Patient Tolerance of Expanded Polytetrafluoroethylene Augmentation in Cheek-Lip Grooves and Lips

Patient Tolerance of Expanded Polytetrafluoroethylene Augmentation in Cheek-Lip Grooves and Lips:

An Eight-Year Experience

Elbert T. Cheng, MD1

Stephen W. Perkins, MD, FACS2,3

Richard Castellano, MD3

1 Elbert T. Cheng, MD, Private Practice, Center for Facial Plastic Surgery, 877 W. Fremont Ave. G1, Sunnyvale, CA 94087-2392.

2 Address for correspondence and reprint requests: Stephen W. Perkins, MD, FACS, Private Practice, Meridian Plastic Surgery Center, 170th W 106th Street, Indianapolis, IN 46290.

3 Dept. of Otolaryngology-Head & Neck Surgery, Indiana University School of Medicine, Indianapolis, IN.

Telephone number: (317) 575-0330

Email address: SWPerkins@aol.com

Fax number: (317) 571-8667

Abstract

Objective: This study examines the safety, efficacy and satisfaction of expanded polytetrafluoroethylene (ePTFE) augmentation in the upper and lower lips and cheek-lip grooves (nasolabial creases) of 176 patients over an eight-year period (1994-2002) placed by the senior author (SWP).

Materials: An exhaustive retrospective review was undertaken reviewing all patient charts in duplicity by two of the authors (ETC and RC); and individually following-up with each patient who had surgical augmentation to the lips or cheek-lip grooves. Objective data was collected regarding number of infections and revisions performed from the charts; subjective data was collected by telephone interview or personal follow-up of each patient regarding patient satisfaction, difficulties with kissing, talking, eating, chewing, smiling and dysesthesias. Follow-up was successfully performed in 91 of 176 (51.7%) patients. Statistical significance was performed for all factors utilizing two different statistical models (i.e. chi-squared and multivariate analysis) to determine chance of random occurrence versus truly meaningful significant data.

Results: Individuals implanted with Advanta noted an increased incidence of dysesthesias, which was found to be statistically significant by chi-squared testing (p=0.013) and again confirmed by multivariate analysis. Significance was noted for patients who had a history of depression. These patients were more likely to be dissatisfied with their lip augmentation (p=0.0003) when compared to patients without a history of depression. Patients who complained of difficulty smiling or laughing often had removal and replacement of the lip augmentation (p=0.025). Objective results demonstrated a low rate of overall infection for patients (2.9%) with a high percentage of patients requiring revision surgery to improve implant placement or degree of augmentation (25.6%). A high percentage of patients had complications (23.9%). Subjective results revealed 71.1% of patients with augmentation of the lips were satisfied; 1 in 3 patients reported a change in sensation of the lips, difficulty smiling, or asymmetry; 10.7% acknowledged difficulty with talking, eating, chewing; 7.4% complained of a difference with kissing. Subjective results for cheek-lip groove patients demonstrated a satisfaction of 58.3% of patients; 1 in 3 patients also complained of noticing asymmetry of cheek-lip grooves; 16.2% of patients complained of sensation changes; no patients had difficulty with kissing, talking, eating, chewing; only 2.5% patients complained of difficulty smiling.

Conclusion: This paper is the largest collection of patients undergoing ePTFE implantation into the lips or cheek-lip grooves with the longest follow-up. It is the first paper in the literature applying rigorous statistical analysis to its data to identify significant functional and sensory changes after implantation. ePTFE is a well tolerated material in the lips and cheek-lip grooves, with a low rate of infection, requiring occasional revision surgery to improve upon implant placement. Lip augmentation leads to an increased percentage of sensation and smiling difficulties. Significance was noted in patients complaining of difficulties smiling or laughing. These patients often had their initial implants removed and replaced. Patients given Advanta implants into the lips or cheek-lip grooves experienced a statistically significant increase in incidence of dyesthesias (changes in sensation, numbness, or pain). In selecting patients, patients with a history of depression may not be satisfied with their lip augmentation. As a result of these findings, the senior author (SWP) has modified his preoperative evaluation of this select group of patients as well as his surgical lip implantation procedure. A more extensive preoperative education on the realistic expectations of lip augmentation and its risks involved in patients with a history of depression is performed prior to placement of the ePTFE implant; splitting the lip implant in the midline is performed in anyone with a tight upper lip.

