Information obligation in surgery.

The following article aims to clarify the guidelines needed for the gaining of informed consent in surgery treatments.  Legal dispositions in the provisions of law n. 219/2017, written according to the regulatory mechanism uphold by the Italian Supreme Court and medical code of practice have been properly analyzed in order answer the questions unanswered by the law. Who is supposed to inform the patient? About which risks?  Does the patient's characteristics affect information obligation? Is necessary to add more information than those required by the law? How do emergency and urgency affect information obligation? Can the patient give consent in advance to an additional operation during the undergoing surgery, if needed? The answers provided by the law and by the Italian Supreme Court picture a state of obligation, where the single physician risks to encounter several responsibilities. It's important to face this problem inside sanitary facilities, creating a suitable informed consent form and planning surgeries to allow the usage of personal data according to the patient's need.

Evolution of Italian laws banning trafficking, use and abuse of psychotropic drugs.

The penalty system implemented by Italian law still represents a barrier against psychoactive drugs and drug addiction, especially at a time when the age of first consumption has considerably dropped. Presidential Decree n. 309 of October 9, 1990 entitled "Consolidation of the laws governing drugs and psychotropic substances, the prevention, treatment and rehabilitation of drug addicts", and referred to as Presidential Decree 309/90, is the reference text for the cultivation, production, trade and use of narcotics and other psychoactive substances in Italy. The Presidential Decree has its origins in the now-forgotten law of December 22, 1975, n. 685, amended by law 162/90, which provided a draft of the current Presidential Decree 309/90. The current text has been amended numerous times over the years.

Recent Medico-Legal Developments on the Issue of Epilepsy and Driver's License Requirements in the Italian and European Legislation.

Epilepsy is a condition that comprises a group of neurological disorders characterized by seizures. Forms of epilepsy that produce abrupt bouts that cause lapses in consciousness may pose a major road safety problem for drivers who, while going through a seizure, could seriously harm themselves as well as others. A fundamental strategy for the purpose of reducing the risk of car accidents caused by epileptic drivers is constituted by prevention, in addition to adequate pharmacological therapies. In that respect, forensic medicine plays a pivotal role, since it deals with the set of requirements that must be met by those who have been diagnosed with epilepsy in order to get a driver's license, and with the obligation to signal such individuals to the national Driver and Vehicle Licensing Agency (in Italian: Motorizzazione Civile). In that regard, the Italian legislative framework is partly hazy in some respects, which the authors have set out to analyze herein, taking into account recently issued European norms. The aim of this paper was to better understand the current Italian legislation in the matter of epilepsy and driver's license requirements, especially regarding the medical criteria that must be met in order to obtain the driving license. The importance of those criteria is underlined by the fact that they directly influence (and are influenced by) the safety for the drivers and for the persons involved in car accidents. Thus, we can consider the issue not only strictly of medico-legal relevance but also from the standpoint of primary prevention. The analysis was conducted by reviewing the most recent documents of medico-legal relevance, in the light of European Union legislation. The authors have ultimately stressed the need for clearer and straightforward regulations, given that professional liability may arise whenever a driver's license is issued, in disregard of legal norms, to an individual who then causes a road accident.

No Correlation between Blood Benzene Levels and Luteinizing Hormone Plasma Values in Outdoor Workers.

OBJECTIVE: The purpose of the study is to evaluate whether low-dose exposure to benzene, an environmental pollutant to which male and female traffic policemen are daily exposed to could cause alterations in plasma luteinizing hormone (LH) levels. METHODS: From an initial sample of 1594 workers, we only selected 95 workers of whom study we knew the values of late-shift benzene and LH hormone. All subjects underwent biological monitoring (final blood benzene evaluation) and luteinizing hormone dosing. Excluding subjects with the main confounding factors, the final sample included 76 workers. The normal distribution of the variables was evaluated using the Kolmogorov - Smirnov test, followed by the logarithmic transformation of the LH and benzene values. The comparison among means was performed by using the t-test for the independent samples. The ANOVA test was performed for variables with more than 2 modes (ages and seniority) and Pearson correlation index between variables in the total sample and after subdivision as to sex, job, sports activity and smoking. The results were considered significant when p values were less than 0.05. RESULTS/CONCLUSION: The study did not show a correlation between benzene levels and LH plasma levels in outdoor workers.

