Jan 5

Are Permanent Fillers Safe? Is the FDA failing in its duties when it comes to Fillers?

The questions are deliberately controversial because the truth is most of the studies done in the US and throughout the world show that Permanent Fillers like Artefill and the possibly soon to be approved Aquamid are both safe and effective. However, despite being the only permanent filler on the market, Artefill went bankrupt in December. And the question is why?

In addressing the topic a few weeks ago the NY Times was very vague in its analysis, instead posting a short article that for all intents and purposes just stated the fact that the company filed for bankruptcy.

There are many in the field who believe that dermatologists, “cosmetic surgeons,” and plastic surgeons who have heavy injectible practices utilize primarily temporary fillers because obviously it makes sense to them to have their patients coming back for more. Along the same lines, because these very doctors who have large injectible practices are then considered the experts in the field, they will also be the ones quoted in the media saying that while they think permanent fillers are likely safe, they are afraid of long term unknown consequences or as this article called them “ticking time bombs.” As a result, the general public and other less experienced injectors become wary of using permanent fillers.

So what do we think?

In our practice, as with the vast majority of practices, when most patients come to see us for fillers we generally end up using temporary fillers after we have gone through explaining the risks and benefits of the various fillers. And that is not because we believe that permanent fillers are unsafe. Unfortunately, however, the FDA and the manufacturers of these products are failing in doing the science required for us to really know how safe these fillers are. The problem is that most of these fillers get approval based on studies utilizing the nasolabial fold, where skin thickness allows you to inject deeper safely and as a result very few if any complications are seen. Longer range studies in Europe and Asia show the fillers to also be safe when utilized for the lips, under the eyes, and elsewhere. But these are usually not well controlled studies and in fact they are often done by a physician who is on the advisory board for the manufacturer of the fillers…so with the FDA doing an inadequate job, the local “experts” saying they are unsure, the rest of the physician base and the general population come to believe the product may not be safe…and a company goes boom…

Time Bomb

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