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.

The FDA's approval is based on the review of data collected from controlled clinical studies that evaluated the safe and effective use of the wrinkle fillers when injected into specified areas of facial tissue and the hands.

Materials

Most dermal 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 dermal fillers also contain lidocaine, which is intended to decrease pain or discomfort related to the injection.

The materials used in dermal fillers include:

Absorbable (temporary) 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. Collagen is a type of protein that is a major part of skin and other tissues in the body.

Unapproved Dermal Fillers

The FDA is aware that unapproved versions of Juvederm, such as Juvederm Ultra 2, 3, and 4 have been sold and distributed in the U.S., including by online retailers. Juvederm is a prescription device that should only be injected and sold by or on the prescription of a licensed health care provider. The FDA is warning health care providers and patients not to use any Juvederm Ultra 2, 3 or 4, because these products are not approved for use in the U.S. As such, the safety and effectiveness of these products cannot be assured. A list of approved products and indications for use in the U.S. can be found in the table below.

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

Approved Dermal Fillers

When FDA approves a new dermal filler or an approved dermal filler for a new indication for use, a Summary of Safety and Effectiveness Data is published, which contains information about the non-clinical and clinical data the FDA reviewed and determined to support a reasonable assurance of safety and effectiveness. The Summary of Safety and Effectiveness Data as well as health care provider and patient labeling for each approved dermal filler may be found by searching the link below for product code "LMH" (dermal fillers for the face) and "PKY" (dermal fillers for the hand):

• PMA Database Search

It should be noted that not all of the dermal fillers listed in the above-linked database are currently marketed.

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 has issued a Safety Communication regarding the risk of using needle-free devices for injection of 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 occur shortly after injection and many resolve in a few weeks. Swelling and pain after hand treatment may last a month or longer. 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.

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:

• 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

Removal of Dermal Fillers

If you choose to have fillers removed or reduced due to side effects, you may undergo injections or surgery. 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 which typically resorb, such as hyaluronic acid (HA).

Are you considering a procedure to shape or increase the size of certain parts of your body? Beware of using injectable silicone for body contouring or any other unapproved products to achieve your goals. Injectable silicone is not approved by the U.S. Food and Drug Administration 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.

Injectable silicone is not an injectable dermal filler. Injectable dermal fillers are medical devices regulated by the FDA. Most FDA-approved dermal fillers are temporary because they are made from materials that the body eventually breaks down and absorbs. Silicone is NOT one of those materials.

The FDA has approved certain injectable dermal fillers for use in the face (for example, to enhance lips, cheeks, and contouring of the jawline,) and the back of the hand. But no dermal fillers are FDA-approved for large-scale body contouring or body enhancement.

The FDA cautions you to never get injectable silicone or an injectable filler as a breast filler, buttocks (butt) filler, or filler for spaces between your muscles.

Safety Tips

Please consider the following advice.

1. NEVER get any type of filler or liquid silicone injected for body contouring or enhancement. This means you should never get breast fillers, “butt fillers,” or fillers for spaces between your muscles. These products, which include certain types of injectable silicone, can be dangerous and can cause serious injury and even death.
2. NEVER buy dermal fillers on the Internet. They may be fake, contaminated, or harmful.
3. NEVER get injectable fillers from unlicensed providers or in non-medical settings like hotels or private homes.
4. ALWAYS work with a licensed health care provider who uses FDA-approved products for treatments. Vials should be properly labeled and sealed. If your health care provider offers a procedure using a dermal filler that is much cheaper than similar procedures using FDA-approved dermal fillers or if a product has labeling that looks strange or different than usual, beware.

More About the Dangers of Injectable Silicone

Injectable silicone is permanent and stays in your body. It can move throughout the body and cause serious health consequences, including death. In fact, when injected into areas with many blood vessels, such as the buttocks (butt), silicone can travel through those vessels to other parts of the body and block blood vessels in the lungs, heart, or brain. This can cause a stroke or even death. Large-scale injectable silicone for body contouring and enhancement can also result in a painful and hard, gravel-like substance that stays permanently beneath the skin.

Side effects can occur even years after injecting silicone in your body. Multiple costly medical and surgical interventions are sometimes needed to treat complications years after initial injection. Even then, patients may continue to have serious side effects that require ongoing treatment.

In addition, the FDA is aware of and concerned about the use of counterfeit and fraudulent versions of dermal fillers that have not been FDA-reviewed or approved for any purpose.

People are seeking treatments to smooth smile lines and crow’s feet and plump up their lips, cheeks, and hands.

Injecting dermal fillers into the face and hands can improve the appearance of facial lines and volume loss caused by age or certain medical conditions. In studies of dermal fillers approved by the U.S. Food and Drug Administration, people generally report they are satisfied with their treatment results.

However, dermal fillers are not for everyone. Dermal fillers may not be appropriate for people with certain conditions, such as bleeding disorders or some allergies. If your health care provider confirms that dermal fillers are an option for you, know that all medical products have benefits and risks. The FDA advises you work with a licensed health care provider who is experienced in injecting dermal fillers, knowledgeable about fillers, anatomy, managing complications, and most importantly, tells you about the risks and benefits before receiving treatment.

