The start of the new millennium proved to be a difficult time for breast augmentation surgeons. For those who were witness to the U.S. Food and Drug Administration (FDA) silicone gel advisory panels, it was evident that, for better or worse, the decision to undergo breast augmentation surgery has had a significant impact on the lives of hundreds of thousands of U.S. women. As devices have evolved over the last 45 years, their improved longevity and reliability have been well documented (1). However, despite these technological advances, the most recent premarket approval application (PMA) data suggest that surgical outcomes, as reflected by revision rates, still lag far behind (2,3).

Considerable effort has been placed on redefining breast augmentation as more than just a surgical procedure. Peer-reviewed publications confirm that markedly improved long-term outcomes can be achieved when there is effective communication between the physician and the patient. The first step in accomplishing improved outcomes in breast augmentation is comprehensive patient education (4). Decisions made by both the surgeon and the patient during the consultation phase of the breast augmentation process may have more of an impact on the quality of the outcome and its longevity than the device selected or the augmentation procedure itself. It is during this educational process that surgeons have the best opportunity to introduce informed-consent documents that will hold patients accountable for their decisions. An effective educational process must link understanding with accountability, and what really matters is whether the patients understand, accept, and take responsibility for their decisions (5).

This chapter focuses on analyzing the current informed-consent issues and how they relate to patient education in breast augmentation. It reviews essential content suggested in the initial consultation, presented in a format that patients will understand while simultaneously integrating informed-consent documents into the patient’s educational experience. Useful educational tools that can be used both in and out of the office are recommended, as well as suggested steps to be taken preoperatively to clearly document the patient’s accountability for decisions made. Finally, this chapter reviews methods that will help manage patient expectations with regard to the financial responsibilities of potential complications or staged procedures, as well as suggested long-term follow-up as both the patient and the devices age.

In the medical setting, the term “informed consent” arose in the United States in 1957. This terminology shifted the physician–patient relationship away from the medical paternalism that had encompassed medicine and surgery for centuries toward that of a duty to respect patient autonomy. The U.S. court case of Cobb vs. Grant 1972 noted that the doctrine of informed consent is “anchored” in four postulates. First, patients are generally ignorant of medicine. Second, patients have a right to control their body and decide about their medical treatment. Third, consent to treatment must be informed to be effective. Fourth, patients depend on their physicians for truthful information and must trust them (6). Informed consent in breast augmentation, therefore, should have two main aims. The foremost goal should be to respect and promote the patients’ autonomy; the second should be to be truthful and protect them from harm. If we assume the provision that accurate, detailed information has been provided in an understandable format, patients should be assured of both of these aims. Only if the patient obtains a comprehensive understanding of the possible benefits, harms, and alternatives to the procedure can she give adequate informed consent. In addition, with respect to breast augmentation, we must also convey the fact that there remain unknown risks associated with the procedure.

Successful communication plays the central role in physician–patient relationships, and it has been shown to influence positively patient satisfaction, compliance, medical outcomes, and the overall quality of the patient experience (7). It is especially important for informed consent, where patients are allowed, and expected, to participate in the decision-making process by weighing the benefits against the risks of recommended options (8). To be able to become true and knowledgeable decision makers, patients need to understand the basis and significance behind those recommendations and discuss them with their physicians properly. The current practice of obtaining informed consent is often centered on the legal duty of having the patient sign a form. Signing does not always represent patient understanding. Furthermore, the U.S. Department of Health and Human Services now requires that all consent forms be “in language understandable to the subject or their representative.” Many states require culturally sensitive informed-consent documents, as this process has also been shown to be compromised when language or cultural barriers are present. It is also recommended that documents and brochures be provided in writing that is understandable to the reading level of eighth grade or lower (9).

One of the roles of the physician is to become an effective communicator. Physicians and their staff must be able to deliver information in language that is familiar to their patients and easy to understand, using common words from everyday language. Studies have shown that medical language and everyday language are seen as two separate languages (10). Most physicians and caregivers can translate the necessary medical information into a language that the patients can understand. An interactive communication loop between the patient and physician or nurse educator should be used to frequently check
comprehension and recall while clarifying and tailoring the information in repeated cycles to improve comprehension (11). Some studies suggest that patient understanding might be improved if the consent forms were short and easy to read. They suggest modifications to consent forms with regard to content, writing style, format, and length (12). Others conclude that these modifications are no more successful than other approaches to improving patient comprehension (13). In addition, the term “fully” informed consent would require that every piece of information available would be provided to every patient. No rational patient desires all the information about a procedure or a device, nor is there sufficient time. It is also particularly difficult to obtain true informed consent in breast augmentation because there remain unknowns that have yet to be identified (14). Patients should be provided with “reasonable” and “adequate” information, which will always be less than all of the available information (15). In breast augmentation, we must also further define risks as either surgical- or implant-related risk (16).

