Chapter 17 Managing Problems and Patient and FDA Concerns
During the United States Food and Drug Administration (FDA) Advisory Panel hearings on October 14 and 15, 2003,1 the FDA panel members and patient advocate organization representatives voiced concerns about four specific areas regarding breast augmentation and breast implant devices:
Four concerns and the rates of reoperation that accompany primary breast augmentation in the augmentation core studies (averaging 20% within just 3 years) have remained largely unchanged for more than a decade,2,3 are independent of the specific type of breast implant, and largely focus on surgeon related issues more than device related issues
These four concerns and the rates of reoperation that accompany primary breast augmentation in the augmentation core studies (averaging 20% within just 3 years) have remained largely unchanged for more than a decade,2,3 are independent of the specific type of breast implant, and largely focus on surgeon related issues more than device related issues. Comparing reoperation rates and panel concerns from the 1990 FDA Advisory Panel hearings to the 2000 and 2003 reoperation rates and concerns reveals that while implant devices may have changed (e.g. saline versus silicone), overall reoperation rates for primary augmentation have not changed appreciably. Understandably, scientists on the panel and patient advocacy representatives question why devices, reoperation rates, and outcomes have not improved substantially over the past decade. Interestingly, when FDA Advisory Panel members questioned surgeons and manufacturer representatives about management of specific clinical entities that concerned the panel, clearly defined management solutions were not readily available. Testimony during the October 2003 panel hearings clearly defined a need for decision and management algorithms for clinical entities that concerned the FDA panel members.
For decades, the world’s most successful businesses have understood and implemented the concept of “best practices”—“best” ways to perform business processes, derived from processes that have proved effective in use4
For decades, the world’s most successful businesses have understood and implemented the concept of “best practices”—“best” ways to perform business processes, derived from processes that have proved effective in use.4 A “best practice” does not necessarily mean that the process is literally “best”; instead, it suggests that a business practice or process “solution” is a method that has been implemented and has delivered consistently positive results. A wide range of medical specialties are currently deriving best practices for specific clinical situations using evidence based medicine principles integrated with process engineering principles that define proved processes and best practices.
This chapter, derived from a paper published in the October 2004 issue of Plastic and Reconstructive Surgery,5 presents decision and management algorithms that have been implemented for over 5 years in a busy augmentation practice and further expanded and refined by a group of surgeons with a wide range of experience and expertise. The author is grateful to each of the coauthors of this paper for their effort and time to define these important algorithms, and to the editor of the journal for permission to reprint them in this chapter.
A Need for “Best Practices”
More than 12 years ago, as we (John B. Tebbetts, Terrye Tebbetts—J.B.T., T.T.) focused on expanding and refining our patient education and informed consent practices,6 we adopted a “best practices” approach to help us and our personnel address specific clinical issues or problems. Problems or situations that arise rarely can often be the most challenging for patients, surgeons, and surgeons’ personnel, because patient interaction, management, and clinical “solutions” are less defined compared to everyday clinical situations and issues. We realized that when faced with an issue or a difficult clinical situation or problem, if we had carefully prospectively defined and documented a process of addressing and managing the problem, management was much easier, more refined, less costly, and more comfortable to us, our patients, and their families. Predefined management templates (decision and management algorithms) also allow surgeons to focus on more sophisticated concerns and innovative solutions instead of having to rethink an entire process each time a problem occurs.
Patient Education and Informed Consent
According to Mark Gorney, M.D., “It is the prerogative of the patient and not the physician to determine the direction in which it is believed his or her best interests lie”,7 emphasizing that informed consent law mandates that patients be involved in the decision making process
When a clinical situation or problem arises postoperatively, the more a patient knows from preoperative education about the problem, how it will be handled, who is responsible for costs, and the chances for correction, the more comfortably the patient can face the challenges. Preoperative informed consent materials and documents addressing the most common potential postoperative problems are available online from a previous publication,6 and are also included in the Resources folder on the DVDs that accompany this book. When a reoperation may be necessary, patients are often more stressed and face additional costs and risks compared to the primary operation. Before undertaking any reoperation procedure, detailed information and informed consent documentation are arguably more critical and more challenging compared to the primary operation. Detailed decision and management algorithms—which contain essential summary information of potential benefits and risks to help clarify the realistic choices or alternatives, and contain spaces for the patient to document her understanding and acceptance of choices at each decision making stage—are invaluable to assure optimal informed consent and guarantee the patient’s involvement in the decision making process. According to Mark Gorney, M.D., “It is the prerogative of the patient and not the physician to determine the direction in which it is believed his or her best interests lie”,7 emphasizing that informed consent law mandates that patients be involved in the decision making process. An integrated document that defines alternatives, provides potential risk and benefit information, and documents the patient’s choices and decisions helps surgeons assure optimal informed consent before a reoperation. More importantly, the documents can sometimes prevent unnecessary reoperations such as implant size exchange by providing patients more definitive information about the risks and tradeoffs they may incur. By demanding that the patient accept responsibility for her decisions, optimal informed consent documents sometimes encourage patients to reconsider their requests and decisions.