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Injectable Fillers

Easy Approval Leads to Health Risks

Do You Know the 14 FDA-Approved Injectable Fillers?

The US FDA has approved only 14 injectable fillers, while the UK has approved over 160.

I just read something that gave me a renewed sense of appreciation for the U.S. Food and Drug Administration. The department’s drug approval process may be long and costly. Consumers in other countries may frequently have access to new products and procedures long before U.S. residents.

On the other hand, sometimes the advantage of such caution is all too clear.

In the U.S., only 14 injectable fillers have completed the rigorous FDA approval process.

The UK's Daily Mail reports that over 160 injectable fillers are in use in the UK and cosmetic surgeons have raised an alarm.

They are seeing cases of facial necrosis, disfigurement and nerve damage in patients that come to them after bad experiences with injectable facial and body fillers.

There have also been cases of anaphylactic shock reported.

In the opinion of the British Association of Aesthetic Plastic Surgeons, one of the biggest issues with using fillers is the lack of regulation on both approval and use.

In the UK injectable fillers are regulated as medical devices rather than drugs or medicines. Medical devices can be used by anyone who can purchase them.

In Britain, new fillers are required to obtain a CE mark in order to be brought to market.

A representative of the Association explained, "It's just too easy for a product to come to market without any long-term testing and results. To get a CE mark, you can test your product on just ten to 20 people and only have to follow them for six months. That's not rigorous enough when a product is being injected into the body."

The Association advises British consumers to only have injectable fillers administered by experienced medical professionals and to only use those fillers approved by the U.S. Food and Drug Administration.

So, my thanks to the FDA for the prudent approach with respect to injectable products.

Right now, I personally am waiting for the STOP™ Radio Frequency Skin Rejuvenation Wand for Home Use to receive FDA approval and become available here.

It has been available in Europe for a couple of years. Perhaps I’ll try to be more patient!

Medical Tourism

Medical tourism is a growing business, but is not without risks.

If you wish to travel abroad for cosmetic procedures, the experience in the UK should give you pause.

Be absolutely sure what you are getting at an overseas hospital or doctor's office.

While no foreign country trying to make inroads in this field will want bad news of shoddy treatment or inferior drugs to ruin their incipient medical industries, the chances are greater for this to occur abroad (although the US had had its own problems, especially with use of non-medically approved botulinum toxin being passed off as Botox - see Botox Dangers.).

There is no reason to avoid foreign doctors or hospitals, just be careful.

For drugs or injectable fillers, ask to see the box or bottle. Make sure it is labled for medical use and that it has not be opened. You should expect qualified doctors to do this without your asking.

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This article is for informational purposes only. It does not purport to offer medical advice.

 

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