The Costs of Breast Reconstruction and Implications for Episode-Based Bundled Payment Models.

BACKGROUND: Implementation of payment reform for breast reconstruction following mastectomy demands a comprehensive understanding of costs related to the complex process of reconstruction. Bundled payments for services to women with breast cancer may profoundly impact reimbursement and access to breast reconstruction. The authors' objectives were to determine the contribution of cancer therapies, comorbidities, revisions, and complications to costs following immediate reconstruction and the optimal duration of episodes to incentivize cost containment for bundled payment models. METHODS: The cohort was composed of women who underwent immediate breast reconstruction between 2009 and 2016 from the MarketScan Commercial Claims and Encounters database. Continuous enrollment for 3 months before and 24 months after reconstruction was required. Total costs were calculated within predefined episodes (30 days, 90 days, 1 year, and 2 years). Multivariable models assessed predictors of costs. RESULTS: Among 15,377 women in the analytic cohort, 11,592 (75 percent) underwent tissue expander, 1279 (8 percent) underwent direct-to-implant, and 2506 (16 percent) underwent autologous reconstruction. Adjuvant therapies increased costs at 1 year [tissue expander, $39,978 (p < 0.001); direct-to-implant, $34,365 (p < 0.001); and autologous, $29,226 (p < 0.001)]. At 1 year, most patients had undergone tissue expander exchange (76 percent) and revisions (81 percent), and a majority of complications had occurred (87 percent). Comorbidities, revisions, and complications increased costs for all episode scenarios. CONCLUSIONS: Episode-based bundling should consider separate bundles for medical and surgical care with adjustment for procedure type, cancer therapies, and comorbidities to limit the adverse impact on access to reconstruction. The authors' findings suggest that a 1-year time horizon may optimally capture reconstruction events and complications.

Postmastectomy Breast Reconstruction: Exploring Plastic Surgeon Practice Patterns and Perspectives.

BACKGROUND: Within the multidisciplinary management of breast cancer, variations exist in the reconstructive options offered and care provided. The authors evaluated plastic surgeon perspectives on important issues related to breast cancer management and reconstruction and provide some insight into factors that influence these perspectives. METHODS: Women diagnosed with early-stage breast cancer (stages 0 to II) between July of 2013 and September of 2014 were identified through the Georgia and Los Angeles Surveillance, Epidemiology, and End Results registries. These women were surveyed and identified their treating plastic surgeons. Surveys were sent to the identified plastic surgeons to collect data on specific reconstruction practices. RESULTS: Responses from 134 plastic surgeons (74.4 percent response rate) were received. Immediate reconstruction (79.7 percent) was the most common approach to timing, and expander/implant reconstruction (72.6 percent) was the most common technique reported. Nearly one-third of respondents (32.1 percent) reported that reimbursement influenced the proportion of autologous reconstructions performed. Most (82.8 percent) reported that discussions about contralateral prophylactic mastectomy were initiated by patients. Most surgeons (81.3 to 84.3 percent) felt that good symmetry is achieved with unilateral autologous reconstruction with contralateral symmetry procedures in patients with small or large breasts; a less pronounced majority (62.7 percent) favored unilateral implant reconstructions in patients with large breasts. In patients requiring postmastectomy radiation therapy, one-fourth of the surgeons (27.6 percent) reported that they seldom recommend delayed reconstruction, and 64.9 percent reported recommending immediate expander/implant reconstruction. CONCLUSIONS: Reconstructive practices in a modern cohort of plastic surgeons suggest that immediate and implant reconstructions are performed preferentially. Respondents perceived a number of factors, including surgeon training, time spent in the operating room, and insurance reimbursement, to negatively influence the performance of autologous reconstruction.

Quantitative assessment and risk factors for nipple-areolar complex malposition after nipple-sparing mastectomy.

