Stock Prosthesis Research Articles

Clinical and Radiologic Follow-Up of Zimmer Biomet Stock Total Temporomandibular Joint Replacement After Surgical Modifications

The aim of this study was to evaluate the clinical and radiologic results of Zimmer Biomet stock prostheses (Jacksonville, FL) in temporomandibular joint replacement after surgical modifications during at least 1year of follow-up. We recruited patients treated by Zimmer Biomet stock prostheses after technical modifications, including digital templates, autogenous ipsilateral bone grafting from the mandible to the fossa, salvaging of the disc remnant and suturing it to the medial aspect of the prosthesis, and fat grafts from a retromandibular incision, between 2010 and 2016. Clinical examination findings including maximal incisal opening; visual analog scale scores for pain, diet, and mandibular movement; and quality of life were compared before the operation and at least 1year postoperatively.The status of the fossa bone graft was evaluated by computed tomography examination. The study comprised 38 joints in 33 patients with diagnoses including osteoarthritis, ankylosis, and neoplasm.Compared with before the operation, maximal incisal opening and visual analog scale scores for diet, function, and pain level, as well as the quality-of-life survey score, were considerably improved during the last follow-up.Computed tomography scans showed all bone grafts were completely healed within the fossa 1year after surgery. There was no ectopic bone formation, screw loosening, or component displacement or breakage. Our surgical modifications of Zimmer Biomet stock prostheses showed good results for at least 1year of follow-up.

Temporomandibular joint reconstruction with stock and custom-made devices: Indications and results of a 14-year experience

Temporomandibular joint (TMJ) reconstruction with alloplastic implants is a reliable, safe and effective treatment option for selected debilitating pathologies of the TMJ. This study retrospectively analyzes our 14-year experience in total alloplastic reconstruction of the TMJ using stock and custom Biomet prostheses. Indications, results and rationale for the choice of stock and custom-made devices are discussed. Patients were enrolled in the study who underwent single-stage alloplastic total joint replacement from January 2000 to October 2014. The subjective and objective variables were as follows: TMJ pain, diet, jaw function, maximum interincisal opening (MIO), quality of life and occlusion. The minimum follow-up was 12 months. A total of 38 patients (55 joints) met the inclusion criteria and were enrolled in the study. Of the patients, 25 underwent Biomet total joint reconstruction system with stock prosthesis, 12 patients underwent total joint reconstruction system with custom made (patient matched) prosthesis, and 1 patient underwent bilateral total joint reconstruction using stock system on one side and custom system on the other side. The following adverse events and complications were recorded: bleeding, 2 cases; malocclusion, 1 case; postoperative infection with prosthesis removal, 1 case; heterotopic bone formation, 1 case; and contralateral TMJ overload in unilateral cases, 1 case. The occlusion was habitual unchanged in 29 of 38 cases. In 1 patient occlusion worsened with less stable functional contact. The patient refused postoperative orthodontic treatment. In 8 patients, a concomitant orthognatic procedure was planned in order to improve the occlusion. In all these patients, the occlusion improved. Quality of life and MIO relevantly improved in all cases. This study supports the use of total joint reconstruction for end-stage TMJ disease. Both stock and custom implants allow consistent results, but there are precise indications for the use of custom implants.

Management of dentofacial deformities and facial asymmetry with orthognathic surgery concomitant alloplastic temporomandibular joint replacement whit stock prosthesis

Temporomandibular joint (TMJ) disorders or pathology and dentofacial deformities (DFD) commonly coexist. The TMJ pathology may be the causative factor of the jaw deformity or develop as a result of the jaw deformity. Total alloplastic replacement is indicated in TMJ ankylosis, congenital deformation or absence of the TMJ, other end-stage TMJ pathologies, etc. Studies have shown that both custom and stock alloplastic TMJ replacements resulted in statistically significant improvement in pain level, jaw function, and incisal opening. The TMJ stock prosthesis has the advantage of having a more flexible adjustment and lower cost compared to custom made prosthesis, also has immediate placement availability. Objective: The aim of this study is to describe stock alloplastic TMJ total replacement with orthognathic surgery in patients with DFD and concomitant facial asymmetry. Methods: Two patients presenting with congenital and acquired disease DFD and facial asymmetry underwent orthognathic surgery with TMJ alloplastic replacement with stock prosthesis. All patients were planned by traditional model surgery. Conclusions: The TMJ is the basis of the mandibular position, the function, occlusion and facial balance. Several authors have described the performance of orthognathic surgery in conjunction with TMJ alloplastic replacement with custom-made prosthesis, however, there is little literature on performing orthognathic surgery concomitant with stock prosthetic.

