Safety of The Fillers

Dermal fillers revolutionized the face aesthetics. Vast majority of the fillers are composed of hyaluronic acid (HA) and poly L lactic acid. These products are very well tolerated by human body and there are numerous companies producing them under different brand names. There are some other materials in the market also known as fillers.

Most countries except U.S. to get permission for producing and marketing these products is relatively easy. These filler materials which are called as medical devices are being distributed all over the world either legally or illegally. The acceptable ingredients and legal commercial availability do not guaranteed that they are safe.

Today the best criteria for medical device reliability is FDA (US Food and Drug Administration) approval. Although EU (European Union) approval is valid in Europa this is not as reliable as FDA at least nowadays. So anybody who seeks facial filler procedures should ask her/his doctor to tell the commercial name of the product which is intended to be used and is it FDA approved or not? To ensure patient’s confidence the product should be opened in front of the patient and after finishing the procedure the vial or package of the product should be given to the patient for her/his information. How patients can learn that this medical device is FDA approved? For dermal fillers the list of FDA-approved fillers can be used.

Another issue for facial fillers is who should apply them? In many countries dermatologists (skin doctors) and aesthetic-plastic surgeons are eligible to use this products. However in realty many doctors including general practitioners, aestheticians (most of them are not received medical education) and even lay people might be applying these products in private offices, medical spas and beauty centers.

Off label use of the medical substances is another important problem. A product which is approved by FDA for intranasal application should not be used for injection. You can find an example of it in FDA website.

In conclusion dermal fillers are safe if they are:

• Approved by FDA as dermal filler
• Applied by dermatologists and aesthetic-plastic surgeons
• Opened in front of the patient and used package is given to the patient for future reference

However, Dr Ozgentas prefers to use patient’s own (autologous) fat as a filler and gets long lasting and favorable results from fat injections.

Related link: Filler for cheek volume replacement is approved by FDA

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