Introduction

Over the past twenty years, the literature has consistently documented the safety of ePTFE for facial augmentation in both animal and human studies.1-4 Since 1993, Gore-Tex (W. L. Gore and Associates, Flagstaff, AZ) received approval from the Food and Drug Administration (FDA) for use in elective facial cosmetic and reconstructive surgery. The indications are well defined and include rhinoplasty, malar augmentation, lip augmentation, facial slings, orbital repair, facial folds, mentoplasty, maxillary augmentation, auriculoplasty, and frontal defects.8 Advanta (Atrium Medical Corporation, Hudson, New Hampshire) received approval in December 1999 from the FDA for facial augmentation. (personal communication, Atrium Medical Corporation)

In 2000, the American Academy of Facial Plastic and Reconstructive Surgery reported 64,700 filler and fat injections for augmentation in the facial region and 13,200 lip augmentations performed.5 The average cost of lip augmentation in the United States is $1778; the average cost of filler injections is $419; the average cost of fat injections is $1466. 5 This translates into a market over $60 million dollars in 2000.

The literature is lacking in long-term studies utilizing rigorous statistical analysis looking specifically at patient tolerance (kissing, dysesthesias, asymmetries, satisfaction). This paper attempts to complement the existing literature on ePTFE. This body of work reemphasizes the safety of this non-degradable and synthetic product in the lips and cheek-lip grooves. As surgeons, we continue to strive for refinement of existing techniques to improve patient satisfaction and tolerance.

Materials and Methods

From January 1995 to January 2002, 176 patients, 162 women and 14 men, underwent augmentation of the lips and/or cheek-lip grooves. The procedures were broken down into: 24 patients with both upper and lower lips, and bilateral cheek-lip groove augmentation, 91 patients with bilateral cheek-lip groove augmentation, 53 patients with upper and lower lip augmentation, 7 patients with upper lip augmentation, and 1 patient with lower lip augmentation. Age ranged from 24 to 76 years (mean age-48.7 years; median age - 49). Follow-up for all patients ranged from a minimum of 3.8 months to a maximum of 7.9 years. The mean length of follow-up for all patients was 3.5 years and the median length of follow-up was 3.1 years.

A retrospective review was undertaken by thoroughly reviewing 176 patient charts. Independently, two of the authors (ETC and RC), reviewed the charts to ensure accuracy of the data collected. After the chart review was completed, follow-up was obtained either in the office or by telephone inquiry. 91 (51.7%) patients were successfully followed-up. At the follow-up, a standard list of questions were asked regarding: overall satisfaction with the implant, dyesthesias, difficulty with talking, eating, chewing, smiling, noticeable difference in kissing, noticeable asymmetry, adequate augmentation, and would they recommend this procedure to a friend.

FileMaker Pro software was utilized for data entry and analysis. To discern correlations between the data sets, chi-squared tests were performed in Excel. Specifically, chi-squared comparisons were made between the following categories: history of tobacco usage, complication (infection, migration, asymmetry, bothersome palpability, or significant sensation of tightness), migration, removal, HSV, HTN, history of headaches, depression or antidepressant usage, implant type (advanta, goretex, goretex and alloderm in combination), and survey responses. All p-values less than or equal to 0.05 found in chi-squared tables were further analyzed in multivariate analysis models developed in SPSS Software Version 10.0 (Table VI). Responder bias was found in the number of survey responses per patient, as interviewees sometimes did not answer all 9 questions within the survey. All responses were included in the data analysis, however, this resulted in an unequal number of patient responses per question. Survey responses were analyzed as an entire group and also as sub-categories of responses for patients with only cheek-lip groove implants or only lip implants.

