Rapid mandible margins for intraoperative assessment.

OBJECTIVES: To determine the feasibility of a rapid method of processing mandible bone margins for intraoperative histopathologic examination and to assess the relative value of fine, coarse, and core specimens in assessing bone margins. STUDY DESIGN: Prospective histologic controlled study. SETTING: A tertiary level academic medical center histopathology laboratory. SUBJECTS AND METHODS: Multiple bone samples were collected from fresh (<12 hours post-mortem) human cadaveric mandible using a 1) standard 4mm otolaryngologic cutting drill bit 2) diamond drill bit and 3) cutting core biopsy trocar. The specimens were placed in one of three decalcifying solutions (Decal A, Calex, EDTA Decal) from 15 to 75 minutes or control (fixation in 10% formalin). After each designated decalcification time period, specimens were cryosectioned or paraffin embedded and subsequently reviewed by a head and neck surgical pathologist. The specimens were assessed for overall quality, adequacy of decalcification, soft tissue quality, marrow quality, and presence of artifact. RESULTS: Bone margin specimens collected with a 4mm burr and processed with EDTA Decal for 30 minutes yielded the highest quality histopathologic slides compared to the other methods in a similar time frame. The adequacy of decalcification directly impacted the quality of histopathologic assessment. CONCLUSIONS: Mandible bone margins can be rapidly and safely prepared and adequately evaluated with only 30 minutes of decalcification. This method may provide acceptable intraoperative assessment of bone margins in patients with tumors which involve or approximate bone. We plan to examine this model in a prospective clinical study of patients with cancer invading mandibular bone.

Ultrasound gel causes fine needle aspiration artifact? A clear choice.

OBJECTIVES: Ultrasound-guided fine needle aspiration (FNA) is a commonly employed tool in cytopathologic practice. Artifacts resulting in misinterpretation of specimens have been noted with various ultrasound gel media. Our purpose was to perform a prospective human cadaveric study of this phenomenon to identify a low-cost solution that eliminates the artifact. STUDY DESIGN: Three separate ultrasound-guided FNAs were performed on the thyroid and parotid glands in situ of a fresh human cadaver using three different types of ultrasound gel media. Slides were prepared in standard fashion (Quik-Diff and Papanicolaou stains). Two cytopathologists subsequently analyzed the slides for the presence of any artifact interfering with their ability to visualize and interpret the cellular aspirate material. RESULTS: Two of the three gel media revealed significant artifacts mimicking apoptosis, necrosis or colloid, making it difficult to visualize the cellular components and differentiate the artifact from the thyroid colloid. One gel medium did not show any significant artifact, and there was no discernable difference in its quality with regard to the ultrasound image during FNA procedures. CONCLUSIONS: Ultrasound gels can be associated with a significant artifact in FNA specimens. To eliminate this artifact, which may alter the adequacy, diagnosis or cytologic appearance, we confirm a specific gel type that is useful for ultrasound-guided FNAs.

Reprocessing Standards for Medical Devices and Equipment in Otolaryngology: Safe Practices for Scopes, Speculums, and Single-Use Devices.

Stringent regulatory standards for reprocessing medical devices and equipment have proliferated in response to patient safety incidents in which improperly disinfected or contaminated endoscopes lead to large-scale disease transmission or outbreaks. This article details best practices in reprocessing reusable and single-use devices in otolaryngology, with particular attention to flexible fiberoptic endoscopes/nasophyarngoscopes, nasal speculums, and other clinic and operating room instruments. High-risk devices require sterilization, whereas lower risk devices may be reprocessed using various disinfection procedures. Reprocessing practices have implications for adequacy, efficiency, and cost. Nuanced understanding of procedures and their rationale ensures delivery of safe, ethical, and quality patient care.

Methylation status of genes in papillary thyroid carcinoma.

