Artecoll® – an injectable micro-implant for longlasting soft tissue augmentation

Our demand for a “filler” that can be injected easily, and which is biologically inert and permanent, has been a major target. Artecoll® is a novel formulation of polymethylmethacrylate (PMMA) microspheres suspended in bovine collagen which would appear to provide such an advance, in terms of permanency.
Dr. Alastair Carruthers¹

Artecoll® consists of homogenous polymethylmethacrylate (PMMA) microspheres evenly suspended 1:3 in a solution of partially denatured 3.5% collagen. All microspheres have a uniform size of 32–40 microns in diameter and have a smooth, round surface. Artecoll® contains an average concentration of 0.3% lidocaine.² Artecoll® is presently available for use in Western Europe, has been granted clearance by the HPB in Canada, but is still awaiting approval by the US FDA.

PMMA has been in common use since 1945, and is used in dental prostheses, hip implants, bone cement, intra-ocular lenses, repair material used in cranio-facial surgery as well as many other medical devices. Many studies have found it to be chemically inert and biocompatible.³ PMMA microspheres have been used for tissue augmentation since 1989, and in more than 100,000 patients worldwide, Artecoll® has shown a high degree of safety and an extremely low complication rate.

Mode of action

Artecoll® exploits the body’s natural disposition to encapsulate foreign bodies with connective tissue. The size of the microspheres hinders macrophagal phagocytosis, or dislocation within the connective tissue. In the first weeks following subdermal injection, the microspheres of PMMA are individually enclosed in connective tissue, as is the case with implants such as cardiac pacemakers. The amount of connective tissue generated often corresponds to the quantity of injected collagen previously suspending the PMMA spheres. The collagen vehicle will be degraded by the body within 1–3 months. The microspheres are expected to remain reaction-free and in place for the rest of the patients life.³ During injection, large deposits of Artecoll® should be avoided to minimize any possibility of granuloma formation.

Indications⁴

The main indication for Artecoll® implantation is the naturally occurring folds and wrinkles in the face. The ideal patient is between 40 and 50 years old, when the excess of skin does not yet justify a facelift. Artecoll® is not an alternative to a facelift but rather is an adjunct to it. Conversely, it does not interfere with later facelifting.

Dermatologic Indications for Artecoll® Implantation⁴

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Contraindications

Contraindications are a known allergy to collagen or lidocaine, and prospective patients should undergo a test implantation of Artecoll®. Thin and flaccid skin, susceptibility to keloids, and atrophic skin diseases are other contraindications. Do not use Artecoll® for atrophy or defects in subcutaneous fat, or rubberlike nodules might result and be felt for the rest of the patient’s life.⁴

Directions for use³

A degree of expertise is required for successful use of Artecoll®. It is essential that the operator be given proper instruction, ensuring subdermal placement and the best possible cosmetic result.

It is critical to inject strictly subdermally – this avoids the possibility of blanching due to microspheres being visible through the skin. Staying in the correct plane, the gray of the needle should never shine through the skin.

Cost of Therapy

Product	Volume	Cost
Artecoll®	0.5 ml The box as delivered contains 4 syringes (0.5 ml)	$350 Canadian
		$1400 Canadian (equivalent to $900 U.S.)

The volume required depends on the extent and number of wrinkles, but 1 ml is sufficient for most uses.⁴ The cost to the patient depends on the overall treatment and services provided by the physician.

Although Zyplast® is cheaper than Artecoll® initially, after one year’s treatment, because Artecoll® lasts longer, the costs become more equivalent.
Dr. Alastair Carruthers.¹

Results

In studies to date, the effects of Artecoll® are long-lasting, being still visible after 3, 4 or more years of follow-up. In two studies, ninety per cent of patients surveyed anonymously were pleased or satisfied with the results after as long as three years⁴, and in one study, 91% of patients would repeat the treatment.^5,6

Side effects

Some local discomfort may occur at the site of injection, along with transient itching which subsides within a matter of weeks. Two reports have been published concerning side effects of PMMA microsphere implants. Dr W.L. Mang of Lindau, Germany has written a critical review⁷, but the lack of specific details makes this report difficult to assess. The second publication by McClelland and others⁸, suggests that Artecoll® has the potential to elicit an immune response in humans, and that the microspheres of PMMA are susceptible to phagocytosis and elimination. Prior to 1994, Arteplast® was the PMMA microsphere product trialled. In this product, the microspheres were not uniform in size and not free of irregular particles, and injection was intradermal in some cases. With Artecoll®, the PMMA spheres are uniform in size and free of fragments, injection is sub-dermal rather than intradermal and side effects are much reduced.

Summary

When used for the proper indications, and when injected at the proper subdermal level, Artecoll® implantation provides cosmetically acceptable results for as long as four to five years. As a precaution against collagen sensitivity, an intradermal challenge should be performed. Prior instruction is advised in order to acquire a satisfactory technique.

Remember that if the plexiglass beads are wrongly placed, the patient has to live with the results. No matter what training is offered, this technique will be widely used and abused by some.
Arnold Klein⁹

Artecoll® is not suitable for treating fine lines.
Sheri Feldman¹⁰

Some precision is required in using Artecoll®, but the relative permanence of the results makes it worthwhile in properly selected patients.
Alastair Carruthers¹

References

1. Carruthers A. Personal communication. November, 1998.
2. Feldman SG. Artecoll, Bioplastique, and Beyond. In: Klein AW, editor. Tissue Augmentation in Clinical Practice. Procedures and Techniques. New York: Marcel Dekker, 1998: 293–306
3. Rofil Medical International. Artecoll® – stable microspheres for the treatment of skin defects and wrinkles.
4. Lemperle G, Hazan-Gaúthier N, Lemperle M. PMMA microspheres (Artecoll) for skin and soft-tissue augmentation. Part II: Clinical investigations. Plast Reconstr Surg 1995; 96: 627–634.
5. Summary of Artecoll clinical studies and articles. From sub-groups of patients from ref4, studied for the Ethics Committee of the University of Frankfurt.
6. Lemperle G, Gauthier-Hazan N, Lemperle M. PMMA-microspheres (Artecoll) for long lasting correction of wrinkles: Refinement and statistical results. Aesth Plast Surg 1998; 22: 356–365.
7. Mang WL, Sawatzki K. Complications after implantation of PMMA (polymethylmethacralate) for soft-tissue augmentation. Zeitschrift fur Hautkrankheiten 1998; 73: 42–44.
8. McClelland M, Egbert B, Hanko V et al. Evaluation of Artecoll polymethylmethacralate implant for soft tissue augmentation: Biocompatibility and chemical characterization. Plast Reconstr Surg 1997; 100: 1466–1474.
9. Klein AW. Personal communication. December, 1998.
10. Feldman AG. Personal communication. December, 1998.

In this issue:

1. Artecoll® – an injectable micro-implant for longlasting soft tissue augmentation
2. Unanswered Questions in Antifungal Therapy for Onychomycosis
3. Update on Drugs and Drug News - Number 2 1998