Breast Augmentation Roundtable
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Breast Augmentation Roundtable
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Breast Augmentation Roundtable[GENERAL: ORIGINAL ARTICLES: COSMETIC] Adams, William P. Jr M.D.; Teitelbaum, Steven M.D.; Bengtson, Bradley P. M.D.; Jewell, Mark L. M.D.; Tebbetts, John M.D.; Spear, Scott M.D. Date of roundtable September 25, 2005; accepted for publication March 20, 2006. William P. Adams, Jr., M.D.; 2801 Lemmon Avenue West, Suite 300; Dallas, Texas 75204; prs@dr-adams.com This roundtable was conducted live at the American Society of Plastic Surgeons meeting in Chicago, Illinois, in 2005. Dr. Spear was not present for the roundtable, and his comments were formulated and added after the completion of the roundtable. For this reason, his comments have been placed in italics. Adams: On behalf of my co-editor for this supplement, Dr. Spear, Plastic and Reconstructive Surgery, and myself, we would like to welcome each of you and thank you for your participation. All of you were selected because this is a roundtable on reoperations in breast augmentation. This is thought to be a significant problem currently in breast augmentation, and you all have experience and insight into potential solutions. As far as the rules of this roundtable, they are written down in front of you. Basically, there is not going to be any content added post-roundtable other than grammar. There are five questions listed at the bottom. Each question will be discussed for a total of 12.5 minutes. The initial question response, which each of you will have time to respond to, will be 1.5 minutes, and the first participant to respond will be rotated. We will have an open discussion for 5 minutes or up to the 12.5-minute time limit, which Dr. Teitelbaum will facilitate. Any questions? I'd like to introduce Steve Teitelbaum, who is going to moderate this. Steve, I'll turn it over to you. QUESTION 1 Teitelbaum: I'll start with my left and we will just go around taking the first question. We'll start with you, Brad. Are reoperations in breast augmentation a problem? Bengtson: Nationwide and internationally, I believe that they are. A significant part of it is that each surgeon really desires to get the best result possible, to use the best implant that they deem is out and available to them, and to decrease uncorrectable deformities and problems in the future. I think they are a problem, and I think our goal should be to do everything we can to limit reoperations in the future. Jewell: I agree. I think a reoperation problem exists. It's a quality marker, and I think we need to approach this in a fashion to help define why reoperations are occurring and what we can do to improve outcomes for patients. We need to ask and answer the question, What are we doing to prevent implants from giving us the outcome that we believe they are capable of? What decisions are we making that are wrong, that predictably produce a reoperative scenario, whether it's implant malposition, stretch deformity, things of this nature? Granted, we can't control the biologic response to an implant or the healing or scarring, but we certainly can control the decisions we make on the front end, which should lower the reoperation rate. Tebbetts: Reoperations, in my opinion, are the number one problem for breast augmentation patients. Any reoperation subjects the patient to risks and costs that she would not have encountered had that reoperation not been necessary. A two-and-a-half decade history of 15 to 20 percent reoperation rates within just 3 years in sequential [premarket approval (PMA)] studies is difficult, to say the least, to explain to the public, especially considering that this is a totally medically unnecessary operation. This unenviable track record sends a clear public message that the processes we use for surgeon education, patient education, clinical evaluation, and decision making are flawed and ineffective. Adams: I would agree with other roundtable participants, what they've alluded to. If you look at the best data that we have collectively from consecutive PMA studies that would indicate reoperation rates of 15 to 20 percent, which I think are excessive, there are good data to support that much lower reoperation rates are attainable. Spear: Reoperations are a problem, but the problem needs some explanation. To begin with, there is a difference between reoperations and revisions. Reoperations might encompass any event that transpires in the vicinity of the patient's breast augmentation. This might include breast biopsies, scar revisions, change of implant size, subsequent mastopexy, and so on. So before looking at the problem of reoperation, it is important to clear up the ambiguity among the reasons for reoperation, some of which are out of the control of the surgeon and the patient, some of which are naturally occurring events, some of which are implant-related problems, and some of which are surgery-related problems. So while it is an appropriate goal to reduce the frequency of reoperations, the reoperations we really want to reduce are the reoperations that are revisions because of problems such as capsular contracture, implant malposition, infection, and extrusion. While it might be desirable to eliminate reoperations because of the patient's desire for a larger or smaller implant, many of those issues are less surgical issues and more whether or not the surgeon is willing to let the patient electively adjust her result later. It is interesting that when reoperations are looked at in prospective blinded trials that include any and all events after breast augmentation surgery, the numbers tend to be fairly consistent at 15 percent to 20 percent at 3 years in several studies, all of which were initiated after 1995. Yet when you ask surgeons what their reoperation rate is, very few will admit to a reoperation rate higher than 5 percent. It is important, therefore, to remember that multicenter, controlled studies probably provide more accurate information than individual surgeons' reporting of their events, no matter how well intended. In summary, then, while it is a desirable goal to reduce the frequency of revisions or reoperations after breast augmentation, the more important goal is to reduce the frequency of revisions because of unsatisfactory results. Teitelbaum: Does anyone else have any comments on what others have said in this discussion so far? Jewell: I think that the reoperation rate can be lowered. It's no different from Jimmy Doolittle getting a B-25 to take off from the deck of a carrier; it's