Although the patient’s signature on a single surgical consent document might represent agreement, it does not always imply understanding. An attempt to assess understanding should be made at varying steps throughout the educational process and documentation recorded at each step. Several options have been suggested that create an integrated approach to patient education and the informed-consent process (5). In addition to providing multiple, short, readable documents in a staged approach, physicians and their staff should frequently check the patient’s level of understanding. The method of “teach back” can confirm understanding. The physician or staff can ask the patient to say in her own words what has been described, and ask again if the patient’s words show incomplete or inaccurate understanding. Probably the most important factor in ensuring a high level of patient understanding is the quality of the time spent with the patient. When the surgeon and the staff are dedicated to providing their patients with a breast augmentation process that is specifically designed to ensure safe, predictable, long-lasting results with the lowest chance of unnecessary revisions, patients should be given the necessary time to make well-informed decisions. Many patients make their surgical decisions too quickly and select surgical options without taking the time to process the information they have received. Patients should, if possible, always be given the opportunity to return for a second consultation. Between the two visits they should be encouraged to read any educational materials provided, search the Internet, and even seek another surgical opinion if they desire. For women who want to be involved in the surgical decisions entailed in breast augmentation, it is crucial that they are reassured that they have time to evaluate their surgical options.

Much of the research focusing on the quality of patient decisions in surgery has been associated with clinical trials of patient decision aids and other decision support tools. The preoperative decisions in breast augmentation are known as “preference-sensitive” decisions to reflect the fact that although medical evidence is necessary to make decisions, it may not be sufficient. The patient’s preferences are also necessary to make the appropriate decision. It follows, however that “preference-sensitive” clinical decisions can be defined as the extent to which the implemented choices reflect the considered preferences of the well-informed patient. Therefore patients should be given ample opportunity to become well informed (17). There has been a great deal of discussion in the plastic surgery literature and at scientific meetings surrounding the balance between patient autonomy, that is, the physician’s obligation to create the conditions necessary for autonomous choice and an individual’s right to self-determination, and beneficence, which is the physician’s responsibility to do what is best for the patient. Beneficence is also the belief that physicians are expected to refrain from causing harm in addition to having an obligation to help their patients. While there has been a long tradition in Western medical ethics toward focusing on autonomy, that prioritization has now been critiqued (18,19). The ethical debate in breast augmentation arises when the patient’s autonomous decisions conflict with the physician’s beneficent duty to look out for the patient’s best interest, for example, if the physician wishes to prevent avoidable breast augmentation complications that may eventually result in potentially uncorrectable deformities. Both surgeons and patients may sense this as a return to an era of paternalism and reject the concept of “doctor-knows-best” with regard to patient education in breast augmentation. However, if we accept that there are quantifiable guidelines that can minimize revision surgeries and optimize long-term results, then there is a need to incorporate beneficent actions in the preoperative education process. Patients may still proceed with autonomy during the informed-consent process involved in breast augmentation, provided they are accurately informed and fully understand the long-term consequences of their decisions. They must then also be willing to be held accountable for those decisions.

The education process in breast augmentation can actually begin before the first consult, at the time of the initial contact between the patient and the physician’s office. The opportunity to set in motion a comprehensive process of patient education starts before the patient even steps foot into the physician’s office. Verbal information presented by the office staff will establish a pattern to be followed throughout the breast augmentation experience. Printed material can be mailed to the patient and website information should be suggested for review prior to the first office visit. Both physicians and patients routinely use the Internet as a source of health-related information; however websites are not monitored, and therefore the quality of information is variable. Prospective breast augmentation patients need to be taught to distinguish between sponsored websites, in which advertisers pay for placement, and unsponsored ones, which do not provide payment to the search engine. A physician’s website, if current, can be an excellent source of information and should include links to additional sites that are both sponsored and unsponsored. The information on the Internet, however, is not intended to replace information provided by the physician. In addition, the sites visited by the patient before the initial consult should be reviewed by the physician or nurse educator at the first visit to correct any inaccuracies encountered (20).

