Why Aren't Cosmetic Fillers FDA Approved for the Under Eye Area?
asked 2 years ago by 2995anon in Chicago
Latest answer by Steven Wallach, MD
Question viewed 324 times
Tags: under eyes, FDA
4 answers to Why Aren't Cosmetic Fillers FDA Approved for the Under Eye Area?
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FDA and filler approval
To obtain FDA approval for a drug indication is very difficult. The filler companies usually seek approval for a specific indication like the nasolabial folds. It is up to the doctor to decide if they want to use it off-label.
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FDA Indications for Fillers
As mentioned by Dr. Placik, obtaining FDA approval for a filler is indication and location specific. Since the original fillers were bovine collagen (zyderm and zyplast), most studies with new fillers performed are designed to compare themselves to collagen. The original studies on collagen were performed in the nasolabial fold region. Use of fillers in the infraorbital area is a relatively recent development. The process of obtaining FDA approval for this area would be arduous and...
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FDA approval of fillers
When filler manufacturers apply for FDA approval they have to prove the products are safe and that they work. In order to prove they work there has to be a grading scale of severity before and after injection. For fillers this is easier to do in the nasolabial folds than other areas.
For botox this easiest for the frown lines between the eyebrows. Regulations being what they are when the material is approved it is only approved for that specific area of the body and when used in other...
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Aaron Stone, MD
Los Angeles Plastic Surgeon
Los Angeles Plastic Surgeon
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Facial filler FDA approval process and new indications.
Fillers are approved according to FDA approved studies. Generally this requires comparing a new filler to older established fillers using them as a gold standard. Trying to get a study approved for a whole new indication can be extremely costly and most companies avoid this. For the face, the vast majority of fillers are evaluated using the nasolabial fold because this was established as the standard when collagen was first approved. Typically most fillers today are compared to Restylane...
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Otto Joseph Placik, MD
Chicago Plastic Surgeon
Chicago Plastic Surgeon
