Paolo Montemurro, MD; Mouchammed Agko, MD; Alessandro Quattrini Li, MD; Stefano Avvedimento, MD; and Per Hedén, MD, PhD.

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1 Breast Surgery Implementation of an Integrated Biodimensional Method of Breast Augmentation with Anatomic, Highly Cohesive Silicone Gel Implants: Short-Term Results With the First 620 Consecutive Cases Aesthetic Surgery Journal 2017, The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com DOI: /asj/sjx024 Paolo Montemurro, MD; Mouchammed Agko, MD; Alessandro Quattrini Li, MD; Stefano Avvedimento, MD; and Per Hedén, MD, PhD Abstract Background: The previously described Akademikliniken (AK) method is a comprehensive approach to breast augmentation with form stable implants that has been shown to afford favorable outcomes when applied by experienced surgeons. Objectives: To evaluate outcomes of a surgeon newly adopting this method at the beginning of his career. Methods: A retrospective review of patients undergoing dual plane subpectoral augmentation with Style 410 implants between April 2009 and December 2014 was undertaken. The review was performed one year after the last operation. The first author (P.M.) performed all operations. Complications and reoperation rates were analyzed and correlated with patient and implant characteristics using the chi-square or Fisher s exact test, as appropriate. Results: A total of 620 consecutive patients met the inclusion criteria with a mean follow up of 8 months (range, 1 week-60 months). Complications occurred in 14.8% of the patients: request for larger size (3.3%), rotation (3%), and Baker III/IV capsular contracture (2.2%) were the most common ones. Low implant projection was a statistically significant risk factor (P < 0.05) for the most common complication request for a larger size. The overall reoperation rate was 8.7%. The most common indication for reoperation was request for larger size (2.2%) followed by rotation (2.2%) and capsular contracture (2%). Conclusions: Breast augmentation with form stable anatomical implants requires a considerably different process. By implementing a systematic approach such as the AK method, novices in this terrain can expect to achieve reasonable outcomes. Level of Evidence: 4 Editorial Decision date: January 24, In 1993, McGhan (Inamed Corporation, Santa Barbara, CA) was the first to introduce a textured, anatomic, highly cohesive silicone breast implant the Style 410. Since then, these implants have been in widespread use in Europe. In 2001, Hedén et al reported the world s largest experience with 1676 anatomic, cohesive gel implants in 823 women. 1 The Akademikliniken (AK) method a structured approach to preoperative consultation, implant selection, preoperative marking, perioperative measures, Drs Montemurro and Hedén are plastic surgeons in private practice in Stockholm, Sweden. Drs Agko, Quattrini Li, and Avvedimento are fellows at a private plastic surgery practice in Stockholm, Sweden. Corresponding Author: Dr Mouchammed Agko, Storängsvägen 10, Stockholm, Sweden. ago77@hotmail.com. Presented at: Plastic Surgery The Meeting in Los Angeles, CA in September 2016.

2 2 Aesthetic Surgery Journal surgical technique, and postoperative management was described. By 2009, close to 12,000 of these implants had been placed at our institution using this method and by 2016 this number has risen to 30,000 devices. The U.S. Food and Drug Administration (FDA) approval of the Style 410 implants (Allergan, Irvine, CA) in 2013 has created a renewed interest in United States. Implementation of a breast augmentation process, such as the AK method, could help avoid early unfavorable results that could dampen the enthusiasm of the surgeons and public alike. This requires a paradigm shift in augmentation mammaplasty from volume to shape and dimensions. Market research confirms shape vs size as the primary goal of the patients. 2 A natural breast shape with long-term stability can be achieved with these teardrop shaped implants that maintain their upper pole fill in standing position. The wide variety of implant options in terms of width, height, and projection allows for a customized selection to accommodate common breast/chest asymmetries and shape abnormalities. Furthermore, the textured surface s adherence to the surrounding structures provides one breast feel. To fully exploit these purported advantages, careful implant selection, precise pocket dissection, and optimal positioning of the implant on the chest below the breast mound is necessary. The AK method incorporates all these steps into a structured process. The safety of the Style 410 implants and efficacy of the AK method have been reported extensively by Hedén et al. 3-5 The 2 core questions that are answered with the AK method are how to ideally place the implant vertically in relation to the nipple-areola complex and how to calculate the exact amount of skin needed in the lower pole of the breast in relation to implant dimensions and amount of glandular cover. This article examines the implementation of this method