OBJECTIVES: To determine the methylation status of gene promoter regions using methylation-specific polymerase chain reaction in genes encoding for thyrotropin receptor (TSHR), E-cadherin (ECAD), sodium iodide symporter protein (NIS-L), ataxia telangiectasia mutated (ATM), and death-associated protein kinase (DAPK) proteins and if methylation status correlates with patient variables, tumor factors, or outcome measures among patients with papillary thyroid carcinoma. DESIGN: Database query and retrospective medical chart review for patients with well-differentiated thyroid cancer and nonmalignant thyroid conditions treated at our institutions (1996-2004). Methylation-specific polymerase chain reaction was performed, and results were compared with controls for these genes. Methylation status was then compared with patient variables, tumor factors, and outcome measures for patients with thyroid carcinoma and controls. PATIENTS: The study population comprised 32 patients with papillary thyroid carcinoma and 27 controls. RESULTS: In our patients, all 5 genes were methylated more frequently in papillary thyroid carcinoma than in controls. NIS-L trended toward a more advanced stage at presentation. NIS-L methylation in cancer cells was not associated with methylation in adjacent benign tissue, unlike the other 4 genes. Neither age nor sex affected methylation status, and methylation status did not correlate with extent of the primary tumor or presence of nodal metastasis at diagnosis. Tumors recurred less frequently in patients with TSHR methylation than in patients with unmethylated TSHR promoter regions. CONCLUSIONS: Promoter methylation may be a marker for malignancy in thyroid carcinoma. Furthermore, methylation status of tumors as determined by methylation-specific polymerase chain reaction may help in determining patient prognosis.

Esophageal stent erosion into the common carotid artery.

A pseudoaneurysm of the common carotid artery was found with computed tomography in a 62-year-old woman with an esophageal stent that had eroded through her skin. The pseudoaneurysm was treated with a self-expanding nitinol stent; after massive hemoptysis, an endograft was placed on the pseudoaneurysm. The patient then underwent ligation of the left common carotid artery, proximal to the carotid bulb, and excision of the endograft and previously placed coils. The esophageal stent wires were so that they could no longer impinge the common carotid artery.

Evaluation of the inferior and superior laryngeal nerve stumps for perineural spread in laryngeal cancer.

OBJECTIVE: Perineural spread (PNS) is an important risk factor for locoregional failure and is correlated with reduced survival rates in squamous cell carcinoma of the larynx. PNS may extend proximally and/or distally in the nerve sheath by leaving uninvolved nerve segments. This method of extension may preclude obtaining tumor-free surgical margins, which may be responsible for recurrent disease. The purpose of this study is to investigate the presence or absence of PNS in extralaryngeal superior and inferior laryngeal nerves in patients who underwent total laryngectomy for squamous cell carcinoma of the larynx. METHODS: Extralaryngeal segments of superior and inferior laryngeal nerves were resected bilaterally during 15 consecutive laryngectomies. Laryngectomy specimens and the harvested proximal nerve segments were histopathologically examined for the presence or absence of PNS. RESULTS: Ten of 15 laryngectomy specimens showed PNS; however, none of the extralaryngeal superior or inferior laryngeal nerve segments revealed perineural involvement. CONCLUSION: Extralaryngeal extension of PNS is highly unlikely in squamous cell carcinoma of the larynx.

Mechanical and clinical rationale of prototype bone reduction forceps.

OBJECTIVE: To describe the mechanical rationale and clinical application of prototype right-angle reduction forceps. METHODS: A pair of prototype right-angle reduction forceps was designed and manufactured specifically to improve the consistency and ease of fracture reduction. It was used to reduce mandible fractures of the mandible body, parasymphysis, and symphysis in 4 patients. The fractures ranged from minimally displaced to comminuted and displaced fractures. RESULTS: The pilot monocortical holes used for insertion of the right-angle reduction forceps into the mandible were easier to drill than the old method of drilling angled holes for standard reduction forceps. The older method required constant guesswork as to the correct angle of the hole relative to the tines of the curved reduction forceps. The right-angle reduction forceps required no guesswork because the pilot hole is drilled at a right angle to the surface of the outer bone cortex and at more than 1 cm laterally on each side of the fracture line. There were no episodes of outer cortical bone avulsion or any necessity for redrilling new pilot holes. These forceps provided sufficient force for excellent reduction of the fracture edges. The design also provided improved access for plating superior and inferior to its shaft while it was engaged. CONCLUSIONS: Although curved bony reduction forceps are standard in most mandibular plating sets, they provide less predictable and efficient reduction of fractures than the right-angle reduction forceps. Prototype reduction forceps require little to no additional training to use properly.

Diagnostic Delays and Errors in Head and Neck Cancer Patients: Opportunities for Improvement.

