Implants in the News

Breast Augmentation Roundtable

Jewell: I also would like to commend John Tebbetts in this situation for writing his article with regard to outpoints, which is in a way saying to a patient, Time out. You've been through three capsulectomies, and you've had new implants each time. You have recurrent capsular contracture; either live with it or take them out. And end the whole process, versus the expectations of trying to get

Tebbetts: I'd like to briefly add to what Dr. Bengtson said about the educational process. Another concept that's very helpful, or at least it's been helpful to me, is, in the educational process, as we present options to patients, to the extent that we can remove all the grays, we do that. In other words, you either want this, this, or this. There are no in-betweens here. When you allow patients to manipulate you into an in-between, regardless of what that is, you cannot deliver, because it's undefined. So to the extent that we can define exactly what we can do and what we cannot do, and we tell the patient what we can do and what we cannot do, those are the only viable choices.

Teitelbaum: Dr. Bengtson, what is the role of the manufacturers in this process to improve patient outcomes?

Bengtson: I really struggled with this whole concept. John would be upset with me, I think, but I was watching The Price Is Right between surgeries, in our surgery lounge. Yeah, little Tebbetts pops up on my shoulder and says, You are not being efficient with your time. What are you doing there? But watching these commercials, 100 percent of the commercials were manufacturer-based commercials direct-marketing to the patient pharmaceuticals, or knee replacement, or hip replacement, those sorts of things. I may come down pretty strong on this, but I think that the role My dad told me one thing. He was an educator for a long, long time, both my parents were, and we were going through this discussion at the hospital. The hospital was basically trying to take over the practice of medicine, and I had this discussion with my dad, who had just retired from education, and he said, Brad, we have the same problems in education. The role of the school or the university is to facilitate the education that occurs between a teacher, a professor, and a student. And I told the hospital administrators that, that they were trying to do this hospital merger in town and that doctors were not really for it. So this whole discussion ensued, and I said, I think the hospital's role is to be a facilitator of the practice of medicine that occurs between a physician or a surgeon and a patient. I think the same is true for manufacturers. They can be a tremendous support. They can sponsor things, they can have very thorough Web sites with the information and everything like that, but I think their primary role should be to facilitate the best outcome possible with whatever device or drug that they have, to facilitate that surgeon-patient interaction and not get into the direct education of patients and that sort of thing.

Teitelbaum: Dr. Jewell, as you answer for us what you believe the role of the manufacturers could be, would you also discuss the role that the societies have, and how the two of them should be working or not working together?

Jewell: With regard to the role of the manufacturers, one is to keep a focus on improvements in these devices to minimize problems that still exist, with regard to an underfilled device, trickling, and things of this nature. Granted that most devices are made in ISO 9000-certified facilities, yet at the same time I think technologic advances can improve the quality of the devices. I think the aspect of a registry with transparent data in terms of how these devices perform is imperative, and it provides a benchmark of quality that surgeons and patients can understand and use to make decisions with regard to which devices are used. Concerning the role of the professional societies, at [The American Society for Aesthetic Plastic Surgery], we are an educational society, and it is hoped that we can meet Dr. Tebbetts' standards with regard to surgeon education and verification of knowledge. But I would say there needs to be sort of a separation between church and state. Too often issues regarding manufacturers relate to competition, and that, in many cases, interferes with education.

Tebbetts: This happens to be an area that I've had a lot of experience with over the years. I plan to be entirely candid, regardless of who may disagree or be offended by the following comments. First, from a very simple standpoint, breast implant manufacturers, like surgeons, should prioritize the patient in decision processes and actions, not just in their verbiage and marketing hype. Manufacturers have a responsibility to provide information that optimizes the use of their products. They, further, in my opinion, have an ethical responsibility to support surgeon education. The most effective way for manufacturers to positively impact reoperation rates is to support surgeon and patient education programs that focus on those seven priorities I listed earlier, and not purport to educate surgeons only in venues that are designed to primarily promote a company's products. While manufacturers have a responsibility to their stockholders to sell products, and they all have a right to hold venues to sell products to surgeons, I believe they also have a responsibility to patients to not only provide the best products possible but to contribute to and facilitate surgeon education using the approved processes that I discussed earlier. Manufacturers also have a responsibility to provide surgeons and patients with complete and honest information about their products, about outcomes data, and about explanted device retrieval data. Currently, manufacturers do not share some basic information about implant products that could possibly impact patient outcomes, claiming that that information is proprietary. Manufacturers reintroduce products as new when in reality products are simply recycled versions of previous products from the past two decades. Manufacturers copy each other's products and design products without input from experienced clinical surgeons who best understand how those implants interact with patients' tissues over time. Manufacturers often select surgeons to teach who they feel will most effectively promote their products and who are least likely to challenge colleagues in an educational venue. Management at high levels in breast manufacturers sometimes lacks the most basic knowledge of clinical information that directly impacts outcomes in breast augmentation. Some high-level managers and decision makers have not reviewed even the most basic scientific literature that documents processes that have positively impacted patient outcomes. The result is a large number of decisions that impact patient outcomes being based primarily on marketing concerns instead of basic clinical knowledge about augmentation. Most recently, manufacturers have virtually excluded expert surgeons and their own appointed medical directors from involvement in PMA study decisions that could directly impact patient outcomes. So, to summarize, manufacturers have a responsibility to their stockholders; they should educate about their products; they should support surgeon education that is not product-related; they should deliver information and make that information transparent when it affects patient outcomes; and finally, they should rely in their decision-making processes on the help of expert surgeons in this area.

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