Do Not Fear an Implant’s Shape: A Single Surgeon’s Experience of Over 1200 Round and Shaped Textured Implants in Primary Breast Augmentation

Do Not Fear an Implant’s Shape: A Single Surgeon’s Experience of Over 1200 Round and Shaped... Abstract Background Breast implants can be characterized by their fill material, surface texture, or shape. Whereas long-term good quality studies have provided evidence for the fill material and texture, there is still little consensus for choosing the shape of an implant. Surveys indicate that many surgeons choose only one implant shape, for reasons that may not always agree with outcomes from long-term studies. Objectives We reviewed the first author’s experience over the last six years with both round and anatomical implants, compared the rate of complications with either implant shape, and discussed the importance of keeping an open mind about using both implant shapes for primary breast augmentation. Methods A review of all consecutive primary breast augmentation patients by the first author over a six-year time period who had a minimum follow up of 6 months after surgery. Results Six-hundred and forty-eight female patients had 1296 silicone breast implants inserted over the six-year period. Mean age at surgery was 30.5 years and mean BMI was 20.6 kg/m2. All implants were textured, 134 (in 67 patients, 10.3%) were round in shape with mean volume of 338 cc (range, 220-560 cc), while 1162 implants (in 581 patients, 89.7%) were anatomical shaped with a mean volume of 309 cc (range, 140-615 cc). Among these patients, 11.9% (n = 8) with round implants and 9.0% (n = 52) of those with anatomical implants developed complications postoperatively. Conclusions A single, ideal implant that is suitable for every primary breast augmentation does not exist. The optimum choice of implant shape in any given situation should take into account the patient’s physical characteristics, available implant types, patient’s desires, and the surgeon’s experience. Together with round implants, anatomical devices ought to be considered as one of the tools in the surgeon’s toolbox. By choosing to ignore them a priori means that the surgeon will only have access to half of his armamentarium and will therefore be able to offer a limited set of options to his patients. Level of Evidence: 4 Breast implants are characterized by their shape, texture, and fill. Long-term data have certainly helped settle the historical controversy about the implant fill. As a result, both saline and silicone implants are available since 2006 in the United States (which is one of the largest markets for these products).1,2 Whereas texture has attracted its own share of discussion, which is still ongoing, there is evidence that surface texturing helps decrease the rate of capsular contracture.3,4 The third physical characteristic of breast implants is the shape. The surgical community appears to be polarized on the question of choosing an appropriate implant shape for breast augmentation, whether anatomical or round. As a recent survey of American Society of Plastic Surgeons (ASPS) members5 showed that half of the surgeons questioned had never used an anatomical implant. Given the fact that there is a considerable variation in patient’s body shape as well as soft tissue cover and distribution, we think that any one shape of implants cannot provide consistent results in every patient. We would like to offer some observations in this open-ended debate based on the first author’s experience of over 1200 consecutive breast implantations during a six-year period. We propose a null hypothesis that one shape is not, a priori, better than the other and suggest that aesthetic outcome ought not be the sole indication for choosing an implant. The references discuss the evidence of other possible indications for choosing an implant. Finally, the clinical photographs illustrate the interaction of different implant shapes with the soft tissue envelope. METHODS All consecutive female patients who underwent primary breast augmentation by the first author (P.M.) from January 2010 to February 2016 at our clinic, were included. Patients whose follow up was less than 6 months were excluded from this analysis. Data was collected prospectively for patient age, BMI (in kg/m2), preoperative cup-size, number of children, existing medications, smoking status, physical characteristics of the implants, length of follow up, and any complications. The data were analyzed using the “R” open source statistical software.6 Fisher’s exact test was used to calculate the significance of binary outcome variables. A P-value of less than 0.05 was regarded as significant. RESULTS Six-hundred and forty-eight female patients had 1296 silicone breast implants inserted between January 2010 and February 2016 at our facility. All patients were counselled in accordance with the Declaration of Helsinki guidelines and written informed consent was obtained preoperatively. Mean age of the patients at surgery was 30.5 years (range, 18-56 years). The mean patient height was 167.3 cm (range, 144-188 cm), and their mean BMI was 20.6 kg/m2 (range, 15.9-30.1 kg/m2). The mean number of children at the index operation was 1.02 (range, 0-5). Two-hundred and eighty-four patients (43.8%) considered themselves to have “A” cup size, 322 (49.7%) a “B,” and 42 (6.5%) a “C” cup size. Eighty patients (12.3%) were using (at least one) medication for an existing medical condition while 167 (25.8%) were only taking the contraceptive pill. Seventy-three patients (11.2%) admitted to smoking an average of 8.8 cigarettes per day (range, 1-20 cigarettes/day). Mean follow up was 12.7 months (range, 6-65 months) after surgery. All operations were performed in general anesthesia via an inframammary incision. Two patients received the implants in the subglandular pocket while the rest of them had dual plane placement. Mean implant volume was 312 cc (range, 140-615 cc). All implants were textured, 134 of them (in 67 patients, 10.3%) were round in shape with mean volume of 338 cc (range, 220-560 cc) while 1162 implants (in 581 patients, 89.7%) were anatomical shaped with a mean volume of 309 cc (range, 140-615 cc). Table 1 shows implant characteristics with respect to shape and projection. Table 1. Implant Characteristics (n = 1296) by Shape and Projection   Low projection  Medium projection  Full projection  Extra full projection  All projections  Shaped full height  0  0  2  28  30  Shaped medium height  16  113  330  533  992  Shaped low height  0  10  38  92  140  Round implant  2  9  77  46  134  All heights  18  132  447  699  1296    Low projection  Medium projection  Full projection  Extra full projection  All projections  Shaped full height  0  0  2  28  30  Shaped medium height  16  113  330  533  992  Shaped low height  0  10  38  92  140  Round implant  2  9  77  46  134  All heights  18  132  447  699  1296  View Large In total, 61 patients (9.4%) developed 63 complications postoperatively. These represented 11.9% (n = 8) of patients with round implants and 9.0% (n = 52) of those with anatomical implants. Table 2 compares the complications with each implant type, with the relevant P value calculated using Fisher’s exact test and the associated confidence intervals. Table 2. Complications Segregated by Implant Shape   Round implants (n = 67)  Shaped implants (n = 581)  P value  95% confidence interval  Rotation  0 (0%)  21 (3.6%)*  0.153  0.00-1.65  Capsular contracture  1 (1.5%)  13 (2.2%)  1.000  