BioForm Medical Research Articles

Role of Permacol Injection in the Treatment of Patients With Fecal Incontinence.

See Article on Page 73-78 Fecal incontinence (FI) is defined as the uncontrolled passage of feces or gas over at least 1-month duration in an individual of at least 4 years of age who had previously achieved control [1,2,3,4]. Incontinence has a negative impact on self-esteem and quality of life (QoL) and may result in significant secondary morbidity, disability, and cost [1]. Prevalence rates vary widely depending on the method used for fecal incontinence examination and the target population examined, but, in general, they range between 1.4% and 18%. In institutionalized patients, however, incontinence may affect up to 50%, which is a frequent reason for transfer to nursing homes [2,3,4,5,6]. The Mature Woman's Health Study, which used Neilson data to survey women aged ≥45 years, indicated that nearly 20% of women have FI at least once per year and that 9.5% have at least 1 episode per month [7]. According to the recommended standard for the treatment of patients with FI specified by the American Society of Colon and Rectal Surgeons Clinical Practice Guideline, medical management is 1C, sphincter repair for external anal sphincter defects is 1B, biofeedback is 1B, and sacral neuromodulation is 1B as well. The recommended standard for injection of bulking agents is 2B, which is lower than other treatment methods [1]. Injection of bulking agents was first used on patients suffering from urinary incontinence, and the first report of such a method being used for anal incontinence was presented in 1993 when Shafik [8] injected polytetrafluoroethylene paste (Teflon, Dupont, Wilmington, DE, USA) into the anus to treat a patient with FI. An ideal bulking agent should be nonirritable, biocompatible, nonimmunogenic and durable. Other elements that must be considered when selecting a bulking agent are ease of implant, migration, inflammation reaction, and more [9]. Of the numerous bulking agents used, the main ones include bovine glutaraldehyde cross-linked collagen (Contigen, Bard Urological, Convington, GA, USA), autologous fat, and carbon-coated zirconium-oxide beads in water-based gel (Durasphere, Boston Scientific Corp., Boston, MA, USA) while dextranomer microspheres in nonanimal stabilized hyaluronic acid gel (Solesta, Oceana Therapeutics Inc., Edison. NJ, USA), porcine dermal collagen (Permacol, Covidien, Gosport, UK), polytetrafluoroethylene paste (Teflon, Dupont, Wilmington, DE, USA), polydimethylsiloxane elastomer in hydrogel carrier (PTQ, Uroplasty BU, Geleen, The Netherlands), synthetic calciumhydroxylapatite ceramic microspheres in an aqueous-based gel carrier (Coaptite, Bioform Medical Inc., San Mateo, CA, USA), and ethylene vinyl alcohol dissolved in dimethyl sulphoxide are also widely used. Newly created or enhanced bulking agents continue to be released into the market [9]. Permacol is cross-linked porcine dermal collagen. It has been designed to resist breakdown by collagenase in the body and maintain a long-standing increase in bulk. The product is biocompatible and once injected is incorporated into host tissue, with associated cellular and microvascular in growth. No evidence has been found for its being associated with irritancy or allergenicity [10,11]. Although the characteristics of Permacol are known, previous research about Permacol injection has shown that the number of patients with recurring symptoms of anal incontinence increases in as little as 6 weeks, which leads one to question the durability of Permacol [12]. In other words, the conditions just after an injection are not maintained, but rather the bulking agent is absorbed by surrounding tissues, often leading to the need for another injection. This research lacks objective data on, for example, anal pressure as it merely assessed patients' conditions centered on an evaluation of QoL. Also, the number of target patients is small while that of tracked and observed patients is even smaller. Six of the 9 research papers on anal manometry presented in this systematic journal review failed to show meaningful changes in the mean resting pressure [13]. Similarly, this research does not show a significant difference from previous research results [14]. Despite the relatively short period of tracking and observation, the QoL showed a meaningful change, which is a result similar to those of other studies done in the past. With the injection of bulking agents, the treatment method normally used in urology clinics has been applied to patients with anal incontinence. The action mechanisms are similar; however, a greater amount of inflating agent is used, and the procedure is less likely to be effective.

