A smooth forceps is used to thread a precut, 2-mm-thick expanded polytetrafluoroethylene strip into the eye of a Wright needle. Withdrawal of the needle then assures proper subdermal placement.
Top, Left nasolabial crease with a preoperative crease severity grade of 3. Bottom, Postoperative improvement to crease severity grade 1 after 1 expanded polytetrafluoroethylene augmentation procedure.
Preoperative crease severity grade distribution.
Average number of procedures performed based on preoperative crease severity.
Average change in crease severity rating per augmentation stratified to the preoperative crease severity score.
Robertson KM, Dyer WK. Expanded Polytetrafluoroethylene (Gore-Tex) Augmentation of Deep Nasolabial Creases. Arch Otolaryngol Head Neck Surg. 1999;125(4):456-461. doi:10.1001/archotol.125.4.456
Copyright 1999 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.1999
To evaluate the safety and efficacy of expanded polytetrafluoroethylene (PTFE) (Gore-Tex; W. L. Gore & Associates, Flagstaff, Ariz) for augmentation of deep nasolabial creases.
Retrospective chart review with a minimum of 12 months of follow-up.
Private practice ambulatory surgery center.
One hundred consecutive patients (average age, 49 years) undergoing expanded PTFE augmentation of the nasolabial crease.
Main Outcome Measures
A standardized, reproducible rating scale assessed preoperative crease severity. Clinical effectiveness was determined by the numerical degree of improvement in crease severity rating after surgery, and by the number of procedures required to achieve the desired aesthetic results.
Patients initially had grade 1 (14.5%), grade 2 (54.0%), grade 3 (20.0%), or grade 4 (11.5%) crease severity ratings. On average, patients with grade 1 creases required 1.17 total augmentation procedures, those with grade 2 required 1.60, those with grade 3 required 1.93, and those with grade 4 required 1.86. On average, with each augmentation, patients with grade 1 improved 0.61 relative severity points; those with grade 2, 0.85; those with grade 3, 1.29; and those with grade 4, 1.28. Nine patients developed late postoperative sequelae. Four creases (2.0%) displayed an unnatural mounded appearance because of superficial expanded PTFE placement. All 4 creases underwent elective removal of a single superficial PTFE strip, with resultant return of aesthetically correct crease augmentation. Five creases (2.5%) developed implant site infections; in all 5 cases, the involved strips were removed and the infection was resolved with a 10-day course of oral antibiotics.
Expanded PTFE augmentation presents a safe, effective method for softening deep nasolabial creases. Patients with more severe creases are likely to show more improvement with each augmentation, but are also more likely to require multiple procedures to achieve the desired aesthetic result.
SURGICAL CORRECTION of the deep nasolabial crease continues to be a topic of numerous clinical publications. Such interest appears to address the concerns of 2 separate patient populations seeking facial rejuvenation. One subset demonstrates an exaggerated nasolabial crease as part of the total facial ptosis, with associated rounding or blunting of the cervicomental angle, and softtissue jowling along the mandibular line. These patients are classically candidates for rhytidectomy to restore a youthful neck profile and refined jawline. Correction of the deep nasolabial fold, however, is often transient and incomplete. Attempts to concurrently soften the nasolabial fold have fueled evolution of rhytidectomy modifications lo include extended subcutaneous dissection, scissors lipectomy, and fold plication. Current proponents advocate the deep plane rhytidectomy technique, as well as the subperiosteal technique, as the state of the art in rhytidectomy to additionally address the deep nasolabial crease. Yet even here, the leading surgeons have seen limitations in long-term improvement. Often, the patient and/or surgeon is pleased with the cervical aesthetic improvement but is more reserved about the results of rejuvenation of the lower midface. These patients continue to be good candidates for an adjunctive measure to improve the deep nasolabial crease.
The second patient population involves individuals with facial ptosis involving only the midface. At the time of initial consultation, these patients have maintained a well-defined mandibular line and cervicomental angle, but are dismayed about their aged perioral appearance and/or melolabial folds. Rhytidectomy is not indicated. In the past, these patients underwent collagen injection, lipotransfer, dermal or fascia grafts, or the previously noted direct crease sculpting techniques. Results, however, were tempered by graft resorption and unsightly surgical incision scars. The search for lasting, effective, tailorable measures for augmentation of deep nasolabial folds continued.
On the basis of its remarkable success in other anatomical sites, in 1993 expanded polytetrafluoroethylene (PTFE) (Gore-Tex; W. L. Gore & Associates, Flagstaff, Ariz) was approved by the Food and Drug Administration for selected augmentation sites in the human face. Since then, more than 3.5 million facial augmentation implants have been safely placed, with no report of allergy, migration, or tissue rejection.1 On the basis of these results and the reports of other facial plastic surgeons with the use of expanded PTFE, in 1994 one of us (K.M.R.) developed a method for augmentation of deep facial creases that uses expanded PTFE.
The study population consisted of the first 106 patients to undergo expanded PTFE augmentation of deep nasolabial folds. Six patients were excluded from this study because of incomplete follow-up or incomplete photographic records. The left and right nasolabial folds were independently evaluated in the remaining 100 patients, thereby yielding 200 augmentation sites at initial examination. The average patient age was 49 years.
On the basis of standard photographic documentation taken preoperatively and at regular intervals postoperatively, a 4-point grading system was developed to assess the depth of the nasolabial crease. A value of 1 was assigned to a mild crease, 2 represented a moderate crease, 3 applied to a moderately severe crease, and 4 reflected a deep nasolabial crease. Each crease was evaluated on initial examination and was subsequently reevaluated 3 months after each augmentation procedure. Three months was the required time for all postoperative edema to resolve and was the minimum time between repeated augmentation procedures. The crease depth was then observed and graded for the duration of follow-up; total postoperative observation ranged from 12 to 34 months after the last augmentation procedure.
All grading was performed by the same investigator (K.M.R.). Photographic documentation was standardized with respect to image magnification, lighting system, camera equipment, patient positioning, and photographer.
The right and left creases were then independently rerated according to the initial crease severity scale. Within each grade, we documented the average number of procedures performed as well as the average change in severity score for each procedure. Throughout the evaluation period, patients also were monitored for evidence of complications, such as infection, extrusion, or inappropriate expanded PTFE placement.
Preoperatively the patient's face was thoroughly washed of all makeup and debris with an antibacterial detergent (pHisoHex), and an oral dose of a broad-spectrum antibiotic was given. With the patient in an upright sitting position, a surgical marking pen was used to carefully delineate the length of the crease undergoing augmentation. With the use of a 3-mL syringe and a 112-inch, 30-gauge needle, the marked depression was anesthetized with 1% lidocaine with 1:100,000 epinephrine, with care taken not to distort the crease with the injection volume. A standard Wright needle was then passed just medial to the indicated line in the subdermal plane until it exited the skin at the end of the nasolabial fold. A precut strip from a 2-mm-thick expanded PTFE sheet, roughly 4 mm wide and 6 cm long, was threaded through the eye of the Wright needle and drawn back under the skin (Figure 1). The strip was then cut so that both ends retracted into the subdermal plane at the entrance and exit puncture sites. The process was then repeated 3 to 8 times as necessary to completely efface the nasolabial crease. The process was facilitated by crushing the end of the expanded PTFE strip with a needle holder for easier threading, and by passing the Wright needle just medial to the nadir of the nasolabial groove for more effective contouring. The puncture sites were sealed with microdroplets of butyl-2 cyanonacrylate.
Postoperatively, patients finished a 1-week course of oral antibiotics. No additional wound care or activity restrictions were required. Patients were informed that the initial "ropy" sensation on palpation of the surgical site would soften during a 6- to 8-week period, and that the implant process was reversible if the desired results were not obtained (Figure 2).
At the time of initial examination, most patients displayed grade 2 (54.0%) or grade 3 (20.0%) nasolabial folds (Table 1). The remainder of the patients had either grade 1 (14.5%) or grade 4 (11.5%) (Figure 3). There was no significant difference between the left and right nasolabial crease when independently evaluated for preoperative crease severity rating.
There was a distinct correlation between crease depth severity and the number of procedures required to achieve the desired aesthetic result (Table 1). On average, grade 1 creases required 1.2 procedures; grade 2, 1.6; grade 3, 1.9; and grade 4, 1.9 (Figure 4). No difference was noted in the average number of procedures required between the left and the right creases with respect to each crease severity subgroup.
