Material For Soft Tissue Augmentation Research Articles

Customizable, biocompatible implants for dorsal nasal augmentation: An in vivo pilot study of eight polylactic acid scaffold designs.

Augmentation of the nasal dorsum often requires implantation of structural material. Existing methods include autologous, cadaveric or alloplastic materials and injectable hydrogels. Each of these options is associated with considerable limitations. There is an ongoing need for precise and versatile implants that produce long-lasting craniofacial augmentation. Four separate polylactic acid (PLA) dorsal nasal implant designs were 3D-printed. Two implants had internal PLA rebar of differing porosities and two were designed as "shells" of differing porosities. Shell designs were implanted without infill or with either minced or zested processed decellularized ovine cartilage infill to serve as a "biologic rebar", yielding eight total treatment groups. Scaffolds were implanted heterotopically on rat dorsa (N = 4 implants per rat) for explant after 3, 6, and 12 months followed by volumetric, histopathologic, and biomechanical analysis. Low porosity implants with either minced cartilage or PLA rebar infill had superior volume retention across all timepoints. Overall, histopathologic and immunohistochemical analysis showed a resolving inflammatory response with an M1/M2 ratio consistently favoring tissue regeneration over the study course. However, xenograft cartilage showed areas of degradation and pro-inflammatory infiltrate contributing to volume and contour loss over time. Biomechanical analysis revealed all constructs had equilibrium and instantaneous moduli higher than human septal cartilage controls. Biocompatible, degradable polymer implants can induce healthy neotissue ingrowth resulting in guided soft tissue augmentation and offer a simple, customizable and clinically-translatable alternative to existing craniofacial soft tissue augmentation materials. PLA-only implants may be superior to combination PLA and xenograft implants due to contour irregularities associated with cartilage degradation.

Evaluation of the effect of injectable platelet-rich fibrin (I-PRF) in reducing the resorption of fat graft during facial lipostructure: A randomized clinical trial.

Fat graft is considered to be the ideal material for soft tissue augmentation. However, its disadvantage are unpredictable outcomes due to variable resorption. This study is the first clinical trial to evaluate the efficacy of adding injectable platelet-rich fibrin (I-PRF) to fat graft and to compare it with the conventional fat graft in terms of absorption rate. The study was designed as a double-blind, split-face, randomized, controlled clinical trial. Twenty patients were randomly assigned with regard to the right or left nasolabial folds into 2 groups (n = 10 in each group): group A (fat graft only); and group B (fat graft with I-PRF). Surgical lipostructure was performed in accordance with the protocols described by Coleman. The adipose tissue was extracted from the umbilical region. Then, for the I-PRF preparation, peripheral venous blood was collected into plastic tubes. The follow-up recall visits took place after 1 and 12 months. Five investigators evaluated the preand post-surgical intervention photographs based on the Modified Fitzpatrick Wrinkle Scale (MFWS). The nasolabial fold depth scores were recorded at each of the study phases: before the intervention (1); after 1 month (2); and after 12 months (3). There were statistically significant differences between the scores at various study phases in each group. The Mann-Whitney U test was used to detect differences between the 2 groups. There was no statistically significant difference between the 2 groups regarding nasolabial fold depth 1 month after the intervention (p = 0.360). After 12 months, however, the patients in group A showed higher nasolabial fold depth scores as compared to group B; this difference was statistically significant (p = 0.000). The study demonstrated the efficacy of I-PRF in reducing the resorption of fat graft, following facial lipostructure.

The Effect of Liposuction Cannula Diameter on Fat Retention-Based on a Rheological Simulation.

Autologous fat is considered as an ideal material for soft-tissue augmentation in plastic and reconstructive surgery. The primary drawback of autologous fat grafting is the high absorption rate, thus fat retention is considered as an essential indicator. There are several researches about the factors that can influence fat retention, including centrifugation and cannula size. However, rheological models of cannula during liposuction are limited. This research focuses on the effects of cannulas with diameters of 2 mm and 2.5 mm on fat retention, which is based on a rheological simulation of inlet pressure and maximum velocity. Experiments on mice were also conducted to confirm the result from the simulation. A simulation was conducted with the physical parameters of the adipose tissue. Human lipoaspirate samples were obtained from patients by liposuction through cannulas of different diameters and were transferred into subcutaneous tissue of nude mice, a part of which were used in viscosity and density measurement. Graft retention was measured and fat quality was assessed through histologic analysis after 6 months. Viscosity and density of the fat tissue had significant effects on fat retention. The 2.5 mm diameter cannula had significantly lower inlet pressure and maximum velocity and thus led to higher graft retention, but oil cystic nodules appeared meanwhile. Cannulas with larger diameters have lower inlet pressure and maximum velocity during the liposuction process, which further influences the viability of adipocytes and adipose stem cells and thus has larger fat graft retention. This research built a mathematical model with less bias than in vivo experiments and provides a general way for analyzing the outcome of a liposuction precisely, which adds to the data for cannula optimization.