0.02-4.54  Bottoming out  5 (7.5%)**  9 (1.5%)  <0.05  1.30-17.6  Double bubble  1 (1.5%)  4 (0.7%)  0.421  0.04-22.5  Hematoma  0 (0%)  4 (0.7%)  1.000  0.00-13.3  Minor seroma  1 (1.5%)  3 (0.5%)  0.354  0.05-36.8  Implant failure  1 (1.5%)  0 (0%)  0.103  0-4.49  Total  9 (13.4%)  54 (9.3%)  0.505  0.52-3.04    Round implants (n = 67)  Shaped implants (n = 581)  P value  95% confidence interval  Rotation  0 (0%)  21 (3.6%)*  0.153  0.00-1.65  Capsular contracture  1 (1.5%)  13 (2.2%)  1.000  0.02-4.54  Bottoming out  5 (7.5%)**  9 (1.5%)  <0.05  1.30-17.6  Double bubble  1 (1.5%)  4 (0.7%)  0.421  0.04-22.5  Hematoma  0 (0%)  4 (0.7%)  1.000  0.00-13.3  Minor seroma  1 (1.5%)  3 (0.5%)  0.354  0.05-36.8  Implant failure  1 (1.5%)  0 (0%)  0.103  0-4.49  Total  9 (13.4%)  54 (9.3%)  0.505  0.52-3.04  * One of these patients had capsular contracture as well. ** One of these patients developed a minor seroma at 7 months after surgery that was addressed with ultrasound guided aspiration. View Large In 21 patients (3.6%) the implants malrotated at a mean 8.9 months after surgery (range, 3-34 months). Eight of these implants were in the right and 13 in the left breast. Fourteen patients (2.2%) developed capsular contracture (CC) at an average 20.0 months (range, 3-48 months). In three patients, only the right side was affected, in 9 the left side, while 2 patients developed bilateral CC. The 13 patients with anatomical implants who developed CC had a mean implant volume of 360 cc (range, 215-615 cc). This capsule was formed at a mean 20.5 months (range, 2-48 months). The only CC in a round implant had a volume of 525 cc (at 14 months after surgery). Four (of these 14) patients (28.6%) developed a recurrent CC at a mean 31 months after the first correction (range, 20-35 months). In one patient, recurrent aggressive CC necessitated explantation (at 57 months). In 14 patients (2.2%), the implants “bottomed out,” six on the right, seven on the left, and one on both sides at a mean 11.5 months after augmentation (range, 5-39 months). Five patients (0.8%) developed a “double bubble” deformity at a mean 16.2 months of follow up (range, 6-34 months). Four patients (0.6%) developed postoperative hematomas that were managed surgically. Three hematomas developed within 24 hours of the operation while one was found at the patient’s outpatient review one week after the operation. There were 4 small volume uncomplicated seromas that were aspirated with ultrasound guidance and managed according to existing protocol. In total, 33 patients (5.1%) had change of implants at a mean 13.1 months postoperative (range, 2-47 months). Of these, 11 (1.7%) were after a complication and 22 (3.4%) patients chose to change the implants in absence of any complication. (Tables 3-4). Thirty of the new implants placed were round and 3 were anatomical shaped. The mean volume of the new implants was 433 cc (range, 295-605 cc) and was a mean 102 cc larger than the previous ones (range, -95 cc to 165 cc). Table 3. Details of Patients Whose Implants Were Exchanged as a Result of a Complication*     Implant shape after exchange      Anatomical  Round  Original implants  Anatomical  1 (0.11%)  8 (1.4%)  Round  0 (0%)  2 (2.9%)      Implant shape after exchange      Anatomical  Round  Original implants  Anatomical  1 (0.11%)  8 (1.4%)  Round  0 (0%)  2 (2.9%)  * No significant difference between original implant shapes (P = 0.317, CI = 0.102-4.97). View Large Table 4. Details of Patients Whose Implants Were Exchanged in Absence of Any Complication     Implant shape after exchange      Anatomical  Round  Original implants  Anatomical  2 (0.2%)  15 (1.8%)  Round  0 (0%)  5 (7.5%)      Implant shape after exchange      Anatomical  Round  Original implants  Anatomical  2 (0.2%)  15 (1.8%)  Round  0 (0%)  5 (7.5%)  View Large Of the 8 patients whose shaped implants were changed to round ones (Table 3), three had implant malrotation, another three had implant bottoming out but also wanted a larger volume with the operation, one had bilateral capsular contracture, and one needed a mastopexy alongside capsulectomy. There were 22 patients (Table 4) in whom the implants were exchanged on patient’s request for a larger volume. Of these, 15 patients chose to replace shaped implants with round ones because of cost efficiency. The rest chose the shame implant shape for the secondary surgery. DISCUSSION Silicone breast devices are available in round or anatomical shapes. Like most topics in breast surgery, the choice of implant shape has attracted much debate as well. In 2015, a total of 279,143 breast augmentation procedures were performed in the United States1 and even though silicone implants have been available there since 2006, the use of anatomical shaped silicone devices is not as frequent as in other parts of the world.5 Hidalgo et al5 surveyed members of ASPS and found that 50% had never used anatomically shaped devices. Another 42% of surgeons had used them in less than half of their surgeries. The three main concerns raised for not using anatomical implants in the survey were risk of rotation, the increased cost and the lack of evidence of aesthetic considerations. Sixty-eight respondents provided comments as well, most common of which stated that anatomical implants were too firm, lacked upper pole fullness, and had an increased risk of wrinkling and palpability. Rotation The risk of rotation is a commonly cited issue in the survey by Hidalgo et al5 as well as in conferences and forums. The anatomical implants are seen by some surgeons as “not safe to use” due to higher risk for complications in general. However, the core studies show that the overall risk of malposition is de facto higher with round implants as compared to shaped devices, from the same manufacturer.3 Since our follow up is less than that of the core studies, a head to head comparison is not possible. Within this limitation, our data appears to have a similar trend. In the Mentor (Mentor Inc., Irvine, CA) core study7 at 3 years follow up, the 551 patients who underwent primary breast augmentation with either smooth or textured round implants had a 8.4% to 9.9% incidence rate of major complications (8.1% Baker grade 3 or 4 capsular contracture, 0.3%-1.8% rippling, no data on malposition) (Figure 1) as compared to 4.2% complications3 in 572 primary augmentations that received Siltex shaped implants (0.8% CC, 1.1% malposition, 1.8% rippling, and 0.5% seroma). Similarly, Allergan’s (Allergan Inc., Irvine, CA) textured and smooth round implants3 had 19.3% major complications rate in 455 primary augmentation patients (13.2% CC, 4.1% malposition, 1.3% seroma, and 0.7% rippling) at 4 years. This compared to 5.8% (1.9% CC, 2.6% malposition, 0.8% seroma, and 0.5% rippling) at 3 years in 492 Biocell textured shaped implants. This trend is persistent between the two major manufacturers and continues even at longer follow up. Even with the 2% rotation rate commonly quoted in the literature, the overall complications in anatomical implants are less than those in round implants. For this reason, rotation rate alone may not be the sole justifying criteria for dismissing anatomical devices. Figure 1. View largeDownload slide Comparison of complications reported by two manufacturers of different implants at 3 to 4 years. Figure 1. View largeDownload slide Comparison of complications reported by two manufacturers of different implants at 3 to 4 years. Our results agree with the trend that overall complications with