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Injectable Cosmetic Wrinkle Fillers


Description

Injectable cosmetic wrinkle fillers are soft tissue fillers approved 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 cosmetic wrinkle fillers are made of various types of materials and some include a combination of these products. Some of these products also contain lidocaine, which numbs the skin at the site of injection.

The materials used in injectable cosmetic wrinkle fillers include:

Temporary – absorbable fillers

Permanent – non-absorbable fillers

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Uses

The absorbable injectable cosmetic wrinkle fillers are FDA approved for:

The non-absorbable injectable cosmetic wrinkle filler is FDA approved for:

Some injectable cosmetic 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.

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Risks

As in any other medical procedure, there are risks involved with the use of injectable cosmetic wrinkle fillers. That is why it is important for you to understand their limitations and potential risks.

Possible side effects include:

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. Non-absorbable fillers may cause long-term side effects.

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Information for Patients

Before deciding to have injectable cosmetic wrinkle fillers, you should:

You should NOT use these products if any of the following applies to you:

In addition, if you have an active inflammatory condition, (cysts, pimples, rashes or hives) or infection, treatment should be postponed until this inflammatory condition is controlled.

FDA has NOT approved injectable cosmetic wrinkle fillers for the following uses:

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Information for Professionals

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program online, by mail or by FAX.

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Laws and Regulations

Manufacturers of injectable cosmetic wrinkle fillers used in the United States are required to get FDA approval of their product. This means they must comply with the medical device regulations. For more information, see Getting to Market with a Medical Device.

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Other Resources

New Device Approvals: Wrinkle Fillers

List of FDA-Approved Injectable Cosmetic Wrinkle Fillers

Laser Facts – Wrinkle Treatment

Information on Cosmetics

Get the Facts: Botox

Adverse Reactions Linked to Botox

Updated February 11, 2008

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