The use of expanded polytetrafluoroethylene (e-PTFE) implants in rhinoplasty

The use of expanded polytetrafluoroethylene (e-PTFE) implants in rhinoplasty

Operative Techniques in Otolaryngology (2008) 19, 285-289 The use of expanded polytetrafluoroethylene (e-PTFE) implants in rhinoplasty Michael S. God...

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Operative Techniques in Otolaryngology (2008) 19, 285-289

The use of expanded polytetrafluoroethylene (e-PTFE) implants in rhinoplasty Michael S. Godin, MD, Thomas Della Torre, MD From Michael S. Godin, MD, PLC Facial Plastic Surgery; and the Department of Otolaryngology/Head & Neck Surgery, Virginia Commonwealth University, Richmond, Virginia. KEYWORDS Rhinoplasty; Implant; Dorsum; e-PTFE; Gore-Tex

Nasal dorsal augmentation in rhinoplasty using synthetic implants remains an intensely controversial surgical practice. The authors describe their experience with expanded polytetrafluoroethylene (e-PTFE) sheeting as an implant material in rhinoplasty. A review of the literature and detailed descriptions of techniques for creating synthetic dorsal implants are offered. Alloplastic implants are powerful tools which may be used by the thoughtful surgeon in carefully selected patients to achieve nasal dorsal augmentation. © 2008 Elsevier Inc. All rights reserved.

Nasal dorsal augmentation with human-made materials remains an intensely controversial subject. The ability to augment cosmetically deficient areas of the face is a powerful tool for the facial plastic surgeon, and yet many excellent rhinoplasty surgeons argue strongly against the use of material implants.1 Autogenous cartilage is the gold standard for grafting in rhinoplasty. Adamson2 has written that “cartilage contributes the dual functions of volume filling and structural support where needed. Alloplasts should be used only for volume filling because extrusion rates are unacceptably high when they are used for structural support.” The authors of this article heartily agree. Alloplastic grafts can be used when indicated for alignment of the profile, i.e., raising the dorsum (either partially or in its entirety), and for filling in and camouflaging defects or asymmetries in the nasal contours, but they should not be used for tip support. Autogenous or homograft tissues, most notably cartilage from the nasal septum, auricle, or rib, are more appropriate choices for providing support of the nasal tip or vault when indicated. When tip support is not required from the implant and the vault is structurally sound, however, a synthetic implant can be considered. The array of synthetic materials available to the surgeon is similar to those for the chin. The nasal dorsum is a far Address reprint requests and correspondence: Michael S. Godin, MD, Department of Otolaryngology/Head & Neck Surgery, Virginia Commonwealth University, P.O. Box 980146 Richmond, VA 23298-0146. E-mail address: [email protected]. 1043-1810/$ -see front matter © 2008 Elsevier Inc. All rights reserved. doi:10.1016/j.otot.2008.03.006

more demanding location, however, and careful thought must go into making the correct decision for the patient. Although there is normally an abundant thickness of soft tissue to lie over a chin implant, this is often not the case in rhinoplasty. The importance of avoiding direct contact between graft and implant has been previously noted.3 This may lead to increased inflammatory response and graft rejection. Thicker nasal skin is thus more forgiving when an implant is placed beneath it. Great care must be taken to choose the best material and to shape it to an inconspicuous implant that blends well with the rest of the nasal bone and cartilage in thin patients with thinner skin. This is also true in revision cases in which scar tissue obscures planes of dissection and where the implant may lie in close proximity to, or even contact the dermis. Autogenous materials are almost always preferable in this situation. On the other hand, in primary rhinoplasty patients with normal or thick skin who require significant dorsal augmentation, a synthetic implant can be very helpful. One study of expanded polytetrafluoroethylene (e-PTFE) implants revealed a 5.4% incidence of graft infection in revision patients, necessitating removal, that was more than 4 times greater than the incidence of infection (1.2%) in patients undergoing primary rhinoplasty.4 The same authors reported a high rate of complications in patients with pre-existing septal perforations and regarded them as an absolute contraindication to placement of synthetic dorsal grafts. A thorough esthetic analysis includes a detailed history, examination of the nasal interior and exterior, and review of

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Operative Techniques in Otolaryngology, Vol 19, No 4, December 2008 Table 1

Characteristics of the ideal implant Biocompatible Natural feel Resistant to infection Not capable of transmitting disease Resistant to migration Readily retrievable Easy to shape and secure Long record of safety and reliability

Figure 1 Lateral view demonstrating the approximate position of placement of a single layered e-PTFE implant. (Color version of figure is available online.)

