The tissue-based preoperative planning allows the surgeon to get on base and prevents the patient from striking out on her first try. The High Five process is one of two published and peer-reviewed tissue-based systems in the literature and provides the simplest way to determine optimal fill volume for any given breast.³ Patients often come to the office wanting to look like a certain centerfold or bathing suit model or be a certain bra cup size, but through the educational process and tissue-based planning it is made very clear that it is “about their tissues.” Interestingly, the High Five process allows the surgeon to adjust the volume based on patient request, and in a separate publication, this author has found a significant increase of complications when volume is added abovethe High Five–recommended volume, particularly in high-risk patients [narrow (breast width �11.5), tight envelope (skin stretch �2)].¹⁰

Also cogent is the artist versus the engineer issue, and who should pick the breast implant size: the patient or the doctor. No doubt, much of plastic surgery is both art and science; however, art in itself is truly unstructured and without definable boundaries. The thought that instituting a process-oriented approach will obstruct the “skills of the artist” is a misconception. Realistically, the process will only serve to enhance one’s artistic qualities, as it defines the limits that the artistic only approach cannot clearly elucidate.

Formerly, the surgical technique was often the only part of a breast augmentation that many surgeons considered. Surgical advances have currently not only enhanced the actual surgical procedure but clearly defined the importance of the educational and tissue-based planning portions of the process, as these allow the surgeon to make nearly every decision before entering the operating room. This not only allows the surgeon to make better decisions than have historically been made in the operating room (particularly implant size) but also allows the surgical procedure to proceed as efficiently as possible. The concept of a very precise, atraumatic dissection with prospective hemostasis (identifying and controlling vessels and perforators under direct vision before they bleed) allows for both breast pockets to be typically dissected in a total time of typically less that 10 minutes. This not only immensely reduces the amount of tissue trauma but reduces intraoperative narcotics, additional paralytics, and the need for reversing agents, all of which slow postoperative recovery.⁹ Although the use of appropriate breast pocket irrigation has been widely accepted,^8,11,12 surgeons often ignore other potential points of periprosthetic contamination, including handling implants without clean gloves and contact of the implant with the outside of the thermoform container or other surgical site components. These practices do not fit with this refined surgical process and should be avoided to minimize complications, including capsular contracture and reoperation.

The last benefit of this refined surgical process is recovery, the second best indicator of the quality of the procedure delivered (with reoperation rate being the first). This report and others have documented full return to normal activities within 24 hours using this process.^9,13,14 In this series, 97 percent of patients (291 of 300) returned to full normal activities of daily living, including washing and drying hair, getting dressed, picking up children younger than 3 years, driving a car, and other similar activities. All aerobic activities that increase heart above 100 beats per minute were restricted for 2 weeks.

Surgeons, patients, and medical personnel are often skeptical about the feasibility of 24-hour, fast track recovery. The process is often modified but, as discussed earlier, a process only functions if it is completed in proper order and procedure. Other adjuncts to the process such as injectables, drains, pain pumps, straps, special bras, narcotics, and limitation of arm movements all detract from the goal of speeding recovery.

On reviewing the data of this study, it is interesting that the reoperation rates were low for all cohorts compared with all premarket approval studies. Also, the lowest reoperation rates were reported for the most stringent studies, with clinical research oversight. The issue of size exchange has also been of interest. There were no patients who underwent reoperation in either cohort for size exchange. It has been suggested that the rate of actual size exchange is dependent on the tendency of the surgeon to respond to a patient’s request for size change. This opinion does not take into account the theme of this article on the true power of “the process” of breast augmentation. Size exchange requests within the first 2 postoperative years that result in reoperations for size or style exchange indicate a failure of the surgeon and staff with the patient education and tissue-based planning parts of the process. A patient who has decided to select her implant based on her individual optimal fill volume and what will be safest for her tissues understands the limitations, and these patients remain well educated postoperatively and generally do not request size exchange procedures. This does not mean that these patients do not go through the normal human psychological acclimatization of “getting accustomed to their new breast size” and “forgetting how they were preoperatively,” which is normal human nature, and approximately 20 percent of patients may make a comment to our staff regarding size postoperatively, but they are reminded of the reasons why the size implant was chosen and shown their side-by-side preoperative and postoperative photographs, which usually results in them reaffirming their initial decision (documented in writing) about implant size selection.

Although not the focus in this article, other differences in these data are consistent with other reports, with a trend for less capsular contracture in the form-stable gel implants and more soft-tissue stretch in saline implants.^15,16 There was more rippling and palpability in the form-stable implants compared with the saline implants in this study and there was more rippling and palpability in the Contour Profile Gel implant than in the 410, which is consistent with other reports and likely attributable to the increased form stability of the

410.¹⁷ Retrospectively, this is not visible rippling but implant edge palpability, generally an innocuous finding that resulted in no further surgical revision, and future studies on form-stable implants should separate these criteria to avoid confusion. The diagnosis in this study was made only if the patient complained about palpability. Nevertheless, excellent overall outcomes were obtained with all implant types using this process-oriented approach.

Also cogent is that surgeons and manufacturers often like to talk in terms of results with specific implants; however, in the end, it is not about the implant but rather the process, as this is the most significant benefit to patients. Advances in implants in the future will enhance the process but never replace it. The process determines the patient experience, reoperation rate, and recovery, and the overall quality of the process delivered is directly proportional to the overall success.

Perhaps the most significant factor is that the process is transferable. This author was inspired by his mentor, John Tebbetts, to take basic principles and refine, customize, and develop them for clinical practice and surgeon education. By means of focused education and a defined curriculum, surgeons can acquire the skill, knowledge, and expertise to deliver the process described in this study. Independent surgeons in different stages of their careers have reported using similar concepts to produce similar patient outcomes. The combination of these reports totals over 2500 primary breast augmentations, with a mean follow-up of 6 years and a reoperation rate of less than 3 percent.^3–5,7–9 The transferability of this process has also been demonstrated routinely in our residency program at the University of Texas Southwestern. Interested residents have been introduced individually to this process and taken through the phases with direct supervision. It is clear with their own developing practices that they are using these concepts to obtain excellent outcomes in patients.

Limitations of this study and comparison include the fact that any comparison between a selected surgeon(s) versus a large premarket approval clinical trial is not totally an “apples to apples” comparison, although the premarket approval trial surgeons are hand picked by the manufacturer based on known expertise with the procedure. Because of stringent follow-up of U.S. Food and Drug Administration clinical trials with clinical research oversight, reoperation rates might be expected to be higher, yet a 5-to 7-fold increase is not explained by this minor factor.

Interestingly, the data in this study would suggest that, in this series, the subcohort of only U.S. Food and Drug Administration premarket approval clinical trial patients is easily comparable and slightly better than the non–premarket approval data. There have also been reports of pre-market approval clinical trial series using similar concepts demonstrating a 0 percent reoperation rate at 3 years.¹⁸

There has also been speculation that the U.S. Food and Drug Administration requirement for reporting of reoperations that included non–device-related issues, such as breast biopsy, falsely elevates the reoperation rates. When correcting for “non–device-related” reoperations (breast biopsy and excisional biopsy), the reoperation rates at 3 years in the core gel studies for the two companies were 14 and 16.5 percent, which would still indicate a 4-to 5-fold decrease in reoperation rates using the process detailed in this study. The re-operation rate in this study was 3.7 percent compared with 15 to 24 percent for the all premarket approval studies performed in the past 10 years. Reoperations remain our most objective measure of how well we are doing with this procedure. The 2-year reoperation rate is most critical because the majority of the reoperations during this period are the ones that are related directly to the surgeon’s decisions and technique.