Facial reconstruction: patient specific implants, success and failure

Background: Implants used in craniofacial surgery can be classified according the biomaterial used or its clinical presentation like stock prostheses. Patient specific implants (PSI), those defined like implants made with specific anatomic dimensions of patient, through design, planning and manufacturing computer guided or aided, which finally will adjust with accuracy and precision in anatomic sites with disturbance in shape and thickness. Objectives: (1) To release different biomaterials used in reconstructive craniofacial surgery implants with their success and failure rates, exposing benefits, contraindications and frequent complications; (2) to present a clinical protocol, which will resume planning, biomaterial choice, design and surgery technique; and (3) to present 2 clinical cases worked in our institution. Methods: Display will be with films, reviewing available literature updated with clinical cases and the setting up of a clinical protocol. Findings: There are not enough randomised controlled trials, meta-analysis, which can determine the ideal biomaterial to develop a PSI. Conclusions: PSI represents the ideal option to reconstruct high complexity craniofacial defects for its safety, reproducibility and high accuracy, even there's not an ideal biomaterial for fabrication, in this review the titanium and polyetheretherketone are biomaterials with less complication rates.

One stage treatment of temporomandibular joint complete bony ankylosis using total joint replacement

Temporomandibular joint ankylosis is a joint disorder due to bone or fibrous adhesion of the joint components that cause loss of function. There are many causes, such as trauma, infections and systemic diseases. To date, no uniform treatment protocol has been established. We enrolled in the study patients that underwent single stage alloplastic total joint replacement for complete bony ankylosis. The subjective and objective variables were as follow: TMJ pain, diet, jaw function, quality of life, maximum interincisal opening (MIO) and occlusion. The minimum follow-up was 12 months. 12 patients met the inclusion criteria. Six patients underwent bilateral or monolateral total joint reconstruction with stock prosthesis, six patients underwent bilateral total joint reconstruction with custom made prosthesis. The mean preoperative MIO was 7.9mm. The mean MIO reordered at 12-month follow-up was 26.5mm (P<0,0001). The occlusion was unchanged in 9 patients out of 12. In two patients the occlusion was changed by means of custom prosthesis design. In one patient occlusion worsened with less stable functional contact. Quality of life and diet relevantly improved in all cases. Single stage resection and reconstruction with total alloplastic TMJ reconstruction is an effective and reliable method to reestablish stable long-term mandibular function in ankylotic patients.

Rehabilitation of a case of enucleated retinoblastoma

Retinoblastoma is one of the commonest malignant intraocular tumors in pediatric population, resulting in evisceration, enucleation or exenteration of orbital contents. An ocular prosthesis can boost the psychological wellbeing of a patient with an anophthalmic socket. Though the stock prosthesis for ocular defects can be used as an interim prosthesis but customized prosthesis is required for better fit, function, esthetics and tissue health of anophthalmic socket. The present case report describes the prosthetic rehabilitation of a surgically treated case of retinoblastoma.

Evaluation of total alloplastic temporo-mandibular joint replacement with two different types of prostheses: A three-year prospective study

