Bariatric surgery among vulnerable populations: The effect of the Affordable Care Act's Medicaid expansion.

BACKGROUND: Obesity disproportionately affects vulnerable populations. Bariatric surgery is an effective long-term treatment for obesity-related complications; however, bariatric surgical rates are lower among racial minorities and low-income and publicly insured patients. The Affordable Care Act's Medicaid expansion improved access to health insurance, but its impact on bariatric surgical disparities has not been evaluated. We sought to determine the impact of the Affordable Care Act's Medicaid expansion on disparate utilization rates of bariatric surgery. METHODS: A total of 47,974 nonelderly adult bariatric surgical patients (ages 18-64 years) were identified in 2 Medicaid-expansion states (Kentucky and Maryland) versus 2 nonexpansion control states (Florida and North Carolina) between 2012 and 2015 using the Healthcare Cost and Utilization Project's State Inpatient Database. Poisson interrupted time series were conducted to determine the adjusted incidence rates of bariatric surgery by insurance (Medicaid/uninsured versus privately insured), income (high income versus low income), and race (African American versus white). The difference in the counts of bariatric surgery were then calculated to measure the gap in bariatric surgery rates. RESULTS: The adjusted incidence rate of bariatric surgery among Medicaid or uninsured and low-income patients increased by 15.8% and 5.1% per quarter, respectively, after the Affordable Care Act in expansion states (P < .001). No marginal change was seen in privately insured and high-income patients in expansion states. The adjusted incidence rates increased among African American and white patients, but these rates did not change significantly before and after the Affordable Care Act in expansion states. CONCLUSION: The gap in bariatric surgery rates by insurance and income was reduced after the Affordable Care Act's Medicaid expansion, but racial disparities persisted. Future research should track these trends and identify factors to reduce racial disparity in bariatric surgery.

Medico-legal claims in bariatric surgery in France between 2010 and 2015.

PURPOSE OF THE STUDY: The practice of bariatric surgery has multiplied 3.5 times in France in the last ten years. The purpose of the study is to analyze medico-legal claims in this area in order to identify lessons to improve patient care. PATIENTS AND METHODS: Two visceral surgeons analyzed 358 independent claim files. Age, gender, socio-economic origin, body mass index, surgical history, depression, smoking, anticoagulants, and pre-operative assessment of patients were recorded. The operative indication, the type and date of occurrence of the event, the existence and causes of intra-operative incidents, re-interventions, inter-hospital transfers and deaths were noted. Any anomaly of care, whether noted by the expert or the court, was considered a fault. RESULTS: The types of bariatric procedures included sleeve gastrectomy in 52.1% of cases and gastric bypass in 33.2% of cases. A third of patients (31.2%) had a history of previous abdominal surgery. The main complications were anastomotic leak (48.6%), followed by vomiting, wounds of neighboring organs, and infections. Fault was found in 30.4% of cases: for delay of care (36.8%), surgical clumsiness or ineptitude (15.5%), incorrect indications, lack of patient information. In 6.4% of cases, metabolic deficiencies with encephalopathy developed. CONCLUSION: The indications of the French High Authority of Health [Haute autorité de santé (HAS)] must be respected and intra-operative difficulties should not be underestimated in patients who have undergone previous surgery. Post-operatively, clinical signs of severity take precedence over complementary examinations, even when negative. Close monitoring is necessary to quickly detect complications that occur outside the facility, whether it is a surgical complication or vitamin deficiency.

Biting the Hands that Feed "the Alligators": A Case Study in Morbid Obesity Extremes, End-of-Life Care, and Prohibitions on Harming and Accelerating the End of Life.

