Return of the Flap; The Empire State Mandate: A Multi-decade Multi-institutional Analysis of the 2010 New York State Legislature's Impact on Postmastectomy Immediate Flap-Based Reconstruction.

PURPOSE: Immediate postmastectomy breast reconstruction plays an integral role in patient care because of its psychosocial benefits. New York State (NYS) passed the 2010 Breast Cancer Provider Discussion Law with the aim of increasing patient awareness of reconstructive options through mandating plastic surgery referral at the time of cancer diagnosis. Short-term analysis of the years surrounding implementation suggests the law increased access to reconstruction, especially for certain minority groups. However, given the continued presence of disparities in access to autologous reconstruction, we aimed to investigate the longitudinal effects of the bill on access to autologous reconstruction along various sociodemographic cohorts. METHODS: Retrospective review identified demographic, socioeconomic, and clinical data for patients undergoing mastectomy with immediate reconstruction at Weill Cornell Medicine and Columbia University Irving Medical Center from 2002 to 2019. Primary outcome was receiving implant or autologous-based reconstruction. Subgroup analysis was based on sociodemographic factors. Multivariate logistic regression identified predictors of autologous reconstruction. Interrupted time series modeling analyzed differences in reconstructive trends for subgroups before and after the 2011 implementation of the NYS law. RESULTS: We included 3178 patients; 2418 (76.1%) and 760 (23.9%) patients underwent implant and autologous-based reconstruction, respectively. Multivariate analysis indicated that race, Hispanic status, and income were not predictors of autologous reconstruction. Interrupted time series showed that with each year leading up to 2011 implementation, patients were 19% less likely to receive autologous-based reconstruction. Following implementation, there was a 34% increase in the odds of receiving autologous-based reconstruction with each passing year. Following implementation, Asian American and Pacific Islander patients experienced a 55% greater increase in the rate of flap reconstruction than White patients. Following implementation, the highest-income quartile experienced a 26% greater increase in the rate of autologous-based reconstruction compared with the lowest-income quartile. After implementation, Hispanic patients experienced a 30% greater decrease in the rate of autologous-based reconstruction compared with non-Hispanic patients. CONCLUSIONS: Our data indicate the long-term efficacy of the NYS Breast Cancer Provider Discussion Law in increasing access to autologous-based reconstruction, especially for certain minority groups. These findings underscore the importance of this bill and encourage its adoption into other states.

The Effect of the Breast Cancer Provider Discussion Law on Breast Reconstruction Rates in New York State.

BACKGROUND: New York State passed the Breast Cancer Provider Discussion Law in 2010, mandating discussion of insurance coverage for reconstruction and expedient plastic surgical referral, two significant factors found to affect reconstruction rates. This study examines the impact of this law. METHODS: A retrospective cohort study of the New York State Planning and Research Cooperative System database to examine breast reconstruction rates 3 years before and 3 years after law enactment was performed. Difference-interrupted time series models were used to compare trends in the reconstruction rates by sociodemographic factors and provider types. RESULTS: The study included 32,452 patients. The number of mastectomies decreased from 6479 in 2008 to 5235 in 2013; the rate of reconstruction increased from 49 percent in 2008 to 62 percent in 2013. This rise was seen across all median income brackets, races, and age groups. When comparing before to after law enactment, the increase in risk-adjusted reconstruction rates was significantly higher for African Americans and elderly patients, but the disparity in reconstruction rates did not change for other races, different income levels, or insurance types. Reconstruction rates were also not significantly different between those treated in various hospital settings. CONCLUSIONS: The aim of the Breast Cancer Provider Discussion Law is to improve reconstruction rates through provider-driven patient education. The authors' data show significant change following law passage in African American and elderly populations, suggesting effectiveness of the law. The New York State Provider Discussion Law may provide a template for other states to model legislation geared toward patient-centered improvement of health outcomes.

Increases in Postmastectomy Reconstruction in New York State Are Not Related to Changes in State Law.