round implants are higher (Table 2). Literature suggests that anatomical implants have a learning curve,8 which may account for the trepidation felt in switching over to them. The patients who received shaped devices in the first half of our series had a slightly higher risk of complications than in the later half. The rate of implant rotation in the first half of our series was 4.0% and once appropriate pocket control was achieved by the surgeon, it decreased to 2.5% in the second half of the case series (with similar length of follow up). Even with the higher figure, the total risk of implant malposition in anatomical implants was less (Table 2). In our series, only 3 shaped implants (out of 21 that malrotated) were exchanged for round ones. The other 18 shaped implants were replaced and did not have a recurrence. Increased Cost While it is true that anatomical devices are more expensive than the corresponding rounds, it should not be the surgeon’s decision to dismiss them solely for this reason. From a professional and ethical point of view, every patient should have the chance to know all the available options. Moreover, an analysis of the lifetime cost of an implant needs to take into account not only the initial expense for the device but also that of further reoperations, both in terms of money, surgical time, and patient satisfaction. In other words, the initial cost of anatomical implants is higher (approximately twice) but when reoperations are considered, the actual difference may be much less. Aesthetic Considerations Another concern that is commonly cited is the lack of evidence of aesthetic considerations of anatomical implants. Al-Ajam et al9 asked 22 plastic surgeons to rate clinical photographs of 60 consecutive aesthetic breast augmentation patients at a mean follow up of 8 months. Thirty-three of these patients had round Inspira (Allergan Inc, Irvine, CA) implants of mean size 300 cc while 27 patients had Style 410 MM or MF with mean size 278 cc. The overall aesthetic result, natural appearance, and upper pole contour was scored slightly better in the shaped implant but did not reach statistical significance. The assessors could not consistently identify the implant shape from the clinical photographs. Friedman et al10 did a double-blind study in which standardized postoperative clinical photographs of 30 primary aesthetic breast augmentation patients were evaluated by 235 lay persons and 11 plastic surgeons. Each assessor scored the photographs on overall “beauty” and “natural shape” and upper pole fullness (less, more, or appropriate). The study did not show an aesthetic difference between breasts that had anatomical or round implants. Interestingly, the plastic surgeons were able to correctly guess the shape of the implant in 63.9% cases of round implants and in 46.7% cases of anatomical implants. Although subgroup analyses would have been very useful, these results can be explained by the fact that an appropriate implant was chosen for the patient’s body frame and tissues.10 Firmness The argument that breasts implanted with highly cohesive gel implants are firmer than those with a saline fill is subjective. The in vivo firmness of an implant is modified by the presence of overlying soft tissue. The only objective measure of a difference in pliability of two sets of implants can be to test this difference in vivo in breasts of comparable soft tissue cover. Furthermore, a firmer implant can be advantageous in some circumstances (eg, constricted lower pole of tuberous breasts are filled in well, and expanded, by the firmness of the highly cohesive gel devices).11 Upper Pole Fullness Round implants achieve upper pole fullness by the shape of the implant whereas anatomical implants achieve it indirectly by projecting the nipple-areola complex. The final shape of the breast is modified by the presence of existing soft tissue and its distribution. When used for appropriate indications, both round and anatomical implants provide an aesthetic upper pole. In the clinical comparisons of both Al-Ajam et al9 and Friedman et al,10 the plastic surgeons assessing the clinical photographs were no better than a coin toss in guessing the type of implant used for the patients’ breast augmentation. This finding goes against the argument that anatomical implants “always” have a hollow upper pole. Wrinkling and Pliability The long-term data support that the rippling rate is similar with either the round or the anatomical implants from either of the major manufacturers.3 Our Observation We think that existing volume and distribution of the breast tissue interact with the underlying breast shape to give the final outcome. In a subgroup of patients, those with good basic breast and chest characteristics, either implant shape can give an aesthetically pleasing result12 (Figure 2) to the extent that even an experience observer could not tell which shape of implant was used (Figures 3 and Supplemental Figure 1). However, this does not hold true for every patient (Figure 4).12 In other subgroups of patients, only if an implant is used for appropriate indications, the patient will have a good outcome (Supplemental Figures 2-3). This suggests that any patient cannot just have any implant. Figure 2. View largeDownload slide Venn diagram showing recommended indications for round or shaped breast implant for aesthetic surgery. Figure 2. View largeDownload slide Venn diagram showing recommended indications for round or shaped breast implant for aesthetic surgery. Figure 3. View largeDownload slide (A, C, E) This 26-year-old woman wanted a moderate enlargement with natural and proportionate look. MF295 Allergan Style 410 implants were used on both sides via a submammary incision with a dual-plane technique. (B, D, F) Appearance at 12 months postoperatively shows the nice and natural shape of the breasts with conservation of the body proportions. Figure 3. View largeDownload slide (A, C, E) This 26-year-old woman wanted a moderate enlargement with natural and proportionate look. MF295 Allergan Style 410 implants were used on both sides via a submammary incision with a dual-plane technique. (B, D, F) Appearance at 12 months postoperatively shows the nice and natural shape of the breasts with conservation of the body proportions. Figure 4. View largeDownload slide (A, C, E) This 26-year-old woman wanted a fairly big enlargement with a full augmented look. She was a nullipara and had a dense gland that offered good soft tissue cover. Inspira TSF 325 implants were used in a dual plane pocket on both sides. (B, D, F) Appearance at 14 months postoperatively shows good upper pole fullness and nice shape of the breasts. Figure 4. View largeDownload slide (A, C, E) This 26-year-old woman wanted a fairly big enlargement with a full augmented look. She was a nullipara and had a dense gland that offered good soft tissue cover. Inspira TSF 325 implants were used in a dual plane pocket on both sides. (B, D, F) Appearance at 14 months postoperatively shows good upper pole fullness and nice shape of the breasts. For example, in patients with short nipple to inframammary fold (IMF) distance and/or constricted lower pole (Supplemental Figure 1), the inferior edge of a round implant would end up well beyond the existing IMF. This would increase the risk of double bubble deformity. In order to avoid such situations, we think that low height anatomical implants are a better option, because the vertical height of the lower pole is approximately 