PURPOSE: Nipple sparing mastectomy (NSM) for breast cancer preserves the nipple-areola complex (NAC) and has limited the extent of the scar, giving good cosmetic results. However, NAC malposition may occur. The aim of this study is to evaluate NAC malposition after NSM and to determine factors associated with malposition in two-stage reconstruction. METHODS: The subjects were 46 patients who underwent unilateral NSM, without contralateral mastopexy or reduction surgery, in two-stage reconstruction using an expander with implant or flap replacement. Vertical and horizontal NAC malposition and predictors of malposition were evaluated before and more than 1 year after reconstruction surgery. RESULTS: The total amount of saline injected into the expander and aging were significant predictors of increased superior malposition of NAC before and more than 1 year after reconstruction or implant surgery. In contrast, the amount of saline injected into the expander until 2 weeks after expander insertion was a significant predictor of decreased superior NAC malposition. BMI was also a statistically significant predictor of decreased superior NAC malposition, but this result was likely to have been due to the measurement method. Autologous reconstruction was a significant negative predictor of superior malposition at more than 1 year after surgery. Superior NAC malposition resulting from full expansion of the expander improved by a mean vertical angle of 4.5° after autologous reconstruction, but hardly improved after implant use. In autologous reconstruction, NAC tended to move slightly to the lateral side after autologous reconstruction, compared to implant use. CONCLUSIONS: Until 2 weeks after expander insertion, as much saline as possible should be injected to prevent superior NAC malposition. At full expansion, superior malposition of vertical angle > 4.5° may require repositioning surgery.

Trends in Physician Payments for Breast Reconstruction.

BACKGROUND: Prosthetic breast reconstruction rates have risen in the United States, whereas autologous techniques have stagnated. Meanwhile, single-institution data demonstrate that physician payments for prosthetic reconstruction are rising, while payments for autologous techniques are unchanged. This study aims to assess payment trends and variation for tissue expander and free flap breast reconstruction. METHODS: The Blue Health Intelligence database was queried from 2009 to 2013, identifying women with claims for breast reconstruction. Trends in the incidence of surgery and physician reimbursement were characterized by method and year using regression models. RESULTS: There were 21,259 episodes of breast reconstruction, with a significant rise in tissue expander cases (incidence rate ratio, 1.09; p < 0.001) and an unchanged incidence of free flap cases (incidence rate ratio, 1.02; p = 0.222). Bilateral tissue expander cases reimbursed 1.32 times more than unilateral tissue expanders, whereas bilateral free flaps reimbursed 1.61 times more than unilateral variants. The total growth in adjusted tissue expander mean payments was 6.5 percent (from $2232 to $2378) compared with -1.8 percent (from $3858 to $3788) for free flaps. Linear modeling showed significant increases for tissue expander reimbursements only. Surgeon payments varied more for free flaps (the 25th to 75th percentile interquartile range was $2243 for free flaps versus $987 for tissue expanders). CONCLUSIONS: The incidence of tissue expander cases and reimbursements rose over a period where the incidence of free flap cases and reimbursements plateaued. Reasons for stagnation in free flaps are unclear; however, the opportunity cost of performing this procedure may incentivize the alternative technique. Greater payment variation in autologous reconstruction suggests the opportunity for negotiation with payers.

Intraoperative Assessment of the Relationship Between Nipple Circulation and Incision Site in Nipple-Sparing Mastectomy With Implant Breast Reconstruction Using the SPY Imaging System.

INTRODUCTION: Nipple-sparing mastectomy (NSM) and immediate breast reconstruction with gel implants have grown in popularity because of superior aesthetic outcomes. One risk of this procedure is overexcision of the flap leading to inadequate circulation in the breast envelope. METHODS: We investigated 17 cases of NSM and gel implant breast reconstruction. Patients were divided into an infra-areolar incision group and a supra-areolar incision group. Nipple-areolar complex perfusion was evaluated using the SPY imaging system after NSM and gel implant breast reconstruction. We aimed to discover any relationships between the incision method and nipple-areolar complex (NAC) circulation in NSM and gel implant breast reconstruction. RESULTS: For successful breast surgery, awareness of the blood supply to the breast, especially the NAC, is very important. In our study, with the indocyanine green SPY imaging system, most ingress (arterial inflow) and egress (venous outflow) rates in the infra-areolar incision group were better than those in the supra-areolar incision group (P < 0.005). CONCLUSIONS: We have shown that an infra-areolar incision provides better blood flow following NSM and gel implant breast reconstruction. In our experience, in order to prevent the possible ischemia of NAC, we used the smaller gel implants, which is approximately 10 to 20 mL smaller than the original implant size measured by the sizer, if the egress rate of NAC is lower than 0.2. These findings have implications in the clinical setting as surgeons have a choice to provide a better outcome for patients.