BACKGROUND: Postmastectomy reconstruction remains underused. In 2011, new legislation in New York State mandated discussion of reconstructive options before mastectomy. This study assesses the impact of this policy on immediate breast reconstruction rates. METHODS: The Statewide Planning and Research Cooperative System database was queried to identify women undergoing mastectomy from January of 2005 to October of 2015 and follow them for at least 1 year postoperatively to determine the incidence and timing of reconstruction. Demographic and socioeconomic characteristics were collected. Chi-square test and multivariable logistic regression were used to compare periods before (2005 to 2010) and after (2011 to 2015) the legislative change. RESULTS: Of 52,837 records, there were 24,340 patients (46 percent) who underwent immediate breast reconstruction. The incidence of immediate breast reconstruction increased over the study period, most significantly in 2008 to 2009. Rates of immediate breast reconstruction continued to increase, although at a slower rate, after 2011 compared with before 2011 across all subgroups. Both implant and autologous reconstructive techniques increased over time. Implant-based reconstruction increased steadily, whereas autologous reconstruction increased most significantly between 2008 and 2009. CONCLUSIONS: Despite an overall increase in immediate breast reconstruction, there was an overall lack of effect on post-2011 reconstructive rates attributable to the legislative changes. Reconstructive rates have increased significantly in New York State over the past decade, and these changes appear to be largely independent of the 2011 New York State Breast Reconstruction Act. There are likely nonlegislative drivers of breast reconstruction use.

Female-to-Male Gender-Affirming Chest Reconstruction Surgery.

There is an increased demand for gender affirmation surgery. Chest contouring, or "top" surgery, is especially important in the female-to-male (FtM) transgender population. This Continuing Medical Education (CME) article critically appraises the available literature on top surgery to allow plastic surgeons to understand current practices and determine the best surgical technique using a decision algorithm and the patient's preoperative anatomy and characteristics. Because a single best surgical approach does not exist due to significant variance in preoperative patient anatomy, and in order to provide a useful framework for decision making, surgical approaches described are categorized as: approach 1-remote incision procedures without skin excision; approach 2-procedures with periareolar skin excision; and approach 3-mastectomy procedures with skin excision other than periareolar skin excision. Decision algorithms that help determine the most suitable surgical technique for individual patients are reviewed. Data on complication rates and patient satisfaction will improve informed consent discussions and create realistic patient expectations.

Association of a Policy Mandating Physician-Patient Communication With Racial/Ethnic Disparities in Postmastectomy Breast Reconstruction.

IMPORTANCE: With the stabilization of breast cancer incidence and substantial improvement in survival, more attention has focused on postmastectomy breast reconstruction (PBR). Despite its demonstrated benefits, wide disparities in the use of PBR remain. Physician-patient communication has an important role in disparities in health care, especially for elective surgical procedures. Recognizing this, the State of New York enacted Public Health Law (NY PBH Law) 2803-o in 2011 mandating that physicians communicate about reconstructive surgery with patients undergoing mastectomy. OBJECTIVE: To evaluate whether mandated physician-patient communication is associated with reduced racial/ethnic disparities in immediate PBR (IPBR). DESIGN, SETTING, AND PARTICIPANTS: This retrospective study used state inpatient data from January 1, 2008, through December 31, 2011, in New York and California to evaluate a final sample of 42 346 women aged 20 to 70 years, including 19 364 from New York (treatment group) and 22 982 from California (comparison group). The primary hypothesis tested the effect of the New York law on racial/ethnic disparities, using California as a comparator. The National Academy of Medicine's (formerly Institute of Medicine) definition of a disparity was applied, and a difference-in-differences method (before-and-after comparison design) was used to evaluate the association of NY PBH Law 2803-o mandating physician-patient communication with disparities in IPBR. Data were analyzed from July 1, 2016, to February 24, 2017. EXPOSURES: New York PBH Law 2803-o was implemented on January 1, 2011. The preexposure period included January 1, 2008, through December 31, 2010 (3 years); the postexposure period, January 1 through December 31, 2011 (1 year). MAIN OUTCOMES AND MEASURES: The primary outcome was use of IPBR among white, African American, Hispanic, and other minority groups before and after the implementation of NY PBH Law 2803-o. RESULTS: Among the 42 346 women (mean [SD] age, 53 [10] years), 65.3% (27 654) were white, 12.7% (5365) were Hispanic, 9.4% (3976) were African American, and 12.6% (5351) were other minorities. The new legislation was not associated with the overall IPBR rate or disparity in IPBR between whites and African Americans (reduction of 1 percentage point; 95% CI, -0.02 to 0.04), but it was associated with a reduction in disparities in IPBR between Hispanic and white patients by 9 (95% CI, 0.06-0.11) percentage points and between other minorities and white patients by 13 (95% CI, 0.11-0.16) percentage points. CONCLUSIONS AND RELEVANCE: Physician-patient communication may help to address inequity in the use of elective surgical procedures, such as IPBR. However, lack of patient trust and/or effective physician-patient communication may reduce the potential effect of mandatory communication for some subpopulations, including African American individuals.