Utility and Safety of Commercially Available Injection Laryngoplasty Materials in a Rabbit Model

To demonstrate foreign body and chronic inflammatory reaction of commercially available injection materials using the rabbit vocal fold paralysis model. Animal study. The left recurrent laryngeal nerve was identified and divided at the tracheoesophageal groove. Amounts (100μL) of phosphate-buffered saline (PBS), polyacrylamide hydrogel (Aquamid; Ferrosan A/S, Søborg, Denmark), calcium hydroxyapatite (Radiesse; BioForm Medical Inc., San Mateo, CA), or hyaluronic acid derivative (Rofilan; Rofil Medical International, Breda, Netherlands) were injected into the left vocalis muscle. Six months later, the larynx was harvested. Hematoxylin/eosin and Masson trichrome staining were performed to compare inflammatory and foreign body reactions, granuloma development, and relative vocal fold areas among groups. Compared with the PBS (control) group, the Aquamid, Radiesse, and Rofilan groups exhibited only mild chronic inflammatory reactions that did not significantly differ among groups, or from controls (P>0.05). However, the Aquamid and Radiesse groups exhibited moderate foreign body reactions that were significantly greater than those of controls (P<0.05). No foreign body granuloma formed in any group. All test groups exhibited significant increases in vocal fold areas at 6months (P<0.05). Although commercially available injection materials induced more foreign body reactions than a control injection of PBS, no foreign body granuloma developed and the augmented vocal fold area was maintained until 6months after injection.

Comparison of the Rheological Properties of Viscosity and Elasticity in Two Categories of Soft Tissue Fillers: Calcium Hydroxylapatite and Hyaluronic Acid

Two types of soft tissue filler that are in common use are those formulated primarily with calcium hydroxylapatite (CaHA) and those with cross-linked hyaluronic acid (cross-linked HA). To provide physicians with a scientific rationale for determining which soft tissue fillers are most appropriate for volume replacement. Six cross-linked HA soft tissue fillers (Restylane and Perlane from Medicis, Scottsdale, AZ; Restylane SubQ from Q-Med, Uppsala, Sweden; and Juvéderm Ultra, Juvéderm Ultra Plus, and Juvéderm Voluma from Allergan, Pringy, France) and a soft tissue filler consisting of CaHA microspheres in a carrier gel containing carboxymethyl cellulose (Radiesse, BioForm Medical, Inc., San Mateo, CA). METHODS The viscosity and elasticity of each filler gel were quantified according to deformation oscillation measurements conducted using a Thermo Haake RS600 Rheometer (Newington, NH) using a plate and plate geometry with a 1.2-mm gap. All measurements were performed using a 35-mm titanium sensor at 30°C. Oscillation measurements were taken at 5 pascal tau (τ) over a frequency range of 0.1 to 10 Hz (interpolated at 0.7 Hz). Researchers chose the 0.7-Hz frequency because it elicited the most reproducible results and was considered physiologically relevant for stresses that are common to the skin. RESULTS The rheological measurements in this study support the concept that soft tissue fillers that are currently used can be divided into three groups. CONCLUSION Rheological evaluation enables the clinician to objectively classify soft tissue fillers, to select specific filler products based on scientific principles, and to reliably predict how these products will perform--lifting, supporting, and sculpting--after they are appropriately injected.

Multicenter, Randomized Trial Assessing the Effectiveness and Safety of Calcium Hydroxylapatite for Hand Rejuvenation

OBJECTIVE To assess the safety and effectiveness of calcium hydroxylapatite (Radiesse Dermal Filler; RDF) for hand rejuvenation. METHODOLOGY One hundred and one randomized patients received RDF in the hands or no treatment (controls) for 3 months. Controls were crossed over at 3 months, and all patients were followed for 12 months. Assessments include the Busso Hand Volume Severity Scale (BHVSS), Global Aesthetic Improvement Scale-Revised (GAIS-R), patient satisfaction, physician satisfaction, hand function, and safety. RESULTS At 3 months and 6 months, 66% and 56% of hands, respectively, showed at least a 1-point improvement on the BHVSS. At the same time points, 89% and 75% of hands, respectively, were improved on the GAIS-R. In the controlled analysis, treated hands were statistically better than controls. At 3 and 6 months, 86% and 88% of physicians, respectively, and 78% and 76% of patients, respectively, were satisfied; 66% indicated likelihood to return for future RDF treatments. Treatment did not affect hand function. Adverse events were generally short in duration and without serious complications. CONCLUSIONS Hands treated with RDF showed statistically and clinically significant improvement, with high patient and physician satisfaction and no serious adverse events. BioForm Medical (San Mateo, CA) provided the Radiesse soft tissue filler, funding, supplies and equipment for photographic documentation for this study. Dr. Mariano Busso owns shares in BioForm Medical, Inc, is a member of the company's Medical Education Faculty, and has received compensation for presentations about Radiesse to the medical community. Dr. Marion Moers-Carpi owns no stock in BioForm but has received compensation for presentations about Radiesse to the medical community. The remaining physicians have nothing to disclose. David J. Howell, PhD, RRT (San Francisco, CA) provided assistance with editorial development of this manuscript.

