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Press Room

Artecoll for Facial Soft Tissue Injection

Abstract

Artecoll is a permanent, injectable, soft tissue filler composed of uniform polymethyl methacrylate microspheres in a bovine collagen gel which has been used in Europe over the past decade 1,2,3. We report our experience with Artecoll, now available in Canada, as an injectable material for the correction of deep static folds of the face, improvement of nasal asymmetries following rhinoplasty and augmentation of the lip 1,4. A total of 109 patients over a four year period were treated with Artecoll injections with follow-up ranging from 6 to 42 months. We reviewed 74 patients who underwent lip augmentation, 21 patients augmentation of deep nasolabial folds, 8 patients augmented glabellar folds, and 6 patients treated for minor nasal dorsal irregularities.

There was no early or delayed allergic response noted. 10 of the lip augmentation group noted mild bruising after injection, which resolved completely within a week. Within the lip augmentation group 38 of the 74 had detectable implant by palpation. However only 5 patients, in the lip augmentation group, required further intervention with massage, steroid injection, and/or local excision to correct for lumpiness. Local excision was carried out only on 2 patients who failed to respond to steroids and massage therapy over 6 months of treatment. Within the study group a total of 11 patients had minor asymmetries or less than optimal results. Lip augmentation was the commonest treatment area with complications. For other sites the commonest complaint was under correction of fold or wrinkle.

Our initial experience suggests that Artecoll is a safe, viable option for the long-term treatment of deep facial wrinkles, nasal asymmetries, and hypo plastic or atrophic lips. In our experience the results have a high degree of patient satisfaction. In lip augmentation the implant often can be palpated but rarely causes significant palpable lumps. Its use and applications are continuing to increase and certainly warrant further investigation as an injectable agent to correct other functional or aesthetic deficiencies of within the head and neck.

Introduction

Artecoll is an injectable implant composed of two components commonly used in both aesthetic and reconstructive surgery. 25% of Artecoll is composed of microspheres of polymethyl methacrylate (PMMA) 2,4,5.  PMMA has had the most extensive use in dentistry and orthopedic surgery where it is largely utilized as a biocompatible cement 6,7. The remaining 75% of Artecoll is composed of bovine collagen.  A trace amount of lidocaine is also included in the formula for Artecoll to help dull local discomfort during injection.  In non-allergic patients, injectable collagen has had a long track record of use as a temporary soft tissue filler.  In Artecoll, the role of collagen is that of a temporary carrier of the microspheres of PMMA as it is deposited in tissues. 

The goal of depositing the PMMA microspheres in the tissue is to elicited fibrosis in the form of microcapsules around each sphere and thereby achieves a more permanent tissue filling or augmentation.  The largest experience with its use is in Europe where it appears that Artecoll has been a viable permanent tissue filler with minimal complications in comparision with other forms of tissue fillers 1,2,4,5.  We review our experience with the efficacy of Artecoll as a soft tissue injectable implant in four common clinical scenarios: 1) deep nasolabial folds, 2) static glabellar grooves, 3) lip augmentation and 4) post-rhinoplasty  dorsal irregularities.

Materials and Methods

Patients seeking cosmetic improvements for deep glabellar grooves, prominent nasolabial folds, atrophic lips, or post-rhinoplasty dorsal asymmetries were treated with Artecoll.  All patients were screened for previous history of reactions to collagen products.  Unless patients had a previous history of collagen use they were given a collagen allergy skin test on the volar aspect of their arm. They were re-inspected after 4 weeks for evidence of allergic reactions.  If tolerated, we proceeded to address specific areas of cosmetic concern.  All risks of allergy were disclosed and patient’s informed consent was obtained.

All patients in the study met study inclusion criteria.  No patient had a history of collagen vascular disease. All patients had not been previously injected with semi permanent or permanent filler. Patients were undergoing correction of one esthetic unit only.  Patients had no adjunct therapy except for Botox used only in the sub group treated for glabeller lines. Patients had no history of collagen allergy.

Our method of Artecoll injection is similar to that described elsewhere 1,2.  Firm, steady pressure was applied to the syringe during injection and the implant was placed as required to achieve aesthetic goal.  Conceptually, small tunnels in the tissue were created with each passage of the needle to create space for the deposition of Artecoll.  If great resistance is encountered during injection, the needle was withdrawn and replaced with a new needle to avoid the potential of uncontrolled delivery of the tissue filler boluses.  The specific fold as well as a few millimeter borders on each side of the fold was injected with avoidance of over correction; the goal during the injection was to raise the folds to a height equal with the peripheral skin surface.  Following injection, fingertip massage to facilitate a more even distribution of the substance was performed.  Patients were instructed afterwards to place cold compresses to the area for comfort.

