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Injectable Wrinkle Fillers
Injectable Wrinkle Fillers
Description
Injectable wrinkle fillers are soft tissue fillers approved as medical devices by the Food and Drug Administration (FDA) to help fill in facial wrinkles, restoring a smoother appearance. Most of these injectable wrinkle fillers are temporary, because they are eventually absorbed by the body. FDA has approved only one product that remains in the body permanently and is not absorbed.
These injectable wrinkle fillers are made of various types of materials and some include a combination of these materials. Some of these products also contain lidocaine, which numbs the skin at the site of injection.
The materials used in injectable wrinkle fillers include:
Temporary – absorbable fillers
- Collagen injections are made of highly purified cow (bovine) or human collagen. Collagen is a natural protein that is a major component of skin and other tissues in the body
- Hyaluronic acid gel is a protective, lubricating gel that is produced naturally by the body and binds with water to plump the skin.
- Calcium Hydroxylapatite is a mineral that is a major component of bone. Calcium Hydroxylapatite is a well-matched (biocompatible with living systems) material that dissolves in the body (biodegradable) and is implanted in the form of a gel.
- Poly-L-lactic acid (PLLA) is a biodegradable, biocompatible synthetic polymer from the alpha-hydroxy-acid family that has been widely used for many years in dissolvable stitches and bone screws.
Permanent – non-absorbable fillers
Uses
The absorbable injectable wrinkle fillers are FDA approved for:
- correcting soft tissue contour defects, such as moderate and severe wrinkles and folds.
The non-absorbable injectable wrinkle filler is FDA approved for:
- correcting deep folds (laugh lines) around the mouth.
Some injectable wrinkle fillers are approved for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus (HIV).
Some patients may need more than one injection to achieve the wrinkle smoothing effect. Successful results will depend on the health of the skin, the skill of the doctor, and type of filler used. The smoothing effect lasts for about six months and sometimes longer.
Risks
As in any medical procedures, there are risks involved with the use of injectable wrinkle fillers. That is why it is important for you to understand their limitations and potential risks.
Possible side effects include:
- Infection
- Bruising
- Redness
- Swelling
- Pain
- Tenderness
- Itching, rash
- Raised bumps of skin (nodules or granulomas that may need to be surgically removed)
- Skin may die if the wrinkle filler is injected and blocks a blood vessel. This may be disfiguring.
- A sore (abscess) may occur at the injection site
- The injectable wrinkle filler may break through your skin.
- The injectable wrinkle filler may move.
- Open or draining wounds may occur
- Blurred vision and flu-like symptoms
- Increased allergic reaction that may lead to a severe allergic reaction that requires immediate emergency medical assistance (anaphylactic shock)
- Your doctor may request an allergy test with the injectable wrinkle filler to determine if you are allergic to the filler.
If you choose to have these fillers removed, you may experience risks typically associated with surgery.
While the majority of the side effects associated with these fillers occur shortly after injection, in some cases the side effects may emerge weeks, months or years after injection.
Most of these side effects usually go away within seven days. All injectable wrinkle fillers may cause long-term side effects, permanent side effects, or both.
Information for Patients
Before deciding to have injectable wrinkle fillers, you should:
- Be aware that the safety of these products is unknown when used during pregnancy, in breastfeeding females or in patients under 18 years of age.
- Be aware that the safety is unknown when these products are used with Botox or other wrinkle therapies.
- Be aware that the safety is unknown when these products are used repeatedly over a long period of time.
- Be aware that the safety of these products have only been studied when in used in the face.
- Make sure you know the type of product that is being used for you and all its possible side effects.
- When considering these fillers, talk with a doctor who can refer you to a specialist in the fields of dermatology and plastic surgery.
- Select a doctor who is trained to perform the wrinkle filler injection procedure.
- Ask for Patient Labeling for the product that your doctor plans to use; this is available for some injectable wrinkle fillers.
- Have realistic expectations about the benefits you want to achieve; discuss the amount of correction that you expect and the amount of correction that your doctor expects to be able to achieve based on your situation.
- Be aware that insurance does not usually cover elective procedures such as wrinkle correction.
You should NOT use these products if any of the following applies to you:
- You have severe allergies marked by a history of anaphylaxis (acute allergic reaction)
- You are allergic to collagen or eggs
- You are allergic to lidocaine
- Your skin is inflamed or infected
- You are prone to form excessive scarring (keloids) and/or thick scarring (hypertrophic scars)
- You have a bleeding disorder
In addition, if you have an active inflammatory condition, (cysts, pimples, rashes or hives) or infection, wrinkle filler injection should be postponed until this inflammatory condition is controlled.
FDA has approved these products only as injectable wrinkle fillers. They should not be used for:
- Plumping the lips (lip augmentation)
- Increasing breast size (breast augmentation)
- Implanting into bone, tendon, ligament, or muscle
- Implantation into blood vessels, because it may obstruct blood flow
You should also know that FDA has not approved silicone, liquid or gel, for injection to fill tissues.
Information for Professionals
Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch adverse Event Reporting program online, by mail or by FAX.
Laws and Regulations
Manufacturers of injectable wrinkle fillers used in the United States are required to get FDA approval of their product before marketing. This means they must comply with the medical device regulations. For more information, see Getting to Market with a Medical Device.
Other Resources
New Device Approvals: Wrinkle Fillers
List of FDA-Approved Injectable Wrinkle Fillers
Laser Facts – Wrinkle Treatment
Updated April 16, 2009
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