Capsular Contracture Rate in a Low-Risk Population After Primary Augmentation Mammaplasty

Capsular Contracture Rate in a Low-Risk Population After Primary Augmentation Mammaplasty Andrew L. Blount, Matthew D. Martin, Kyle D. Lineberry, Nicolas Kettaneh, David R. Alfonso

Breast Surgery Capsular Contracture Rate in a Low-Risk Population After Primary Augmentation Mammaplasty Aesthetic Surgery Journal 33(4) 516 521 2013 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: http://www.sagepub.com/ journalspermissions.nav DOI: 10.1177/1090820X13484465 www.aestheticsurgeryjournal.com Andrew L. Blount, MD; Matthew D. Martin, MD; Kyle D. Lineberry, BS; Nicolas Kettaneh, BS; and David R. Alfonso, MD Abstract Background: The safety of augmentation mammaplasty has increased dramatically in the past 20 years. Capsular contracture (CC) is the most commonly reported complication of augmentation mammaplasty. Objectives: The authors report the incidence of CC in a low-risk patient population after primary augmentation. Methods: The authors retrospectively reviewed the charts of 856 consecutive patients who underwent primary augmentation mammaplasty between 1999 and 2009. This series did not include patients who underwent breast augmentation mastopexy, secondary augmentation, revision, and/or reconstruction. Data points included demographics, functional and aesthetic outcomes, complications, and revision rate/type. Results: The overall incidence of CC in 856 patients was 2.8%. Average follow-up time was 14.9 months. Antibiotic irrigation decreased CC rates from 3.9% to 0.4% (P =.004). Tobacco users had higher rates of contracture than nonsmokers (5.5% vs 1.9%; P =.036). Saline implants had a higher CC rate than silicone gel (4.3% vs 1.3%; P =.032). Using multivariate logistic regression, CC was 7.89 times more likely in saline implants than in silicone gel (P =.027, 95% confidence interval, 1.26-49.00). Conclusions: Based on our findings, it is apparent that the early CC rate in primary augmentation can be less than 1%. To avoid CC, we advocate an inframmamary approach, submuscular implant placement, and antibiotic irrigation of the breast pocket. Level of Evidence: 3 Keywords capsular contracture, breast implant, breast augmentation, cosmetic breast surgery, primary augmentation, breast surgery Accepted for publication September 14, 2012. The safety of augmentation mammaplasty has increased dramatically in the last 20 years. Specific advancements that have led to lower complication rates include the inframammary 1 and submuscular 2,3 approaches and the use of antibiotic irrigation of the breast pocket. 4,5 Capsular contracture (CC) is the most commonly reported complication of augmentation mammaplasty. High rates of CC have been reported in the literature, but these could be due to the wide variety of surgical techniques used and the variability of the inclusion criteria for the patients in these studies (eg, primary augmentation patients combined with breast reconstruction patients). 6,7 Few reports have detailed CC rates in a population composed of purely primary augmentation patients, and those that have are mostly Drs Blount and Martin are plastic surgery residents and Dr Alfonso is the Associate Program Director at Grand Rapids Medical Education Partners (GRMEP), in affiliation with the Michigan State University College of Human Medicine in Grand Rapids, Michigan. Mr Lineberry and Mr Kettaneh are medical students in the Michigan State University College of Human Medicine. This article was presented at the 2011 annual meeting of the American Society of Plastic Surgeons; September 24, 2011; Denver, Colorado. Corresponding Author: Dr Andrew L. Blount, 221 Michigan St. NE Suite 200a, Grand Rapids, MI 49503, USA. E-mail: andrewlblount@gmail.com