a process, it's a project, it's a mindset, and it's important that we do this. Tebbetts: And not only can they be lowered, but there is a clear body of peer-reviewed and published data that proves that they can be lowered and goes further to specify exactly how they can be lowered. Teitelbaum: Can anybody comment more about the specific reasons that reoperations should be reduced? Dr. Tebbetts spoke about the risks to the health of the patient and the costs to the patient. Are there other reasons that you can mention, any of you? Why is it important to reduce it? We know about patient health and safety and costs. Are there any other reasons anybody can comment on? Jewell: Prevent irreversible changes and damage to tissue. Bengtson: Pain, deformities, decreased sensation, patient dissatisfaction. Tebbetts: Those all come under the categories of risk, and certainly all those things can happen. Adams: I think that certainly, ultimately, we are all here to deliver the best optimal care to these patients, and I think that minimizing reoperation rates is going to serve that purpose best. Other things include litigation issues. As patients have more and more reoperations, the chance for litigation is higher, and that's another reason to consider what we are talking about. Bengtson: The reoperation patient, particularly if it's not my patient, is one of the most difficult patients to deal with, because they come to you for another opinion and we have the option of either not seeing them or just not seeing them in consultation or offering anything or choosing not to operate on them. But generally they come with extremely high expectations. They want you to fix the problem, and they typically have not been adequately educated previously. Typically, some major principles at the time of the first breast augmentation have been violated and have produced, a lot of times, some problems that are just not correctable. Adams: The other thing that struck me when we were talking is that in a primary augmentation patient, everything is better in that patient. The tissues are better, and the psychological well-being of the patient is better. So, certainly, the fewer reoperations we have to do, the better it's going to be for the patient, the surgeon, everybody involved. Spear: No question that with each subsequent operation on a patient, the risk increases and the likelihood of success decreases. For that reason, it is certainly desirable to reduce the frequency of reoperations as much as possible. Ideally, each patient should only need one operation, but on the other hand, the longer these patients are followed, the more likely there will be a reoperation for one reason or another. Teitelbaum: Does anyone have any comment about the rate of reoperations and how that is perceived by the [Food and Drug Administration (FDA)] and by women advocacy groups and the media? Tebbetts: I think that's a very simple question. Ask yourself. If you put yourself in the patient's place, or if it was your wife, or if you were an advocate, how do you explain a 20 percent 3-year reoperation rate for a totally medically unnecessary operation? I can't fathom how you'd explain that. Jewell: Yes. The implication is, we either aren't getting it right or haven't figured it out. Something's wrong here. For, as John said, a medically unnecessary, elective operation in healthy patients with good tissue, we should be able to figure it out and deliver a consistency in outcomes. I mean, this is a manufacturing concept. The Harvard Business Review article that I sent you that Steven Spear talks about is Toyota's concept of manufacturing. How do we learn as we do to get better? How do we make improvements versus making the same mistake? John Tebbetts and I share this quote by Einstein that insanity is doing the same thing time and time again and expecting different outcomes. Tebbetts: Further, I can just imagine any of us sitting in a [morbidity and mortality] conference when we were general surgery residents and trying to explain to any faculty member this kind of reoperation rate for a totally elective procedure. Adams: Steve, you asked specifically about the FDA. One thing I do remember from attending the last silicone implant PMA hearings in April of 2004 is that the number one term that you heard at that hearing was implant rupture, but the second thing was reoperation. That was something the FDA and the breast implant women's advocacy groups consistently mentioned. So it's clearly a major issue raised by those groups. Spear: I would state that reoperations were one of the many things that women's advocacy groups and the media were inclined to use as a weapon against the implant manufacturers and plastic surgeons. For that reason, they were quite prone to lump together all the various causes of reoperation and assign them the same level of complicity in terms of danger or risk. Reoperations for such things as a staged mastopexy or a breast biopsy are a totally different matter than a reoperation because of capsular contracture or implant malposition or implant rupture. So, for those who are opposed to breast implants on any basis, it was convenient to use the biggest number possible for reoperations. In my opinion, although it is desirable to lower the reoperation rate, this has become as much a political issue as a medical one. Teitelbaum: One last question on this issue before we move to topic 2. I've heard well-known plastic surgeons at the podium at national meetings say that since this is an elective operation to start with and was done for unclear medical reasons in the beginning, it's just like redecorating your living room. It's justifiable to have a high reoperation rate because it's all about patient request. What do you say to that person? Jewell: I think that we should be able to get this right. It's an operation that delivers value to patients--positive psychological outcomes with regard to quality of life and body image. We should be able to deliver this operation in a way that's safe and predictable. Tebbetts: Well, patients' wishes are directly affected by the level of education that every patient has. Just because a patient wants something doesn't mean in any sense that it's medically reasonable to deliver that. So to me that is a completely illogical and lame excuse. QUESTION 2 Teitelbaum: We need to move on, but we may revisit this later if there is time. Question 2: Dr. Jewell, have you changed your position on reoperations from years past, and why? Jewell: I have, yes. With the ability to put insight into the process, to control each step of the process, reoperation