Conceptual Considerations for Payment Bundling in Breast Reconstruction.

Rising health care costs and quality demands have driven both the Centers for Medicare and Medicaid Services and the private sector to seek innovations in health system design by placing institutions at financial risk. Novel care models, such as bundled reimbursement, aim to boost value though quality improvement and cost reduction. The Center for Medicare and Medicaid Innovation is leading the charge in this area with multiple pilots and mandates, including Comprehensive Care for Joint Replacement. Other high-cost and high-volume procedures could be considered for bundling in the future, including breast reconstruction. In this article, conceptual considerations surrounding bundling of breast reconstruction are discussed.

Liposuction-Augmentation Mammaplasty.

BACKGROUND: The female breast loses superior fullness and becomes more ptotic over time. Women often present to their plastic surgeon requesting reversal of this evolution. While liposuction alone has been proven to lift the breast, no solution combining augmentation and liposuction has been reported. OBJECTIVES: Herein, we introduce a technique called liposuction-augmentation mammaplasty (LAM) that can achieve "scarless" lifting or simply volume equalization prior to inserting same-sized implants. We then compare its safety and efficacy to two gold-standard techniques with similar aims, mastopexy-augmentation mammaplasty (MAM) and reduction-augmentation mammaplasty (RAM). METHODS: A retrospective 3-year chart review was conducted on 359 patients (652 breasts) undergoing LAM (n = 125), MAM (n = 188), and RAM (n = 46). Patient demographics, operative details, and revisions were documented. Degree of lift was measured on pre- and postoperative photographs using sternal notch-to-nipple distances (SN-N). Statistical differences were assessed between the groups. RESULTS: The LAM group's mean age and OR time (37 years, 46 minutes) were significantly lower than those of MAM (43 years, 90 minutes) and RAM (42 years, 106 minutes). Mean BMIs and revision rates were uniform between the LAM and MAM groups (24, 2.5%), but significantly higher for RAM (28, 4.6%). Aspirate volumes and resection weights averaged 151 cc and 307 g (left breast) and 173 cc and 298 g (right breast). Minimum follow up was 12 months. The LAM group's mean SN-N reduction (~6%) was statistically significant, albeit much lower than MAM (~16%) and RAM (~22%). CONCLUSIONS: LAM is a safe, facile, reliable solution for the ptotic, fatty breast. Patients can direct their volumetric outcome and enjoy lower costs and shorter downtime.

Acellular Dermal Matrix in Immediate Expander/Implant Breast Reconstruction: A Multicenter Assessment of Risks and Benefits.

BACKGROUND: Acellular dermal matrix has gained widespread acceptance in immediate expander/implant reconstruction because of perceived benefits, including improved expansion dynamics and superior aesthetic results. Although previous investigators have evaluated its risks, few studies have assessed the impact of acellular dermal matrix on other outcomes, including patient-reported measures. METHODS: The Mastectomy Reconstruction Outcomes Consortium Study used a prospective cohort design to evaluate patients undergoing postmastectomy reconstruction from 10 centers and 58 participating surgeons between 2012 and 2015. The analysis focused on women undergoing immediate tissue expander reconstruction following mastectomies for cancer treatment or prophylaxis. Medical records and patient-reported outcome data, using the BREAST-Q and Numeric Pain Rating Scale instruments, were reviewed. Bivariate analyses and mixed-effects regression models were applied. RESULTS: A total of 1297 patients were evaluated, including 655 (50.5 percent) with acellular dermal matrix and 642 (49.5 percent) without acellular dermal matrix. Controlling for demographic and clinical covariates, no significant differences were seen between acellular dermal matrix and non-acellular dermal matrix cohorts in overall complications (OR, 1.21; p = 0.263), major complications (OR, 1.43; p = 0.052), wound infections (OR, 1.49; p = 0.118), or reconstructive failures (OR, 1.55; p = 0.089) at 2 years after reconstruction. There were also no significant differences between the cohorts in the time to expander/implant exchange (p = 0.78). No significant differences were observed in patient-reported outcome scores, including satisfaction with breasts, psychosocial well-being, sexual well-being, physical well-being, and postoperative pain. CONCLUSIONS: In this multicenter, prospective analysis, the authors found no significant acellular dermal matrix effects on complications, time to exchange, or patient-reported outcome in immediate expander/implant breast reconstruction. Further studies are needed to develop criteria for more selective use of acellular dermal matrix in these patients. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Standardization of Disposable Instruments in Microvascular Breast Reconstruction: A Case Study in Cost Reduction.

