Dermal Fillers (Soft Tissue Fillers)

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dermal fillers, also known as injectable implants, soft tissue fillers, lip and facial fillers, or wrinkle fillers are medical device implants approved by the FDA for use in helping to create a smoother and/or fuller appearance in the face, including nasolabial folds (the lines extending from the sides of the nose to the edges of the mouth), cheeks, chin, lips, and back of the hands.

Since some dermal fillers are naturally absorbed over time, patients may need to repeat the procedure after some time to maintain the desired effect. Successful results will depend on the underlying tissue structure and the volume and type of filler used. The time that the effect lasts depends on the filler material and the area where it is injected.

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Approved Uses of Dermal Fillers

The FDA has approved dermal fillers for use in adults 22 years of age or older (over the age of 21) for specific uses:

• Absorbable (temporary) fillers are approved for moderate to severe facial wrinkles and skin folds, such as nasolabial folds (lines extending from the sides of the nose to the edges of the mouth) and perioral lines (small wrinkles in the skin around the mouth and lips).
• Augmentation (increased volume) of lips, cheeks, chin, and back of the hand.
• Non-absorbable (permanent) fillers are approved for only nasolabial folds and cheek acne scars.
• The restoration and correction of signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus (HIV).
• Correction of contour deficiencies, such as wrinkles and acne scars.

Unapproved Uses of Dermal Fillers

The FDA recommends against using dermal fillers or any injectable filler for body contouring and enhancement to:

• Increase breast size (breast augmentation)
• Increase size of the buttocks
• Increase fullness of the feet
• Implant into bone, tendon, ligament, or muscle
• Inject the glabella (area between eyebrows), nose, periorbital area (around the eyes), forehead, or neck

These uses for dermal fillers are not approved by the FDA. 

Injectable silicone is not approved for any aesthetic procedure including facial and body contouring or enhancement. Silicone injections can lead to long term pain, infections, and serious injuries, such as scarring and permanent disfigurement, embolism (blockage of a blood vessel), stroke, and death.

Needle-free devices are not approved by the FDA for the injection of dermal fillers. The safety and effectiveness of needle-free devices for injection of dermal fillers is not known. The FDA has also not approved any dermal fillers for over-the-counter (OTC) use. The FDA is aware of serious adverse events with the use of needle-free devices for injection of dermal fillers and issued a Safety Communication (Archived) regarding the risk of using needle-free devices for injection of dermal fillers. 

Removal of Dermal Fillers

If you choose to have fillers removed or reduced due to side effects, you may need injections, surgery, or other interventions. These procedures carry their own risks. You should be aware that it may be difficult or impossible to remove the filler material, especially "permanent" fillers, or fillers that are not made of materials such as hyaluronic acid (HA).

Risks of Using Dermal Fillers

As with any medical procedure, there are risks involved with the use of dermal fillers. It is important to understand their limits and probable risks.

Any dermal filler can cause temporary side effects, permanent side effects, or both. Most side effects associated with dermal fillers, such as swelling and bruising, occur shortly after injection and many resolve in a few days to weeks. In some cases, side effects from a dermal filler injection may appear weeks, months, or years after injection.

Unintended injection into blood vessels:

The most concerning risk associated with the use of dermal fillers is unintentional injection into a blood vessel, leading to blocked blood vessels and poor blood supply to tissues. While the chances of this happening are low, if it does happen, the resulting complications can be serious and may be permanent. Complications reported include necrosis (death of tissue), vision abnormalities including blindness, and stroke.

Allergies

Patients should be tested for allergies before using fillers made with certain materials, especially animal-derived materials (for example, cow (bovine) or rooster comb).

The following risks accompany FDA-approved uses of dermal fillers. The risks associated with unapproved uses of dermal fillers, or with the use of unapproved products are not known.