Six-Month, Double-Blind, Randomized, Split-Face Study to Compare the Efficacy and Safety of Calcium Hydroxylapatite (CaHA) Mixed with Lidocaine and CaHA Alone for Correction of Nasolabial Fold Wrinkles

BACKGROUND Safety, pain, duration of effect, and patient satisfaction are important concerns for physicians performing dermal filler injections. OBJECTIVE This randomized, double-blind, split-face study compared the 6-month safety profile of dermal injections of calcium hydroxylapatite (CaHA) mixed with lidocaine (RDF-L) with that of CaHA alone (RDF) in nasolabial folds (NLFs). The study also assessed differences in pain perception, efficacy, and patient satisfaction of RDF-L and RDF for correction of nasolabial wrinkles. METHODS Sixteen adult subjects with moderate to deep NLFs according to the Lemperle Rating Scale were enrolled. Pain perception was recorded from patients using a validated visual analog pain scale. Efficacy judged by a blinded injector and an independent observer was evaluated up to 24 weeks. Patient satisfaction surveys were also collected. Adverse events were recorded throughout the study. RESULTS/CONCLUSIONS Neither RDF-L nor RDF led to significant adverse events. Comparable and limited local adverse events typical of dermal fillers were noted in both groups. No difference in duration of effect in the NLFs was shown between RDF-L and RDF. Much less pain was reported on the RDF-L side. In general, patients were extremely satisfied with the treatment on both sides. BioForm Medical (San Mateo, CA) provided Radiesse soft tissue filler, lidocaine, and other necessary supplies. Dr. Grunebaum has received compensation for presentations to the medical community about products manufactured by BioForm Medical.

Dispersion of Calcium Hydroxylapatite Accumulations in the Skin

OBJECTIVES To describe a method whereby accumulated calcium hydroxylapatite (CaHA) can be dispersed into surrounding dermal or subcutaneous tissues by local injection of an aqueous solution followed by vigorous massage. DESIGN Researchers examined three possible antidotes to correct CaHA nodularity: massage alone, injection of saline into the site followed by massage, and injection of sterile water into the site followed by massage. During the 21-day study period of CaHA alone and CaHA mixed with adjuvant, researchers observed inflammatory reactions on Day 0 and Day 21. Antidote efficacy was observed immediately after injection on Day 0 and again on Day 21. RESULTS The sterile water and CaHA+adjuvant saline solutions combined with massage demonstrated significantly less nodularity. In addition, CaHA+adjuvant blebs (nodules) were flattened out more upon massage than were CaHA-only blebs, a finding consistent with deliberate decrease in elasticity of CaHA alone. Clinical experience results also demonstrated that use of lidocaine injection followed by massage resulted in dispersion of CaHA accumulation and restoration of even contours. CONCLUSIONS The protocol described here may represent a mechanism by which improper placement of CaHA in facial tissues may be effectively corrected without the need for excision or injection of steroids. CONCLUSIONS Robert Voigts is a paid employee of Bioform Medical. Dr. DeVore is a consultant to Bioform Medical with stock options. Dr. Grazer is a paid consultant for Bioform. David J. Howell, PhD, RRT (San Francisco, CA) contributed to the writing of this manuscript.

Multinational, Multipatient Study of Calcium Hydroxylapatite for Treatment of the Aging Hand

RESULTS Final results showed that 86% of patients were satisfied or better on a 6-point scale. At week 12, investigators expressed high satisfaction, with a 93% satisfaction rating or better. At weeks 2 and 12, physicians evaluated 98% of patients as improved or better on the Global Aesthetic Improvement Scale. Mild adverse events generally resolved within 2 weeks. Three cases of delayed edema reported 7 to 14 days after treatment resolved without intervention. CONCLUSION Ease of use, minimal postprocedure events, desirable cosmetic outcome, and duration underscore the benefits of CaHA as a safe, efficient, noninvasive treatment option for the aging hand. BioForm Medical Europe commissioned this study and the attendant postmarketing surveillance. BioForm Medical Europe reimbursed each physician a designated sum for each completed patient treatment, including five sets of questionnaires and photos. In return for their participation and completion of the Media Release Form, patients received a maximum of three syringes of BioForm Medical product for treatment of the hands. The individual treating physician determined total cost of treatment.

