The FDA Warns Against the Use of Injectable Silicone for Body Contouring and Enhancement

Dermal fillers, also known as injectable implants, soft tissue 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.

• Approved Uses
• Risks
• Information for Health Care Providers
• Information for Patients

Approved Uses

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

The FDA approved a dermal filler made from non-absorbable (permanent) material ONLY for the correction of nasolabial folds and cheek acne scars in patients over the age of 21 years.

The FDA has approved some dermal fillers 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 several absorbable dermal fillers for uses such as lip and cheek augmentation in patients over the age of 21, and the correction of contour deficiencies, such as wrinkles and acne scars.

The FDA has also approved one filler for hand augmentation, which increases the volume of the back of the hands.

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 dermal 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 injectable silicone for large-scale body contouring or enhancement. Such use can lead to ongoing pain, infections, and serious injuries, such as scarring and permanent disfigurement, embolism (blockage of a blood vessel), stroke, and death.

Risks

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

Any dermal filler can cause short- or long-term side effects, permanent side effects, or a combination. However, most side effects associated with dermal fillers occur 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.

Patients should be tested for allergies before using fillers made with certain materials, especially animal materials (e.g., cow 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 side effects include:

• 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 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 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 permanent fillers removed or reduced 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.

Information for Health Care Providers

• Only use 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.
• 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 into blood vessels in the face.
• 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 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 applying 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 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 dermal fillers, including unintentional injection of dermal filler into a blood vessel.

Information for Patients

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 doctor 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.
• Do not inject yourself with dermal fillers.
• Do not purchase dermal filler products online, because they could be counterfeit products, or products not approved for use in the U.S.
• 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 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, or you can find it on the FDA's website.
• Seek immediate medical attention if you experience 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, visual changes, 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.
• 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).

Ask your health care provider for the patient labeling to help determine whether the dermal filler you are considering is appropriate for you. Carefully review the patient labeling with your health care provider if you have any of the following conditions or symptoms:

All Dermal Fillers

• 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).

Dermal Fillers Containing Certain Materials

• 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.
• You have joint, tendon, or vascular disease affecting the hand when considering hand augmentation.