Obesity, recognized as a disease in the U.S. and at times as a terminal illness due to associated medical complications, is an American epidemic according to the Centers for Disease Control and Prevention ("CDC"), American Heart Association ("AHA"), and other authorities. More than one third of Americans (39.8% of adults and 18.5% of children) are medically obese. This article focuses on cases of "extreme morbid obesity" ("EMO")-situations in which death is imminent without aggressive medical interventions, and bariatric surgery is the only treatment option with a realistic possibility of success. Bariatric surgeries themselves are very high risk for EMO patients. Individuals in this state have impeded mobility and are partially, if not entirely, bedridden, highly vulnerable, and dependent upon caregivers who often are enablers feeding their food addictions. The article draws from existing Centers for Medicare and Medicaid Services ("CMS") and Social Security Administration ("SSA") policies and procedures for severe obesity treatment and disability benefits. The discussion also encompasses myriad areas in which the law imposes a duty to report on professionals to protect vulnerable individuals from harm from others, and constraints and prohibitions on accelerating the end of life. The article proposes, among other law and policy measures, to introduce an obligation on medical professionals to investigate and report instances of enablement when food addiction has put the lives of individuals at risk of imminent death. The objectives of the proposals are to give providers more leverage to prevent food addiction enablers from impeding treatment and to enable EMO patients to comply with treatment protocols, to save lives and, ironically, to empower enablers to stand firm against the demands of individuals whose lives have been consumed by their food addictions.

Advances in endoscopic balloon therapy for weight loss and its limitations.

The field of medical and surgical weight loss is undergoing an explosion of new techniques and devices. A lot of these are geared towards endoscopic approaches rather than the conventional and more invasive laparoscopic or open approach. One such recent advance is the introduction of intrgastric balloons. In this article, we discuss the recently Food and Drug Administration approved following balloons for weight loss: the Orbera™ Intragastric Balloon System (Apollo Endosurgery Inc, Austin, TX, United States), the ReShape® Integrated Dual Balloon System (ReShape Medical, Inc., San Clemente, CA, United States), and the Obalon (Obalon® Therapeutics, Inc.). The individual features of each of these balloons, the method of introduction and removal, and the expected weight loss and possible complications are discussed. This review of the various balloons highlights the innovation in the field of weight loss.

Bariatric surgery tourism hidden costs? How Canada is not doing its part in covering bariatric surgery under the Canada Health Act.

SUMMARY: Many Canadians seek medical treatment outside our borders. Waiting times, rather than lack of expertise, are the number one culprit, and with globalization of health care, the number of patients who travel to obtain medical care will continue to rise. Though the provinces have covered the costs of complications from surgeries performed abroad for many years, complications from bariatric surgery performed abroad have been receiving negative attention. This commentary discusses associated costs and questions how the Canada Health Act should be covering bariatric procedures.

The Regulatory Perspectives on Endoscopic Devices for Obesity.

The recent increase in US Food and Drug Administration-approved weight-loss devices has diversified obesity treatment options. The regulatory pathways for endoscopically placed weight-loss devices and considerations for clinical trials are discussed, including the benefit-risk paradigm intended to aid in weight-loss-device trial development. Also discussed is the benefit-risk analysis of recently approved endoscopic devices. A strategic priority of the FDA Center for Devices and Radiological Health is to increase the use of patient input in decision making. Thus, we consider how endoscopic weight-loss devices with profiles similar to those that have been approved may be viewed in a patient preference study.

NHS litigation in bariatric surgery over a ten year period.

Negligence claims in the UK NHS has increased over the last 30 years. The aim of this present study was determine the number of claims and the cost of litigation in Bariatric Surgery and compare it to similar other specialties. Data was received from NHS Litigation Authority (NHSLA) in response to Freedom of Information data request. There was a total of 7 claims, of which 4 were successful. The total pay out sum was £210,000 in 10 years. This is a very low amount compared to other surgical specialties. This low level of litigation probably indicates that the current bariatric surgical services in the NHS are delivering safe care with good patient satisfaction. This needs to be carefully considered prior to changing the payment tariffs for bariatric surgery.

Medical Malpractice in Bariatric Surgery: a Review of 140 Medicolegal Claims.