Viscoelastic properties of phonosurgical biomaterials at phonatory frequencies

The purpose of this study was to examine the functional biomechanical properties of several injectable biomaterials currently or potentially used for vocal fold augmentation. Rheometric investigation of phonosurgical materials in vitro. Linear viscoelastic shear properties of 3% bovine collagen (atelocollagen), micronized AlloDerm (Cymetra; LifeCell Corp., Branchburg, NJ), calcium hydroxylapatite (CaHA) (Radiesse; BioForm Medical, San Mateo, CA), and 2.4% cross-linked hyaluronic acid (HA) gel (Juvéderm; Allergan, Inc., Irvine, CA) were quantified as functions of frequency covering the phonatory range, and compared to those of the human vocal fold cover. Measurements of elastic shear modulus (G') and dynamic viscosity (eta') were made at up to 250 Hz with a controlled-strain simple-shear rheometer. Linear least-squares regression was conducted to curve-fit log G' and log eta' versus log frequency, and statistical analysis was performed with one-way analysis of variance. Radiesse and Cymetra were found to be the stiffest and the most viscous materials, followed by Juvéderm and atelocollagen. There were significant differences in the magnitudes of G' and eta' among the phonosurgical materials and the normal human vocal fold cover (p < .001), whereas there was no significant difference in the frequency dependence of G' and eta' among the materials. Post hoc Tukey tests revealed significant differences (p < .05) in pairwise comparisons of the magnitudes of G' and eta' among all materials and the vocal fold cover. These findings suggested that although these biomaterials may be injected lateral to the lamina propria for the treatment of glottic insufficiency, none of them are rheologically optimal for the functional reconstruction of the vocal fold lamina propria.

Controlled, Randomized Study of Pain Levels in Subjects Treated with Calcium Hydroxylapatite Premixed with Lidocaine for Correction of Nasolabial Folds

Calcium hydroxylapatite (CaHA) has been administered after nerve block injection of anesthetic agents. This prospective, randomized, split-face, single-blind study (50 subjects) assessed the pain reduction, safety, and effectiveness of premixing CaHA with 2% lidocaine for the treatment of nasolabial folds (NLFs). Subjects were randomized to receive treatment with CaHA alone in one NLF (control) and with CaHA premixed with lidocaine in the other NLF (treatment). Subjects completed pain assessments using a validated visual analog scale at specified time points immediately after injection, 1 hour after injection, and 1 month later. Subjects also indicated relative pain experience and preference assessments. Investigators completed aesthetic assessments at 2 weeks and 1 month. Subjects and investigators recorded adverse events. Subjects reported statistically significantly less pain in the treatment fold than in the control fold and expressed unanimous preference for the treatment injection over the control. Aesthetic results were essentially equivalent for both treatments. Investigators concluded that CaHA premixed with lidocaine results in significant pain reduction during dermal filler injection while maintaining the aesthetic improvement of CaHA without lidocaine and demonstrating comparable local transient adverse events for treatment and control. BioForm Medical (San Mateo, CA) provided the soft tissue filler, lidocaine, and other necessary supplies used in this study. All authors are members of the Bioform Medical Education Faculty.

An Evaluation of Calcium Hydroxylapatite (Radiesse) for Cosmetic Nasolabial Fold Correction

The use of calcium hydroxylapatite (Radiesse, BioForm Medical, San Mateo, California) for cosmetic soft tissue augmentation has increased significantly in recent years. Only a handful of authors have reported patient satisfaction data. A meta-analysis of published data was performed using a 5-point scale for patient satisfaction to allow data comparison across studies. A patient-centric outcomes study was also performed at our institution, using a blinded questionnaire. Five usable studies were identified for meta-analysis. Patient satisfaction was 4.16 of 5 in 324 patients at 3 to 6 months and 4.15 in 86 patients at 1 year. In our institutional patient-centric outcomes study, the early satisfaction rate was 3.7 of 5. At 1 year the rate was only 2.3 of 5. Calcium hydroxylapatite remains a viable option for augmentation of facial soft tissue structures. However, this report shows that further, accurate, large population outcomes assessments are absolutely required.