Surgical Techniques

Permanent lip augmentation was performed with multi-strand Gore-Tex from 1995-2001 and Advanta over the past 12 months. Stab incisions are performed in the mucosal surface of the lip approximately 1 cm medial to the oral commissure grooves. The subcutaneous tunnel is created using either a Wright needle or trocar device (Figure 1A and B). Removal of the Wright needle allows passage of a tendon passer in the same tunnel. The predetermined piece of ePTFE, which has been soaking in bacitracin and gentamicin solution, is placed in the grasp of the tendon passer (Figure 2) and pulled through the lip in a retrograde fashion (Figure 3). (The senior author initially placed multiple 1 and 2 mm cut strips of 2mm thick Gore-Tex into lips and cheek-lip grooves. When a pre-fashioned 10 multi-strand piece was introduced by the company, the senior author switched over to reduce the number of malpositions. Beginning in 2001, Advanta was introduced as a permanent implant with the a more natural feel, the senior author utilized the 3.5 mm oval implant for lip and cheek-lip groove implants.) Clamps are attached to both ends of the implant to allow for adjustment of position. Careful stretching of the overlying skin over the implant and decreasing tension on the implant decreases recoil postoperatively. The ends are trimmed in a beveled fashion (Figure 4). Stab incisions are closed with 6-0 mild chromic. If postoperative tightness of the lip is anticipated, a separate midline stab incision is performed on the mucosal surface with splitting of the implant.

For cheek-lip groove augmentation, the patient’s groove is marked in the sitting position. The groove is displaced after the patient is recumbent on the operating room table (Figure 5). Two stab incisions are performed, one in the inferior aspect of the cheek-lip groove and the other in the nasal vestibule. A subcutaneous tunnel is performed with the trocar device from the inferior stab incision to the nasal vestibule (Figure 6). The subcutaneous tunnel is performed medial to the groove because the implant ultimately fixates higher in the cheek-lip groove than expected at the end of the procedure. The straight alligator is threaded through the subcutaneous tunnel and the implant material is pulled retrograde from nasal vestibule to inferior groove. The implant is always soaked in antibiotic solution prior to placement. A similar method of clamping the implant and stretching the skin overlying the skin is performed to prevent recoil. Intravenous preoperative antibiotics are given as a prophylaxis against infection for both procedures and the patient continues cephalosporin prophylaxis, orally, for four days.

Results

176 patients received implants into lips, cheek-lip grooves, or both anatomic sites. Table III summarizes the data from the chart review. Chart review revealed 5/176 (2.8%) patients had a post-operative course complicated by infection; 42/176 patients had a complication (23.9%); 13/176 (7.4%) patients experienced migration of the implant, 8/13 of these patients underwent revision surgery to correct the position of ePTFE; 5/176 (2.8%) patients felt their implant was palpable to a bothersome degree, and all of these patients underwent surgery to correct this complaint; 3/176 (1.7%) patients complained their implant was visible; 2/176 (1.1%) patients complained of tightness of the lip; 3/176 (1.7%) patients reported asymmetry of implant placement and all patients underwent surgery to revise the implant; and 36/176 (20.5%) patients underwent surgery to revise their implant.

Social histories and significant past medical histories were documented (Table IV) from the chart review. 30/176 (17%) patients were currently smoking; 44/176 (25%) patients reported a history of depression, bipolar disease, panic attacks were taking anti-depressant medication; 12/176 (6.8%) patients had a history of herpes labialis; 22/176 (12.5%) patients reported a history of headaches; 10/176 (5.7%) patients had a history of hypertension.

Patient surveys were sent to patients resulting in a 30% response rate. Due to a low response, all 176 patients were subsequently telephoned. 91/176 (51.7%) patients were successfully reached and asked the patient survey. For non-responders, the authors (ETC and RC) attempted a minimum of two calls before ceasing efforts to obtain subjective follow-up. Table V (includes all patients - both lip and cheek lip groove implant) reveals the results of the 32/45 (71.1%) patients were satisfied with lip augmentation; 35/60 (58.3%) patients were satisfied with cheek-lip groove augmentation; 16/87 patients (18.4%) experienced dyesthesia with lip and/or cheek-lip augmentation; 3/88 (3.4%) patients noted difficulty talking, eating, chewing; 3/80 (3.8%) reported a difference in kissing; 59/77 (76.6%) patients would recommend the specific augmentation procedure they received to a friend or relative; 29/81 (35.8%) patients noted an asymmetry with their implants; 8/77 (10.4%) patients noted difficulty with smiling; and 53/83 (63.9%) patients believe the augmentation was adequate. (When broken down, 69.2% of lip only patients believed augmentation was adequate, while 61.4% of cheek-lip groove patients felt they had enough augmentation after the procedure.)