Evaluation of folded amniotic membrane and injectable amniotic membrane pieces as soft tissue filler materials

ObjectiveThe search for safe and effective tissue fillers has been an ongoing effort for many years. Obtaining biological materials from patients can require additional incisions and brings surgical and cosmetic risks as a major disadvantage. The aim of this experimental study was, therefore, to evaluate the efficacy of folded amniotic membrane as a soft tissue filler and to assess its volume, and to investigate the possible usage of injectable amniotic membrane for augmentation. MethodsMulti-layer amniotic membranes are transplanted to the subcutaneous tunnels created in the rat’s back, and the amniotic membrane transformed into the injection material is inoculated transcutaneously under the rat’s skin. At the end of two months, the amount of volume loss and histopathological changes in the grafts were examined under light microscope. ResultsThe multi-layer amniotic membrane grafts maintain its volume around 92%. It has been shown that the injectable amniotic membrane maintains its presence in the tissue, can augment it, and can be used as a soft tissue filler. The availability of using amniotic membrane for injection material is shown. No foreign body reaction to the amnion grafts, fibrosis, and necrosis were observed in our study. ConclusionAccording to our study results, multi-layer amnion graft and amnion injection seem to be used as camouflage grafts and soft tissue augmentation materials. Although further clinical trials are mandatory before considering the use of amniotic membrane as a tissue filler material in humans, we are hopeful about its long-term safety and efficacy.

Application of adipose-derived stromal cells in fat grafting: Basic science and literature review

Autologous fat is considered the ideal material for soft-tissue augmentation in plastic and reconstructive surgery. The primary drawback of autologous fat grafting is the high resorption rate. The isolation of mesenchymal stem cells from adipose tissue inevitably led to research focusing on the study of combined transplantation of autologous fat and adipose derived stem cells (ADSCs) and introduced the theory of ‘cell-assisted lipotransfer’. Transplantation of ADSCs is a promising strategy, due to the high proliferative capacity of stem cells, their potential to induce paracrine signalling and ability to differentiate into adipocytes and vascular cells. The current study examined the literature for clinical and experimental studies on cell-assisted lipotransfer to assess the efficacy of this novel technique when compared with traditional fat grafting. A total of 30 studies were included in the present review. The current study demonstrates that cell-assisted lipotransfer has improved efficacy compared with conventional fat grafting. Despite relatively positive outcomes, further investigation is required to establish a consensus in cell-assisted lipotransfer.

Soft Tissue Augmentation Techniques and Materials Used in the Oral Cavity: An Overview.

Oral soft tissue augmentation or grafting procedures are often necessary to achieve proper wound closure after deficits resulting from tumor excision, clefts, trauma, dental implants, and tooth recessions. Autologous soft tissue grafts still remain the gold standard to acquire a functionally adequate zone of keratinized attached gingiva. However, soft tissue substitutes are more commonly used because they minimize morbidity and shorten surgical time. This review aimed to assess soft tissue grafting techniques and materials used in the oral cavity from existing literature. There are a large variety of materials and techniques, including grafts, local flaps, allogenic derived matrices such as acellular dermal allograft, xenogenic tissue matrices from animal origin, and synthetic materials. Tissue engineering of oral mucosa represents an interesting alternative to obtain sufficient autologous tissue for reconstructing oral wounds using biodegradable scaffolds, and may improve vascularization and epithelialization, which are critical for successful outcomes.

Development and characterization of a rapid polymerizing collagen for soft tissue augmentation.