by a single plastic surgeon at the beginning of his career in a high case volume facility. Hence, conclusions can be drawn in regards to reproducibility of previously reported favorable outcomes with these implants during the initial experience of a novice surgeon. METHODS All patients were counseled in accordance with the Declaration of Helsinki guidelines and written informed consent was obtained from them preoperatively. A retrospective chart review of prospectively collected data on patients undergoing primary dual plane subpectoral breast augmentation bilaterally between April 2009 and December 2014 was undertaken. The review was performed in January 2016, one year after the last operation. Only patients who received textured, anatomic, cohesive silicone gel implants (Allergan Style 410) through an inframammary incision were included. One author (P.M.) performed all operations starting from the beginning of his career as a plastic surgeon. A total of 620 consecutive cases met these criteria. The operating surgeon saw all patients at least once, while additional follow-up visits were conducted by nurse practitioners. Any patient noted to have a complication was evaluated by the operating surgeon. Patient data noted included age, body mass index (BMI), smoking status, parity, and preoperative cup size. Implant characteristics, such as height, projection, and volume were documented. Type of dual plane and operative time were recorded. Complications investigated were request for larger size implant, rotation, Baker grade III/IV capsular contracture, malposition, infection, delayed wound healing, double-bubble deformity, double capsule formation, seroma, hematoma, rippling, implant rupture, and reoperation. Time to complication and time to reoperation were recorded. Data were expressed as means and ranges. Statistical analysis was performed using SPSS statistical software (Macintosh Version 21.0; IBM Corp., Armonk, NY). Potential associations between individual patient or implant characteristic, type of dual plane, and overall or specific complications were evaluated using the chi-square or Fisher s exact test, as appropriate. The differences were considered significant for values of P < The AK Method The method is described in detail in Videos 1-4 (available as Supplementary Material at com) and representative cases are shown in Figures 1 and 2. RESULTS The mean follow up for the 620 consecutive patients (1240 implants) included in this study was 8 months (range, 1 week-60 months) (Table 1). The average age was 31 years (range, years), and the average BMI was 20.9 kg/m 2 (range, kg/m 2 ). The majority of patients were nonsmokers (86.6%). The cohort included almost an equal number of parous and nulliparous women (52% vs 48%, respectively). Most of the patients had an A or B cup size breast with only 5.9% presenting with C. Average implant volume was 310 cc (range, cc). Half of the patients received an implant volume in the range of 200 to 299 cc (Table 2). The second most common range was 300 to 399 cc (38%). Only 9.7% of the patients received a volume equal or greater than 400 cc. An overwhelming majority received with a medium height implant (Figure 3). Most implants had an extra (56%) or full (34%) projection, only 1% had a low projection. The most common height/profile combination was MX (medium/extra) (46%) followed by MF (medium/full) (30%). No implants with the LL (low/ low) or FL (full/low) combination were used. A dual

3 Montemurro et al 3 A B C D E F Figure 1. (A, C, E) Preoperative views of a 34-year-old woman. (B, D, F) Views at 4.5 years after dual plane II subpectoral breast augmentation using bilateral MM245 implants. plane 2 or 3 was created in the majority (98.1%) of the breasts. Complications occurred in 14.8% (92/620) of the patients and 10% (125/1240) of the implants (Table 3). A single type of complication was identified in 85 patients, whereas the remaining patients had two or three synchronous or metachronous complications. The most common complication was request for larger size (3.3% of patients) followed by rotation (3%) and capsular contracture (2.2%). Each one of the remaining complications malposition, redness/infection, delayed wound healing, double bubble, double capsule, late seroma, severe pain/ anxiety, and hematoma occurred in 2% or less of the patients. Notably, no rippling or implant rupture was noted on follow-up clinical exam (magnetic resonance imaging follow up was not done routinely). Average time to development of a complication was 286 days (range, days). Low implant projection was a statistically significant risk factor (P < 0.05) for implant exchange due to a request for a larger size. A total of 54 patients (8.7%) required a reoperation. Request for larger size (2.2%), rotation (2.2%), and capsular contracture (2%) were the most frequent causes. The risk for reoperation for each one of the other reasons malposition, double bubble, pain/anxiety, superficial wound dehiscence, seroma, or hematoma was less than 1%. Average time to reoperation was 442 days (range, days).

