Informed consent in Italy-traditional versus the law: a gordian knot.

BACKGROUND: Italian law no. 86 of 5 June 2012, which establishes a set of rules on the matter of breast implants, came into effect in July 2012. The law is at the center of a widespread and animated cultural debate that in recent years has been taking place in Italy. DISCUSSION: The fundamental prohibition imposed by the law concerns the age limit. Breast implants for exclusively aesthetic purposes are allowed only if the legal age (18 years) has been reached. This prohibition does not apply in cases of severe congenital malformations certified by a physician operating within the National Health Service or by a public health care institution. The legal imposition of an age limit raises a number of perplexities: one at a bioethical level and one that is strictly juridical. In fact, it is impossible to deal with this issue unless the wider debate concerning the self-determination and autonomy of underage patients in biomedical matters is considered. It appears, then, that the issue is again exclusively related to the peculiarity of cosmetic surgery, which when aimed at correcting "only" the pathologic experiences of self-image, does not acquire the dignity of therapy. If, however, the improvement of self-image serves to achieve a better psycho-emotional balance and favors the development of social relations undermined by evident physical defects, age restrictions can be disregarded. The authors believe the real risk is that the law imposed by the Italian state is based on assumptions and preformed value judgments. Furthermore, in the understanding of needs, legislation often is biased toward objective biophysical problems without attaching due importance to subjective psychological and social problems. While acknowledging the seriousness of the issue, the authors do not agree with the legislature's rigidity. However, plastic surgeons must form a plan for addressing the concerns about breast implants and evaluating whether they are appropriate for adolescents, taking into account the unique psychological and developmental considerations of adolescent cosmetic surgery patients. 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 .

Escolha da técnica de mastoplastia de aumento: uma ferramenta na prevenção de litígio médico / Choosing the augmentation mammaplasty technique: a method for preventing medical disputes

INTRODUÇÃO: A cirurgia plástica é uma das especialidades médicas expostas ao risco de reivindicações abusivas. A maioria das queixas em cirurgia plástica não decorre de falhas técnicas, mas de inadequados critérios de seleção de pacientes, falha na indicação cirúrgica e falta de comunicação adequada entre o paciente e o cirurgião. O treinamento, a utilização cuidadosa de técnicas, a adoção de precauções, o cumprimento de normas de segurança e o formulário de consentimento informado são princípios fundamentais na prática da medicina defensiva. Ademais, ter nos registros dos pacientes informações objetivas sobre a cirurgia realizada avaliza o trabalho do cirurgião plástico, tornando os procedimentos profícuos e técnicos. O objetivo deste estudo é descrever uma ferramenta de prevenção de litígios médicos na mastoplastia de aumento baseada em dados de escala em graus I a IV. MÉTODO: Foram avaliadas 40 pacientes com indicação de mastoplastia de aumento. Todas as pacientes foram submetidas a mensurações anatômicas, documentação fotográfica e registro de doenças hereditárias e congênitas encontradas nas pacientes candidatas a aumento mamário. Além disso, todas as pacientes receberam explicação da indicação e do procedimento cirúrgico a ser realizado. As pacientes concordaram com a indicação cirúrgica e assinaram o termo de consentimento. RESULTADOS: O tempo de seguimento das pacientes foi de 6 meses. Todas as pacientes apresentaram alto grau de satisfação com o resultado obtido após o procedimento e não houve caso de queixa ou litígio. CONCLUSÕES: Os autores propõem o uso regular de tabelas e classificações para escolha prévia dos implantes, com o objetivo de tornar a indicação cirúrgica objetiva, facilitar o entendimento da paciente e prevenir o litígio.

BACKGROUND: Plastic surgery is a medical specialty that is particularly at risk of unwarranted claims. Most complaints regarding plastic surgery are not a consequence of technical failures but rather of inadequate criteria of patient selection, failure in surgical indication, and lack of effective communication between the patient and the surgeon. Training, careful use of techniques, adopting precautions, compliance with safety regulations, and the informed consent document are fundamental principles of defensive medical practice. Moreover, documenting objective information about the surgery in the medical records validates the work of the plastic surgeon and ensures that procedures are productive and technical. The aim of this study was to develop a tool for preventing medical litigations in augmentation mammaplasty based on data expressed on the scale from I to IV. METHODS: Forty patients with an indication for augmentation mammaplasty were evaluated. All the patients were subjected to anatomical measurements, which were photographically documented, and the hereditary and congenital diseases of the patients presenting for breast augmentation were recorded. In addition, all the patients were informed about the indication and surgical procedure to be performed. They agreed with the surgical indication and provided informed consent. RESULTS: The follow-up period was 6 months. All the patients expressed a high degree of satisfaction with the results obtained after the procedure, and no cases of complaints or disputes were encountered. CONCLUSIONS: The authors propose the regular use of tables and classifications for the selection of implants, with the aim of establishing surgical indication as an objective parameter, facilitating patients' understanding of the procedure, and preventing litigation.