OBJECTIVE: Given the current rate of obesity in the USA, it has been estimated that close to half of the US adult population could be obese by 2030, resulting in greater demand for bariatric procedures. Our objective was to analyze malpractice litigation related to bariatric surgery. METHODS: We conducted a retrospective review of Westlaw (Thompson Reuters) of all bariatric operations that resulted in the filing of a malpractice claim. Each case was reviewed for pertinent medicolegal information related to the procedure, claim, and trial. RESULTS: The search criteria yielded 298 case briefs, of which 140 met inclusion criteria. Thirty-two percent (n = 49) of cases involved male plaintiffs (patients). Mean patient age with standard deviation (SD) was 43 (10) years. The most common procedure litigated was the Roux-en-Y gastric bypass (76 %, n = 107). Overall, the most common alleged reason for a malpractice claim was delay in diagnosis or management of a complication in the postoperative period (n = 66, 47 %), the most common of which was an anastomotic leak (45 %, n = 34). Death was reported in 74 (52 %) cases. Fifty-seven cases (47 %) were decided in favor of the plaintiff (patient), with a median award payout of $1,090,000 (interquartile range [IQR] $412,500 to $2,550,000). CONCLUSION: Delay in diagnosing or managing complications in the postoperative setting, most commonly an anastomotic leak, accounted for the majority of malpractice claims. Measures taken to identify and address anastomotic leaks and other complications early in the postoperative period could potentially reduce the amount of filed malpractice claims related to bariatric surgery. LEVEL OF EVIDENCE: III.

A tutela jurisdicional da cirurgia bariátrica: uma análise sob a ótica da responsabilidade civil por erro médico / The judicial protection of bariatric surgery: an analysis from the viewpoint of civil liability for medical error

O princípio da dignidade humana e da proteção à saúde são decorrentes do direito fundamental à vida. São direitos definidos como prerrogativas mínimas sem as quais o cidadão não existiria dentro do estado democrático de Direito. O pluralismo e os tempos modernos evidenciam outros problemas para a humanidade e, dentre eles, está a obesidade. Trata-se de problema que decorre de um processo histórico, expondo que a alimentação humana mudou substancialmente com a crescente urbanização, somada ao fenômeno da globalização e a disseminação da cultura de consumo, fatores que foram predominantes para o aumento exponencial desta doença. Atualmente é problema grave de saúde pública mundial, que dependendo do país e de acordo com seu desenvolvimento, pode chegar a ser causa de discriminação social, vulnerabilidade e exclusão social. Nesse aspecto, na mesma medida em que a obesidade é crescente em todo mundo, as diversas formas de sanar tal questão também são presentes. Logo, evidencia-se naturalmente constatação do crescimento das chamadas cirurgias bariátricas e, como consequência óbvia de tal aumento, a possibilidade de erros médicos em tais intervenções também é cada vez mais crescente. A medicina é atividade que pela sua própria natureza envolve riscos e lida com o bem mais essencial e fundamental. Assim, o erro médico não pode ser apenado com benevolência. Quaisquer ofensas a tais direitos são repelidas pelo Poder Judiciário que, por meio do instituto da responsabilidade civil, evidencia as premissas básicas de prudência, perícia e diligência, expondo a necessidade de atitudes regulares dos profissionais ligados à atividade médica e o bom senso na apuração de eventual ilícito, bem com condenações justas e igualitárias, pautadas na análise técnica e específica a respeito da conduta do profissional, após a observância de todos os princípios éticolegais e processuais. Assim, neste trabalho busca-se apresentar a tutela jurisdicional da cirurgia bariátrica no que diz respeito a responsabilização do médico por erro, aplicando-se a teoria da responsabilização civil e apontando-se a natureza e a ocorrência dos erros que potencializam e embasam demandas judiciais, bem como os procedimentos regulares e recomendados com o objeto de prevenir a responsabilização.(AU)

The principles of human dignity and health protection are derived from the fundamental right to life. They are rights defined as the minimum prerogatives without which citizens could not exist within a democratic state. Pluralism and the modern times point to other issues for mankind, among them, obesity. This is a problem that derives from a historical process, evidenced by changes in human nutrition due to the ever-growing trend of urbanization, in addition to the phenomenon of globalization and we spread culture of consumption, which have been major factors for the exponential growth of this disease. In the present day it presents itself as a serious global public healthcare issue, and depending on which country and stage of development, may become the cause of vulnerability, social prejudice and exclusion. Meanwhile obesity has been shown to be growing worldwide, various means of addressing and solving this matter have also been made available. It may be verified a growth in the number of the so-called bariatric surgeries, and as a direct outcome, the enhanced possibility of medical failure during these procedures. The practice of medicine inherently involves risks while dealing with one´s most fundamental and essential belonging. Hence, medical failure cannot be taken lightly or benevolently. Any offenses to such rights are rebuked by the Judiciary, that bring forth the basic assumptions of prudence, skill and diligence through the institution of civil responsibility, pointing to the need for regular attitudes of medical-related professionals and proper reasoning when examining possible illicit, as well as fair and equal conviction, based on the specific technical analysis regarding the professional´s conduct, whilst observing all procedural, ethical and legal principles. Therefore, this publication intends to present the jurisdictional tutelage of bariatric surgery concerning the physicians accountability for his or her mistake by applying the theory of civil accountability, identifying the nature and occurrence of the errors that provoke or lay grounds for legal action, as well as the regular procedures advised in order to prevent accountability.(AU)

Medico-legal analysis of legal complaints in bariatric surgery: a 15-year retrospective study.