Results of the chi-squared testing and subsequent multivariate analysis confirmed 16 statistically significant factors in our analysis (refer to Table VI). Patients with Advanta placed into the lips experienced a statistically significant rate of dyesthesia (p=0.013). This was not seen with the Gore-Tex lip augmentations. Statistical significance was seen in patients who noted difficulty smiling and laughing and then had removal and replacement of lip augmentation with ePTFE (p=0.025). Patients with a history of depression were noted to have a statistically significant decreased incidence of satisfaction with their lip augmentation (p=0.0003).

Statistically significant data was found in the group of patient with complications. These patients would not recommend either the lip implant or the cheek-lip groove implant to friends or family (p=0.015 and p=0.0087, respectively). Patients who noted migration of their cheek-lip groove implants would not recommend the implants as well (p=0.011). Individuals who requested removal, removal and replacement, or revision of their ePTFE implant, tended not to recommend the implant to friends or family (p=0.048).

Patients who had complications or migration of their implants were not satisfied with their ePTFE cheek-lip groove implant (p=0.043 and p=0.004, respectively). Patients that underwent revision of the lip implant were not satisfied with the lip implants (p=0.019). Patients who had removal and replacement of cheek-lip implants often felt they had adequate augmentation after the procedure (p=0.006).

Discussion

Perioral augmentation is important to young and old patients. Women in their twenties or early thirties want fuller or protruding lips, emulating what the media has portrayed as ideal and sensuous. Older women desire youthful lips, or the lips they had when they were in their twenties. Aging of the perioral complex leads to loss of elasticity, atrophy of subcutaneous fat, and bony resorption of the maxilla and mandible.6 This translates into lengthening of the white portion of the upper lip, flattening of the vermilion border and philtral ridges, disappearance of cupid’s bow, and deepening of the cheek-lip groove (Figure 7 A and B). Women compensate for the loss of their lips by painting and drawing in their ideal lips.

The ideal lips have the upper red lip height slightly less than the lower red lip on anterior view (Figure 8).7 On lateral view, the ideal upper lip should project approximately 1.5 to 2 mm over the lower lip (Figure 9).7 In youthful lips, there is often a prominence of the philtral ridges and the soft M of Cupid’s bow often permits a slight central incisor show (Figure 10). It is often the strength of the philtral ridges along with the strong M of Cupid’s bow, which gives the impression of sensuality of the lips.

The breadth of procedures for perioral rejuvenation is extensive (Table 1). Augmentation can be achieved through injectable fillers: such as reconstituted, purified, enzyme digested bovine dermal collagen (Zyderm or Zyplast [Collagen Corporation, Palo Alto, CA]), a suspension of homogeneic human tissue matrix prepared from human donor tissue (Dermalogen [Collagnesis Laboratories, Beverly, MA]), purified autologous collagen (Autologen [Collagnenesis Laboratories, Beverly, MA]), and autogeneic cultured dermal fibroblasts and extracellular matrix Isologen [Isolagen Technologies, Paramus, NJ]).9 These injectable fillers allow the physician to sculpt and mold the lip through carefully placed intradermal and subdermal collagen and tissue. Obviously, the drawbacks are the short-lived nature of the material, possible allergic reactions, need of donor tissue, and the cost of repeated injections. Patients often desire for something more permanent. Currently, the bovine dermal collagen fillers are the most popular of the fillers used in cosmetic practices. 21

Other forms of injectable fillers, which are not popular in the United States or have not received FDA approval are: Restylane (Q-Med, Uppsala, Sweden) is a form of hyaluronic acid gel produced from bacteria; Resoplast (Rofil Medical International BV, Bredia, The Netherlands) is bovine collagen produced in Europe; 360 liquid silicone and MDX 4-4011 (Dow Corning, Midland, MI); Polymethylmethacrylate microspheres (PMMA) (Artecoll, Rofil Medical International, BV, Netherlands) are permanent 20-40 µm microspheres used commonly in Europe; Bioplastique (Uroplasty, BV, The Netherlands) is a copolymer of solid vulcanized silicone rubber microparticles and liquie biocompatible plasdone hydrogel.21 There is a role for permanent injectable fillers in cosmetic surgery, but the risks and social stigma currently limit its usefulness.

