Effect of Incision Choice on Outcomes in Primary Breast Augmentation

Transcription

1 Breast Surgery Effect of Incision Choice on Outcomes in Primary Breast Augmentation Jeffrey M. Jacobson, MD; Margaret E. Gatti, MD, MPH; Adam D. Schaffner, MD; Lauren M. Hill, MD; and Scott L. Spear, MD Aesthetic Surgery Journal 32(4) The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journalspermissions.nav DOI: / X Abstract Background: Capsular contracture (CC) is the most common complication following primary breast augmentation and one of the most common causes of reoperation. Various studies have suggested certain risk factors, including incision choice. Objectives: The authors investigate a possible association between the three most common breast augmentation incisions (inframammary, periareolar, and transaxillary) and CC. Methods: The authors conducted a retrospective chart review of 197 primary breast augmentation patients treated between 2003 and Significant CC was determined to have occurred if the patient required reoperation for her CC. Patients were excluded if they underwent an augmentation/ mastopexy, had previously undergone breast surgery, or received shaped silicone gel implants. CC rates were analyzed on a per-patient basis with Fisher s exact test and on a per-breast basis with the Rao-Scott chi-squared test. Results: One hundred eighty-three patients (336 augmented breasts) were included. Average patient age was 36.5 years. Mean follow-up was days. Surgical complications included six breasts with CC (1.8%), three with hematoma (0.9%), and one with an infection (0.3%). Transaxillary incisions produced the highest incidence of contracture (6.4%), followed by periareolar (2.4%) and inframammary (0.5%). There was a statistically-significant difference in the incidence of CC among the three incision sites (P =.03). The increased rate seen with transaxillary incisions versus inframammary incisions was also statistically-significant. No significant association between implant fill material and contracture was found (P =.27). Conclusions: The risk of CC is significantly higher with transaxillary incisions than with periareolar or inframammary incisions. Level of Evidence: 4 Keywords breast enhancement, breast enlargement, capsular contracture, periareolar, breast augmentation, risks, transaxillary, implants Accepted for publication November 17, Capsular contracture (CC) is the most common complication following primary breast augmentation, with a reported incidence from 4% to 5% during the first two years of follow-up. 1,2 While some studies have suggested a direct correlation between CC and the time elapsed since implant placement, 2,3 others have found that over 90% of contractures still do occur within the first 12 months after surgery. 1,4 CC is one of the most common causes of reoperation following an augmentation. 3,5-7 Not all cases of CC require surgical correction, but the discomfort or distortion associated with CC may be significant enough to justify further surgery. The etiology of CC is not completely understood and is most likely multifactorial. 5 While most patients experience contractures within the first year after surgery, some risk for CC persists as long as the patient has the implant, which further supports the multifactorial nature of CC, since the effects of short-term risk factors (eg, bacterial contamination, surgical technique, drains, and antibiotics) most likely dissipate with time. 2 Studies have also identified certain patient-specific risk factors for CC, including exposure to radiation therapy, 3,8 implant placement as part of reconstructive surgery, 2,3,8 or a prior history of CC. 1,2 The association between implant-specific properties and the development of CC has also been closely examined. Studies of the implant fill material (saline vs silicone From Georgetown University Hospital, Washington, DC. Corresponding Author: Dr. Scott L. Spear, Professor and Chairman, Department of Plastic Surgery, 1 PHC Building, Georgetown University Hospital, 3800 Reservoir Road NW, Washington, DC , USA. spears@gunet.georgetown.edu

