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Tradeoffs in Implant Selection for Reconstructive Surgery and Adjuncts Utilized to Maximize Aesthetic Outcomes

Unger, Jacob G. MD; Keller, Patrick R. MD

Plastic and Reconstructive Surgery: July 2019 - Volume 144 - Issue 1S - p 51S-59S
doi: 10.1097/PRS.0000000000005950
Original Articles
Free

Background: With many US Food and Drug Administration–approved cohesive gel implant styles currently available in the United States, surgeons and patients may feel overwhelmed by the implant-selection process. We discuss the relative merits of the most commonly used silicone cohesive gel implants and associated adjuncts, particularly in the reconstructive setting.

Methods: A literature review was conducted in PubMed to identify articles that assessed the clinical impact of differing cohesive silicone gel implants and associated adjuncts on aesthetic outcomes and complications profile.

Results: First, we review how the shape, cohesivity, and texture of cohesive gel implants impact breast aesthetics and complications after implant-based breast reconstruction (IBBR). Second, we review common adjuncts used in IBBR, including fat grafting and acellular dermal matrix (ADM), and we explore their roles in prepectoral IBBR. Finally, we review future directions in IBBR, including nanoscale implant surface modifications.

Conclusions: In the absence of data showing that shaped implants are aesthetically preferable over round implants, we turn to a risk-benefit analysis of the complication profile of each type of implant. In selecting a smooth, round cohesive silicone implant that offers a variety of cohesivity levels, the patient can enjoy the benefits of smooth shells and avoid the drawbacks of textured shells, all without sacrificing clinically significant visual aesthetics. In the era of the bioengineered breast, this remains even more true.

Nashville, Tenn.

From Maxwell Aesthetics and Vanderbilt University School of Medicine.

Received for publication January 16, 2019; accepted April 4, 2019.

Disclosure:Dr. Unger is a member of the Allergan speakers bureau. No funding was received for this article. Dr. Keller has no financial interest in any of the products, devices, or drugs mentioned in this article.

Jacob G. Unger, MD, Maxwell Aesthetics, 2020 21st Avenue S, Nashville, TN 37212, Instagram: @drjacobunger

Implant-based breast reconstruction (IBBR) with silicone gel implants is the most commonly performed reconstructive breast procedure worldwide.1,2 Silicone implants are generally preferred over saline implants because of their more natural look and feel.3,4 Most modern silicone gel implants contain cohesive gels, but the level of cohesivity varies greatly between styles.1,3,5 With many US Food and Drug Administration–approved cohesive gel implant styles currently available in the United States (Table 1), each with a different level of cohesivity, both reconstructive breast surgeons and their patients may feel overwhelmed by the implant-selection process. The decision-making tree multiplies when you add to this the concept of the “bioengineered breast,” wherein regenerative cells and scaffolds are used to further define breast shape and feel.6,7 Our aim is to provide an overview of the advantages and disadvantages of different cohesive gel implants, specifically in the reconstructive setting.

Table 1.

Table 1.

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IMPLANT TRADEOFFS

Overview

Cohesive gel implants come in 2 general shapes: round or anatomical. Round implants are either textured or smooth, whereas anatomical implants are always textured to lessen the risk of malposition.3 Although both fourth- and fifth-generation implants contain cohesive gel, fourth-generation gels have a lower degree of molecular cross-linking, and hence cohesivity, than fifth-generation products.5 Most round implants currently used in the United States are fourth-generation, whereas most modern anatomical implants contain fifth-generation (i.e., highly cohesive) gels to help them maintain “form-stability” in vivo.8 Highly cohesive gel implants have been available in round form in the United States since the Sientra HSC was approved in 20128; however, because round implants do not require form stability, most surgeons use less cohesive gel due to its softer, more natural feel. Over the last decade, however, plastic surgeons have realized that highly cohesive gels offer more control in directly imparting shape onto the breast, whether for augmentation or reconstruction.1,3,8,9 For that reason, implant manufactures have produced round implant alternatives that contain highly cohesive gel, sometimes with graded levels of cohesivity (Fig. 1).9,10

Fig. 1.