Surgical procedures for augmentation of the lips and cheek-lip groove include: placement of allogeneic, acellular human processed dermis (Alloderm [Life Cell, The Woodlands, TX]), injection of autologous fat, placement of dermal strips, mucosal V-to-Y advancement flaps to thicken thin lips10, and direct excision of the cheek-lip groove for effacement. The advantage of alloderm is no donor site morbidity; the advantage of fat and dermal strips are the usual abundance in one’s own body; the advantage of the mucosal advancement flaps are no external incision; and the advantage of direct excision is a simple and exact removal of the cheek-lip groove. The disadvantages are alloderm and fat’s seemingly 6-12 month length of augmentation and the irreversibility of the latter two procedures. The disadvantage of harvesting fat and dermis can be the donor site morbidity. The surgical procedures for shortening the long upper lip are subnasal lip lift and lip advancement. These last two procedures increase red lip mucosal show, but do little to increase lip protrusion.

The disadvantages of these augmentation procedures either relate to the temporary nature of the implants or the irreversibility of the procedure. The ideal soft tissue implant of the lips and cheek-lip groove involves a permanent substance, no tissue reactivity, natural tissue feel, no surgically related morbidity, no donor site morbidity, ease of placement, ease of removal, low implant cost, non-toxic and non-carcinogenic substance, ease of contouring and trimming implant, sufficient tissue ingrowth to stabilize implant, and stability of implant over time. At this time, ePTFE is the synthetic material, which most closely approximates the criteria for an ideal implant material. There are four ePTFE implants currently available on the market: Gore-Tex, Softform (Collagen Corp, Palo Alto, CA), Ultrasoft (Tissue Technologies, San Francisco, CA), and Advanta.

The literature has extensively covered the safety, strength, durability, porosity, and healing properties of ePTFE over the past 30 years.11,12 Studied initially in animals, it’s initial usage came as a vascular graft. 11 From the early 70’s to the early 80’s, approximately 5 million ePTFE vascular grafts were utilized with no reported cases of rejection. 12 If this data is extrapolated, a minimum of 10 million ePTFE vascular grafts were utilized up to the end of the 20th century. The longevity and biocompatibility of this synthetic implant is unparalleled. Currently, the Gore-Tex or ePTFE is utilizied throughout the body continuing to demonstrate its reliability: patching material for abdominal, hernia, or chestwall defects; vascular graft material in cardiovascular surgery; sling material in rectal/vaginal prolapse repair; and synthetic ligament in temporomandibular joint reconstructions.13

Since 1993 when it received FDA approval, Gore-Tex PTFE sheeting has been a popular facial implant. As a monomeric molecule, ePTFE is composed of two doubly bonded carbon atoms that are bonded with two fluorine atoms; as a polymer, ePTFE forms long chains of repeating units with molecular weights that range from 400,000 to 10,000,000 kd.15 It’s stability resides in the polymer composition of chains of carbon surrounded by a sheath of highly electronegative fluorine atoms.15 The polytetrafluoroethylene is expanded and oriented in a grid pattern held together by solid nodes.13 Tissue ingrowth is possible with pore sizes ranging between 10 and 30 m and fibrils between 5 and 10 m.13 Gore-Tex is available in multi-strand configuration with 1-mm or 2-mm thickness or subcutaneous augmentation material (SAM Facial Implant) in patches of 1-mm, 2-mm, and 4-mm thickness in specially configured sizes. It is a soft, pliable and durable material, which is easily trimmed and contoured, resembling tissue.

Advanta PTFE was introduced in January, 2001. It has received a 510K FDA approval from an existing implant for the face without specific indications as of 12/99. (personal communication with Atrium Medical Corporation, Hudson, NH). This material is a dual porosity implant of expanded polytetrafluoroethylene.14 The dual nature of the implant allows a more porous inner core (100 m internodal distance) for increased softness to touch and a outer layer of 40 m internodal distance for limited cellular ingrowth providing implant stability. (Figure) Other ePTFE implants have a internodal distance of 30 m which allows less tissue ingrowth. Improved biointegration, minimal shrinkage, and long-term soft palpability were the goals of its engineers.14 Advanta is marketed as a softer implant, which mimics natural tissues such as the lip. The long-term biocompatibility and tolerance is yet to be determined.

