Reoperations as a Benchmark: The Rhetoric, the Logic, and the Patient

Editorials in this Journal have presented different perspectives of reoperation rates.1,2 One author states, “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.”1 In the same editorial, however, the author makes the following observations: “ 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.”1 My perspective is just the opposite: the essential ethical question is why any surgeon who prioritizes the patient would not decline to perform medically unnecessary, elective cosmetic surgery whenever any patient is at a higher risk of a complication or reoperation. With any medically unnecessary procedure, as recognized risks of complications and compromised outcomes become evident preoperatively, what is the logic of knowingly subjecting a patient to those increased risks when the procedure is not medically indicated? The author also states, “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.”1 In fact, every item the author lists does represent the same thing: a reoperation. Other than breast biopsies, the incidence of reoperation for every other condition the author lists relates directly to the surgeon’s decision and execution skills. In a more recent editorial,2 a different pair of authors directly challenge reoperation rates as a benchmark for surgeon performance and patient outcomes when they state, “In cosmetic surgery, the aesthetic success of a procedure is subjective, and thus the indications to revise that surgery for cosmetic reasons are also subjective.” That line of reasoning, in my opinion, is one of the primary reasons for excessively high reoperation rates in aesthetic surgery and particularly in breast augmentation—subjectivity instead of objectivity, and opinion instead of science. If surgeons accept the premises in the previous paragraph, science cannot exist in cosmetic surgery. Subjectivity and opinions seem to be inevitable in surgical forums, but subjectivity and opinion are not science. Science requires objectivity, not subjectivity. Rationalizing and prioritizing subjectivity over objectivity presents challenges in any area of medicine. The effect on patient outcomes when surgeons promote subjectivity and make excuses for reoperations is clearly documented in 15 to 25 percent reoperation rates in just 3 years following primary breast augmentation in premarket approval studies—a rate that has not changed over the past three decades. Although every other subspecialty in medicine has moved and continues to move to evidence-based decision processes and outcomes analysis, do plastic surgeons want to send the message to patients that we really do not prioritize objectivity, science, and evidence-based outcomes analysis? Increasing objectivity in cosmetic surgery requires that cosmetic surgeons change patterns of decision-making and practice and work toward the following: Defining outcomes criteria for aesthetic results that are objective and can be subjected to scientific analysis. Delivering patient satisfaction studies that are more than a snapshot in time postoperatively, by including questions that ask not only whether the patient is satisfied, but also why the patient is satisfied, and on what knowledge base or patient education is the patient’s opinion based? Analyzing the processes that define outcomes, not just opining about visual photographic results or preferred surgical techniques. Insisting that professional presentations and peer-reviewed and published articles in professional journals require presenters and authors to specifically state whether the content is opinion based or science based, and if science based, on what data. If the patient receives an optimal outcome from the primary operation, the necessity of a reoperation logically declines. Single-example exceptions to this logic do not change the reality that the better a surgeon performs, the less risk of reoperation, even acknowledging factors that are beyond surgeon and patient control. In the conclusion to their editorial,2 the authors state, “The existence of an indication for secondary surgery only translates to a ‘reoperation’ if the patient undergoes surgery. Reoperation rates may be artificially high or low based on a surgeon’s assessment of the result, practice policy, and personal philosophy. Therefore, comparing reoperation rates for cosmetic procedures is not a valid analysis of the safety or efficacy of an operation, device, or surgeon.” The last sentence of the paragraph does not logically derive from the previous sentences. Indications for secondary surgery should be highly defined, and subjectivity in assessment or indications is part of the problem, not a valid excuse for higher reoperation rates. If a surgeon’s patient education, assessment of the aesthetic result, practice policies, personal philosophy, and surgical skills result in higher reoperation rates, should the surgeon not adjust the deficient processes for the benefit of the patient rather than make excuses for them? Rationalizing that a minor revision should not be categorized as a reoperation challenges logic. If surgeons are willing to rationalize “small” reoperations, history suggests that in principle, we are certainly willing to rationalize almost any reoperation instead of preventing it. Reoperations In Breast Augmentation The history of U.S. Food and Drug Administration premarket approval data is the only current, independently monitored, and most scientifically valid track record that documents patient outcomes in breast augmentation. Other data, published or unpublished, may be more appealing to breast implant manufacturers and others, for various reasons, but U.S. Food and Drug Administration premarket approval data, though imperfect, remain the standard. Overall reoperation rates in saline premarket approval studies for Mentor and Inamed were 13 percent at 3 years and 26 percent at 5 years, respectively.3 In the premarket approval studies for conventional silicone gel implants, overall reoperation rates for the same manufacturers were 15.4 and 23.5 percent, respectively, at 3-year follow-up.4,5 For the latest generation of more form-stable devices, overall reoperation rates were 9.4 percent at 2-year follow-up for the Mentor CPG and 12.5 percent at 3 years for the Allergan Style 410.6,7 Device failure rates for these categories were 10.4 and 10 percent, respectively, at 7 years for saline; 0.5 percent and 2.7 percent, respectively, in the magnetic resonance imaging cohorts at 