Breast Implants: Rolling Up Our Sleeves

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I was privileged to be one of those representing the specialty of plastic surgery at the recent Food and Drug Administration (FDA) advisory panel hearings on silicone gel-filled breast implants. I have attended some of the past hearings as well, and found many similarities between the proceedings then and now—but also some important differences.
There was still the drama, with testimony from anguished women who believe that breast implants are responsible for their particular health problems and, on the other side, women expressing gratitude that implants have helped them to feel “whole” again or made them happier and more confident in their daily lives. The ratio of consumers pro and con was about equal this time, unlike previous hearings in which those holding negative views seemed more numerous and vocal.
And there was still the junk science—the anecdotal “evidence” and the erroneous conclusions drawn from it. These sensational claims, however, seem to have lost much of their headline-grabbing appeal, thanks to 13 additional years of solid scientific data that support the safety of breast implants.
One of the things that struck me about this hearing, compared to others I have attended, was the significant number of individual plastic surgeons who provided testimony. In previous years, the participation of plastic surgeons was largely limited to the official representatives of the major national societies, the American Society for Aesthetic Plastic Surgery (ASAPS) and the American Society of Plastic Surgeons (ASPS). It was heartening that many more surgeons this time felt that they wanted to publicly support the right of patients to choose their preferred type of implant. The testimony of these individual surgeons helped to provide the panel with a more complete view of the issues involved in patient selection, clinical care, and patient satisfaction.
At the time of this writing, the FDA has not yet announced whether it will follow the panel's recommendation to approve at least one manufacturer's silicone gel-filled implants for general use. Regardless of the final outcome of these proceedings, the important contribution of the ASPS/ASAPS Breast Implant Task Force should not be overlooked. This cooperative effort between the two major plastic surgery organizations resulted in a well-orchestrated presentation of the viewpoint of organized plastic surgery. I felt very proud of the focus on patient safety that was maintained throughout our collective testimony.
If silicone gel-filled implants again become available for general use, it is critical that we maintain the positive momentum begun by the joint Task Force as we continue our efforts to educate both patients and surgeons about these devices. There was a clear imperative from the FDA panel to raise the bar for physician education on implant techniques. Likewise, there was reaffirmation that communication with patients concerning the risks and benefits of these devices must be thorough and effective. Finally, a continued commitment to gathering data is essential so that we can give women a more accurate estimate of the longevity of these devices. As plastic surgeons we now must roll up our sleeves to ensure that we are prepared to fulfill these responsibilities with all the expert knowledge and experience at our disposal.
When it comes to the issues of patient safety and patient education, it's time now to expand our circle of partners. We've seen encouraging results from the joint efforts of ASAPS and ASPS—results that ultimately should impact positively on our patients. If we are able to move forward with the availability of gel devices for breast augmentation, we have a fresh opportunity to chart new territory with regard to patient and public education. We must reach out to women, both those who share our views and those who don't, in the process of developing educational tools that really work—tools that effectively communicate risk and benefit in terms that every woman can understand. We must also expand the scope and accuracy of information available to the general public so that the patients who arrive in our offices are more likely to have realistic ideas about their options.
The combination of well-prepared practitioners and well-educated patients will help to ensure that our future experience with silicone gel-filled breast implants meets everyone's best expectations
Article by
Chicago Plastic Surgeon