Greater effacement of nasolabial creases was obtained with each subsequent augmentation (Figure 5). Grade 1 creases improved an average of 0.61 relative severity points with each procedure, while grade 2 creases improved an average of 0.85 points. Deeper creases, such as grade 3 (average improvement of 1.29) and grade 4 (average improvement of 1.28), showed more complete resolution with each individual procedure.
Complications arose in a total of 9 creases (4.5%). In 4 (2%) of these 9 cases, superficial placement of expanded PTFE resulted in a persistent, unnatural mounded appearance of the augmented crease. All 4 patients underwent elective removal of a single superficial strip of expanded PTFE, with the resultant return of a smooth, natural contour. There was no correlation between the number of procedures, the number of expanded PTFE strips in place, or the preoperative crease depth and the appearance of any subcutaneous graft-in-relief. Five creases (2.5%) developed an implant site infection. Again, there was no correlation between the likelihood of infection and the number of procedures, the number of PTFE strips placed, or the preoperative crease depth. Those patients were all culture positive for Staphylococcus aureus. In each case, the involved individual strip (or strips) was easily identified by percutaneous removal through an existing drain site or point of maximal fluctuance. In each case, only a portion of the strips required removal to resolve the infection. Antibiotic treatment required a 10-day bactericidal dose of an oral cephalosporin.
The nasolabial crease is a complex, dynamic structure that creates the normal aesthetic transition between the perioral region and the cheek facial unit. In their classic anatomical study, Mitz and Peyronie2 described the cutaneous fold as a fibrous end point of the superficial musculoaponeurotic systems (SMAS) layer. However, more detailed study of the area by Rubin et al3 has shown this to be an oversimplification. The depth of the nasolabial fold is created by a dense, fibrous layer of connective tissue. Inferiorly, this serves as a stable origin for levator and lateral retractor muscles that insert on the upper lip.3 Superiorly, the cheek fold consists of skin, abundant subcutaneous fat, and deeper midface musculature. In the fetus and newborn, the subcutaneous fat forms a complete sheath throughout the upper lip and cheek, obliterating the distinction between these 2 facial units. With development, however, the adipose tissue of the lip, chin, and nasolabial fold atrophies, while the cheek fat remains more prominent.4 The zygomaticus major, levator labii superioris,3,4 zygomaticus minor, and levator labii alaeque nasi4 muscles insert on the deep dermis of the fold to draw the lip, fold, and cheek to a more superior position. With time, the cheek fat atrophies as well, allowing the overlying skin to become more ptotic. The levator muscles also lose the resistance of this adipose tissue and deepen the fold by their more exaggerated activity.3 Anatomical studies suggest that cadavers that demonstrate a pronounced nasolabial fold will also display greater development of the midface levator muscles.4
Failure to provide long-term improvement of the nasolabial fold with rhytidectomy is anatomically based on the deep-fold fascia and its relationship with the SMAS layer. Barton5 found that the SMAS extends anteriorly to the level of the zygomaticus major muscle, where it splits to become indistinguishable from the investing fascia of the muscle. Posterior traction on the SMAS is countered by the anchored midface muscles, and, therefore, pull on the nasolabial fold is minimized. Freeing the SMAS attachment to the zygomaticus muscles improves the immediate postoperative configuration of the nasolabial crease, yet long-term improvement is conservative. There may be several explanations for this. Since the dense, fibrous foundation of the fold is unaltered, it therefore reasserts itself as elevated fold skin and simply reattaches to the underlying structures. Similarly, the levators of the fold in the midface and the levators of the lips in the perioral region are unaffected and therefore continue to contribute to fold formation. Finally, tightening of the fold complex may be lost as the skin, subcutaneous tissue, and SMAS stretch after rhytidectomy.3
Such limitations with rhytidectomy have prompted numerous modifications and adjunctive procedures to address the deep nasolabial crease. Direct excision of the redundant skin and subcutaneous tissue,6,7 suction-assisted liposuction,8- 11 fat curettage,12 and tissue advancement at the alar-facial groove13 have all been described. Rhytidectomy modifications such as direct cheek fat excision,14 sutured-in-place fat grafts,15 extended sub-SMAS dissection,5 deep-plane release of the ligamentous structures associated with the zygomaticus muscle,16,17 resuspension of the malar fat pad,18 and repositioning the midface musculature by the subperiosteal approach have all been promoted.19 Such ongoing debate suggests no clear advantage to any rhytidectomy approach when evaluated for long-term effect. As Vasconez et al20 noted after extensive SMAS and subperiosteal rhytidectomy, "There has been lasting improvement of the fronto-orbital area, but not as much in the nasolabial folds as we would like."