4 4 Aesthetic Surgery Journal A B C D E F Figure 2. (A, C, E) Preoperative views of a 23-year-old woman. (B, D, F) Postoperative views at 13 months after dual plane II subpectoral breast augmentation using bilateral MF295 implants. DISCUSSION Rate of Complications and Reoperations in Early vs Late Cases For a surgeon adopting a new method or new implants, it is important to have an estimate of complication and reoperation rates to be expected during the early period. Both rates are expected to increase, to a lesser or greater degree for each individual complication, with extended follow up as evidenced by the core studies. 6-8 Therefore, we did not attempt a statistical comparison of early vs late cases in our series. However, the total number of cases was divided equally into 5 chronologically sequential groups, each containing 124 patients. Data plotted on a linear graph reveal a clear trend towards decreased rates of both complication and reoperation in late cases (Figure 4). Request for Larger Size Implants One could argue that this request is not a complication by itself as long as the patient does not undergo an implant exchange. Many surgeons report as complication only reoperation for size change. Furthermore, it can be debated whether request for size change years after the procedure or after weight loss/pregnancy is a failure of the implant selection process and a complication per se. We elected to report it as a complication; desire

5 Montemurro et al 5 Table 1. Patient Demographics Number of patients, 620 Age (years) (mean, 30.8; range, 18-56) Number (%) < (30.3) (16.9) (17.4) (18.2) (16.9) BMI (kg/m 2 ) (mean, 20.9; range, ) < (8.7) (86.7) (4.5) Tobacco use Yes 83 (13.3) No 537 (86.6) Postpartum Yes 323 (52) 1 child 64 (10.3) 2 children 193 (31.1) 3 children 66 (10.6) No 297 (47.9) Cup size A 260 (41.9) B 323 (52) C 37 (5.9) Follow-up (mean, 8 months; range, 1 week-60 months) <6 months 239 (38.5) 6-12 months 286 (46.1) >12 months 95 (15.3) BMI, body mass index. for larger breast size was the most common complication (3.3%, 21/620) and reason for reoperation (2.2%, 17/620). Of the total 17 patients who received a larger size implant, 13 had a style change to textured round gel implant in order to accommodate the larger size implant while maintaining a similar implant width. The average increase in implant volume was 109 cc (range, cc). Upon closer analysis of the sequential subgroups, none of the last 124 patients (last quintile) had requested a larger implant at one year after the completion of this study (Figure 4). It is possible that the surgeon was extremely cautious in the beginning and became more comfortable accommodating an implant up to 0.5 cm wider than the calculated breast gland footprint. As further experience was gained, the larger size implant was chosen when the patient was ambivalent between 2 devices. Nevertheless, it is expected that a certain percentage of patients, while initially content with the size of their augmented breasts, will continue to ask for larger implants as they go through a process of psychological acclimatization. Patients initially concerned about having too large breasts may change their mind later. The postoperative breast size becomes their new norm such that, after a certain period of time or due to mild ptosis (postpartum, aging, weight loss), it is felt to require further improvement. Even though, the Style 410 core studies do not provide details on implant size, they report a similar finding. Style/ size change was the most common reason for reoperation and explantation at 6 and 10 years. 7,8 Eventually, 13.2% of the augmentation cohort underwent reoperation for this purpose. Most of our patients are aiming for a natural look. While patients desires are definitely taken into consideration, we counsel them against implant sizes and volumes that would violate the limitations of their chest and/or breast anatomy. This is reflected on the implant sizes used. More than half of our patients received an implant volume of less than 300 cc. In a study of 440 patients undergoing subglandular breast augmentation with similar implants, Lista et al reported a 0.9% rate of reoperation for size/style change. 