Background A key avoidable expense in the surgical setting is the wastage of disposable surgical items, which are discarded after cases even if they go unused. A major contributor to wastage of these items is the inaccuracy of surgeon preference cards, which are rarely examined or updated. The authors report the application of a novel technique called cost heatmapping to facilitate standardization of preference cards for microvascular breast reconstruction. Methods Preference card data were obtained for all surgeons performing microvascular breast reconstruction at the authors' institution. These data were visualized using the heatmap.2 function in the gplot package for R. The resulting cost heatmaps were shown to all surgeons performing microvascular breast reconstruction at our institution; each surgeon was asked to classify the items on the heatmap as "always needed," "sometimes needed," or "never needed." This feedback was used to generate a lean standardized preference card for all surgeons. This card was validated by all surgeons performing the case and by nursing leadership familiar with the supply needs of microvascular breast reconstruction before implementation. Cost savings associated with implementation were calculated. Results Implementation of the preference card changes will lead to an estimated per annum savings of $17,981.20 and a per annum reduction in individual items listed on preference cards of 1,693 items. Conclusion Cost heatmapping is a powerful tool for increasing surgeon awareness of cost and for facilitating comparison and standardization of surgeon preference cards.

A comparison of long-term cost and clinical outcomes between the two-stage sequence expander/prosthesis and autologous deep inferior epigastric flap methods for breast reconstruction in a public hospital.

BACKGROUND: Postmastectomy breast reconstruction involves the use of large amounts of hospital resources. This study provides comparative data on the clinical results and long-term economic costs of two methods of breast reconstruction in a public hospital. METHODS: A prospective cohort study was performed to evaluate the costs incurred by delayed unilateral breast reconstruction performed using either the two-stage sequence expander/prosthesis (E-P) or autologous deep inferior epigastric flap (DIEP) method during 2005-2013 in 134 patients. The major evaluated variables included previous clinical records, history of radiotherapy, and number of surgical procedures. Total costs accounted for both direct intra- and extra-hospital costs derived from the initial reconstruction and those resulting from associated reoperations due to aesthetic retouches and/or complications. RESULTS: Patients undergoing E-P reconstruction required a higher number of surgery sessions to complete the reconstruction (3.07 vs. 2.32, p < 0.001) and showed higher rates of surgery-related complications (40.29% vs. 32.82%). No statistically significant differences were found between the two surgical methods in terms of total costs (€18857.77 DIEP vs. €20502.08 E-P; p = 0.89). In the E-P cohort, active smoking and history of radiotherapy were statistically significant risk factors of complications. In the DIEP group, only active smoking was significantly associated with complications. CONCLUSIONS: Compared to the E-P method, breast reconstruction using the DIEP method is more cost-effective and involves fewer serious complications that result in reconstruction failure or undesirable aesthetic results. E-P reconstruction presents a higher number of complications that may cause surgical failure or poor outcomes.

Autologous Fat Grafting to the Breast Using REVOLVE System to Reduce Clinical Costs.

BACKGROUND: With the increasing popularity of fat grafting over the past decade, the techniques for harvest, processing and preparation, and transfer of the fat cells have evolved to improve efficiency and consistency. The REVOLVE System is a fat processing device used in autologous fat grafting which eliminates much of the specialized equipment as well as the labor intensive and time consuming efforts of the original Coleman technique of fat processing. This retrospective study evaluates the economics of fat grafting, comparing traditional Coleman processing to the REVOLVE System. METHODS: From June 2013 through December 2013, 88 fat grafting cases by a single-surgeon were reviewed. Timed procedures using either the REVOLVE System or Coleman technique were extracted from the group. Data including fat grafting procedure time, harvested volume, harvest and recipient sites, and concurrent procedures were gathered. Cost and utilization assessments were performed comparing the economics between the groups using standard values of operating room costs provided by the study hospital. RESULTS: Thirty-seven patients with timed procedures were identified, 13 of which were Coleman technique patients and twenty-four (24) were REVOLVE System patients. The average rate of fat transfer was 1.77 mL/minute for the Coleman technique and 4.69 mL/minute for the REVOLVE System, which was a statistically significant difference (P < 0.0001) between the 2 groups. Cost analysis comparing the REVOLVE System and Coleman techniques demonstrates a dramatic divergence in the price per mL of transferred fat at 75 mL when using the previously calculated rates for each group. CONCLUSIONS: This single surgeon's experience with the REVOLVE System for fat processing establishes economic support for its use in specific high-volume fat grafting cases. Cost analysis comparing the REVOLVE System and Coleman techniques suggests that in cases of planned fat transfer of 75 mL or more, using the REVOLVE System for fat processing is more economically beneficial. This study may serve as a guide to plastic surgeons in deciding which cases might be appropriate for the use of the REVOLVE System and is the first report comparing economics of fat grafting with the traditional Coleman technique and the REVOLVE System.

