A Decade of Lawsuits Against Surgeons Performing Female Genital Cosmetic Surgery (FGCS) in Tehran, Iran.

BACKGROUND: The objective of this study is to evaluate the legal proceedings that arise from Female Genital Cosmetic Surgeries (FGCS) and analyze the reasons why women file complaints against their surgeons. Additionally, we examined the outcomes of the legal decisions associated with these complaints. METHODS: This descriptive cross-sectional study was conducted in Tehran province, Iran, from 2012 to 2021. The primary data source for this study was forensic medical records, which were reviewed to gather relevant information. The collected data included the characteristics of the participants, the reasons for lawsuits, the procedure setting, and the outcomes of the legal decisions. RESULTS: A total of 121 patients were examined in the study, revealing that Labiaplasty was the most prevalent procedure (49.6%), followed by vaginoplasty (19.8%) and perineoplasty (13.2%). The most common complaints were related to cosmetic concerns (57%), lack of recovery (26.4%), and sexual dysfunctions (22.3%). Healthcare providers were found liable for malpractice in 52.1% of cases. Additionally, having the surgery performed by a gynecologist decreased the risk of malpractice (ß = 0.21, p= 0.034), while procedures in private clinics increased the risk (ß = 2.95, p = 0.040). CONCLUSION: The study's findings emphasized the importance of providing women with comprehensive education and consultations to ensure they are well-informed about the potential outcomes and risks of FGCS. Furthermore, the study highlighted the significance of having these surgical procedures performed by skilled and experienced surgeons. LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these evidence-based medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Never events in plastic surgery: An analysis of surgical burns and medical malpractice litigation.

INTRODUCTION: Burns and fires in the operating room are a known risk and their prevention has contributed to many additional safety measures. Despite these safeguards, burn injuries contribute significantly to the medical malpractice landscape. The aim of the present study is to analyze malpractice litigation related to burn and fire injuries in plastic and reconstructive surgery, identify mechanisms of injury, and develop strategies for prevention. METHODS: The Westlaw and LexisNexis databases were queried for jury verdicts and settlements in malpractice lawsuits related to burn and fire injuries that occurred during plastic surgery procedures. The Boolean terms included "burn & injury & plastic", "fire & injury & "plastic surg!"" in Westlaw, and "burn & injury & "plastic surg!"", "fire & injury & "plastic surg!"" in LexisNexis. RESULTS: A total of 46 cases met the inclusion criteria for this study. Overheated surgical instruments and cautery devices were the most common mechanisms for litigation. Plastic surgeons were defendants in 40 (87%) cases. Of the included cases, 43% were ruled in favor of the defendant, while 33% were ruled in favor of the plaintiff. Mishandling of cautery devices 6 (13%), heated surgical instruments 6 (13%), and topical acids 2 (4%) were the most common types of errors encountered. CONCLUSION: Never events causing burn injury in plastic and reconstructive surgery are ultimately caused by human error or neglect. The misuse of overheated surgical instruments and cauterizing devices should be the focus for improving patient safety and reducing the risk of medical malpractice. Forcing functions and additional safeguards should be considered to minimize the risk of costly litigation and unnecessary severe harm to patients.

Overcoming the Patent Gap: A Guide to Patenting for Plastic Surgeons.

BACKGROUND: Patenting protects innovation, fosters academic incentives, promotes competition, and generates new revenue for clinician-inventors and their institutions. Despite these benefits, and despite plastic surgery's history of innovation, plastic surgery-related patent applications are few. The goal of this article was to use unpublished data and formulate a robust discussion. METHODS: The U.S. Patent and Trademark Office's boolean search was investigated between the timeline of 1975 and June 23, 2020, to identify patents related to the key phrases to contrast patent (both, issued and filed) tally in each specialty. Queries for two key phrases related to plastic surgery and a core plastic surgical activity, both with and without the added term "plastic surgery," were performed. RESULTS: Total patents with "cardiology" outnumber those with "plastic surgery" by 22,450 versus 7749 (i.e., almost 3:1). The overwhelming number of patents with "cosmetic" are non-plastic-surgery related: 87,910 total versus 2782 for those with plastic surgery. The corresponding numbers for "wound healing" are 36,359 versus 2703. Reasons for the patent gap between clinical innovations in plastic surgery and number of patents in our field are identified. Clear steps to bridge this gap are delineated that include a step-by-step process for patenting, from idea creation through commercialization. The authors propose "breakthrough to bank," a framework wherein academic medical centers can create an environment of innovative freedom, establish the infrastructure for technological transfer of intellectual property, and generate a pipeline toward commercial applications. CONCLUSIONS: Innovation and inventions are important hallmarks for the progress of plastic surgery. Using a stepwise process, it may be possible to convert ideas into patents.