front, oblique, lateral, base, and reverse nasal views with the patient to understand his or her preferences and expectations. If dorsal augmentation is selected, a determination should be made concerning whether the entire dorsum, or only a portion of it requires augmentation. The most common partial augmentation that the authors perform is a radix graft, which is used to fill in a gap from the nasion to the upper slope of the bony hump. Because of the relatively small area involved, autologous septal or conchal cartilage is almost always used. It is important to consider the appearance not only from the lateral aspect but also from the front and lateral views when carving this graft because it is easy to leave it too wide and create a visible edge. As demonstrated in Figure 1, when augmentation of all or most of the dorsum is required and the skin is thick enough to cover well, a synthetic graft can be a good choice. Figure 2 shows before and after results for a patient who had a disproportionately low dorsum and a “polly beak” appear-

ance of the nasal tip as the result of poorly performed rhinoplasty. The balance between tip height and dorsal height is always a crucial one in rhinoplasty. In addition to restructuring of the tip, she underwent dorsal grafting with synthetic material to bring the dorsum into proper alignment with the tip. When selecting the material for any type of implantation, it is wise to consider how well it compares with a list of favorable characteristics (Table 1). The material should first and foremost be highly compatible with the tissues that it will lie in approximation to, whether that is bone, muscle, fat, dermis, or even the submucosa of the oral or nasal cavity epithelium. The material should be readily available and not prohibitively expensive. It should not be capable of transmitting disease, which is to say that if it is derived from an animal or human source steps have been taken to assure that the material cannot harbor bacteria, viruses, or prion proteins. The implant material should be inherently resistant to infection. It must feel natural in the area it is placed. It is ideal if the implant will fix in place strongly enough to prevent migration but not so much that it cannot be removed if infection necessitating its removal occurs.5 The ideal material would be easy to shape and secure. Finally, the ideal implant material would have a long history of safety and longevity after implantation into human tissue.

Figure 2 Revision rhinoplasty patient who received augmentation of the full length of the dorsum with e-PTFE as well as nasal tip restructuring to improve nasal harmony. Patient also received an e-PTFE chin implant. Photos show the patient (A) preoperatively and at (B) 1 and (C) 12 years postoperatively. (Color version of figure is available online.)

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Types of implants The materials most commonly used to fabricate nasal dorsal implants are the same as those most commonly used in creating chin implants. They are e-PTFE (Surgiform Technology, Columbia, SC), Medpor (porous polyethylene; Porex Surgical, Newnan, GA), and Silastic (Polymethyl Silicone; Dow Corning, Midland, MI). Although each material has its specific benefits and enthusiastic proponents, the senior author has been using e-PTFE implants for 15 years with excellent results and reliability.

e-PTFE Originally produced under the trade name Gore-Tex, e-PTFE facial implants were manufactured by W.L. Gore and associates (Flagstaff, AZ). In the Fall 1996, the company announced its decision to discontinue the manufacturing of e-PTFE implants for facial cosmetic and reconstructive applications. According to company officials, this decision reflected no problems with clinical use of the material or for that matter, with its popularity. The company continues to manufacture e-PTFE for other medical uses and has shifted its entire focus to cardiac and vascular surgery applications. This came as a bit of bad news for surgeons who had come to rely on e-PTFE as a facial skeletal implant because of its excellent durability, natural feel, supreme ease of contouring, and biocompatibility. Fortunately, 2 companies, Surgiform Technology Ltd of Columbia, South Carolina (www.surgiform.com) and Implantech of Ventura, California (www.implantech.com), have since gained approval from the Food and Drug Administration to manufacture and distribute e-PTFE implants in the United States. Both companies currently have the ability to sell this material in sheet form, and neither offers a preformed e-PTFE implant. e-PTFE is microporous, with an average internodal space of 20 to 40 ␮m (in Gore-Tex), which should allow sufficient ingrowth of tissue to prevent migration while preventing more robust tissue incorporation that would occur with a porous implant or mesh material. Therefore, if necessary it can be removed without undue trauma to surrounding tis-

Figure 3 Lateral view demonstrating placement of a carved, multilayered e-PTFE implant. (Color version of figure is available online.)

Figure 4 Illustration demonstrating a typical shape of a nasal dorsal implant with beveled edges to reduce contour irregularities. (Color version of figure is available online.)

sues. e-PTFE sheets are soft and pliable, and the material performs well on bone and when contacting fat or muscle. It should not be placed in contact with dermis as an inflammatory reaction frequently occurs. e-PTFE has been used successfully in nasal augmentation, with follow-up of more than 10 years reported.4 It also has an enviable record of reliability in chin augmentation.6 A 2003 report of pooled data by 6 facial plastic surgeons revealed a complication rate of less than 1% in 324 patients.7 e-PTFE has been an excellent implant material that is close to the ideal in many ways.8,9

Surgical technique Dorsal implants can be introduced though a closed or open approach. It is the authors’ preference to place most of these through an open approach, but if a closed one is chosen certain safeguards must be taken. It is important to place the intranasal incisions in such a way that they do not lie directly beneath a synthetic graft. Thus an intracartilaginous incision is not appropriate if the entire dorsum is being grafted. If transnasal placement is desired, an infracartilaginous incision can be made and dissection performed over

Figure 5 Intraoperative photo demonstrating carving of the implant with a beveled #10 blade. (Color version of figure is available online.)