We used local anesthesia xylocaine 1% with 1 in 100000 epinephrine prior to injection of Artecoll. Improvement of glabellar lines was accomplished with supraorbital/supratrochlear nerve blocks and injection through (27 or 30 g) needles in a subdermal and deep intradermal plane.  For nasolabial folds, infraorbital nerve blocks were performed.

The locations for injection of Artecoll in lip augmentation varied depending upon the effect that was desired.  Prior to injection, field blocks of the gingivobuccal sulcus for the upper lip injection and a mental nerve block for lower lip injections were performed to avoid distortion of the red lip.   To improve atrophic vermillion borders, Artecoll was deposited in multiple tunnels parallel to the vermillion at the subdermal level; for eversion off the incisors and added projection, the wet line was injected subcutaneously.  When greater body of the lip was desired, artecoll placement into the mid-lip was performed. Again, the goal was even correction rather than over-correction.  Massage was also performed to improve contouring. 

Asymmetries of the nasal dorsum in patients following rhinoplasty were corrected with Artecoll injection. All patients in this group were a minimum of 12 months post rhinoplasty surgery.  We created multiple subdermal tunnels in a fan-like fashion with an overlapping grid pattern in the region of the deformity addressed.

The decision for a subsequent addition of Artecoll, if needed, would follow a waiting generally period of 4 months.  Since Artecoll was utilized mainly for static lines, patients with a significant component of dynamic folds in the glabellar region were also simultaneously or sequentially given Botox injections.

Results

A total of 109 patients over three years were injected with Artecoll. None demonstrated allergic response to Artecoll on testing. 74 patients desired lip augmentation; 21 nasolabial fold augmentation and 8 patients glabellar folds augmentation, 6 patients underwent treatment of dorsal irregularities following rhinoplasty. Average follow up was 17 months with a range from 6 to 42 months.

Of the 74 patients in the lip augmentation group, 19 patients only had upper lip injection; 11 patients, lower lip only; and 44 patients, combined upper and lower lip injection. 108 of 118 lips required only 1 vial of Artecoll. The remaining 10 lips required up to 2 vials. Patients experienced minimal discomfort during injection and in the immediate post-injection period. 68 of the 74 patients reported complete satisfaction with the outcome. Artecoll appeared to be a permanent filler, maintaining good volume on subsequent follow-up for at least 1year in all patients. On palpation, the areas injected with Artecoll appeared in most patients to blend into surrounding tissues smoothly. However in 38 of the lip augmentation group we could detect a texture to the lip which would suggest implant augmentation. However we only noted 5 patients who had exhibited localized lip lumpiness that caused patient awareness of the implant. Lump formations or palpable lip deformities were treated with massage and Kenalog injection. These measures failed in 2 patients who subsequently underwent excision of the palpable lip defect under local anesthesia. No sequelae resulted.

A total of 21 patients had treatment of there nasolabial folds. A total of 40 folds were filled. Two patients required unilateral injections only. We used one vial in 13 folds, 2 vials in 23 folds, and 3 vials in 4 folds. A significant number of nasolabial folds required up to 2 vials for satisfactory improvement of the folds at the initial injection. Deep nasolabial lines subjectively did not respond as well as mild to moderate lines. While maintaining good volume over time, the implants did not demonstrate an unnatural induration or nodularity to palpation. Overall satisfaction of this patient group was 18 of 21 patients treated. The three patients who were not totally satisfied all felt there was some improvement but had wished for a more significant change. These patients had deferred further treatment.

A total of 14 glabellar folds in 8 patients were injected. All glabellar folds required on average less than one vial for complete treatment. In 4 patients with excessive muscular activity causing prominent dynamic frown lines, the glabellar region was adjunctively treated with botulinum toxin injection 2 weeks prior to injection with Artecoll. Six of eight patients treated in this group expressed satisfaction from Artecoll injection. The two patients who were not completely satisfied had persistent linear lines into the dermis, which was not completely effaced by the artecoll.

