The meaning of words - closing the gap in understanding between doctors and patients in 21st century consent.

'When I use a word' Humpty Dumpty said, in a rather scornful tone, 'it means just what I choose it to mean, neither more nor less'. 'The question is' said Alice 'whether you can make words mean so many different things'. Through the Looking-Glass, Lewis Carroll, 1872.

Legal Review of Vasectomy Litigation and the Variables Impacting Trial Outcomes.

OBJECTIVE: To demonstrate the substantial litigious risks associated with vasectomy, a common urologic procedure. We examined the risk factors and types of negligence involved in vasectomy cases that go to trial and their associated outcomes. METHODS: Using the Westlaw legal database, we searched all jury verdicts and settlements for the term "vasectomy" from January 1, 1990 to December 31, 2017. Each case was evaluated for defendant specialty, alleged malpractice breach, resulting complications, outcome including verdict and monetary payment, and whether or not a pregnancy was involved. RESULTS: The Westlaw database query returned 67 unique cases which were settled (13.3%) or went to trial in court (86.7%). Of these, the majority (64.2%) were decided in favor of the defending physician. The most commonly alleged breach of duty was negligence in postoperative care (38.8%). This was followed by negligent surgical performance (37.3%) and negligence in performing informed consent (29.9%). The cases filed for negligence in postoperative care, surgical performance, and informed consent were all generally decided in favor of the defendant (61.5%, 56%, and 90%, respectively). Of the 57 cases that specified, 82.5% of the physicians listed in the litigation were urologists. The average settlement won by each plaintiff was $401,913, although most cases were settled for the medical and litigation costs themselves. CONCLUSION: Medical malpractice cases related to the perioperative aspects of vasectomy involve many areas of negligence. This data may guide vasectomists in where to focus time and communication to best serve patients and minimize litigation.

Responsabilidad profesional médica en embarazo posvasectomía / Medical professional responsibility for postvasectomy pregnancy

Introducción: El seguimiento de los pacientes posvasectomía queda frecuentemente limitado a un seminograma a los 3 meses si se objetiva azoospermia. Este trabajo evalúa una serie de casos de reclamaciones por embarazo posvasectomía, con el objetivo de establecer recomendaciones de seguimiento que aumenten la seguridad clínica y disminuyan el riesgo de reclamaciones. Material y métodos: Se revisó la base de datos del Servicio de Responsabilidad Profesional del Consejo del Colegio de Médicos de Cataluña, localizándose 28 reclamaciones por embarazo posvasectomía entre 1992 y 2011. Se analizaron las variables clínicas y jurídicas de los casos. Resultados: Se registraron 13 reclamaciones extrajudiciales (46,43%), 13 demandas civiles (46,43%) y 2 penales (7,14%). Únicamente en 10 casos constaba la firma de un documento de consentimiento informado específico para vasectomías. En 26 casos se dispuso de los datos correspondientes al espermiograma. En 20 casos (76,92%) se realizó un único espermiograma, en 4 se realizaron 2 (15,38%) y en 2 casos no se realizó ninguno (7,69%). Cuando solo se llevó a cabo un único espermiograma, en 9 casos (45%) este se realizó antes de los 3 meses. En 17 casos (65,38%) el resultado del último espermiograma fue de azoospermia, 3 casos de oligospermia (11,54%), hubo 2 fallos de interpretación del espermiograma (7,69%), 2 de normospermia (7,69%) y en 2 casos no se realizó espermiograma (7,69%). El embarazo se produjo entre los 4 y los 50 meses de la intervención. En 12 casos (42,86%) se consideró que existía responsabilidad profesional. Discusión: Se recomienda enfatizar en la información al paciente la posibilidad de la recanalización espontánea y solicitar 2 espermiogramas con resultado de azoospermia, resultando de riesgo su realización antes de los 3 meses o basar el tiempo de espera en un número de eyaculaciones