9 In the same study, 90% of the implants had a volume larger than 300 cc and 39.5% were more than 400 cc. A larger implant volume was the only statistically significant factor for increased complications. In the largest study of Style 410 implants to date, Hedén et al reported a reoperation rate of 1.9% for size change. 1 In smaller studies with similar implants, Tebbetts and Brown have reported no reoperations for size/style change at 21 months and 3 years, respectively. 10,11 Rotation/Malposition Rotation, defined as angulation of the vertical axis of the implant in relation to the vertical axis of the breast and consequent distortion the breast shape, was the second most common complication (3%, 19/620). In addition, it led to the second highest rate of reoperation 2.2% (14/620). Except one patient, all rotations were unilateral (18/19). Average time to occurrence of rotation and reoperation was 283 days (range, days) and 334 days (range, days), respectively. Five patients did not undergo a reoperation as the rotated implant returned to normal position either spontaneously or by external repositioning

6 6 Aesthetic Surgery Journal and did not recur. In those operated, a neosubmuscular pocket was created followed by replacement of the existing or placement of a new but similar style/size implant. Only one patient, who desired more volume, had an exchange to a larger round implant. Table 2. Distribution of Implants Per Volume and Height/Profile Combination Implant type Number of implants (%) cc cc cc cc LL LM 8 (0.6) LF 38 (3) LX 99 (7.9) ML 12 (0.9) MM 106 (8.5) MF 373 (30) MX 572 (46) FL FM 1 (0.08) FF 5 (0.4) FX 26 (2) cc Total 1240 (100) 24 (1.9) 621 (50%) 473 (38.1%) 116 (9.3%) 6 (0.4) Implant Type: The first letter denotes height; the second represents profile (projection). L, Low; M, Medium; F, Full; X, Extra. Upon initial statistical analysis, a BMI >25 appeared to be significantly related to rotation. However, because of the low percentage of patients with BMI >25 (only 4.5%) and therefore small expected frequency, we were advised by our statistician that more patients with a BMI >25 were needed to overcome this inherent limitation of the chi-square test. The primary focus of this manuscript was to report the early experience of a surgeon incorporating the AK method and anatomic implants at the beginning of his career. With that in mind, we did not delve into sophisticated statistical analysis, limiting ourselves to descriptive statistics. We did not perform a multivariate analysis, so we could not confirm the substantive significance of this correlation that might have been affected by several confounding factors. The first author has undertaken a separate study to specifically address this issue by recruitment of additional patients. The study has been completed and is expected to be published in the near future. He did not find high BMI to be a risk factor for rotation. To prevent any future confusion in the literature, we elect not to report this as a statistically significant finding, but instead as a most likely artificial finding. Malposition was defined as displacement in the vertical or horizontal plane without significant angulation of the vertical axis of the implant. No horizontal displacement was noted in this series. However, cranial (high-riding implant) or caudal (bottoming out) displacement was noted in 2% (13/620) of the patients and was severe enough to require a reoperation in 0.8% (5/620). The malposition was unilateral in all but 2 patients. In patients with bottoming out, surgical intervention was tailored to the degree of the deformity. Milder deformities were treated with capsulorrhaphy A B Figure 3. Distribution of implants per (A) height and (B) projection.