A retrospective review of 100 sequential patients (2009-2012) with head and neck cancer was performed to determine the frequency of 5 types of diagnostic delays and errors outlined by the Institute of Medicine. There were a total of 105 diagnostic delays/errors. The most common was delay in being seen in the otolaryngology clinic after referral placement (28.6%), followed by diagnostic error by the referring physician (22%), delay in referral of a symptomatic patient to the otolaryngology clinic (16.2%), delay in employing an appropriate diagnostic test or procedure (15.2%), delay in action following reporting of pathology or imaging results for an incidental lesion (11.4%), diagnostic error by the otolaryngology clinic (2.8%), delay in action following reporting of pathology or imaging results for the symptomatic lesion (2.8%), and use of outmoded tests or therapy (1%). Increased awareness of these types of delays/errors will direct actions and processes to reduce or eliminate them.

Considerations in incorporating office-based ultrasound of the head and neck.

OBJECTIVE: The purpose of this study was to determine the cost considerations and strategies for incorporating ultrasound (US) in a head and neck practice. STUDY DESIGN AND SETTING: A retrospective chart review of office-based US procedures from 2001 to 2005 was completed at our academic medical center. Billing and coding for US and US guided fine needle aspiration (USFNA) were examined. RESULTS: The appropriate CPT codes are 76536 for US and 76942 and 10022 for USFNA-related procedures. The USFNA codes should be used repeatedly for correct coding of biopsies from multiple sites. Cost (equipment) sharing between specialties is a potential strategy for office-based US incorporation. CONCLUSION: Based on practice volume, specific CPT coding, and Medicare reimbursements, office-based US equipment and certification costs could be offset in 1 year. SIGNIFICANCE: Office-based US can be readily incorporated with significant benefits to patients. Billing and usage strategies were identified that would improve the economics of providing office-based US.

Lean Belt Certification: Pathway for Student, Resident, and Faculty Development and Scholarship.

Since July 2013, 20 trainee participants have completed the quality improvement curriculum within the Indiana University Department of Otolaryngology-Head & Neck Surgery, including 7 otolaryngology residents, 6 otolaryngology-bound medical students, and 7 psychiatry residents. Nine faculty and staff attended. Participants were highly satisfied with the quality and effectiveness of the program. Following program implementation, 2 otolaryngology residents and 2 medical students initiated their own quality improvement projects. Lean training directly resulted in oral and poster presentations at national conferences, journal publications, and institutional research and quality awards. Students completing the program established a local affiliate group of an international health care quality organization. Quality improvement training can be successfully incorporated into residency training with overwhelming program satisfaction and results in greater scholarly and professional development for motivated participants. The skillset acquired by participants leads to projects that improve patient care, increase value, and justify equipment and personnel retention and expansion.

Impact of Lean on surgical instrument reduction: Less is more.

OBJECTIVES/HYPOTHESIS: To determine whether instrument sets that are frequently used by multiple surgeons can be substantially reduced in size with consensus. STUDY DESIGN: Prospective quality improvement study using Lean Six Sigma for purposeful and consensual reduction of non-value-added instruments in adenotonsillectomy instrument sets. METHODS: Value stream mapping was utilized to determine instrumentation usage and reprocessing workflow. Preintervention instrument utilization surveys allowed consensual and intelligent set reduction. Non-value-added instruments were targeted for waste elimination by placement in a supplemental set. Times for pre- and postintervention instrument assembly, Mayo setup, and surgery were collected for adenotonsillectomies. Postintervention satisfaction surveys of surgeons and staff were conducted. RESULTS: Adenotonsillectomy sets were reduced from 52 to 24 instruments. Median assembly times were significantly reduced from 8.4 to 4.7 minutes (P < .0001) with a set assembly cost reduction of 44%. Following natural log transformations, mean Mayo setup times were significantly reduced from 97.6 to 76.1 seconds (P < .0001), and mean operative times were not significantly affected (1,773 vs. 1,631 seconds, P > .05). The supplemental set was opened in only 3.6% of cases. Satisfaction was >90% regarding the intervention. Set build cost was reduced by $1,468.99 per set. CONCLUSIONS: Lean Six Sigma improves efficiency and reduces waste by empowering team members to improve their environment. Instrument set reduction is ideal for waste elimination because of tool accumulation over time and instrument obsolescence as newer technologies are adopted. Similar interventions could easily be applied to larger sinus, mastoidectomy, and spine sets. LEVEL OF EVIDENCE: NA.

Conjunctival melanoma metastasis diagnosed by sentinel lymph node biopsy.

PURPOSE: Evaluate the use of sentinel lymph node biopsy (SLNB) in staging and directing treatment of patients with conjunctival malignancy. DESIGN: Retrospective, noncomparative, interventional case reports. METHODS: Two patients with conjunctival melanoma underwent SLNB, which consisted of lymphoscintigraphy with injection of sulfur colloid technetium-99m. Lymphazurin blue was injected intraoperatively into the area of prior excision. The combination of a signal through the sulfur colloid technetium-99m and blue staining identified SLNs. RESULTS: In both patients, the SLNs containing metastatic disease were identified and biopsies obtained, aiding staging and optimal therapy. CONCLUSION: Sentinel lymph node biopsy has been recently reported as an aid in evaluating patients with periocular malignancies. These reports of patients with tumor-positive SLNs arising from the lymphatic metastasis of conjunctival malignancies underscore the utility of this important technique in evaluating patients with periocular malignancies.

Computer-aided reduction of zygomatic fractures.

Reconstruction of the craniofacial skeleton after traumatic injury relies on immediate adjacent nondisplaced bone for restoration of contour. In complex fractures, neighboring bone may be lost or significantly fragmented, leaving little guidance to the 3-dimensional skeletal architecture. Recently, image guidance systems have been used in neurosurgery and sinus and spine surgery for intraoperative corroboration using preoperative radiologic images. We report the intraoperative use of an image guidance system for real-time localization of displaced facial skeletal segments during reduction and internal fixation.

Middle-vault narrowing in the wide nasal dorsum: the "Reverse Spreader" technique.

The middle vault is a transition zone between the nasal tip and nasal bones and plays an important role in profile, tip projection, tip rotation, and tip support. This report presents an alternative to conventional techniques specific to the middle nasal vault for a patient population with particular nasal features. A narrow middle vault with internal nasal valve collapse is functionally and aesthetically addressed by the insertion of spreader grafts. However, the inverse of this situation is sometimes encountered. A patient with a broad middle vault and without internal nasal valve collapse will benefit from reduction of the horizontal width of the cartilaginous dorsum, which is in effect the reverse of spreader grafts. This effect is achieved by excising a vertical wedge-shaped strip of cartilage that follows the length of the upper lateral cartilage at the junction of the upper lateral cartilage and the dorsal nasal septum.

Experimental facial augmentation with hydroxyapatite cement.

OBJECTIVE: To study the results of implantation of preformed hydroxyapatite (HA) disks and HA cement in onlay augmentation. METHODS: In this prospective study involving 16 adult New Zealand rabbits, HA disk and HA cement samples were implanted separately and together along the bony and cartilaginous nasal dorsum as well as over the supraorbital bone. Gross and histologic examinations of the implants were performed at intervals ranging from 3 to 24 months. RESULTS: There was no evidence of infection, adverse reaction, or implant extrusion in the 15 rabbits surviving the planned period. Grossly, all rabbits had prominent noses and supraorbital regions that were immobile on digital palpation. No measurable change in HA disk height and width was noted but there was a 15% decrease in height and width in the HA cement implant. Microscopically, preformed HA disks were found to be enclosed in a vascularized fibrous capsule. When disks were combined with HA cement, a vascular fibrous capsule was still noted around the implant but there was osteoconversion in the underlying cement layer. Used alone, HA cement underwent both osteoconversion and osteointegration. Neither the preformed HA disk with and without HA cement nor the HA cement alone elicited giant cell reaction or inflammatory changes. The HA cement alone was found to have microscopic fissures at the edges. CONCLUSION: This animal study suggests that preformed HA implants and HA cement, alone or in combination, can be used to augment the non-stress-bearing craniofacial skeleton.

Modifications of eyebrow position with botulinum exotoxin A.