Background: The follow-up of patients postvasectomy is frequently limited to a seminogram at 3 months if azoospermia is observed. This study evaluates a series of cases of complaints for postvasectomy pregnancy to establish follow-up recommendations that increase the clinical safety and reduce the risk of complaints. Material and methods: We reviewed the database of the Department of Professional Responsibility of the Council of the College of Physicians of Catalonia, finding 28 complaints for postvasectomy pregnancy between 1992 and 2011. We analysed the clinical and legal variables of the cases. Results: A total of 13 extrajudicial complaints (46.43%), 13 civil lawsuits (46.43%) and 2 criminal lawsuits (7.14%) were recorded. Only 10 cases had a signed document of informed consent specific to vasectomy. In 26 cases, the data from the spermogram was available. A single spermogram was conducted in 20 cases (76.92%), 2 spermograms were conducted in 4 cases (15.38%) and none were performed in 2 cases (7.69%). For 9 of the cases (45%) where only a single spermogram was performed, the test was performed before 3 months postvasectomy. In 17 cases (65.38%), the result of the last spermogram was azoospermia, and 3 cases had oligospermia (11.54%). There were 2 failures of interpretation of the spermogram (7.69%) and 2 of normospermia (7.69%). In 2 cases, a spermogram was not performed (7.69%). Pregnancy occurred between 4 and 50 months after the intervention. In 12 cases (42.86%), it was considered that the practitioner was responsible. Discussion: It is recommended that physicians emphasise (during the patient information stage) the possibility of spontaneous recanalisation and to request 2 spermograms, whose result should be azoospermia. Performing the test in the 3 months after vasectomy is risky, as is basing the waiting time on the number of ejaculations

Nódulos espermiogénicos post-vasectomía / Nódulos espermiogénicos post-vasectomía

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Vasectomy within the public health services in Campinas, São Paulo, Brazil.

OBJECTIVE: To describe some of the characteristics of men who underwent a vasectomy in the public health network of Campinas, São Paulo, Brazil. METHODS: A descriptive study including 202 men randomly selected from a list of all the men vasectomized between 1998 and 2004 in the public health network. RESULTS: Most of the men were 30 years of age or older when vasectomized, had completed elementary school and had two or more children of both sexes. Most of the men came from the lowest income segment of the population: 47.6% in 1998-1999 and 61.3% in 2003-2004. Although the men knew various contraceptive methods, 51.2% reported that their partners were using combined oral contraceptives at the time of surgery. Most men initially sought information on vasectomy at health-care clinics where care was provided by a multidisciplinary team; most received counselling, however, 47.9% of the men waited more than 4 months for the vasectomy. CONCLUSIONS: The profile of the vasectomized men in this study appears to indicate that the low-income population from Campinas, São Paulo, Brazil has access to vasectomy; however, the waiting time for vasectomy reveals that difficulties exist in obtaining this contraceptive method in the public health service.

The law and vasectomy.

This article explores why the national court system has seen a steady influx of claims alleging practitioners' failure properly to perform vasectomy or ensure sterilization and the manner in which that influx has caused physicians to reassess their methods of practicing medicine in an increasingly litigious environment and make the appropriate and necessary accommodations. Through their experiences as medical malpractice litigators and through the analysis of reported cases, national jury verdicts, and insurance claims made and paid in lawsuits arising from claims regarding the performance of vasectomy, the authors enlighten the reader as to the legal theories and hurdles applicable to such claims and the medical theories most often elucidated and litigated by the patients who bring them. Also offered are suggestions as to the manner in which the practitioner may be proactive in both preventing and defending exposure to malpractice litigation.

[Provision of voluntary surgical sterilization in the Campinas Metropolitan Area, São Paulo State, Brazil: perceptions of public health services managers and professionals]. / Atendimento à demanda pela esterilização cirúrgica na Região Metropolitana de Campinas, São Paulo, Brasil: percepção de gestores e profissionais dos serviços públicos de saúde.

This study describes the perceptions of public health services managers and professionals concerning provision of voluntary surgical sterilization in the Campinas Metropolitan Area, São Paulo State, Brazil. The study adopted a qualitative approach in four municipalities (counties), where semi-structured interviews were conducted with 26 health professionals and health services managers involved in the provision of surgical sterilization. The interviewees identified difficulties in scheduling visits at Outpatient Family Clinics or Reference Centers (APF/CR), and the number of available surgeries in the accredited hospitals was insufficient. They emphasized the lack of physical infrastructure and human resources for conducting family planning activities in the primary health units as well as in the APF/CR.They also criticized the legal criteria for authorizing surgical sterilization, and mentioned adaptations to make them more appropriate to the each municipality's situation. According to the health services managers and professionals, despite the efforts, meeting the demand for surgical sterilization in the Campinas Metropolitan Area was jeopardized by its centralization in the APF/CR, which in practice had to cover the gap in family planning activities in each municipality's primary care units.

