Lip filler: what it is, what the FDA says, what to ask

MedSpaGrades editorial teamUpdated 22 Oct 20267 sources checkedHow we write

Lip filler is a gel-like substance injected under the skin of the lips to make them look fuller or smoother. The FDA regulates dermal fillers as medical devices. This page says what the FDA and the American Society of Plastic Surgeons (ASPS) say about them. It does not say whether you should have them.

What it is

Dermal fillers, also called injectable implants, soft tissue fillers or wrinkle fillers, are described by the FDA as medical device implants approved to help create a smoother or fuller appearance in the face. The FDA's approved uses include increasing the fullness of the lips, in adults aged 22 and older. The FDA names other approved uses too, such as moderate to severe facial wrinkles and fullness in the cheeks, chin and back of the hand.

ASPS says fillers can plump thin lips, and the American Society for Dermatologic Surgery (ASDS), a society of dermatologists who do surgery, says dermal fillers temporarily plump lips. It lists hyaluronic acid fillers as able to redefine the lip border.

What the filler is made of

The FDA says most approved fillers are temporary because the body breaks them down and absorbs them. It names three temporary types: hyaluronic acid, a sugar found naturally in the body; calcium hydroxylapatite, a mineral and a major component of bone; and poly-L-lactic acid, a biodegradable synthetic material. It says only one approved filler is not absorbed, and that one is made with tiny plastic beads in a solution containing cow collagen.

ASPS lists these hyaluronic acid brands: Belotero, Juvederm, Restylane, Revance RHA and Revanesse. A clinic may list the products it uses on its own website. Ask which one you are being offered, and which areas it is approved for.

How long it lasts

The FDA says the effects of most approved fillers are temporary, and that the injections may need repeating to maintain the effect. It says the time the effect lasts depends on the filler material and the area where it is injected. On its list of approved fillers, the FDA says the effects of hyaluronic acid fillers last approximately 6 to 12 months. The American Society for Dermatologic Surgery (ASDS), a society of dermatologists who do surgery, says results in the lips may last about 6 months, and that outcomes vary with the product, the person's age and skin, and the injection location. Ask the provider what the patient labeling for the product says.

What to expect afterward

ASPS says recovery varies by person and by filler type. It says you can resume most activities right away, but it is generally recommended that you avoid intense physical activity for the first 24 to 48 hours to limit swelling and bruising. Your provider will tell you the plan for your treatment.

ASPS lists what you may see after any filler: an "overfilled" appearance, swelling or bruising from mild to severe, temporary numbness or redness, lumps or hard areas at the injection sites, and a reaction that can look like an allergic one, with hives and swelling. It says most of these ease with icing and massage and improve within hours or a few days, and that some reactions need medication or injections.

The FDA says most side effects, such as swelling and bruising, happen soon after injection and many resolve in days to weeks. It says some can appear weeks, months or even years later.

Risks to know before you go

The FDA says any filler can cause temporary or permanent side effects, or both. Common ones are bruising, redness, swelling, pain, tenderness, itching and rash. Less common ones include raised lumps under the skin (nodules or granulomas) that may need treatment, infection, open or draining wounds, an allergic reaction and tissue death.

The FDA says the most serious risk is accidental injection into a blood vessel. It says the chance is low, but that the complications can be serious and may be permanent. It lists tissue death, vision problems including blindness, and stroke.

The FDA also says it may be difficult or impossible to remove filler, especially a permanent one or one that is not made of hyaluronic acid. If you want filler removed or reduced because of side effects, you may need injections, surgery or other procedures, and these carry their own risks.

What the FDA warns against

The FDA says not to buy filler sold directly to the public, because it may be fake, contaminated or not approved. It says not to inject yourself with fillers or with needle-free injection "pens". It says needle-free devices are not approved for filler and that serious injuries, including permanent harm to the skin, lips or eyes, have happened.

The American Academy of Dermatology (AAD), a society of dermatologists, repeats the warning. It says some beauty bars and spas offer needle-free fillers, and that when the term is not used it can be hard to know what you are getting. It says that forcing filler into the lips this way can lead to lumpy, uneven lips, and that if filler blocks a blood vessel in the lips, skin and tissue can begin to die and you need immediate medical care. It suggests asking if you cannot tell, and says it is better to say no than risk serious injury.

What to tell your provider

The FDA says to tell your provider before treatment if your skin is inflamed or infected, or you have a bleeding disorder, severe allergies or a history of anaphylaxis. Also tell them if you are allergic to collagen, eggs, animal products, lidocaine or bacteria, since some fillers contain these.

The FDA also says some things are not known. The safety of fillers used with Botox or other treatments has not been evaluated in a controlled clinical study. Their safety over a long period of repeated use has not been evaluated either. Their safety is unknown during pregnancy and breastfeeding, in people under 22, and in people prone to excessive scarring.

Who injects it

The FDA says to work with a licensed health care provider who has experience in dermatology or plastic surgery and is trained to inject dermal fillers. It says the provider should use properly labeled, sealed vials or pre-filled syringes of FDA-approved filler. Which licensed professionals may inject fillers, and under whose supervision, depends on the state. See our guide to who may inject.

What results look like

In studies of FDA-approved dermal fillers, the FDA says people generally report they are satisfied with their treatment results. The FDA also says that successful results depend on the underlying tissue structure and the volume and type of filler used. ASPS says fillers are temporary treatments, and that ongoing treatments are needed for long-term results.

We do not show before-and-after photos on this page. If a clinic shows you photos, ask how long after treatment they were taken, and whether they were edited.

Questions to bring

The FDA says to ask your provider for the patient labeling of the filler you are offered. These questions can help you start.

What it costs

We do not give prices on this page. Our cost guide covers how clinics quote lip filler and what to ask about.

Common questions