Fig. 1.

Inherent tradeoffs must be weighed when choosing the ideal cohesive implant for breast reconstruction. The lenses through which to assess their value include visual aesthetics, complications profile, dynamic response to changes in body position, and tactile feel. Implant characteristics such as shape, texture, and cohesivity influence these domains in different ways.

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Shape

Expert opinion has settled on a set of beliefs about the different ways that the shape of round and anatomical implants impacts the visual aesthetics of the final breast shape. Round implants are believed to achieve a fuller or more convex upper pole appearance and are thought to be ideal for patients receiving a primary augmentation who have a good skin envelope.1 Anatomical implants have been noted for their ability to provide a natural-looking upper pole, more volume in the lower breast, and more medial fullness and lateral protrusion.1,11–15 They are thought to be good for patients with thoracic hypoplasia, mild ptosis or pseudoptosis, and complex asymmetries.1,16

Beyond expert opinion, many studies have demonstrated that both plastic surgeons11,17,19,20 and patients17–19 have great difficulty discerning aesthetic differences between shaped versus round implants, and that both are equally aesthetically pleasing (Table 2). In 2017, Hidalgo et al19 published results from their randomized controlled trial in 75 patients receiving primary breast augmentation. Intraoperatively, they temporarily placed either a round or anatomical cohesive gel implant subpectorally in one or the other randomly assigned breasts of a given patient. After taking upright photos, 10 plastic surgeons and 10 lay people blindly evaluated breast aesthetics. Survey results showed that 44% of plastic surgeons and 29% of lay people could not detect an aesthetic difference between sides. When a difference was noted, neither group preferred one side over the other. Debate exists over the conclusions of this and similar studies.15 Indeed, a limitation of their study is that it was done in primary augmentation, and their results do not necessarily apply to breast reconstruction cases where greater control of implant dimensions may be helpful. This limitation was explored in a recent retrospective study by Dorfman et al14 in patients who received 2-stage submuscular breast reconstruction after nipple-sparing mastectomy. They found that nipple position geometry and aesthetic outcome were slightly more favorable in the anatomical implant group.14 By contrast, a cohort study by Macadam et al18 comparing the visual aesthetics of round versus anatomical cohesive implants, also in the reconstructive setting, found that implant shape had no difference on patient satisfaction with their breasts or overall outcome as measured by the BREAST-Q. In sum, it appears that in the hands of an experienced plastic surgeon, the shape alone of cohesive gel implants is unlikely to impact either patient satisfaction with or the aesthetic appearance of reconstructed breasts in a clinically meaningful manner.

Table 2.

Table 2.

It is currently unknown how the use of highly cohesive gel in a round implant will affect its final impact on breast aesthetics. Of note, the round implants used in the study of Macadam et al18 were fourth generation (i.e., not highly cohesive). Supporting this concept, some have utilized imaging techniques to examine the in vivo shape assumed by fourth-generation round implants and found that in the upright position, they take on a contoured shape comparable to that of anatomic implants.3 Additionally, ex vivo testing of Allergan’s Inspira highly cohesive round implants showed that, depending on the degree of cohesivity, each assumed a different ex vivo shape when held vertically.10 It remains to be seen whether these factors will significantly impact final breast aesthetics.