25% to 33% of the total implant height.13 In these situations, choosing to ignore anatomical implants because of a perceived risk of rotation may not be a good strategy due to the alternative risk of double bubble deformity with the round implants.12,14 Rubi et al15 recently compared aesthetic results after primary breast augmentation with round or anatomical implants but specifically excluded the group of patients who had a short nipple to IMF distance. Chest wall deformities and breast asymmetries are also better addressed with anatomical implants, as the implant width, height, and projection can be controlled independently to offer greater possibility of customization. This is because while round implants only give the possibility of choosing two dimensions (width and projection), shaped implants can be customized in all three dimensions (height, width, and projection) to suit the patient’s chest shape and soft tissues. Supplemental Figures 2 and 3 demonstrate how two patients with the same body shape can look completely different with the different implant choices. Our precise indications for the choice of implant shape have been previously discussed in the literature12 and are therefore not the subject of this paper. This manuscript is about how important it is for the surgeons to bear in mind that there are both anatomical and round implant shapes to choose from. To rule out one shape a priori would limit the solutions offered to the patients. We are certainly not suggesting that round implants give poor aesthetic outcome, or that anatomical devices should always be preferred. We think that for a breast with a given soft tissue distribution, the final result depends also on the choice of implant shape. The clinical photographs (Figures 3, 4 and Supplemental Figures 1-3) illustrate how breast tissue distribution and an implant shape interact. Limitations All implants used in this series were textured which have their known risks of double capsule formation, late seromas, and breast implant associated-anaplastic large cell lymphoma (BIA-ALCL). As more is known about BIA-ALCL, we counsel our patients with the available evidence. Round implants were used in only about 10.3% of patients and having a larger proportion in the series would have provided a better comparison of complications. This is a retrospective review and ideally, a prospective study with a longer follow up could better evaluate the long-term results. However, this is difficult to achieve outside a clinical trial. We hope that this paper will help the reader remember to keep an open mind when choosing an implant’s shape. As surgeons, we feel comfortable in using techniques and devices that we have grown acquainted with. However, in some cases doing so risks limiting our range of choice and offer only a narrow subset of solutions to our patients. CONCLUSION In the past, surgeons held a dichotomous view of either using only round or only shaped implants. This may had been due to availability, training, (and hence) experience as well as perceived learning curve and risk of complications. This dichotomous view can no longer be maintained and restricting oneself to only one type of implant reduces the patient choice and prevents the surgeon from using the complete range of choices available. This is akin to a lawyer practicing half a law book. A single, ideal implant that is suitable for every primary breast augmentation does not exist and one implant shape is not, by itself, aesthetically superior to another. Together with round implants, anatomical devices ought to be considered as one of the tools in the surgeon’s toolbox. By choosing to ignore them a priori means that the surgeon will only have access to half of his armamentarium and will therefore be able to offer a limited set of options to his patients. The optimum choice of implant shape in any given situation is determined by the patient’s physical characteristics, available implant types, and the surgeon’s experience while taking into account patient’s wishes and expectations. Supplementary Material This article contains supplementary material located online at www.aestheticsurgeryjournal.com. 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. Cosmetic Surgery National Data Bank Statistics. Aesthet Surg J . 2017; 37( Suppl 2): 1- 29. 2. Berry MG, Cucchiara V, Davies DM. Breast augmentation: part III—preoperative considerations and planning. J Plast Reconstr Aesthet Surg . 2011; 64( 11): 1401- 1409. Google Scholar CrossRef Search ADS PubMed  3. Derby BM, Codner MA. Textured silicone breast implant use in primary augmentation: core data update and review. Plast Reconstr Surg . 2015; 135( 1): 113- 124. Google Scholar CrossRef Search ADS PubMed  4. Kovacs L, Eder M, Zimmermann Aet al.   Three-dimensional evaluation of breast augmentation and the influence of anatomic and round implants on operative breast shape changes. Aesthetic Plast Surg . 2012; 36( 4): 879- 887. Google Scholar CrossRef Search ADS PubMed  5. Hidalgo DA, Sinno S. Current trends and controversies in breast augmentation. Plast Reconstr Surg . 2016; 137( 4): 1142- 1150. Google Scholar CrossRef Search ADS PubMed  6. The R Project for Statistical Computing. https://www.r-project.org. Accessed December 1, 2016. 7. Cunningham B. The mentor study on contour profile gel silicone memorygel breast implants. Plast Reconstr Surg . 2007; 120( 7 Suppl 1): 33S- 39S. Google Scholar CrossRef Search ADS PubMed  8. Montemurro P, Cheema M, Hedén P, Ferri M, Quattrini Li A, Avvedimento S. Role of macrotextured shaped extra full projection cohesive gel implants in primary aesthetic breast augmentation. Aesthet Surg J . 2017; 37( 4): 408- 418. Google Scholar PubMed  9. Al-Ajam Y, Marsh DJ, Mohan AT, Hamilton S. Assessing the augmented breast: a blinded study comparing round and anatomical form-stable implants. Aesthet Surg J . 2015; 35( 3): 273- 278. Google Scholar CrossRef Search ADS PubMed  10. Friedman T, Davidovitch N, Scheflan M. Comparative double blind clinical study on round versus shaped cohesive gel implants. Aesthet Surg J . 2006; 26( 5): 530- 536. Google Scholar CrossRef Search ADS PubMed  11. Kinney BM, Jeffers LL, Ratliff GE, Carlisle DA. Silicone gel breast implants: science and testing. Plast Reconstr Surg . 2014; 134( 1 Suppl): 47S- 56S. Google Scholar CrossRef Search ADS PubMed  12. Hedén P, Montemurro P, Adams WPJr, Germann G, Scheflan M, Maxwell GP. Anatomical and round breast implants: how to select and indications for use. Plast Reconstr Surg . 2015; 136( 2): 263- 272. Google Scholar CrossRef Search ADS PubMed  13. Atlan M, Bigerelle M, Larreta-garde V, Hindié M, Hedén P. Characterization of breast implant surfaces, shapes, and biomechanics: a comparison of high cohesive anatomically shaped textured silicone, breast implants from three different manufacturers. Aesthetic Plast Surg . 2016; 40( 1): 89- 97. Google Scholar CrossRef Search ADS PubMed  14. Bronz G. A comparison of naturally shaped and round implants. Aesthet Surg J . 2002; 22( 3): 238- 246. Google Scholar CrossRef Search ADS PubMed  15. Rubi CG, Lozano JA, Pérez-Espadero A, Leache ME. Comparing round and anatomically shaped implants in augmentation mammaplasty: the experts’ ability to differentiate the type of implant. Plast Reconstr Surg . 2017; 139( 1): 60- 64. Google Scholar CrossRef Search ADS PubMed  © 2017 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Aesthetic Surgery Journal Oxford University Press

