Why Aren't Cosmetic Fillers FDA Approved for the Under Eye Area?

Doctor Answers 4

FDA Indications for Fillers

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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 expensive and may not confer any competitive advantage to the company that proceeds.

Fort Myers Facial Plastic Surgeon
4.9 out of 5 stars 103 reviews

FDA approval of fillers

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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 areas it is considered off label use. If they tried to get the fillers approved for all possible areas of the body it would be very expensive to do so and it may be difficult or impossible to grade severity in a photo of some body areas.

Aaron Stone, MD
Los Angeles Plastic Surgeon

Facial filler FDA approval process and new indications.

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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 which also was initially approved for filling the nasolabial fold. Once approval is achieved for a specific area, it can be used "off-label" for filling nearly any other area.

Otto Joseph Placik, MD
Chicago Plastic Surgeon
4.9 out of 5 stars 86 reviews

FDA and filler approval

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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.

Steven Wallach, MD
New York Plastic Surgeon
4.2 out of 5 stars 30 reviews

These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.