Financial Toxicity in Breast Implant-Associated Anaplastic Large Cell Lymphoma.

BACKGROUND: Financial toxicity is a growing concern due to its considerable effects on medical adherence, quality of life, and mortality. The cost associated with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is substantial from diagnosis to treatment, including adjuvant therapy and surgery. This study aims to assess the prevalence of financial toxicity in BIA-ALCL patients. METHODS: We performed a cross-sectional, survey-based study on women with confirmed cases of BIA-ALCL from December 2019 to March 2023. The primary study outcomes were financial toxicity measured by Comprehensive Score for Financial Toxicity (COST) score and patient-reported financial burden measured by the responses to the Evaluation of the Financial Impact of BIA-ALCL survey. Lower COST scores signify higher financial toxicity. Responses were linked to patient data extracted from the medical records. RESULTS: Thirty-two women treated for confirmed BIA-ALCL were included. Patients were all White and were diagnosed at a median age of 51 years (range, 41-65 years). The mean COST score was 27.9 ± 2.23. Lower COST scores were associated with receipt of radiotherapy ( P = 0.033), exceeding credit card limits ( P = 0.036), living paycheck to paycheck ( P = 0.00027), requiring financial support from friends and family ( P = 0.00044), and instability in household finances ( P = 0.034). CONCLUSIONS: Financial toxicity is prevalent in BIA-ALCL patients and has a substantial impact on patient reported burden. Insurance denial is frequent for patients with a prior history of cosmetic augmentation. Risk assessments and cost discussions should occur throughout the care continuum to minimize financial burden.

Assessment, Complications, and Surveillance of Breast Implants: Making Sense of 2022 FDA Breast Implant Guidance.

As more information about the potential risks and complications related to breast implants has become available, the United States Food and Drug Administration (FDA) has responded by implementing changes to improve patient education, recalling certain devices and updating the recommendations for screening for silicone implant rupture. In addition to staying up-to-date with FDA actions and guidance, radiologists need to maintain awareness about the types of implants they may see, breast reconstruction techniques including the use of acellular dermal matrix, and the multimodality imaging of implants and their complications. Radiologists should also be familiar with some key differences between the updated FDA guidelines for implant screening and the imaging recommendations from the American College of Radiology Appropriateness Criteria. The addition of US as an acceptable screening exam for silicone implant rupture by the FDA is one of the most notable changes that has potentially significant implications.

Self-Reported Risk Factors for Financial Distress and Attitudes Regarding Cost Discussions in Cancer Care: A Single-Institution Cross-Sectional Pilot Study of Breast Reconstruction Recipients.

BACKGROUND: High treatment costs associated with breast cancer are a substantial burden to patients and society. Despite mounting awareness, patient perspectives about the value of cost discussions in breast reconstruction and risk factors for financial distress are unknown. METHODS: The authors performed a single-institution, cross-sectional survey of all women who underwent breast reconstruction following mastectomy or lumpectomy for breast cancer or risk reduction. Questions were derived from previously published survey items, and the authors leveraged regression analysis to identify patient-level risk factors for major financial distress. RESULTS: A total of 647 of 2293 patients returned the survey questionnaires (28.2 percent response rate). From the 647 respondents, 399 (62 percent) underwent breast reconstruction, and of these, 140 (35 percent) reported that total treatment expenses were higher than expected. One hundred twenty-nine breast reconstruction patients (32 percent) paid over $5000 in out-of-pocket costs. Two hundred eighty-four (71 percent) felt that surgeons should explain the estimated out-of-pocket costs when choosing a type of breast reconstruction and 205 (51 percent) believed that a financial consultation should be scheduled with every new cancer diagnosis. However, only 52 patients (13 percent) reported having had cost discussions with the treatment team. The incidence of major financial distress was n = 70 (18 percent), and following regression analysis, higher credit score and annual income were associated with a 66 percent and 69 percent risk reduction, respectively. CONCLUSIONS: Recipients of breast reconstruction demonstrate unanticipated and unplanned financial strain related to out-of-pocket expenses and believe that cost-consciousness should impact treatment decisions. Lower income and credit score are associated with financial distress. Cost discussions may optimize decision-making in preference sensitive conditions.

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL): Review of Epidemiology and Prevalence Assessment in Europe.

BACKGROUND: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) epidemiologic studies focus on incidence and risk estimates. OBJECTIVES: The aim of this study was to perform a thorough literature review, and to provide an accurate estimate of BIA-ALCL prevalence in Europe. METHODS: We searched PubMed, Web of Science, SCOPUS, and Google Scholar databases to identify publications reporting BIA-ALCL epidemiology. Research was conducted between November 2019 and August 2020. European prevalence was assessed as the ratio between pathology-confirmed cases and breast implant-bearing individuals. The Committee on Device Safety and Development (CDSD) collected data from national plastic surgery societies, health authorities, and disease-specific registries to calculate the numerator. The denominator was estimated by combining European demographic data with scientific reports. RESULTS: Our research identified 507 articles: 106 were excluded for not being relevant to BIA-ALCL. From the remaining 401 articles, we selected 35 that discussed epidemiology and 12 reviews. The CDSD reported 420 cases in Europe, with an overall prevalence of 1:13,745 cases in the 28 member states of the European Union (EU-28). Countries where specific measures have been implemented to tackle BIA-ALCL account for 61% of the EU-28 population and actively reported 382 cases with an overall prevalence of 1:9121. CONCLUSION: Countries where specific measures have been implemented show a higher prevalence of BIA-ALCL compared with the European mean, suggesting that these countries have improved the detection of the condition and reduced underreporting, which affects the numerator value. Other nations should adopt projections based on these measures to avoid underestimating how widespread BIA-ALCL is.

