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

It is with great pleasure that we discuss “Do Not Fear an Implant’s Shape: A Single Surgeon’s Experience of Over 1200 Round and Shaped Textured Implants in Primary Breast Augmentation” by Montemurro et al.1 In this article, the authors reviewed their 6-year experience using textured, anatomically shaped and round silicone gel implants in 648 patients for primary breast augmentation. They specifically examined the complication rate for both types of implants. All implants were placed through an inframammary incision into a dual plane pocket, except for 2 patients who had implants placed in a subglandular pocket. A total of 581 patients had anatomically shaped implants with an overall complication rate of 9.0% while 67 patients had round implants with an overall complication rate of 11.9%. Rotation (3.6%) was the most common complication to occur with anatomically shaped implants while bottoming out (7.5%) was the most common complication after round implants. The difference in overall complication rate was not statistically significant (P = 0.505). The authors conclude that “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.” Although we would agree with this statement, there are several important issues requiring further discussion. The authors highlight rotation as a commonly cited problem that deters surgeons from using anatomically shaped implants but go on to state that “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.” As we have pointed out previously, it is important to clearly define exactly what we mean when discussing terms such as rotation/malrotation, and malposition.2,3 During surgery anatomical implants may be intentionally oriented off the vertical axis and this should not be considered rotation/malrotation.2,3 Once healed, an implant can rotate several ways. In our experience,2,3 clinically apparent rotation more commonly occurs when an implant flips back to front − the back surface of the implant becomes anterior. Patients with this problem usually report suddenly noticing a difference in the appearance of their breast(s).3 Malposition refers to an implant being located where it was not intended to be. This may result from over- or underdissection during surgery, loss of control of the inframammary fold or medial pectoralis major muscle attachments, or may be due to long-term changes such as inferolateral migration of an implant or descent of the breast. Hence rotation/malrotation and malposition are not the same. In our experience, rotation occurred in 5.2% of patients.2 This is similar to rates from this study and others,4,5 and in some cases necessitates reoperation. Although back to front flipping of a textured round implant can occur, this does not occur with smooth round implants. When discussing rotation, another important consideration is the difference between clinically apparent and clinically undetectable rotation.3 Sieber et al6 recently used high resolution ultrasound to demonstrate a 27% anatomical implant rotation rate (42% of patients) that was clinically undetectable in most cases. Another significant issue that should be part of the discussion when using a textured breast implant is breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Although, this complication is relatively rare,7 it is significant for both the patient and her surgeon. For many years, the use of texturization was purported to reduce the risk of capsular contracture, however, this was based on dated studies that are probably not reflective of current best practice or available devices.8 Strategies to reduce biofilm and contamination of the device during breast augmentation as well as improve device design reducing gel bleed likely play a significant role in capsular contracture reduction. In almost two decades, there has not been one well-designed, prospective, comparative study to specifically examine the effect of texturization on capsular contracture reduction.8 One issue that the authors did not mention is that the use of anatomically shaped implants necessitates the use of a textured device and exposure to the risk of BIA-ALCL, as there is still no known case of BIA-ALCL where only a smooth device was ever used.7 The authors cite data from the core studies to compare complications between round and shaped implants.4,5,9,10 The authors summarize the core studies by concluding that “the overall complications in anatomical implants are less than those in round implants.” However, the core studies were designed to evaluate the overall safety of these devices and not to directly compare different device characteristics such as shape or surface type. With a study design having so many uncontrolled variables, one cannot reliably derive any conclusion by comparing the data between the studies. Although there were some interesting differences observed in the core studies, data mining is unscientific, can be very misleading, and results in erroneous conclusions. With regards to the results of this current study, although there is an absolute difference in overall complication rate between textured anatomically shaped and round implants, this did not even trend towards statistical significance, and should not be misinterpreted as being significant. It is important to keep in mind that, to date, most studies that examine our ability to detect an aesthetic difference between anatomically shaped and round implants show that we have a difficult time doing this.11-16 So by choosing an anatomically shaped implant, we do expose the patient to certain risks unique to these implants – so the most important discussion around textured, anatomical, silicone gel implants should focus on identifying specific indications for their use.3 The authors declared no potential conflicts of interest with respect to the research, authorship, and publication of this article. The authors received no financial support for the research, authorship, and publication of this article.

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