FDA Consumer Health Information: Filling in Wrinkles Safely

Right: Being injected with dermal fillers poses some risks. The most common side effects include bruising, redness, swelling, pain, and itching. Additional side effects include: infections, lumps and bumps, and discoloration or change in pigmentation

Being injected with dermal filler

These days, people across the country are seeking treatments to smooth smile lines and crow's feet and to plump up their lips and cheeks.

One treatment involves injecting dermal fillers into the face. In studies of dermal fillers approved by the US Food and Drug Administration, people generally report they are satisfied with their treatment results.

But injectable dermal fillers are not for everyone and may not be indicated for people with certain conditions (such as bleeding disorders or certain allergies). If your health care provider confirms that dermal fillers are an option for you, know that all products have benefits and risks. The FDA advises you to work with a licensed health care provider and to understand all of the risks and benefits before receiving treatment. (See more safety tips below.)

What are dermal fillers, and how are they used?

In general, injectable dermal fillers are intended to help fill in wrinkles and give a smoother appearance. They are generally injected into the skin with a needle and are regulated by the FDA as medical devices.

Temporary fillers include the following materials:

Collagen injections, made of highly purified cow or human collagen
Hyaluronic acid gel, a protective lubricating gel, produced naturally by the body
Calcium hydroxylapatite, a mineral and a major component of bone
Poly-L-lactic acid (PLLA), a biodegradable, biocompatible, synthetic material

These products are used for correcting soft tissue defects in the face, such as moderate to severe facial wrinkles and skin folds, lip and cheek augmentation, and to restore or correct the signs of facial fat loss in people with human immunodeficiency virus (HIV). An FDA approved dermal filler is also used to fill in the back of the hand.

Most FDA-approved fillers are temporary and achieve a smoothing or "filling" effect, which lasts for about six months or longer in most people. (These injectable dermal fillers are temporary because the body eventually absorbs them.)

That said, not all products have been approved for every indication. You can find specific information on each product by reading the FDA’s list of approved dermal fillers.

The FDA has approved only one permanent wrinkle filler, which contains "polymethylmethacrylate" beads. These are tiny round, smooth, biocompatible plastic particles that are not absorbed by the body. The filler is FDA-approved only for correcting facial tissue around the mouth.

Although the FDA has approved certain injectable dermal fillers for use in the face (for example, to enhance lips and cheeks) and the hands, the FDA has never approved any injectable fillers for large-scale body contouring or enhancement.

That means you should never get an injectable filler intended as a breast filler, "butt filler," or muscle filler. And you should never get any type of injectable filler for any other large-scale body contouring or body enhancement.

Dermal fillers are not FDA approved for large-scale body contouring and can lead to serious injury, permanent scarring or disfigurement, and even death. (Read “The FDA Warns Against Injectable Silicone for Body Contouring and Enhancement” to learn more.)

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FDA Consumer Health Information: Filling in Wrinkles Safely

What are dermal fillers, and how are they used?

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