Redefining Reoperations

THE PROBLEM The term “reoperations” has historically not been part of the risk analysis of breast augmentation. It is not evident in published clinical reports in the plastic surgery literature before 1998, and it was not listed in the earlier package inserts distributed with breast implants. One must assume that the U.S. Food and Drug Administration developed this category to most completely capture any event that occurred to the breast of a woman after breast implant insertion in the core breast implant studies. The standard complications of breast augmentation were also tallied. The problem with listing “reoperations” along with other standard complications is the implication that reoperations are a subset of complications. A complication may result in a reoperation but a reoperation is not necessarily a complication. They are not identical. Reoperations are rather a collection of events stemming from widely different causes and vary greatly in significance. The current method of collecting disparate events and labeling them all as reoperations is not only confusing but misses the opportunity to more closely link specific complications with revisions. The current core study data list reoperations and then the causes for those reoperations. It would be far better to know whether one of the listed known complications resulted in revisional surgery and thus what the true complication and resulting associated revision rate actually is. Lumping together all interventions after breast implant surgery implies that they are of equal significance and of similar origin, which they are not. A SOLUTION If the term “reoperations” is to continue to be used and listed as a separate category, I propose that the various types of reoperation be broken down into several categories that may or may not involve the breast implant: Unrelated events that occur commonly in women without implants: Breast biopsy Nipple procedure Lumpectomy Mastectomy Other Revisions or interventions after implant surgery that may occur following any breast (and even nonbreast) operation: Drainage/aspiration of hematoma Drainage/aspiration of seroma Drainage/aspiration of abscess Injection of scar Scar revision Wound repair Other Elective revisions or interventions following implant surgery that are at the patient’s discretion and are more cosmetic in nature: Size/style change Correction of minor malposition (<1 cm) Correction of minor asymmetry Correction of rippling Correction of palpability Correction of nipple ptosis Elective implant removal Other Revisions or interventions for significant cosmetic problems associated with the implant: Correction of major malposition (>1 cm) Correction of major (i.e., disfiguring) asymmetry Correction of significant capsular contracture (Baker grade III and IV) Correction of rotational deformities Removal with replacement of ruptured implant Removal of implant without replacement for any of the above Revision or intervention for symptomatic physical problems associated with the device: Correction of capsular contracture Removal with or without replacement of ruptured implant Correction of physically symptomatic malposition Removal without replacement for any of the above Although I agree that thoughtful and thorough patient education, proper patient selection, excellent operative technique, and astute professional postoperative management, both short and long term, will reduce the frequency of complications and revisions, they have no influence on extraneous events such as those listed above under category 1, all of which are lumped together as reoperations. Some surgeons may choose to discourage their patients from making discretionary or elective changes after their cosmetic breast augmentation (such as those listed in category 3), and although it is true that each revision or intervention carries with it new and perhaps increased risks, not allowing a patient to choose a revision has the potential of taking away the right to make an informed choice from the same patient that we argue should have the right to choose an implant in the first place. The decision to undergo primary breast augmentation is clearly a more momentous decision than asking, for example, to increase the implant size by 60 cc, switch from saline to silicone, change from a round to a shaped device, correct breast ptosis, or improve an asymmetry that the patient finds embarrassing. It also glosses over the highly elective nature of breast augmentation surgery in the first place, where the decision to have an implant is no more rational than to remove it a few years or many years later for reasons of taste, lifestyle, weight gain, and health, among others. I can personally think of many patients who electively chose to have their implants removed or replaced because of weight gain or loss, change in career, change in personal relationships, or some other factor. By defining reoperation as a complication, there could be a tendency for surgeons to game the system by refusing to operate on women with more challenging and arguably more deserving problems. Similarly, some women might be denied legitimate revisions or reasonable discretionary changes simply to keep a given surgeon’s reoperation rate artificially low. In summary, by listing reoperations as complications, widely different events are lumped together, implying that they are similar in nature and significance. Not only is this unnecessarily confusing to patients, it detracts from the more important message of how often the real and more significant risks such as capsular contracture and rupture result in a revision that is truly related to the device. I recommend abandoning the term “reoperation” and substituting instead the term “revision.” Complications should be listed, and those complications also resulting in an intervention, revision, or hospitalization should be listed as a subset of the specific complication. It is hoped that by properly and more accurately listing complications and revisions we can better support the message that improving informed consent, refining methods of patient selection, upgrading surgical technique, and standardizing postoperative care will lower the frequency of complications and associated revisions.