[What went wrong? Analysis of Medical Malpractice Arbitration Proceedings Conducted by a German Arbitration Board after Breast Reductions]. / Was geht schief? Schlichtungsverfahren nach Mammareduktionen - eine Analyse der Eingriffe mit Behandlungsfehler und Haftungsanspruch der Norddeutschen Schlichtungsstelle.

INTRODUCTION: The Arbitration Board for Medical Liability Issues of the Medical Association of North Germany ("Norddeutsche Schlichtungsstelle") is responsible for 10 federal states in Germany (Berlin, Brandenburg, Bremen, Hamburg, Mecklenburg-Western Pomerania, Lower Saxony, Saarland, Saxony-Anhalt, Schleswig-Holstein and Thuringia) and is the largest arbitration board in Germany. The data available from the Norddeutsche Schlichtungsstelle provides an insight into sources of malpractice during the treatment of reduction mammoplasty. MATERIAL UND METHODS: We analysed patient request, expert opinions prepared by independent physicians on behalf of the Norddeutsche Schlichtungsstelle and the final verdicts of 88 arbitration proceedings after breast reduction mammoplasties performed between 2000 and 2007. This data allows for each case to be addressed from different viewpoints. Furthermore we analysed the statistical data entered into the Medical Error Reporting System by the arbitration board. RESULTS: Among the 88 patient requests after reduction mammoplasty, the arbitration board found a causal relationship between damage caused to a patient's health and medical malpractice in 37 cases. Therefore, 42% of requests resulted in a liability case. This is a higher rate than that of general arbitration proceedings, where only in 24% of all cases a causal relationship is confirmed by the Norddeutsche Schlichtungsstelle. Most patients were operated on by gynaecologists. In 92% of liability cases, mistakes happened during the planning and the performance of the surgical procedure, mainly during planning (65%) and surgical incisions (41%). The patients mainly complained about scars (78%), asymmetry (68%) and skin necrosis of the areola (24%). Financial disadvantage was mentioned less often (46%) than psychological stress (70%). DISCUSSION: The higher rate of liability claims may be due to the fact the surgical procedures changing the shape of breasts are more complex than generally expected. Not only the surgery itself, but also the adequate planning and aftercare are of predominant importance for patient satisfaction. All these factors lead to the relatively high rate of medical malpractice in plastic aesthetic breast surgery. Also the communication factor should not be underestimated.

Medicolegal Issues in Breast Reduction.

Areas of general risk are discussed with patients before surgery. Procedure-specific risks inherent in each technique are a key part of informed consent. Issues related to insurance coverage must be settled preoperatively to decrease litigation risk. Protection of patient information has become a key part of the overall treatment process and this information must be protected.

Effect of federal and state policy changes on racial/ethnic variation in immediate postmastectomy breast reconstruction.

