Reoperations or Revisions

During the U.S. Food and Drug Administration’s panel meetings on silicone gel breast implants in Gaithersburg, Maryland, in October of 2004 and April of 2005, much was made about the problem of reoperations. Those issues raised by the Administration’s staff, the advisory panel members, the press, various political activists, and even some plastic surgeons prompted this commentary. The problem of reoperations is far more complex and sophisticated than a simple statistic that can subsequently be easily manipulated by those with an agenda. To put this matter in context, let me begin by pointing out that many of the commonly cited data on reoperations were derived from prospective multicenter trials with more than 80 percent compliance. Data such as these have substantially more reliability and credibility than any individual’s reported experience, no matter how talented and credible that surgeon might be. Beyond that, as a multicenter prospective trial, the resulting data should be substantially more free of selection or other bias whereby high-risk or undesirable candidates might be excluded. Although it may be a very wise practice decision to exclude complex or difficult cases, that leaves unanswered the ethical question of denying elective surgery to individuals because they are at higher risk for a complication or reoperation. Similarly, in a multicenter prospective trial there would be less incentive for investigators to underreport the numbers of reoperations by simply refusing to do them in cases where there might be a reasonable option. I expect that to capture the largest population of possible problems, the Food and Drug Administration–sponsored implant studies purposely tracked not revisions but reoperations. Hence breast biopsies, scar revisions, seroma drainage, size changes, mastopexies, capsulectomies for capsular contracture, and implant replacements for rupture were all lumped together as if they all represented the same thing. It has always been clear to me that this large universe of reoperations represented not one but several very diverse and unrelated families of events. The first group would comprise events that could be described as most likely unrelated to the breast implants or the specific type of operation, such as augmentation mammaplasty. This group is best represented by reoperations for breast biopsy or scar revision. Certainly having a breast implant or well-performed breast augmentation does not make a woman immune to those possibilities. On the opposite extreme are events that are at least in some way probably related to the device, and those events are most clearly represented by reoperation for implant rupture (leakage) and capsular contracture. Even for those events, one could argue that surgical technique as well as the device itself might also have some bearing on their frequency. A third category might be termed cosmetic and is best represented by an elective reoperation for size change and mastopexy. These are cosmetic issues where reoperation would seem to be highly discretionary and perhaps avoidable by either simply saying “No” or exercising better judgment in picking the “right” size implant and knowing for certain who would need or want a mastopexy after an augmentation. But what about the patient who is a borderline case for mastopexy whose mastopexy is deferred in case it turns out be unnecessary? A fourth group of reoperations would be for true early complications and would include surgery for things such as bleeding, infection, seroma, skin necrosis, wound dehiscence, and pneumothorax. All of those problems are pretty clearly related to breast surgery or the breast surgeon and are not specific to breast augmentation or even breast implants. We would rightfully hope the vast majority of these complications would be avoidable in competent hands. Finally, there are later complications that might in some cases be properly associated with surgical technique, such as implant malposition, including bottoming out and symmastia. The lumping together of these diverse families of events has always troubled me, because some have a tendency to imply that they are all similar complications or that they are equally bad, equally undesirable, or equally avoidable. Personally, I would prefer that we not just look at them lumped together but be willing to split them as well. This discussion is not an excuse for reoperations or revisions. There is no valid argument against the desirability of reducing the frequency of revisions. It is likely true that careful planning, better technique, better implants, better judgment, and learning how and when to say “No” to patients will all, in their own way, help to reduce the frequency of revisions. However, there are different sorts of revisions with varying significance and consequences. In the coming months, many of us are likely to be performing many more revisions or reoperations as we replace saline-filled breast implants with those filled with silicone gel, assuming they are approved by the Food and Drug Administration. In reviewing my own experience, I have found that some women request a switch to smaller implants as they get older or even choose to remove their implants if they have gained weight or simply grown tired of them. I believe that those sorts of revisions are certainly okay. Similarly, the onset or worsening of ptosis might justify a mastopexy later, and that is okay, too. There are certain clichés that have stood the test of time. One says that there are two types of surgeons: those who have been sued and those who will be. The same has been said about termites and homeowners. So while it may be highly laudable to seek to reduce the frequency of revisions in any operation that plastic surgeons perform, I would argue that there are one or more revisions out there waiting for each of us or our colleagues, sooner or later.