Six patients were treated for minor asymmetries of the nose post rhinoplasty. All patients were treated at least 12 months following rhinoplasty surgery. On average, less than one half of a vial was needed for each patient. All patients in this group were satisfied with treatment.

A total of 11 patients expressed a less than complete satisfaction with artecoll of the 109 patients in the study group.

Discussion

The multitude of soft tissue fillers used for effacement of wrinkles and tissue augmentation attests to the fact that an ideal tissue filler does not exists 8,9,10,11,12. The ideal tissue filler should be easy to administer, non-immunogenic, biocompatible, predictably permanent, identical in texture to surrounding tissue, and affordable. The downside of most biological fillers is resorption over time. Bovine collagen injection disappears with time, necessitating periodic injections 12. A small percentage of patients are not candidates secondary to allergic reactions to bovine collagen. Homologous collagen in the form of Alloderm, which is processed human dermis also, resorbs with time although a certain volume of tissue does remain from replacement by host tissue. In lip augmentation, Alloderm can leave a palpable as well as visible implant. Autologous fat injection requires harvesting and processing of fat and subjects the donor site to small but not insignificant risks. Despite reports of autologous fat injection approaching 100% survival, the majority of clinicians note unpredictable fat graft takes and do not consider fat injection as a permanent filler 8,10. In anticipation of resorption, both fat and collagen injection and Alloderm placement require the operator to over-correct, resulting in a period of swelling in the patient that is difficult to camouflage.

Although permanent, injectable allograft implants like silicone can subject patients to chronic inflammation and often leave tissue with an unnatural appearance and texture. Silicone injections, which are oil based, may have a greater tendency to spread beyond the intended areas of treatment. It is difficult to reverse the effects of silicone injection and thus, should be used with caution. Finally injectable silicone is currently prohibited in Canada.

Gortex, used in lip augmentation or the effacement of nasolabial folds, allows ingrowth of host tissue but often remains palpable and unnatural in texture. Occasionally, gortex can also leave visible margins. Finally use of gortex for small defects is less practical than the use of semipermanent or permanent injectable products.

Acrylic Hyrdrogels have recently been used as an alternative semipermanent injectable. Products such as DermaLive and Dermadeep are composed of hyaluronic acid and acrylic. The hyaluronic acid makes up 60 percent of the product and acts as the carrying fluid vector for the acrylic. It has no collagen and therefore needs no allergy testing. Its use has been in Europe since 1998 and requires careful evaluation of its results 13.

PMMA microspheres are suspended in a gel of collagen in Artecoll. Since it is anticipated that the collagen is resorbed, its role is that of a vehicle for smooth delivery and even dispersal of the PMMA spheres. PMMA has a long and proven track record for use as a biocompatible material. Since its invention by Rohm in 1902, PMMA has been used in orthopedic surgery, dentistry, neurosurgery and ophthalmology. The immunologic inertia of PMMA is best demonstrated in orthopedic surgery where it has been used as cement for over 50 years.

PMMA microsphere-induced granulomatous reactions are rare 14. 15 This is attributed to the uniform size (30-40 ?m), purity, and smooth, polished surface of the spheres, which prevent phagocytosis, by macrophages. There have been only 10 reported cases of granuloma formation reported to the manufacturer since its introduction in Europe in 1993. There has been no reported granuloma formation reported in Canada since its introduction in 1998.

Histological studies demonstrate that over a 2 to 3 month period, the collagen is phagocytized and degraded by macrophages and replaced by host collagen laid down by fibroblasts. This fibrotic tissue is essentially composed of multiple small capsules surrounding each individual PMMA sphere, analogous to the capsule surrounding breast implants. The maintenance of tissue filling is attributed to this "mesh" of fibrous capsular tissue encompassing these colonies of microspheres. Based on serial histologic specimens and computerized calculations, it is estimated that 75-100% of the initial injected volume is maintained and this volume becomes stable indefinitely at approximately 4 months. Long-term follow up of up to 4 years demonstrates no significant change in tissue volume.

The most extensive clinical experience with use of Artecoll as a skin and soft tissue filler comes from Europe where it has been in use for approximately 10 years. Lemperle et al. treated 2000 patients for static lines and lip augmentation and prospectively reported on the initial 100 patients. 90% of patients were satisfied with their results in long-term follow-up to 5 years; less than 2% expressed dissatisfaction 1,2,4. In addition to the indications reported here, Artecoll has also been used by European practioners for nipple reconstruction, tear trough or naso-orbital grooves, and chin augmentation. Other reported uses for Artecoll have been for treatment of functional problems (vocal cord paralysis, cleft palate, velopharyngeal insufficiency, urinary incontinence).

