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What Can Happen to a Dr. Who Injects Areas That Aren't FDA Approved?

What Can Happen to a DR for Performing Non FDA Approved Areas with Injectibles?

If a dr is providing for example Radiesse under your eyes and its not FDA approved- does that show he quality of the ethics of the DR ? Can anything be done to him to stop him for possibly harming people as they trust his judgement ? Please advise...

Doctor Answers (3)

What Can Happen to a Dr. Who Injects Areas That Aren't FDA Approved?

+2

This is referred to as "off-label" use. If you review the FDA indications for Botox and each of the dermal fillers you will note that many of the injections performed by plastic surgeons are "off-label" and outside the FDA indication for that specific product. This is legal. If physicians feel that an FDA approved product could be helpful in an area other than that included in the original studies submitted to the FDA then that product can be used elsewhere.

For example, hyaluronic acid fillers were used in the lips for many years before Restylane received its recent FDA approval for lip injections. The companies and the studies (which cost millions of dollars) and FDA approval (which can take years) tend to lag way behind clinical practice. For off label treatments it is very important to find an experienced, honest and ethical plastic surgeon for your treatments as good judgement is required.

Regarding Radiesse it is safe around the eye if placed deep on the bone. It shouldn't be placed superficial in the muscle. This is an area where hyaluronic acid fillers such as Juvederm or Restylane are more appropriate.

I hope this information is helpful.

Stephen Weber MD, FACS


Denver Facial Plastic Surgeon
5.0 out of 5 stars 34 reviews

Non-FDA approved use of fillers

+1
The FDA has been slow off the mark to approve fillers for particular areas. I would be much more concerned about injection of silicone, for example, which is known to be problematic. In fact, many of the most "chichi" doctors around market their use of "new" fillers prior to approval on an investigationalbasis. Your post seems to be alluding to something else. If you feel that you were "harmed" by the use of Radiesse under your eyes, could you please be more specific or post photos?

Robert L. Kraft, MD
New York Plastic Surgeon
5.0 out of 5 stars 8 reviews

Using fillers for non-FDA approved sites

+1

FDA approval can take years and millions and millions of dollars. Last year Restylane finally received FDA approval for use in the lips, however, most physicians preferred that injectable in the lips for years before it. Sometimes the usage of a product leads the company to go back for further FDA approvals.

It's not illegal or unethical for a physician to use injectables "off label". Botox is only FDA approved on the face for the glabella, however, most physicians use it on the forehead and around the eye area. Most patients would be unhappy if we said we'd only treat the glabella region because that's all that's on record for FDA approval. However, there is no reason not to treat the forehead and other regions - as long as you know what you're doing!

There is nothing to say that "off label" usage is harmful. What's harmful is when inexperienced physicians or worse non-physicians inject things they don't understand - that's dangerous! "Off label" usage by experienced practioners isn't.

F. Victor Rueckl, MD
Las Vegas Dermatologist
4.5 out of 5 stars 7 reviews

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