The impact of implant shape on complication rates is an area of active research. In terms of shape alone, malrotation is the most important complication of anatomical implants, estimated to occur in 1.1%–2.7% of patients.19,21 In one study, McGuire et al. found the rate of malrotation for Natrelle 410 implants to be 1.5%–2.7%.21 Because of their radial symmetry, round implants cannot malrotate (although expert opinion indicates they can very rarely flip in an anterior–posterior vector). With regard to other complications, Antony et al showed that implant shape was not predictive of capsular contracture (CC) or rippling.22 Acellular dermal matrix (ADM) use, which is associated with significantly reduced risk of CC,23–28 was not used in their study cohort. In a different study by Bronz,11 50 round (McGhan Style 110) or 50 anatomical (McGhan Style 410) cohesive gel textured implants were placed prepectorally for primary augmentation. They found no significant difference between the two groups with respect to incidence of CC after 5 years. As both implant shapes were textured, this supports the conclusion that shape alone does not impact rate of CC. With regard to rippling, a study found that among patients reconstructed with either fourth-generation round (Allergan Styles 10, 15, and 20) or fifth-generation anatomical (Allergan Style 410) cohesive implants, there was no effect of implant shape on patient-perceived rippling.18 A final aspect of shape to consider is incision length, as anatomical implants tend to require longer scars than round implants for placement.29

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Texture

The effect of texture on postoperative complications has and continues to receive much attention, especially with regard to CC, double capsule, late seroma, and breast implant–associated anaplastic large cell lymphoma (BIA-ALCL).

Many believe that textured implants are associated with a decreased rate of CC as compared with smooth implants, especially concerning prepectoral placement.30–33 A 2018 study of Sientra implants by Calobrace et al32 retrospectively analyzed risk factors for CC in 2565 primary augmentation patients where either a smooth or textured round implant was used. In their multivariate model, they found that the odds of developing CC were 4.5 times greater with smooth implants and 4.6 times greater with prepectoral placement. Multiple meta-analyses support their conclusions.33,34

There is, however, a growing body of literature not convinced of the smooth surface and CC connection, especially with ADM use.1,19,29 As noted by Adams and Mallucci,1 there are as many level I studies that have not supported the association between textured implants and CC as there are that have.15 This is likely in part due to the recent increase in ADM use for both prevention and treatment of CC.23–28 Indeed, a major limitation of both the Calobrace 2018 study32 and similar meta-analyses33,34 is that they do not include use of ADM as a predictive variable in their models. Without ADM use, CC rates range from 10% to 20% in standard IBBR.27,29 By contrast, with ADM use, rates of CC plummet for both smooth and textured implants to between 0% and 4%.23,25,27,35 In a recent study, Salzberg et al23 assessed the rate of CC in 863 patients who received ADM-assisted direct-to-implant breast reconstruction. They reported a CC rate of 0.8%, with all cases occurring within the first 2 years after reconstructive surgery (mean follow-up 4.7 years). Most importantly, 97% of the implants they used had a smooth surface. For an excellent graphical comparison of CC rates among implant manufacturers, we refer the reader to the article by Salzberg et al23; note, however, that ADM is generally not controlled for in the studies they report on. In 2012, Hester et al. showed that in 49 patients who received primary breast augmentations with Strattice ADM, the CC rate after 1.1 years follow-up was 0%.27 The implants they used were smooth, round cohesive implants (Mentor), and the ADM was placed prepectorally for primary prevention. Considering this data, ADM should be used in most IBBR unless contraindicated, especially if a smooth implant is to be used. This practice will minimize the risk of developing CC, regardless of implant texture characteristics.

The connection between textured implants and late seromas, double capsules, and BIA-ALCL has received a significant amount of attention recently. It has led many to speculate on if and how all 4 variables might be related through some common mechanism, such as biofilm formation or chronic inflammation surrounding macrotextured surfaces.36–40 Late (or delayed) seroma is a clinically symptomatic fluid collection that develops in the periprosthetic space at least 1 year after the most recent breast implant operation.21,40 Most cases have been associated with macrotextured implants, in particular Biocell texturing.41,42 Although rare with a reported incidence of less than 1%,21,37,40,42 it is concerning because of its similar presentation to BIA-ALCL, which is also associated with textured implants.29,37,43–45 A recent European population-based, case-controlled study confirmed the association of BIA-ALCL with textured implants and estimated that the number of women with implants needed to cause one case of BIA-ALCL before the age of 75 years was 6,920.45 According to current guidelines set by the American Society of Plastic Surgeons, seromas occurring more than 1 year after implantation not readily explainable by infection or trauma should be considered suspicious for disease.37 Initial management and treatment approaches have been discussed elsewhere.37,40,46,47 Until the etiology of BIA-ALCL is determined, it may be wise to avoid the use of textured cohesive implants unless absolutely necessary.