Acute complications, which have been previously reported elsewhere and noted in some of our patients, include echymoses and erythema, which lasted a few days, and itching which, can take several weeks to resolve. None of our patients had an allergic reaction. The delayed complication of lump formation was noted in 5 (4.6%) patients, all of who had undergone lip augmentation. Palpable implants do not appear to be a problem for treatment of folds or dorsal irregularities.

The main limitation of the use of Artecoll appears to be its cost and lip lumpiness. Placement of Artecoll in locations with thin skin, such as the periorbital region is also to be done with caution. It must be stressed to patients the indications and limitations of the product and the possible need for adjunct therapies to achieve optimal results.

There has been some discussion in the medical community about the role of massage for prevention of lump formation. Some surgeons recommend use of massage of the lips over the first few days after injection. The belief was that massage would spread artecoll evenly within the subcutaneous space and avoid lump formation from initial poor technique. Others believe that there is a propensity for lump formation as a result of the obicularis activity pushing the implant in the clumps similar to pearl formation. Therefore massage may conteract the obicularis muscle and reduces lumpiness. Finally there have been suggestions that the adjunct use of Botox in low doses into the obicularis may reduce the clumping of artecoll and therefore be useful to prevent lumpiness. These theories are all speculative and require further evaluation.

Overall, our experience indicates that Artecoll is a permanent, injectable filling agent that is biocompatible and results in relatively natural tissue texture and appearance. Our study had a high complete satisfaction rate of 97 of 109 patients treated. As it becomes more available in North America, it warrants consideration from clinicians as a viable option for the treatment of facial wrinkles and folds, soft tissue augmentation, nasal irregularities, and depressed scars.

Bibliography

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2. Lempel G, Hazan-Gauthier Nelly and Lemperle M. PMMa Microspheres for skin and soft tissue augmentation Part 11: Clinical Investigations. Plastic and Reconstructive Surgery 96:627,1995.
3. Nishan T, Klinische Studie uber die Biokompatibilitat von PMMA- Mikrospharen in der Haut. This, Johann Wolfgang Goethe University, Frankfurt /Main, Germany, 1995.
4. Lemperle, G, Gauthier-Hazan, Lemperle M, PMMA-Microspheres for Long- Lasting Correction of Wrinkles: Refinements and Statistical Results. Aesthetic Plastic Surgery 22:356-365,1998
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6. Convery F. R, Gunn D.R, Hughes, J.D, and Martin W.E. The Relative Safety of Polymethylmethacrylate, Journal of Bone Surgery, 57-A:57.1975.
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8. Ersek R.A, Transplantation of purified autologous fat: A 3 year follow-up is disappointing. Plast Reconstructive Surg. 87:219, 1991.
9. Silver, W.E. Injectable silicone: Previous use and current status (Editorial). Facial Plast Surgery 8:1, 1992.
10. Coleman SR: Facial recontouring with lipostructure. Clinical Plastic Surgery 24: 347,1997
11. Matti B. A/ Nicolle F.Y. Clinical use of Zyplast in correction of age and disease related contour deficiencies of the face. Aesthetic Plastic Surgery 14:227,1990.
12. Knapp TR, Kaplan EN, Daniel JR, Injectable collagen for soft tissue augmentation . Plast Reconstructive Surgery. 60:398,1977.
13. Bergeret-Galley C, Latouche X, Illouz Y-G, The Value of a New Filler Material in Corrective an Cosmetic Surgery: DermaLive an DermaDeep: Aesthetic Plastic Surgery 25:249-255, 2001
14. Lemperle G. Ott h, Charrier u, Hecker J, Lemperle m. PMMA microspheres for the intradermal implatntation: Part 1: Animal research. Ann. Plastic Surgery 26:57,1991.
15. Nischan T. klinische Studie uber die Biokompatibilitat von PMMA Mikrospharen in der haut, Thesis, Johann Wolfgang Goethe University, Frankfurt Main, Germany, 1995.
 

Author

Dr Philip Solomon MD, FRCSC
Private practice Toronto Ontario Canada.  Lecturer Dept Otolaryngology, University of Toronto


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