Atendimento à demanda pela esterilização cirúrgica na Região Metropolitana de Campinas, São Paulo, Brasil: percepção de gestores e profissionais dos serviços públicos de saúde / Provision of voluntary surgical sterilization in the Campinas Metropolitan Area, São Paulo State, Brazil: perceptions of public health services managers and professionals

A presente pesquisa descreve a percepção de gestores e profissionais de serviços públicos de saúde de municípios da Região Metropolitana de Campinas, São Paulo, Brasil, acerca do atendimento à demanda pela esterilização cirúrgica voluntária. Trata-se de estudo qualitativo, em quatro municípios, onde se realizaram entrevistas semi-estruturadas com 26 gestores e profissionais de saúde envolvidos no atendimento às solicitações de esterilização cirúrgica. Apontaram-se dificuldades para agendamento de consultas nos ambulatórios de planejamento familiar ou centros de referência e número insuficiente de cirurgias que podiam ser agendadas semanalmente nos hospitais credenciados. Enfatizou-se a falta de estrutura física e recursos humanos tanto nas unidades básicas de saúde, quanto nos ambulatórios de planejamento familiar ou centros de referência. Houve críticas aos critérios legais para autorizar a esterilização, bem como se mencionaram adaptações para torná-los mais adequados à situação de cada município. Gestores e profissionais de saúde entendiam que, apesar dos esforços empenhados, o atendimento à demanda pela esterilização cirúrgica na Região Metropolitana de Campinas estava prejudicado pela centralização em ambulatórios de planejamento familiar ou centros de referência, que, na prática, tinham que suprir as deficiências da oferta de ações de planejamento familiar em geral na rede básica de cada município.

This study describes the perceptions of public health services managers and professionals concerning provision of voluntary surgical sterilization in the Campinas Metropolitan Area, São Paulo State, Brazil. The study adopted a qualitative approach in four municipalities (counties), where semi-structured interviews were conducted with 26 health professionals and health services managers involved in the provision of surgical sterilization. The interviewees identified difficulties in scheduling visits at Outpatient Family Clinics or Reference Centers (APF/CR), and the number of available surgeries in the accredited hospitals was insufficient. They emphasized the lack of physical infrastructure and human resources for conducting family planning activities in the primary health units as well as in the APF/CR.They also criticized the legal criteria for authorizing surgical sterilization, and mentioned adaptations to make them more appropriate to the each municipality's situation. According to the health services managers and professionals, despite the efforts, meeting the demand for surgical sterilization in the Campinas Metropolitan Area was jeopardized by its centralization in the APF/CR, which in practice had to cover the gap in family planning activities in each municipality's primary care units.

[New aspects of case law on andrological questions: what does this mean for physicians in private practice?]. / Neue Aspekte der Rechtsprechung bei andrologischen Fragestellungen : Was bedeutet dies für die niedergelassenen Kollegen?

In recent years there have been several Supreme Court adjudications concerning andrological issues. Among other things it was reconfirmed that drug therapy for erectile dysfunction does not have to be paid by compulsory health insurance providers. In contrast one Supreme Court decided that cryoconservation of ejaculates has to be paid by compulsory health insurance providers under certain circumstances.Vasectomy in men under guardianship is performed approximately 100 times per year in Germany. Before vasectomy is performed judicial authorisation has to be obtained in an extensive court proceeding.The Tissue Act regulates the implementation of the EG guideline 2004/23/EG into German law. This is only important for urologists who perform MESA/TESE procedures. Current case law does not allow use of the title Männerarzt as patients can confuse it with the official title andrologist.

[Voluntary surgical sterilization in Greater Metropolitan Campinas, São Paulo State, Brazil, before and after legal regulation of the procedure]. / Esterilização cirúrgica voluntária na Região Metropolitana de Campinas, São Paulo, Brasil, antes e após sua regulamentação.

