SILICONE GEL BREAST IMPLANTS

Breast Augmentation Roundtable

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 whtever 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.

QUESTION 3

Teitelbaum: I am going to move on to the third question, and this will go to you, Dr. Tebbetts. What do you say to people who say that reoperations are not a problem?

Tebbetts: If anyone thinks that reoperation in breast augmentation is not a problem, I suggest that they ask any patient who has had a reoperation, or who requires a reoperation, if she thinks that reoperation is a problem. Further, I think that for surgeons who really think that reoperations are not a problem, I respectfully suggest that all surgeons' reoperation rates be documented in a registry that is transparent to patients and to patient advocate groups. With transparency and surgeon accountability, perhaps patients and patient advocates might change the perspective of surgeons who don't see reoperations as a problem.

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