Carving Out Financial Success: The Power of Insurance Carve-Outs in a Private Plastic Surgery Practice.

BACKGROUND: Since the Patient Protection and Affordable Care Act was signed into law, there has been a push away from fee-for-service payment models. The rise of bundled payments has drastically impacted plastic surgeons' incomes, especially nonsalaried surgeons in private practice. As a result, physicians must now attempt to optimize contractual reimbursement agreements (carve-outs) with insurance providers. The aim of this article is to explain the economics behind negotiating carve-outs and to offer a how-to guide for plastic surgeons to use in such negotiations. METHODS: Based on work relative value units, Medicare reimbursement, overhead expenses, physician workload, and desired income, the authors present an approach that allows surgeons to evaluate the reimbursement they receive for various procedures. The authors then review factors that influence whether a carve-out can be pursued. Finally, the authors consider relevant nuances of negotiating with insurance companies. RESULTS: Using tissue expander insertion (CPT 19357) as an example, the authors review the mathematics, thought process required, and necessary steps in determining whether a carve-out should be pursued. Strategies for negotiation with insurance companies were identified. The presented approach can be used to potentially negotiate a carve-out for any reconstructive procedure that meets appropriate financial criteria. CONCLUSIONS: Understanding practice costs will allow plastic surgeons to evaluate the true value of insurance reimbursements and determine whether a carve-out is worth pursuing. Plastic surgeons must be prepared to negotiate adequate reimbursement carve-outs whenever possible. Ultimately, by aligning the best quality patient care with insurance companies' financial motivations, plastic surgeons have the opportunity to improve reimbursement for some reconstructive procedures.

Are You Ready to Negotiate Your First Employment Contract? Experience of More Than 700 Plastic Surgeons.

BACKGROUND: Plastic surgeons have been shown to be unprepared to negotiate their first employment contracts. Previous survey studies have attempted to assess plastic surgeons' first employment contracts to outline common pitfalls in contract negotiation. With this study, the authors aim to expand these previous studies and help plastic surgeons become prepared to negotiate their employment contracts. METHODS: A seven-question, cross-sectional survey was sent to attending-level surgeon members of the California Society of Plastic Surgeons, the American Society of Plastic Surgeons, the Texas Society of Plastic Surgeons, and the American Cleft Palate-Craniofacial Association. Questions investigated plastic surgeons' first contracts. Correlations were determined using a two-sample Wilcoxon rank sum test in an attempt to link these questions with overall satisfaction. RESULTS: From the 3908 distributed surveys, 782 (20 percent) responses were collected, and 744 were included for analysis. The majority of respondents were found to join a group-centered, private practice following residency. Surprisingly, 69 percent of surgeons did not use attorney assistance when negotiating their contract. Although greater than 70 percent of respondents reported a salary of $200,000 or less, satisfaction with one's contract was most strongly correlated with a salary of greater than $300,000 (p < 0.0001). However, only 12 percent of respondent surgeons were able to secure such a salary. CONCLUSIONS: This study examined the largest, most diverse plastic surgeon cohort to date regarding surgeons' first employment contract. Although the authors' findings indicate that certain factors should be prioritized when approaching a first employment contract, they ultimately recommend that all surgeons take into account their personal priorities and attempt to proactively define their terms of employment before signing a contract.

A Century in Review: Medicolegal Implications of Facial Nerve Paralysis.