2 Jacobson et al 457 gel), surface (smooth vs textured), and profile have all produced inconsistent results. 3 Placement of the implant into the subglandular plane has generally been associated with an increased risk of contracture when compared with placement into either the submuscular plane or dual plane. 3 The location of the augmentation incision that provides access to the mammary pocket has been postulated as another potential risk factor for CC. Each of the most common augmentation incisions (inframammary, periareolar, and transaxillary) has its own advantages and disadvantages. 11 No single choice is necessarily appropriate for all patients. Two studies have found an increased risk of contracture with periareolar incisions when compared with inframammary incisions. 12,13 One hypothesis is that the greater degree of ductal system disruption that occurs with a periareolar incision when compared with an inframammary incision enables the normal breast bacterial flora to leak from the ductal system and colonize the device pocket. 12 Few studies have extended beyond periareolar incisions and inframammary incisions to include transaxillary incisions in their analysis. The objective of this study was to investigate the relative risk of CC between the three most common incisions for primary breast augmentation. Methods A retrospective chart review was conducted of all women who had undergone a primary breast augmentation between 2003 and 2009 in the senior author s (SLS) practice. Data collected included various demographic variables, specifics of breast augmentation procedures, and follow-up information. Patients were excluded from the study if they had undergone a simultaneous augmentation/mastopexy, had a previous mastopexy, had previously undergone breast surgery (eg, prior augmentation or reduction), or had anatomic silicone gel implants placed, since these are currently investigational devices in the United States. Patients requiring reconstructive surgery, mastopexy, or reduction on one breast who underwent a primary breast augmentation on the contralateral breast for symmetry were included in the study as a unilateral augmentation, so long as they had not received radiation therapy to the augmented breast. The Georgetown University Institutional Review Board approved this study. All analyses were performed with and without the breast reconstruction patients. Only procedural data from the augmented breast were analyzed. The primary end point of the study was the development of clinically-significant CC, defined as reoperation or recommended reoperation. CC was also graded with the Baker Classification (Table 1), a common scale in both practice and studies due to its easy application. Demographic variables were analyzed via Fisher s exact test and paired t-tests where appropriate. Per-patient data were analyzed with a Fisher s exact test due to the low incidence of CC in our study population. Due to the uncommon occurrence of bilateral CC and the relatively Table 1. Baker Classification System for Capsular 4 Baker Grade I II III IV more common occurrence of unilateral CC, we analyzed each breast as a single case in addition to analyzing the data on a per-patient basis. The interrelatedness of our observations (ie, a patient s right and left breasts during a bilateral augmentation are not completely unrelated, as they belong to the same person and are exposed to the same procedural environment) was accounted for with the Rao-Scott chi-squared test. 14 This statistical test is more appropriate than a basic chi-square or Fisher s exact test when multiple observations may be interrelated. An a priori alpha level of 0.05 was applied for all statistical tests. Analyses were performed with SAS for Windows, Version 9.2 (SAS Institute, Cary, North Carolina). Of note, irrigation of the breast pocket with Betadine (Purdue Products LP, Stamford, Connecticut) solution diluted one-to-one with sterile saline followed by triple antibiotic irrigation is standard procedure at the authors institution and was implemented for all patients in the study. 9,10 In addition, all patients, regardless of incision choice, received perioperative antibiotic prophylaxis, which in virtually all cases was cefazolin except when there was a contraindication (eg, allergy). Results Breast Description Breast soft to palpation and easily compressible Greater breast firmness than desired; implant palpable but no visible deformity External breast deformity visibly apparent from contracture Extreme breast firmness, marked deformity, pain or tenderness, and sometimes coolness to touch Of the 197 charts identified for screening, 14 were excluded; 183 patients met inclusion criteria (Figure 1), of whom 153 patients (83.1%) had a bilateral breast augmentation. Of the remaining 30 patients, 18 had a primary breast augmentation and a contralateral breast reconstruction. Twelve remaining patients underwent a unilateral breast augmentation with a contralateral mastopexy or other procedure. The average patient age was 36.5 years (range, years). Twenty-one patients were active smokers and two patients had diabetes mellitus (Table 2). Patients in the study were followed for a mean of days (median, days), with a range of zero days (patient deferred follow-up visits due to her occupation as a plastic surgeon) to 2320 days. Of the 183 patients in the study, five patients (2.7%) developed a clinically-significant CC, defined as having or needing surgical intervention. One patient had a bilateral contracture. Three patients had hematomas (1.6%), and one developed an infection (0.5%). The three hematomas in our series all occurred in

