ArteFill

ArteFill (Artes Medical) is an implant composed of non-resorbable polymethylmethacrylate (PMMA) microspheres, 30 to 50 microns in diameter, suspended in a water-based carrier gel composed of 3.5% bovine collagen, in buffered, isotonic water for injection, with 0.3% lidocaine hydrochloride, 2.7% phosphate buffer, and 0.9% sodium chloride.

It is supplied in a sealed tray containing 5 syringes, 3 containing 0.8 cc and 2 containing 0.4 cc. It should be refrigerated and never frozen.

[Prior to US approval of ArteFill, predecessor products, Artecoll and Arteplast, were available outside the United States.]

Is a skin test required to use ArteFill?

Four weeks prior to treatment, patients are given a 0. 1 cc test injection of collagen intradermally in the volar forearm, to determine a patient's sensitivity to the treatment material. The patient should observe the test site daily during the 4-week test period and notify the physician immediately if any effects indicative of a positive or equivocal response are observed or if systemic effects are experienced. A positive response consists of erythema of any degree, induration, tenderness, and swelling, with or without pruritus, which can appear immediately following implantation and persists for more than 24 hours or appears more than 24 hours following implantation. An equivocal response is one in which there is no localized skin reaction, but the patient does elicit a possible systemic reaction such as a rash, arthralgia (aching joints), or myalgia (aching muscles) that occurs at any time during the observation period. If an equivocal response is observed, a second injection in the opposite arm is required, with observation for another four weeks.

Does ArteFill work to improve the appearance of wrinkles?

A clinical trial compared ArteFill to a commercially available collagen implant, using a primary endpoint of cosmetic correction at 6 months, as assessed using the facial fold assessment (FFA) scale (0-5; 0=no folds) using standardized photographs. Secondary endpoints were effectiveness at 1 and 3 months; determination of effectiveness by the treating physician (unblinded) at 1,3, and 6 months; and patient self-assessment at 1,3, and 6 months.

In patients receiving nasolabial fold implants, there was an average of 2.28 treatment session in the ArteFill group and 2.18 in the control group. At 6 month follow-up, the ArteFill treated group showed a mean change in FFA score of 0.77 versus 0.00 for the control. At one month post-treatment the scores were not significantly significant.

Curiously, on patient self-assessment there was not a statistically significant difference between ArteFill and control at 1, 3, and 6 months, with patient, on average, being "satisfied" with both treatments. Though not statistically significant, there was a trend toward higher scores in the ArteFill group.

Significant improvement versus control was not observed at other treated sites (glabellar folds, upper lip lines, and mouth corners).

What side-effects occur with use of ArteFill?

In the clinical trial, adverse events were not statistically different from control. The following adverse events occurred at an incidence of 1% or greater: lumpiness at injection area > 1 month after injection (4.6%); persistent swelling or redness (3.5%); increased sensitivity (1.8%); rash/itching >24 hours after injection (1.4%). However, a number of other adverse events occurred with lower frequency including: granuloma or enlargement of the implant; persistent swelling or redness; blurred vision; flu-like symptoms; abscess; visibility of puncture area; recurrence of herpes labialis, alopecia areata, and dry skin. Since the product contains bovine collagen, adverse effects seen with that material should be considered as well. Though not seen in the clinical trial, these include hypersensitivty to bovine collagen, severe anaphylaxis, drainage of fluid from the injection site, and nodule formation requiring excision or drug treatment.

Who should not use ArteFill?

ArteFill is contraindicated in patients with a positive skin test; severe allergies; history of multiple allergies; lidocaine hypersensitivity; history of allergy to any bovine collagen products; known susceptibility to keloid or hypertrophic scar formation; or undergoing or planning to undergo desensitization to meat products. ArteFill is contraindicated for lip augmentation or injection into the vermillion border or wet mucosa of the lips.

How is ArteFill injected?

ArteFill in injected using a 26 gauge needle, ideally into the deep dermis and not into the subcutaneous fat. According to the product label, for best results the needle should be moved back and forth 2 to 3 times beneath each skin fold while maintaining constant pressure (tunneling technique). The injection pressure is correct if the implant flows slowly and evenly, without great exertion. Gentle massage may facilitate even distribution. Successive treatment sessions at two week intervals may be necessary to achieve the desired appearance. There should be no overcorrection (i.e. correct to 100%).

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