Importance: It is important to recognize factors that may mitigate the risk of a potential lawsuit and increase knowledge and awareness of physicians. Objective: To evaluate and characterize facial nerve paralysis litigation claims and related potential causes. Design, Setting, and Participants: These data were extracted from the two main computerized legal databases: WestLaw and LexisNexis. The data were queried on April 2, 2020. The records from 1919 to 2020 were obtained from a population-based setting. A total of 186 cases were included. Data were gathered for all alleged cases of facial nerve paralysis. Main Outcomes and Measures: There was a continuous rise in the amount of malpractice payments with the highest mean amount being in the past decade. Results: From 1919 to 2020, a total of 186 malpractice cases for facial nerve damage were identified. A total amount of $89,178,857.99 was rewarded to plaintiffs in 66 cases. The mean amount of paid malpractice claim was $1,351,194.80. Improper performance/treatment was the most common reason for alleged litigation (n = 97). This was followed by misdiagnosis/delayed diagnosis (n = 47), and failure of informed consent (n = 34). The highest number of malpractice claims with a total of 53 cases was from 1991 to 2000. The highest mean amount per payment was in the past decade (2011-2020) with a mean of $3,841,052.68. Conclusions and Relevance: Over the past century, improper performance/procedure, delayed/misdiagnosis, and failure of informed consent were the most common reasons for litigations related to facial nerve paralysis.

Lessons from American Board of Plastic Surgery Maintenance of Certification Tracer Data: A 16-Year Review of Clinical Practice Patterns and Evidence-Based Medicine in Cleft Palate Repair.

BACKGROUND: As a component of the Maintenance of Certification process from 2003 to 2019, the American Board of Plastic Surgery tracked 20 common plastic surgery operations. By evaluating the data collected over 16 years, the authors are able to examine the practice patterns of pediatric/craniofacial surgeons in the United States. METHODS: Cumulative tracer data for cleft palate repair was reviewed as of April of 2014 and September of 2019. Evidence-based medicine articles were reviewed. Results were tabulated in three categories: pearls, or topics that were covered in both the tracer data and evidence-based medicine articles; topics that were covered by evidence-based medicine articles but not collected in the tracer data; and topics that were covered in tracer data but not addressed in evidence-based medicine articles. RESULTS: Two thousand eight hundred fifty cases had been entered as of September of 2019. With respect to pearls, pushback, von Langenbeck, and Furlow repairs all declined in use, whereas intravelar veloplasty increased. For items not in the tracer, the quality of studies relating to analgesia is among the highest of all areas of study regarding cleft palate repair. In terms of variables collected by the tracer but not studied, in 2019, 41 percent of patients received more than 1 day of antibiotics. CONCLUSIONS: This article provides a review of cleft palate tracer data and summarizes the research in the field. Review of the tracer data enables cleft surgeons to compare their outcomes to national norms and provides an opportunity for them to consider modifications that may enhance their practice.

Influence of socioeconomic factors on litigation in surgery: Addressing the gap in malpractice literature.

The practice of medicine is occasionally volatile and increasingly litigious. Within the specialities, plastic surgery has a high risk, with negative outcomes seen as dissatisfaction, as compared to actual physical harm. To date, most research has focused on potential triggers for litigation, such as poor communication and perceived behavioural deficiencies among physicians. Few studies have addressed patient characteristics or socioeconomic factors. The 'Influence of Socio-Economic Factors on Attitudes Towards Surgery' questionnaire was designed to reflect these goals. It was distributed for a 12-month period to patients in an Emergency Department waiting room. Three hundred twelve completed questionnaires were submitted for analysis. Within the study population, we identified certain socioeconomic trends among those with a low threshold to pursue litigation. Patients with a low threshold to sue were more likely to be male, aged 25-55 years, currently unemployed, without dependents and divorced. However, these parameters did not reach statistical significance. Although these characteristics are interesting, they cannot reliably identify or predict those with a low threshold for litigation. For now, the clinical focus should remain on careful adherence to best practice in an effort to reduce the risk of potential litigation.