BackgroundTemporo-Mandibular Joint (TMJ) replacement has been used clinically for years. The objective of this study was to evaluate outcomes achieved in patients with two different categories of TMJ prostheses.Material and MethodsAll patients who had a TMJ replacement (TMJR) implanted during the study period from 2006 through 2012 were included in this 3-year prospective study. All procedures were performed using the Biomet Microfixation TMJ Replacement System, and all involved replacing both the skull base component (glenoid fossa) and the mandibular condyle.ResultsFifty-seven patients (38 females and 19 males), involving 75 TMJs with severe disease requiring reconstruction (39 unilateral, 18 bilateral) were operated on consecutively, and 68 stock prostheses and 7 custom-made prostheses were implanted. The mean age at surgery was 52.6±11.5 years in the stock group and 51.8±11.7 years in the custom-made group. In the stock group, after three years of TMJR, results showed a reduction in pain intensity from 6.4±1.4 to 1.6±1.2 (p<0.001), and an improvement in jaw opening from 2.7±0.9 cm to 4.2±0.7 cm (p<0.001). In the custom-made group, after three years of TMJR, results showed a reduction in pain intensity from 6.0±1.6 to 2.2±0.4 (p<0.001), and an improvement in jaw opening from 1.5±0.5 cm to 4.3±0.6 cm (p<0.001). No statistically significant differences between two groups were detected.ConclusionsThe results of this three-year prospective study support the surgical placement of TMJ prostheses (stock prosthetic, and custom-made systems), and show that the approach is efficacious and safe, reduces pain, and improves maximum mouth opening movement, with few complications. As such, TMJR represents a viable technique and a stable long-term solution for cranio-mandibular reconstruction in patients with irreversible end-stage TMJ disease. Comparing stock and custom-made groups, no statistically significant differences were detected with respect to pain intensity reduction and maximum mouth opening improvement. Key words:Temporo-mandibular joint, temporo-mandibular joint replacement, prosthesis, biomaterials, biomedical engineering, computer-aided design and manufacturing.

EACMFS Prizes and Awards

To describe a new glenoid fossa bone graft technique, and to evaluate its effect on the stability of stock fossa prosthesis implantation in total alloplastic joint replacement surgery.Eight patients who underwent total joint replacement surgery with a Biomet stock prosthesis (Biomet, Warsaw, IN, USA) from November 2013 to April 2014 were included in this study. ProPlan CMF 1.4 software (Materialise NV, Leuven, Belgium) was used to choose the prosthesis size and place it in the right position. The depth of the fossa was measured, and the osteotomy line was designed to cut the bone which overlapped the fossa prosthesis. A bone graft, taken from the bottom of the articular eminence or the condylar neck, was used to fill in the fossa and make a flat plane in combination with the residual eminence for the positioning of the fossa prosthesis. The stability of the fossa prosthesis was evaluated both intra-operatively and postoperatively with computed tomography (CT) scanning after at least 6 months of follow-up. The bone contact area of the fossa prosthesis and the volume of the grafted bone were measured.Fossa prostheses were intra-operatively stable after bone grafting. All patients had stable occlusion after surgery and at follow-up. Postoperative measurement showed that the bone contact area with the fossa prosthesis increased from 52.8% to 88.5% after bone grafting. Postoperative CT measurements (at an average of 9 months after surgery) showed that the bone graft volume decreased by 11.1%.Bone grafts in the glenoid fossa help to improve the stability of Biomet stock fossa prosthesis implantation.

Comparison of Temporomandibular Joint Reconstruction With Custom (TMJ Concepts) Vs. Stock (Biomet) Prostheses

The prostheses used today for alloplastic replacement of the temporomandibular joint (TMJ) were just recently developed over the last two decades. Currently, there is limited research on the efficacy of TMJ prosthetic systems when compared to each other. This study aims to compare the differences in maximal incisal opening (MIO) and pain levels in patients treated with custom TMJ prostheses made by TMJ Concepts and stock prostheses made by Biomet.

Application of fossa bone graft to stabilize stock total joint prosthesis in temporomandibular joint surgery.

To describe a new glenoid fossa bone graft technique, and to evaluate its effect on the stability of stock fossa prosthesis implantation in total alloplastic joint replacement surgery. Eight patients who underwent total joint replacement surgery with a Biomet stock prosthesis (Biomet, Warsaw, IN, USA) from November 2013 to April 2014 were included in this study. ProPlan CMF 1.4 software (Materialise NV, Leuven, Belgium) was used to choose the prosthesis size and place it in the right position. The depth of the fossa was measured, and the osteotomy line was designed to cut the bone which overlapped the fossa prosthesis. A bone graft, taken from the bottom of the articular eminence or the condylar neck, was used to fill in the fossa and make a flat plane in combination with the residual eminence for the positioning of the fossa prosthesis. The stability of the fossa prosthesis was evaluated both intra-operatively and postoperatively with computed tomography (CT) scanning after at least 6 months of follow-up. The bone contact area of the fossa prosthesis and the volume of the grafted bone were measured. Fossa prostheses were intra-operatively stable after bone grafting. All patients had stable occlusion after surgery and at follow-up. Postoperative measurement showed that the bone contact area with the fossa prosthesis increased from 52.8% to 88.5% after bone grafting. Postoperative CT measurements (at an average of 9 months after surgery) showed that the bone graft volume decreased by 11.1%. Bone grafts in the glenoid fossa help to improve the stability of Biomet stock fossa prosthesis implantation.

