Breast Implant-Related Adverse Events During Mammography: An Assessment of the Food and Drug Administration Manufacturer and User Facility Device Experience Database.

BACKGROUND: Adverse events arising in patients with breast implants during mammography reported by the Food and Drug Administration include implant rupture, pain, and impaired visualization. However, data supporting these claims were collected in 2004, and since, newer implant generations have been developed with overall rate of implantation increasing by 48%. OBJECTIVES: This article aims to determine the current incidence of implant-related adverse events arising during mammography. METHODS: We analyzed reports regarding silicone and saline breast implants published in the Food and Drug Administration Manufacturer and User Facility Device Experience database between 2008 and November 2018. Search terms included "mammogram," "mammography," "radiograph," "breast cancer screening," "breast cancer test," and "x-ray." RESULTS: Of the 20 539 implant-related adverse events available in the Manufacturer and User Facility Device Experience database, 427 were retrieved using our search strategy and 41 were related to mammography. Thirty-five of identified cases (85.4%) reported implant rupture, of which 19 (54.3%) were confirmed by a healthcare professional, 9 (25.7%) were clinically confirmed by saline implant deflation, and 7 (20.0%) were unverified reports by patients. Sixteen ruptures (45.7%) occurred with silicone implants, whereas 19 ruptures (54.3%) occurred with saline. Other adverse events included pain (29.3%), change in implant appearance (14.6%), and swelling (7.3%). CONCLUSIONS: Although implant rupture, pain, change in implant appearance, and swelling may occur, minimal implant-related adverse events arise during mammography. Given the extremely low reported risk of implant rupture, this should neither prevent patients from adhering to breast cancer screening programs nor deter patients from seeking breast implants. Patients should be aware of these reported risks and discuss screening options with their breast cancer screening team.

Analysis of Utility Assessment Scores to Objectify the Health Burden Caused by Breast Conservation Therapy.

BACKGROUND: Lumpectomy followed by radiation, known as breast conservation therapy (BCT), is a viable surgical treatment option for early-stage breast cancer. However, the current literature suggests that patients prefer mastectomy over BCT, likely due to the wide variety of postmastectomy reconstructive options. Our aim is to investigate the objective health burden of living with BCT to help surgeons gain a better understanding of patient treatment preferences. METHODS: Three validated health state utility tools were used to objectify the burden of living with post-BCT results: visual analogue scale (VAS), time trade-off (TTO), and standard gamble (SG). A prospective sample of the general population and medical students were recruited, and their responses analyzed to attain these scores. RESULTS: Utility scores for living with BCT are VAS 0.81 ± 0.19, TTO 0.93 ± 0.10, and SG 0.92 ± 0.14. The TTO and SG suggest a willingness to trade 2.5 years of life years and an 8% chance of death undergoing reconstructive procedures to correct a BCT defect, respectively. Age, gender, race, education, and income were not statistically significant independent predictors for higher or lower utility scores. CONCLUSION: The impact of the health burden of BCT was ascertained using validated objective numeric utility scores. These indices demonstrate a willingness to trade less life years to undergo correction of a BCT defect than reconstruction following unilateral mastectomy. They can provide surgeons with the best objective understanding of patient preferences for shared decision-making in the management of breast cancer.

HISTORIQUE: La lumpectomie suivie d'une radiothérapie, ou conservation mammaire (CM), est un traitement chirurgical viable du cancer du sein précoce. Selon les publications, les patients préfèrent toutefois la mastectomie à la CM, probablement en raison du large éventail de possibilités de reconstructions après la mastectomie. Les chercheurs visent à explorer le fardeau objectif d'une vie avec une CM pour la santé, afin d'aider les chirurgiens à mieux comprendre les préférences des patientes en matière de traitement. MÉTHODOLOGIE: Les chercheurs ont utilisé trois outils utilitaires validés sur l'état de santé pour objectiver le fardeau de la vie après une CM : l'échelle visuelle analogique (ÉVA), l'arbitrage temporel (AT) et le pari standard (PS). Ils ont recruté un échantillon prospectif de la population générale et d'étudiants en médecine et ont analysé leurs réponses pour obtenir les scores. RÉSULTATS: Les scores d'utilité d'une vie avec une CM s'établissent comme suit : ÉVA 0,81 ± 0,19, AT 0,93 ± 0,10 et PS 0,92 ± 0,14. L'AT et le PS indiquent respectivement la volonté de perdre 2,5 années de vie et d'accroître le risque de décès de 8 % pendant les interventions de reconstruction pour corriger une anomalie de CM. L'âge, le genre, la race, l'instruction et le revenu n'étaient pas des prédicteurs indépendants statistiquement significatifs des scores d'utilité plus élevés ou plus faibles. CONCLUSION: Les chercheurs ont évalué les répercussions du fardeau de la CM sur la santé au moyen de scores d'utilité numériques validés. Ces indices démontrent la volonté de réduire le nombre d'années de vie pour corriger une anomalie de la CM plutôt qu'une reconstruction après une mastectomie unilatérale. Ils peuvent aider les chirurgiens à mieux comprendre les préférences des patientes pour parvenir à une décision commune en matière de prise en charge du cancer du sein.