BACKGROUND: Bariatric surgery for severe obesity has become an effective and accepted treatment for sustained weight loss. OBJECTIVES: The aim of our study was to analyze the complications and issues raised by the experts on which jury or judges' decisions were made for the different types of bariatric surgery. SETTING: University Hospital, France. MATERIALS AND METHODS: We have carried out a retrospective study of 59 expert review dossiers over a period of 15 years (1999-2014) on the different types of bariatric surgery (laparoscopic adjustable gastric band [LAGB], sleeve gastrectomy [SG], Roux-en-Y gastric bypass [RYGB], vertical banded gastroplasty [VBG], and gastric plication [GP]). RESULTS: Of the cases, 81% were women and the average age was 39 years old (range 19 to 68 years). Among the procedures giving rise to the complaints, 40% were for LAGB, 28% for RYGB, and 23% for SG. The most common initial complications were perforations (30%), fistulae (27%), bowel obstruction (14%), vascular injuries (9.5%), and infections (peritonitis, pleurisy, abscesses, and so forth) (8%). Revision surgery was required in 78% of patients, and perioperative complications accounted for 28.5% of dossiers. The experts concluded that fault had occurred in 40% of case. Negligence arising from an error deemed to be an act of negligence was found in 30% of cases, 67% of which were because of delayed diagnosis. Major long-term complications accounted for 8% of dossiers and minor long-term complications for 22%. Forty-seven percent of patients completely recovered. CONCLUSION: Delayed diagnosis was the main error established by the experts. Surgeons should remain vigilant postoperatively after every bariatric surgical procedure.

Bariatric-related medical malpractice experience: survey results among ASMBS members.

BACKGROUND: The medicolegal aspects of bariatric surgery are very difficult to analyze scientifically because there is no central, searchable database of closed case claims and little incentive for malpractice insurers to divulge data. Examining medicolegal data may provide insight into the financial and psychological burden on physicians. Detailed data also may be used to improve patient safety and determine common causes of negligence. METHODS: All U.S.-based members of the American Society of Metabolic and Bariatric Surgeons were asked to complete a survey regarding their bariatric-related medical malpractice experience. RESULTS: Of the 1672 eligible members that received the survey, 330 responded (19.7%). Mean years in practice was 15.3 ± 9. Mean annual cost of malpractice insurance was $59,200 ± $52,000 (N = 197). The respondent surgeons experienced 1.5 ± 3.2 lawsuits on average over the course of their practice. Of the 330 respondents, 144 (48%) did not report a bariatric-related lawsuit filed against them. Of the 464 lawsuits reported by 156 surgeons, 126 were settled out of court (27%), 249 were dropped (54%), and 54 (18%) went to trial. Seventy-two percent of cases that went to trial were found to be in favor of the defense. The mean lifetime amount paid for suits was $250,000±$660,000. The probability of a bariatric surgeon experiencing a lawsuit was independently associated with the years in practice (P = .03) and number of total cases the surgeon has performed (P = .01). The annual cost of malpractice insurance was independently predicted by the amount paid in previous claims (P = .01). CONCLUSIONS: The probability of a medical malpractice lawsuit correlates positively to the number of procedures performed and the number of years the surgeon has been in practice.

[Constitutional analysis of Mexican Official Norm NOM-174-SSA1-1998 for the handling of obesity]. / Análisis Constitucional de la Norma Oficial Mexicana NOM-174-SSA1-1998, Para el Manejo Integral de la Obesidad.

