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]

During the U.S. Food and Drug Administration's advisory panel hearings on October 14 and 15, 2003, the panel members and patient advocate organization representatives voiced concerns about four specific areas regarding breast augmentation and breast implant devices: reoperation rates in primary breast augmentation; levels, depth, and methods of patient education and informed consent; modes, frequency, and management of silicone gel implant device failures, including management of silent ruptures; and methods of monitoring and managing symptoms or symptom complexes that may or may not be associated with connective tissue disease or other undefined symptom complexes

These four areas of concern and the rates of reoperation that accompany primary breast augmentation in the augmentation core studies (average rate of 20 percent within just 3 years) have remained largely unchanged for more than a decade.2,3 Reoperation rates in premarket approval studies since 1992 have remained high while devices have changed from silicone to saline and back to silicone. Consistently high reoperation rates using different devices over more than a decade raise interesting questions: (1) To what extent are reoperation rates primarily device related, or (2) to what extent do patient and surgeon decisions and surgical techniques influence reoperation rates? A comparison of reoperation rates and panel concerns from the 1990 Food and Drug Administration's advisory panel hearings to those from the 2000 and 2003 hearings 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 during the past decade. Interestingly, when panel members questioned surgeons and manufacturer representatives about the 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 advisory panel members.

For decades, the world's most successful businesses have understood and implemented the concept of best practices, or 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 the 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, by integrating individual clinical experience with the best available clinical evidence. This article presents decision and management algorithms that have been implemented for more 7 years in a busy augmentation practice and that have been further expanded and refined by a group of surgeons with a wide range of experience and expertise. Combined with a staged, repetitive system of patient education,5 the TEPID6 system (tissue characteristics of the envelope, parenchyma, and implant and the dimensions and fill distribution dynamics of the implant) for implant selection and pocket location based on quantifiable, individual patient tissue characteristics, and anatomic saline implants with fill volumes designed to minimize shell collapse and fold fatigue,7 these algorithms have been a major factor contributing to an overall reoperation rate of 3 percent in 1662 patients with up to 7 years of follow-up in peer-reviewed and published studies

A Need for Best Practices

More than 7 years ago, as we (Tebbetts and Tebbetts) focused on expanding and refining our patient education and informed consent practices,5 we adopted a best practices approach to help us and our personnel address specific clinical issues or problems. Problems or situations that rarely arise can often be the most challenging for patients, surgeons, and surgeons' personnel, because patient interaction, management, and clinical solutions are less defined compared with 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 for us, for our patients, and for their families. Having predefined management templates (decision and management algorithms) also allows the surgeon to focus on more sophisticated concerns and innovative solutions instead of having to rethink an entire process each time a problem occurs.

Decision and Management Algorithm Flowcharts

As a first step to developing a best practices approach to managing issues and problems, we developed decision and management algorithms for specific clinical problems or issues that we had encountered during the past two decades. Developing decision and management algorithms is a stimulating and challenging process. Despite the fact that there exist alternative approaches to every clinical problem or issue, a flowchart-documented, algorithmic approach demands a solution rather than a list of alternatives that stimulate endless debate. A decision algorithm flowchart is a visible template that depicts one process that has proved clinically useful, and it can be easily changed or adjusted when new facts or data become available. Graphic representation of thought processes, decisions, and actions stimulates alternative thinking about problems or issues. A graphic algorithm flowchart helps surgeons define the sequence of decisions and the logic of management alternatives. In addition, the process stimulates surgeons to reexamine sacrosanct answers and develop even better solutions.

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