rates can be improved, versus doing it the way that it always has been done, accepting poor outcomes, dissatisfied patients, and reoperation. What I'm saying is I think my position certainly has done a dramatic change since I took a process-oriented approach to this and realized, from years of experience, that by making good decisions on the front end, problems were prevented from occurring later. Tebbetts: I certainly agree with Dr. Jewell, and I would add that my opinions about reoperations changed somewhere after the first decade that I'd been in practice. Until that time, I really didn't realize, based on my resident education and my early surgical experience, that reoperations are largely totally preventable by logical processes to which Dr. Jewell alluded. Once we know that a process exists, and once we have solid scientific data that are peer-reviewed in this Journal and that show us that there are ways to do this, then certainly I have problems saying that it can't be done. So yes, my opinions have changed. Teitelbaum: Dr. Adams, have your opinions changed? Adams: I think my opinions have changed in the regard that I've been in practice 10 years, and when I first started in practice I don't think I was educated enough that reoperations were a problem and that there was an answer to that issue. Through good mentorship, I think, I've learned, first of all, that reoperations are a problem and that there are good methods and data out there to lower that rate. Now, in the past 5 years, I have implemented the processes and seen that it's really possible to do in your practice. There has definitely been an evolution, but it's been more at my end, of educating myself to show that there is a method that works. Bengtson: I think that surgeons, including myself, previously tend to overestimate the number of surgeries they perform. They tend to overestimate the quality of the results, and they tend to underestimate the complications and reoperations. So what really changed for me is when I actually started documenting and tracking things very specifically, not only with the measurements and changes that occurred in the breast over time but also very specifically tracking the patients and getting very, very good follow-up and being brutally honest with myself, including some accountability with my partners. That really has changed things a lot, because for reasons that I am sure we are going to get into, for reoperations, I think we may vary a little bit on this with the people here, but I think it's important to look at what specifically we are reoperating for. If it's an elective reoperation, and the patient is desiring an implant change, I think that's a failure in education, in the preoperative planning, in the measurements, and all that can be done up front, from the surgeon's standpoint. If it's a technical complication or whatever, I think we can learn from that and decrease our reoperations over time, so that the only things that are left are things that really we can't control, ultimately. We can do as much as we can to decrease capsular contraction, that sort of thing, but ultimately there is going to be a distillation of things down to, it is hoped, a very low percentage, in my practice probably less than 1 percent, of complications that truly are medically necessary that we need to correct. Spear: I must admit that I have thought about the issue of reoperations frequently over the last several years. Although I probably do not consider it as much an issue as some of the other panelists do, I have been inclined to rethink my approach to revision surgery and reoperations. In light of the thoughts of my fellow panelists, as well as some introspective thinking, I have tried to be somewhat more conservative and cautious in agreeing to perform reoperations on patients where the risk/benefit ratio was less inviting. For example, adjusting one or the other inframammary folds by some small amount to improve symmetry is something that I would have been quite willing to do several years ago, but am now less willing to do. Similarly, for mild degrees of capsular contracture, where one breast is a little firmer than the other, this is something where I would probably be somewhat less willing to reoperate today as compared with several years ago. Perhaps the most important area where I have learned to be more cautious in terms of reoperation is on the issue of symmetry. I have been truly impressed that breast asymmetry is a natural condition that exists in at least 80 percent to 90 percent of women. While breast augmentation can enlarge both breasts and improve the appearance of the patient, there is certainly no guarantee or even likelihood that the asymmetry will be corrected. I now tell all patients--in fact, I will guarantee them--that their breast asymmetry will not be solved by breast augmentation, although it might be improved in some cases. Just as likely or more likely, the degree of asymmetry may actually be magnified by the presence of the implants. In general, although I do not perceive reoperation as being as serious an issue as my fellow panelists do, I have nevertheless tried to reduce my frequency of reoperation, not just in my patients but in any patient who comes to me, because of the increased risk of reoperation as well as the decreased likelihood of success in terms of whatever the presenting problem is. Teitelbaum: Any comments? Jewell: A few more comments. Unfortunately, plastic surgery does have a culture of reoperation, from our reconstructive heritage. With that in mind, that mindset needs to be changed in terms of the aesthetic procedures. We should be able to get it right. We should be able to do lipoplasty right the first time around, or a breast reduction, or other procedures. I agree with Brad that we need to define better, each of us, why we are reoperating and what the situations are. All of us in this roundtable have totally transparent data with [institutional review board] oversight that demonstrate the approaches that we use here, as opposed to anything otherwise. Tebbetts: I think that Dr. Bengtson alluded to the accountability factor, and Dr. Jewell mentions the fact that I think everyone at this table is involved in PMA studies. That, in fact, as Dr. Jewell said, makes our data totally transparent, and I think the experience of being an investigator in a PMA study and having clinical review organizations come in and review your data on a regular basis is quite enlightening. It's almost brow-beating for me. Jewell: Not to mention the FDA. |
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