The First Chamber of the Mexican Supreme Court of Justice decided, by a majority of four votes, on a case where it had to be evaluated if some articles of a Mexican Official Norm (NOM) on obesity violated human rights. The majority in the chamber concluded that the restrictions went against Medics' prescribing or therapeutic rights, and therefore their freedom to work. Justice Cossío Díaz voted against the judgment and wrote a separate opinion where he holds, first of all, that the prescribing right works as a guideline for the medical profession and is not an essential element of the freedom to work. Secondly, he points out that the freedom to work is not an absolute right, for it has certain limits permitted by the Constitution. Consequently, experts' opinions should have been consulted for them to be able to determine if the NOM´s requirements were in accordance with the Constitution. Finally, he considers that the judgment should have introduced a balancing test between freedom to work and the patient's health rights, since this last-mentioned right was what the NOM intended to protect.

Consentimiento informado en el balón intragástrico avalado por SENPE, SEEDO, SEN y SECO; aspectos médico-legales / Informed consent in the intragastric balloon supported by SENPE, SEEDO, SEN and SECO; legal aspects

Introducción: El Balón Intragástrico (BIG) es una técnica invasiva, no quirúrgica, de carácter temporal, para el tratamiento de la obesidad, cuyos resultados dependen en gran medida de la colaboración del paciente. Objetivo: El objetivo es adaptar el Consentimiento Informado propio de la cirugía bariátrica, a un método que reviste las características especiales descritas. Material y método: Se utiliza el Consentimiento Informado propuesto por la ASAC para cirugía bariátrica, así como 8 sentencias relacionadas con el BIG tal como se hallan en la base de datos WESTLAW ES. Resultado: La revisión de las sentencias define el tratamiento mediante BIB como tratamiento con intención curativa y no satisfactiva, con obligación de medios aunque no de resultados, por parte del médico tratante. Se han de respetar además las obligaciones de una información correcta y completa -incluyendo las pautas dietéticas a seguir-, así como de las alternativas terapéuticas posibles, y por fin, de una constancia del proceso por escrito. Conclusiones: El Consentimiento Informado es un importante documento médico-legal cuyo contenido debe tener en cuenta la jurisprudencia recientemente aparecida en el campo de las técnicas mínimamente invasivas para el tratamiento de la obesidad (AU)

Introduction: Intra-gastric balloon (IGB) is an invasive, temporary, non-surgical technique for the treatment of obesity. Its outcomes mainly depend on the patient's collaboration. Objective: The aim was to adapt the informed consent used for bariatric surgery to a method that has especial characteristics. Materials and methods: We used the informed consent proposed by ASAC for bariatric surgery and 8 statements related to IGB included in the WESTLAW ES database. Results: The review of the statements defines the IGB treatment as a curative-intended and non-satisfactive therapy with an obligation of the means used, but not the outcomes, by the treating physician. Moreover, the obligations of providing a correct and complete information -which includes the dietary regime- should be observed, as well as the possible therapeutic alternatives and finally, the proceeding used should be in written. Conclusions: The informed consent is a medico-legal document which content should consider the latest jurisprudence on the minimally invasive techniques for the treatment of obesity (AU)

[Medicolegal analysis of legal claims in bariatric surgery]. / Análisis médico-legal de las reclamaciones judiciales en cirugía bariátrica.

OBJECTIVES: To analyse the causes for claims due to alleged malpractice in bariatric surgery and the results of the legal process. MATERIAL AND METHOD: A review was carried out on the case files of claims for damages as a result of bariatric surgery presented to the Professional Liability Department of the Catalonian Medical Colleges Council from 1992 to 2009. The claims rate was calculated using a survey of bariatric surgeons. RESULTS: A total of 49 cases were analysed, which represented 0.6% of the patients operated on. The patient died in 23 (47%) of the cases, 14% were left with serious after effects, 18% had mild after effects, and 21% made a complete recovery. The most frequent causes of death were peritonitis due to suture dehiscence (48%), and respiratory complications (17.4%). Retrospectively, malpractice was considered to have occurred in 10 (20%) of the sued cases due to lack of an adequate informed consent document, delay in recognising a complication, or an error in interpretation, or treatment of the complication. The doctor sued was convicted in 10 of the cases, 3 in a criminal court, and 7 in a civil court. There was acquittal in 19 cases, an out-of court settlement with payment of compensation in 4, withdrawal of the claim in 4, and judgement or sentence is still pending in 12 cases. CONCLUSION: The study showed a relatively low rate of claims for complications associated with bariatric surgery. The number of convictions was relatively high. The early detection of surgical complications is essential in order to reduce legal claims associated with bariatric surgery.

