Medical Devices

Dermal Fillers

Injectable facial implants, also known as dermal fillers, wrinkle fillers or facial soft tissue fillers, are medical device implants approved  by the Food and Drug Administration (FDA)  for use in helping to create a smoother and/or fuller appearance in the face, including cheeks and lips.


Materials

Most injectable dermal fillers have a temporary effect, because over time they are absorbed by the body. FDA has approved only one product made from a material that remains in the body and is not absorbed. Some dermal fillers contain lidocaine, which is intended to decrease pain or discomfort related to the injection.

The materials used in injectable dermal fillers include:

Absorbable (temporary) materials

  • Collagen: Collagen is a type of protein that is a major part of skin and other tissues in the body. Sources of purified collagen used in wrinkle fillers can be from cow (bovine) or human cells. The effects of collagen fillers generally last for 3-4 months. They are the shortest lasting of injectable filler materials.
  • Hyaluronic acid: Hyaluronic acid is a type of sugar (polysaccharide) that is present in body tissues, such as in skin and cartilage. It is able to combine with water and swell when in gel form, causing a smoothing/filling effect. Sources of hyaluronic acid used in dermal fillers can be from bacteria or rooster combs (avian). In some cases, hyaluronic acid used in dermal fillers is chemically modified (crosslinked) to make it last longer in the body. The effects of this material last approximately 6 – 12 months.
  • Calcium hydroxylapatite: Calcium hydroxylapatite is a type of mineral that is commonly found in human teeth and bones. For wrinkle filling, calcium hydroxylapatite particles are suspended in a gel-like solution and then injected into the wrinkle. The effects of this material last approximately 18 months.
  • Poly-L-lactic acid (PLLA): PLLA is a biodegradable, biocompatible man-made polymer. This material has wide uses in absorbable stitches and bone screws. PLLA is a long lasting filler material that is given in a series of injections over a period of several months. The effects of PLLA generally become increasingly apparent over time (over a period of several weeks) and its effects may last up to 2 years.

Non-absorbable (permanent) materials

  • Polymethylmethacrylate beads (PMMA microspheres): PMMA is a non-biodegradable, biocompatible, man-made polymer. This material is used in other medical devices, such as bone cement and intraocular lenses. PMMA beads are tiny, round, smooth particles that are not absorbed by the body. For dermal filling, PMMA beads are suspended in a gel-like solution that contains cow (bovine) collagen and injected into the face.

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Uses

The injectable dermal fillers made from absorbable (temporary) material are FDA approved for the correction of moderate to severe facial wrinkles and skin folds, such as nasolabial folds. Nasolabial folds are the wrinkles on the sides of your mouth that extend towards the nose. They are commonly referred to as "smile lines" or "marionette lines."

The injectable wrinkle filler made from non-absorbable (permanent) material is FDA approved ONLY for the correction of nasolabial folds.
Some injectable wrinkle fillers are approved for the restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus (HIV).

The FDA has approved two absorbable injectable wrinkle fillers for lip augmentation, and one filler for cheek augmentation, in patients over the age of 21.

Patients may need more than one injection to get the desirable smoothing/filling effect. Successful results will depend on the health of the skin, the skill of the doctor, and type of filler used. The time that the effect lasts depends on the filler material used and the area where it is injected.

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Risks

As in any medical procedure, there are risks involved with the use of injectable dermal fillers. That is why it is important for you to understand their limits and possible risks.

Most side effects associated with dermal fillers happen shortly after injection and most go away in less than two weeks.

In some cases the side effects may appear weeks, months or years after injection.

Any injectable dermal filler could cause long-term side effects, permanent side effects, or both.

Common side effects include:

  • Bruising
  • Redness
  • Swelling
  • Pain
  • Tenderness
  • Itching, rash

Less common side effects include:

  • Raised bumps in or under the skin (nodules or granulomas) that may need to be surgically removed
  • Infection
  • Open or draining wounds
  • A sore at the injection site
  • Allergic reaction
  • Necrosis (tissue death)

Allergy testing is required for particular types of filler materials, such as those taken from cows (bovine). In rare cases, severe allergic reaction (anaphylactic shock) that requires immediate emergency medical assistance can occur.

The following rare side effects have also been reported to FDA:

  • Migration/ movement of filler material from the site of injection
  • Leakage or rupture of the filler material at the injection site or through the skin (which may result from tissue reaction or infection)
  • The formation of permanent hard nodules in the face
  • Injury to the blood supply and damage to the skin or the lips if a health care provider inadvertently injects the product into a blood vessel.
  • Vision abnormalities, including blindness, when dermal fillers are used in areas around the eyes and nose

If you choose to have these fillers removed through surgery, you may experience the same adverse events typically associated with surgery. You should be aware that it may be difficult to remove the filler material.

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Unapproved Uses

FDA has approved injectable dermal fillers for treatment of moderate to severe wrinkles and localized fat loss (lipoatrophy), as well as lip and cheek augmentation in the face. The FDA has approved two absorbable injectable dermal fillers for lip augmentation, and one for cheek augmentation, in patients over the age of 21.

FDA has NOT approved injectable wrinkle fillers to:

  • Increase breast size (breast augmentation)
  • Increase size of the buttocks
  • Rejuvenate the hands or feet
  • Implant into bone, tendon, ligament, or muscle

FDA has NOT approved liquid silicone or silicone gel for injection to fill wrinkles or augment tissues anywhere in the body.

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Information for Patients

Before deciding to have a procedure using injectable dermal fillers, the FDA  recommends that:

  • You seek a specialist in the fields of dermatology or plastic surgery.
  • Select a doctor who is trained to perform the dermal filler injection procedure. Having filler injected should be considered a medical procedure, not a cosmetic treatment.
  • You know the type of product being used and all possible side effects.
  • You ask for the patient labeling for the product  your doctor plans to use. Patient labeling should be available for all FDA approved injectable dermal fillers.
  • You have realistic expectations about the benefits you want to achieve. Discuss the amount of smoothing/filling effect that you expect and the amount of smoothing/filling effect that your doctor expects to be able to achieve based on your situation.

Additionally, you should be aware that:

  • FDA approval is based on controlled, clinical study of these products when used in the face.
  • The safe use of these products with Botox or other dermal therapies has not been evaluated in a controlled, clinical study.
  • The safe use of these products repeatedly over a long period of time has not been evaluated in a controlled, clinical study.
  • Health insurance does not typically cover elective surgical procedures such as wrinkle correction.
  • The safety of these products is unknown when used during pregnancy, while breast feeding or in patients under 18 years of age.

You should NOT use some of these products if any of the following applies to you:

  • Your skin is inflamed or infected. If you have an active inflammatory condition, (cysts, pimples, rashes, or hives) or infection, dermal filler injection should be delayed until this inflammatory condition has been managed.
  • You are prone to excessive scarring (keloids) and/or thick scarring (hypertrophic scars).
  • You have a bleeding disorder.
  • You have severe allergies or have a history of anaphylaxis (acute allergic reaction).
  • You are allergic to collagen or eggs (when considering dermal fillers that contain collagen or egg-derived products).
  • You are allergic to animal products (when considering dermal fillers that contain materials from animals).
  • You are allergic to lidocaine (when considering dermal fillers that contain lidocaine). 
  • You are allergic to bacteria (when considering dermal fillers that contain hyaluronic acid material derived from bacteria fermentation).

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Page Last Updated: 08/06/2014
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