Blount et al 517 anecdotal. In this study, we report the incidence of and risk factors for CC in a low-risk patient population after primary augmentation. Methods Patients In this retrospective cohort study, we reviewed the charts of 856 patients from a single, 6-surgeon practice in Grand Rapids, Michigan. The study protocol was approved by the Spectrum Health Institutional Review Board. All patients who underwent primary augmentation mammaplasty between January 1999 and January 2009 were reviewed. We collected data only for those patients who underwent primary augmentation mammaplasty with no associated reconstructive, revision, or adjunct rejuvenative procedures. Data points for this study included demographics, functional outcomes, complications, and revision rate and type. Our discussion of contracture within this article refers only to grade III or IV CC as established by the Baker classification. 8 Surgical Technique Surgical incisions were made using both inframammary and transaxillary approaches. When applied, the antibiotic rinse was a triple antibiotic (bacitracin, cefazolin, and gentamicin in normal saline), a bacitracin, or a Betadine solution. Incision type was based on both surgeon and patient preference based on preoperative interviews. Irrigation used was based on surgeon preference. Triple antibiotic solution consisted of 500 ml of saline with 50 000 units of bacitracin, 1 g of cefazolin, and 80 mg of gentamicin. Bacitracin solution consisted of 500 ml of saline with 50 000 units of bacitracin. Betadine irrigation consisted of equal parts 10% Betadine and saline. All irrigants were used to rinse the pocket before suctioning and subsequent introduction of the implant. The surgeon (D.R.A.) utilizing the inframammary incision method was consistent in his technique; the submuscular pocket was dissected under direct vision with a lighted retractor, and monopolar cautery was applied to coagulate perforators and minimize blood loss. The transaxillary approach was utilized by 2 surgeons in the practice, and it consisted of blind technique and blunt dissection with no endoscopic assistance. A no-touch technique was employed when handling all implants. Care was taken to minimize the time period between opening implant packages and insertion. On opening, the implant was immediately rinsed with antibiotic solution (when utilized) to limit exposure to particulate matter. The operating surgeon was the only person to handle the implant. Gloves and instruments were rinsed prior to implant handling. No barrier drapes or nippleareolar dressings were utilized. Table 1. Patient Demographics Data Analysis Data analysis was performed using the chi-square and Fisher exact tests. All independent variables in our data set were also analyzed with logistic regression using grade III to IV contracture and reoperation rate as the dependent variables. Significance was assigned at P <.05. Results Mean Range Age, y 33.5 ± 8.5 17.00-68.00 Height, in. 65.2 ± 2.8 54.00-77.00 Weight, kg 58.2 ± 7.6 42.00-98.00 Body mass index 21.2 ± 3.0 15.00-34.00 Length of follow-up, mo 14.9 ±17.6 0.03-147.00 Left breast implant size, cc 347.9 ± 55.6 150.00-600.00 Right breast implant size, cc 350.3 ± 55.1 150.00-600.00 Time until first complication, mo 22.8 ± 24.1 0.00-99.00 The average age of the patients in our study was 33.5 years (range, 17-68 years). Patient demographics can be found in Table 1. One hundred forty-six (18.9%) patients were smokers. None had a history of radiation. Only 5 (0.6%) had their implants placed subglandularly; all other implants (99.4%) were placed submuscularly. Four hundred fiftyseven patients (53%) received silicone gel implants, and 399 patients (47%) received saline implants. Antibiotic irrigation was used in 42.9% of silicone gel patients and 16% of saline patients. Due to this large disparity, both antibiotic irrigant and implant type were included in multivariate regression analyses. Bacitracin rinse was used to irrigate the breast pocket in 18.5% of patients, triple antibiotic (bacitracin, cefazolin, and gentamicin in normal saline) was used in 11.7% of patients, and Betadine was used in 0.6% of patients. The remainder of patients did not receive antibiotic irrigation of the breast pocket. The mean follow-up period for all patients was 14.9 months (14.5 months for the silicone gel cohort and 15.1 months for the saline cohort). Complication rates are detailed in Table 2. Twenty-four patients (2.8%) had grade III or IV CC. The most common complication was malposition, which occurred in 63 patients (7.4%). Capsular contracture and reoperation rate comparisons are shown in Figures 1 and 2, respectively. Capsular contracture was significantly associated with antibiotic irrigation use, implant type, and tobacco use. Reoperation rates were significantly associated with antibiotic irrigation use,