A Longitudinal Assessment of Outcomes and Healthcare Resource Utilization After Immediate Breast Reconstruction-Comparing Implant- and Autologous-based Breast Reconstruction.

OBJECTIVES: Immediate breast reconstruction (IBR) after mastectomy for cancer has increased in recent years, yet long-term, modality-specific comparative data are lacking. We performed this study to compare short- and long-term outcomes after expander, autologous (AT), and direct-to-implant (DI) breast reconstruction. METHODS: Using four state-level inpatient and ambulatory surgery databases, we conducted a retrospective cohort study of adult women who underwent mastectomy with immediate breast reconstruction from 2008 to 2009. Our primary outcomes were complications within 90 days of surgery, rate of secondary breast surgery within 3 years, and cumulative healthcare charges. RESULTS: The final cohort included 15,154 women who underwent mastectomy with tissue expander (TE: 70.5%), autologous (AT: 18.1%), or direct to implant (DI: 11.3%) reconstruction. Ninety-day complications were lowest after expander and highest after AT breast reconstruction (TE = 6.5% [reference] vs AT = 13.1% [2.09, 1.82-2.41] vs DI = 6.6% [1.03, 0.84-1.27], P < 0.001). However, adjusted rates of secondary breast procedures were most frequent after expander (2021/1000 discharges) and least frequent after AT (949.0/1000 discharges) reconstruction (P < 0.001). Specifically, unplanned revisions were highest among the tissue expander cohort (TE = 59.2% vs AT = 34.4% vs DI = 45.9%, P < 0.001). The cumulative, adjusted healthcare charges for secondary breast procedures differed slightly across groups (TE = $63,806 vs AT = $66,882 vs DI = $64,145, P < 0.001). CONCLUSIONS: Complications and secondary breast procedures, including unplanned revisions, after breast reconstruction are common and vary by reconstructive modality. The frequency of these secondary procedures adds substantial healthcare charges to the care of the breast reconstruction patient.

Evaluating the use of a barbed suture for skin closure during autologous breast reconstruction.

This study compared the use of barbed suture to a traditional skin closure method for incision closure in free flap breast reconstruction. A retrospective study compared the two closure methods in consecutive series of patients undergoing autologous breast reconstruction between January 2007 and January 2009. Outcomes included total duration of operation and wound complications. We also performed a cost analysis. Use of the barbed suture significantly decreased operative time for unilateral cases by an average of 45 minutes (405 versus 360 minutes, P = 0.02). For bilateral cases, the mean operative time was decreased by an average of 10 minutes (510 versus 500 minutes, P = 0.44). There were more episodes of delayed wound healing in the bilateral barbed suture group (33/46 [72%] versus 15/31 [48%], P = 0.04). No statistical difference was noted between the two groups with regard to dehiscence, infection, or suture extrusion. Use of the barbed suture was, however, more cost-effective. The use of a barbed suture in the closure of abdominal and breast incisions in free flap breast reconstruction may expedite wound closure and reduce the cost of the procedure but may increase wound complications.

Underfinancing of 90.3% for implant costs of prostheses and expanders in DRG revenues for uni- and bilateral mastectomy with immediate breast reconstruction.

