Dr. P. Aldea
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.
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" injections that turned out to be industrial silicone. Very, very scary.
The only way to know for sure what you are getting is to go to a board certified physician that values their license enough not to cut corners.
These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.