3 458 Aesthetic Surgery Journal 32(4) Figure 1. Retrospective chart analysis of the patients included in this study. patients with inframammary incisions, and they all required exploration in the operating room. In all three cases of hematoma, the same implant was replaced. There was one documented infection, which was diagnosed three weeks postoperatively when the patient presented with drainage from her inframammary incision. This was treated with two weeks of antibiotics and never required implant exchange. No patient with a hematoma or infection developed a CC. In total, 336 primary augmentations were performed on 183 patients. Less than 2% of the 336 augmented breasts developed a significant CC (Table 3). Patients who developed CC were older (average, 42.4 years) but not significantly older than patients who did not develop them (average, 36.3 years; P =.17). None of the patients who developed CC were active smokers or had diabetes mellitus. As expected, patients with CC were followed longer (mean, days) than those without contracture (mean, days); however, this was not statistically-significant (P =.09; Table 4). Analysis of contractures on a per-patient basis (Table 4) and per-breast basis (Table 3) produced similar results. On a per-breast basis, transaxillary incisions produced the highest number of CC cases (n = three/47) followed by periareolar (n = two/84) and inframammary (n = one/205). The Rao-Scott chi-square test was statistically-significant with a P value of.03 (Table 3). While there was statistical significance, there were few cases of CC, so this significance must therefore be interpreted with caution. This association remained when breast cancer patients were removed from the sample. No significant association between implant contents (eg, saline or silicone gel) and contracture was found (P =.27). Due to the small number of CC cases, no P values could be calculated for the association of CC

4 Jacobson et al 459 Table 2. Patient Characteristics Total No. patients 183 Total No. breasts augmented 336 Demographic information Age, years, mean (SD) 36.5 (9.6) Diabetes mellitus, No. (%) 2 (1.1) Smokers, No. (%) 21 (11.5) History of breast cancer a 14 (7.7) Follow-up, days Median Mean Range Complications after a primary augmentation (per patient), No. (%) Capsular contracture 5 (2.7) Hematoma 3 (1.6) Infection 1 (0.5) a Patients who had a history of breast cancer were included in the study if they (1) had undergone a primary augmentation on the contralateral side to the cancer and (2) had not received radiation. implant placement, implant surface, or implant shape. All patients who developed contracture had dual-plane placement and implants that were round and smooth. Only one patient who developed CC had a saline implant (Table 5). Overall incidence of significant CC was 1.8 contractures per 100 breasts augmented (Table 6). Transaxillary incisions produced the highest incidence of contracture, with 6.4 per 100 breasts augmented, followed by periareolar incisions (2.4 contractures per 100 breasts) and inframammary incisions (0.5 contractures per 100 breasts). One patient experienced an immediate (less than six months postoperative) CC following a transaxillary augmentation and later experienced a delayed contracture (more than one year postoperative) on the contralateral breast. Of the six CC cases in our study, five were Baker II and one was Baker III. No Baker IV capsular contractures were present in this study population. Five patients experienced significant CC, but six CC were reported (Table 7). Five of the contractures were corrected through surgical revision. One patient who developed a unilateral Baker II contracture following a transaxillary incision did not undergo surgical correction due to patient refusal, although the case was included because surgical correction was recommended. Surgical correction of the contracture occurred or was noted on average days after the initial surgery, with a range of 73 to 559 days. The two patients with contractures following periareolar incisions had their CC surgically corrected sooner (73 and 104 days) than patients with inframammary (559 days) or transaxillary incisions (130 and 380 