7 Montemurro et al 7 Table 3. Complications and Reoperations Complication No. of patients (%) (N = 620) No. of breasts (%) (N = 1240) Days to complication mean (range) Request for larger size 21 (3.3) 42 (3.3) 333 ( ) Rotation 19 (3) 21 (1.6) 283 ( ) Capsular contracture 14 (2.2) 20 (1.5) 570 ( ) Malposition 13 (2) 15 (1.2) 338 ( ) Antibiotic/redness 13 (2) 13 (1) 30 (7-125) Delayed wound healing 8 (1.2) 9 (0.7) 21 (7-35) Double bubble 6 (0.9) 8 (0.6) 381 ( ) Double capsule 3 (0.4) 4 (0.3) 337 ( ) Seroma 2 (0.3) 3 (0.2) 261 ( ) Severe pain/anxiety 1 (0.1) 2 (0.1) 14 Hematoma 1 (0.1) 1 (0.08) 0 Total 101 complications in 92/620 patients (14.8%) 138 complications in 125/1240 implants (10%) 286 (0-1352) Reoperation reason No. of patients (%) (N = 620) No. of breasts (%) (N = 1240) Days to reoperation mean (range) Request for larger size 17 (2.2) 34 (2.2) 452 ( ) Rotation 14 (2.2) 15 (1.2) 334 ( ) Capsular contracture 13 (2) 18 (1.4) 603 ( ) Malposition 5 (0.8) 7 (0.5) 474 ( ) Double bubble 2 (0.3) 3 (0.2) 570 ( ) Pain/anxiety 1 (0.1) 2 (0.1) 14 Superficial wound dehiscence 1 (0.1) 1 (0.08) 29 Seroma 1 (0.1) 1 (0.08) 250 Hematoma 1 (0.1) 1 (0.08) 0 Total 55 reasons for reoperation in 54/620 patients (8.7%) 82 reasons for reoperation in 79/1240 implants (6.3%) 442 (0-1372) of the inferior part of the implant pocket and resetting of the inframammary fold. More severe cases required crescentic excision of the stretched skin and mesh suspension of the implant using TIGR Matrix (Novus Scientific AB, Uppsala, Sweden). The high-riding implant was removed, a neosubmuscular pocket was created in the correct position, and a new implant was placed. The combined rotation and malposition rate of 5% in this study corroborates with the 4.7% rate reported in the Style 410 core study. 8 Lista et al found a similar rate of 5.2%. 9 While both the core studies and other authors have elected to report these 2 complications collectively, we believe they have to be analyzed separately as both their pathophysiology and treatment differs. It is postulated that precise dissection of a snugly fitting pocket along with the optimum pore size of the textured surface could minimize these complications. Experts have reported rotation rates as low as 0% to 0.42% with Style 410 implants. 5,10,11 In our series, after the relatively high rate of rotation of 6.4% in the first 2 consecutive subgroups of 124 patients, its occurrence decreased significantly to 0.08% in the last three subgroups (Table 4). Since, in the majority of the patients (73%) rotation occurred within the first year of the operation, we can assume that the decreased rate of this complication in the later cases is not only due to a shorter follow up as the review was undertaken a year after the last case in the series. With experience, the surgeon masters the skill of developing the appropriate pocket for any given implant. The hand-in-glove fit is of paramount importance in anatomic implants. While the pocket should exceed the width of the implant by 1 cm in the horizontal plane and 1 to

8 8 Aesthetic Surgery Journal Table 4. The Three Most Common Complications Per Each Sequential Quintile Case number Desire for larger size Rotation Contracture Figure 4. Total number of complications and reoperations in the 5 sequential groups. The x-axis denotes the chronological order of the cases. 2 cm in the vertical to permit optimum draping of the soft tissues over the implant, further dissection should be avoided. Utmost attention is required during intraoperative assessment of the pocket limits. Instead of just visually inspecting the pocket, beginners might find it helpful to check the height with a ruler. The width of the pocket can be controlled with placement of an instrument (eg, the backside of a forceps) under direct vision in the pocket followed by pushing it vertically up against the surface and palpating medial and lateral borders of the pocket. Another important factor in preventing rotation is avoidance of periprosthetic fluid collection by creation of a dry pocket. It requires precision, sharp dissection, and preemptive hemostasis. As simple as it may sound, it is not an easy task for a novice surgeon. Capsular Contracture The capsular contracture rate (Baker scale grades III and IV) of 2.2% (14/620) accounting for 2% (13/620) rate of reoperation should be approached cautiously as the short median follow up of 8 months (range, 1 week-60 months) is certainly inadequate to determine the true rate of this complication. On the other hand, time elapsed from surgery ranges from 1 to 6 years. As an overwhelming majority of our patients elect to purchase the additional capsular insurance that covers reoperation for capsular contracture related problems, we believe that we have captured most of the patients who have developed this complication. Even though, most of the capsular contractures occur primarily in the first 2 years, the rate doubled from 4.6% at 6 years to 9.2% at 10 years in the core study. 