I'm confused if there are any fillers that are approved by the FDA to treat the under eye / tear trough area, or if it is all off label use?
What Fillers Are FDA Approved for Use in the Tear Trough / Under Eye Area?
Doctor Answers (6)
The most important question is not whether they are approved, but whether your injector can do this well!
Fillers under the eyes are incredibly difficult and you need to make sure your injector is a good one or you may have long term issues after they are done. These can last for years!
It is exceedingly important that you go to someone who truly knows what they are doing and understands how to 'subtly' improve this area or you might have a disaster on your hands! Good luck!
FILLERS FDA APPROVED FOR TEAR TROUGH
At this point and time none of the fillers are FDA approved for injecting into the tear trough area. There are many surgeons that have an abundance of experience with placing injectables in this area with great results. Good Luck!
FDA Approved Tear-Trough Fillers
The short answer to your question is "None". The FDA has not specifically authorized filling in that area. Using HA fillers in the tear-trough area, however, is commonly performed "off-label". Using drugs "off-label" is a common practice with many medications. Once a drug is approved for any purpose, physicians are free to use it as they see fit. Use of Restylane in the tear-trough is a common treatment and many clinical studies support its use.
I doubt you will ever see FDA approval for use in the tear-trough area because, as mentioned, the costs associated with doing the FDA designed studies and all of the other associated hassles would be very expensive. Since physicians and patients are already very accepting of its use there, the FDA approval formalizing its use would likely do little to increase sales and therefore the manufacturers are unlikely to spend the money.
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Fillers for tear troughs
The FDA has not approved any fillers for the tear trough as far as I know. Commonly fillers are approved for the nasolabial folds and doctors use them off -label inthese other areas. I personally prefer restylane for the tear troughs because I think it is more malleable than the others and potentially leads to less risks.
The FDA only approves ADVERTISING, not actual uses
The FDA only approves what a drug or device can be ADVERTISED FOR, but the FDA [and the Canadian equivalent] do not control what a drug or device is used for once it is on the market.
The reason why additional perfectly reasonable indications for drugs and devices are not sought is that it can cost $10,000,000 or more [and take a number of years] to run the studies and deal with the legal hassles in order to be allowed to ADVERTISE a drug or device for a particular purpose, and in a lot of cases it is not worth it to the drug or device company to spend that time and money.
The physician is responsible for what a drug or device is used for.
Kevin C Smith MD FRCPC [Derm.] Niagara Falls Ontario
FDA approval and fillers
When a filler goes to the FDA for trials, usually, they only go in for one specific area because the cost of FDA trials is so expensive. For instance, Restylane was, for years, only FDA approved for the NLF lines. However, most physicians used it in the lips too. Restylane went back and got FDA approval for use in the lips in just 2011 - years and years and years after their original FDA approval. The short answer to your question is that no fillers are currently FDA approved for use in the tear trough/under eye area. However, that doesn't mean that physicians aren't using them very effectively and safely in this area.