What Fillers Are FDA Approved for Use in the Tear Trough / Under Eye Area?

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?

Doctor Answers (7)

The most important question is not whether they are approved, but whether your injector can do this well!

+6

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!


Omaha Dermatologist
5.0 out of 5 stars 23 reviews

FILLERS FDA APPROVED FOR TEAR TROUGH

+5

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!

David Alessi, MD
Beverly Hills Facial Plastic Surgeon
4.5 out of 5 stars 7 reviews

FDA Approved Tear-Trough Fillers

+4

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.

Louis W. Apostolakis, MD
Austin Facial Plastic Surgeon
5.0 out of 5 stars 20 reviews

You might also like...

Fillers for tear troughs

+3

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.

Steven Wallach, MD
Manhattan Plastic Surgeon
4.5 out of 5 stars 18 reviews

The FDA only approves ADVERTISING, not actual uses

+3

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

Kevin C. Smith, MD
Niagara Falls Dermatologic Surgeon
4.0 out of 5 stars 2 reviews

FDA approval and fillers

+2

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.

F. Victor Rueckl, MD
Las Vegas Dermatologist
4.5 out of 5 stars 9 reviews

The ONLY Filler I use under the eyes in your own fat

+1
Dermal fillers are excellent for mid face volumizing and low face volume loss. What they are not indicated for are under eye hollow and tear troughs. This area of the face has thin, unforgiving skin. The dermal fillers by nature are meant to draw in water making them hydrophilic. The combination of thin unforgiving skin along with a "water binding" dermal filler is that you can be left with fluid pockets that do not go away unless injected with a hyaluronidase. Even after injection of this dermal filler dissolving agent, the prediction of where and how much dermal filler it will remove is completely unpredictable. The other down side of having dermal filler placed in such a delicate area is something called the "tyndall effect" which essentially is light reflecting off of the superficial dermal filler causing a bluish hue. This bluish hue will leave the under eyes looking darker and even more hollow. Even if one has seen a patient do well with dermal fillers immediately post procedure, these effects take days to be acquired. This is why 'before and after' photos may not present with these effect. Also there are some patients who don't experience these effect but because there is no way to predict if one will be left with permanent or lengthy unsightly side effects, a conservative experienced injector will NOT perform this procedure on their patients.

Fat grafting also required a very skilled plastic surgeon. This procedures requires expertise, specialized instrumentation, and oatience on the part of the physician. Viewing before and after photos is only the first of many steps a person needs to take before trusting someone to make a possible permanent chance to their under eye area, but viewing patient photos, each from three different perspectives with similar lighting, distance from the camera and cropping is essential. 

Michael Law, MD
Raleigh-Durham Plastic Surgeon
4.5 out of 5 stars 42 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.