8 Hedén et al reported similar contracture rates of 5.3% and 5.6% in two different long-term studies. 4,12 The complication was bilateral in almost half of the cases (6/14). Of these, only 3 patients had a double capsule on reoperation, one of whom had associated bilateral late seroma. Average time to diagnosis and reoperation was 570 days (range, days) and 603 days (range, days), respectively. One patient refused reoperation. Of the remaining patients, the overwhelming majority underwent capsulotomy/capsulectomy and creation of a neosubmuscular pocket followed by placement of a similar size/ style implant. One patient had a smaller textured round implant placed, whereas the other patient desired a bigger volume, thus a larger size anatomic implant was inserted. Other Complications The individual rate of all other complications was 2% or less, prompting a reoperation rate of 0.8% or less. Of those, the most common one was early postoperative redness (2%, 13/620) that was preemptively treated with a week of oral antibiotics. Only 1 patient developed a unilateral subareolar abscess 4 months after surgery requiring drainage. One of the patients with early redness subsequently developed rotation that required reoperation. None of these patients has presented with a capsular contracture yet. Eight patients (1.25%) had delayed wound healing. One of these patients developed superficial wound dehiscence after early vigorous exercise that required suturing under local anesthesia. Six (0.9%) patients presented with evidence of varying degrees of double-bubble deformity. Only two required fat grafting to improve the contour. One patient (0.1%) had an immediate hematoma that was drained. An unusual complication was that of severe pain and anxiety in 1 patient (0.1%) who, despite counseling and appropriate pain control, insisted on explantation 2 weeks postoperatively. The occurrence of only 1 hematoma and the relatively low rate of minor wound problems is attributed to the preemptive hemostasis and meticulous wound closure in 4 layers which leaves a tension-free suture line. 13 Absence of rippling and implant rupture is probably related to the nature of the highly cohesive silicone gel implants and the overall approach to implant selection and pocket creation that matches the anatomy of the patient. The chest and breast anatomy determines the limits of the pocket and

9 Montemurro et al 9 therefore size of the implant. As an overly large implant is not squeezed into a small pocket, rippling and consequent friction of the folds on each other leading to shell rupture is avoided. Double Capsule and Seroma Recently, the occurrence of double capsule and late seroma (>1 year postoperatively) has attracted increased attention. In the present series, double capsule formation was documented in 3 patients (0.4%) at the time of reoperation for capsular contracture. Of these, 1 patient had bilateral capsular contracture associated with bilateral late seroma formation. The second patient had unilateral capsular contracture associated with ipsilateral double capsule and no fluid accumulation. Finally, the third patient had bilateral capsular contracture with double capsule only on one side without associated periprosthetic fluid. The only case (0.1%) of late seroma mentioned above was diagnosed 18 months after initial surgery. Due to the small amount, clear straw colored nature of the fluid, and absence of any suspicious lesion, both on clinical breast examination and intraoperative assessment of the capsule, no further investigation was undertaken. At that time, cytologic and immunohistochemical studies were not routinely performed at our institution. Since then, we have implemented the recommendations by FDA. An additional case of seroma, that occurred 8 months postoperatively, was drained under ultrasonographic guidance. It should be noted that both patients have been followed since then without recurrence of seroma. While double capsule was only documented in capsular contracture cases, the opposite is not true. Only four of the total 20 breasts with capsular contracture had double capsule. Thus, no cause-effect relationship can be postulated. Double capsule is an indication of partial or total nonadherence of the implant to the tissue pocket and by itself not clinically distinguished, unless associated with a complication requiring surgical intervention (ie, capsular contracture). Therefore, the true incidence of double capsule formation is unknown. When not associated with another complication, it does not warrant any treatment by itself. In previously published cases, double capsule is similarly an incidental finding upon reoperation for another reason. In Hall-Findlay s review of 14 cases, double capsule formation was found around 2 subglandular Style 410 implants upon exploration for seroma and unfavorable shape, respectively. 14 Lista et al reported a late seroma rate of 1.4%. 