Are Off-label Uses of Restylane Injection Safe?

asked 4 years ago by anon
Latest answer by Kris M. Reddy, MD, FACS
Question viewed 2,445 times
Tags: safety

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?

7 answers to Are Off-label Uses of Restylane Injection Safe?

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

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... more

Arnold W. Klein, MD
Beverly Hills Dermatologic Surgeon

Ask specific questions about off label treatments

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... more

Jeffrey Kenkel, MD
Dallas Plastic Surgeon

Off-label Uses of Restylane

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

www.drkrisreddy.com

What does off-label use mean for Restylane?

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,... more

Richard Baxter, MD
Seattle Plastic Surgeon

Off Label Uses for Restylane

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... more

Harold J. Kaplan, MD
Los Angeles Facial Plastic Surgeon

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

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 A. Codner, MD
Atlanta Plastic Surgeon

Off-label use of Restylane

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

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