The bulk of the literature on ePTFE are papers summarizing current techniques.8,15-17 A handful of papers were identified in the literature review looking at postoperative complications of ePTFE implanted into the lips or cheek-lip grooves. None of these papers examined there data using statistical models; none of the papers examined patient satisfaction and tolerance in a standardized manner. Linder examined 20 patients with lips augmented with ePTFE implant and 1 patient with ePTFE implant and mucosal V-Y advancement flap; follow-up averaged 14.33 months.18 He found 1 out of 20 patients with malposition of the implant and the one patient with mucosal advancement flap and implant developed an infection. No statistical analysis was performed and subjective patient tolerance was not reported.18 Conrad et al. examined his results of using a wide ePTFE implant in the lips and cheek-lip grooves. 19 33 patients underwent the lip procedure; 62 patients underwent augmentation of the cheek-lip groove region. Follow-up was from 12 to 54 months. Charts were reviewed and revealed a 18.5% infection rate for the lips, 2.2% infection rate for the cheek-lip grooves, 48.5% surgical revision rate for lip implants and 30.3% revision rate for implants into the cheek-lip grooves.18 No documented cases of dysesthesia, articulation, and facial expression were noted and no kissing complaints from the sexual partners were noted. It is unclear whether a standardized questionnaire was given or these findings came solely from the chart notes. The subjective findings seem to suggest the latter. Sherris and Larrabee performed augmentation of 41 patients in lips and cheek-lip grooves over a period of two years.4 The follow-up was 2.5 to 4.5 years and the overall complication rate 9.8%, five patients had revisions and one implant was removed secondary to a seroma.4 No subjective patient data was obtained. Truswell et al. reported the results of five facial plastic surgeons using Advanta implants over the past year.14 130 patients had implants placed into lips, cheek-lip grooves and other facial creases. Results of the study revealed an infection rate of 1.4%, 2% of patients reported shrinkage of the implant and 87% percent of patients reported a “pleased” or “very pleased” result at the one year follow-up.14 Truswell et al. reported his initial result of Advanta implants into 42 patients into lips, cheek-lip grooves and marionette lines performed from October, 1997 to September, 2000.20 The infection rate was 4.8%.20 Again, no statistical analysis was performed and patient tolerance was briefly examined.

The senior author has had eight years of experience with ePTFE implant into the lips and cheek-lip grooves. After a thorough literature review, this is the longest follow-up with the greatest number of patients in this select population. To date, no publication has documented patient tolerance (kissing, dysesthesias, eating, talking, smiling difficulties) of this material when implanted into the lips or cheek-lip grooves over a long period of time with rigid statistical models applied to search for significant differences. Our data shows an infection rate of 2.8%, a total complication rate of 23.9% and a revision rate of 20.5%. This compares favorably to the rates published in the literature. In 1996, Conrad and Macdonald reported an infection rate of 18.5% with lip ePTFE implantation and 2.2% with cheek-lip groove ePTFE implantation. Revision rates for the lips were 48.5% and 30.3% for cheek-lip grooves. Our data shows that if patients had removal and replacement of cheek-lip implants, these patients were ultimately satisfied with the level of augmentation. Despite 71.1% of patients satisfied after lip augmentation, patients who had revision of the lip implant still tended not to be satisfied (p=0.019). We continue to strive to improve satisfaction in these patients. The sensitivity of lips, their unique functions of eating, talking, smiling and prominence on the face make lip augmentation a difficult and exacting surgical procedure.

The finding of implantation of Advanta into the lips or cheek-lip grooves produced dyesthesia and sensation changes was significant (p=0.013). Significance for this finding was not seen in the use of Gore-Tex implant or Gore-Tex in combination with alloderm. It is difficult for us to explain this finding. One must also consider the potential for selection bias of the Advanta, Gore-Tex, and Gore-Tex with Alloderm groups. The Advanta group has the most recent implantation and the shortest follow-up. It is reasonable to offer that perhaps these patients have a better recollection of the changes in sensation that can occur during convalescence, or that recovery of sensation is not complete in this shorter follow-up period. Further study of this matter is warranted, yet this is an interesting finding none-the-less.

A history of depression or antidepressant usage was found in 25% of our patients who had lip or cheek-lip groove augmentation with ePTFE. These patients who had strictly lip implantation were often not as satisfied with their implants (p=0.0003). Our finding emphasizes to us the importance of patient selection and education. Choosing whom to operate on and informing them of realistic expectations and possible complications are especially important in this group of patients.