9 Three patients underwent bilateral implant exchange. In each case, double capsule formation was bilateral, whereas seroma was unilateral. In the core study, the 10-year overall seroma rate was 1.6% in the breast augmentation cohort, with 0.6% qualifying as late seromas. 8 Similarly, several authors have reported rates less than 1%. 15,16 Strength and Weaknesses This study was specifically designed to assess the experience of a single surgeon implementing a well-defined breast augmentation process. Therefore, any conclusions regarding efficacy/reproducibility of the AK method and efficacy of Style 410 implants are not confounded by variations in preoperative consultation, surgical technique, and postoperative care as in the case of multicenter studies or those involving more than one surgeon. Moreover, given that the study reports the outcomes of a surgeon at the beginning of his career, novices and surgeons with limited experience may find it more applicable to their practice than similar studies from experienced surgeons. Irrespective of the particular method or implants used, the current study provides detailed information on the learning curve of breast augmentation and may serve as a basis for identifying areas of improvement for future trainees. The time to development of a complication and subsequent reoperation as presented in this study (Table 3) is not commonly reported. We believe it is useful information for patient education and future research. However, there are several limitations to the study. Undoubtedly, the high caseload in these series has allowed the surgeon to adjust certain aspect of the process and improve outcomes in a shorter period than it would be possible with fewer patients. As only one type of implant was used, reproducibility of the results with comparable anatomic highly cohesive implants while expected needs to be confirmed with similar studies. The report lacks patient reported outcomes. To that end, Hedén et al demonstrated 97% satisfaction rate using similar method and implants. When only the mean follow up is taken into consideration, 8 months is admittedly a short time interval for development of the long-term complications. Unfortunately, the no-show rate for the long-term follow-up appointments is relatively high among this young patient cohort (82% of the patients <40 years old), more so when satisfied with the aesthetic result. To mitigate this shortcoming, the review was undertaken on January 2016 one year after the last patient in the series resulting in an average interval of 37 months (range, months) between the date of surgery and the review time. Furthermore, the insurance policy intrinsic to our institution serves as financial incentive for the patient with a complication, especially one requiring reoperation, to return to our clinic. Other than capsular contracture related procedures, all expenses of a reoperation are covered by the in-house insurance that the patient is entitled at no additional cost. To complement this, most of the patients elect the additional capsular contracture insurance that covers procedures related to capsular contracture. Therefore, we believe that we have captured most of the complications so far, particularly those requiring reoperation. Nevertheless, we

10 10 Aesthetic Surgery Journal acknowledge that, as shown in the core study, the rate of complications increases up to 10 years after the procedure and the results presented herein should be interpreted cautiously in this regard. 6-8 Lessons Learned and Suggestions for Implementation of the AK Method The process starts with selecting an implant that matches the anatomy of the patient and not trying to accommodate the tissues to the selected implant. We have found the initial instruction by a trained patient educator and trial of implants with the help of 3-dimensional imaging prior to the consultation with the operating surgeon extremely valuable in reaching a shared decision on a specific implant size and shape. Implants up to 0.5 cm wider than the breast footprint can be accommodated, while maintaining an intermammary distance of 2 to 3 cm. However, even if the patient is initially happy with the size, the surgeon should expect 2% to 3% of the patients to desire a larger size in the future. In this case, a round implant may be needed to avoid violating the anatomic boundaries. Preoperative measurements (as described in Video 1) allow for increased accuracy in assessment of the anatomy, selection of the appropriate implant dimensions, positioning of the implant vertically on the chest, and placement of the inframammary incision. During preoperative marking, prediction of the postoperative nipple position by elevating the arms lies at the crux of proper placement of the implant. With half the implant above the nipple and half below, the new inframammary fold is easily determined in a reliable fashion. Precise pocket creation using an atraumatic technique and preemptive hemostasis is a prerequisite for prevention of unfavorable results such as rotation/ malposition, seroma, and hematoma. Meticulous