Materials
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.
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 hands or 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.
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. But in some cases the 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
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
- 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.
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
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 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 soft tissue fillers, including unintentional injection of soft tissue filler into a blood vessel.
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.
- 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:
- 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 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 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).