What are dermal fillers?

Dermal fillers are gel-like substances injected under the skin. Dermal fillers are meant to create a smoother or fuller appearance, or both.

The FDA regulates dermal fillers as medical devices. As reported in clinical trials, the effects of most FDA-approved dermal fillers are temporary because they are made from materials that the body eventually breaks down and absorbs. The injection procedure may have to be repeated to maintain the desired effect.

Types of dermal fillers

Temporary fillers include the following materials:

• Hyaluronic acid, a sugar that is naturally found in the body
• Calcium hydroxylapatite, a mineral and a major component of bone
• Poly-L-lactic acid (PLLA), a biodegradable, synthetic material

There’s only one FDA-approved dermal filler that is not absorbed by the body. It is made with polymethylmethacrylate (PMMA) beads suspended in a solution that contains bovine (cow) collagen. PMMA beads are tiny round, smooth, plastic beads.

FDA-approved uses of dermal fillers

Dermal fillers are approved for specific uses in people aged 22 and older. Those uses include:

• Correcting moderate-to-severe facial wrinkles and skin folds
• Increasing fullness of lips, cheeks, chin, under-eye hollows, jawline, and back of the hand
• Restoring facial fat loss in people with human immunodeficiency virus (HIV)
• Correcting acne scars on the cheek

FDA warnings about unapproved fillers

• The FDA has not approved injectable silicone or any injectable fillers for body contouring or enhancement. The FDA has warned against getting filler injected into the breasts, buttocks, or spaces between the muscles. Using injectable filler for large-scale body contouring or body enhancement can lead to serious injury, including long-term pain, infection, permanent scarring or disfigurement, and even death.

• The FDA has not approved needle-free devices for the injection of dermal fillers and warns against using them to inject hyaluronic acid or other lip and facial fillers. The injectors use high pressure and do not provide enough control over where filler will be placed. Serious injuries and in some cases, permanent harm to the skin, lips or eyes have occurred.

• The FDA also warns against buying or using lip or facial fillers that are sold directly to the public. They are not FDA approved and may be contaminated with chemicals and infectious organisms. The only FDA-approved dermal fillers are supplied by a prescription for injection by a licensed health care professional using a syringe with a needle or a cannula (a small flexible tubing with a blunt tip that is inserted under the skin).

Risks of FDA-approved fillers

As with any medical procedure, there are risks involved with the use of dermal fillers. Most side effects reported in clinical trials and post-market surveillance occur shortly after injection and go away within a few weeks. In some cases, side effects may emerge weeks, months, or years later.

Common risks include:

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

People should be tested for allergies before receiving dermal fillers made with certain materials, especially materials derived from animals, such as collagen.

Unintended injection into blood vessels
The most serious risk associated with dermal fillers is accidental injection into a blood vessel. Filler that enters a blood vessel can cause skin necrosis (death of tissue), stroke, or blindness. While the chances of this happening are low, if it does happen, the resulting complications can be serious and may be permanent.

Removing Dermal Fillers
If you want to have fillers removed or reduced because of side effects, you may need additional procedures to reduce the filler or surgery to remove it. These procedures carry their own risks. Be aware that it may be difficult or impossible to remove some filler materials.

6 Tips for Consumers About Injectable Dermal Fillers

1. Do work with a licensed health care provider who has experience in the fields of dermatology or plastic surgery and is trained to inject dermal fillers. The provider should use properly labeled, sealed vials or pre-filled syringes of FDA-approved filler.
2. Do request and read the patient labeling information on FDA-approved injectable dermal fillers from your licensed health care provider.
3. Do know the type of product to be injected and the possible risks. Know where each product you will be receiving is to be injected. Talk to your licensed health care provider if you have any questions.
4. Do not buy dermal fillers that are sold directly to the public. They may be fake, contaminated, or not approved for use in the U.S. FDA-approved dermal fillers are indicated for prescription use only.
5. Do not inject yourself with dermal fillers or with needle-free injection “pens.”
6. Do not get any type of filler or liquid silicone injected for body contouring.

Dermal Fillers and Botulinum Toxin Products

The FDA also has approved botulinum toxin products such as Botox, Dysport, Xeomin and Jeuveau to treat facial wrinkles. These products are not dermal fillers. They are injectable drugs that work by keeping muscles from tightening, so the wrinkles don’t show as much. The safe use of dermal fillers in combination with Botox and other treatments has not been evaluated in clinical studies.

Although botulinum toxin products are derived from the same bacteria that cause botulism, the amounts used for cosmetic purposes are purified and many orders of magnitude smaller.

The FDA has approved these injectable drugs for the temporary improvement in the appearance of one, or perhaps several types of facial lines, including frown lines, forehead lines, and crow’s feet.

Side effects reported in clinical trials include facial weakness, eyelid drooping, and brow drooping. Other adverse events included localized pain, swelling, reddening, and bruising at the injection site. In rare cases, injections have resulted in double vision, dry eyes, or difficulty swallowing or breathing. The injection of botulinum toxin products for cosmetic purposes is not recommended for use while pregnant or lactating.

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.