Common risks include:

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

Less common risks include:

• Inflammation such as swelling or redness may develop near the dermal filler injection site following viral or bacterial illnesses or infections, vaccinations, or dental procedures 
• Raised bumps in or under the skin (nodules or granulomas) that may need to be treated with injections, oral antibiotics, or surgically removed
• Infection
• Open or draining wounds
• A sore at the injection site
• Allergic reaction
• Necrosis (tissue death)

The following rare risks have also been reported to the 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
• Injury to the blood supply due to unintended injection into a blood vessel, resulting in necrosis (tissue death), vision abnormalities including blindness, or stroke
• Death

Information for Patients About Dermal Fillers

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

• You seek a licensed health care provider with experience in the fields of dermatology or plastic surgery.
• Select a health care provider who is trained to perform the dermal 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 dermal fillers in the face and hands.
• Do not inject yourself with dermal fillers.
• Do not purchase dermal filler products online, because they could be counterfeit products or products that are not approved for use in the U.S.
• Talk with your health care provider about injection sites and the risks associated with the procedure at each site.
• Be aware that FDA reviewed and approved different products for use in specific areas of the face and hands. The FDA may not have reviewed the use of certain dermal 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.
• Seek immediate medical attention if you experience unusual pain, vision changes, a white, gray, or blue 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, visual changes, face drooping, severe headache, dizziness, or confusion) during or shortly after the procedure.
• If you ever have a problem with an FDA-regulated product—such as an injury or an issue with the way the product works—please report the problem to the FDA. The agency continues to monitor approved products for safety even after they've been sold. You can file a voluntary report by phone at 1-800-FDA-1088 or online at MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Additionally, you should be aware that:

• The FDA's approval is based on controlled, clinical study of these products when used in the face or hand.
• The safe use of these products in combination with neuromodulators ( "Botox") or other treatments 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.  Every dermal filler has a different use and expected duration of effect. Please review the individual dermal filler and its labeling for additional information.
• The safety of these products is unknown when used during pregnancy, while breast feeding, and in patients under 22 years of age.
• The safety of these products is unknown in patients who are prone to excessive scarring (keloids or hypertrophic scars).

Ask your health care provider for the patient labeling to help determine whether the dermal filler you are considering is appropriate for you.

If you have any of the following conditions or symptoms prior to the procedure, alert your health care provider:

• 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 have a bleeding disorder.
• You have severe allergies or have a history of anaphylaxis (acute allergic reaction).
• You are allergic to collagen or eggs (some dermal fillers contain collagen or egg-derived products).
• You are allergic to animal products (some dermal fillers contain materials from animals).
• You are allergic to local anesthetic such as lidocaine (some dermal fillers contain lidocaine).
• You are allergic to bacteria (some dermal fillers contain hyaluronic acid material derived from bacterial fermentation).
• You have joint, tendon, or blood vessel disease affecting the hand, when considering hand augmentation.

Information for Health Care Providers About Dermal Fillers

• Use only FDA-approved dermal fillers. The FDA urges health care providers to carefully inspect all dermal filler packages for authenticity. The FDA is aware of counterfeit products being marketed and used in the U.S: March 2017, July 2018 and October 2018.
• Do not inject dermal 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, and do not inject dermal fillers near blood vessels.
• Before injection, thoroughly inform the patient of all risks of the procedure and the specific product you intend to use.
• Be aware that FDA-approved dermal fillers are supplied by for injection using a syringe with a needle or cannula. Do not perform any dermal filler procedures with needle-free injection devices.
• Note that the approved indications for use of dermal fillers vary depending on the product. The FDA may not have reviewed use of dermal fillers in some locations in the body.
• Inject dermal fillers slowly and apply the least amount of pressure necessary.
• Know the signs and symptoms associated with injection into blood vessels and have an updated plan detailing how the patient will be treated should this occur. This plan may include on-site treatment and/or immediate referral 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 blanching of the skin, change in vision, signs of a stroke, 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.
• If you have a problem with an FDA-regulated product—such as an injury to a patient or an issue with the way the product works—please report the problem to the FDA. The agency continues to monitor approved products for safety even after they've been sold. You can file a voluntary report by phone at 1-800-FDA-1088 or online at MedWatch, the FDA Safety Information and Adverse Event Reporting program.

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