If patient education is to be a staged repetitive learning process, it will require participation from several members of the surgeon’s staff. Many large practices have a patient educator who plays an active role in the educational process. For smaller practices, it may be the responsibility of the surgeon and a well-trained staff member to develop a detailed precise
approach to patient education and informed consent. Extremely well thought out programs that integrate patient education and informed consent have been published (6). Comprehensive informed-consent documents have been developed that are incorporated directly into the preoperative educational process. These documents are specifically designed to verify the patients understanding of content and their acceptance of responsibility for their decisions. These documents are available for downloading from the Plastic and Reconstructive Surgery website (21) and can be modified to meet the needs of individual practice styles (Fig. 109.1). There is a substantial quantity of information that will be transferred to the patient.

An approach to education that documents decisions made between the surgeon and patient after each topic has been discussed may produce a more valid informed consent than a single consent document signed at the time of payment for the procedure. It is also extremely important to document whether a spouse, significant other, or relative will be involved in the decision-making process. That individual should be present for at least one of the office educational visits if he or she is to be allowed to participate in any postoperative discussions on the surgical outcome (5,6). Although it may not be the preference or style of all breast augmentation practices to interject the signing of multiple documents throughout the patient’s preoperative experience, there should be a verbal discussion with clear written documentation preoperatively that the patient understands the alternatives offered and accepts trade-offs, risks, and possible short- and long-term complications associated with her decisions. In addition, there should be written documentation of the financial responsibilities that the patient may encounter postoperatively either for possible untoward complications or for future radiologic imaging and eventual replacement of her implant.

Most surgeons develop their communication skills over the years are turning with increasing frequency to tools and technology as aids in the patient education process. From use of a simple illustration to the use of interactive digital education, there is a perceived need to reach out to patients with better educational tools so they can make better-informed decisions (22). Most women seeking breast augmentation are highly motivated to learn about the breast augmentation process. Many practices offer patients printed materials or a Web-based introduction to the practice that includes their philosophy on breast augmentation and can be read before the first consultation. These materials are then reviewed by the patient educator or the physician during the initial consultation.

Many patients present with little or no knowledge concerning the history of breast implants and may have biases based on the media, personal experiences, or the experiences of friends or relatives. By incorporating the patient’s senses into the learning experience, physicians can utilize both visual and tactile tools to reinforce the messages presented. Visuals have proven to be an important asset in improving patient–physician communications, enhancing education, and advancing the informed consent process. Visuals can increase patient satisfaction and comprehension while reducing the amount of time a physician needs to spend explaining specifics, such as implant designs or fill. Visual tools have also been shown to overcome virtually any literacy or cultural barriers that a patient may display (23). The use of older-generation silicone implants as educational tools can be invaluable when discussing the important changes that have occurred in implant technology over the last 45 years (24,1). The 1992 FDA moratorium on silicone breast implants generated a cohort of women who still maintain a preconceived notion on the safety of breast implants to this day (25). A great deal of misunderstanding can be eliminated when patients are given the opportunity to see and feel the older devices and compare them to the latest generation of saline, round, and form-stable gel devices. Women seeking breast augmentation are increasingly aware of the many implant choices available to them. Providing the patient the opportunity to hold an optimally filled saline device, a round gel, and a shaped form-stable, highly cohesive gel implant may be far more informative than merely describing the differences in shape, shell, and fill. Patients hold on to much more information when it is presented repeatedly, and combining educational modalities has been shown to enhance both written and verbal communication. Most important, patients can be educated to the benefits and trade-offs of each device that they may be considering. In a study designed to evaluate a patient’s acceptance of softer or firmer implants, patients were given the opportunity to observe round or shaped saline implants filled to optimal volume. This hands-on demonstration was combined with scripted information regarding implant fill issues and their possible effect on the tissues over time. Patients were then allowed to select a device based not only on their sense of feel, but also on the knowledge of potential outcomes of that decision. Given the choice of implant, along with information describing the possible long-term consequences of each device, the majority of patients in the study chose the optimally filled implants, despite their firmer feel (26). Patients must eventually decide on the fill and shape of their implant and should be informed of their options as well as the trade-offs of each choice. Utilizing actual implants as an educational tool creates a more engaged and informed patient.