**3. Assessment of complications**

In the Tessler method, between the pectoralis major muscle and a part of the serratus anterior muscle or inframammary sulcus line are slung using an absorbable mesh (VICRYL Mesh®). From 2016 to the present, we performed the DTI breast reconstruction in 123 patients (with mesh). In December 2019, we started to apply our modified method in which the pectoralis major muscle and inframammary sulcus are anchored using only absorbable strings (VICRYL PLUS® 4–0) like shoelaces without using absorbable mesh. Thirty-five patients underwent DTI reconstruction with this method (Without Mesh).

Although both VICRYL Mesh® and VICRYL PLUS® 4–0 are absorbable substances, it is a foreign substance. If the amount of the use is reduced, it is expected that surgical site infections will also decrease.

We retrospectively compared the outcome, especially from the viewpoint of complication due to ischemia in 35 patients who underwent DTI without Mesh and 123 patients with Mesh.

*Direct-to-Implant Breast Reconstruction Method: Muscle Anchoring Technique Using Absorbable… DOI: http://dx.doi.org/10.5772/intechopen.112918*

To check for surgical complications, we checked ischemic changes and surgical site infections for all patients during hospitalization, and in visiting the hospital as an outpatient about 1 and 2 weeks after surgery. Since 2010, we have been prospectively investigating complications in breast reconstruction cases at our institution. We checked and made an independent database for the occurrence and time of occurrence (days after surgery) about the following items; presence of seroma, wound edge necrosis, nipple ischemia or necrosis, surgical site infection (SSI), hematoma formation, hospitalization due to complications, request of reoperation due to complications, and implant removal. Other complications are described and evaluated.

In this study, we did the assessment in using this database, but hence, we did not consider implant displacement, the presence or absence of capsular contracture, deformation, which should be accessed in long-term observation. The grade classification of complications was based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Published: Nov 27, 2017 and Japanese translation by JCOG [5].

Because we examined perioperative complications observed within 2 months after surgery, postoperative adjuvant treatments such as chemotherapy, radiotherapy, and hormone agents are, if any, almost negligible. We have never performed bilateral simultaneous DTI breast reconstruction.

For statistical analysis, the computer software EZR was used [6]. The analysis method was described for each.

#### **3.1 Result**

Since this study is a retrospective analysis, it is not appropriate to compare significant differences in complication rates in two methods (with or without Mesh).

First, the time when the surgery was performed was different, so the learning curve of the operator affected against the group without mesh (**Table 1**). Second, some significant differences are shown in the patient background; in the presence or absence of hypertension as a medical history, T factor, and stage in the TNM classification. With mesh group, which includes more advanced cases, is at a disadvantage. On the other side, without mesh group underwent a larger mastectomy and was reconstructed using a larger implant. In this regard, without mesh group is at a significant disadvantage (**Table 1**).

Complications occurred from the day of surgery to 43 days. We experienced cases of surgical site infection (SSI) on the 137th day and the 202nd day in the with mesh group. These were not perioperative complications, but due to a local trauma. Excluding these, the mean time to SSI was 12.5 days.

Overall complications were not affected by the presence or absence of Mesh, and indeed no significant difference was observed. We expected a decrease in SSI by not using mesh, but this was not observed. Concerning about any ischemic changes around the wound, we checked even small ones, which patients do not seem to notice, and converted them into data according to the grade. However, no increase was observed even after stopping the use of Mesh (**Table 2**).

Through the recruitment period, only three cases in the with mesh group resulted in discontinuation of reconstruction with IMP removal.


