Transoral injection of Restylane SubQ for aesthetic contouring of the cheeks

Transoral injection of Restylane SubQ for aesthetic contouring of the cheeks

SUPPLEMENT Transoral Injection of Restylane SubQ for Aesthetic Contouring of the Cheeks Giuseppe Sito, MD Dr. Sito was formerly Clinical Professor in...

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Transoral Injection of Restylane SubQ for Aesthetic Contouring of the Cheeks Giuseppe Sito, MD Dr. Sito was formerly Clinical Professor in the Department of Anatomy at the Second University of Naples, and is a member of the Italian Society of Cosmetic Surgery and the American Academy of Facial Plastic and Reconstructive Surgery.

For malar augmentation procedures with Restylane SubQ, the transoral route of injection offers some advantages over the transdermal route. It allows ready access to the zygomatic periosteum, avoids the need for identification of soft tissue fascia planes and detachment of muscle, and reduces the risk of damage to important nerves and blood vessels and resulting hematoma. By using the transoral technique, the possibility of visible local complications (edema and ecchymosis) can be reduced. Use of this injection route does not appear to increase the risk of introducing infection into the soft tissues, and prophylactic antibiotic use is considered unnecessary, although good oral hygiene is important and mouth washing should be encouraged. In summary, the transoral method of Restylane SubQ injection is as reliable as the transdermal route, and this approach is likely to appeal to patients because of its lower risk of inflammatory reactions following treatment.

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acial attractiveness is associated with regularity of facial features, harmony between the nose, chin and malar eminence, and pronounced convexity and concavity in the facial profile.1 Aesthetic judgments of facial shape and profile are generally consistent across different racial and ethnic groups, 2 and a prominent malar eminence is universally regarded as a hallmark of female beauty. Thus, facial profile studies among both Japanese and Caucasian subjects (male and female) have highlighted the importance of high cheek bones to female attractiveness.3 In keeping with this observation, soft tissue augmentation of the malar region for improving malar projection is one of the most frequently performed aesthetic surgical procedures. Flattening or depression of the malar eminence may arise through disease, trauma, or congenital deformity of the craniofacial skeleton,4 as well as through facial aging, a condition marked by progressive thinning of facial subcutaneous fat and bone resorption. Subjects who may benefit from malar augmentation include those with posttraumatic depressions, congenital deformities, the flat “dish face,” the aged face, the round and full face, and the unbalanced face.5 Numerous techniques for corrective and augmentative malaroplasty are detailed in the literature, including an intraoral surgical approach that eliminates the potential for facial and infraorbital nerve damage,6 and these techniques can be used either alone or in combination with face lift, lower blepharoplasty,

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rhytidectomy, or chin augmentation procedures. Malar augmentation has been accomplished by means of autologous materials such as bone, cartilage, and soft-tissue grafts,7 and a variety of alloplastic materials including ceramic, metal, acrylic, polytetrafluoroethylene (PTFE), high-density polyethylene (HDPE), and silicone.8–10 Resorbable soft tissue fillers such as collagen and hyaluronic acid have increasingly been used in recent years for correction of fine and deep facial wrinkles. Following intradermal injection, non-animal stabilized hyaluronic acid (NASHA) provides a more durable aesthetic effect than bovine collagen or avian hyaluronic acid11-13 and a potentially lower risk of inflammatory reactions. Restylane SubQ is a new NASHA product that is intended for subcutaneous implantation to replace lost volume in the cheeks and chin, thereby creating a more sculpted facial contour. In cheek augmentation procedures, the product is usually injected via the transdermal route. We report here a less invasive technique for cheek augmentation with Restylane SubQ, based on transoral injection.