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Cohesivity

The effect of both surface texturization and gel cohesivity on the aesthetics of the reconstructed breast are predominately based on expert opinion.9 Fourth-generation smooth implants are thought to be softer and offer the feel and movement that best mimics natural breast tissue.3,18,29 Some believe that highly cohesive anatomical implants have a “one-breast feel” due to the propensity for their textured surface to integrate into the surrounding breast tissue.18 Opinions about surface texturization, however, are confounded by the degree of cohesivity of the filler gel. For instance, Macadam et al18 noted that anatomical, textured, highly cohesive implants were perceived by recipients to be firmer than round, smooth, non–highly cohesive implants. This effect could be explained both by the thinner smooth surface and by the decreased cohesivity of the round implants.

Perhaps the greatest benefit of fifth-generation implants is that their highly cohesive gel is able to resist external force imposed on it. This feature allows the plastic surgeon to impart shape onto breast, and not vice versa.3,8 Another benefit of highly cohesive gel implants is that they cause less rippling, because the silicone does not move within the implant shell and has a firmer, more robust consistency thereby imparting stable shape to the shell. Furthermore, they are less likely to leak and rupture.8,29 The drawback to highly cohesive gels is that they have a less natural feel, though the degree of firmness varies significantly between implant styles and manufacturers.8

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ADJUNCT SELECTION AND PREPECTORAL BREAST RECONSTRUCTION

The bioengineered breast concept has established a reliable pathway to achieve excellent aesthetic results in breast reconstruction.6,7 Several key adjuncts have made this possible: autologous fat grafting, ADM, and the nipple- or skin-sparing mastectomy.

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Acellular Dermal Matrices

ADMs have gained popularity for use in all forms of IBBR for many reasons, including expansion of lower pole with hammocks and slings; reconstitution of the lower pole; extension of the pectoralis major; soft-tissue thickening; reconstitution of the inframammary fold; prevention and treatment of CC; and treatment of rippling, symmastia, malrotation, and bottoming out.6,23,25,27,48–50

A number of ADMs are currently approved by the US Food and Drug Administration for use in IBBR; their relative merits and indications have been reviewed elsewhere.49 Debate continues as to which ADM is best for a given purpose,51 but in a study of 564 2-stage IBBRs, it was noted that there was no difference in complication rates between human and bovine ADMs.50 The authors found that patient-related and operative factors, including obesity, larger breasts, radiation therapy, higher intraoperative fill volumes, and larger ADM size are notable risk factors for complications, suggesting that ADM-related complications are not product specific, but rather are related to how and in whom they are used.

ADM-assisted prepectoral direct-to-implant breast reconstruction has garnered recent attention.52–58 This technique is safe and effective if chosen for the right patient and is preferable over submuscular placement because it avoids animation deformity, weakness caused by partial disinsertion of the pectoralis major muscle, and pain from spasm of stretched muscle.7,54,57,59 Previously used and subsequently abandoned because of a high incidence of CC, the prepectoral technique has experienced a renaissance over the past few years, partly because total ADM implant coverage has mitigated the high rates of CC seen previously.7,56 A recent study demonstrated additional benefits of ADM in prepectoral reconstruction: in ADM-assisted direct-to-implant breast reconstructions that were subsequently irradiated, the prepectoral implant group experienced a lower rate of CC than the retropectoral group.60

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Fat Grafting

Fat grafting is a safe and effective treatment for a variety of problems in breast reconstruction, including correction of contour deformities and release of scar contractures.61,62 Its use in breast contouring is associated with improvement in patients’ breast satisfaction, and psychosocial and sexual well-being.63 Regarding the role of implant shape on the aesthetics of prepectoral reconstruction, it remains to be seen whether round and anatomical implants display any clinically meaningful aesthetic differences.9 In keeping with the bioengineered breast paradigm for reconstructive cases, however, most experts agree that fat grafting is essential to the success of prepectoral direct-to-implant breast reconstruction, especially for thin mastectomy skin flaps.9,53,57

