Comparison of Allergan, Mentor, and Sientra Contoured Cohesive Gel Breast Implants: A Single Surgeon s 10-Year Experience.

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1 COSMETIC Comparison of,, and Sientra Contoured Cohesive Gel Breast Implants: A Single Surgeon s 10-Year Experience Erin L. Doren, M.D. Yvonne N. Pierpont, M.D. Steven C. Shivers, Ph.D. Lewis H. Berger, M.D. Tampa, Fla. Background: Contoured cohesive gel breast implants have been recently approved in the United States. These implants have been available for premarket approval studies for selected surgeons. The purpose of this study was to assess a single surgeon s outcomes in three specific clinical situations breast augmentation, secondary augmentation, and breast reconstruction using implants of all three contoured cohesive gel implant manufacturers (,, and Sientra) over a 10-year period. Methods: The authors performed a prospective study of contoured cohesive silicone gel breast implants. Demographic and outcomes data were recorded. Complication rates were compared among the three implant manufacturers. Results: From 2001 to 2013, 695 patients were included from U.S. Food and Drug Administration clinical trials. Mean age at implantation was 42.7 years (range, 18 to 82 years), and mean time enrolled was 5.3 years (range, <1 to 10 years). One hundred sixty-four patients (24 percent) received implants, 245 (35 percent) received implants, and 286 (41 percent) received Sientra implants. Three hundred eighty-four patients (55 percent) underwent primary augmentation, 198 (29 percent) underwent secondary augmentation, and 113 (16 percent) underwent breast reconstruction. The total complication rate was the lowest for primary augmentation of the group compared with the and Sientra groups (p < 0.05). There were no significant differences in complication rates when used for secondary augmentation and reconstruction. There was no statistically significant difference between implant group reoperation, explantation, or capsular contracture rates. Overall implant rupture and rotation rates were low (0.7 percent and 1.3 percent, respectively). Patient and surgeon satisfaction was high. Conclusions: Contoured cohesive gel breast implants overall have low complication rates and high patient and surgeon satisfaction. The authors believe these implants to be safe and effective in breast augmentation and reconstruction. (Plast. Reconstr. Surg. 136: 957, 2015.) CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III. Breast augmentation is the number one cosmetic procedure performed by plastic surgeons in the United States. 1 Patients and plastic surgeons continue to push for an improved breast implant that provides safety, versatility, and a superior aesthetic result. In 2012, the U.S. Food and From the Division of Plastic Surgery, Department of Surgery, and the Breast Health Program, University of South Florida; and the Cosmetic and Reconstructive Surgery Center. Received for publication February 4, 2015; accepted May 21, Presented in part at the 57th Annual Meeting of the Southeastern Society of Plastic and Reconstructive Surgeons, in Nassau, Bahamas, June 8 through 12, Copyright 2015 by the American Society of Plastic Surgeons DOI: /PRS Disclosure: The authors did not receive any financial support for this research study. Sponsors (,, and Sientra) supplied a small stipend to cover the administrative costs of paperwork and submission for the FDA clinical trials. All patients paid for their procedures with all implants priced at cost but received stipends from the breast implant manufacturers to return for follow-up visits and MRIs during the 10-year duration of the studies. A Video Discussion by Matthew M. Hanasono, M.D., accompanies this article. Go to PRSJournal. com and click on Video Discussions in the Videos tab to watch

2 Plastic and Reconstructive Surgery November 2015 Drug Administration approved the first contoured cohesive gel breast implant for clinical use. However, limited data exist on the efficacy, outcomes, complications, and comparability of these new implants. Benefits of these implants have been theorized and reported as low capsular contracture and rupture rates, less rippling, a more natural appearance, improved projection, stability of shape, improved ability to achieve symmetry and lower pole fullness, correction of ptosis, and correction of acquired and congenital breast deformities Contoured implants have been available for premarket approval U.S. Food and Drug Administration clinical trials to a select number of surgeons for over 10 years. Preliminary studies show that contoured implants have similar complication rates and overall effectiveness in breast augmentation and reconstruction. 