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Are Off-label Uses of Restylane Injection Safe?

How do you know if an injectable (like Restylane injections) is safe for a use that it is not specifically approved for -- like injecting the back of the hands for example?

Doctor Answers (7)

Restylane and Injectable Fillers - Off- Label Use: Is It Safe?

+5

The short answer to your question is that you don't know if it is safe. Off-label means that the proposed use is not approved by the FDA. Off-label is perfectly legal, but as a consumer, you do not know if it is safe and effective.

When medical corporations present a drug or device (Restylane) to the FDA for approval, they must conduct clinical studies showing the FDA that it is safe and effective for a particular indication. In the case of Restylane, it is only FDA approved for moderate to severe facial wrinkles and folds such as the nasolabial folds, the lines between the nose and mouth. This means that all other uses of Restylane are off-label.

Of couse, Restylane and other hyaluronic acids are safely used for many other indications, but they are all off-label. It is only when a company presents a specific indication to the FDA, with proof that it is safe for that purpose, that it can be "FDA approved" for that use. The same is true for medications.

Once something is FDA approved for any indication, it is up to the doctor how to prescribe it and for what purpose. It is important for doctors to be able to use drugs and devices for off-label purposes because it allows for the treatment of many diseases and serious conditions, without having to wait years for FDA approval.

For these reasons, it is essential that you select a very well qualified doctor who has a lot of experience in the use of fillers. There is much debate in the media about off-label use of drugs and medical devices, and it is illegal for a company to promote a drug or device for any off-label use.

When there are large sums of money at stake, as there is with cosmetic procedures and injectable devices, some doctors and some manufacturers may be tempted to cross this line. All the more reason to seek a well-known and well-qualified doctor for your filler and Botox injections.


Beverly Hills Dermatologic Surgeon
5.0 out of 5 stars 5 reviews

Ask specific questions about off label treatments

+2

Once a device is FDA approved it may be used "off label" by a physician. This means it may not be as thoroughly studied for that specific application through scientific methods as the original FDA approval.

Because of that, we recommend that you thoroughly explore the off label use with your physician and ask specific questions about:

  • Longevity
  • Potential side effects
  • Number of cases
  • Experience of the injector
  • Ask to see some photos
  • If you want, you could even ask to speak to a patient or two who has had the procedure.

Jeffrey Kenkel, MD
Dallas Plastic Surgeon
5.0 out of 5 stars 5 reviews

Off-label Uses of Restylane

+1

The short answer is that you don't know.  The most important choice you can make is to find experienced and expert injectors. An expert injector will understand what areas to inject and what to avoid.

Kris M. Reddy, MD, FACS
West Palm Beach Plastic Surgeon
4.5 out of 5 stars 18 reviews

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What does off-label use mean for Restylane?

+1

The whole process of FDA clearance for medical products and devices is confusing for many people. Clearance is given for a specific use, based on clinical trials and other testing, but once on the market other uses are perfectly legitimate if it is judged by a physician to be appropriate. However, off-label uses cannot be promoted by the company.

A classic example is Botox, which was approved for therapeutic use some 20 years ago. When it became clear that cosmetic uses were possible, Allergan started to promote it but was slapped down by the FDA. They then invested millions of dollars in clinical trials and finally got cosmetic use approval, but the only "on-label" use is the area between the eyebrows.

It is however very commonly and successfully used in several other areas. Restylane is only approved for the Nasolabial lines, but there are many other areas including hands where it may be appropriate.

Richard Baxter, MD
Seattle Plastic Surgeon
5.0 out of 5 stars 28 reviews

Off Label Uses for Restylane

+1

One of the key questions when it comes to off label use of a product like Restylane is whether or not the usage is a common practice among other physicians. If the usage is common practice among many physicians, there is a much higher likelihood that it is safe than if you are the guinea pig being injected for a new application of the product. Restylane for the hands is quite common. We perform this procedure and have not had any adverse outcomes.

Many consumers don't realize that one of the main reasons products are used "off label" is that it does not make financial sense for the manufacturer to get the FDA approval for the off label areas. For example, Botox. Botox is injected in numerous areas of the face by many practitioners and has been found to be universally beneficial in non-FDA approved areas like the forehead, the crow's feet and even the upper lips. But, the manufacturer will not undertake a separate FDA approval for all of these areas because it is time intensive and expensive, NOT because there is any question about the usefulness of the Botox in these areas. The same can be said for Restylane. The manufacturer will not apply for FDA approval in other areas of the face because it is too time and cost intensive to do so.

Harold J. Kaplan, MD
Los Angeles Facial Plastic Surgeon
5.0 out of 5 stars 6 reviews

Off label uses similar to approved use are safe under certain circumstances

+1

Off label uses that are similar to the approved use, and that are commonly practiced among physicians are generally safe, so long as all the proper procedures are followed, including:

  • Your doctor is qualified
  • It is an FDA approved brand
  • Safety practices including sterilization and patient education and risk are appropriately followed

Mark Codner, MD
Atlanta Plastic Surgeon
5.0 out of 5 stars 16 reviews

Off-label use of Restylane

+1

Off-label use refers to doctors using medications that are FDA approved for one type of treatment and use it for another non-approved treatment. As to the use of restylane on the hands, some doctors inject these products and other fillers to improve the aged appearance. I would use a doctor that has experience and success doing this first before I would suggest having it done.

Steven Wallach, MD
Manhattan Plastic Surgeon
4.5 out of 5 stars 18 reviews

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.