*\*1 Smokers were instructed to abstain from smoking for at least 28 days before surgery.*

*\*2 We took the value of cT at admission as the value of pT, in the case of requiring neoadjuvant chemotherapy.*

*\*3 We took the value of cStage at admission as the value of pStage, in the case of requiring neoadjuvant chemotherapy. \*4 Including cases in which margins were positive in the first surgery and subcutaneous mastectomy was performed in reoperation.*

*¶Student-t.*

*§Fisher's Exact Test χ 2 test.*

#### **Table 1.**

*Baseline characteristics.*


#### **Table 2.**

*Adverse events per breast.*

*Direct-to-Implant Breast Reconstruction Method: Muscle Anchoring Technique Using Absorbable… DOI: http://dx.doi.org/10.5772/intechopen.112918*

#### **4. Discussion**

#### **4.1 Anchoring with absorbable materials**

Our series with absorbable mesh sling or with absorbable anchor strings for DTI breast reconstruction confirmed Tessler's excellent results with a low complication profile [3]. As well as their experience, the complications in our series were more favorable than that reported complication profiles of up to 14.8–18% for DTI with using Allodermnew*®* [7, 8] and 33.9% of reoperation incidence, and 10.9% of explantation and replacement in the Mentor [9] study. Our results are encouraging for Japanese surgeons, who cannot access Alloderm*®* at present. Both Vicryl mesh*®* and Vicryl PLUS*®* are widely available and relatively inexpensive materials, which have been used in numerous surgical procedures for many years.

We experienced surgical site infection (Grade 1–2) in this series (4.1% in group with mesh, 2.6% in group without mesh). In one case of them, we had misled the inadequate candidate who was with atopic active dermatitis to the implant-based reconstruction. Through these experiences, we found thought-provoking facts concerning about the infectious complication in using the implant that surgical site infection could develop in outpatients even more than 6 weeks after the surgery. From these findings, we made a hypothesis that these infections were not usual surgical site infections, and might be caused by the lymphogenous dissemination of "hand or finger contamination" from the patients' everyday affairs. We now routinely give the patients specific guidance on hand hygiene; occasionally glove use to steer clear of injury, daily skin care, and avoidance of gardening or handling of kitchen garbage. We keep them strictly in order, especially during the three months after the surgery. SSI complications were obviously reduced since we started this guidance.

As this fact shows, patient cooperation is essential for successful reconstructive surgery. Smoking cessation in the perioperative period would be an almost absolute requirement.

Implant exposure is the major complication requiring the explantation. To prevent this tragedy, it is important to cover of the implant with the healthy muscle to the extent possible. Although complete muscle coverage using both the pectralis major and serratus anterior muscle would decrease the risk of infection, this technique may prevent smooth expansion, especially in the lower pole of the breast, thereby resulting in a high-riding device placement [10]. In the case of the breast with ptosis, the pectoralis major muscle alone is insufficient to cover the lower pole of the implant. Thus, the implant comes into direct contact with the skin, and that potentially causes ischemia of the skin. Breast surgeons in the USA are trying to overcome this anatomical limit by using Alloderm® [11, 12]. Absorbable materials should be resorbed at 3 to 4 weeks. If this happens, the implant will always come into direct contact with the skin. Using mesh sling or anchoring strings cannot improve the blood flow in the flap. But it is the same with Alloderm®. Then why does a sling with Alloderm® prevent capsular contracture [8, 13]? Iwahira said that the muscle envelope of the implant at the inferolateral site is not indispensable if the skin flap in there is sufficiently thick [14]. She also advocated that applying the serratus anterior muscle for the implant envelope would cause not only insufficient projection by the shortening of the lower part, but postoperative pain, or implant displacement. It is important that the implant is covered by a solid capsule with good blood flow. It does not matter if the muscle is there or not. The results of our present study seem to support this.

For studies of prosthesis-based breast reconstruction, extended follow-up is mandatory, as many complications, especially capsular contracture, develop long after the initial operation. We will continue to follow up with the patients of this study from this perspective. Nonetheless, once esthetics are compromised during the primary surgery, it will not improve spontaneously thereafter. Since DTI should be performed only in one operation, there is no opportunity for revision. For this decade, we performed the 158 DTI reconstruction with using absorbable materials and have never suffered from capsular contracture from early perioperative period. While performing DTI reconstruction using absorbable mesh sling technique and absorbable strings anchoring technique, we have got satisfaction about the results, both cosmetically and safely.

