SILICONE GEL BREAST IMPLANTS

Breast Augmentation Roundtable

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?

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