OBJECTIVE: To determine if clinically used botulinum exotoxin A (Botox) injections to the forehead and glabellar and crow's-feet regions result in modifications of eyebrow position. DESIGN: Prospective study. SETTING: Academic medical center in St Louis, Mo. SUBJECTS: Twenty-nine adult patients treated with botulinum exotoxin A injections for rhytids. INTERVENTION: The eyebrow position at 13 different sites was measured before injection and 2 weeks after treatment. The areas injected were based on patient preference and physician assessment. Of the 29 patients, 14 received injections into the glabella only and 15 received injections into the glabella and forehead, with or without treatment of the crow's-feet. RESULTS: In 29 patients at rest, we found no significant (P value range,.17 to.97) change in eyebrow position, except for a point depression at the right lateral eyebrow. The 15 patients who received injections into the forehead and glabella, with or without treatment of the crow's-feet, had no significant (P value range,.11 to.84) change in eyebrow position, except for a point of depression at the left medial eyebrow. Both groups exhibited eyebrow depression in the active state (eyebrow maximally elevated). CONCLUSIONS: Botulinum exotoxin A injections into the forehead and glabellar, and crow's-feet regions did not significantly change the resting eyebrow position. However, forehead injections contributed to eyebrow depression in the active state.

A comparative study of surgical techniques on the cervicomental angle in human cadavers.

BACKGROUND: The cervicomental (CM) angle is formed by the horizontal plane of the submental region and the vertical plane of the neck. OBJECTIVE: To compare the 2-dimensional effect of 4 surgical techniques on the CM angle in a human cadaver model. DESIGN: Anatomic presurgical and postsurgical comparative study performed on human cadavers preserved with ethylene glycol. SETTING: Academic medical research center in St Louis, Mo. SUBJECTS: Twelve cadaver specimens with obtuse CM angles with heads attached to the sternum and upper thorax. INTERVENTIONS: Standard superficial musculoaponeurotic system rhytidectomy techniques were performed on all cadaver heads. Four techniques were compared: (1) platysmal plication; (2) platysmal plication and plication of the anterior bellies of the digastrics; (3) platysmal plication, plication of the anterior bellies of the digastrics, and interlocking mastoid-to-mastoid sutures; and (4) platysmal plication and interlocking mastoid-to-mastoid sutures. MAIN OUTCOME MEASURES: The comparative changes in CM angle, the distance between the mentum and CM angle (mentum-CM distance), and the distance between the sternum and CM angle (sternum-CM distance) obtained with each of the 4 surgical techniques. Anatomic characteristics of the cadavers were also noted. RESULTS: On average, the CM angle was significantly reduced after all procedures (P<.001). The mean sternum-CM distance increased significantly (P =.01). A trend toward significance was observed in the change in mentum-CM distance (P =.10). The presence of a low hyoid was significantly associated with a smaller CM angle after surgery (P =.009) and demonstrated a trend toward significance with an increase in mentum-CM distance (P =.07), but it was not significantly associated with an increase in sternum-CM distance (P =.58). After controlling for the presence of a low hyoid, the mastoid-to-mastoid suture significantly reduced the CM angle by approximately 11.3 degrees (P =.002) and the sternum-CM distance by 1.15 cm (P<.001). CONCLUSIONS: The CM angle and the sternum-CM distance were significantly affected by all procedures. The addition of the mastoid-to-mastoid suture had the greatest effect on the CM angle, and the reduction in CM angle was strongly associated with an increase in the sternum-CM distance. Presence of a low hyoid was the only preoperative factor associated with a significant postoperative reduction in CM angle.

Lean Six Sigma Applied to Ultrasound Guided Needle Biopsy in the Head and Neck.

OBJECTIVES: (1) Confirm the positive value stream of office-based ultrasound using Lean Six Sigma; (2) demonstrate how ultrasound reduces time to diagnosis, costs, patient inconvenience and travel, exposure to ionizing radiation, intravenous contrast, and laboratory tests. STUDY DESIGN: Case series with historical controls using chart review. SETTING: Tertiary Veterans Administration Hospital (university-affiliated). SUBJECTS AND METHODS: Patients with a consult request or decision for ultrasound guided fine needle aspiration (USFNA) from 2006 to 2012. Process evaluation using Lean Six Sigma methodologies; years study conducted: 2006-2012; outcome measurements: type of diagnostic tests and imaging studies including CT scans with associated radiation exposure, time to preliminary and final cytopathologic diagnosis, episodes of patient travel. RESULTS: Value stream mapping prior to and after implementing office-based ultrasound confirmed the time from consult request or decision for USFNA to completion of the USFNA was reduced from a range of 0 to 286 days requiring a maximum 17 steps to a range of 0 to 48 days, necessitating only a maximum of 9 steps. Office-based USFNA for evaluation of head and neck lesions reduced costs, time to diagnosis, risks and inconvenience to patients, radiation exposure, unnecessary laboratory, and patient complaints while increasing staff satisfaction. In addition, office-based ultrasound also changed the clinical management of specific patients. CONCLUSION: Lean Six Sigma reduces waste and optimizes quality and accuracy in manufacturing. This is the first known application of Lean Six Sigma to office-based USFNA in the evaluation of head and neck lesions. The literature supports the value of office-based ultrasound to patients and health care systems.