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Operative Techniques in Otolaryngology, Vol 19, No 4, December 2008 occurrence of this has been reported to be as low as 2.6% with Medpor, 3.2% with e-PTFE, and as high as 10% with Silastic.10-12 Such patients are aggressively treated with antibiotics and drainage if infection occurs. If extreme thinning of the skin develops and extrusion seems imminent, or if the infection cannot be controlled, removal of the implant with as little trauma to the nasal skin as possible should be considered. If the implant can be removed through the nose, additional trauma to the skin may be avoided. Healing usually occurs quickly once the implant is removed and the patient will require reassurance during this period. As with autologous and homograft materials, displacement of the implant or gradual thinning of the skin with increased prominence of the graft and visible telangiectatic vessels in the overlying skin may also occur.

Summary Figure 6 Top view demonstrating multilayer Gore-Tex implant. Note that mattress sutures are placed at 90° angles to prevent movement of the individual layers relative to one another. (Color version of figure is available online.)

the lower and upper lateral cartilages and bony dorsum to create a pocket for the implant. Antibiotics are used in the same way as described above in the section on chin augmentation. The implant is carved to the appropriate shape and placed on the dorsum so that it extends from the nasion to the anterior septal angle (Figure 3). Before placement of the implant, any dorsal irregularities, including small humps, can be reduced. It is important to remember that the dorsal skeleton must have a somewhat convex shape to appear straight when the skin, which is thin at the rhinion but thicker in the supratip and nasion, lays on it. A 4-0 monofilament polypropylene suture is used to secure the caudal end of the implant to the cartilage of the anterior septal angle. This end should not project above the lateral crurae and domes. It is also important to make the implant inconspicuous by creating a bevel along the edges of whatever type of material is chosen using a blade and sterile carving block (Figure 4). Preparation of an e-PTFE nasal implant of the proper size is crucial, and can be constructed by stacking of 2-mm e-PTFE sheets. This can be performed before the surgical procedure in an appropriately sterile field. As seen in Figure 5, the 2-mm sheets are cut with a #10 blade taking care to bevel the blade to avoid any contour irregularity. These sheets can then be combined by stacking and suturing of the sheets using 4-0 Prolene sutures with the knots “buried” to lie against the dorsal bone and cartilage. Mattress sutures are placed at right angles to one another to prevent individual movement of the sheets relative to each other (Figure 6).

Complications The most feared complications of dorsal augmentation are extrusion and infection resulting in loss of the implant. The

Alloplastic materials in general and e-PTFE in particular afford the rhinoplasty surgeon a powerful tool for improving cosmesis. Such implants have a well-demonstrated record of safety and efficacy in the medical literature, and yet there are drawbacks to synthetic materials which the surgeon and patient must be aware of before surgery occurs. When considering a synthetic implant, the surgeon must consider if an autologous, homologous, or animal-derived material would better serve the patient’s needs. If the answer to this question is no, then the task at hand is to select the best material available for the specific facial site. Knowledge of the advantages and disadvantages of each type of material implant material should help guide selection of the proper material. When used in conjunction with proper preoperative planning, surgical technique, and postoperative care, the surgeon can often deliver consistent and pleasing results.

References 1. Tardy ME: Rhinoplasty, in Cummings CW (ed): Otolaryngology-Head and Neck Surgery. St. Louis, CV Mosby Company, 1986, pp 699-749 2. Adamson PA: Grafts in Rhinoplasty. Arch Otolaryngol Head Neck Surg 123:561, 2000 3. Schoenrock LD, Repucci AD: Correction of subcutaneous facial defects using Gore-Tex. Facial Plast Surg Clin North Am 2:373-387, 1994 4. Godin MS, Waldman SR, Johnson CM: Nasal augmentation using Gore-Tex: A ten-year experience. Arch Facial Plast Surg 1:118-121, 1999 5. Maas CS, Gnepp DR, Bumpous J: Expanded polytetrafluoroethylene (Gore-Tex soft tissue patch) in facial augmentation. Arch Otolaryngol Head Neck Surg 119:1008-1014, 1993 6. Godin M, Costa L, Romo T, et al: Gore-Tex chin implants: A review of 324 cases. Arch Facial Plast Surg 5:224-227, 2003 7. Stucker F, Shaw G, Ephrat M: Biologic tissue implants, in Papel I (ed): Facial Plastic and Reconstructive Surgery (ed 2). New York, Thieme Medical Publishers, 2002, pp 61-72 8. Quatela V, Sabini P: Synthetic Implant, in Papel I (ed): Facial Plastic and Reconstructive Surgery (ed 2). New York, Thieme Medical Publishers, 2002, pp 73-78

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9. Porex Surgical Products Group: MEDPOR Biomaterial Implants. Available at: http://www.porexsurgical.com/english/surgical/smedpor. asp. Accessed August 2007 10. Deva AK, Merten S, Chang L: Silicone in nasal augmentation rhinoplasy: A decade of clinical experience. Plast Reconstr Surg 102:1230, 1998

289 11. Davis PK, Jones SM: The complications of silastic implants. Br J Plast Surg 24:405-411, 1971 12. Romo T, Sclafani AP, Sabini P: Use of porous high-density polyethylene in revision rhinoplasty and in the platyrrhine nose. Aesth Plast Surg 22:211-21, 1998