#### **4.2 Direct-to-implant or taking two steps reconstruction**

In this work, we introduced a unique DTI breast reconstruction technique that we developed with reference to Tessler's procedure. As a matter of fact, only these techniques can be practiced in our country where Alloderm® cannot be used. Long-term outcomes are yet to be accessed, but from the viewpoint of perioperative complications, safety appears acceptable in clinical practice.

In June 2013, the Japanese Central Social Insurance Medical Council of the Ministry of Health, Labor and Welfare approved insurance coverage for implants (prosthesis) used in breast reconstruction surgery, and insurance coverage began on July 1. The Japanese Society of Breast Oncoplastic Surgery began to collect data [15] from 2013, and then, there were 1281 cases undergone the breast reconstruction. With the exception of 2019, when breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) gained public attention, the number of prosthesis breast reconstruction surgeries has continued to augment every year.

As described in "introduction", prosthesis-based breast reconstructive surgeries covered by insurance are classified into DTI and two-stage reconstruction. In the social burden of hospital visits, duration of hospitalization, and the medical costs associated with surgery, DTI reconstruction is superior. However, not only in Japan but also in the rest of the world, breast reconstruction is performed in two-stage.

According to aggregate results enforced by the Japanese Society of Breast Oncoplastic Surgery, the latest statistics in 2021 show that 388 cases were reconstructed in DTI manner, while 3667 cases were reconstructed in two-stage. The difference between the DTI and two-stage is almost ten times, and it can be said that two-stage reconstruction is the standard surgical procedure in Japan, de facto.

Japanese public insurance covered both DTI and two-stage breast reconstruction. In addition, two-stage reconstruction is clearly inferior in terms of patient burden than DTI manner. Why does as many as 90% of the surgeon select two-stage manner and DTI manner only 10%?

There are two notable papers.

The first is a big data study of 941,191 breast reconstruction cases after total mastectomy in the United States published by Kamali et al. in 2016 [16]. Using the Nationwide Inpatient Sample Database in the United States, they analyzed almost all patients who underwent DTI and two-stage reconstructive surgery, and investigated the basis for the selection of the two surgical procedures investigated. In the United States, 13.6% patients underwent DTI and 86.4%, two-stage reconstruction. As a result, DTI reconstruction is more likely to be selected for in the case of bilateral breast surgery. This reason is a patient factor. However, the

#### *Direct-to-Implant Breast Reconstruction Method: Muscle Anchoring Technique Using Absorbable… DOI: http://dx.doi.org/10.5772/intechopen.112918*

patients, being nonwhite, being on Medicare, and living in a relatively western region, underwent DTI manner more often significantly. These factors could not be understood as a patient factor but should be accepted as rather a social factor. Two-stage reconstruction is more likely to be selected for patients aged 60 or over, which is a patient factor. However, two-stage reconstruction is more likely to be selected for patients; black, Hispanic, the person live in urban, undergoing surgery at the facility of the educational institution such as a university hospital, and are on Medicaid. Kamali said that the rationale for deciding the surgical manner, which was found to be highly significant by statistical processing, was not any patients' physical or disease-related factors, but more social reasons such as race and household income.

University hospitals and large facilities in urban areas are the centers of dissemination of information that determines a trend of the times. In these facilities, young doctors receive training of two-stage reconstruction manner as a standard. The ratio of doctors accustomed to two-stage manner and those accustomed to the DTI manner is 9:1, therefore the ratio of the patients underwent two-stage reconstruction and those underwent DTI reconstruction come down to 9:1. Most surgeons simply follow and perform the familiar procedure because the trend of the surgical manner of reconstruction in the past was so. As my interpretation of Kamali's work, that is thought to be the real reason why two-stage manner continues to be mainstream up to now.