Modified surgical techniques for total alloplastic temporomandibular joint replacement: One institution's experience

ObjectiveTo present three modified techniques of total alloplastic temporomandibular joint replacement (TMJ TJR) and to evaluate the outcomes regarding prosthesis stability and heterotopic bone formation. Material and methodsA total of 15 patients (19 joints), treated with the Biomet stock prosthesis from May 2006 to May 2013, were retrospectively analyzed. Surgical procedures were performed with the following three modifications: bone grafting of the glenoid fossa; salvage of TMJ discs; and harvesting of retro-mandibular subcutaneous fats. The glenoid fossa depth was measured preoperatively by Surgicase 5.0 software. All patients were evaluated by radiographic examination and surgical observation. ResultsThe fossa was grafted with an autogenous bone in 15 joints (78.9%). In 4 joints (21.1%), only bone repair was performed. Radiographic evaluation revealed a good integration between the autogenous and host bones. All patients showed postoperative occlusal stability. In 5 joints (26.3%), the discs were salvaged. Both bleeding and operation time were reduced. Fat grafts were harvested in 17 joints (89.5%), in which there were no abnormalities in the periprosthetic bone structure. In 2 joints (10.5%), with no fat grafting, heterotopic bone formation was found. ConclusionsThe modified techniques of TJR help to improve prostheses stability, reducing heterotopic bone formation and avoiding additional scars.

Custom-made artificial parts for improving functional and cosmetic results of ocular prosthetics

Aim - to justify the use of custom-made ocular prostheses aimed at better functional and cosmetic outcomes. Cosmetic outcomes in 520 patients operated for either anophthalmia (89.1%), or ocular subatrophy (6.7%), or congenital micro-/anophthalmia have been analyzed. General and ophthalmic assessment was performed. Relationships were investigated between the results obtained in a particular patient, on the one hand, and primary etiology in his/her case, eye removal technique, postoperative management details, complications, treatments, and preventive measures, on the other. It has been found that, if aiming to avoid the development of anophthalmic syndrome, the choice of surgical technique should be done most carefully so that a muscle stump could be formed and primary prosthesis inserted. Indications for the use of complexly shaped ocular prostheses have been identified. We have also explored the possibilities for correction of cosmetic defects associated with the use of modified stock prostheses. Moreover, in this article particular attention is paid to the importance of cooperation between the oculoplastic surgeon and the ocularist in order to ensure timely orbital reconstruction. Indications for the use of custom-made ocular prostheses of complex shapes have been identified. The range of complications that may arise from their irrational use are discussed.

Total alloplastic temporomandibular joint reconstruction using Biomet stock prostheses: the University of Florida experience

The purpose of this study was to report the subjective and objective outcomes of temporomandibular joint (TMJ) replacement with Biomet stock prostheses at a single institution in Florida. In this retrospective study, patients who underwent TMJ replacement using a Biomet stock prosthesis from 2005 to 2012 were analyzed. Subjective (pain, diet) and objective (maximal incisal opening) information was obtained. In addition, a quality of life measure was obtained pre- and postoperatively. Significance was set at <0.01. Thirty-six patients (26 bilateral, 6 left, and 4 right) who underwent TMJ replacement using a Biomet stock prosthesis were eligible for the study. Maximal incisal opening improved from 26.1mm preoperatively to a mean of 34.4mm postoperatively. The pain score decreased from 7.9 preoperatively to a mean of 3.8 postoperatively. Diet restriction decreased from 6.8 preoperatively to a mean of 3.5 postoperatively. Quality of life improved from a median of 4 preoperatively to a postoperative median of 2. Four implants were removed/replaced because of heterotopic bone formation, infection, and/or loose hardware. Follow-up ranged from 6 to 83 months. Overall, TMJ reconstruction using the Biomet stock joint is effective and safe in this patient population.