BACKGROUND: Breast reconstruction after mastectomy has been shown to provide substantial clinical and psychosocial benefits for many patients; however, disparities in the use of immediate postmastectomy breast reconstruction persist. Using the unique dataset from the New York State Inpatient Database, the following developments were studied: (1) trends in immediate postmastectomy breast reconstruction between 1998 and 2006 among white, African American, and Hispanic women; (2) factors associated with its use; and (3) changes in racial/ethnic variation in immediate postmastectomy breast reconstruction before and after implementation of the New York State Medicaid expansion in 2001. METHODS: A step-in multivariable logistic regression model was used to assess the effect of race/ethnicity, age, mastectomy type, number of comorbidities, socioeconomic status, and insurance on the probability of undergoing immediate postmastectomy breast reconstruction. Then, adjusted immediate postmastectomy breast reconstruction rates for before and after Medicaid expansion were predicted, stratified by race/ethnicity. RESULTS: The probability of undergoing immediate postmastectomy breast reconstruction increased (p < 0.001); however, even with Medicaid expansion occurring during the 8 years studied, gaps in use between white and African American women and between white and Hispanic women increased by 6 percent (95% CI, 0.07 to 0.05) and 5 percent (95% CI, 0.07 to 0.04), respectively. Being younger, having greater income and education, and having private health insurance are associated with a greater probability of immediate postmastectomy breast reconstruction. CONCLUSION: These findings indicate that expanding safety-net policies such as Medicaid without providing support such as consultation or health literacy education might not be effective in reducing disparities in health care. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, III.

A look inside the courtroom: an analysis of 292 cosmetic breast surgery medical malpractice cases.

BACKGROUND: Malpractice claims affect the cost and quality of health care. OBJECTIVE: The authors examine litigation in cosmetic breast surgery and identify factors influencing malpractice litigation outcomes. METHODS: The Westlaw database was searched for jury verdict and settlement reports related to medical malpractice and cosmetic breast surgeries. Cases included for analysis were examined for year, geographic location, patient demographics, procedure performed, alleged injury, causes of action, verdict, and indemnity payments. RESULTS: Of 292 cases, the most common injury sustained was disfigurement (53.1%). Negligent misrepresentation had a 98% greater chance of resolution in favor of the plaintiff (relative risk [RR], 1.98; 95% confidence interval [CI], 1.41-2.79), and fraud had a 92% greater chance of disposition in favor of the plaintiff (RR, 1.92; 95% CI, 1.32-2.80). The most common causes of action cited were negligence (88.7%) and lack of informed consent (43.8%). One hundred sixty-nine (58.3%) cases resulted in favor of the defendant and 121 (41.7%) cases were disposed in favor of the plaintiff; 97 (33.4%) cases resulted in damages awarded and 24 (8.3%) cases resulted in settlement. No significant difference was found between the medians of indemnity payments awarded to plaintiffs ($245 000) and settlements ($300 000). CONCLUSIONS: Based on this study, negligent or intentional misrepresentation strongly favors plaintiffs in either awarded damages or settlements in cases of cosmetic breast surgery litigation. This study emphasizes that transparency and adequate communication are at the crux of the physician-patient relationship and are tools by which plastic surgeons may reduce the frequency of litigations, thereby containing health care costs at a minimum.

Cáncer de mama y discapacidad. Criterios de valoración y controversias médico-legales / Breast cancer-associated disability. Assessment criteria and medical-legal conflicts

Objetivo. Valorar la legislación española vigente y los criterios aplicables en discapacidad referentes a los procesos neoplásicos en general y al cáncer de mama en particular, y revisar la conflictividad jurídica que las reclamaciones por discapacidad, incapacidad o minusvalía generan en el cáncer de mama. Métodos. Se realizó una revisión de la normativa española en discapacidad para el cáncer en general y, de forma concreta, para el cáncer de mama, y junto con ello se llevó a cabo una búsqueda jurisprudencial mediante la base de datos jurídica (Westlaw Insignis) en relación con la conflictividad que generan estas materias, las áreas de derecho involucradas y su evolución por años (1999-2012). Resultados. La valoración de la discapacidad asociada a cáncer de mama ha de ajustarse de forma estricta a criterios legales y depende del estadio en que se encuentre, la respuesta a las terapias, las secuelas residuales y la adaptación de la paciente a las limitaciones. En la jurisprudencia española, la conflictividad por estas materias es escasa, centrada en el ámbito de lo social y con un incremento lento y paulatino en los últimos años. Conclusiones. Es necesario que todos los sanitarios implicados en el tratamiento y seguimiento de los enfermos con cáncer de mama posean un conocimiento básico de la normativa vigente y criterios de baremación de la discapacidad por esta enfermedad, y se requiere de un trabajo coordinado entre todos los profesionales afectados por este tema para optimizar los medios y resultados finales(AU)