3 years for conventional gel; and 0 percent at 2 years and 0.7 percent at 3 years for the more form-stable devices.3–7 Capsular contracture rates at 3 years with saline implants averaged approximately 13 percent at 7 years with saline, 10 percent with conventional gel, and less than 1.4 percent at 2 to 3 years with more form-stable gels.3–5 These data strongly suggest that breast implant devices have improved with respect to device failure and capsular contracture, with conventional silicone better than saline and more form-stable silicone significantly better than either saline or conventional silicone. Average overall reoperation rates have decreased from as high as 26 percent at 5 years for saline3 to an average of 10 to 15 percent with conventional gels.4,5 However, although device performance improved immensely with the latest generation of more form-stable implants, overall reoperation rates did not, averaging 11 percent at 2 to 3 years.5,6 An obvious question is why overall reoperation rates remain above 10 percent at just 3 years for the same category of implants that showed a 10-fold decrease in device failure rates. Answering this question requires that surgeons and others do not attempt to make data appear anything other than what they are, and that they carefully and honestly examine causes of reoperations. The third most common cause of reoperation at 3 years after breast augmentation is implant size exchange. If surgeons attempt to recategorize reoperation rates and emphasize reoperations that result from complications, they conveniently ignore the third most common cause of reoperations. Size exchange is a patient education and surgeon decision process issue. Reoperations as a result of poor patient education—specifically, size exchange—subject patients to additional risks, costs, and potentially uncorrectable tissue compromises and deformities. Larger and/or more projecting implants unquestionably increase risks of permanent and uncorrectable tissue deformities, including skin and subcutaneous tissue thinning, visible rippling, and parenchymal atrophy. These reoperations, although not the result of a complication resulting in a revision, carry potential risks and costs that are as great as or greater than many complications that require reoperations. Although some surgeons, professional organizations, and breast implant manufacturers may attempt to dilute the importance of overall reoperation rates or emphasize only complication-related reoperations, the U.S. Food and Drug Administration, patient advocates, and informed patients are less likely to embrace potentially self-serving rationalizations. Peer-reviewed and published studies in this Journal define processes that definitively reduce overall reoperation rates and dramatically decrease postoperative morbidity and shorten patient recovery.8–17 Unfortunately, these processes are not currently a part of the public or surgeon educational curriculum by any breast implant manufacturer or professional organization. It is not that the processes are not defined and verified in peer-reviewed literature. The processes are simply not being implemented effectively. In the interests of patients, implementing proven processes is logically simpler and more likely effective compared with massaging data or rationalizing what is. The individual who can most definitively and credibly answer the question of the role and importance of reoperations is the patient. If overall reoperation rates do not matter and are not a valid means of comparing patient outcomes, perhaps surgeons should fully disclose this position to patients preoperatively. What should matter most to every surgeon is the patient. What matters to patients is their outcome. Patient outcomes are inevitably linked to recovery and reoperations. If the decision processes and surgical processes of their operation were optimal at the primary operation, no patient wants a reoperation, and few patients need a reoperation. A reoperation means time away from family, work, or pleasurable leisure. A reoperation means costs. A reoperation inherently subjects the patient to additional risks and unpredictability in addition to the risks and unpredictability of the primary operation. A reoperation to any experienced surgeon means a surgical endeavor in previously operated tissues, with less predictable positive outcomes. To argue otherwise challenges logic and prioritizing the patient. Beauty may be in the eye of the beholder, but a reoperation is not beautiful to any informed beholder patient who has experienced an untoward issue that requires reoperation, because a reoperation implies a less than optimal primary outcome, regardless of the cause, with additional risks, costs, and downtime. Sophistication, verifiability, and accountability are not about more sophisticated rationalizations. They are not about more excuses; instead, they are about painful self-assessment, commitment to improvement every day, and then not rationalizing but instead getting it right the first time. When a rationalization generates another operation that generates income for a surgeon, regardless of the argument, one must question the logic from a patient’s perspective. Patients should know from the outset, through comprehensive patient education and informed consent, the factors that a surgeon cannot control. They should also know the specific reasons for medically logical reoperations, who pays for any eventuality, and who makes the decisions about reoperations postoperatively. Challenging logic and rationalizing reoperation rates will undoubtedly continue in professional forums and publications, with authors taking contrasting positions even in the same article. Despite all of the hedging and statements of exceptions, the author cited in the first paragraph on the topic of reoperations got it right when he said: “There is no valid argument against the desirability of reducing the frequency of revisions.”1 The same is true of reoperations, regardless of the reasons. If patients are our priority, that statement is undoubtedly true. Three decades of 20 percent reoperation rates in just 3 years after breast augmentation in premarket approval studies is embarrassing. Continuing to rationalize excessively high reoperation rates is even more embarrassing. Patients benefit more from our focusing efforts on minimizing reoperations instead of rationalizing them. Our patients will appreciate fewer reoperations more than they will appreciate more rationalizations.