Avaliação de sentenças e jurisprudências relacionadas a ações judiciais envolvendo cirurgias plásticas estéticas / Evaluating judgments and decisions related to lawsuits involving aesthetic plastic surgery

Introdução: É consenso no meio jurídico que os resultados referentes às atividades médicas sejam obrigação de meio, e não de resultado. Contudo, há grande discussão quando se trata de procedimentos estéticos. A Resolução nº 1621/2001, do Conselho Federal de Medicina, define que o objetivo do ato médico na cirurgia plástica também constitui obrigação de meio. O estudo avaliou, entre novembro de 2015 a novembro de 2017, 106 casos, para verificar se o entendimento do Judiciário se alinha à Resolução do CFM [Conselho Federal de Medicina]. Foram quantificados o número de processos e a porcentagem dos casos julgados como procedentes ou improcedentes, além de verificar as principais posições doutrinárias e jurisprudenciais que embasaram as sentenças admitidas como procedentes. Foi, ainda, quantificado o número de casos cuja decisão do magistrado foi relacionada com o posicionamento do laudo pericial médico. Métodos: Foi feita busca no banco de sentenças do site do Tribunal de Justiça do Estado de São Paulo (SP), por meio da palavra-chave "Cirurgia Plástica", de todos os processos de indenização relacionados a cirurgias plásticas estéticas. Resultados: Foram sentenciados como improcedentes 61 casos (58%). Foram sentenciados como procedentes 45 casos (42%). Em 96% dos casos (102) a sentença relacionou-se positivamente com a análise pericial. Conclusão: Foram 102 sentenças concordantes aos laudos periciais e apenas quatro casos cuja sentença divergiu do entendimento do laudo. Estes dados mostram a importância crucial da análise pericial para a definição das sentenças judiciais. Analisando todas as sentenças, observou-se que em nenhum caso os juízes levaram em conta a Resolução do CFM [Conselho Federal de Medicina].

Introduction: There is a legal consensus that the results of medical activities represent obligations of means, not results. However, there is ample discussion when it comes to aesthetic procedures. Resolution 1621/2001 of the Federal Council of Medicine also defines the objective of a medical act in plastic surgery as an obligation of means. This study evaluated 106 cases between November 2015 and November 2017 to verify whether the decisions of the Judicial Power agree with the Resolution of the Federal Council of Medicine. The number of lawsuits and the percentage of claims granted or denied were quantified, and the opinions of jurists and courts that supported the claims granted were verified. The number of cases in which the judge's decision was related to the opinion of a medical expert was also quantified. Methods: The authors searched the judgment database located on the website of the Court of Justice of the State of São Paulo (SP) for damage related to aesthetic plastic surgery, using the keyword "Plastic Surgery" for all actions. Results: A total of 61 claims (58%) were denied, and 45 (42%) were granted. In 96% of cases (102) the judgment was positively related to the expert report. Conclusion: There were 102 cases in which the judgment agreed with the expert reports and only four cases in which the judgment did not agree with the reports. These data show the crucial importance of experts' reports in defining judicial judgments. The analyses of all judgments showed that there were no cases in which the judge considered the Resolution of the Federal Council of Medicine.

Limits to consent in cosmetic interventions: an update.

This update restates the legal limits of consent to medical treatment. It reviews the classic statement of law set down by the case of R v Brown, where 'proper medical treatment' was stated to be exempted from the ordinary laws of consent. This position has been recently developed further by the 2018 English case of R v BM where a non-medical body modification artist was convicted for having carried out substantive body modification procedures. This article considers how these developments may affect Australian law, particularly laws pertaining to cosmetic procedures.

El Derecho Médico, vital en el ejercicio de la Cirugía Plástica de hoy / Medical Law, vital in the practice of Plastic Surgery today

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A Primer on Social Media Use by Young Plastic Surgeons.

Similar to the outcry over the ethics of website marketing by physicians in the 1990s, the resistance to plastic surgeons' use of social media has been loud and vehement. Many physicians, although receptive to website marketing, view social media as too radical or unprofessional. Despite the controversy, the value of social media as a communication tool for interacting with and educating patients is supported by studies showing that 65 percent of Americans and 90 percent of young adults use social media. Many plastic surgeons have been early adopters, as reflected by the articles written to help board-certified plastic surgeons use social media in academic medicine and for their practice. However, there is little guidance for young plastic surgeons who wish to use social media for professional purposes. In this study, the authors discuss the ethics and current literature on social media use by young plastic surgeons and make recommendations for how to use social media during training and after residency graduation.