2 4,10,12 18 The purpose of this study was to examine and compare a single surgeon s outcomes and complications using the contoured breast implants, manufactured by (Irvine, Calif.), (Santa Barbara, Calif.), and Sientra (Santa Barbara, Calif.), in three clinical situations: primary augmentation, secondary augmentation, and breast reconstruction. Results of this study will provide information to assist patients and surgeons in the selection of breast implants for augmentation and reconstruction. PATIENTS AND METHODS Study Design This is a prospective study of female patients 18 years or older undergoing implantation with contoured cohesive gel breast implants performed by a single surgeon between January of 2001 and April of Implants used were inclusive of available premarket approval implants of three implant manufacturers: (style ), (Contour Profile Gel), and Sientra (HCG). This study includes three cohorts per implant manufacturer: primary augmentation, secondary augmentation, and primary reconstruction. This study was conducted with institutional review board oversight by all sponsors and performed in accordance with U.S. Food and Drug Administration regulations. All patients were given financial stipends by the respective manufacturers at the time of enrollment and with each study-mandated visit to encourage compliance with follow-up. All magnetic resonance imaging scans requested by the company were paid for by the respective manufacturer. Sponsors supplied a small stipend to cover the administrative costs of paperwork and submission for the U.S. Food and Drug Administration trials. Patients determined by the senior author (L.H.B.) to be candidates for contoured implants were given the option of contoured implants and all other implant options, such as round silicone or saline implants. Implants were selected based on availability and patient sizing requirements. No adjustments were made to the implant costs to encourage the choice of any company. Surgical Procedure All implantation procedures were performed by the senior author. The inframammary incision was preferred. The size of the incision was consistent with the implant manufacturer s recommendations to avoid implant rupture. Pocket selection for primary augmentation (subglandular, dualplane) was based primarily on the thickness of the soft tissue. For reconstruction patients, all implants were placed in a subpectoral or dual plane. Intravenous antibiotics were given preoperatively in all cases. All patients were given oral antibiotics starting 3 days preoperatively and for 90 days postoperatively, with sulfamethoxazole/trimethoprim (Bactrim; Roche Pharmaceuticals, Nutley, N.J.) being the antibiotic of choice. Breast pockets were dissected meticulously to avoid implant rotation. All breast pockets were irrigated with bacitracin and instilled with gentamicin at the conclusion of the case. Patients were instructed to wear a surgical bra for 1 week postoperatively and then go braless for 1 year. Implant massage was not recommended. Data Collection and Statistical Analysis All patients were enrolled in premarket approval, U.S. Food and Drug Administration clinical trials. Data collection began at the initial consultation and included the patient s comprehensive history. Patients were seen the day after surgery; on days 5 to 7, 6 to 12 weeks, and 1 year postoperatively; and then yearly for up to 10 years. Complication analysis included but was not limited to hematoma, seroma, infection, capsular contracture, implant rotation, implant malposition, implant rupture, rippling, development of autoimmune disease, occurrence of new breast cancer, and any need for reoperation. In this study, a grade I capsular contracture included any breast that felt and appeared natural. A grade II breast was firmer than expected/desired from an implant alone. A grade III breast was firm with some distortion of shape. A grade IV breast is a very firm, distorted, and painful breast. 958

3 Volume 136, Number 5 Contoured Cohesive Gel Breast Implants Effectiveness of the implants was assessed by patient and surgeon satisfaction. At each office visit, both surgeon and patient were asked to record satisfaction with outcome. Satisfaction was graded on a Likert scale, with 1 = definitely satisfied, 2 = somewhat satisfied, 3 = neither, 4 = somewhat dissatisfied, and 5 = definitely dissatisfied. Patient responses were obtained in private or with a nonmedical staff person present. Patient data were recorded for a maximum of 10 years. Deidentified data were analyzed using SPSS 17.0 (SPSS, Inc., Chicago, Ill.). Univariate analysis was used for distribution (ranges of values, frequency distribution), central tendency (mean, median, mode), and dispersion (range, standard deviation). A t test was used to compare the groups for outcomes, complications, and satisfaction. A Bonferroni correction was used to make the p values tighter and decrease the number of erroneous p values. RESULTS Patient Demographic and Surgical Characteristics Seven hundred thirty-three patients enrolled