Do Not Fear an Implant’s Shape: A Single Surgeon’s Experience of Over 1200 Round and Shaped Textured Implants in Primary Breast Augmentation

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Abstract

Abstract Background Breast implants can be characterized by their fill material, surface texture, or shape. Whereas long-term good quality studies have provided evidence for the fill material and texture, there is still little consensus for choosing the shape of an implant. Surveys indicate that many surgeons choose only one implant shape, for reasons that may not always agree with outcomes from long-term studies. Objectives We reviewed the first author’s experience over the last six years with both round and anatomical implants, compared the rate of complications with either implant shape, and discussed the importance of keeping an open mind about using both implant shapes for primary breast augmentation. Methods A review of all consecutive primary breast augmentation patients by the first author over a six-year time period who had a minimum follow up of 6 months after surgery. Results Six-hundred and forty-eight female patients had 1296 silicone breast implants inserted over the six-year period. Mean age at surgery was 30.5 years and mean BMI was 20.6 kg/m2. All implants were textured, 134 (in 67 patients, 10.3%) were round in shape with mean volume of 338 cc (range, 220-560 cc), while 1162 implants (in 581 patients, 89.7%) were anatomical shaped with a mean volume of 309 cc (range, 140-615 cc). Among these patients, 11.9% (n = 8) with round implants and 9.0% (n = 52) of those with anatomical implants developed complications postoperatively. Conclusions A single, ideal implant that is suitable for every primary breast augmentation does not exist. The optimum choice of implant shape in any given situation should take into account the patient’s physical characteristics, available implant types, patient’s desires, and the surgeon’s experience. Together with round implants, anatomical devices ought to be considered as one of the tools in the surgeon’s toolbox. By choosing to ignore them a priori means that the surgeon will only have access to half of his armamentarium and will therefore be able to offer a limited set of options to his patients. Level of Evidence: 4 Breast implants are characterized by their shape, texture, and fill. Long-term data have certainly helped settle the historical controversy about the implant fill. As a result, both saline and silicone implants are available since 2006 in the United States (which is one of the largest markets for these products).1,2 Whereas texture has attracted its own share of discussion, which is still ongoing, there is evidence that surface texturing helps decrease the rate of capsular contracture.3,4 The third physical characteristic of breast implants is the shape. The surgical community appears to be polarized on the question of choosing an appropriate implant shape for breast augmentation, whether anatomical or round. As a recent survey of American Society of Plastic Surgeons (ASPS) members5 showed that half of the surgeons questioned had never used an anatomical implant. Given the fact that there is a considerable variation in patient’s body shape as well as soft tissue cover and distribution, we think that any one shape of implants cannot provide consistent results in every patient. We would like to offer some observations in this open-ended debate based on the first author’s experience of over 1200 consecutive breast implantations during a six-year period. We propose a null hypothesis that one shape is not, a priori, better than the other and suggest that aesthetic outcome ought not be the sole indication for choosing an implant. The references discuss the evidence of other possible indications for choosing an implant. Finally, the clinical photographs illustrate the interaction of different implant shapes with the soft tissue envelope. METHODS All consecutive female patients who underwent primary breast augmentation by the first author (P.M.) from January 2010 to February 2016 at our clinic, were included. Patients whose follow up was less than 6 months were excluded from this analysis. Data was collected prospectively for patient age, BMI (in kg/m2), preoperative cup-size, number of children, existing medications, smoking status, physical characteristics of the implants, length of follow up, and any complications. The data were analyzed using the “R” open source statistical software.6 Fisher’s exact test was used to calculate the significance of binary outcome variables. A P-value of less than 0.05 was regarded as significant. RESULTS Six-hundred and forty-eight female patients had 1296 silicone breast implants inserted between January 2010 and February 2016 at our facility. All patients were counselled in accordance with the Declaration of Helsinki guidelines and written informed consent was obtained preoperatively. Mean age of the patients at surgery was 30.5 years (range, 18-56 years). The mean patient height was 167.3 cm (range, 144-188 cm), and their mean BMI was 20.6 kg/m2 (range, 15.9-30.1 kg/m2). The mean number of children at the index operation was 1.02 (range, 0-5). Two-hundred and eighty-four patients (43.8%) considered themselves to have “A” cup size, 322 (49.7%) a “B,” and 42 (6.5%) a “C” cup size. Eighty patients (12.3%) were using (at least one) medication for an existing medical condition while 167 (25.8%) were only taking the contraceptive pill. Seventy-three patients (11.2%) admitted to smoking an average of 8.8 cigarettes per day (range, 1-20 cigarettes/day). Mean follow up was 12.7 months (range, 6-65 months) after surgery. All operations were performed in general anesthesia via an inframammary incision. Two patients received the implants in the subglandular pocket while the rest of them had dual plane placement. Mean implant volume was 312 cc (range, 140-615 cc). All implants were textured, 134 of them (in 67 patients, 10.3%) were round in shape with mean volume of 338 cc (range, 220-560 cc) while 1162 implants (in 581 patients, 89.7%) were anatomical shaped with a mean volume of 309 cc (range, 140-615 cc). Table 1 shows implant characteristics with respect to shape and projection. Table 1. Implant Characteristics (n = 1296) by Shape and Projection   Low projection  Medium projection  Full projection  Extra full projection  All projections  Shaped full height  0  0  2  28  30  Shaped medium height  16  113  330  533  992  Shaped low height  0  10  38  92  140  Round implant  2  9  77  46  134  All heights  18  132  447  699  1296    Low projection  Medium projection  Full projection  Extra full projection  All projections  Shaped full height  0  0  2  28  30  Shaped medium height  16  113  330  533  992  Shaped low height  0  10  38  92  140  Round implant  2  9  77  46  134  All heights  18  132  447  699  1296  View Large In total, 61 patients (9.4%) developed 63 complications postoperatively. These represented 11.9% (n = 8) of patients with round implants and 9.0% (n = 52) of those with anatomical implants. Table 2 compares the complications with each implant type, with the relevant P value calculated using Fisher’s exact test and the associated confidence intervals. Table 2. Complications Segregated by Implant Shape   Round implants (n = 67)  Shaped implants (n = 581)  P value  95% confidence interval  Rotation  0 (0%)  21 (3.6%)*  0.153  0.00-1.65  Capsular contracture  1 (1.5%)  13 (2.2%)  1.000  0.02-4.54  Bottoming out  5 (7.5%)**  9 (1.5%)  <0.05  1.30-17.6  Double bubble  1 (1.5%)  4 (0.7%)  0.421  0.04-22.5  Hematoma  0 (0%)  4 (0.7%)  1.000  0.00-13.3  Minor seroma  1 (1.5%)  3 (0.5%)  0.354  0.05-36.8  Implant failure  1 (1.5%)  0 (0%)  0.103  0-4.49  Total  9 (13.4%)  54 (9.3%)  0.505  0.52-3.04    Round implants (n = 67)  Shaped implants (n = 581)  P value  95% confidence interval  Rotation  0 (0%)  21 (3.6%)*  0.153  0.00-1.65  Capsular contracture  1 (1.5%)  13 (2.2%)  1.000  0.02-4.54  Bottoming out  5 (7.5%)**  9 (1.5%)  <0.05  1.30-17.6  Double bubble  1 (1.5%)  4 (0.7%)  0.421  0.04-22.5  Hematoma  0 (0%)  4 (0.7%)  1.000  0.00-13.3  Minor seroma  1 (1.5%)  3 (0.5%)  0.354  0.05-36.8  Implant failure  1 (1.5%)  0 (0%)  0.103  0-4.49  Total  9 (13.4%)  54 (9.3%)  0.505  0.52-3.04  * One of these patients had capsular contracture as well. ** One of these patients developed a minor seroma at 7 months after surgery that was addressed with ultrasound guided aspiration. View Large In 21 patients (3.6%) the implants malrotated at a mean 8.9 months after surgery (range, 3-34 months). Eight of these implants were in the right and 13 in the left breast. Fourteen patients (2.2%) developed capsular contracture (CC) at an average 20.0 months (range, 3-48 months). In three patients, only the right side was affected, in 9 the left side, while 2 patients developed bilateral CC. The 13 patients with anatomical implants who developed CC had a mean implant volume of 360 cc (range, 215-615 cc). This capsule was formed at a mean 20.5 months (range, 2-48 months). The only CC in a round implant had a volume of 525 cc (at 14 months after surgery). Four (of these 14) patients (28.6%) developed a recurrent CC at a mean 31 months after the first correction (range, 20-35 months). In one patient, recurrent aggressive CC necessitated explantation (at 57 months). In 14 patients (2.2%), the implants “bottomed out,” six on the right, seven on the left, and one on both sides at a mean 11.5 months after augmentation (range, 5-39 months). Five patients (0.8%) developed a “double bubble” deformity at a mean 16.2 months of follow up (range, 6-34 months). Four patients (0.6%) developed postoperative hematomas that were managed surgically. Three hematomas developed within 24 hours of the operation while one was found at the patient’s outpatient review one week after the operation. There were 4 small volume uncomplicated seromas that were aspirated with ultrasound guidance and managed according to existing protocol. In total, 33 patients (5.1%) had change of implants at a mean 13.1 months postoperative (range, 2-47 months). Of these, 11 (1.7%) were after a complication and 22 (3.4%) patients chose to change the implants in absence of any complication. (Tables 3-4). Thirty of the new implants placed were round and 3 were anatomical shaped. The mean volume of the new implants was 433 cc (range, 295-605 cc) and was a mean 102 cc larger than the previous ones (range, -95 cc to 165 cc). Table 3. Details of Patients Whose Implants Were Exchanged as a Result of a Complication*     Implant shape after exchange      Anatomical  Round  Original implants  Anatomical  1 (0.11%)  8 (1.4%)  Round  0 (0%)  2 (2.9%)      Implant shape after exchange      Anatomical  Round  Original implants  Anatomical  1 (0.11%)  8 (1.4%)  Round  0 (0%)  2 (2.9%)  * No significant difference between original implant shapes (P = 0.317, CI = 0.102-4.97). View Large Table 4. Details of Patients Whose Implants Were Exchanged in Absence of Any Complication     Implant shape after exchange      Anatomical  Round  Original implants  Anatomical  2 (0.2%)  15 (1.8%)  Round  0 (0%)  5 (7.5%)      Implant shape after exchange      Anatomical  Round  Original implants  Anatomical  2 (0.2%)  15 (1.8%)  Round  0 (0%)  5 (7.5%)  View Large Of the 8 patients whose shaped implants were changed to round ones (Table 3), three had implant malrotation, another three had implant bottoming out but also wanted a larger volume with the operation, one had bilateral capsular contracture, and one needed a mastopexy alongside capsulectomy. There were 22 patients (Table 4) in whom the implants were exchanged on patient’s request for a larger volume. Of these, 15 patients chose to replace shaped implants with round ones because of cost efficiency. The rest chose the shame implant shape for the secondary surgery. DISCUSSION Silicone breast devices are available in round or anatomical shapes. Like most topics in breast surgery, the choice of implant shape has attracted much debate as well. In 2015, a total of 279,143 breast augmentation procedures were performed in the United States1 and even though silicone implants have been available there since 2006, the use of anatomical shaped silicone devices is not as frequent as in other parts of the world.5 Hidalgo et al5 surveyed members of ASPS and found that 50% had never used anatomically shaped devices. Another 42% of surgeons had used them in less than half of their surgeries. The three main concerns raised for not using anatomical implants in the survey were risk of rotation, the increased cost and the lack of evidence of aesthetic considerations. Sixty-eight respondents provided comments as well, most common of which stated that anatomical implants were too firm, lacked upper pole fullness, and had an increased risk of wrinkling and palpability. Rotation The risk of rotation is a commonly cited issue in the survey by Hidalgo et al5 as well as in conferences and forums. The anatomical implants are seen by some surgeons as “not safe to use” due to higher risk for complications in general. However, the core studies show that the overall risk of malposition is de facto higher with round implants as compared to shaped devices, from the same manufacturer.3 Since our follow up is less than that of the core studies, a head to head comparison is not possible. Within this limitation, our data appears to have a similar trend. In the Mentor (Mentor Inc., Irvine, CA) core study7 at 3 years follow up, the 551 patients who underwent primary breast augmentation with either smooth or textured round implants had a 8.4% to 9.9% incidence rate of major complications (8.1% Baker grade 3 or 4 capsular contracture, 0.3%-1.8% rippling, no data on malposition) (Figure 1) as compared to 4.2% complications3 in 572 primary augmentations that received Siltex shaped implants (0.8% CC, 1.1% malposition, 1.8% rippling, and 0.5% seroma). Similarly, Allergan’s (Allergan Inc., Irvine, CA) textured and smooth round implants3 had 19.3% major complications rate in 455 primary augmentation patients (13.2% CC, 4.1% malposition, 1.3% seroma, and 0.7% rippling) at 4 years. This compared to 5.8% (1.9% CC, 2.6% malposition, 0.8% seroma, and 0.5% rippling) at 3 years in 492 Biocell textured shaped implants. This trend is persistent between the two major manufacturers and continues even at longer follow up. Even with the 2% rotation rate commonly quoted in the literature, the overall complications in anatomical implants are less than those in round implants. For this reason, rotation rate alone may not be the sole justifying criteria for dismissing anatomical devices. Figure 1. View largeDownload slide Comparison of complications reported by two manufacturers of different implants at 3 to 4 years. Figure 1. View largeDownload slide Comparison of complications reported by two manufacturers of different implants at 3 to 4 years. Our results agree with the trend that overall complications with round implants are higher (Table 2). Literature suggests that anatomical implants