Análisis médico-legal de las reclamaciones judiciales en cirugía bariátrica / Medicolegal analysis of legal claims in bariatric surgery

Objetivos Analizar las causas de reclamación por presuntos defectos de praxis en cirugía bariátrica y los resultados del proceso judicial. Material y método Revisión de los expedientes de los casos de reclamación presentados al Servicio de Responsabilidad Profesional del Consejo de Colegios de Médicos de Cataluña desde 1992 hasta 2009 por daños como consecuencia de cirugía bariátrica. Se calculó la tasa de reclamaciones mediante una encuesta en los cirujanos bariátricos. Resultados Se analizaron 49 casos, que representan una tasa de reclamaciones del 0,6% de los pacientes operados. En 23 ocasiones (47%) tuvo lugar el fallecimiento del paciente, en el 14% quedaron secuelas graves, en el 18% secuelas leves y en el 21% hubo una recuperación completa. Las causas más frecuentes de muerte fueron peritonitis por dehiscencia de sutura (48%) y complicaciones respiratorias (17,4%). Se consideró retrospectivamente que habían existido defectos de praxis en 10 (20%) de los casos reclamados por falta de documento de consentimiento informado adecuado, retraso en el reconocimiento de la complicación, o error en la interpretación o tratamiento de la misma. En 10 casos hubo sentencia condenatoria para el médico reclamado, 3 en un juicio penal y 7 en juicio civil, hubo absolución en 19, acuerdo extrajudicial con pago de indemnización en 4, retirada de la reclamación en 4 y están todavía pendientes de juicio o de sentencia 12 casos. Conclusión Se demuestra una relativamente baja tasa de reclamaciones por complicaciones relacionadas con la cirugía bariátrica. La muerte del paciente fue la principal causa de reclamación. El número de sentencias condenatorias fue relativamente elevado. La detección precoz de las complicaciones quirúrgicas es indispensable para la reducción de la litigiosidad relacionada con cirugía bariátrica (AU)

Objectives To analyse the causes for claims due to alleged malpractice in bariatric surgery and the results of the legal process. Material and Method A review was carried out on the case files of claims for damages as a result of bariatric surgery presented to the Professional Liability Department of the Catalonian Medical Colleges Council from 1992 to 2009. The claims rate was calculated using a survey of bariatric surgeons. Results A total of 49 cases were analysed, which represented 0.6% of the patients operated on. The patient died in 23 (47%) of the cases, 14% were left with serious after effects, 18% had mild after effects, and 21% made a complete recovery. The most frequent causes of death were peritonitis due to suture dehiscence (48%), and respiratory complications (17.4%). Retrospectively, malpractice was considered to have occurred in 10 (20%) of the sued cases due to lack of an adequate informed consent document, delay in recognising a complication, or an error in interpretation, or treatment of the complication. The doctor sued was convicted in 10 of the cases, 3 in a criminal court, and 7 in a civil court. There was acquittal in 19 cases, an out-of court settlement with payment of compensation in 4, withdrawal of the claim in 4, and judgement or sentence is still pending in 12 cases. Conclusion The study showed a relatively low rate of claims for complications associated with bariatric surgery. The number of convictions was relatively high. The early detection of surgical complications is essential in order to reduce legal claims associated with bariatric surgery (AU)

Quality control in gastrointestinal surgery.

We analyzed the Mexican legal framework, identifying the vectors that characterize quality and control in gastrointestinal surgery. Quality is contemplated in the health protection rights determined according to the Mexican Constitution, established in the general health law and included as a specific goal in the actual National Development Plan and Health Sector Plan. Quality control implies planning, verification and application of corrective measures. Mexico has implemented several quality strategies such as certification of hospitals and regulatory agreements by the General Salubrity Council, creation of the National Health Quality Committee, generation of Clinical Practice Guidelines and the Certification of Medical Specialties, among others. Quality control in gastrointestinal surgery must begin at the time of medical education and continue during professional activities of surgeons, encouraging multidisciplinary teamwork, knowledge, abilities, attitudes, values and skills that promote homogeneous, safe and quality health services for the Mexican population.