SILICONE GEL BREAST IMPLANTS

Plastic and Reconstructive Surgery: Volume 114(5)October 2004pp 1252-1257 Decision and Management Algorithms to Address Patient and Food and Drug Administration Concerns Regarding Breast Augmentation and Implants [COSMETIC SECTION: COSMETIC]

When issues or problems occur, the patient usually speaks first with the surgeon's personnel. The information the patient receives in response to his or her problem, concern, or issue can have a critical effect on the patient's comfort and confidence as the surgeon and the surgeon's staff address the problem. Decision and management algorithms are invaluable in training personnel-not necessarily to deliver definitive answers but to develop a basic knowledge of how problems will be approached when they arise. Consistency in decision-making and management processes builds confidence in surgeons' personnel, and that confidence transmits directly to patients when they most need confidence to deal with issues and adversity.

Defined processes to manage issues and problems are most effective when patients are aware of how an issue or problem will be managed before the issue or problem arises. As we (Tebbetts and Tebbetts) implemented our decision and management algorithms, we learned that their value increased exponentially when we used them to help educate our patients preoperatively about how we would manage each issue or problem postoperatively, offering them management alternatives and an opportunity to help make sometimes difficult decisions.

Patient Education and Informed Consent

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.4 When a reoperation may be necessary, patients are often more stressed and face additional costs and risks compared with the primary operation. Before any reoperation procedure is undertaken, detailed information and informed consent documentation are arguably more critical and more challenging compared with those for the primary operation. Detailed decision and management algorithms that contain essential summary information about the potential benefits and risks help clarify the realistic choices or alternatives. They contain spaces for the patient to document his or her understanding and acceptance of choices at each decision-making stage, and they are invaluable in assuring optimal informed consent and guaranteeing 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, as the informed consent law mandates that patients be involved in the decision-making process.10 An integrated document that defines alternatives, provides information on potential risks and benefits, and documents the patient's choices and decisions helps the surgeon ensure optimal informed consent before a reoperation. More importantly, the documents can sometimes prevent unnecessary reoperations, such as implant size exchange operations, by providing patients with more definitive information about the risks and tradeoffs. By demanding that patients accept responsibility for their decisions, optimal informed consent documents sometimes encourage patients to reconsider their requests and decisions.

Practical Clinical Integration and Implementation

Currently in our practice (Tebbetts and Tebbetts), each decision and management algorithm is integrated with (a) information provided to the patient in preoperative patient education and informed consent documents and (b) more detailed information and alternatives contained in additional education and informed consent documents when an issue or problem occurs. After providing the patient with detailed information addressing a specific clinical situation or problem, a patient educator and the surgeon review the information with the patient in detail. After the surgeon discusses and answers the patient's questions, the patient then re-reads and signs the informed consent document and defines his or her choices on the decision and management flowchart to verify his or her understanding and acceptance of the information and the choices made.

Reality sometimes demands difficult choices, none of which may seem ideal. One of the most difficult challenges in managing issues and problems is defining choices-translating a myriad of grey areas, unknowns, questions, wishes, and fears into realistic alternatives from which a patient may choose. A second challenge is helping the patient understand that there is no perfect choice, not at the primary operation and certainly not at a reoperation for an issue or problem. There are only different sets of tradeoffs, benefits, risks, and costs for each alternative. A clearly defined approach to management of each issue or problem and a practical, efficient system to optimize patient education and informed consent are invaluable. On first review, decision and management algorithms may seem complex, but they are only as complex as required to define the alternatives available to the patient according to the informed consent law

Management and Decision Algorithm Flowcharts: Objectives and Logic

Each of the following flowcharts (Figs. 1 through 6) addresses a specific clinical problem or issue. They are not intended to be definitive. No best practice is ever definitive. Instead, each algorithm is a snapshot in time of a process that has proved clinically useful and effective-a template alternative that surgeons can examine, modify, individualize, and evolve according to surgeon and patient preferences and specific clinical situations. Each algorithm flowchart is a continuous work in progress that provides a basic set of alternatives from which to evolve better solutions.

Continue reading about whats happening with breast implants.

Contact us online or at 310.315.1121 for more information about Silicone Gel Breast Implants.