SILICONE GEL BREAST IMPLANTS

Breast Augmentation Roundtable

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?

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