BACKGROUND: From the clinic's point of view economic patient care requires comparison and adjustment of costs to revenues. To verify cost coverage for implants in mastectomy with immediate breast reconstruction, a comprehensive cost-reimbursement analysis was performed. METHODS: Retrospective analysis of the German diagnosis-related group (G-DRG) revenues for implants from the DRG Browser 2007/2009HA and comparison with actual costs for implants in 2009 from the annual clinic report and the database of the controlling department. Calculation of the relative cost coverage for implants in unilateral (DRG J06Z) and bilateral mastectomy (DRG J16Z). RESULTS: In 2009, n = 98 J06Z and n = 18 J16Z were performed. DRG-calculated expenses for implants were € 69.65 for J06Z and € 123.07 for J16Z, i.e. a total of € 9,040.96. Actual costs for all implants were € 121,645.60, mean € 699.11 (€ 404.94-1,171.44). Attributable implant costs for 100% immediate breast reconstruction rate were € 93,679.28. Thus, implants are not cost covering by -90.3% (-82.8 to -94.7%). Subsidies for implants from the clinic's budget range from € 335.29 to € 2,219.81 per case. CONCLUSIONS: Immediate breast reconstruction with implants after mastectomy is - even 6 years after introduction of the DRGs - not adequately calculated to be cost covering since the actual implant costs exceed the calculated revenues by far. At present, these implants are subsidized by the clinic at, on average, 90.3%. If economic patient care is mandatory, a maximum of only 1 in 10 patients with mastectomy can be offered immediate breast reconstruction with implants in Germany.

Assessment of a suction-assisted cartilage shaver plus liposuction for the treatment of gynecomastia.

BACKGROUND: The development of feminized breasts in men may cause significant emotional distress and embarrassment, particularly in young men and adolescents. Numerous techniques have been described for the correction of gynecomastia, many of which include the removal of fat and glandular tissue. OBJECTIVE: The authors assess the utility of combining vibroliposuction with the use of a power-assisted arthroscopic-endoscopic cartilage shaver to correct gynecomastia and suggest a treatment algorithm for patients with gynecomastia. METHODS: Forty consecutive patients with a median age of 32 years (range 19-57 years) and with varying degrees of gynecomastia underwent a combined approach that included vibroliposuction (power-assisted tumescent liposuction) for the removal of fatty tissue, followed by the removal of fibrous tissue with the use of a power-assisted cartilage shaver. Follow-up periods ranged in duration from six to 18 months. RESULTS: All patients had satisfactory results. However, expansive hematomas requiring surgical drainage developed in three patients. Other complications included one case of insufficient resection requiring reoperation and three cases of hyperpigmentation and skin irregularities in patients with grade I gynecomastia. CONCLUSIONS: Combination treatment using vibroliposuction and a power-assisted arthroscopic-endoscopic cartilage shaver is an effective treatment for gynecomastia, but the technique has a learning curve. This procedure is most appropriate for patients with grades II and III gynecomastia, or as a first-stage treatment for patients with grade IV gynecomastia.

Long-term quality-of-life assessment following one-stage immediate breast reconstruction using biodimensional expander implants: the patient's perspective.

BACKGROUND: Biodimensional devices may provide a superior breast form when an implant is considered for immediate breast reconstruction for breast cancer. The authors prospectively report patient perception of outcome using a permanent anatomical expander implant following a planned one-stage procedure. METHODS: The Quality of Life Questionnaire BR-23 was modified to measure body image perception, physical effects, cancer worry, and surgical choice. Responses were classified into four categories. A subset of patients completed the questionnaire 1 and 6 years after surgery. Data were compared using nonparametric analyses. RESULTS: One hundred ten patients were studied, with a mean follow-up of 63 months (range, 25 to 108 months); 46 patients had submuscular implant reconstruction and 64 had an implant-assisted latissimus dorsi flap. The mean patient age was 46 years (range, 20 to 76 years). There was no difference in patient perception of outcome between the two groups, although the latissimus dorsi group found it easier to fit into bras (p = 0.03, Mann-Whitney test). For patient perception of body image, the median score was within the most favorable category in four of six fields. Restricted arm movement and pain in the treated breast had resolved completely by 5 years after surgery. More than 80 percent of patients would choose the same surgical option if the cancer scenario presented itself again. CONCLUSIONS: A biodimensional permanent expander implant, when used appropriately, can achieve high levels of patient satisfaction. The authors' data provide long-term outcome measures with which to counsel patients about one-stage implant-assisted immediate breast reconstruction using an anatomical device.