New surgical techniques and informed consent--safety first.
Surgical techniques always imply uncertainty about risks and outcome. Many law systems explicitly recognise the patient's right with respect to informed decision-making. This right refers to information about the risks and benefits, the experience of the surgeon, and the performance of the surgical team. In practice, the informed consent is difficult to obtain, and patients have often difficulty to recall the adequate information. Especially when risk and benefit assessment has to be done with the focus on a new technology that is expected to prevent disease in the future, safety of this less invasive technique compared with the current strategy is important. Therefore, it is also of importance to look at the mid-term and long-term follow-up. Appropriate knowledge of the technology involved, follow-up data, and risk information provided by a professional safety-committee should be the input of the informed consent procedure.
Department of Cardio-thoracic Surgery, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. B.A.deMol@AMC.UVA.NL
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D017544:Aortic Aneurysm, Abdominal / Q000601:surgery; D001530:Belgium; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D018570:Risk Assessment; D012449:Safety; D014656:Vascular Surgical Procedures / Q000331:legislation & jurisprudence