A liquid collagen has been developed that fibrilizes upon injection. Rapid polymerizing collagen (RPC) is a type I porcine collagen that undergoes fibrillization upon interaction with ionic solutions, such as physiological solutions. The ability to inject liquid collagen would be beneficial for many soft tissue augmentation applications. In this study, RPC was synthesized and characterized as a possible dermal filler. Transmission electron microscopy, ion induced RPC fibrillogenesis tests, collagenase resistance assay, and injection force studies were performed to assess RPC's physicochemical properties. An in vivo study was performed which consisted of a 1‐, 3‐, and 6‐month study where RPC was injected into the ears of miniature swine. The results demonstrated that the liquid RPC requires low injection force (<7 N); fibrillogenesis and banding of collagen occurs when RPC is injected into ionic solutions, and RPC has enhanced resistance to collagenase breakdown. The in vivo study demonstrated long‐term biocompatibility with low irritation scores. In conclusion RPC possesses many of the desirable properties of a soft tissue augmentation material. © 2015 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 104A: 758–767, 2016.

Multicenter prospective cohort study of the incidence of adverse events associated with cosmetic dermatologic procedures: lasers, energy devices, and injectable neurotoxins and fillers.

Common noninvasive to minimally invasive cosmetic dermatologic procedures are widely believed to be safe given the low incidence of reported adverse events, but reliable incidence data regarding adverse event rates are unavailable to date. To assess the incidence of adverse events associated with noninvasive to minimally invasive cosmetic dermatologic procedures, including those involving laser and energy devices, as well as injectable neurotoxins and fillers. A multicenter prospective cohort study (March 28, 2011, to December 30, 2011) of procedures performed using laser and energy devices, as well as injectable neurotoxins and soft-tissue augmentation materials, among 8 geographically dispersed US private and institutional dermatology outpatient clinical practices focused on cosmetic dermatology, with a total of 23 dermatologists. Participants represented a consecutive sample of 20 399 cosmetic procedures. Data acquisition was for 3 months (13 weeks) per center, with staggered start dates to account for seasonal variation. Web-based data collection daily at each center to record relevant procedures, by category type and subtype. Adverse events were detected by (1) initial observation by participating physicians or staff; (2) active ascertainment from patients, who were encouraged to self-report after their procedure; and (3) follow-up postprocedural phone calls to patients by staff, if appropriate. When adverse events were not observed by physicians but were suspected, follow-up visits were scheduled within 24 hours to characterize these events. Detailed information regarding each adverse event was entered into an online form. The main outcome was the total incidence of procedure-related adverse events (total adverse events divided by total procedures performed), as verified by clinical examination. Forty-eight adverse events were reported, for a rate of 0.24% (95% CI, 0.18%-0.31%). Overall, 36 procedures resulted in at least 1 adverse event, for a rate of 0.18% (95% CI, 0.13%-0.25%). No serious adverse events were reported. Adverse events were infrequently associated with known risk factors. Noninvasive to minimally invasive cosmetic dermatologic procedures, including energy, neurotoxin, and filler procedures, are safe when performed by experienced board-certified dermatologists. Adverse events occur in less than 1% of patients, and most of these are minor and transient.

Autologous fibroblast transplantation at the vesico-ureteral junction as potential reconstructive cell replacement in an animal model

To evaluate the cellular survival of donor fibroblasts after transplantation at the vesico-ureteral junction (VUJ) and to analyse their potential for reconstructive cell replacement in an animal model as autologous fibroblasts have been used as soft tissue augmentation material for scared and damaged tissue. Muscles biopsies were procured from the lower limb muscles of 4 pigs; cytoplasm of fibroblasts was labelled with nano-sized iron oxide particles. Six weeks after taking of the muscle biopsies, fibroblast transplantation was performed, 3×10(6) cells suspended in transplantation medium (in 1-ml syringes) were injected at the VUJ using the modified STING technique. Animals were killed 8weeks later; seeded fibroblasts were identified using prussian blue staining protocol; histological evaluation and morphological analysis were performed by light microscopy (Mayer's haematoxylin-eosin staining); and bladders were scanned by MRI for visualization and localization of the iron-labelled donor cells. Donor fibroblast cell colonization and cellular viability at the VUJ was demonstrated by MRI and histochemically indicating cellular uptake of iron particles at the VUJ. It was also evident that transplanted fibroblasts integrate into the extracellular matrix of the distal ureter augmenting ureteral host tissue. Labelled implanted autologous fibroblasts were visualized by staining procedure as well as MRI scan demonstrating persistence at the VUJ, suggesting that in vitro expanded fibroblasts survived in vivo after transplantation.