Objective. To assess current Spanish legislation on disability and criteria on neoplastic processes in general and breast cancer in particular and to review the legal conflicts generated by claims for breast cancer-associated disability. Methods. We reviewed the Spanish legislation on cancer-associated disability in general and on breast cancer-associated disability in particular. We also searched a database on jurisprudence (Westlaw Insignis) to identify the conflicts generated by these issues, the areas of law involved in their resolution, and their trends over time (1999-2012). Results. Assessment of breast cancer-associated disability should comply strictly with legal criteria and depends on factors such as tumoral stage, response to therapy, residual sequelae, and the patient's adaptation to limitations. In Spain, these issues generate little conflict. Conflicts center on the social sphere and have slowly and gradually increased in recent years. Conclusions. All the health professionals involved in the treatment and monitoring of patients with breast cancer should be familiar with current regulations and criteria scales for breast cancer-associated disability. A coordinated effort among all professionals affected by this issue is required to optimize resources and end results(AU)

Racial disparities in immediate breast reconstruction after mastectomy: impact of state and federal health policy changes.

BACKGROUND: Federal and Pennsylvania state policies instituted in the late 1990s were designed to improve access to postmastectomy breast reconstruction. We sought to evaluate the impact of these policy changes on access to care among racial minorities. METHODS: Mastectomy patients ≥18 years old were identified in the Pennsylvania Health Care Cost Containment Council inpatient database (1994-2004) and classified by immediate breast reconstruction (IBR) status. Rates of IBR were calculated by patient characteristics and year. Patients were stratified by race before (1994-1997) and after (2001-2004) policy changes, and relative odds of IBR were estimated by univariate and multivariate logistic regression analyses with adjustment for known confounders. RESULTS: Overall rates of IBR were significantly higher in the time period after policy change compared to before policy change (18.5 vs. 32.7 %, p < 0.01). White, black, and Asian patients all saw a significant rise in rates of IBR. However, after adjustment for potential confounders, black patients, Asian patients, and those of mixed or other races all remained less likely to undergo IBR when compared to white patients after policy changes (odds ratio [OR] 0.66, 95 % confidence interval [CI] 0.55-0.80; OR 0.30, 95 % CI 0.18-0.49; OR 0.29, 95 % CI 0.16-0.51, respectively). CONCLUSIONS: Rates of IBR increased across all racial groups after policy changes. However, not all races were affected equally, and thus disparities remained. Future studies are needed to investigate the role of other factors, including cultural preferences in utilization of IBR that might explain residual disparities.

Uso do termo de consentimento informado em cirurgia plástica estética / Use of the informed consent form in aesthetic plastic surgery

INTRODUÇÃO: O termo de consentimento informado representa uma segurança para o cirurgião plástico e para o paciente, sendo sua utilização preconizada pelo Código de Defesa do Consumidor. MÉTODO: Realizada análise de 100 acórdãos dos Tribunais de Justiça de 5 estados brasileiros, em casos envolvendo cirurgias plásticas estéticas. O estudo retrospectivo foi realizado no período de julho de 2010 a agosto de 2012, em um universo de 3.427 cirurgiões plásticos. Foram avaliadas as causas mais frequentes das ações e os principais elementos probatórios que levaram à condenação ou absolvição dos casos. RESULTADOS: Houve uma taxa média de condenação entre os estados avaliados de 55%, variando de 35% a 85%. O valor médio das indenizações por dano moral foi de R$ 30.900,00. As principais cirurgias que motivaram as ações e as condenações foram abdominoplastia, mamoplastia e implante de próteses mamárias. Nos casos de absolvição do médico, houve perícia oficial favorável em 84,6% dos acórdãos, além da prestação de informações adequadas em 100% dos casos avaliados. CONCLUSÕES: Este estudo permitiu observar que a perícia oficial favorável e o fornecimento adequado das informações sobre os tratamentos preconizados foram fundamentais para a absolvição do médico.

