This analysis has resulted in a redefinition of this procedure to a much broader process beyond the actual surgical placement of the implant. Essential components include comprehensive patient education that enhances informed consent, tissue-based preoperative planning, refined surgical technique and rapid recovery, and a strictly defined postoperative management plan. Previous reports have defined individual key areas, and these principles have been integrated, refined, and customized into a comprehensive process that encompasses every key surgeon-staff-patient action point. Although each component may exist individually, the combination of these steps in succession has resulted in enhanced outcomes for patients far better than any one component practiced in isolation. In recent years, as key components of this process have been elucidated, it has been demonstrated that the process is transferable and reproducible. The purpose of this study was to clinically define and evaluate the process of breast augmentation and to prospectively analyze patient outcomes using these practices compared with existing premarket approval trial data.

All patients were treated by a single surgeon’s practice. Patients were followed prospectively from 2001 to 2006. A subgroup of the patients were followed in a U.S. Food and Drug Administration-approved clinical trial with clinical research organization oversight. The four primary subprocesses used for patient care were structured patient education, tissue-based clinical analysis, refined surgical technique, and defined postoperative regimen.

All patients underwent a patient education and informed consent process using a multimodality approach. Initial contact included verbal information and a web-based introduction to the practice philosophy of breast augmentation. Once the decision for consultation was made, a specific patient education consultation was performed to answer specific issues about breast augmentation. After 2002, a specific set of breast augmentation education and informed consent documents was customized based on previous publications in this Journal. Patients were required to complete the documents before their education consultation that was performed either over the phone or in person, lasting on average 45 to 60 minutes, and performed by a patient education specialist. During the education consultation, all concepts, issues, and limitations were addressed directly and covered with the patient, ultimately having the patient assume responsibility for the final decisions.

The surgeon consultation was performed only after successful completion of the education consultation. The average surgeon consultation time was 30 minutes. The two primary goals of the surgeon consultation were to objectively evaluate the patient’s breast and to ensure that the patient’s goals (previously defined in writing during the education consultation) were reasonable based on their breast dimensions and tissue. The tissue-based evaluation was based on previously published techniques. The basics of the High Five process allow the surgeon to preoperatively make the five critical decisions that determine outcomes for a breast augmentation:

1. Pocket plane.

2. Implant size (based on predicted tissue-based optimal fill volume of the breast).

3. Implant type.

4. Inframammary fold position.

5. Incision.

The implant size and type were based on two key factors: breast width and breast type (skin envelope compliance and preoperative fill). The rationale for selecting the individualized implant was reviewed with the patient and anyone else participating in the decision-making process.

The patient’s breast photographs were also reviewed with the patient and a photograph-analysis sheet was completed and initialed by the patient. Patient asymmetries were identified (size and shape) and discussed, and the reality that the postoperative breast will not match, realistic expectations for cleavage based on current intermammary distance, rationale for recommended pocket plane, and likelihood of implant palpability, particularly in the inferior and lateral parts of the breast, were all addressed directly with the patient by the surgeon while viewing the photographs.

The surgical plan was developed preoperatively following the surgeon consultation. All operations were performed under general anesthesia with short-acting full muscle paralysis, and patients were premedicated with a single dose of 400 mg of Celebrex (Pfizer, New York, N.Y.). The new inframammary fold incision was planned and executed as previously described. Implant pockets were created under direct vision with no blunt dissection using techniques to minimize tissue trauma. The same surgical principles were applied to all implant types, including smooth, round, and textured anatomical implants. Pocket preparation included the use of triple antibiotic irrigation and other techniques to minimize contamination of the implant, including glove change and wiping the skin before implant placement. Sizers were not found to be necessary in [297 of 300 (99 percent)] of cases, and the implant selection was determined during the preoperative consultation before the operative day. Incision closure was performed in three layers using a deep absorbable suture (3-0 Vicryl; Ethicon, Inc., Somerville, N.J.) for closure of the superficial fascia of the breast, a deep subdermal suture (4-0 polydioxanone), and subcuticular skin closure (4-0 Monocryl; Ethicon).

All patients were given detailed defined postoperative instructions. These were reinforced before the day of surgery and on the day of surgery, and verification of compliance was completed after the patient returned home. Patient outcomes, complications, and recovery were assessed and analyzed.

A total of 300 primary augmentation patients were followed prospectively between 2001 and 2006. Two subcohorts were also analyzed: (1) 128 consecutive patients undergoing saline primary breast augmentation from 2001 to 2006; and (2) 172 consecutive patients undergoing primary breast augmentation in U.S. Food and Drug Administration premarket approval clinical trials from 2002 to 2006 with standard clinical research oversight monitoring.

Patient demographics are listed. The mean age for the main cohort and subcohorts was 36 years. The average implant size was 289 cc for the entire cohort and 302 cc and 276 cc for the saline and form-stable cohesive gel subcohorts, respectively.

The belief that breast augmentation is a simple procedure encompassing little more than placing an implant in a pocket is a misconception, and advances in this procedure have been significant over the past 10 years; however, controlled clinical trials have demonstrated that reoperations continue to be significant (15 to 24 percent at 3 years) for this elective procedure. This procedure is much more complex than typically perceived, and the concept of the process of breast augmentation emphasizes the equal if not larger importance of the nonsurgical part of the process (e.g., education, tissue-based planning, and postoperative care compared with the surgical procedure itself).

The educational component cannot be overemphasized, as this remains the most critical yet often neglected part of the process. The key components of the educational subprocess are (1) to educate the patient on the practice philosophy and have the patient assume mutual responsibility that the implant will be selected based on her chosen preferences and in accordance with her breast dimensions and tissue or alternative methods recognizing the tradeoffs; and (2) by means of direct doctor-patient interaction to review the patient’s own photographs and point out key aspects that should be addressed preoperatively, including 100 percent asymmetry in all patients and limitation in correcting these asymmetries, reasons for implant palpability, and the likelihood of inferior and lateral pole deformity. The image analysis sheet is an extremely powerful yet simple tool that is part of the educational process and the surgeon planning consultation.

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.  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 above the High Five-recommended volume, particularly in high-risk patients [narrow (breast width <11.5), tight envelope (skin stretch <2)].

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. Although the use of appropriate breast pocket irrigation has been widely accepted, 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. 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. 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. 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. 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 premarket approval clinical trial series using similar concepts demonstrating a 0 percent reoperation rate at 3 years.

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 reoperation 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.