Evaluation of the surface physical properties of β-tricalcium phosphate/silicone rubber, a prospective soft-tissue implant material

Silicone rubber (SR) is one of the most commonly used and effective implant materials for soft-tissue augmentation, but it has been implicated in many adverse reactions. To overcome this drawback, a novel composite β-tricalcium phosphate/silicone rubber (β-TCP/SR) was prepared by compounding a SR matrix with β-TCP. The surface physical properties of β-TCP/SR were evaluated. AFM images showed that β-TCP/SR exhibited greater surface roughness than SR. The XRD and XPS analyses revealed that the addition of β-TCP changed the surface microstructure and charge distribution. FTIR analysis showed that the interaction between β-TCP and SR was weak, which may be due to the tetrahedral structure of PO 4 3−. These results suggest that the addition of β-TCP in a SR matrix can change the surface microstructure and may improve cytocompatibility, consistent with results from a previous study.

Soft Tissue Augmentation in Connection to Dental Implant Treatment Using a Synthetic, Porous Material – A Case Series with a 6‐Month Follow‐Up

Bony defects/concavities in the aesthetic zone of maxillae may interfere with the results of prosthetic procedures by producing shading superior to the crown. Such regions can be augmented either by bone or soft tissue autografts, allografts, or xenografts. Tissue shrinkage is thus anticipated, and a method to objectively measure the tissue change is valuable. The aim of this study was to evaluate the use of a synthetic, porous material made of polyurethaneurea for buccal soft tissue augmentation in connection with implant placement in the maxillary front region. Further, to measure over time the change in buccal contour using a computerized technique. Ten patients received 12 Artelon® cylinders (5 × 10 mm) in connection to implant placement. Preoperative and postoperative (at 3 and 6 months) study casts were obtained for computer measurements, using the preoperative reference model as a base. The volume created between the surfaces of the reference model and each of the two following superimposed models was measured in cubic millimeter. Differences in volume from pretreatment to 3 and 6 months, respectively, were compared. The clinical observation during follow-up showed normal healing. The increase in mean buccal tissue volume was 50 mm(3) (SD 18) after 3 months and 43 mm(3) (SD 21) after 6 months, measured over a 6 mm × 8 mm area in the maxillary front region, in comparison to before insertion of the cylinder. The reduction from 3 to 6 months was not statistically significant (p = .17). A synthetic, porous material for soft tissue augmentation was tested in connection to implant placement in the aesthetic zone of maxillae. The buccal contour was followed-up for 6 months using a computer volumetric technique on preoperative and postoperative study casts. Measured tissue volume showed an obvious increase during the study period. The material was biologically well received.

Quantitative Evaluation of Volume Augmentation in the Tear Trough with a Hyaluronic Acid-Based Filler: A Three-Dimensional Analysis

Despite the prevalent use of hyaluronic acid-based filling materials for facial soft-tissue augmentation and favorable reports of durability in the infraorbital region, no quantitative data exist on the long-term durability of these products following injection. This study represents the first attempt to use three-dimensional imaging to quantify augmentation achieved and duration of effect with one hyaluronic acid product in the tear trough. The authors conducted a prospective, blinded case series in a clinical setting. One non-animal stabilized hyaluronic acid material was used to augment 20 tear troughs to address cosmetic deficiency in this region. Patients were followed long term with three-dimensional imaging. Posttreatment and pretreatment images were compared, volume change was calculated at each time point, and percentage change between immediate and long-term posttreatment was evaluated. All measurements and calculations were performed independent of the injector. Residual effect from the hyaluronic acid product was demonstrable on three-dimensional imaging in 100 percent of tear troughs augmented in this study at the final follow-up visit. Average follow-up was 14.4 months (range, 8.5 to 22.75 months). Average initial augmentation measured by three-dimensional imaging was 0.21 cc per site. Average maintenance of effect for patients at the final follow-up visit was 85 percent. The long-term durability of a small gel particle-based hyaluronic acid in the tear trough is substantiated for the first time in an objective, quantitative fashion using three-dimensional imaging for evaluation of volumetric facial rejuvenation. Three-dimensional photographic imaging offers clinicians a precise and expeditious method for quantitatively evaluating volumetric changes in the face, and represents a significant advance in technology for studying the effects of facial aging.