Materials and Methods Between April and December 2004, a total of 52 patients (44 women and 8 men) aged 20 to 58 years requesting malar augmentation were treated with Restylane SubQ. At the initial evaluation, patients underwent facial profiling, and the degree of malar

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Figure 1. Hinderer’s lines are 2 intersecting lines—one drawn from the ala to the tragus and the other from the oral commissure to the lateral canthus. The implant is placed in the upper outer quadrant. Reproduced with permission from Constantinides et al.8

prominence was assessed objectively from measurement of Peck’s (nasal, maxillary, and mandibular) and Holdway angles.14 The most suitable sites for malar region augmentation were identified using the Hinderer technique15 and the Powell technique.16 In the former case, the site for volume augmentation is identified from 2 intersecting lines—one running from the tragus to the ipsilateral alar cartilage of the nose, and the other from the ipsilateral canthus to the labial commissure (Figure 1).15 The implant position is represented by the upper outer quadrant as defined by the crossed lines. In the latter case, the site for volume augmentation corresponds to the point of intersection of the horizontal and most lateral of the 4 Powell lines—a vertical line drawn from the nasion to the nose tip, a curve joining the 2 tragi and dividing the previous line in half, a line running from the lateral canthus to the ipsilateral alar cartilage of the nose, and a line (parallel to the previous one) drawn from the tragus to the ipsilateral oral commissure (Figure 2). All patients underwent local anesthesia and/or infraorbital nerve block prior to treatment with Restylane SubQ. Local anesthesia of the proposed mucosal injection site was obtained through infiltration of local anesthetic (mepivicaine 2%) into the upper gingival fornix, whereas direct anesthesia of the infraorbital nerve was achieved by transcutaneous injection of local anesthetic (mepivicaine 2%) at a point 0.5 to 1.0 cm below the midpoint of the lower margin of the orbit (Figure 3). In the transoral technique, after mouth rinsing and administration of local anesthesia, a mucosal incision was made with a No. 11

Transoral Injection of Restylane SubQ for Aesthetic Contouring of the Cheeks

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Figure 2. Powell’s analysis of the malar eminence. A vertical line from the nasion to the nasal tip is bisected with a curved line from the tragus to the ear; this line locates the vertical position of the malar eminence. Two other lines are drawn; the first extends from the ala to the lateral canthus, and the second is drawn from the lateral commisssure parallel to the first. The point where the most lateral line crosses the horizontal defines the most aesthetic location for the malar eminence. From Larrabee et al,14 with permission.

blade in the upper gingival fornix at the level of the second incisor/canine junction (Figure 4, A). Restylane SubQ was then placed supraperiosteally over the zygomatic bone using a blunt 18-gauge Coleman infiltration cannula (Byron Medical Inc, Tucson, AZ) (Figure 4, B-D). A multiple-tunneling technique was used to allow diffuse placement of small aliquots (~0.1 mL) of the product at discrete sites within the treatment area. The product was modeled during the injection procedure to assist contouring of the malar region. Twelve patients underwent subcutaneous treatment with Restylane SubQ via the transdermal route; the product was injected in a volume ranging from 1.0 to 2.8 mL (mean 2.0 mL) on contralateral sides of the face. In the remaining 40 patients, Restylane SubQ was implanted above the zygomatic periosteum using the transoral route of injection.

Results Patients were highly satisfied with the cosmetic result obtained with Restylane SubQ, regardless of the route of administration (transdermal or transoral). Both injection

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Figure 3. (A) Local anesthesia of the mucosal injection site is achieved through infiltration of mepivicaine, 2% into the upper gingival fornix; (B) direct anesthesia of the infraorbital nerve is achieved by transcutaneous injection of mepivicaine, 2% below the lower orbital margin.

procedures were well tolerated, with only 6 out of the 40 patients (15%) injected transorally reporting discomfort (burning sensation or “tension”) in the first few hours after treatment. Of the group of patients receiving Restylane SubQ via the transdermal route, 2 experienced transient hematoma (this resolved spontaneously within 7 days), and 3 patients demonstrated prolonged erythema (3 days’ duration). No patients in either group experienced product lumping, product mobility, or other treatment complications. The Restylane SubQ implants remained clinically stable for up to 10 months, and no treatment-site infections were reported. Representative aesthetic results obtained with transorally administered Restylane SubQ are illustrated in Figure 5. The patient shown in Figure 5 is a previously untreated 42-year-old woman with Fitzpatrick type 3 skin who underwent cheek augmentation with Restylane SubQ (1.8 mL on each side).

