Pros and cons of immediate Vicryl mesh insertion after lumpectomy

+

MODEL

Asian Journal of Surgery (2017) xx, 1e6

Available online at www.sciencedirect.com

ScienceDirect journal homepage: www.e-asianjournalsurgery.com

ORIGINAL ARTICLE

Pros and cons of immediate Vicryl mesh insertion after lumpectomy Wakako Tsuji*, Fumiaki Yotsumoto Department of Breast Surgery, Shiga Medical Center for Adults, 5-4-30, Moriyama, Shiga, Japan Received 25 June 2017; received in revised form 3 August 2017; accepted 7 August 2017

KEYWORDS Breast cancer; Cosmetic outcome; Immediate Vicryl mesh insertion; Lumpectomy; Ultrasonography

Summary Background: Lumpectomy is a standard surgery for breast cancer; however, it results in breast deformity, especially after radiation therapy. Wider surgical margin correlates lower local recurrence rate. However, bigger defect brings worse cosmetic outcome. The use of a simple filler for the defect is expected. We aimed to improve the cosmetic outcome by using an absorbable Vicryl mesh for breast reconstruction immediately post-lumpectomy. Methods: One sheet of Vicryl woven mesh was prepared for insertion, washed the cavity with natural saline, and placed into the space. The cosmetic outcome was scored for the size, shape, scar, and softness of the breast. The size, shape, color, and position of the nipple eareola complex were also scored. Adverse events were collected retrospectively. Results: From April 2008 to October 2014, 24 female patients received immediate Vicryl mesh insertion. A lumpectomy only group was recruited for cosmetic analysis. All patients received postsurgical radiotherapy. The mean cosmetic assessment score was 8.0 and 9.1 of 12 for the Vicryl mesh group and lumpectomy only group, respectively (P Z 0.17). Sixteen patients had adverse events such as erythema at approximately 2 weeks post-surgery. No significant differences were shown except adverse events between two groups. No patient has had local recurrence thus far. Conclusion: Immediate Vicryl mesh insertion leads to significantly increased incidence of postoperative complications and delay in commencement of adjuvant radiotherapy. Furthermore, the cosmetic outcomes are not superior to that of no reconstruction. The development of superior biomaterials is anticipated for breast reconstruction after lumpectomy. ª 2017 Asian Surgical Association and Taiwan Robotic Surgical Association. Publishing services by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).

* Corresponding author. Department of Breast Surgery, Shiga Medical Center for Adults, 5-4-30, Moriyama, Shiga 524-8524, Japan. Fax: þ81 77 582 6149. E-mail address: [email protected] (W. Tsuji). http://dx.doi.org/10.1016/j.asjsur.2017.08.001 1015-9584/ª 2017 Asian Surgical Association and Taiwan Robotic Surgical Association. Publishing services by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Please cite this article in press as: Tsuji W, Yotsumoto F, Pros and cons of immediate Vicryl mesh insertion after lumpectomy, Asian Journal of Surgery (2017), http://dx.doi.org/10.1016/j.asjsur.2017.08.001

+

MODEL

2

W. Tsuji, F. Yotsumoto

1. Introduction Breast cancer is the most common malignancy among women world wide.1 Primary breast cancer treatments consist of surgery, radiation therapy, endocrine therapy, and chemotherapy.2 Lumpectomy is a standard surgery for early-stage breast cancer. However, lumpectomy results in breast deformity, especially in patients with large tumors, small breast, or tumors in the lower inner quadrant. Local control of breast disease is very important. Surgery is the most effective treatment to reduce the tumor burden. In addition, radiotherapy is necessary for patients who undergo lumpectomy. Radiotherapy reduces not only local breast cancer recurrence, but also distant recurrence and the mortality rate due to breast cancer.3 However, breast deformity is enhanced especially after radiotherapy. Wider surgical margin correlates lower local recurrence rate.4 However, bigger defect brings worse cosmetic outcome. The use of a simple filler for the defect is expected. Vicryl woven mesh (Ethicon Division, Johnson and Johnson, Somerville, NJ, USA) is copolymer made from 90% poly-glycolic acid and 10% L-lactic acid. The mesh is currently used for a broad range of procedures in general surgery, gynecology, and urology; it has gained acceptance in abdominal wall reconstruction, and it has been characterized as an inexpensive material.5 Vicryl mesh is a synthetic, absorbable material and is approved for implantation after lumpectomy. Immediate Vicryl mesh insertion is a simple method to fill the defect. The use of Vicryl mesh after lumpectomy was proposed in 2003, and some reports indicated its simplicity and satisfactory cosmetic outcome.6 We aimed to improve the cosmetic outcome by using an absorbable Vicryl mesh for breast reconstruction immediately after lumpectomy.

Figure 1 The tumor was marked under ultrasonography before the surgery.

Figure 2 insertion.

Vicryl mesh appearance after preparation for

2. Patients and methods Informed consent for surgery was obtained from every patient who underwent breast cancer surgery. This study was approved by the ethics committee at Shiga Medical Center for Adults. Female patients whose tumor size was greater than 2 cm (cT2) were recruited. Vicryl woven mesh (polyglactin 910) was purchased from Ethicon Division, Johnson and Johnson Co., Ltd (Somerville, NJ, USA). The size of the Vicryl mesh was 15  15 cm. Briefly, the tumor was marked under ultrasonography before the surgery (Fig. 1). Tumors are usually resected with a safety margin of 1.5 cm from the tumor. The skin incision was not made right above the cavity because the Vicryl mesh was supposed to stimulate the skin incision site. After the tumor removal, the surgeons changed their gloves to avoid foreign body contamination or infection. The cavity was washed with 1 L of natural saline. One sheet of Vicryl mesh was prepared for insertion (Fig. 2) and placed into the space (Fig. 3). The skin was closed by three layers with 4-0 and 5-0 Vicryl sutures. The cosmetic outcome was scored based on the following parameters that conformed to the evaluation of postoperative cosmetic outcome by the Japanese Breast Cancer Society Sawai group6 (Table 1):

Figure 3 The tumor is resected with 1.5-cm safety margin from the marking. After removal via para-areola incision, the cavity is washed with 1 L natural saline.

1. