Medical Devices

Soft Tissue Fillers (Dermal Fillers)

Soft Tissue Fillers, also known as injectable implants, dermal fillers, or wrinkle 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 nasolabial folds, cheeks and lips and for increasing the volume of the back of the hand.


Materials

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

The materials used in soft tissue 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 soft tissue 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 in the face or for the hand, calcium hydroxylapatite particles are suspended in a gel-like solution and then injected into the wrinkle in the face or under the skin in the back of the hand. The effects of this material last approximately 18 months. While in the body, calcium hydroxylapatite will be visible in x-rays and may obscure underlying features.
  • 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. When used as a soft tissue filler, PMMA beads are suspended in a gel-like solution that contains cow (bovine) collagen and injected into the face.

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Uses
Approved Uses

Soft tissue 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 soft tissue filler made from non-absorbable (permanent) material is FDA approved ONLY for the correction of nasolabial folds.

Some soft tissue 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 soft tissue fillers for lip augmentation, and one filler for cheek augmentation, in patients over the age of 21. The FDA has also approved one filler for hand augmentation.

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 amount and type of filler used. The time that the effect lasts depends on the filler material used and the area where it is injected.

 

Unapproved Uses

The FDA has NOT approved soft tissue fillers to:

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

The 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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Risks

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

Any soft tissue filler can cause long-term side effects, permanent side effects, or both. However, most side effects associated with soft tissue fillers happen shortly after injection and most go away in less than two weeks. Swelling and pain after hand treatment may last a month or more. In some cases side effects may appear weeks, months or years after injection.

Allergy testing is required for particular types of filler materials, such as those taken from animals (e.g., cows, rooster combs).

The following risks are for FDA-approved uses of Soft Tissue Fillers. The risks associated with unapproved uses are not known. 
 

  • Bruising
  • Redness
  • Swelling
  • Pain
  • Tenderness
  • Itching, rash
  • Difficulty in performing activities (only observed when injected into the back of the hand)

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)

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

  • Severe allergic reaction (anaphylactic shock) that requires immediate emergency medical assistance
  • 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 or hand
  • Vision abnormalities, including blindness
  • Stroke
  • Injury to the blood supply, 
  • Damage to the skin or the lips

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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Information for Health Care Providers
  • Do not inject soft tissue fillers if you do not have the appropriate training or experience.
  • Make sure that you are familiar with the anatomy at and around the site of injection, keeping in mind that blood vessel anatomy disclaimer icon can vary among patients.
  • Before injection, thoroughly inform the patient of all risks of the procedure and the specific product you intend to use. 
  • Note that the approved indications for use of soft tissue fillers vary depending on the product. The FDA may not have reviewed use of soft tissue fillers in some locations in the body. 
  • During injection, take extra care when injecting soft tissue fillers, such as, injecting the product slowly and applying the least amount of pressure necessary.
  • Know the signs and symptoms disclaimer iconassociated with injection into blood vessels, and have an updated plan detailing how the patient will be treated should this occur. This may include on-site treatment and/or immediately referring the patient to another health care provider for treatment. 
  • Immediately stop the injection if a patient exhibits any signs or symptoms associated with injection into a blood vessel, such as changes in vision, signs of a stroke, white appearance (or blanching) of the skin, or unusual pain during or shortly after the procedure. 
  • Tell patients that they should seek immediate medical attention after the procedure if they experience signs and symptoms associated with injection into a blood vessel. 
  • Educate facility staff and employees on how to quickly assist patients calling with signs and symptoms of filler complications on how to receive appropriate medical care.
  • Report to the FDA and the manufacturer if you become aware of any adverse event associated with the use of soft tissue fillers, including unintentional injection of soft tissue filler into a blood vessel.
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Information for Patients

Before deciding to have a procedure using soft tissue 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 soft tissue filler injection procedure. Having filler injected should be considered a medical procedure, not a cosmetic treatment. Ask your health care provider about their training and experience injecting soft tissue fillers in the face.
  • Before deciding to have soft tissue filler injections, talk with your health care provider about appropriate treatment injection sites and the risks associated with the procedure.
  • Be aware that FDA reviewed and approved different products for use in certain areas of the face. The FDA may not have reviewed the use of certain soft tissue fillers for all locations in the body.
  • Read and discuss the patient labeling for the specific filler you are receiving. Your doctor can provide this information, or you can find it on the FDA’s website.
  • Manage expectations by researching the available products and the benefits they provide. Discuss the amount of smoothing/filling effect that you expect, as well as, the amount of smoothing/filling effect that your doctor expects to be able to achieve based on your situation.
  • Seek immediate medical attention if you develop symptoms such as unusual pain, vision changes, a white appearance of skin near the injection site, or any signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms, or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion) during or shortly after the procedure.

Additionally, you should be aware that:

  • FDA approval is based on controlled, clinical study of these products when used in the face or hand.
  • The safe use of these products with Botox or other dermal (skin) therapies has not been evaluated in a controlled, clinical study.
  • The safety of these products used 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 or hand volume augmentation.
  • The safety of these products is unknown when used during pregnancy, while breast feeding or in patients under 18 years of age.
  • The safety of these products is unknown in patients who are prone to excessive scarring (keloids) and/or thick scarring (hypertrophic scars).

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

  • Your skin is inflamed or infected. If you have an active inflammatory condition, (cysts, pimples, rashes, or hives) or infection, soft tissue filler injection should be delayed until this inflammatory condition has been managed.
  • 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 soft tissue fillers that contain collagen or egg-derived products).
  • You are allergic to animal products (when considering soft tissue fillers that contain materials from animals).
  • You are allergic to lidocaine (when considering soft tissue fillers that contain lidocaine). 
  • You are allergic to bacteria (when considering soft tissue fillers that contain hyaluronic acid material derived from bacteria fermentation).
  • You have joint, tendon, or vascular disease affecting the hand (when considering hand augmentation).

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Page Last Updated: 06/26/2015
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