BACKGROUND: The informed consent form provides security for the plastic surgeon and the patient, and its use is recommended by the Consumer's Defense Code. METHODS: A total of 100 judgments made by the courts of 5 Brazilian states were analyzed, in cases involving aesthetic plastic surgeries. This retrospective study was conducted between July 2010 and August 2012 involving a total of 3,427 plastic surgeons. The most common causes of lawsuits and the evidence that led to conviction or acquittal decisions in these cases were assessed. RESULTS: There was an average conviction rate of 55% among the states under study (range, 35-85%). The average compensation for moral damages was R$30,900. The main surgical procedures that resulted in the lawsuits and the convictions were abdominoplasty, mammoplasty, and breast implantation. In the cases in which the physician was acquitted, there was a favorable expert opinion in 84,6% of the judgments, whereas adequate information was provided in 100% of such cases. CONCLUSIONS: This study showed that a favorable expert opinion and the adequate provision of information about suggested treatments were instrumental in physician acquittal.

Legal disputes over informed consent for cosmetic procedures: a descriptive study of negligence claims and complaints in Australia.

BACKGROUND: Plastic surgeons and other doctors who perform cosmetic procedures face relatively high risks of malpractice claims and complaints. In particular, alleged problems with the consent process abound in this area, but little is known about the clinical circumstances of these cases. METHOD: We reviewed 481 malpractice claims and serious health care complaints resolved in Australia between 2002 and 2008 that alleged failures in the informed consent process for cosmetic and other procedures. We identified all "cases" involving cosmetic procedures and reviewed them in-depth. We calculated their frequency, and described the treatments, allegations, and outcomes involved. RESULTS: A total of 16% (77/481) of the legal disputes over informed consent involved cosmetic procedures. In 70% (54/77) of these cases, patients alleged that the doctor failed to disclose risks of a particular complication, in 39% patients claimed that potential lack of benefit was not explained, and in 26% patients allegations centred on the process by which consent was sought. Five treatment types-liposuction, breast augmentation, face/neck lifts, eye/brow lifts, and rhinoplasty/septoplasty-featured in 70% (54/77) of the cases. Scarring (30/77) and the need for reoperation (18/77) were among the most prevalent adverse health outcomes at issue. CONCLUSION: A mix of factors "supercharges" the informed consent process for cosmetic procedures. Doctors who deliver these procedures should take special care to canvas the risks and possible outcomes that matter most to patients.

Mammaplasties and medicolegal issues: 50 cases of litigation in aesthetic surgery of the breast.

BACKGROUND: Aesthetic surgery procedures are increasing all over the world, and so are related medicolegal questions and litigation cases. Aesthetic mammaplasties represent a very important part of this field and consequently many cases of error appear. Most of these errors lead to litigation from which plastic surgeons rarely can be exonerated. The aim of this article was to evaluate different errors ascribed to the plastic surgeon, the rate of cases in which professional responsibility has been identified, and the type of guilt imputed. METHODS: Each case is based on the evaluation of both documentation used by the judge and the relationships of two specialists involved in the assessment of the presumed error. In every case, problems complained about by the patient and the eventually related error of the surgeon were analyzed. Moreover, the eventual identification of professional responsibility, the quantified damage, and its possible reduction by another corrective operation were considered. RESULTS: The cases studied (N=50) were divided into 34 cases of augmentation mammaplasty, 11 cases of reduction mammaplasty, and 5 cases of mastopexy. Most of the problems complained about by patients were in the preoperative and intraoperative phases. In only 10% of the cases was the informed consent contested and an expected reduction of the damage was individuated in less than half of cases. CONCLUSIONS: The evaluation of aesthetic damage is a tricky question due to different aspects such as the psychological component or the frequent lack of adequate photographic documentation of the patient before the operation. Moreover, whenever possible reduction of the damage is proposed, the patient's willingness to undergo another operation, with all its related costs and benefits, must be considered.