Patient evaluation is important in all cosmetic, elective consultations. Our data revealed patients who developed difficulty smiling or laughing often had surgical revision of their lip augmentation (p=0.025). This reminds us of the importance of lip function in expressing ourselves. In the preoperative consult, the senior author specifically looks for a natural tendency toward banding of the upper lip. This can be seen when on smiling, the lips extend above the whites of the teeth and the lip appears tight and stretched. In these individuals, the upper or lower lip ePTFE is split in the middle through a separate stab incision. This simple maneuver relieves any difficulty in smiling or laughing.

Patients who had subsequent complications, additional surgical procedures, or migration would often not recommend this to a friend or family. This significant data supports the validity of our data and our patient survey information. The same applies to the finding of complications and migration after cheek-lip groove implantation. These patients were often not satisfied.

Our paper is limited by its study design, a retrospective review of charts with follow-up by telephone or clinic visit. The ideal paper would have randomized, double-blinded, controlled groups in consecutive surgically operated patients. With our cosmetic patients in private practice, this is not possible. The ideal control group would entail sham surgery, without actually placing the ePTFE implant. Because of these limitations we were not able to apply statistical analysis to all of our data. Despite these limitations, this paper is important. The statistics applied are rigorous; the data is verifiable; the number of patients is large; and the follow-up is lengthy.

Conclusion

This paper confirms the tolerance and acceptability of ePTFE in the body, especially the lips and cheek-lip grooves. The low rate of infections is testimony of this statement. Lip sensation and function are important and because of these two factors alone, patient tolerance of implant material is highly important. 1 out of every 3 patients with lip augmentation with ePTFE had sensation changes, asymmetry or difficulty smiling; 10.7% had difficulty eating, chewing or talking; 7.4% noted a difference with kissing. These percentages are important to document in the literature. Three findings from our paper have caused us to change our surgical procedure or evaluation of the cosmetic patient: Advanta causing dyesthesias and sensation changes in the lips and cheek-lip grooves; patients with difficulty smiling or laughing after implantation undergo revision surgery ; and patients with a past medical history of depression may not be satisfied with their lip implants.

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Table I

Techniques for Perioral Augmentation

Injectable Fillers Type Duration of Effect

1. Zyplast/Zyderm bovine collagen 2-4 months

2. Autologen purified autologous collagen 2-4 months

3. Dermalogen purified autologous dermal collagen 2-4 months

4. Isologen cultured autologous dermal fibroblasts > 4 months?

(Other synthetic injectables are not included because of lack of FDA approval.)

Fat and Grafts Type Duration of Effect

1.Fat injectfion autologous fat >6 months

2.Dermis graft autologous dermis > 6 months

3.Alloderm human cadaveric acellular dermis > 6 months

Table II

Patient Satisfaction and Tolerance Questionnaire

(Mailed to all patients and contact via telephone was attempted for all patients)

1. Satisfied with lip augmentation?

2. Satisfied with cheek-lip groove augmentation?

3. Do you have any difficulty kissing?

4. Do you have any difficulty with talking, eating, chewing?

5. Do you have any difficulty smiling?

6. Would you recommend this to a friend?

7. Has the augmentation been enough?

8. Are your results symmetrical?

9. Have you noticed any changes in sensation, numbness, or tingling?

Table III

Summary of Chart Data

Total Charts Reviewed 176 patients

Age 24-76 years old

Gender 14 men, 162 female

Implant Location 24 upper/lower lips and cheek-lip grooves

91 cheek-lip grooves

53 upper/lower lips

1 lower lip

7 upper lips

Complications 42/176 (23.9%)

Infections 5/176 (2.8%)

Migration of Implant† 13/176 (7.4%)

Palpability 5/176 (2.8%)

Visible 3/176 (1.7%)

Tightness 2/176 (1.1%)

Asymmetry 3/176 (1.7%)

Unspecified 11/176 (6.3%)

Surgical Revisions 36/176 (20.5%)

 All required revision surgery.

† Migration +/- revision

Table IV

Summary of Past Medical History & Social History

Tobacco 41/176 (23.3%)

Depression

Antipsychotic hx, no hx of Depression 32/176 (18.2%)

Depression hx, no Antipsychotic hx 12/176 (6.8%)

Depression hx and Antipsychotic hx 44/176 (25%)

Herpes Simplex Virus (HSV)۰ 12/176 (6.8%)

Headache 22/176 (12.5%)

Diabetes Mellitus 1/176 (0.6%)

Hypertension 10/176 (5.7%)

Coronary Artery Disease 0

Includes patients on antidepressants without officially documented history of depression by patient.