Comparison of the outcomes of three surgical treatments for end-stage temporomandibular joint disease

The aim of this study was to determine whether there are any differences between condylectomy, rib grafts, and prosthetic joints (Biomet TMJ stock prosthesis) with regard to outcomes for patients with end-stage temporomandibular joint (TMJ) disease. Fifty-six of a total 127 patients who presented with category 5 end-stage TMJ disease over 3 years (2010–2013) agreed to participate in this retrospective, comparative, cohort study. Patients were divided into four groups: preoperative (n=16), condylectomy (n=8), rib graft (n=16), and prosthetic joint (n=16). They were assessed for major postoperative complications (i.e., return to theatre) and maximum range of mandibular motion, and all completed a specific quality of life (QOL) questionnaire. Whilst the condylectomy group demonstrated the best mandibular range of motion (P<0.01), rib graft patients were more likely to experience complications (43.8%) necessitating a return to theatre. The prosthesis group recorded the best mean aggregate QOL score, but the difference compared to the rib graft and condylectomy groups was not statistically significant. The results of this study suggest that for dentate patients, prosthetic joints are highly dependable with no returns to theatre and favourable QOL outcomes. For edentulous patients, condylectomies alone also appear to work well. Future TMJ prosthetic designs should focus on improving mandibular range of motion, as the current stock prosthesis allows only a restricted range, no better than that achieved with rib graft (P>0.05) and far less than that achieved with condylectomy (P<0.01).

Custom Made Ocular Prosthesis at Optometry Clinic Universiti Kebangsaan Malaysia (UKM)

Patients who lost their eyes as results of accidents or diseases (e.g. retinoblastoma) usually underwent enucleation or evisceration. They were then fi tted with ocular prosthesis to prevent collapse of the globe and also for cosmetic effects. Custom made ocular prosthesis is almost unheard of in this country for most hospitals supply ready-made (stock) prosthesis. The cosmetic results of stock prosthesis are often unsatisfactory. Besides being uncomfortable, stock prosthesis may also induce allergic reaction that may lead to papillary conjunctivitis. The Optometry Clinic at UKM started its custom made prosthetic service in 2010. We described here two cases of patients who complained of discomfort with their old stock prosthesis and re- fi tted with custom made prosthesis. We also highlight the importance of proper hygiene and maintenance so that ocular prosthesis can be used for as long as possible. This article aims to create awareness among eye care practitioners and showcase the cosmetic bene fi ts of custom made ocular prosthesis.

Functional Outcomes in Bilateral Temporomandibular Joint Ankylosis Treated With Stock Prosthesis

The purpose of this study was to evaluate the functional outcomes in patients affected by bilateral temporomandibular joint (TMJ) ankylosis treated with TMJ total alloplastic reconstruction with stock prosthesis. As a matter of fact, ankylosis of the TMJ may produce the narrowing of the oropharyngeal airway space resulting in the obstructive sleep apnea syndrome, a pathological condition characterized by repetitive upper airway obstructions during sleep, resulting in arousal from sleep, sleep fragmentation, arterial oxygen desaturation. and daytime hypersomnolence.Clinical results demonstrate that total TMJ reconstruction with prosthesis is the surgical modality of choice to obtain the counterclockwise rotation and the advancement of the maxillomandibular complex, which significantly increase the volume of the oropharyngeal airway space in this kind of patients.

Different Techniques in Fabrication of Ocular Prosthesis

Loss of an eye caused by cancer, trauma, or congenital defect creates a deep psychological impact on an individual's life especially social and professional life. Custom-made prosthesis, compared to stock prosthesis, provides a better fit to the eye socket, better cosmetic results, and less discomfort to the patient in the long term. The main objective of this article was to describe 3 different alternative and practical techniques of fabricating custom-made ocular prosthesis. An impression of anophthalmic socket was made with the addition of cured silicone-based precision impression material in all techniques. A master cast was prepared and duplicated with condensation silicone. A self-cure acrylic resin was polymerized in the silicone model and was fitted into the patient's eye socket. A digital photograph of the patient's iris was made using a digital camera and printed on good-quality photo paper in various shades and sizes in the first and the second techniques. Then the photo paper was coated with PVC so as not to allow any color flowing. The proper iris was then inserted to the acrylic base. The prosthesis was final processed using orthodontic heat polymerizing clear acrylic resin.In the other technique, after the trying-in process with wax pattern, an acrylic base was fabricated using heat polymerizing scleral acrylic resin. The prosthetic iris was fabricated from a transparent contact lens by painting the lens with watercolor paints and attaching it to an acrylic resin with tissue conditioner. The final process was made with heat polymerizing transparent acrylic resin. Custom-made prosthesis allows better esthetic and functional results to the patient in comparison to stock prosthesis. Further follow-up is necessary to check the condition and fit of the ocular prosthesis in such patients.