in the contoured implant studies; 695 patients had complete data and were included in this study. Three hundred eighty-four patients underwent primary augmentation, 198 underwent secondary augmentation, and 113 underwent breast reconstruction. studies began in 2001 and were completed in Sientra studies began in 2002 and continue at present. studies began in 2004 and were completed in Twenty-four percent of patients received implants (164 patients), 35 percent received implants Table 1. Patient Characteristics* Implant Type All Patients Mean Range Mean Range Mean Range Mean Range Age at implantation, yr a b b Time in study, yr 5.3 < a < a < b <1 10 Implant size, cc a b b *Values in the same row not sharing the same subscript letter (a or b) are significantly different at p < 0.05 in the two-sided test of equality for column proportions. Tests assume equal variances. Categories in which the column proportion is equal to 0 or 1 and categories in which the sum of case weights is <2 are not used in comparisons. Tests are adjusted for all pairwise comparisons within a row using the Bonferroni correction. Table 2. Surgical Characteristics* Implant Type All Patients No. % No. % No. % No. % Anesthesia type General a b a 42.9 MAC a b a 57.1 Epidural/MAC Incision location Inframammary Transaxillary V-Q incision/mastopexy Periareolar Latissimus dorsi Implant placement Submuscular a b b 50.2 Subglandular Type of surgery a b b 49.8 Primary augmentation a b a 60.7 Secondary augmentation After mastectomy a b c 15.6 MAC, monitored anesthesia care. *Values in the same row not sharing the same subscript letter (a, b, or c) are significantly different at p < 0.05 in the two-sided test of equality for column proportions. Tests assume equal variances. Categories in which the column proportion is equal to 0 or 1 and categories in which the sum of case weights is <2 are not used in comparisons. Tests are adjusted for all pairwise comparisons within a row using the Bonferroni correction. 959

4 Plastic and Reconstructive Surgery November 2015 Table 3. Complications by Type of Surgery and Type of Implant* Primary Augmentation Secondary Augmentation After Mastectomy No. % No. % No. % No. % No. % No. % No. % No. % No. % All cases Cases with no complications 106 a a b Cases requiring reoperation Cases requiring explantation Complications Hematoma Capsular contracture Malposition 9 a,b a b Implant rotation Implant rupture Implant fracture Scar/hypertrophic scar 14 a,b a b Breast cancer after implant Wrinkling/rippling Palpability Pain/tenderness Asymmetry 14 a a b Hard/firm Wound separation Giant galactocele Bottom dropout/pseudoptosis Delayed healing Symmastia 1 a Loss of nipple sensation Other complications 26 a a b *Values in the same row not sharing the same subscript letter (a or b) are significantly different at p < 0.05 in the two-sided test of equality for column proportions. Tests assume equal variances. Categories in which the column proportion is equal to 0 or 1 and categories in which the sum of case weights is <2 are not used in comparisons. Tests are adjusted for all pairwise comparisons within a row using the Bonferroni correction. 960

5 Volume 136, Number 5 Contoured Cohesive Gel Breast Implants (245 patients), and 41 percent received Sientra implants (286 patients). Patient and surgical characteristics are listed in Tables 1 and 2. Safety Outcomes Complications by type of procedure and implant manufacturer are listed in Table 3. In this study population, there were no breast infections that required surgical treatment. There were two postoperative hematomas and no cases of early (first year) seromas. No autoimmune disease was diagnosed. The incidence of newly diagnosed breast cancer in the primary and secondary augmentation groups was 1 percent (six patients). There were no cases of anaplastic large cell lymphoma. The percentage of total complications was significantly lower for the primary augmentation patients compared with Sientra and primary augmentation patients (p < 0.05). There were no statistically significant differences between implant manufacturer overall complication rates when compared for secondary augmentation and breast reconstruction. Overall rates of complications were higher for the secondary augmentation group and highest for the breast reconstruction group compared with the primary augmentation group. Explantation was defined as removal of the implant for any reason, with or without replacement. There was no statistically significant difference between implant manufacturers explantation rates when used for primary augmentation, secondary augmentation, or reconstruction. Ninety-five percent of all patients having implants explanted had them replaced immediately with the same or different implants. The causes for explantation were not a part of the comparative data evaluated for this article. Explantation rates were higher in the secondary augmentation and breast reconstruction groups compared with the primary augmentation group. Reoperation was defined as any additional surgical procedure related to the implant, inclusive of explantation. No statistically significant differences between implant manufacturer reoperation rates were found. Overall reoperation rates were low for primary augmentation, with higher rates for the secondary augmentation group and highest rates for the breast reconstruction group. Reasons for reoperation were not directly recorded. Implant rupture rate did not differ significantly by implant manufacturer. The overall rupture rate was 0.7 percent (five patients). Ruptures were diagnosed clinically or by routine magnetic resonance imaging. All ruptures were confirmed by explantation of the implant. Implant rotation rate did not differ significantly between the implant manufacturers. The overall rotation rate was 1.3 percent (nine patients). Six rotations were treated with manual manipulation of the implant and then taped for 3 to 6 weeks, with avoidance of surgery. Three rotations required an operation (capsulorrhaphy) to correct the rotation, with no recurrences. The rate of implant rippling did not differ significantly between implant manufacturers. Rippling rates were low for primary augmentation, with higher rates for secondary augmentation and highest rates for the breast reconstruction group. Table 4. Capsular Contracture by Type of Surgery and Type of Implant* Primary Augmentation Secondary Augmentation After Mastectomy No. % No. % No. % No. % No. % No. % No. % No. % No. % All cases Cases with capsular contracture Baker class I I III I V Required reoperation Time to capsular contracture By 1 yr By 5 yr After 5 yr *Values in the same row not sharing the same subscript are significantly different at p < 0.05 in the two-sided test of equality for column proportions. Tests assume equal variances. Categories in which the column proportion is equal to 0 or 1 and categories in which the sum of case weights is <2 are not used in comparisons. Tests are adjusted for all pairwise comparisons within a row using the Bonferroni correction. 961

6 Plastic and Reconstructive Surgery November 2015 Table 5. Capsular Contracture by Type of Surgery and Type of Implant* Primary Augmentation Secondary Augmentation After Mastectomy Mean Range Mean Range Mean Range Mean Range Mean Range Mean Range Mean Range Mean Range Mean Range Year capsular contracture % *Values in the same row not sharing the same subscript are significantly different at p < 0.05 in the two-sided test of equality for column proportions. Tests assume equal variances. Categories in which the column proportion is equal to 0 or 1 and categories in which the sum of case weights is <2 are not used in comparisons. Tests are adjusted for all pairwise comparisons within a row using the Bonferroni correction. Capsular contracture rates are listed in Tables 4 and 5. There were no statistically significant differences between implant manufacturers capsular contracture rates. The total capsular contracture rate for all primary augmentation patients inclusive of Baker grade II was 4.7 percent, with 0.8 percent occurring at 1 year and 3.8 percent occurring at 5 years. For all patients with primary augmentation, the capsular contracture rate was 3.6 percent for submuscular implants and 5.2 percent for subglandular implants. The Pearson chi-square test did not detect a significant difference in these rates (p = 0.50). Total capsular contracture rate for secondary augmentation patients was 8.6 percent, with 1 percent occurring at 1 year and 6.6 percent occurring at 5 years. The total capsular contracture rate for reconstruction patients was 13.3 percent, with 2.7 percent occurring at 1 year and 11.5 percent occurring by 5 years. The total rate of reoperation for capsular contracture was 1.3 percent for the primary augmentation group, 3.0 percent for the secondary augmentation group, and 7.1 percent for the reconstruction group. Effectiveness Patient and surgeon satisfaction were measured on a Likert scale. The percentage of patients definitely satisfied with their breasts after implant procedures chosen at two time points, 1 and 5 years, is shown in Figure 1. For all manufacturers and procedures, surgeon and patient satisfaction was initially high at 1 year but declined at 5 years. Breast reconstruction patients were the least satisfied. Some statistically significant differences for satisfaction between implant manufacturers were found for the primary augmentation group (Table 6). and Sientra primary augmentation groups were found to have a higher rate of patients definitely satisfied compared with. had the highest rate of physician satisfaction at 1 year, followed by Sientra and then. Physician satisfaction at 5 years was highest for implants. DISCUSSION In 2012, Sientra marked the first U.S. approval and commercially available contoured cohesive silicone gel breast implants. and implant approval followed in This is the first prospective study directly comparing outcomes with use of all three implant manufacturers. This study includes data collected prospectively from almost 700 patients undergoing augmentation or breast reconstruction with a standardized surgical approach. Overall, there were no statistically significant differences between implant manufacturer 962