The second important paper was published by Dikmans et al. in Lancet Oncology in 2017 [17]. This study was a prospective, randomized, multicenter, Phase IV trial designed to conclude the superiority of DTI versus two-stage reconstruction. As a result, it was revealed that DTI reconstruction was associated with a three-fold risk of perioperative complications (Odds 3.81, 95% CI 2.67–5.43, p < 0.001) and a risk of implant removal. Was eight times higher (8.80, 8.24–9.40, p < 0 001). By this work, this dispute which is a better manner between DTI and two-stage seems to have settled. Compared to two-stage reconstruction, DTI reconstruction has more complications and a higher risk of failure. We should select two-stage manner even if the disadvantages such as hospitalization and cost related to surgery are considered.

However, after considering this chapter in detail, it is unreasonable to apply this conclusion to clinical practice. The first point is breast size undergoing the reconstruction. Indeed, women's breasts in Japan may be relatively small compared to those in the United States. The average size of implants used in our hospital for breast reconstruction was 233.4 (80–595) ml (out of 205 cases). On the other hand, the average implant size used in Dikmans study was 392.1 or 416.2 ml in each group, and then, these averages were almost double the size of ours. The larger and heavier size of implant should cause the greater weight-bearing stress, especially in the lower half of the breast where the pectoralis major muscle defect. This condition compromises flap blood flow and increases complications. DTI is not suitable for reconstructing large mammary glands. Randomizing surgical procedures without considering breast size becomes disadvantageous to DTI.

Being with an incomplete muscle capsule is disadvantageous of DTI manner. Dikmans study also included currently smokers in 20% of DTI group and 13% of two-stage group. A decrease in skin flap blood flow due to smoking habit should increase ischemic complications, especially in DTI cases. Smoking cessation should be strictly enforced before surgery. Smoking cessation failures suggest that the patient's cooperation was not obtained in postoperative wound management, which is very important in reconstructive surgery with implants. This is especially true if the ratio of the smoker is higher in the DTI reconstruction group.

In this chapter, implant removal in the DTI group reached 11% of the total, but the expander removal rate in Two-stage was only 3%. However, 11% result is too high. The tabulated results of the Japanese Society of Breast Oncoplastic Surgery in Japan showed that the rate of implant removal in DTI group is 4.1% and in Two-stage is 3.8%, respectively [15]. In our result, the rate of implant removal in DTI was 3/158 cases (1.9%). Compared to these data, the outcomes of DTI reconstruction in Dikmans study was unnaturally bad. Again, the following factors may have contributed that the ratio of doctors accustomed to two-stage manner are nine-folds high to that accustomed to DTI manner. However, if you do not take any factors (breast size, smoker, surgeon proficiency) into consideration and choose a procedure at random, there is no doubt that you should definitely choose two-stage.

In Japan, where Alloderm® is not practical, the technology for DTI reconstruction has not been developed and never been trained. However, Tessler's method, our anchoring method using absorbable strings, can be practiced. Compared to the Tessler method, our method succeeded in lowering the possibility of SSI while retrospectively and with fewer observations.

Regarding the superiority of DTI reconstruction and two-stage reconstruction, a conclusion may eventually be drawn from the accumulation of big data in Japan. However, as Dikmans indicated, we must carefully select suitable patients for DTI reconstruction, and otherwise, we must be prepared for serious and highly frequent complications. In the current situation, patient selection criteria for DTI have not yet been established. From the patient's point of view, the DTI manner is clearly attractive because at the time when breast cancer surgery is over, and when she waked up from general anesthesia, the breast has already been reconstructed. No conclusions can be drawn until a situation arises in which a randomized trial is conducted at a facility with operators who are sufficiently familiar with both DTI and two-stage reconstruction. Until then, we must not abandon the pursuit and training of DTI reconstruction techniques just because we are unfamiliar with them.

*Direct-to-Implant Breast Reconstruction Method: Muscle Anchoring Technique Using Absorbable… DOI: http://dx.doi.org/10.5772/intechopen.112918*