This cross-sectional study compared the provision of surgical sterilization in public health services in Greater Metropolitan Campinas, São Paulo State, Brazil, and the characteristics of women and men who underwent sterilization before and after its legal regulation. Structured and pre-tested questionnaires were applied to 398 women, 15 directors of municipal family planning programs, and 15 coordinators of basic health units. Eight municipalities in Greater Metropolitan Campinas provided tubal ligation and nine performed vasectomy. Approximately half reported following the guidelines of the prevailing family planning legislation. There were no significant differences before or after legal regulation in terms of the characteristics of women and men sterilized or the waiting time for surgery. Most tubal ligations were still performed in combination with cesarean sections (the additional payment for sterilization had decreased, but the difference was not significant). There is strong evidence that in Greater Metropolitan Campinas the changes expected from legal regulation of surgical sterilization did not materialize. Although progress has been made, several distortions still need to be corrected.

[Vasectomy and vas deferens contraceptive surgery: legal and technical aspects]. / Vasectomie et chirurgies contraceptives déférentielles: aspects légaux et techniques.

OBJECTIVES: To analyse technical innovations, their results and the changing legislation in France concerning sterilizing or contraceptive vas deferens surgery. MATERIAL AND METHODS: A review of the literature was performed using the key words: male/contraception/vas deferens. From the 332 research articles obtained from PUBMED, we selected 54 articles for their methodological quality and the importance of their results. RESULTS: Vasectomy remains the only validated vas deferens surgical technique. Although microsurgical reconstructive techniques have improved the vas deferens restoration rate, vasectomy must be considered to be a definitive method of sterilization. The other contraceptive (reversible) vas deferens surgical techniques have not demonstrated sufficient efficacy to be used outside of the context of clinical trials. However the encouraging results ofsome ofthese studies could allow their development in the intermediate term. From a legal point of view, since the reform of sterilizing surgery in Article L2123-1 of the French Public Health Act, vasectomy is now authorized in a regulatory framework. CONCLUSION: The urology community must take into account progress in the field of contraceptive vas deferens surgical techniques.

Características dos candidatos à esterilização cirúrgica e os fatores associados ao tipo de procedimento / Characteristics of candidates for surgical sterilization and factors associated with type of procedure

Em 1999, a Secretaria Municipal de Ribeirão Preto, São Paulo, Brasil, implantou a oferta de métodos de esterilização cirúrgicos, de acordo com a legislação vigente. Este estudo objetivou caracterizar os candidatos à esterilização cirúrgica e estudar as variáveis associadas ao tipo de procedimento. Foram pesquisados 95 prontuários de candidatos e realizada análise estatística por meio de regressão logística e do teste exato de Fisher, considerando-se o nível de significância de p = 0,05. A maioria dos candidatos são casais estáveis, de baixa escolaridade e baixa renda, satisfeitos com o número de filhos e que já haviam tentado limitar a prole com o uso de anticoncepcionais reversíveis. A média de idade era de 34,2 anos; 45,3 por cento se submeteram à esterilização feminina; 35,8 por cento, à vasectomia, e 18,9 por cento não obtiveram o procedimento. A chance de o homem, com 35 anos ou mais, fazer vasectomia é 6,1 vezes a do homem mais jovem (OR = 6,1; IC95 por cento: 2,4-16,4); submetem-se à vasectomia mais homens casados do que os que coabitam (OR = 4,0; IC95 por cento: 1,5-12,4) e mulheres com quatro filhos ou mais fazem mais laqueadura do que aquelas com menos de quatro filhos (OR = 3,1; IC95 por cento: 1,1-8,5).

Exporting ethics: a narrative about narrative research in South India.

The article notes some problems with the prepositional discourse of research ethics that is dominant in the West, and joins the call for an ethics-in-context approach in the human sciences. Using detailed examples from my fieldwork in South India to develop a narrative about ethical conflicts, I explore the problematics of informed consent, confidentiality and other concepts central to research ethics in the USA. The article underscores the inherent and practical risks associated with ethical universalism - applying 'universal' moral principles that have been constructed (that is, derived) in one cultural context and exporting them, without modifications, to another. The personal narrative includes my emotions in the field; they do moral work. The article draws theoretically from Bakhtin, Rabinow and feminist scholars of the Indian diaspora.