Financial toxicity and contralateral prophylactic mastectomy: an analysis using propensity score methods.

PURPOSE: Contralateral prophylactic mastectomy (CPM) is increasingly performed in average-risk patients despite the lack of survival benefit. In an era of heightened awareness of healthcare costs, we sought to determine the impact of CPM on financial toxicity in breast cancer. METHODS: A single-institution propensity-matched analysis of female patients who underwent unilateral mastectomy (UM) with or without CPM for breast cancer over an 18-month period. Patients with a history of genetic predisposition or bilateral cancer were excluded. The validated Comprehensive Score for financial Toxicity (COST) evaluated financial toxicity among participants. Multivariable regression analysis evaluated the relationship between CPM and financial toxicity. Relevant domains of the Breast Q and SF12 instruments were examined as secondary outcomes. Sensitivity analysis was performed using propensity-weighting to examine robustness of results and increase our sample size. RESULTS: Overall, 104 patients were identified, equally distributed across UM and CPM. CPM was not associated with financial toxicity, as evidenced by comparable COST scores (adjusted difference, 1.53 [- 3.24 to 6.29]). Minor complications were significantly lower in UM patients (UM, 8%; CPM, 31%). CPM was associated with significantly higher Breast Q psychosocial well-being score (adjusted difference, 10.58 [1.34 to 19.83]). BREAST Q surgeon satisfaction, SF12 mental and physical component scores were comparable. Similar results were noted on sensitivity analysis involving 194 patients. CONCLUSIONS: Choice for CPM was associated with higher minor complications, but led to improved psychosocial well-being without a higher degree of patient-reported financial toxicity. Prospective studies are needed to discern the influence of CPM on the incidence and trajectory of financial toxicity.

Breast Implant Imaging Surveillance among U.S. Plastic Surgeons: U.S. Food and Drug Administration Recommendations versus Clinical Reality.

BACKGROUND: Device rupture is considered a major complication associated with breast implants. The U.S. Food and Drug Administration recommends magnetic resonance imaging (MRI) surveillance 3 years after implantation and then every 2 years, but adherence to these recommendations is poor. The authors identified current practice management for breast implant rupture surveillance by surveying practicing U.S. plastic surgeons. METHODS: An online survey of all active members of the American Society of Plastic Surgeons was performed. Questions analyzed imaging practice patterns related to breast implants. Logistic regression models were used to analyze determinants for radiographic imaging in breast implant patients. RESULTS: The survey had a response rate of 16.5 percent. For patients with breast implants, 37.7 percent of respondents recommended MRI at the recommended intervals. Fifty-five percent perform imaging only if there is a problem with the implant. Academic surgeons more frequently recommended MRI (56.3 percent and 39.3 percent; p = 0.0002). Surgeons with less than 5 years of experience are four times more likely to order MRI than surgeons with over 25 years' experience (60.8 percent and 28.1 percent; p < 0.0001). Furthermore, lower volume surgeons recommend significantly more MRI (45.2 percent and 27.3 percent; p = 0.001). Respondents are almost two times more likely to recommend MRI in reconstructive versus cosmetic patients (51.2 percent and 35.6 percent; p = 0.0004). CONCLUSIONS: MRI limitations include high costs, time commitments, and equipment constraints. Fewer than 40 percent of survey respondents suggest the recommended screening frequency to their patients; however, academic, low-volume, early-career surgeons are more likely to recommend MRI implant monitoring. Screening recommendations need to be evidence based and align with common practices to prevent undue system, provider, and patient burden.

Outcome assessment of breast distortion following submuscular breast augmentation.

BACKGROUND: Animation deformity or breast distortion during pectoralis muscle contraction following subpectoral breast augmentation is a known entity, but its prevalence and significance remain unclear. The purpose of this study was to identify the incidence and severity of animation deformity as well as its effect on patient satisfaction and interference with certain activities. METHODS: All procedures were performed by the senior author using a variation of a previously described dual-plane technique. The first part of this study was an evaluation of breast distortion by a group of independent observers in a series of 40 consecutive patients who underwent primary subpectoral breast augmentation. The second part of the study was a questionnaire sent to 195 consecutive patients asking about overall satisfaction, degree of animation deformity, and whether there was interference with any activities. RESULTS: Of the 40 patients' photographs that were evaluated, 9 (22.5%) had no distortion, 25 (62.5%) had minimal distortion, 4 (10%) had moderate distortion, and 2 (5%) had severe distortion. Of the 195 questionnaires, there were 69 responses, a 35% response rate. Fifty-six (82%) described mild to no distortion, 7 (10%) were moderate, and 5 (7%) were severe. According to the survey, the most common activities that were problematic were lifting weights and exercising (24 and 19%, respectively). Only one (1%) patient stated that she would not recommend subpectoral positioning. CONCLUSION: Although animation deformities do exist, nearly all patients in this study would still choose subpectoral positioning. Patients who may be better candidates for subglandular placement are those for whom exercise is central to their daily living. As a result of this study, surgeons and patients should have more accurate and reliable information regarding the significance of animation deformity after subpectoral breast augmentation.