Discussion Clinical findings from this noncontrolled study suggest that Restylane SubQ is an effective alternative to permanent alloplastic implants for malar augmentation. Although lacking the permanent aesthetic effect of the latter materials, Restylane SubQ offers a minimally invasive implantation procedure that avoids the need for hospitalization and general anesthesia. Initial results obtained in this limited number of patients would also suggest that the transoral injection technique allows a more homogenous distribution of Restylane SubQ than the transdermal technique, leading to a more satisfacto-

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ry aesthetic result.17 The transoral injection technique not only produces less soft tissue trauma, but also has the advantage of causing no erythema and minimal edema in the postoperative period. Moreover, by injecting through the oral mucosa rather than the skin, visible wounds (and potential facial scarring) are avoided, and the patient is able to apply make-up immediately after the procedure. Although the volume of Restylane SubQ used in the present study was generally in accordance with the manufacturer’s instructions, some patients with particularly flat malar areas received injection volumes in excess of 2 mL. Over-correction should be strictly avoided; if the initial aesthetic outcome is suboptimal, a touch-up procedure may be performed 4 to 6 weeks later. For cheek augmentation, Restylane SubQ should be placed below the margin of orbicularis oculi, taking care to avoid the orbital septum, and in contact with the zygomatic bone. Infiltration above the plane of orbicularis oculi should be avoided to prevent possible pooling of the implant, as should infiltration at the level of the peribuccal fat, as the septum is very thin and may fail to retain the product. Massage of the implant (by the practitioner, not the patient) may be considered if redistribution of the implant material is necessary. In the opinion of the author, antibiotic prophylaxis is not considered necessary when injecting Restylane SubQ via the transoral route, as the salivary proteins (notably lysozyme, lactoferrin, and peroxidases) exert a bacteriostatic or bacteriocidal effect and may be considered to provide a first line of defense in the oral cavity. 18–19

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E Figure 4. The transoral injection technique involves (A and B) placement of a microincision in the upper gingival fornix with minimal bleeding; (C) insertion of a Coleman infiltration cannula below the muscular plane, to the periosteum; (D) micro-deposition of Restylane SubQ at the injection site, and modeling of the product between 2 fingers of the contralateral hand to assist malar contouring; (E) control of any residual bleeding in the oral cavity.

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F E Figure 5. A, C, E, Pretreatment views of a 42-year-old patient. B, D, F, Posttreatment views 10 months after undergoing cheek augmentation with Restylane SubQ (1.8 mL injected on each side) via the transoral route of administration and facial skin rejuvenation (hydration) with Restylane Vital.

However, as is the case when inserting dental implants, use of a cyclohexidine-based mouthwash is advisable immediately prior to transoral injection of Restylane SubQ. If antibiotic prophylaxis is considered necessary, a third-generation cephalosporin can be administered. As with any injection, patients may experience bruising or bleeding at the injection site; hence, patients should be advised to cease treatment with nonsteroidal antiinflammatory drugs or aspirin 10 days prior to Restylane SubQ administration.

Conclusion For malar augmentation with Restylane SubQ, transoral injection offers several advantages over transdermal injection, including a potentially lower risk of implant mobility. The transoral route allows ready access to the zygomatic periosteum, avoids the need to detach muscle, and reduces the risk of damage to important nerves and blood vessels, and resulting hematoma. Use of this injec-

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tion route does not appear to increase the risk of soft-tissue infection, and prophylactic antibiotic use prior to Restylane SubQ treatment is unwarranted where patients have good oral hygiene and no recent history of dental treatment. Because the transoral injection technique avoids the need for cutaneous incision and may reduce the likelihood of visible local complications (edema and ecchymosis), patients may prefer this technique to the standard transdermal approach. The author thanks Mario Boltri, MD, and Giada Spagnoli, MD, for their valuable assistance and cooperation in the conduct of this research. References 1. Sergl HG, Zentner A, Krause G. An experimental study of the esthetic effect of facial profiles. J Orofac Orthop 1998;59:116-126. 2. Bernstein IH, Lin TD, McClellan P. Cross- versus within-racial judgements of attractiveness. Percept Psychophysiol 1982;32:495-503. 3. Perrett D, May K, Yoshikawa S. Facial shape and judgements of female attractiveness. Nature 1994;368:239-242.