days). Table 3. Primary Breast Augmentation and Capsular on a Per-Breast Basis a Breasts augmented, No. (%) Incision location, No. (%) Discussion Total No Capsular Capsular P Value b (98.2) 6 (1.8) Inframammary 205 (61.0) 204 (60.7) 1 (0.3).03 c Transaxillary 47 (14.0) 44 (13.1) 3 (0.9) Periareolar 84 (25.0) 82 (24.4) 2 (0.6) Implant placement, No. (%) Dual plane 312 (92.8) 306 (92.7) 6 (1.8) Subglandular 24 (7.2) 24 (7.3) 0 (0.00) Implant type, No. (%) Silicone 204 (60.7) 199 (59.2) 5 (1.5).27 Saline 132 (39.3) 131 (39.0) 1 (0.3) Implant surface, No. (%) Smooth 316 (94.0) 310 (92.3) 6 (1.8) Textured 20 (6.0) 20 (6.0) 0 (0.0) Implant shape, No. (%) Round 331 (98.5) 325 (96.7) 6 (1.8) Anatomical 5 (1.5) 5 (1.5) 0 (0.0) a No difference in statistically-significant relationships with or without the patients who had breast cancer. b Due to a small number of capsular contractures, interpret P values with extreme caution. P values were unable to be calculated for implant placement, surface and shape due to inadequate numbers in some cells. c Significant at P.05. Since breast augmentation is currently the most commonly performed cosmetic surgical procedure in the United States with 318,123 augmentations estimated to have been performed in 2010 alone 15 and CC is the most frequently encountered complication of this high-volume procedure, the value of an evidence-based approach to decrease its incidence by even a small percentage is important. Incision choice is one of the many variables in this procedure and yet, despite the fact that almost all augmentations are performed through one of three incisions, a direct comparison of these options does not currently exist. Consistent with the scant amount of published literature specific to this issue, this study demonstrates the lowest CC rate with inframammary incisions. What is striking about these data is that they show a fivefold increase in contracture rate with periareolar incisions and a 13-fold increase with transaxillary incisions. The 13-fold

5 460 Aesthetic Surgery Journal 32(4) Table 4. Primary Breast Augmentation and Capsular on Per-Patient Basis a Total No Capsular Capsular P Value b Patients, No. (%) (97.3) 5 (2.7) Patient demographics Table 5. Description of s Patient Location Shape Texture Type Location 1 Dual plane Round Smooth Saline Periareolar 2 Dual plane Round Smooth Silicone Transaxillary 2 a Dual plane Round Smooth Silicone Transaxillary Age, years, mean (SD) Diabetes mellitus, No. (%) 36.5 (9.6) 36.3 (9.7) 42.4 (4.8).17 2 (1.1) 2 (1.1) 0 (0.0) 3 Dual plane Round Smooth Silicone Periareolar 4 Dual plane Round Smooth Silicone Transaxillary 5 Dual plane Round Smooth Silicone Inframammary Smokers, No. (%) 21 (11.4) 21 (12.4) 0 (0.0) Follow-up, days, mean (SD) Incision location, No. (%) (473.3) (471.8) (747.6).09 Inframammary 115 (62.8) 114 (62.3) 1 (0.6).05 c Transaxillary 24 (13.1) 22 (12.0) 2 (1.1) Periareolar 44 (24.0) 42 (23.0) 2 (1.1) Implant placement, No. (%) Dual plane 169 (92.3) 164 (92.1) 5 (2.8) Subglandular 14 (7.7) 14 (7.9) 0 (0.00) Implant type, No. (%) Silicone 113 (61.8) 109 (59.6) 4 (2.2).41 Saline 70 (38.2) 69 (37.7) 1 (0.5) Implant texture, No. (%) Smooth 170 (92.9) 165 (90.2) 5 (2.7) Textured 13 (7.1) 13 (7.1) 0 (0.0) Implant shape, No. (%) Round 180 (98.4) 175 (95.6) 5 (2.8) Anatomical (saline) 3 (1.6) 3 (1.6) 0 (0.0) a No difference in statistically-significant relationships with or without the patients who had breast cancer. b Due to a small number of capsular contractures, interpret P values with extreme caution. P values were unable to be calculated for implant placement, surface, and shape due to inadequate numbers in some cells. c Significant at P.05. increased rate seen with transaxillary incisions compared with inframammary incisions was statistically-significant, whereas the fivefold increased rate seen with periareolar incisions compared with inframammary incisions did not reach statistical significance. The theory that bacterial contamination is responsible for CC is entirely possible, but our data do not provide any specific scientific support for that hypothesis. Therefore, a more conclusive study a One patient developed contractures in both breasts. Table 6. Incidence of Capsular per 100 Breasts Augmented Category Overall incidence 1.8 Incision location Inframammary 0.5 Transaxillary 6.4 Periareolar 2.4 Implant placement Dual plane 1.9 Subglandular 0.0 Implant type Silicone 2.5 Saline 0.8 Implant surface Smooth 1.9 Textured 0.0 Implant shape Round 1.8 Anatomical 0.0 No. of Patients proving the causality of bacterial contamination and capsular contracture is needed. An ideal study would include the investigators taking cultures, looking for evidence of bacteria-contaminated biofilm, and sending capsule specimens for microbiology and pathology when a revision is performed for CC. While our study is a modest-size, single-surgeon retrospective analysis, it certainly has encouraged us to look more carefully at this issue. If this were a larger, randomized, prospective trial with the same results, it would be potentially practice-altering for surgeons who perform