7 Volume 136, Number 5 Contoured Cohesive Gel Breast Implants Fig. 1. Percentage of patients definitely satisfied with their breast after implant procedures at 1 and 5 years. complication rates when compared for secondary augmentation and breast reconstruction. When compared for primary augmentation, patients had a lower rate of complications. This may be attributable to several factors. patients spent overall less time in the study, as was the last manufacturer to join. Although not statistically significant, implants did trend toward lower capsular contracture rates and lower rates of explantation and reoperation, all adding to the overall lower complication rate. Rates of implant explantation were uniformly low for all primary augmentation groups (1.4 to 5.5 percent). Reoperation rates for primary augmentation were 5.4 percent for implants, 10.2 percent for Sientra implants, and 15.1 percent for implants. Our rates were similar to or lower than previously published data, with reoperation rates for primary augmentation at 18 percent for, percent for Sientra, 12 and 12.5 to 19.4 percent for. 16,19 To assess the integrity of the implants, we looked at implant rupture rates. Previous literature suggests that the risk of contoured cohesive gel implant rupture is 1.8 percent for Sientra, percent for, 3 and 0.3 to 6.4 percent for. 14,16,20 Our total rupture rate was lower at 0.7 percent and occurred between 3 and 8 years. Onethird of all of our patients had been selected for routine magnetic resonance imaging surveillance. We cannot exclude the possibility of silent ruptures in the asymptomatic population that had not been selected for magnetic resonance imaging. None of the patients with rupture demonstrated gross extracapsular gel, silicoma formation, or axillary lymphadenopathy on imaging or at time of surgery. One of the major concerns with use of an asymmetrically shaped implant is rotation. Meticulous pocket dissection and use of support brassieres with binder strips have been recommended. 21 Some authors propose always using subfascial placement of the implant to prevent its rotation. 22 The rotation rate in this study was low, 1.3 percent. Rotation or back-to-front flipping can be treated with manual manipulation; this was the case in six of our nine patients. 23 Similarly low rotation rates for primary augmentation with contoured implants have been documented in the literature: Sientra, 1.9 percent 12 ;, 1.1 percent 3 ; and, 2.3 to 2.6 percent. 16,19 Capsular contracture is one of the most common complications of breast augmentation surgery. In the 1980s, Dubin noted the association of capsular contracture and bacteria (70 percent of those affected had positive cultures) and attempted use of bacitracin foam. 24 Burkhardt et al. suggested the use of intraluminal antibiotic for saline implants. 25,26 Based on this background, we began the use of long-term (90 days) low-dose Bactrim. Recently, this practice gained traction, with a publication by Mirzabeigi et al. that supported the use of Bactrim for 30 days in the mastectomy irradiated patient with implant reconstruction. 27 In this study, capsular contracture rates for primary augmentation, inclusive of grade III to IV, were low:, 1.8 percent; Sientra, 6.6 percent; and, 0 percent. These rates are comparable to those previously reported in the literature: Sientra, 963

8 Plastic and Reconstructive Surgery November 2015 Table 6. Patient and Physician Satisfaction by Type of Surgery and Type of Implant* Primary Augmentation Secondary Augmentation After Mastectomy No. % No. % No. % No. % No. % No. % No. % No. % No. % Patient satisfaction at 1 yr Total a b a a b a Patient satisfaction at 5 yr a Total a b a a b a Physician satisfaction at 1 yr Total a,b a b a b a Physician satisfaction at 5 yr Total a a b a,b a b *Values in the same row not sharing the same subscript letter (a or b) are significantly different at p < 0.05 in the two-sided test of equality for column proportions. Tests assume equal variances. Categories in which the column proportion is equal to 0 or 1 and categories in which the sum of case weights is <2 are not used in comparisons. Tests are adjusted for all pairwise comparisons within a row using the Bonferroni correction. and Sientra primary augmentation groups were found to have a higher rate of patients definitely satisfied at 1 and 5 yr compared with. had the highest rate of physician satisfaction at 1 yr followed by Sientra and then. Physician satisfaction at 5 yr was highest for implants. 964