Synovial Metaplasia Found in Tissue Encapsulating a Silicone Spacer During 2-Staged Temporomandibular Joint Replacement for Ankylosis

Multiple previous surgeries, a history oftrauma, and ineffective postsurgical physical therapyregimens have been postulated as possible contribut-ing factors to its development. Different therapeuticoptions have been proposed, each showing variablesuccess in preventing reankylosis.We report the first case in which papillary syno-vial metaplasia occurred due to placement of atemporary silicone implant in a patient in whomHBF developed after total alloplastic TMJ replace-ment with a stock prosthesis and present a reviewof the literature.

E-Manuscript Article Summaries*

Background: Of all mastectomy patients, 90% will use an external prosthesis where the standard of care uses a stock prosthesis that is purchased “off the shelf.” Our objectives were to determine patient demand for and perceived value of a custom breast prosthesis. The information obtained will influence future research and program direction. Methods: We asked 65 women who had undergone lumpectomy or mastectomy to participate before exploring rehabilitation options. The quantitative outcome measures were the European Organisation for Research and Treatment of Cancer QLQ-C30 general and -BR23 breast cancer–specific quality of life questionnaires, and the Ambulatory Oncology Patients Satisfaction Tool. The QLQ results were analyzed using the Mann–Whitney U-test. Results of the satisfaction tool were compared using the Fisher exact and chi-square tests. A descriptive qualitative approach—involving in-depth interviews exploring the experiences of the women—was used to establish the perceived value of the services to the patients. The analysis of the interview transcripts was conducted using a standardized content method to describe the experiences of the women. Results: All the women had had previous experiences with a conventional prosthesis, and they reported that wearing a custom prosthesis was more satisfying for them. They reported comfort and ease in wearing it, coupled with a sense of feeling less like a victim. Comparison of the qlq and patient satisfaction scores showed no significant difference between the women wearing the conventional prosthesis and those wearing the custom prosthesis. Conclusions: The willingness of women to pay for a prosthesis and the qualitative results from the present study demonstrate that there is demand for a custom approach to treatment. However, if a mixed-methods approach had not been applied during this initial exploration of women’s experiences with custom breast prostheses, the essence of the perceived value of the custom prosthesis would have been lost. Quantitative measures suggest that there is no difference between custom and conventional breast prostheses, but the qualitative data captured in the study provide a sense of aspects of care that a standardized outcome measure cannot capture. Further research with a larger sample size is needed to determine if real differences from a quantitative perspective are possible. Suggestions for improvements in the device and in program operations were gathered and will influence the future development and implementation of a breast prosthesis service, but financial assistance will most likely be needed to make such a service universally accessible.

A Mixed-Methods Cohort Study to Determine Perceived Patient Benefit in Providing Custom Breast Prostheses

Of all mastectomy patients, 90% will use an external prosthesis where the standard of care uses a stock prosthesis that is purchased "off the shelf." Our objectives were to determine patient demand for and perceived value of a custom breast prosthesis. The information obtained will influence future research and program direction. We asked 65 women who had undergone lumpectomy or mastectomy to participate before exploring rehabilitation options. The quantitative outcome measures were the European Organisation for Research and Treatment of Cancer QLQ-C30 general and -BR23 breast cancer-specific quality of life questionnaires, and the Ambulatory Oncology Patients Satisfaction Tool. The QLQ results were analyzed using the Mann-Whitney U-test. Results of the satisfaction tool were compared using the Fisher exact and chi-square tests. A descriptive qualitative approach-involving in-depth interviews exploring the experiences of the women-was used to establish the perceived value of the services to the patients. The analysis of the interview transcripts was conducted using a standardized content method to describe the experiences of the women. All the women had had previous experiences with a conventional prosthesis, and they reported that wearing a custom prosthesis was more satisfying for them. They reported comfort and ease in wearing it, coupled with a sense of feeling less like a victim. Comparison of the QLQ and patient satisfaction scores showed no significant difference between the women wearing the conventional prosthesis and those wearing the custom prosthesis. The qualitative data provide a strong case in support of the new device. Patient demand, perceived benefit, and experience wearing the prosthesis were documented. Suggestions for improvements in the device and in the program operations were gathered and will influence future development of this service.