۰Any patient with a positive history of herpes labialis was given anti-herpetic viral prophylaxis.

Table V (reviewed, additions made)

Summary of Patient Surveys

Total Surveys 91 answered, 85 not completed (51.7%)

Lip Satisfaction 32 yes, 13 no (71.1%)

Cheek-Lip Groove Satisfaction 35 yes, 25 no (58.3%)

Sensory Changes, Dysesthesia 16 yes, 71 no (18.4%)

Lips only (28.6%)

Cheek-Lip Groove only (16.2%)

Difficulty Talking, Eating, Chewing 3 yes, 85 no (3.4%)

Lips only (10.7%)

Cheek-Lip Groove only (0 patients)

Difference Kissing 3 yes, 77 no (3.9%)

Lips only (7.4%)

Cheek-Lip Groove only (0 patients)

Recommend Procedure 59 yes, 18 no (76.6%)

Lips only (76.9%)

Cheek-Lip Groove only (74.6%)

Adequate Augmentation 53 yes, 30 no (63.9%)

Lips only (69.2%)

Cheek-Lip Groove only (61.4%)

Difficulty Smiling, Laughing 8 yes, 69 no (10.4%)

Lips only (31.8%)

Cheek-Lip Groove only (2.5%)

Asymmetry 29 yes, 52 no (35.8%)

Lips only (34.8%)

Cheek-Lip Groove only (37.2%)

Table VI

Comparison of P-Values Found to Be Significant in Multivariate Analysis

PATIENT HISTORY PATIENT SURVEY RESPONSE P-VALUES

Advanta (12 yes, 75 no) Sensation changes, dysesthesias (16 yes, 71 no) p=0.013

Removal and Replacement (11 yes, 66 no) Difficulty smiling, laughing (8 yes, 69 no) p=0.025

PMH of Depression (8 yes, 34 no) Satisfaction with Lip Implant (31 yes, 11 no) p=0.0003

Additional Surgical Procedure (18 yes, 59 no)Recommend (59 yes, 18 no) p=0.048

Complication (16 yes, 61 no) Recommend (59 yes, 18 no) p=0.009

Complication (9 yes, 43 no) Recommend Cheek-Lip Groove (39 yes, 13 no) p=0.0087

Complication (12 yes, 27 no) Recommend Lip Implant (30 yes, 9 no) p=0.015

Migration Implant (3 yes, 49 no) Recommend Cheek-Lip Groove (39 yes, 13 no) p=0.011

Complication (11 yes, 47 no) Satisfaction with Cheek-Lip Implant (33 yes, 25 no) p=0.043

Migration Cheek-Lip Implant (5 yes,55 no) Satisfaction with Cheek-Lip Implant (35 yes, 25 no) p=0.004

Revision of Lip Implant (5 yes, 37 no) Satisfaction with Lip Implant (31 yes, 11 no) p=0.019

Removal and Replacement (6 yes, 51 no) Adequate Augmentation of Cheek-Lip (34 yes, 23 no) p=0.0062

Legend of Figures

Figure 1A Wright Needle

Figure 1 B Trocar Device

Figure 2 Subcutaneous Tunnel Created by Trocar.

Figure 3 ePTFE pulled retrogradely through the lip.

Figure 4 The ends of the implant are trimmed in a beveled fashion.

Figure 5 The cheek-lip groove is marked with a solid line. The dotted line represents actual location of implant.

Figure 6 Subcutaneous tunnel created in cheek-lip groove.

Figure 7 Age related changes to the perioral region. (Lengthening of the white portion of the upper lip, flattening of the vermilion border and philtral ridges, disappearance of cupid’s bow and deepening of the cheek-lip grooves.)

Figure 8 The aesthetically ideal lips demonstrate a slightly lower height to the upper lips versus the lower lips.

Figure 9 The ideal lips from a lateral lip demonstrate a projection of approximately 1.5 to 2 mm over the lower lips.

Figure 10 Youthful lips have prominence of the philtral ridges and the soft M of Cupid’s bow often permits a slight central incisor show.

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