Post Vaccinal Temporary Sensorineural Hearing Loss.

In our systematic research we identified four studies concerning the onset of neurological adverse events following vaccination and two excluding this association. A 33-year-old Italian man, belonging to the Italian Army was hospitalized because he suffered from vertigo, nausea and sudden right hearing loss not classified (NDD), that set in 24 h after the administration of tetanus-diphtheria and meningococcal vaccines. Some neurological events arising after vaccination are very difficult to treat. In our case, the functional recovery on low and medium frequencies was possible about 6 months after the morbid event.

Ethics and/or aesthetics? Reflections on cosmetic surgery for adolescents / ¿Ética o estética? Reflexiones sobre la cirugía estética en adolescentes

Cosmetic surgery entails various ethical issues, even more so in cases involving adolescent patients. Cosmetic surgeons need to take into account how modern societies consider physical appearance an essential component of everyday life, as well as the vulnerability of youths and adolescents. For that reason, it is imperative to thoroughly assess the psychological and emotional states, in addition to the motivations, of minor patients. That goal can be achieved through the use of the DAS-59, (the Derriford Appearance Scale)1 , an effective and dependable tool devised to evaluate the psychological difficulties and distress experienced by people living with problems of appearance. Prior to undergoing cosmetic surgery procedures, adolescents should be required to go through adequate counseling, over multiple sessions and extended to their family members as well, on account of the complex issues inherent in evaluating the risk-benefit ratio and a prospective patient’s decision-making capability. A concerted effort on the part of surgeons, psychiatrists or psychologists is key in determining the real motivations behind a minor's decision to opt for cosmetic surgery in the first place. Possible psychiatric conditions may in fact prevent a minor from making a free, informed decision. From an ethical standpoint, cosmetic surgery procedures should be geared to serve the best interest of the minor patient, who may experience distress over his or her body image, from a health and psychological balance perspective and improve his or her social, affective and working life. Besides, cosmetic surgery should not be overly invasive compared to its potential benefits. Those procedures aimed at achieving "ideal beauty" are not desirable and ought to be banned. By virtue of such criteria, the authors have set out to evaluate the ethical admissibility of some aesthetic treatments. Thus, doctors should not consent to any request coming from their patients, but rather, intervene only in presence of an objective physical flaw or deformity, e.g. protruding ears, which have a potential to negatively affect social life and interactions

La cirugía estética está en constante aumento, especialmente entre los adolescentes, que son sujetos particularmente vulnerables. Es importante establecer la verdadera motivación que impulsa a la persona joven a ponerse en contacto con el cirujano estético. Por lo tanto, el médico, antes de someter al adolescente a una cirugía cosmética, debe evaluar su estado psicológico y emocional. Puede hacerlo utilizando el DAS59, una herramienta válida y confiable para evaluar la angustia psicológica. Si el adolescente muestra un trastorno psiquiátrico, este trastorno debe tratarse primero, esto permite que el paciente tome una decisión informada. Por lo tanto, la colaboración entre un cirujano estético y un psiquiatra o psicólogo es fundamental. El especialista puede evaluar las motivaciones a través de un asesoramiento cuidadoso, que se llevará a cabo en varias sesiones, también con la participación de la familia. Si el médico cree que el adolescente no está lo suficientemente maduro, debe posponer la operación. Vale la pena señalar que el adolescente va al cirujano estético no para tratar una enfermedad, sino para mejorar su apariencia, por esta razón debe recibir una información amplia y adecuada sobre los riesgos, resultados y posibles complicaciones. Desde un punto de vista ético, el Comité Nacional Italiano de Bioética considera legítimas las intervenciones estéticas que responden a un interés objetivo exclusivo de los adolescentes en términos de salud y equilibrio psicológico. Por otro lado, las intervenciones desproporcionadas, que son excesivamente invasivas o innecesariamente arriesgadas y inadecuadas en comparación con los posibles beneficios solicitados por el paciente, son inaceptables. Por lo tanto, el médico no tiene que satisfacer todas las solicitudes, sino que debe intervenir solo cuando existe una imperfección física, como orejas prominentes, que pueden impedir la vida social

Ethics and/or Aesthetics? Reflections on Cosmetic Surgery for Adolescents.