closure and standardized postoperative care (Video 4) further improve wound outcomes and adherence of the implant surface to the surrounding tissues. While the AK method is a constellation of principles and technical steps that suggest a more structured approach to breast augmentation, its implementation does not require extraordinary skills. Rather, it requires transitioning from an arbitrary process to a carefully made plan that is applied in a calculated and consistent manner. Preoperative patient education and simulation is particularly important as it permits shared decision making and therefore responsibility with a well-informed patient. Measurements and calculations might appear overwhelming to a beginner, however they are simpler compared to other methods and can easily become second nature with some practice. The novice can do this by applying the method to implant types they are used to prior to switching to anatomic implants. CONCLUSION The AK method can serve as a reliable roadmap to surgeons introducing anatomic, highly cohesive silicone gel implants into their practice. By applying this method, a novice surgeon achieved a complication rate of 14.8% and reoperation rate of 8.7% in the first 5 years of his practice, with a tendency towards lower complication rates as experience was gained. Supplementary Material This article contains supplementary material located online at Acknowledgement The authors thank Hayriye Şentürk Çiftçi from Istanbul University (Istanbul Faculty of Medicine/Medical Biology Department) for assistance with statistical calculations. Disclosures Dr Montemurro is a consultant and speaker for Allergan, Inc. (Irvine, CA). Dr Hedén is a consultant and speaker for Allergan, Inc. and an unpaid consultant for Canfield Scientific (Fairfield, NJ). The other authors declared no potential conflicts of interest with respect to the research, authorship, and publication of this article. Funding The authors received no financial support for the research, authorship, and publication of this article. REFERENCES 1. Hedén P, Jernbeck J, Hober M. Breast augmentation with anatomical cohesive gel implants: the world s largest current experience. Clin Plast Surg. 2001;28(3): Hedén P. Form stable shaped high cohesive gel implants. In: Hall-Findlay EJ, Evans GRD, eds. Aesthetic and Reconstructive Surgery of the Breast. Philadelphia, PA: Saunders/Elsevier; 2010: Hedén P, Boné B, Murphy DK, Slicton A, Walker PS. Style 410 cohesive silicone breast implants: safety and effectiveness at 5 to 9 years after implantation. Plast Reconstr Surg. 2006;118(6): Hedén P, Bronz G, Elberg JJ, et al. Long-term safety and effectiveness of style 410 highly cohesive silicone breast implants. Aesthetic Plast Surg. 2009;33(3): ; discussion Hedén P. Breast augmentation with anatomic, high-cohesiveness silicone gel implants (European experience). In: Spear S, ed. Surgery of the Breast: Principles and Art. 3rd ed. Philadelphia, PA: Wolters Kluwer/Lippincott Williams & Wilkins; 2011: Bengtson BP, Van Natta BW, Murphy DK, Slicton A, Maxwell GP; Style 410 U.S. Core Clinical Study Group. Style 410 highly cohesive silicone breast implant core study

11 Montemurro et al 11 results at 3 years. Plast Reconstr Surg. 2007;120(7 Suppl 1):40S-48S. 7. Maxwell GP, Van Natta BW, Murphy DK, Slicton A, Bengtson BP. Natrelle style 410 form-stable silicone breast implants: core study results at 6 years. Aesthet Surg J. 2012;32(6): Maxwell GP, Van Natta BW, Bengtson BP, Murphy DK. Ten-year results from the Natrelle 410 anatomical form-stable silicone breast implant core study. Aesthet Surg J. 2015;35(2): Lista F, Tutino R, Khan A, Ahmad J. Subglandular breast augmentation with textured, anatomic, cohesive silicone implants: a review of 440 consecutive patients. Plast Reconstr Surg. 2013;132(2): Tebbetts JB. Achieving a zero percent reoperation rate at 3 years in a 50-consecutive-case augmentation mammaplasty premarket approval study. Plast Reconstr Surg. 2006;118(6): Brown MH, Shenker R, Silver SA. Cohesive silicone gel breast implants in aesthetic and reconstructive breast surgery. Plast Reconstr Surg. 2005;116(3): ; discussion Hedén P, Boné B, Murphy DK, Slicton A, Walker PS. Style 410 cohesive silicone breast implants: safety and effectiveness at 5 to 9 years after implantation. Plast Reconstr Surg. 2006;118(6): Montemurro P, Avvedimento S, Hedén P, Quattrini Li A. A four-layer wound closure technique with barbed sutures for stable reset of the inframammary fold in breast augmentation. Aesthet Surg J. 2016;36(8): Hall-Findlay EJ. Breast implant complication review: double capsules and late seromas. Plast Reconstr Surg. 2011;127(1): Spear SL, Rottman SJ, Glicksman C, Brown M, Al-Attar A. Late seromas after breast implants: theory and practice. Plast Reconstr Surg. 2012;130(2): Maxwell GP, Scheflan M, Spear S, Nava MB, Hedén P. Benefits and limitations of macrotextured breast implants and consensus recommendations for optimizing their effectiveness. Aesthet Surg J. 2014;34(6):