6 Jacobson et al 461 Table 7. Descriptions of Capsular s Breasts with capsular contracture Baker grade Total Inframammary Incision Transaxillary Incision Periareolar Incision a 2 II III Surgical correction of contracture b Mean days until surgical correction a One patient developed an immediate capsular contracture (<6 months) and subsequently developed a delayed capsular contracture (>1 year) on the contralateral breast. b One patient developed a unilateral Baker II capsular contracture following a transaxillary breast augmentation but did not undergo surgical correction due to patient choice. breast augmentation. However, at this point, our report should be interpreted with care as it raises some important questions and suffers from a few limitations. This study was intended to serve as a preliminary or pilot analysis to justify a future larger multicenter study, which would have sufficient power to provide more conclusive evidence. It is notable that, throughout our study, our choice of incision was never made with consideration of CC risk. We chose incisions based exclusively on patient preference and patient-specific breast anatomy. An inframammary incision was our default choice, particularly when the patient had a well-defined inframammary fold in the appropriate location. A periareolar incision was favored in patients with larger areolas and patients who we predicted might need a mastopexy in the future. A transaxillary incision was favored in small-breasted patients with poorly defined inframammary folds and small areolas. Because we were systematically favoring specific incisions in specific types of patients, it is possible that any of the observed anatomic factors that guided our thinking might have been confounding variables. Additionally, although our breakdown of incision choices was well representative of all three options, we performed significantly more inframammary fold incisions, raising the possibility that our technique for this approach is more refined through increased repetition. It is also worth noting that all of our transaxillary augmentations were performed with an endoscope. Since the transaxillary approach was significantly more prone to CC and this is the only approach that made use of the tool, there exists the possibility that either for technical or institutional reasons, this was a contributing factor. Besides CC, other well-known complications of breast augmentation such as hematoma and infection occurred in our patients. Our rate of hematoma was 1.6% and infection was 0.5%. All hematomas and the one infection occurred in patients with inframammary incisions. Our overall number of complications is very low, so drawing any significant conclusions correlating incision type to risk of hematoma or infection is not possible. That said, there are clearly inherent differences between the three approaches, including transecting more ductal and glandular tissue with the periareolar incision and more blunt dissection with the transaxillary incision. With a higherpowered study, the significance of these other complications might be more clearly elucidated. There are, as in any retrospective study, many potential confounding factors. Two of these include plane of placement and fill material. In this study, 93% of all implants were subpectoral or dual plane. As a plane of placement, subpectoral has been supported by the literature to have a lower rate of CC than subglandular placement. Of all the subglandularly-placed implants (30 in total), seven were periareolar incisions (23.3%), two were transaxillary (6.7%), and 21 were inframammary (70%). Only two of the transaxillary augmentations were subglandular, and neither of these patients experienced contracture. None of the breasts with contractures had subglandular placement. Therefore, we believe subglandular placement is not a confounding factor in the results of our study. We also examined the transaxillary and periareolar incisions in terms of type of fill material. The study population as a whole showed that the majority of implants placed (60.7%) were silicone gel. The patients with periareolar incisions had 55% silicone gel implants (or 46 of 84 breasts), and 