Cosmetic surgery entails various ethical issues, even more so in cases involving adolescent patients. Cosmetic surgeons need to take into account how modern societies consider physical appearance an essential component of everyday life, as well as the vulnerability of youths and adolescents. For that reason, it is imperative to thoroughly assess the psychological and emotional states, in addition to the motivations, of minor patients. That goal can be achieved through the use of the DAS-59, (the Derriford Appearance Scale)1 , an effective and dependable tool devised to evaluate the psychological difficulties and distress experienced by people living with problems of appearance. Prior to undergoing cosmetic surgery procedures, adolescents should be required to go through adequate counseling, over multiple sessions and extended to their family members as well, on account of the complex issues inherent in evaluating the risk-benefit ratio and a prospective patient's decision-making capability. A concerted effort on the part of surgeons, psychiatrists or psychologists is key in determining the real motivations behind a minor's decision to opt for cosmetic surgery in the first place. Possible psychiatric conditions may in fact prevent a minor from making a free, informed decision. From an ethical standpoint, cosmetic surgery procedures should be geared to serve the best interest of the minor patient, who may experience distress over his or her body image, from a health and psychological balance perspective and improve his or her social, affective and working life. Besides, cosmetic surgery should not be overly invasive compared to its potential benefits. Those procedures aimed at achieving ″ideal beauty″ are not desirable and ought to be banned. By virtue of such criteria, the authors have set out to evaluate the ethical admissibility of some aesthetic treatments. Thus, doctors should not consent to any request coming from their patients, but rather, intervene only in presence of an objective physical flaw or deformity, e.g. protruding ears, which have a potential to negatively affect social life and interactions.

An atypical case of trigeminal trophic syndrome: A legal medicine perspective in medical responsibility.

BACKGROUND: Trigeminal trophic syndrome is a rare complication of peripheral or central damage to the trigeminal nerve characterized by anesthesia, paresthesia and a secondary persistent facial ulceration. METHODS: We describe the case of a 40-year-old woman with previous history of Le Fort I osteotomy for a class III malocclusion who developed trigeminal trophic syndrome. Atypically, the cutaneous symptoms appeared bilaterally and 8 years after surgery. RESULTS: Differential diagnosis was based on clinical history, tissue biopsy and serologic evaluation. Atypical findings could be linked to the surgical burdens of Le Fort I osteotomy, a procedure characterized by a bilateral incision on the maxillofacial bones with a reasonable probability of causing a bilateral injury of the peripheral branches of the trigeminal nerve. CONCLUSION: Although the long delay between trigeminal trophic syndrome onset and surgery and the absence of adequate medical evidence cannot confirm a link with previous surgery in this case, the increasing number of maxillofacial surgery cases suggests that this complication may be more frequent in the next decades, and thus, involved specialists should be aware of this condition as a possible complication of maxillofacial surgery procedures.

Volatile lipophilic substances management in case of fatal sniffing.

Death due to inhalation of aliphatic hydrocarbons such as butane and propane is a particularly serious problem worldwide, resulting in several fatal cases of sniffing these volatile substances in order to "get high". Despite the number of cases published, there is not a unique approach to case management of fatal sniffing. In this paper we illustrate the volatile lipophilic substances management in a case of a prisoner died after sniffing a butane-propane gas mixture from prefilled camping stove gas canisters, discussing the comprehensive approach of the crime scene, the autopsy, histology and toxicology. A large set of accurate values of both butane and propane was obtained by gas chromatography-mass spectrometry analyzing the following post-mortem biological samples: peripheral blood, heart blood, vitreous humor, liver, lung, heart, brain/cerebral cortex, fat tissue, kidney, and allowed an in depth discussion about the cause of death. A key role is played by following the proper sampling approach during autopsy.

Ventricular androgenic-anabolic steroid-related remodeling: an immunohistochemical study.