High-Volume Calcium Hydroxylapatite Filler to the Lower One-Third of the Face

High-Volume Calcium Hydroxylapatite Filler to the Lower One-Third of the Face

Radiographic and Computed Tomographic Studies of Calcium Hydroxylapatite for Treatment of HIV–Associated Facial Lipoatrophy and Correction of Nasolabial Folds

This study sought to assess the radiographic appearance produced by calcium hydroxylapatite soft tissue filler (CaHA; Radiesse, BioForm Medical Inc.) following augmentation to correct the nasolabial folds or facial wasting associated with human immunodeficiency virus lipoatrophy. A total of 58 patients, with either lipoatrophy or pronounced nasolabial folds, were treated with CaHA. Radiographic (X-ray) and computed tomographic (CT) imaging studies were conducted pre- and posttreatment in most patients; the images were sent to an independent laboratory to be analyzed by two evaluators who were board-certified radiologists and blinded to study purpose, product, and patient condition. While results for X-ray evaluation showed inconsistencies in visualization of CaHA, CT scans showed consistent visualization in nearly all cases in patients who were imaged immediately after treatment. In addition, the results indicated no obscuration of underlying structures by CaHA and no evidence of CaHA migration. Earlier clinical trials established CaHA as a safe and effective soft tissue filler. This CaHA study shows no overt radiographic safety concerns. CaHA is unlikely to be confused with conventional abnormal and adverse radiographic findings. The product is not always visible on X-ray. Although usually visible on CT scans, its appearance is distinct from surrounding bony structures and does not interfere with normal analysis. In addition, the product does not obscure underlying structures on CT scans.

Radiographic and Computed Tomographic Studies of Calcium Hydroxylapatite for Treatment of HIV–Associated Facial Lipoatrophy and Correction of Nasolabial Folds

OBJECTIVES This study sought to assess the radiographic appearance produced by calcium hydroxylapatite soft tissue filler (CaHA; Radiesse, BioForm Medical Inc.) following augmentation to correct the nasolabial folds or facial wasting associated with human immunodeficiency virus lipoatrophy. METHODS A total of 58 patients, with either lipoatrophy or pronounced nasolabial folds, were treated with CaHA. Radiographic (X-ray) and computed tomographic (CT) imaging studies were conducted pre- and posttreatment in most patients; the images were sent to an independent laboratory to be analyzed by two evaluators who were board-certified radiologists and blinded to study purpose, product, and patient condition. RESULTS While results for X-ray evaluation showed inconsistencies in visualization of CaHA, CT scans showed consistent visualization in nearly all cases in patients who were imaged immediately after treatment. In addition, the results indicated no obscuration of underlying structures by CaHA and no evidence of CaHA migration. CONCLUSIONS Earlier clinical trials established CaHA as a safe and effective soft tissue filler. This CaHA study shows no overt radiographic safety concerns. CaHA is unlikely to be confused with conventional abnormal and adverse radiographic findings. The product is not always visible on X-ray. Although usually visible on CT scans, its appearance is distinct from surrounding bony structures and does not interfere with normal analysis. In addition, the product does not obscure underlying structures on CT scans.

Hand augmentation with Radiesse® (Calcium hydroxylapatite)

The hand has remained a considerable treatment challenge, as new soft tissue fillers have arrived in the esthetic marketplace. The challenge has been the result of both the multiple visits required for treatment in, for example, autologous fat grafting and the simple management of pain in the innervated areas of the hand between the bones. This paper introduces a novel, noticeably less painful approach to treatment of the hand with calcium hydroxylapatite (CaHA; Radiesse, BioForm Medical, San Mateo, CA). Anesthetic is added to the compound prior to injection, resulting in a homogenous admixture of CaHA and anesthetic. A bolus of the mixture is injected into the skin, using tenting, and then spread throughout the hand. The result of this approach - mixing anesthetic with CaHA - is treatment that is easier to massage and disseminate, less painful to the patient than conventional hand injection, and characterized by less swelling and bruising, with minimal post-treatment downtime.