47% of transaxillary incisions corresponded to silicone gel implants (22 of 47). Given that the majority of transaxillary augmentations were performed with saline devices and all contractures in this group were silicone gel, saline fill is not likely to be a confounding factor. The literature is varied in outcomes investigating the role of silicone gel in causing higher rates of CC. While silicone gel fill could theoretically cause higher rates of contracture, it is unlikely that silicone gel itself confounded our finding of interest, which is the effect of incision type on the rates of CC. The strength of this study is its avoidance of subjective grading and bias through its objective end point of reoperation, which was applied to all patients regardless of previous incision. This end point allowed us to identify a discrete, indisputable occurrence of contracture that was by definition clinically significant, removing any observer bias between incision types. To further investigate the observed difference in CC rates between these incisions, a valuable next step would be to examine multicenter retrospective data, since it would correct for many of our study s noted limitations. Despite these limitations, we believe this study to be a valuable addition to our current knowledge of CC because it represents the first direct comparison of inframammary, periareolar, and transaxillary incisions. Conclusions The risk of clinically-significant CC appears to be higher with transaxillary incisions as compared with periareolar

7 462 Aesthetic Surgery Journal 32(4) or the inframammary alternatives. This increase was statistically-significant. There is also the suggestion that there is an increased risk of CC after a periareolar incision as compared with an inframammary one, although this increase did not reach statistical significance. These preliminary, retrospective data should be considered as one of many factors when planning a patient s breast augmentation. Disclosures Dr. Spear is a paid consultant for LifeCell Corp. (Branchburg, New Jersey) and Allergan, Inc. (Irvine, California). Drs. Jacobson, Gatti, Schaffner, and Hill have no financial interest in any of the products, devices, or drugs mentioned in this article. Funding The authors received no financial support for the research, authorship, and publication of this article. References 1. Henriksen TF, Holmich LR, Fryzek JP, et al. Incidence and severity of short-term complications after breast augmentation: results from a nationwide breast implant registry. Ann Plast Surg 2003;51: Handel N, Cordray T, Gutierrez J, Jensen JA. A longterm study of outcomes, complications, and patient satisfaction with breast implants. Plast Reconstr Surg 2006;117: ; discussion Araco A, Gravante G, Araco D, Delogu D, Cervelli V, Walgenbach K. A retrospective analysis of 3,000 primary aesthetic breast augmentations: postoperative complications and associated factors. Aesthetic Plast Surg 2007;31: Baker JL Jr, Owsley JQ, Peterson R. Symposium on Aesthetic Surgery of the Breast. St. Louis, MO: Mosby; Adams W. Capsular contracture: what is it? What causes it? How can it be prevented and managed? Clin Plast Surg 2009;36: Spear SL, Low M, Ducic I. Revision augmentation mastopexy: indications, operations, and outcomes. Ann Plast Surg 2003;51: Spear SL, Murphy DK, Slicton A, Walker PS. Inamed silicone breast implant core study results at 6 years. Plast Reconstr Surg 2007;120(suppl 1):8S-16S. 8. Cordeiro PG, McCarthy CM. A single surgeon s 12-year experience with tissue expander/implant breast reconstruction, part II: an analysis of long-term complications, aesthetic outcomes, and patient satisfaction. Plast Reconstr Surg 2006;118: Adams WP Jr, Conner WC, Barton FE Jr, Rohrich RJ. Optimizing breast-pocket irrigation: the post-betadine era. Plast Reconstr Surg 2001;107: Adams WP Jr, Conner WC, Barton FE Jr, Rohrich RJ. Optimizing breast pocket irrigation: an in vitro study and clinical implications. Plast Reconstr Surg 2000;105: ; discussion Spear S, Erwin E, Venturi M. Breast augmentation. Plast Reconstr Surg 2006;118(suppl):188s-196s. 12. Wiener TC. Relationship of incision choice to capsular contracture. Aesthetic Plast Surg 2008;32: Henriksen TF, Fryzek JP, Holmich LR, et al. Surgical intervention and capsular contracture after breast augmentation: a prospective study of risk factors. Ann Plast Surg 2005;54: Rao N, Scott A. On chi-squared tests for multiway contingency tables with cell proportions estimated from survey data. Ann Stat 1984;12: American Society for Aesthetic Plastic Surgery. Top 5 procedures, surgical and nonsurgical. Available at: Last accessed July 7, 2011.