Similar to the bioengineered breast paradigm for reconstructive cases, the concept of composite breast augmentation has been proposed for primary augmentation wherein implants are coupled with fat grafting to camouflage contour deformities.64,65 A recent study of primary augmentations used this concept to examine whether the “natural look” of anatomical implants could be obtained with round implants plus fat grafting to the upper and medial poles.64 The authors found that patients were highly satisfied with their outcome, and argued that their technique reduced implant edge palpability, smoothened the upper pole, and achieved an anatomically natural appearance. There was neither control nor randomization in this study, and its results must be interpreted with caution. Nonetheless, it suggests the need to study the role of fat grafting in leveling aesthetic outcomes between shaped and anatomical implants, especially when used in prepectoral direct-to-implant breast reconstruction. Cohesivity should be explored in a similar manner. Fat grafting may level the playing field of all implants, such that we can choose the safest implant possible to obtain general breast shape, and subsequently utilize fat grafting to contour the final outcome.

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FUTURE DIRECTIONS

Nanotexturing, nanomaterial use, and surface coating of silicone breast implants are also rapidly developing concepts in the field of IBBR, mainly because they have the potential to mitigate common complications such as CC, infection, device failure (including implant rupture), delayed wound healing, and BIA-ALCL.66 The goal of most surface nanotechnologies is to either disrupt pathogen colonization and biofilm formation, or alter host-prothesis interactions such that biocompatibility is improved and chronic inflammation is reduced. With regard to the former goal, multiple in vitro studies have shown that either fixed (e.g., immobilized graphene nanoflakes) or free nanoparticle coatings (such as Ag, ZnO, and CuO) are able to kill pathogens by creating reactive oxygen species or inducing intracellular oxidative stress.66,67 Nanotextured surfaces (e.g., Motiva SilkSurface) are currently being investigated for their ability to retain low incidence of CC while simultaneously being antimicrobial and minimally inflammatory.68 A recent clinical study by Quirós et al69 examined the safety of Motiva implants with SmoothSilk/SilkSurface texture in 35 primary augmentation patients and documented no occurrences of CC, rupture, double capsules, or late seroma after 6 years of follow-up. Although this is certainly not enough time and too small a sample size to mitigate concerns of BIA-ALCL, the hope is that these nanotextured surfaces may fend off association with BIA-ALCL because of their unique nanoproperties. Other researchers are working to model the nanoarchitecture of human biomaterials such as ADM, and then synthetically recreate the model using polydimethylsiloxane.69 A study by Kyle et al70 found that their synthetic ADM polydimethylsiloxane replication was able to significantly attenuate the acute foreign body inflammatory response to silicone, in vitro. The clinical in vivo effects of the aforementioned innovations are notably lacking66,71; while they do require further investigation as to their safety and efficacy, the potential for nanoscale and surface coating technology to improve outcomes in IBBR is no less exciting.

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CONCLUSIONS

In choosing the ideal breast implant, many factors must be weighed. In the absence of data showing that shaped implants are aesthetically preferable over round implants, we must turn to a risk-benefit analysis of the complication profile of each. Because shaped implants are textured to avoid malrotation, they suffer from the drawbacks of all textured implants, including a growing association with ALCL. With the use of ADMs in breast reconstruction, rates of CC have plummeted, putting smooth and textured surfaces on equal footing with respect to CC. With the advent of round implants that contain varying levels of cohesivity, greater dimensional control can be achieved. With tools of the bioengineered breast paradigm, contour deformities can be corrected. In summary, by selecting a smooth, round cohesive silicone implant, the patient can enjoy the benefits of smooth shells and avoid the drawbacks of textured shells, all without giving up clinically significant visual aesthetics.

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