Dr. Ziya Saylan is to be commended for his important article on the various dermal filler substances that are used in Europe but not yet approved by the Food and Drug Administration in the United States (Aesthetic Surg J 2003;23:221-224). It is always important to outline any potential problems with a new treatment option, especially when it is being considered for approval in a new market. In doing so, however, Dr. Saylan did not discuss the possibility of effectively treating these complications. This is particularly important in the case of Artecoll (Rofil Medical International B. V. The Netherlands) because complications resulting from the use of this filler have become extremely rare since it was reformulated and purified and because Artecoll may soon be approved for use in the United States and marketed under the name Artefill.

Dr. Saylan’s statement that long-term effects of the new facial fillers, “cannot be removed without surgical intervention” must be contradicted. Surgical excision of true granulomas is difficult because they invade the tissue in all directions without a capsule. Moreover, excision may be contraindicated, for granulomas may dissolve easily when treated with the appropriate dose of intralesionally applied steroid crystals. Like hypertrophic scarring or keloids, these late hyperreactions to foreign bodies react preferably to corticosteroids (eg, Kenalog). Depending on the size and extent of the granuloma, Kenalog (10 to 40 mg) injected strictly intralesionally for every 3 weeks solves most problems. Proper supervision of the patient and patience are prerequisites for effective treatment, which depends mainly on the individual patient’s reaction to the administered dose of steroids. For most patients, the treatment is completed in 3 to 6 months.

For effective treatment of granulomas, it is critical to understand the nature of a foreign body granuloma and to distinguish between a true granuloma and a simple lump. A granuloma is an implant than can appear quickly and without known reasons. It can increase to the size of a pea or bean and look reddish or bluish in the skin. Granulomas may occur after the injection of quickly absorbable, slowly absorbable, or nonabsorbable fillers, 6 to 24 months after injection. Their causes are unknown but may be related to the use of multiple injection sessions and to the presence of serious generalized infections (eg, pneumonia, pharyngitis, facial trauma). Granuloma formation has little to do with the amount of filler implanted. In treating acne scars and augmenting facial bones, for example, I have implanted up to 40 mL of Artecoll without any late reaction.

By contrast, simple lumps or nodules develop within weeks after the implantation of a filler and do not increase in size. They are caused mainly by implantation in non-indicated areas (eg., eyelids, lips) or technical problems during implantation. In the lips, development of nodules is often caused by excessive motion within the first 24 to 36 hours after injection; patients pout their lips with each chewing motion. Even if the filler substance is implanted as a smooth strand, the movement of the orbicularis oris muscle compresses the strand to a lump during the first 2 to 3 days after treatment. Therefore the use of any particulate filler substance for lip augmentation, in my opinion, should be contraindicated as long as the lip cannot be kept still for 3 days. For example, another filler substance, Radiance (BioForm, Franksville, WI), recommended for lip augmentation and used off-label in the United States, often results in the formation of hard nodules in the lips, which do not react to Kenaog injections since in general little ingrowth takes place. Unfortunately, most pathologists call every foreign body reaction a foreign body granuloma if macrophages and giant cells are involved. With some fillers (DermaLive [Dermatech SARL, Paris, France] New-Fill [Dermik Laboratories, Berwyn, PA]) Radiance; and or absorbable sutures, this reaction continues until all material is absorbed. In the case of other products (Artecoll/Artefill), this reaction slows down and becomes scar tissue formation.