Nipple-areolar Complex Reconstruction following Postmastectomy Breast Reconstruction: A Comparative Utility Assessment Study.

BACKGROUND: Nipple-areola complex (NAC) reconstruction occurs toward the final stage of breast reconstruction; however, not all women follow through with these procedures. The goal of this study was to determine the impact of the health state burden of living with a reconstructed breast before NAC reconstruction. METHODS: A sample of the population and medical students at McGill University were recruited to establish the utility scores [visual analog scale (VAS), time trade-off (TTO), and standard gamble (SG)] of living with an NAC deformity. Utility scores for monocular and binocular blindness were determined for validation and comparison. Linear regression and Student's t test were used for statistical analysis, and significance was set at P < 0.05. RESULTS: There were 103 prospective volunteers included. Utility scores (VAS, TTO, and SG) for NAC deformity were 0.84 ± 0.18, 0.92 ± 0.11, and 0.92 ± 0.11, respectively. Age, gender, and ethnicity were not statistically significant independent predictors of utility scores. Income thresholds of <$10,000 and >$10,000 revealed a statistically significant difference for VAS (P = 0.049) and SG (P = 0.015). Linear regression analysis showed that medical education was directly proportional to the SG and TTO scores (P < 0.05). CONCLUSIONS: The absence of NAC in a reconstructed breast can be objectively assessed using utility scores (VAS, 0.84 ± 0.18; TTO, 0.92 ± 0.11; SG, 0.92 ± 0.11). In comparison to prior reported conditions, the quality of life in patients choosing to undergo NAC reconstruction is similar to that of persons living with a nasal deformity or an aging neck requiring rejuvenation.

Population preferences of undergoing brachioplasty for arm laxity.

BACKGROUND: The number of patients requesting surgical procedures performed for brachioplasty and massive weight loss is increasing. The authors set out to quantify the health state utility outcome assessment of living with arm deformity requiring brachioplasty. METHODS: Utility assessments using the visual analog scale (VAS), time trade-off (TTO), and standard gamble (SG) were used to obtain utilities scores for arm deformity, monocular blindness, and binocular blindness from a sample of the general population and medical students. Linear regression and Student t test were used for statistical analysis. A P value less than 0.05 was deemed statistically significant. RESULTS: All the measures for arm deformity of the 107 volunteers (VAS, 0.80 ± 0.14; TTO, 0.91 ± 0.12; SG, 0.94 ± 0.10) were significantly different (P < 0.001) from the corresponding measures for monocular blindness and binocular blindness. When compared to the sample of the general population, having a medical education demonstrated a statistical significance of being less likely to trade years of life and less likely to gamble risk of death for a procedure such as a brachioplasty. Race and sex were not statistically significant independent predictors of risk acceptance. CONCLUSIONS: We have objectified the health state of living with upper arm deformity requiring brachioplasty. Utility outcome scores (VAS, 0.80 ± 0.14; TTO, 0.91 ± 0.12; SG, 0.94 ± 0.10) were comparable to living with health states such as aging neck needing rejuvenation, excess skin in the thighs necessitating thigh lift, and massive weight loss requiring panniculectomy based on previously reported studies.

A methodological analysis of the plastic surgery cost-utility literature using established guidelines.

