An approach that integrates patient education and informed consent in breast augmentation

Informed consent requires surgeons to provide information about all available alternatives and their associated risks and tradeoffs to every prospective breast augmentation patient. The informed patient and surgeon then make decisions based on the information the patient has received, clinical parameters that may affect those decisions, and the patient's willingness to accept specific risks and tradeoffs. During the authors' 22 years of clinical practice, substantial changes have occurred in the requirements for adequate informed consent and the methods of ensuring that patients receive it. The numbers of alternatives for augmentation and the relative benefits and risks of each method have changed substantially over the past two decades. Four specific areas of postoperative issues stimulated major changes in the authors' approach to patient education and informed consent: 1) questions or dissatisfaction with implant size postoperatively, 2) questions about financial responsibility for costs associated with untoward events requiring reoperation postoperatively including capsular contracture or other problems, 3) spouses or other concerned parties rendering opinions postoperatively when they had not been involved in the informed consent process, and 4) criteria for whether reoperations were indicated, how many were indicated, and when implant removal without replacement might be most logical. This paper describes an approach that integrates patient education and informed consent in stages by 1) providing detailed, highly specific written and verbal information, 2) utilizing a staged approach to education and informed consent that provides information and requires simultaneous, informed consent in stages, 3) repeating each critical topic at least two or three times during the process, requiring repetitive written documentation by the patient on at least three different occasions, 4) emphasizing patient accountability for choices selected, and 5) organizing the education and informed consent process so that it is clinically practical and also increases thoroughness and documentation while conserving surgeon time. This staged, integrated system of patient education and informed consent uses a comprehensive set of informed consent documents that are available for downloading from the Plastic and Reconstructive Surgery Web site (www.plasreconsurg.org). Before incorporating any of the informed consent documents or statements reported in this paper, each surgeon should seek review by the surgeon's malpractice insurance carrier and by appropriate legal counsel to ensure compliance with state and federal laws applicable to the surgeon's practice. These documents have evolved to prospectively address patient management issues that have occurred over the authors' 22-year experience in augmentation. The documents are not endorsed by ASPS and do not necessarily represent the views of ASPS.