Filler for nasolabial folds and marionette lines: what the FDA has approved

Nasolabial folds are the use dermal fillers were first approved for. The FDA's approval record names more than a dozen products approved for correcting moderate to severe facial wrinkles and folds, such as nasolabial folds, starting in 2003.¹

Here is what the record lists by year, what it does and doesn't say about marionette lines, and the risks. It gives no dose and no technique. Whether to have filler is for you and a clinician.

What the FDA record lists

These are some of the approvals that name nasolabial folds. Restylane came first in 2003, followed in 2004 by Hylaform and Hylaform Plus. In 2006 came Juvederm, Artefill (now Bellafill), Radiesse and Hydrelle, then Perlane in 2007 and the Evolence collagen filler in 2008. Sculptra Aesthetic was approved in 2009 for people with a healthy immune system, Belotero Balance in 2011, and Restylane Refyne and Defyne in 2016. In 2017 came Juvederm Vollure XC, Revanesse Ultra and the RHA fillers, and in 2025 Saypha MagIQ.¹ Several of the products may no longer be sold.

The record's age wording is "over the age of 21" or "22 or older," which the FDA's consumer update gives as 22 and older.² It describes fillers as gel-like substances injected under the skin, regulated as medical devices.² Our pages on Restylane, Juvederm, Radiesse and Sculptra go into individual products.

Marionette lines

The marionette lines are the lines that run down from the corners of the mouth. The FDA's approval statements that we read name nasolabial folds, and none names marionette lines. They do cover facial wrinkles and folds in general terms, and the dermatologic surgeons' society (ASDS) lists marionette lines among the areas calcium hydroxylapatite filler can treat.¹³ So ask which product is planned for them, and whether that use is on its labeling.

Risks

Common risks are bruising, redness, swelling, pain, tenderness, itching and rash. Most appear shortly after injection and many resolve in days to weeks, though in some cases side effects emerge weeks, months or years later.²

The most serious risk is accidental injection into a blood vessel. The FDA says that can cause skin necrosis (death of tissue), stroke or blindness, and that while the chance is low, the complications can be serious and may be permanent.² Reducing or removing filler may need further injections or surgery, and for some materials it may be difficult or impossible.²

Which licensed professionals may inject depends on your state. See our guide to choosing a lip filler provider, whose checks apply to any filler, and our dermal filler overview.

Here is what to bring to a consultation.

Cost

We don't give prices on this page. Our lip filler cost guide shows how clinics quote filler, per syringe.

Common questions