518 Aesthetic Surgery Journal 33(4) Table 2. Number of Patients With Complications After Primary Breast Augmentation Complication Incidence in 856 Patients, No. (%) Malposition 63 (7.4) Implant rupture 32 (3.7) Grade III-IV capsular contracture 24 (2.8) Scar issues 19 (2.2) Hematoma 8 (0.9) Infection 6 (0.7) Dehiscence 2 (0.2) Seroma 2 (0.2) Implant deflation 2 (0.2) Total 158 (18.5) implant type, and incision choice. We did not find a significant association between CC rate and shell type (textured vs smooth implants; 2.7% and 2.4%, respectively, P =.815). We did, however, see a significantly lower rate of reoperation in textured versus smooth devices (8.2% and 13.8%, respectively, P =.032). Our data were also analyzed using multivariate logistic regression. Capsular contracture was the dependent variable, while the independent variables tested included age at time of the operation, body mass index, tobacco use, implant type (silicone gel or saline), shell type (smooth or textured), placement of implant (subglandular or submuscular), incision (transaxillary or inframmamary), and use of antibiotic irrigation. Only 1 of the variables tested in the equation achieved statistical significance, and this was implant type. Saline implants were 7.89 times more likely to lead to grade III to IV CC than silicone gel (P =.027; 95% confidence interval [CI], 1.26-49.00). Furthermore, grade III to IV CC was 6.98 times more likely if no antibiotic irrigant was used, but this only approached statistical significance (P =.066; 95% CI, 0.88-55.30). A temporal relationship was found regarding CC and operative date. Eleven of our 24 CC occurred in the first 12 months postoperatively, 3 CC occurred in months 13 to 24, and 3 or fewer per year occurred in subsequent years of follow-up. Discussion In 2000, the Institute of Medicine (IOM) released its report on complications resulting from the placement of silicone gel breast prostheses. 9 Its findings included a CC rate ranging from 8% to 41%. These data are provided in educational materials given to patients as part of their preoperative augmentation consults. 10,11 The studies used by the IOM for this report were mixed with regard to types of surgical procedures and patients included. Among those studies cited by the IOM was the Inamed Core Study, 6 a Food and Drug Administration sponsored report on the safety and efficacy of Inamed silicone gel implants. Six-year data have been published by Spear et al. 6 They reported a CC rate of 14.8% in their primary augmentation cohort. Interestingly, this was similar to a 15.9% CC rate for primary reconstruction patients. The investigators postulated that this was due to a higher proportion of patients receiving textured implants and submuscular implant placement in the reconstruction group. Furthermore, in these trials, periareolar incision was utilized much more frequently among the primary augmentation and revision augmentation cohorts than among the reconstruction groups. This could have led to lower rates of CC in the reconstruction group and a potentiation of CC in the augmentation group. The Mentor Core Study 7 had similar aims of proving silicone gel implants safe and efficacious. The authors quoted similarly high but more differentiated CC rates for primary augmentation and primary reconstruction (9.8% and 13.7%, respectively). The study did not stratify results by implant type, implant position, surgical approach, or use of antibiotic irrigant. A large sample of augmentation patients was studied by Handel et al. 12 They found significant (grade III-IV) CC in 7.4% of augmentation and augmentation-mastopexy patients at a mean follow-up of 29.1 months. The investigators found no long-term benefit of a textured implant surface in preventing CC, as opposed to other authors. 13-15 Also, Handel et al found no difference in subpectoral implant placement, while many other authors reported the opposite. 2,3,16-19 Furthermore, the Handel study included a significant proportion of patients who received polyurethane-coated implants, which have since fallen out of favor due to toluenediamine breakdown products. The wide variability in CC occurrence found in previously published studies does not necessarily reflect the complication profile of primary augmentation patients within a single cosmetic surgery practice. In the past decade, antibiotic irrigation of the breast pocket as well as the breast prosthesis has emerged as a way to decrease CC complications. In 2007, Wiener 4 described his use of intraoperative Betadine irrigation in primary breast augmentation patients. He reported a grade II to IV CC rate of 2.2% over a 14-month mean follow-up period. Adams et al 5 performed a prospective study of CC rates in 335 patients using triple antibiotic irrigation. They achieved a CC rate of 1.8% in primary augmentation patients, also over a 14-month mean follow-up period. In addition, they noted that most cases of CC occurred within 1 year. In an effort to further minimize CC, Wiener 1 studied the effect of inframammary incision. Theoretically, this method prevents bacterial seeding by the breast ducts that may occur with the periareolar approach. In a cohort of 338 patients who underwent augmentation with an inframammary incision and Betadine irrigation, he attained a CC rate of 0.59% over an 8.1-month mean follow-up period. Furthermore, Wiener demonstrated a statistically significant increase in the CC rate in patients who underwent periareolar augmentation (9.5%).

Blount et al 519 Figure 1. Comparison of capsular contracture rates for antibiotic use, incision choice, implant type, and smoking status. Figure 2. Comparison of reoperation rates for antibiotic use, incision choice, implant type, and smoking status.