Nasolabial crease augmentation without rhytidectomy has also been extensively described. Medical-grade silicone21 is no longer approved for this use and has been partially replaced by fat9,10 or collagen22,23 as the material of choice for injection augmentation. Strips of dermis,24 fascia,25 or fat26 have also been threaded into the tunnels to augment the depth of the crease. The effectiveness of these materials has been limited by graft resorption, fibrosis, contour irregularities, and the need for additional harvest sites.
EXPANDED PTFE (Gore-Tex) was first introduced for use in facial soft-tissue augmentations by Neel27 in 1983. He found that the microporous, fibrillar nodules induced few or no histiocytes or giant cells at the graft-host interface, and that mature connective tissue around the implant formed a strong supporting envelope for the material. The resulting collagen incorporation stabilized the graft in the host site, yet was limited by the 30-µm pore size so that explantation was uncomplicated.28 Building on the 20-year experience with expanded PTFE for vascular procedures, numerous investigators28- 32 have unequivocally confirmed its biocompatibility when applied to subdermal augmentation in head and neck sites.
Expanded PTFE was first reported for augmentation of the nasolabial crease by Lassus in 1991.33 In that publication, he described more than 100 cases of nasolabial or facial creases treated, with only 1 infection caused by S aureus. A second study by Lassus in 1996 combined expanded PTFE with noncommunicating cheek fat liposuction to achieve the desired results.34 However, in his follow-up work, no patient data were provided, and the author noted patient improvement of only "50 to 60 percent and even more in certain circumstances." Such limited improvement may have been the result of using only a single, triangle-shaped 2-mm sheet of expanded PTFE for augmentation. In 1993, Cisneros and Singla35 used 4 bundled expanded PTFE threads to tunnel into the deep dermis of the nasolabial sulcus in 41 patients. Although the results note that no implants were removed for incompatibility, there was no mention of removal or revision for infection, extrusion, or patient dissatisfaction. In 1994, Schoenrock and Reppucci28 reported on their experience with more than 750 expanded implants placed throughout the facial and cervical anatomy for soft tissue defects. In that series, there were 2 infections in nasal sites (0.3%) and 5 cases of revision (0.7%). Nasolabial augmentation was performed by means of a closed trocar retraction technique that only allowed a single 1-mm strip of material per application. Sherris and Larrabee36 reported on their long-term experience with 41 patients who underwent expanded PTFE implantation of the lower face.36 In 212 to 412 years of follow-up, they noted 1 seroma, 1 repositioning, and 4 secondary augmentations. In 18 nasolabial folds, subcutaneous tunnels were dissected with scissors, and the wedge-shaped implants were drawn into the recipient site with alligator forceps. For deeper creases, the 2-mm implants were stacked and sutured together. Most recently, Conrad and MacDonald37 reported on nasolabial augmentation of 62 patients with prominent sulci. This technique used a 4-mm-thick, triangle-shaped implant drawn under the skin with a modified Freer elevator. Conrad and MacDonald described 3 cases of infection and other episodes of revision because of placement of the alloplast too close to the incision sites. Both complications were experienced less frequently as the techniques were perfected.
