Mean patient age was 51 years (SD, ±9.9; range, 28–73). Mean follow-up was 81.7 months (SD, ±39.2; range, 15–151). Ten patients were lost to follow-up and excluded. Five patients with congenital breast deformities were also excluded. A total of 162 implants in 105 patients were included in this study. Immediate reconstruction was performed in 63.8% of cases. Patient, cancer, and treatment characteristics are listed in Table 1. Complication rates were as follows: 0.62% extrusion, 1.2% partial mastectomy flap necrosis, 1.2% hematoma, 1.9% dehiscence, 2.5% seroma, 4.9% infection, and 15.4% deflation (Table 2). Five patients had capsular contracture requiring reoperation.
The following associations were identified by logistic regression: adjuvant radiotherapy and capsular contracture (P = 0.034), tumor size and deflation (P = 0014), and smoking history and infection (P = 0.013). Of the 162 implants, 31 (19.1%) were replaced for the following reasons: extrusion (1 patient), capsular contracture (5 patients), and deflation (25 patients). Overall, 81% of breasts were successfully reconstructed using a single stage with the expander/implant approach.
In 2015, a total of 77,219 procedures were performed by a 2-stage alloplastic approach (expander/implant), representing 73% of the overall reconstructive breast procedures in the United States.3 Single-stage reconstruction (implant alone) was performed 8,794 times, approximately 8% of the overall procedures, a new trend that has recently gained popularity. The complication rates of the 2 procedures were found comparable in a recent systematic review, 35% for single-stage reconstruction and 34% for 2-stage expander-implant reconstruction.7 Voineskos et al.8 performed a review of complication rates in expander/implant reconstruction. Their findings are compared with those in this study in Table 3. Hematoma, infection, and mastectomy flap necrosis rates using Spectrum all-in-one expander/implants are comparable with 2-stage reconstruction rates. However, with only 1 surgical procedure, the patient is subjected to anesthesia-related complications only once.
Capsular contracture rates in 2-stage alloplastic procedures vary significantly in the literature. Cordeiro et al.9 reported that 68% of irradiated patients developed capsular contracture, compared with 40% in the nonirradiated group (P = 0.025). Another study evaluated the long-term outcomes of 2-stage expander/implant reconstruction and postmastectomy radiation therapy.10 Over a period of 7 years, they reported that 17 patients (11.2%) underwent replacement of implant for grade 3 or 4 capsular contractures. Despite the advantage of performing capsulotomy/capsulectomy during expander/implant exchange in the 2-stage approach, our outcomes of capsular contracture are comparable with the reported rates in the literature. In our review, 3 of the 16 patients (18.8%) who underwent postmastectomy radiation required an exchange of implant due to capsular contracture.
Initially, when the implant first came to market, Mentor11 conducted a study on 416 patients and reported a deflation rate of 18.0% within 5 years of breast reconstruction using Spectrum, 26.9% within 7 years, and 33.2% within 10 years. Deflation was the most common reason for reoperation in our study. There were 25 (15.4%) deflated implants, all of which were replaced. Although our deflation rate is lower than the aforementioned study, it remains higher than the reported deflation rates of permanent implants in the literature. Long-term saline implant deflation rates range from 0.01% to 6.8% in the literature.12–15 Companies often report valves as frequent sites of implant failure. In our experience, most deflations occur shortly after the removal of the fill tube. Failure at the site of the self-sealing T-shaped valve tubing appeared to be at the origin of deflation. Before reviewing this series, the senior author contacted the company to inquire about a defect possibility after a few implants deflated immediately after valve removal. A specific technical information became available to us regarding the importance of the direction of extraction during the simple local procedure of valve removal. The angle of removal must be perpendicular to the inframammary crease in a straight vertical downward pull maneuver (video, Supplemental Digital Content 1). As a result of this new information, our deflation rates have drastically decreased in more recent years, which we hope to demonstrate in a follow-up study.
In a population-based study over a 25-year period consisting of 3,495 implants, the authors report a reoperation rate of 35.5% after breast reconstruction.12 They did not perform a subgroup analysis to compare the rates between single and two-stage alloplastic reconstruction. In a retrospective review of 582 breasts over an 8-year period, Susarla et al.16 found that 32.3% of patients required additional operative interventions after single-stage reconstruction. They also report additional operative interventions in 21.5% of patients who underwent 2-stage reconstruction. Some of the arguments against single-stage reconstruction are that a revision procedure is often required. Due to improved techniques, the use of acellular dermal matrix, and better patient selection, reoperation rates of single-stage alloplastic reconstruction has declined.4,5 In our experience, an attempt at avoiding a second surgery under general anesthesia is appealing to patients and their family, even with a high deflation rate. The additional benefit of postoperative adjustments renders the all-in-one expander/implant even more appealing to patients. Moreover, due to recent concerns of anaplastic large cell lymphoma, the option of a smooth surfaced expander/implant is also appealing to patients, a safe addition to the armamentarium of breast reconstruction.
The cost of bilateral implant-based reconstruction is an estimated $75,013 (USD), compared with $94,065 with bilateral DIEP reconstruction.17 In the event that a complication occurs, the total cost can be upward of $100,000 (USD). Spectrum implants were introduced at our institution by the senior author as part of a strategy aimed at more efficient use of limited OR resources, in the context of increasing breast reconstruction demand. Krishnan et al.7 performed a cost-utility analysis comparing direct-to-implant breast reconstruction relative to 2-stage reconstruction. Their comparative economic analysis compared the cost, outcomes, and quality of life for patients undergoing either method of reconstruction. The authors found a cost decrease of US$4,492.66 and a clinical benefit of 0.89 quality-adjusted life-year with the direct-to-implant approach, yielding a dominant incremental cost-utility ratio of US$5,047.93 Grover et al.18 also found that immediate implant placement was more cost-effective than expanders with implant exchange (2 stages), and patients had superior quality measure parameters.
We acknowledge that our results are subject to the forms of bias associated with retrospective reviews, such as inferring causality. Several confounding factors may affect the results such as variation in mastectomy approach, type, and incision. Mastectomies were not all performed by the same general surgeon, and procedures varied from total mastectomies to skin and nipple-sparing mastectomies. In addition, there has been evolution in radiation and chemotherapy in the past decade, including the type of drugs, dose of radiation, and timing of treatment. These variables could not be accounted for in this study but could potentially be confounding factors.
Overall, 81% of breasts in this series were successfully reconstructed in a single surgical procedure. Single-stage reconstruction using all-in-one adjustable expander/implants is cost effective, eliminates the necessity for a second procedure under general anesthesia, and can achieve results comparable with other alloplastic approaches reported in the literature.
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Supplemental Digital Content
Copyright © 2018 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of The American Society of Plastic Surgeons.