have a learning curve,8 which may account for the trepidation felt in switching over to them. The patients who received shaped devices in the first half of our series had a slightly higher risk of complications than in the later half. The rate of implant rotation in the first half of our series was 4.0% and once appropriate pocket control was achieved by the surgeon, it decreased to 2.5% in the second half of the case series (with similar length of follow up). Even with the higher figure, the total risk of implant malposition in anatomical implants was less (Table 2). In our series, only 3 shaped implants (out of 21 that malrotated) were exchanged for round ones. The other 18 shaped implants were replaced and did not have a recurrence. Increased Cost While it is true that anatomical devices are more expensive than the corresponding rounds, it should not be the surgeon’s decision to dismiss them solely for this reason. From a professional and ethical point of view, every patient should have the chance to know all the available options. Moreover, an analysis of the lifetime cost of an implant needs to take into account not only the initial expense for the device but also that of further reoperations, both in terms of money, surgical time, and patient satisfaction. In other words, the initial cost of anatomical implants is higher (approximately twice) but when reoperations are considered, the actual difference may be much less. Aesthetic Considerations Another concern that is commonly cited is the lack of evidence of aesthetic considerations of anatomical implants. Al-Ajam et al9 asked 22 plastic surgeons to rate clinical photographs of 60 consecutive aesthetic breast augmentation patients at a mean follow up of 8 months. Thirty-three of these patients had round Inspira (Allergan Inc, Irvine, CA) implants of mean size 300 cc while 27 patients had Style 410 MM or MF with mean size 278 cc. The overall aesthetic result, natural appearance, and upper pole contour was scored slightly better in the shaped implant but did not reach statistical significance. The assessors could not consistently identify the implant shape from the clinical photographs. Friedman et al10 did a double-blind study in which standardized postoperative clinical photographs of 30 primary aesthetic breast augmentation patients were evaluated by 235 lay persons and 11 plastic surgeons. Each assessor scored the photographs on overall “beauty” and “natural shape” and upper pole fullness (less, more, or appropriate). The study did not show an aesthetic difference between breasts that had anatomical or round implants. Interestingly, the plastic surgeons were able to correctly guess the shape of the implant in 63.9% cases of round implants and in 46.7% cases of anatomical implants. Although subgroup analyses would have been very useful, these results can be explained by the fact that an appropriate implant was chosen for the patient’s body frame and tissues.10 Firmness The argument that breasts implanted with highly cohesive gel implants are firmer than those with a saline fill is subjective. The in vivo firmness of an implant is modified by the presence of overlying soft tissue. The only objective measure of a difference in pliability of two sets of implants can be to test this difference in vivo in breasts of comparable soft tissue cover. Furthermore, a firmer implant can be advantageous in some circumstances (eg, constricted lower pole of tuberous breasts are filled in well, and expanded, by the firmness of the highly cohesive gel devices).11 Upper Pole Fullness Round implants achieve upper pole fullness by the shape of the implant whereas anatomical implants achieve it indirectly by projecting the nipple-areola complex. The final shape of the breast is modified by the presence of existing soft tissue and its distribution. When used for appropriate indications, both round and anatomical implants provide an aesthetic upper pole. In the clinical comparisons of both Al-Ajam et al9 and Friedman et al,10 the plastic surgeons assessing the clinical photographs were no better than a coin toss in guessing the type of implant used for the patients’ breast augmentation. This finding goes against the argument that anatomical implants “always” have a hollow upper pole. Wrinkling and Pliability The long-term data support that the rippling rate is similar with either the round or the anatomical implants from either of the major manufacturers.3 Our Observation We think that existing volume and distribution of the breast tissue interact with the underlying breast shape to give the final outcome. In a subgroup of patients, those with good basic breast and chest characteristics, either implant shape can give an aesthetically pleasing result12 (Figure 2) to the extent that even an experience observer could not tell which shape of implant was used (Figures 3 and Supplemental Figure 1). However, this does not hold true for every patient (Figure 4).12 In other subgroups of patients, only if an implant is used for appropriate indications, the patient will have a good outcome (Supplemental Figures 2-3). This suggests that any patient cannot just have any implant. Figure 2. View largeDownload slide Venn diagram showing recommended indications for round or shaped breast implant for aesthetic surgery. Figure 2. View largeDownload slide Venn diagram showing recommended indications for round or shaped breast implant for aesthetic surgery. Figure 3. View largeDownload slide (A, C, E) This 26-year-old woman wanted a moderate enlargement with natural and proportionate look. MF295 Allergan Style 410 implants were used on both sides via a submammary incision with a dual-plane technique. (B, D, F) Appearance at 12 months postoperatively shows the nice and natural shape of the breasts with conservation of the body proportions. Figure 3. View largeDownload slide (A, C, E) This 26-year-old woman wanted a moderate enlargement with natural and proportionate look. MF295 Allergan Style 410 implants were used on both sides via a submammary incision with a dual-plane technique. (B, D, F) Appearance at 12 months postoperatively shows the nice and natural shape of the breasts with conservation of the body proportions. Figure 4. View largeDownload slide (A, C, E) This 26-year-old woman wanted a fairly big enlargement with a full augmented look. She was a nullipara and had a dense gland that offered good soft tissue cover. Inspira TSF 325 implants were used in a dual plane pocket on both sides. (B, D, F) Appearance at 14 months postoperatively shows good upper pole fullness and nice shape of the breasts. Figure 4. View largeDownload slide (A, C, E) This 26-year-old woman wanted a fairly big enlargement with a full augmented look. She was a nullipara and had a dense gland that offered good soft tissue cover. Inspira TSF 325 implants were used in a dual plane pocket on both sides. (B, D, F) Appearance at 14 months postoperatively shows good upper pole fullness and nice shape of the breasts. For example, in patients with short nipple to inframammary fold (IMF) distance and/or constricted lower pole (Supplemental Figure 1), the inferior edge of a round implant would end up well beyond the existing IMF. This would increase the risk of double bubble deformity. In order to avoid such situations, we think that low height anatomical implants are a better option, because the vertical height of the lower pole is approximately 25% to 33% of the total implant height.13 In these situations, choosing to ignore