BACKGROUND: Cost-utility studies, common in medicine, are rare within plastic surgery despite their capability of measuring the value of procedures by considering the societal costs of improving quality of life. The objectives of this study were to analyze the design quality of the plastic surgery cost-utility literature and to identify areas of needed improvement for future studies. METHODS: A scoring tool was constructed based on the Recommendations of the Panel on Cost-Effectiveness in Health and Medicine. A PubMed search through October of 2012 was conducted for English-language plastic surgery utility studies. Articles were selected using two inclusion criteria and evaluated using the scoring tool. RESULTS: A 9-point scoring tool was created, and 37 publications were selected. Their average score was 3 out of 9 points. Thirty studies (81 percent) used population preferences in utility measurements. Fifteen studies (41 percent) measured costs, but only four (11 percent) included indirect costs and only five (14 percent) applied discount rates to calculate the value of treatments over time. Three studies (8 percent) earned zero points. The highest scoring study earned 8 points. CONCLUSIONS: The identified studies manifest the potential of cost-utility analyses in plastic surgery. Nonetheless, they are inconsistent in applying established cost-utility guidelines, especially in measuring costs and conducting recommended sensitivity analysis. Following this simple scoring tool can help future studies achieve some necessary improvements.

Living with a unilateral mastectomy defect: a utility assessment and outcomes study.

BACKGROUND: The gold standard for the treatment of breast cancer includes mastectomy surgery. Our goal was to quantify the health state utility assessment of living with unilateral mastectomy. METHODS: The visual analogue scale (VAS), time trade-off (TTO), and standard gamble (SG) were used to obtain utilities for unilateral mastectomy, monocular blindness and binocular blindness from a prospective sample of the general population and medical students. RESULTS: All measures (VAS, TTO, SG) for unilateral mastectomy (0.75 SD 0.17, 0.87 SD 0.14, and 0.86 SD 0.18, respectively) of the 140 volunteers were significantly different from the corresponding scores for monocular (0.61 SD 0.18, 0.84 SD 0.17, and 0.84 SD 0.18, respectively) and binocular blindness (0.38 SD 0.17, 0.67 SD 0.24, and 0.69 SD 0.23, respectively). Age, gender, race, education, and income were not statistically significant independent predictors of utility scores. CONCLUSION: In a sample of the general population and medical students, utility assessments for living with unilateral mastectomy were comparable with those of living with bilateral mastectomy and severe breast hypertrophy. Our sample population, if faced living with unilateral mastectomy was willing to gamble a theoretical 14% chance of death and willing to trade 4.2 years of existing life-years.

Thigh laxity after massive weight loss: a utilities outcomes assessment.

BACKGROUND: The presence of excess skin after massive weight loss, particularly in the thighs, not only contributes to a negative body image but can also lead to functional deficits in mobility. In the present study, we quantified the health state utility of living with excess skin in the thighs in an attempt to objectively establish the burden on the quality of life in patients living with excess thigh skin laxity. METHOD: Using visual analog scale (VAS), time trade-off (TTO), and standard gamble (SG), we compared the utility outcome scores for thigh skin excess with monocular and binocular blindness from a prospective sample of medical students and the general population. Utility scores were compared using paired t test. Linear regression was performed using age, race, and education as independent predictors of each of the utility scores. RESULTS: One hundred thirty-four prospective participants were enrolled during a 6-month period, and 112 participants met our inclusion criteria. The utility outcome scores for thigh lift (VAS, TTO, and SG, 0.77 ± 0.15, 0.90 ± 0.11, and 0.89 ± 0.14, respectively) were statistically different from binocular blindness (VAS, TTO, and SG, 0.37 ± 0.18, 0.70 ± 0.23, and 0.70 ± 0.26; P < 0.001), but other than VAS (0.67 ± 0.15, P < 0.001), similar to monocular blindness (TTO and SG, 0.89 ± 0.13 and 0.81 ± 0.14, respectively; P > 0.05). SG (0.89 ± 0.14 vs 0.97 ± 0.02, P = 0.003) and TTO (0.89 ± 0.11 vs 0.95 ± 0.03, P = 0.038) were different between general population and medical students, respectively, corresponding to 3.96 versus 1.80 potential years willing to be traded (P < 0.05). Additionally, SG was higher in whites versus nonwhites who were willing to take a potential 8% chance of mortality compared to 15%, respectively (P = 0.001), to achieve "perfect" health. CONCLUSIONS: We have objectified the utility of living with thigh deformity after massive weight loss. Our sample population if faced with the condition was willing to sacrifice a potential 3.6 years of life and potentially undergo a procedure with 11% chance of mortality to address excess thigh laxity.