Biomechanical Testing of Commercially Available Soft-Tissue Augmentation Materials

To evaluate several physical properties and physical dimensions of commercially available soft-tissue augmentation devices. After 2 x 5-cm strips of several graft materials were hydrated, load elongation, cyclic and permanent displacement, percent elastic displacement, tensile modulus, stiffness, and ultimate load-to-failure strength were determined. With a 5-N preload, 30 cyclic loads between 5 N and 50 N were applied at 12.5 mm/s followed by destructive testing. A vertical stitch suture retention test was also performed. SportMesh (Biomet Sports Medicine, Warsaw, IN) displaced more than any other material (P < .001). GraftJacket MaxForce Extreme (Wright Medical Technology, Arlington, TN) and Allopatch HD 2 (Musculoskeletal Tissue Foundation, Edison, NJ) displaced more than RC Allograft (Arthrex, Naples, FL) (P < .05). Percent elastic deformation did not differ among these materials. OrthAdapt (Pegasus Biologics, Irvine CA) had a higher tensile modulus than RC Allograft, SportMesh, and Allopatch HD 2 (P < .001). Allopatch HD 1 and GraftJacket MaxForce Extreme had a higher tensile modulus than RC Allograft and SportMesh. GraftJacket MaxForce had a higher tensile modulus than RC Allograft (P < .001). GraftJacket MaxForce Extreme stiffness was greater than that of OrthAdapt and SportMesh (P < .001), and GraftJacket MaxForce, RC Allograft, Allopatch HD 1, and Allopatch HD 2 stiffness was greater than that of SportMesh (P < .001). The ultimate strength of GraftJacket MaxForce, GraftJacket MaxForce Extreme, Allopatch HD 1, and Allopatch HD 2 was greater than that of OrthAdapt and SportMesh (P < .05). Acellular human collagen matrix grafts (GraftJacket and Allopatch HD) showed greater suture retention strength than RC Allograft and SportMesh, which were both stronger than OrthAdapt (P < .05). The acellular human collagen matrix grafts showed greater elongation than the cuff tendon allograft (RC Allograft), although SportMesh elongated more than all other materials tested. The tensile modulus, which is "normalized" to eliminate differences in the size of the tissue tested, was greater for the OrthAdapt material than for GraftJacket, Allopatch, RC Allograft, and SportMesh. Suture retention strength was greatest in the acellular human collagen matrix grafts (GraftJacket and Allopatch), whereas both SportMesh and RC Allograft had greater suture retention strength than OrthAdapt. Acellular human collagen matrix grafts (GraftJacket and Allopatch) are stronger after cyclic loading than SportMesh and OrthAdapt and show greater stiffness.

Injectable volumetric fillers and botulinum toxin in facial rejuvenation

There has been an upsurge in the technology of injectable volumetric filler materials for soft tissue augmentation of the face in the past decade. This is a dynamic field that has provided plastic surgeons and dermatologists who treat the aging face with newer tools and techniques. Injectable volumetric fillers can be applied in a variety of combinations and can be added to the various surgical options in conjunction with surgery or as maintenance following surgery. In practice, there are essentially four classes of materials that may be considered gold standard for minimally invasive rejuvenation and beautification of the face: botulinum toxin A, autologous fat, derivatives of hyaluronic acid, and, to a limited extent, hydroxyapatite. These coincide with the philosophy of applying materials and devices associated with the least amount of risk. Long lasting, or permanent–nondegradable, nonextractable, and nonabsorbable fillers remain an unresolved controversial issue, as the longer lasting the device, the greater also is the likelihood for long-term or even irreversible complications. The current trend for nonsurgical minimally invasive procedures for beautifying the face will most probably continue to surge, in light of their affordability in the growing economies around the globe, the increasing demand for a youthful look, and the need for less downtime for these procedures. There will be a rising demand for more hi-tech (bio- or genetically engineered) safe fillers with higher purity and less immunogenicity that allow a short recuperation time in order to attain a product that will serve as an ideal injectable volumetric filler for soft tissue augmentation.