anatomical implants because of a perceived risk of rotation may not be a good strategy due to the alternative risk of double bubble deformity with the round implants.12,14 Rubi et al15 recently compared aesthetic results after primary breast augmentation with round or anatomical implants but specifically excluded the group of patients who had a short nipple to IMF distance. Chest wall deformities and breast asymmetries are also better addressed with anatomical implants, as the implant width, height, and projection can be controlled independently to offer greater possibility of customization. This is because while round implants only give the possibility of choosing two dimensions (width and projection), shaped implants can be customized in all three dimensions (height, width, and projection) to suit the patient’s chest shape and soft tissues. Supplemental Figures 2 and 3 demonstrate how two patients with the same body shape can look completely different with the different implant choices. Our precise indications for the choice of implant shape have been previously discussed in the literature12 and are therefore not the subject of this paper. This manuscript is about how important it is for the surgeons to bear in mind that there are both anatomical and round implant shapes to choose from. To rule out one shape a priori would limit the solutions offered to the patients. We are certainly not suggesting that round implants give poor aesthetic outcome, or that anatomical devices should always be preferred. We think that for a breast with a given soft tissue distribution, the final result depends also on the choice of implant shape. The clinical photographs (Figures 3, 4 and Supplemental Figures 1-3) illustrate how breast tissue distribution and an implant shape interact. Limitations All implants used in this series were textured which have their known risks of double capsule formation, late seromas, and breast implant associated-anaplastic large cell lymphoma (BIA-ALCL). As more is known about BIA-ALCL, we counsel our patients with the available evidence. Round implants were used in only about 10.3% of patients and having a larger proportion in the series would have provided a better comparison of complications. This is a retrospective review and ideally, a prospective study with a longer follow up could better evaluate the long-term results. However, this is difficult to achieve outside a clinical trial. We hope that this paper will help the reader remember to keep an open mind when choosing an implant’s shape. As surgeons, we feel comfortable in using techniques and devices that we have grown acquainted with. However, in some cases doing so risks limiting our range of choice and offer only a narrow subset of solutions to our patients. CONCLUSION In the past, surgeons held a dichotomous view of either using only round or only shaped implants. This may had been due to availability, training, (and hence) experience as well as perceived learning curve and risk of complications. This dichotomous view can no longer be maintained and restricting oneself to only one type of implant reduces the patient choice and prevents the surgeon from using the complete range of choices available. This is akin to a lawyer practicing half a law book. A single, ideal implant that is suitable for every primary breast augmentation does not exist and one implant shape is not, by itself, aesthetically superior to another. Together with round implants, anatomical devices ought to be considered as one of the tools in the surgeon’s toolbox. By choosing to ignore them a priori means that the surgeon will only have access to half of his armamentarium and will therefore be able to offer a limited set of options to his patients. The optimum choice of implant shape in any given situation is determined by the patient’s physical characteristics, available implant types, and the surgeon’s experience while taking into account patient’s wishes and expectations. Supplementary Material This article contains supplementary material located online at www.aestheticsurgeryjournal.com. 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. Cosmetic Surgery National Data Bank Statistics. Aesthet Surg J . 2017; 37( Suppl 2): 1- 29. 2. Berry MG, Cucchiara V, Davies DM. Breast augmentation: part III—preoperative considerations and planning. J Plast Reconstr Aesthet Surg . 2011; 64( 11): 1401- 1409. Google Scholar CrossRef Search ADS PubMed  3. Derby BM, Codner MA. Textured silicone breast implant use in primary augmentation: core data update and review. Plast Reconstr Surg . 2015; 135( 1): 113- 124. Google Scholar CrossRef Search ADS PubMed  4. Kovacs L, Eder M, Zimmermann Aet al.   Three-dimensional evaluation of breast augmentation and the influence of anatomic and round implants on operative breast shape changes. Aesthetic Plast Surg . 2012; 36( 4): 879- 887. Google Scholar CrossRef Search ADS PubMed  5. Hidalgo DA, Sinno S. Current trends and controversies in breast augmentation. Plast Reconstr Surg . 2016; 137( 4): 1142- 1150. Google Scholar CrossRef Search ADS PubMed  6. The R Project for Statistical Computing. https://www.r-project.org. Accessed December 1, 2016. 7. Cunningham B. The mentor study on contour profile gel silicone memorygel breast implants. Plast Reconstr Surg . 2007; 120( 7 Suppl 1): 33S- 39S. Google Scholar CrossRef Search ADS PubMed  8. Montemurro P, Cheema M, Hedén P, Ferri M, Quattrini Li A, Avvedimento S. Role of macrotextured shaped extra full projection cohesive gel implants in primary aesthetic breast augmentation. Aesthet Surg J . 2017; 37( 4): 408- 418. Google Scholar PubMed  9. Al-Ajam Y, Marsh DJ, Mohan AT, Hamilton S. Assessing the augmented breast: a blinded study comparing round and anatomical form-stable implants. Aesthet Surg J . 2015; 35( 3): 273- 278. Google Scholar CrossRef Search ADS PubMed  10. Friedman T, Davidovitch N, Scheflan M. Comparative double blind clinical study on round versus shaped cohesive gel implants. Aesthet Surg J . 2006; 26( 5): 530- 536. Google Scholar CrossRef Search ADS PubMed  11. Kinney BM, Jeffers LL, Ratliff GE, Carlisle DA. Silicone gel breast implants: science and testing. Plast Reconstr Surg . 2014; 134( 1 Suppl): 47S- 56S. Google Scholar CrossRef Search ADS PubMed  12. Hedén P, Montemurro P, Adams WPJr, Germann G, Scheflan M, Maxwell GP. Anatomical and round breast implants: how to select and indications for use. Plast Reconstr Surg . 2015; 136( 2): 263- 272. Google Scholar CrossRef Search ADS PubMed  13. Atlan M, Bigerelle M, Larreta-garde V, Hindié M, Hedén P. Characterization of breast implant surfaces, shapes, and biomechanics: a comparison of high cohesive anatomically shaped textured silicone, breast implants from three different manufacturers. Aesthetic Plast Surg . 2016; 40( 1): 89- 97. Google Scholar CrossRef Search ADS PubMed  14. Bronz G. A comparison of naturally shaped and round implants. Aesthet Surg J . 2002; 22( 3): 238- 246. Google Scholar CrossRef Search ADS PubMed  15. Rubi CG, Lozano JA, Pérez-Espadero A, Leache ME. Comparing round and anatomically shaped implants in augmentation mammaplasty: the experts’ ability to differentiate the type of implant. Plast Reconstr Surg . 2017; 139( 1): 60- 64. Google Scholar CrossRef Search ADS PubMed  © 2017 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com

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Aesthetic Surgery JournalOxford University Press

Published: Mar 1, 2018

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