Medication Guide App

ArteFill

Generic Name: dermal filler
Company: Suneva Medical Inc.
Treatment for: Correction of Nasolabial Folds

What is ArteFill?

ArteFill is an FDA-approved dermal filler for permanent implantation into the skin for the correction of nasolabial folds, or smile lines. It can be used in both women and men. Artefill is a non-resorbable dermal filler, unlike many other dermal fillers that are absorbed and require reinjection.

ArteFill is a combination of microsphere enhanced bovine collagen with the local anesthetic lidocaine. The microspheres are produced from a synthetic implant material called polymethylmethacrylate (PMMA) in accordance with FDA and USDA guidelines and are roughly 30 to 50 microns in size, barely visible to the naked eye. An allergy skin test is required prior to first use.

ArteFill should only be administered under the supervision of a licensed practitioner.

ArteFill Clinical Trial

A 12-month U.S. clinical trial in over 250 patients was completed in support of the approved uses for ArteFill. These trials evaluated the safety and effectiveness of ArteFill compared to another collagen control (Zyplast) for nasolabial folds. At the 6-month evaluation period, wrinkle correction with ArteFill persisted while patients treated with the collagen control returned to their pretreatment status. Wrinkle control effectiveness at one year was similar to 6 months. Safety was comparable among products. ArteFill was approved by the FDA in 2006.

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Do not use ArteFill in patients with:

  • a positive reaction to the ArteFill allergy skin test
  • a history of severe allergies, hypersensitivity, or anaphylaxis
  • an allergy to the anesthetic (lidocaine) in ArteFill
  • a history of allergies to any bovine collagen product
  • a tendency for thick scar formation (hypertrophic scars) and/or excessive scar formations (keloid scars)
  • current or planned desensitization injections to meat products
  • ArteFill is contraindicated for use in lip augmentation and injection into the vermilion or wet mucosa of the lip.

ArteFill Side Effects

As with any injectable wrinkle filler, temporary (< 24 hours) mild swelling and redness may occur at the treatment site. Bruising is usually mild and usually lasts 3 to 7 days.

  • Bruising
  • Redness
  • Swelling
  • Pain/Soreness
  • Tenderness
  • Itching
Less common side effects:
  • Rash and itching after 48 hours
  • Persistent swelling or redness
  • Injection site sensitivity
  • Lumps and/or granulomas

Patient Information1

What is ArteFill used for?

ArteFill is used to smooth moderate to severe facial folds and wrinkles from the nose to the corners of the mouth (nasolabial folds). ArteFill is meant to be a permanent wrinkle solution. It has been found to be a safe dermal filler that restores volume and fullness to the skin.

How does ArteFill work?

ArteFill is injected into the skin with an ultrafine needle. ArteFill plumps the skin to smooth away wrinkles and folds. ArteFill is composed of nonabsorbable microsphere collagen which acts to provide support for a longer-lasting wrinkle correction. Most patients see results within one or two treatments. Allergy pre-testing is required.

How long does ArteFill last?

Artefill is a non-resorbable dermal filler, unlike many other dermal fillers that are absorbed and require reinjection. Results are permanent and surgical removal of the collagen is required for reversal of effects.

Who should not use ArteFill (contraindications)?

Do not use ArteFill in patients with:
  • a positive reaction to the ArteFill allergy skin test
  • a history of severe allergies, hypersensitivity, or anaphylaxis
  • an allergy to the anesthetic (lidocaine) in ArteFill
  • a history of allergies to any bovine collagen product
  • a tendency for thick scar formation (hypertrophic scars) and/or excessive scar formations (keloid scars)
  • current or planned desensitization injections to meat products
  • ArteFill is contraindicated for use in lip augmentation and injection into the vermilion or wet mucosa of the lip.

What are the warnings or side effects to consider?

The use of ArteFill at sites with skin sores, pimples, rashes, hives, cysts, or infections should be postponed until healing is complete. Use of ArteFill in these instances could delay healing or make your skin problems worse.

ArteFill must not be implanted into blood vessels. Implantation of ArteFill into dermal vessels may cause vascular occlusion, infarction or emboli.

If you are taking aspirin (NSAIDs) or anti-inflammatory drugs or have any medical condition that affects your blood, you may experience increased bruising or bleeding at the injection sites.

In addition, you should inform your doctor if you:

  • have had any dermal filler treatments in the last 6 months
  • are receiving UV light therapy
  • are currently on immunosuppressive therapy (medication commonly prescribed for those who have undergone an organ transplant, or are suffering from rheumatoid arthritis, psoriasis, inflammatory bowel disease, cancer, or other conditions.)

What are some risks or side effects that may be experienced?

As with any injectable wrinkle filler, you can expect mild swelling and redness at the treatment site. These side effects are usually temporary.

Occasionally, there is mild bruising that typically disappears in three to seven days. Less common side effects include rash and itching more than 48 hours after treatment, persistent swelling or redness, and increased sensitivity at some or all injection sites. Two other rare potential side effects of all dermal fillers are lumps and granulomas, both of which can be treated by your physician. Be sure to call your doctor immediately if you notice any unusual skin reactions around the treatment area.

  • Artefill contains microspheres that help provide the support for wrinkle correction. The microspheres are not absorbed and can only be removed surgically.
  • The safety of Artefill in pregnant or breastfeeding women, and individuals under 18, has not been established.
  • There is always a risk of infection with any injection. Discuss the symptoms of infection with your doctor so you will be able to recognize them.

Check to see if your doctor is properly trained to provide ArteFill.

What should patients do prior to treatment?

An allergy skin test is required 4 weeks prior to first use. The skin test is a safety precaution to ensure that you are not allergic to the collagen in Artefill. Talk to your doctor about other treatment options, if needed.

Do the injections hurt?

Artefill is formulated with an anesthetic (lidocaine) for patient comfort. For additional comfort, the doctor may numb the treatment area with additional topical or local anesthetic agent.

What should I call my doctor about after the treatment?

As with any injectable wrinkle filler, you can expect mild swelling and reddening at the treatment site. These side effects are usually gone within 24 hours. Occasionally, there is mild bruising that typically disappears in 3 to 7 days. Less common side effects include rash and itching more than 48 hours after treatment, persistent swelling or redness, and increased sensitivity at some or all injection sites. Two other rare potential side effects of all dermal fillers may be lumps and granulomas, both of which can be treated by your physician.

Be sure to call your doctor immediately if you notice any unusual skin reactions around the treatment area.

What is the dose of ArteFill?

The amount used depends on your face and what you would like to have treated. The safety of injecting greater amounts than 3.5 cc per treatment site or 8.9 cc overall has not been established. Your healthcare provider will determine the appropriate amount to be injected. Larger amounts are injected based on the level of wrinkle being corrected. Most people require more than one treatment to reach the level of correction that they want.

References:

  1. ArteFill. [product insert]. Suneva Medical Inc. Inc. 2010 February.

See also:

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