The effects of alar batten grafts on nasal airway obstruction and nasal steroid use in patients with nasal valve collapse and nasal allergic symptoms: a prospective study.

IMPORTANCE: Clinical management of nasal airway obstruction (NAO) in patients with and without nasal allergic symptoms and nasal valve collapse (NVC). OBJECTIVE: To examine the impact that autologous alar batten grafts have on patients with NAO owing to NVC and their affect on nasal steroid use and allergic symptoms. DESIGN: A prospective study. SETTING: Indiana University Medical Center, Indianapolis. PARTICIPANTS: Patients with NAO due to NVC with or without symptoms of nasal allergic symptoms. INTERVENTIONS: All of the patients had placement of autologous batten grafts during the study period. STUDY SELECTION: Prospective study of patients with dynamic NVC undergoing alar batten graft treatment. DATA EXTRACTION: Nasal Obstruction Symptom Evaluation survey preoperatively and postoperatively, prospective outpatient questionnaire to determine use of nasal steroids and presence of nasal allergic symptoms preoperatively and postoperatively. RESULTS: A total of 126 patients underwent surgical intervention for the treatment of NAO due to NVC. All of these patients were using nasal steroid sprays, and 78 patients (62%) also reported nasal allergic symptoms at their initial presentation. At 6-month and 1-year postoperative evaluations, 118 (94%) and 122 (97%), respectively, reported significant improvement of their NAO, regardless if they had presented with or without allergic nasal symptoms. Sixty-two of the 78 patients (79%) who initially presented with NAO owing to NVC and nasal allergic symptoms preoperatively reported significant improvement in their NAO and nasal allergic symptoms postoperatively. Eight of 126 (6%) restarted their use of nasal steroids postoperatively. All 8 of these patients reported nasal allergic symptoms preoperatively. No patients in the nonallergic group continued the use of nasal steroids postoperatively. There was no increase in nasal steroid use at the 12-month follow-up visit. CONCLUSIONS AND RELEVANCE: Nasal airway obstruction due to NVC in patients can be surgically treated with autologous alar batten grafts. In addition, the use of alar batten grafts may improve NAO in patients with nasal allergic symptoms and reduces their use of nasal steroids. These results support the idea of potential surgical repair of the nasal valve to treat patients with NAO due to nasal allergic symptoms and NVC. LEVEL OF EVIDENCE: 4.

Nasal batten grafts: are patients satisfied?

OBJECTIVES: To learn how nasal batten grafts affect patients' assessment of their nasal airway patency and to determine the extent to which patients believe batten grafts altered their appearance. METHODS: A prospective survey study of 18 patients in a tertiary veterans hospital who had nasal airway obstruction (NAO) due to nasal valve collapse was completed. Patients had placement of bilateral polyethylene batten grafts during a 36-month study period. The Nasal Obstruction Symptom Evaluation (NOSE) validated survey was used to measure a patient's subjective postoperative change in nasal airway obstruction. In addition, the patients were asked to rate the extent their appearance had changed. RESULTS: All patients presented with complaints of NAO due to nasal valve collapse either in isolation or in combination with another anatomical source of obstruction. The nasal valve collapse was identified by clinical examination. All patients had preoperative photographs. Most patients had a trial with an intranasal stent before opting for surgical implantation of the batten grafts. The results of the NOSE survey demonstrate significant improvement in nasal obstruction. Patients also reported only a minimal change in appearance. There was 1 patient with implant extrusions and only a few implants were removed. CONCLUSIONS: Nasal airway obstruction due to nasal valve collapse can be effectively treated with polyethylene batten grafts. The implants are well tolerated, and patients report a significant improvement in NAO. There is little risk of implant extrusion, exposure, or intolerance. In addition, patients did not note a significant change to their appearance.