ASDS Guidelines of Care: Injectable Fillers

S 1 1 5 Injectable soft tissue augmentation materials available for use in the United States have proliferated during the past 5 years. In addition to bovine collagen and autologous fat, physicians can now choose between numerous other options, including hyaluronic acid derivatives, poly-L-lactic acid, injectable calcium hydroxylapatite, injectable liquid silicone, polymethylmethacrylate microspheres, and human collagen. While these materials are generally safe and versatile, each has specific features that inform its best use. The guidelines presented herein are not intended to delineate the standard of care but rather to present how most injectors commonly use these materials in patients. These guidelines are a consensus document produced by the ASDS Guidelines of Care Task Force in conjunction with recognized experts in the field who have volunteered their time. While efforts have been made to maintain accuracy and timeliness at the point of submission, these guidelines will no doubt evolve over time and should be considered in the context of the patients’ individual needs. In the 1970s, research into collagen production led to a bovine formulation that could be placed in a syringe and injected. Because of bovine collagen’s temporary persistence, and requirement for skin testing, other fillers were developed and tested in Europe, Asia, and North America in the 1990s. Today, there are a number of fillers to choose from, each with its own strengths and drawbacks.

Management of Complications and Sequelae with Temporary Injectable Fillers

Injectable nonpermanent soft-tissue augmentation materials are extremely well-tolerated products that can be used safely in virtually all patients who are candidates for facial augmentation. In this article, the authors review the management of the few common and minor undesirable effects that may be associated with temporary fillers; in addition, the authors mention the rare incidence of serious complications. The authors conducted a MEDLINE-based (1990 to 2005) review of complications and side effects of nonpermanent injectable filler materials. This review was supplemented with evidence presented at recent plastic surgery and dermatology scientific meetings and unpublished information made available to the authors. Nonpermanent injectable soft-tissue augmentation materials are extremely safe substances that are unlikely to cause more than mild injection discomfort, transient redness and swelling, and occasional short-term bruising when used for facial augmentation. Symmetry can usually be maintained with judicious bilateral use of injectant, and injection-site necrosis is rare and treatable. Proper technique minimizes the already very low risk of visible implants, nodule formation, and hypersensitivity reactions. Other serious effects are exceedingly rare, and retinal artery thrombosis, previously associated with injectable collagen, has not been seen with newer fillers. Injectable nonpermanent fillers are extremely safe substances. Attention to injection technique further minimizes the low risk of adverse events, which are usually minor, spontaneously resolving, and easily treated.

Histological comparison of implanted cadaveric and porcine dermal matrix grafts

Histological comparison of human-based (AlloDerm) and porcine-based (ENDURAGen) dermal matrices regarding tissue incorporation and neovascularization as potential soft tissue augmentation materials. In vivo, rat model. Subcutaneous implantation of 1-mm thick, 1 cm x 1 cm pieces of AlloDerm, ENDURAGen, and meshed ENDURAGen was performed in 24 Sprague Dawley rats. Implant materials were harvested at 4 (n = 12) and 8 weeks (n = 12). Histological quantification of soft tissue ingrowth and microvascular density was performed following hematoxylin-eosin staining and CD34 immunohistochemistry, respectively. AlloDerm showed significantly greater soft tissue ingrowth and microvascular density compared with both ENDURAGen and meshed ENDURAGen at 4 and 8 weeks (P < 0.001). Although these results may differ in human host tissues, AlloDerm seems to be a more suitable dermal matrix implant than ENDURAGen for cases in which tissue incorporation and neovascularization are sought for the optimal outcome based on this animal model.

Multicenter Prospective Randomized 52-Week Trial of Calcium Hydroxylapatite Versus Bovine Dermal Collagen for Treatment of Stress Urinary Incontinence