In our series, patients initially had a continuum of nasolabial crease depths. Whereas most had grade 2 (54.0%) or grade 3 (20.0%) creases, a substantial proportion still displayed grade 1 (14.5%) or grade 4 (11.5%) nasolabial creases (Table 1). The ability to stratify patients at initial evaluation provides valuable information. Such analysis can then be used to predict the relevant amount of expanded PTFE required for each augmentation procedure, the expected improvement with each augmentation, and the total number of procedures likely to be required for aesthetic satisfaction. Further analysis of the data supports this concept. Greater preoperative crease depth required a greater number of procedures to attain effacement of the sulcus. As seen in Table 1 numerically and Figure 4 graphically, patients with mild to moderate (grade 1 or 2) creases required an average of 1.17 to 1.60 procedures to attain complete augmentation. Patients with moderately severe or severe (grade 3 or 4) nasolabial depths usually required almost 2 (1.86-1.93) sequential procedures. With each procedure, the surgical end point is reached when enough expanded PTFE is placed to completely ablate the cheek-lip fold. Most secondary and tertiary operations augmented only portions of the previous creases, and often required only 1 or 2 unilateral strips to "fine tune" the ultimate result. Therefore, basing the surgical efficacy of expanded PTFE on the number of required procedures alone is misleading. Secondary and tertiary augmentations were always less extensive than the initial procedure.
The ability to tailor the amount and location of expanded PTFE placed with this technique to the crease severity results in more complete augmentation of the deep nasolabial fold. Patients with mild or moderate (grade 1 or 2) creases obtain modest but aesthetically appropriate improvement (an average change of 0.61 to 0.85 point) with each augmentation. These patients commonly required 2 to 5 strips of 2 mm each to achieve effacement of the sulcus. Moderately severe or severe (grade 3 or 4) creases require more implant material, but subsequently result in greater effacement (an average change of 1.28 to 1.29 points) (Table 1 and Figure 5). The total number of expanded PTFE strips placed per individual patient or per crease depth severity was not recorded. Variations in the length, width, and depth of each individual crease would make this information unrepresentative.
The superiority of this technique lies in its ease of minimally traumatic, exact placement of expanded PTFE in the precise sites that require augmentation. The Wright needle easily penetrates the skin surface and slides through the subdermal plane with complete control of depth and location. The expanded PTFE strips are atraumatically drawn back under the dermis without the need for suture fixation, and the strips are secured in the precise pocket created by the small needle to prevent any migration. Tactile feedback of tissue resistance during subsequent needle passes assumes accurate placement of multiple strips without disruption. The entire length of a deep nasolabial sulcus may be augmented, with additional shorter strips used to selectively and completely fill the deeper portions of the crease.
In this series, a complication rate of 4.5% compares favorably with other published studies.28- 38 The 4 cases of overaggressive augmentation occurred early in the study period in patients with severe nasolabial depths and have not been evident as additional experience with the technique has evolved. The microporous composition of the expanded PTFE allows limited tissue ingrowth; therefore, simple removal of the involved material was performed through a small stab incision with the use of a toothed forceps. No patients have required more extensive revision or removal. The unique microscopic structure of expanded PTFE also allows rapid fibrovascular ingrowth of native tissue around the implant strip. Coupled with perioperative oral antibiotics, this vascularized host tissue in and around the implant may help to explain the low infection rate of 2.5%. A recent study suggests that host tissue incorporation of expanded PTFE decreases the ability for bacterial adhesion and may serve as a conduit to deliver a competent immune response.38 In our study, antibiotic impregnation of the implant was not required, as studies have refuted the ability to transmit antibiotic solution into the graft material.28,39 With this technique, an infection rate of 2.5% is comparable with the infection rate of 1.2% found in the 1721 reported cases of facial augmentation thus far.39
With the use of the method described, expanded PTFE augmentation of the nasolabial crease is safe, effective, and versatile. Preoperative stratification by crease severity allows valuable predictive information on the amount of augmentation expected and the number of procedures required to achieve the desired aesthetic result. Patients who demonstrate deeper nasolabial creases have more substantial improvement with each implantation and are more likely to require multiple procedures.
Future studies will focus on 2 issues. The first is to investigate the long-term efficacy of this and related techniques with expanded PTFE. The material thus far appears to be an ideal soft tissue alloplast but will clearly require longer follow-up. The second issue is to compile similar evaluation of expanded PTFE in other sites of facial augmentation. Such work is currently under way.
Accepted for publication April 16, 1998.
Corresponding author: Kevin M. Robertson, MD, Division of Otolaryngology–Head and Neck Surgery, University of Wisconsin, 600 Highland Ave, H4/372 Clinical Science Center, Madison, WI 53792-3236 (e-mail: firstname.lastname@example.org).