Calcium Hydroxylapatite (Radiesse) for Correction of the Mid- and Lower Face: Consensus Recommendations

Restoring volume in the middle and lower portions of the face is becoming an indispensable component of modern facial rejuvenation. Radiesse (BioForm Medical, San Mateo, Calif.) is an injectable filler material composed of synthetic calcium hydroxylapatite microspheres (30 percent) suspended in an aqueous carrier gel (70 percent). At present, Radiesse is indicated in the United States for correction of moderate to deep nasolabial folds and for correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Its off-label use in other facial aesthetic indications is widely reported in the literature. The ability of Radiesse to provide immediate and durable effects has fueled interest in its use for expanded aesthetic applications, particularly in the middle and lower face. The authors' consensus panel, consisting of a cross-section of experts in plastic surgery, facial plastic surgery, and dermatology, was convened to review the scientific literature and compare clinical experiences regarding the use of calcium hydroxylapatite. This report describes the characteristic effects of aging in the middle and lower face and reviews the composition of calcium hydroxylapatite, its safety and durability, and its appropriate use in a variety of facial applications, including nasolabial folds, correction of human immunodeficiency virus-associated lipoatrophy, augmentation of the malar, submalar, and zygomatic regions, and correction of oral commissure defects, marionette lines, and prejowl sulcus. Recommendations for Radiesse use in each area, including anesthesia, and injection techniques are provided. Measures for enhancing patient comfort, anticipating and minimizing potential complications, and optimizing aesthetic results are also discussed.

The use of calcium hydroxylapatite [Radiesse; BioForm Medical] in two facial aesthetic applications has been recommended for FDA approval

The use of calcium hydroxylapatite [Radiesse; BioForm Medical] in two facial aesthetic applications has been recommended for FDA approval

Wire subcision for complete release of depressions, subdermal attachments, and scars

Deep lines, facial folds, retracted scars, and contour depressions on all areas of the body have typically been resistant to efforts at release. A method using a wire dissector to achieve complete release or subcision of these subdermal attachments with access only through the needle insertion sites is described. The wire dissector was inserted into the subcutaneous tissue just below the dermal-subcutaneous tissue junction and brought out of the skin on one side of the defect. The needle was then passed back and forth through the same puncture holes until the depression was circled entirely in the subcutaneous plane by the wire. Traction was applied by the assistant, and the wire was sawed gently back and forth until the depression was completely released. The areas most commonly treated with the wire were the deep nasolabial folds; among the other areas treated were marionette lines, cheek and chin lines, and retracted scars of the face and body. Of 38 patients treated, 27 underwent simultaneous fat injection, 1 received an AlloDerm (LifeCell Corp., Branchburg, NJ) graft, 1 received a Radiesse (Bioform Medical, Inc., San Mateo, CA) injection; and 1 received injection with Sculptra (Dermik Laboratories, Berwyn, PA). Eight patients had nothing placed under the subcision area. Follow-up of 1 to 19 months showed persistent correction in all patients. Postoperative complications included one hematoma, one localized abscess, and overcorrection in three cases where fat was used. The wire dissector holds promise as a tool for complete subcision of deep lines, folds, depressions, and scars of the face and body without incisions and with few complications.

Results of a 2-Year Multicenter Trial of Endoscopic Treatment of Vesicoureteral Reflux With Synthetic Calcium Hydroxyapatite

With no FDA approved material available for endoscopic treatment of vesicoureteral reflux, in 2001 we began a prospective multicenter trial of synthetic calcium hydroxyapatite as a subureteral bulking agent in children with traditional indications for surgical repair. A total of 98 patients (155 ureters) with grades II to IV reflux were enrolled at 10 sites in the United States to obtain 86 patients with completed protocol end points at 3 months. Of the 86 patients 74 underwent renal and bladder ultrasonography, blood count and serum chemistry analysis, and VCUG at 1 year. A total of 46 patients (47%) completed 2-year study end points, including VCUG. At 1 and 2 years 24 of the 74 patients (32%) were cured. Ureteral cure rates were 46% and 40% at 1 and 2 years, respectively. With 35 patients treated and 85% compliance with the required 2-year VCUG the primary center achieved 2-year cure rates of 66% of patients and 72% of ureters. Synthetic calcium hydroxyapatite is a safe, durable and effective material for endoscopic treatment of VUR. Increased experience with the injection of synthetic calcium hydroxyapatite yields improved results.