BACKGROUND: Several fatal cases of bodybuilders, following a myocardial infarction after long exposure to androgenic-anabolic steroids (AAS), are reported. In recent years, evidence has emerged of cases of heart failure related to AAS consumption, with no signs of coronary or aorta atherosclerosis. This study aims to further investigate the pathogenesis of the ventricular AAS-related remodeling performing immunohistochemistry (IHC). METHOD: In order to examine innate immunity activity and myocytes and endothelial cell apoptosis, IHC analyses were performed on heart tissue of two cases of bodybuilders who died after years of supratherapeutic use of metelonone and nandrolone and where no atherosclerosis or thrombosis were found, using the following antibodies: anti-CD68, anti-iNOS, anti-CD163, anti-CD 15, anti-CD8, anti-CD4, anti-HIF1 α, and in situ TUNEL staining. RESULTS: Results confirm the experimental findings of recent research that, in the absence of other pathological factors, if intensive training is combined with AAS abuse, myocytes and endothelial cells undergo apoptotic alterations. The absence of inflammatory reactions and the presence of an increased number of M2 macrophages in the areas of fibrotic remodeling confirm that the fibrotic changes in the heart are apoptosis-related and not necrosis-related. CONCLUSIONS: In conclusion, the study indicates that, in very young subjects with chronic hypoxia-related alterations of the heart, signs of a heart failure in the other organs and a history of AAS abuse, death can be ascribed to progressive heart failure due to the direct apoptotic cardiac and endothelial changes produced by AAS.

Italian law n. 24/2017 on physicians' criminal liability: a reform that does not solve the problems of the psychiatric practice

For years psychiatrists have been facing the risk of being prosecuted for professional liability. One of the reasons for this situation depends on the fact that professionals cannot rely on clear rules of conduct. Indeed, in psychiatry, it may happen that a judge considers negligent a conduct not punishable by another court, as in cases of hospital discharges. In order to solve this situation, on March 8, 2017 Italian legislators issued the law no. 24. First of all, it establishes that health care providers must follow the guidelines that will be published on the website of the High Institute of Health, with the exception of specific situations on a given case. In the absence of such guidelines, the good clinical-care practice should be applied (Art. 5). In addition, if health care providers have met the guidelines as appropriate to the specific case or, in their absence, to the good clinical-care practice, they cannot be sentenced for homicide or accidental injury due to incapacity (Art. 6). The authors analyze these provisions with the aim of verifying if they are adequate to achieve the purposes that the legislator had set: 1) protecting patients' health; 2) offering psychiatrists clear rules of conduct in order to reduce the risk of being subjected to criminal proceedings. The first objective is endangered by the fact that the law does not indicate the level of the evidences trustworthiness necessary to make them be considered as binding guidelines. The second objective appears unreachable. In fact, the law under consideration states that only incapacity is not punishable, whereas homicide and lesions caused by negligence or imprudence, even if slight, are considered a crime. In the psychiatric field, more than in other branches of medicine, charges normally concern negligence or imprudence. Therefore, this reform does not limit at all psychiatrists' criminal liability.

Variability in findings of anogenital injury in consensual and non-consensual fisting intercourse: A systematic review.

Fisting is an uncommon and potentially dangerous sexual practice. This is usually a homosexual activity, but can also be a heterosexual or an autoerotic practice. A systematic review of the forensic literature yielded 14 published studies from 8 countries between 1968 and 2016 that met the inclusion/exclusion criteria, illustrating that external anogenital (anal and/or genital) trauma due to fisting is observed in 22.2% and 88.8% (reported consensual and non-consensual intercourse, respectively) of the subjects, while internal injuries are observed in the totality of the patients. Establishing the reliability of the conclusions of these studies is difficult due to a lack of uniformity in methodology used to detect and define injuries. Taking this limit into account, the aim of this article is to give a description of the external and internal injuries subsequent to reported consensual and non-consensual fisting practice, and try to find a relation between this sexual practice, the morphology of the injuries, the correlation with the use of drugs, and the relationship with assailant, where possible. The findings reported in this paper could be useful, especially when concerns of sexual assault arise.

Hydraulic Resistance of Vitreous Cutters: The Impact of Blade Design and Cut Rate.