520 Aesthetic Surgery Journal 33(4) Submuscular placement has also been proposed to lower CC rates, theoretically due to the enhanced blood supply of the surrounding pectoralis major preventing infection, as well as the flexibility of the pocket preventing a scarred down capsule. Vazquez et al 3 presented 89 patients who underwent augmentation with either submuscular or subglandular implant placement. They reported a CC rate of 9.4% with submuscular and 58.0% with subglandular placement. Henriksen et al 2 also documented improved CC rates with the submuscular approach over a 19.5-month mean follow-up period, with data showing an increased risk of CC when not using the inframammary approach. Many other authors have reported similar findings. 16-20 Fewer investigators have studied the rates of CC after transaxillary augmentation. Huang et al 21 reported a perpatient CC rate of 1.9%, with 0.6% in saline augmentation and 2.9% in silicone gel augmentation. Jacobson et al 22 reported a clinically significant CC rate of 6.4% with the transaxillary approach, 2.4% with the periareolar approach, and 0.5% with the inframammary approach. Some of these cases were Baker grade II contractures. Our overall rate of grade III to IV CC with the transaxillary approach was 3.5%. We did not observe an increase in CC as duration of follow-up increased. In fact, we saw 11 of our 24 cases of CC in the first 12 months postoperatively and 3 in months 13 to 24, but just 3 or fewer diagnoses of CC per year in subsequent years of follow-up. Our data compare favorably with recent literature reporting improved rates of CC in primary augmentation patients, who now have a lower rate of CC than reported in the original implant core studies. 6,7 Our overall CC rate was 2.8% over a mean follow-up of 14.9 months, pointing to the benefits of submuscular implant placement and an inframammary incision, which were the most common techniques in our retrospective series. Furthermore, as demonstrated by Wiener 1,4 and Adams et al, 5 antibiotic irrigation decreases the rate of CC, which was confirmed in our cohort by a decrease from 3.9% to 0.4%. Possible limitations to our study include its retrospective nature, as well as the length of our follow-up period, which, ideally, would have been a mean of 2 years. We recognize that patients are commonly lost prior to followup and that, consequently, they may have presented to surgeons outside of this practice for evaluation and treatment of their CC. In addition, data were not available regarding volume of saline implants or their status regarding overfill. These data would have been helpful in determining potential causes of the higher CC rate in the saline group. Conclusions Based on our findings, it is apparent that the early CC rate in primary augmentation can be less than 1%. Furthermore, our findings suggest that use of an inframmamary approach, submuscular implant placement, and antibiotic irrigation of the breast pocket can reduce CC rates. We believe that the results of our study allow us to more accurately educate our patients on the risks of their primary augmentation procedures. Disclosures Dr Alfonso is a paid member of the speaker s bureau for Life- Cell, Inc (Bridgewater, New Jersey). Funding The authors received no financial support for the research, authorship, and publication of this article. References 1. Wiener TC. Relationship of incision choice to capsular contracture. Aesthetic Plast Surg. 2008;32(2):303-306. 2. Henriksen TF, Hölmich 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(6):531-539. 3. Vazquez B, Given KS, Houston GC. Breast augmentation: a review of subglandular and submuscular implantation. Aesthetic Plast Surg. 1987;11:101-105. 4. Wiener TC. The role of Betadine irrigation in breast augmentation. Plast Reconstr Surg. 2007; 119(1):12-15, discussion 16-17. 5. Adams WP Jr, Rios JL, Smith SJ. Enhancing patient outcomes in aesthetic and reconstructive breast surgery using triple antibiotic breast irrigation: six-year prospective clinical study. Plast Reconstr Surg. 2006; 118(7) (suppl):46s-52s. 6. Spear SL, Murphy DK, Slicton A, Walker PS. Inamed silicone breast implant core study results at 6 years. Plast Reconstr Surg. 2007; 120(7)(suppl 1):8S-16S, discussion 17S-18S. 7. Stevens WG, Pacella SJ, Gear AJ, et al. Clinical experience with a fourth-generation textured silicone gel breast implant: a review of 1012 Mentor MemoryGel breast implants. Aesthetic Surg J. 2008; 28(6):642-647. 8. Spear SL, Baker JL. Classification of capsular contracture after prosthetic breast reconstruction. Plast Reconstr Surg. 1995;96:1119-1123. 9. Institute of Medicine. Information for Women About the Safety of Silicone Breast Implants. Washington, DC: National Academies Press; 2000. 10. Mentor Corporation. Guide to Breast Augmentation With MemoryGel Breast Implants. Santa Barbara, CA: Mentor Corporation; 2009. 11. Allergan Inc. Your Surgery Planner, Breast Augmentation With Natrelle Silicone-Filled Breast Implants. Irvine, CA: Allergan, Inc; 2009. 12. Handel N, Jensen JA, Black Q, Waisman JR, Silverstein MJ. The fate of breast implants: a critical analysis of complications and outcomes. Plast Reconstr Surg. 1995; 96(7):1521-1533.

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