9 Volume 136, Number 5 Contoured Cohesive Gel Breast Implants 3 percent 12 ;, 2.4 percent 3 ; and, 1.8 to 5.6 percent. 10,14,16,19,20 Although not statistically significant, implants had the lowest rate of capsular contracture for primary and secondary augmentations. When directly comparing all three implant manufacturers inclusive of all three types of surgical procedures, implants overall were found to have a significantly lower capsular contracture rate. This may be attributed to subjects having less total years in the study, 4.2 years, compared with 6 years for Sientra and, as the capsular contracture rates noted at 1 year were extremely low for all manufacturers (Sientra, 1.7 percent;, 0 percent; and, 0 percent). In addition, subjects were more likely to have submuscular implants versus subglandular. However, when looking at all manufacturers, our statistical analysis did not reveal a significant difference between capsular contracture rates of submuscular and subglandular implants. As capsular contracture rates are overall extremely low, we believe this may be secondary to the texturing of the contoured devices, the shape, the cohesive nature, and other intraoperative and postoperative factors. A Sientra 5-year follow-up study found a significant difference in textured versus smooth implants and capsular contracture rates, with a 10 percent risk of contracture at 5 years for smooth implants and a 3 percent risk for textured. 12 Other studies have similarly documented decreased capsular contracture rates with textured implants. 2,28 30 There is some evidence to support that the texturing may in fact cause better implant anchoring, organization of fibroblasts, and therefore a decrease in capsular contracture. 31 With regard to the exact method of implant texturing, the three implant manufacturers differ. uses Biocell, an aggressive open-pore textured surface created with a lost-salt technique. 32 Some authors have found Biocell to be associated with higher capsular contracture rates and late seromas and double capsules. 33 Siltex is created using a negative-contact imprint off a texturing foam. 32 Siltex has been known to cause less adherence of the implant to the capsule. 33 Sientra uses TRUE Texture, a proprietary texturing technique. Previous literature suggests high satisfaction rates with the use of the contoured cohesive gel implants. 2,13 16,19 Although patients are guided to rate satisfaction with their breasts, breast satisfaction cannot always be separated from how one may view their overall appearance and satisfaction with self; therefore, this is a subjective measure of effectiveness. In this study, patient and surgeon satisfaction correlated and was found to be highest at 1 year. Satisfaction did decline for all cohorts at 5 years, which is likely related to issues such as capsular contracture, implant rupture, or other implant-related complications. When used for primary augmentation, and Sientra were found to have significantly higher rates of patient and surgeon satisfaction, with having the highest rate. This is likely secondary to the fact that had the lowest overall rate of complications, explantation, reoperation, and capsular contracture and a greater ability to achieve symmetry in asymmetrical breasts and a more natural appearing upper pole because of the wider assortment of sizes and shapes available from this company. However, our evaluation of satisfaction is limited to a subjective measurement on a Likert scale. Previous studies using a validated survey (i.e., BREAST-Q) have shown comparable satisfaction between round and shaped cohesive gel breast implants. 34 This study does present some obvious limitations. The study was performed by a single surgeon, which allowed us to directly compare implant manufacturers; however, a multicenter study may have been more generalizable. The choice of implant manufacturer was not randomized. The first study enrolled was in 2001, followed by Sientra in 2002 and in As all three implants were not available at any given time, choice was often based on what implant was immediately available. Nonrandomization leads to some differences between our patient populations. Specifically, patients had fewer total years in the study, as they were the last to be enrolled. patients had fewer primary augmentations and more breast reconstructions, which is likely attributable to the senior author performing more breast reconstruction earlier on in his practice. CONCLUSIONS Contoured cohesive gel breast implants are an additional tool available to the plastic surgeon. All three implant manufacturers perform similarly, with low rupture, rotation, rippling, and capsular contracture rates. Contoured implants have been found to be both safe and effective, with high patient and surgeon satisfaction. We plan to discuss patient selection, implant choices, and operative technique in a future article. Lewis H. Berger, M.D West St. Isabel Street, Suite 2C Tampa, Fla lberger@tampabay.rr.com 965