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4. Tessier P. The definitive plastic surgical treatment of the severe facial deformities of craniofacial dystosis: Crouzon’s and Apert’s diseases. Plast Reconstr Surg 1971;48:419-442.

Copyright © 2006 by The American Society for Aesthetic Plastic Surgery, Inc.

5. Mladick RA. Alloplastic cheek augmentation. Clin Plast Surg 1991; 18:29-38.

doi:10.1016/j.asj.2005.09.013

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6. Jabaley ME, Hoopes JE, Cochran TC. Transoral Silastic augmentation of the malar region. Br J Plast Surg 1974;27:98-102. 7. Wolfe SA, Vitenas P. Malar augmentation using autogenous materials. Clin Plast Surg 1991;18:39-54. 8. Constantinides MS, Doud Galli SK, Miller PJ, Adamson PA. Malar, submalar and midfacial implants. Facial Plast Surg 2000;16:35-44. 9. Metzinger SE, McCollough G, Campbell JP, Rousso DE. Malar augmentation: a 5-year retrospective review of the Silastic midfacial malar implant. Arch Otolaryngol Head Neck Surg 1999;125:980-987. 10. Maas C, Merwin G, Wilson J, Frey MD, Maves MD. Comparison of biomaterials for facial bone augmentation. Arch Otolaryngol Head Neck Surg 1990;116:551-556. 11. Narins RS, Brandt F, Leyden J, Lorenc ZP, Rubin M, Smith S. A randomized, double-blind, multicenter comparison of the efficacy and tolerability of Restylane versus Zyplast for the correction of nasolabial folds. Dermatol Surg 2003;29:588-95 12. Lindqvist C, Tveten S, Bondevik BE, Fagrell D. A randomized, evaluator-blind, multicenter comparison of the efficacy and tolerability of Perlane versus Zyplast in the correction of nasolabial folds. Plast Reconstruct Surg 2005;115:282-9 13. Carruthers A, Carey W, De Lorenzi C, Remington K, Schachter D, Shapra S. A randomized, double-blind comparison of the efficacy of two hyaluronic acid derivatives, Restylane Perlane and Hylaform, in the treatment of nasolabial folds. Dermatol Surg 2005;31(11 Pt 2): 1591-1598. 14. Larrabee WF, Makielski KH, Henderson JL, editors. Surgical Anatomy of the Face. 2nd ed. Philadelphia, PA: Lippincott, Williams & Wilkins; 2003:176-177. 15. Hinderer UT. Malar implants for the improvement of facial appearance. Plast Reconstr Surg 1975;56:157-165. 16. Powell NB, Riley RW, Lamb DR. A new approach to evaluation and surgery of the malar complex. Ann Plast Surg 1988;20:206-214. 17. DeLorenzi C, Weinberg M, Solish N, Swift A. A multicenter study of the efficacy and safety of subcutaneous Restylane in aesthetic facial contouring: an interim report. Dermatol Surg 2006;32:208-215. 18. Tenovuo J, Lumikari M, Soukka T. Salivary lysozyme, lactoferrin and peroxidases: antibacterial effects on cariogenic bacteria and clinical applications in preventive dentistry. Proc Finn Dent Soc 1991;87:197208. 19. Van Nieuw Amerongen A, Bolscher JG, Veerman EC. Salivary proteins: protective and diagnostic value in cariology? Caries Res 2004;38:247253.

This supplement is funded through sponsorship by Q-Med. Restylane SubQ is not approved for any use by the US Food and Drug Administration. Dr. Sito acts as a consultant for Q-Med AB, Uppsala, Sweden. Accepted for publication September 14, 2005. Reprint requests: Giuseppe Sito, MD, Via della Cavallerizza 14, 80121 Naples, Italy

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