To evaluate the safety and effectiveness of soft-tissue augmentation of the urethral sphincter with calcium hydroxylapatite (CaHA; Coaptite) compared with glutaraldehyde cross-linked bovine collagen (Contigen) in female patients with stress urinary incontinence due to intrinsic sphincter deficiency and without associated urethral hypermobility. This 12-month prospective, randomized, comparative, multicenter, single-blind, parallel, clinical trial of CaHA and collagen for soft-tissue augmentation of the urethral sphincter in the treatment of stress urinary incontinence enrolled 296 women. Up to five injections were performed in the first 6 months of the trial. Twelve-month postinjection efficacy data were available for 231 patients. The results indicated that CaHA and collagen were both well tolerated in this study. No systemic adverse events were observed with either product. We used the Stamey Urinary Incontinence Scale to grade the improvement, which was the primary endpoint of the study. At 12 months, 83 (63.4%) of 131 CaHA patients compared with 57 (57.0%) of 100 collagen patients showed improvement of one Stamey grade or more (P = 0.34). More CaHA patients required only one injection (n = 60; 38.0%) during the study compared with the Contigen patients (n = 36; 26.1%; P = 0.034). Also, the average total volume of material injected during the course of the study was less for CaHA than for collagen (4.0 mL versus 6.6 mL, respectively; P <0.0001). The results of the study have demonstrated that Coaptite is an appropriate and well-tolerated treatment for patients with incontinence due to intrinsic sphincter deficiency. This new soft-tissue augmentation material has a good safety profile and appears to provide durable improvement.

Technique for calcium hydroxylapatite injection for correction of nasolabial fold depressions

Injectable calcium hydroxylapatite is a soft-tissue augmentation material that is used off-label for facial augmentation, including repletion of depressed nasolabial folds. We sought to assess the safety of calcium hydroxylapatite injection for correction of nasolabial fold depressions. Specifically, we sought to obtain a quantitative assessment of injection-related adverse events using a reproducible placement technique with long-term follow-up. We conducted an open-label, single-center prospective study using reproducible technique with 1- to 1.5-year follow-up. All patients were treated with infraorbital nerve blocks. Then, parallel linear threading technique using 27-gauge/1.25-in needles was used to place 1 to 2 mL of injectant at the dermal subcutaneous junction into each pair of depressed folds. A triangular array of injectant was deposited under the melonasal junction. At follow-up at 2 to 3 weeks and at 1 to 1.5 years, respectively, patients were asked to report and characterize injection-related redness, swelling, bruising, nodule or granuloma formation, asymmetric correction, textural change, hypersensitivity reactions, degree of correction remaining, and overall satisfaction. In addition, patients who had received other injectable soft-tissue materials were asked to compare these with calcium hydroxylapatite in terms of risk profile and longevity of effect. In all, 22 patients were treated and complete follow-up data were obtained from 18. Of the 18 patients, all reported at least mild postinjection redness and swelling, which abated within 1 to 5 days. Bruising was reported by fewer than half, and resolved within 4 to 10 days. Palpable but not visible nodules were reported by 2 of 18 patients; these resolved within 3 months of injection. Asymmetric correction, textural change, granulomas, and hypersensitivity reactions were not reported. In all, 14 of 18 patients reported that cosmetically significant correction lasted longer than 1 year. Two thirds of injected patients who had received other fillers for nasolabial fold correction preferred calcium hydroxylapatite, with the primary reason being increased longevity of effect. There was a lack of objective outcomes measures. When a consistent, defined injection technique is used, injectable calcium hydroxylapatite appears to be a well-tolerated soft-tissue augmentation material for correction of nasolabial fold depressions. A long duration of effect may make this material particularly desirable for some patients.

Clinical Trial of a Novel Filler Material for Soft Tissue Augmentation of the Face Containing Synthetic Calcium Hydroxylapatite Microspheres

The ideal injectable filler should yield great, long-lasting results, be biocompatible, reliable, safe, easy to use, and inexpensive. Radiesse (Bioform Inc., Franksville, WI) is a synthetic calcium hydroxylaptic filler that has all of the above qualities. OBJECTIVE To evaluate the effectiveness of Radiese as an injectable filler. Eighty-two patients who underwent facial soft tissue augmentation using Radiese from April 2003 to 2004 were enrolled in this study. Pre-filled sterile syringes were used to inject the material into the soft tissues of the face. At the 3 month and six month visits, the physicians and the patients were asked to evaluate the result. Eighty-two patients were injected with Radiesse. The most common area of injection was the melolabial folds. All patients were evaluated during the 3 month follow up visit. There was an overwhelmingly positive response to the look and feel of the implant, averaging 4.6 on a grading scale from 1 to 5, for the patients as well as the injecting physicians. Similar responses were found at the 6 month follow up visit. Preliminary data indicate that Radiesse is easy to use and effective with little or no associated morbidity.