PURPOSE: To measure the hydraulic resistance (HR) of vitreous cutters equipped with a Regular guillotine Blade (RB) or double edge blade (DEB) at cut rates comprised between 0 and 12,000 cuts per minute (CPM) and compare it with vitreous fragment size. This was an in vitro experimental study; in vivo HR measure and vitreous sampling. METHODS: HR, defined as aspiration pressure/flow rate, was measured in balanced salt solution (BSS; Alcon, Fort Worth, TX) (in vitro) and during pars plana vitrectomy of 20 consecutive patients aged 18 to 65, undergoing macular surgery. HR was recorded at increasing cut rates (500-6000 CPM for the RB and 500-12,000 CPM for the DEB; 5 mL/min flow). Vitreous samples were withdrawn and analyzed with Western and collagen type II and IX immunostaining to evaluate protein size. The main outcome measures were hydraulic resistance (mm Hg/ml/min [±SD]) and optic density for Western blot and immunostaining. RESULTS: RB and DEB showed identical HR in BSS between 0 and 3000 CPM. Above 3000 CPM, RB HR steadily increased, and was significantly higher than DEB HR. Vitreous HR was also similar for the two blades between 0 and 1500 CPM. Above 1500 CPM, RB offered a significantly higher resistance. Western blot and immunostaining of vitreous samples did not yield a significant difference in size, regardless of blade type and cut rate. CONCLUSIONS: DEB is more efficient, offering a lower HR than RB over 1500 CPM in human vitreous. There is no viscosity reduction as a function of cut-rate between 1500 and 12,000 CPM, as HR does not vary. TRANSLATIONAL RELEVANCE: Future vitreous cutters will benefit of a DEB; optimal cut rate needs to be defined, and the simple increase of cut rate does not provide benefits after a certain limit to be assessed.

Ethical and legal implications of elective ventilation and organ transplantation: "medicalization" of dying versus medical mission.

A critical controversy surrounds the type of allowable interventions to be carried out in patients who are potential organ donors, in an attempt to improve organ perfusion and successful transplantation. The main goal is to transplant an organ in conditions as close as possible to its physiological live state. "Elective ventilation" (EV), that is, the use of ventilation for the sole purpose of retrieving the organs of patients close to death, is an option which offsets the shortage of organ donation. We have analyzed the legal context of the dying process of the organ donor and the feasibility of EV in the Italian context. There is no legal framework regulating the practice of EV, neither is any real information given to the general public. A public debate has yet to be initiated. In the Italian cultural and legislative scenario, we believe that, under some circumstances (i.e., the expressed wishes of the patient, even in the form of advance directives), the use of EV does not violate the principle of beneficence. We believe that the crux of the matter lies in the need to explore the real determination and will of the patient and his/her orientation towards the specific aim of organ donation.

[Legislative evolution in matter of protection for disabled persons]. / Evoluzione normativa in materia di tutela dei soggetti portatori di handicap.

The authors examine the laws that aim to favour the integration of the disabled persons in the society, with particular refer to work and school, and that also aim to make easy the relationships for those who live with a disabled person. Even though the appreciation for the engagement of the legislator, they wish the development of the funds allocated to this purpose.

[Blood transfusion: history ethic and law]. / La trasfusione di sangue: storia, etica e diritto.

The paper outlines the stages of the history of blood transfusion from the earlier attempts and difficulties to the important discoveries of the early XX century and to recent developments, that have made blood transfusion an easy life-saving method. The authors also examine the ethical motivations underlying transfusion refusal as well as the economical measures of solidarity contained in the Italian law n. 210/1992 to protect HIV HCV or HBV patients, especially those having contracted infection because of mandatory vaccinations or infected blood transfusions.

[Female genital mutilations: ethical and forensic medicine aspects]. / Le mutilazioni genitali femminili: profili etici, deontologici e medico-legali.

The female genital mutilation involves both anthropological and ethical aspects as well as legal issues: because the spreading of population from Africa and Middle East to Western countries, the problem is world wide considered by both International (e.g. WHO, UNICEF, UNFPA) and National Authorities. The Italian Parliament are now examining many proposal of law to prevent the female genital mutilations.