10 Plastic and Reconstructive Surgery November 2015 acknowledgments A special thanks to the staff at the Cosmetic and Reconstructive Surgery Center, Tampa, for their years of hard work and dedication to our patients and the success of this study. references 1. American Society of Plastic Surgeons. Cosmetic plastic surgery statistics Available at: plastic-surgery-statistics/2013.html. Accessed April 15, Caplin DA. Indications for the use of MemoryShape breast implants in aesthetic and reconstructive breast surgery: Longterm clinical outcomes of shaped versus round silicone breast implants. Plast Reconstr Surg. 2014;134(Suppl):27S 37S. 3. Hammond DC, Migliori MM, Caplin DA, Garcia ME, Phillips CA. Contour Profile Gel implants: Clinical outcomes at 6 years. Plast Reconstr Surg. 2012;129: Nahabedian MY. Shaped versus round implants for breast reconstruction: Indications and outcomes. Plast Reconstr Surg Glob Open 2014;2:e Weum S, de Weerd L, Kristiansen B. Form stability of the Style anatomically shaped cohesive silicone gel-filled breast implant in subglandular breast augmentation evaluated with magnetic resonance imaging. Plast Reconstr Surg. 2011;127: Delgado JF, García-Guilarte RF, Palazuelo MR, Mendez JI, Pérez CC. Immediate breast reconstruction with direct, anatomic, gel-cohesive, extra-projection prosthesis: 400 cases. Plast Reconstr Surg. 2010;125: Cárdenas-Camarena L, Encinas-Brambila J. Round gel breast implants or anatomic gel breast implants: Which is the best choice? Aesthetic Plast Surg. 2009;33: Brown MH, Shenker R, Silver SA. Cohesive silicone gel breast implants in aesthetic and reconstructive breast surgery. Plast Reconstr Surg. 2005;116: ; discussion Panettiere P, Marchetti L, Accorsi D. Soft cohesive silicone gel breast prostheses: A comparative prospective study of aesthetic results versus lower cohesivity silicone gel prostheses. J Plast Reconstr Aesthet Surg. 2007;60: 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: Panchapakesan V, Brown MH. Management of tuberous breast deformity with anatomic cohesive silicone gel breast implants. Aesthetic Plast Surg. 2009;33: Stevens WG, Harrington J, Alizadeh K, et al. Five-year followup data from the U.S. clinical trial for Sientra s U.S. Food and Drug Administration-approved brand round and shaped implants with high-strength silicone gel. Plast Reconstr Surg. 2012;130: Jewell ML, Jewell JL. A comparison of outcomes involving highly cohesive, form-stable breast implants from two manufacturers in patients undergoing primary breast augmentation. Aesthet Surg J. 2010;30: Hedén P, Bronz G, Elberg JJ, et al. Long-term safety and effectiveness of style highly cohesive silicone breast implants. Aesthetic Plast Surg. 2009;33: ; discussion Niechajev I, Jurell G, Lohjelm L. Prospective study comparing two brands of cohesive gel breast implants with anatomic shape: 5-year follow-up evaluation. Aesthetic Plast Surg. 2007;31: Maxwell GP, Van Natta BW, Murphy DK, Slicton A, Bengtson BP. Natrelle style form-stable silicone breast implants: Core study results at 6 years. Aesthet Surg J. 2012;32: Friedman T, Davidovitch N, Scheflan M. Comparative double blind clinical study on round versus shaped cohesive gel implants. Aesthet Surg J. 2006;26: Bronz G. A comparison of naturally shaped and round implants. Aesthet Surg J. 2002;22: Bengtson BP, Van Natta BW, Murphy DK, Slicton A, Maxwell GP; Style U.S. Core Clinical Study Group. Style highly cohesive silicone breast implant core study results at 3 years. Plast Reconstr Surg. 2007;120(Suppl 1):40S 48S. 20. Hedén P, Boné B, Murphy DK, Slicton A, Walker PS. Style cohesive silicone breast implants: Safety and effectiveness at 5 to 9 years after implantation. 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Plast Reconstr Surg. 1981;68: Burkhardt BR, Dempsey PD, Schnur PL, Tofield JJ. Capsular contracture: A prospective study of the effect of local antibacterial agents. Plast Reconstr Surg. 1986;77: Mirzabeigi MN, Lee M, Smartt JM Jr, Jandali S, Sonnad SS, Serletti JM. Extended trimethoprim/sulfamethoxazole prophylaxis for implant reconstruction in the previously irradiated chest wall. Plast Reconstr Surg. 2012;129:37e 45e. 28. Barnsley GP, Sigurdson LJ, Barnsley SE. Textured surface breast implants in the prevention of capsular contracture among breast augmentation patients: A meta-analysis of randomized controlled trials. Plast Reconstr Surg. 2006;117: Collis N, Coleman D, Foo IT, Sharpe DT. Ten-year review of a prospective randomized controlled trial of textured versus smooth subglandular silicone gel breast implants. Plast Reconstr Surg. 2000;106: Wong CH, Samuel M, Tan BK, Song C. 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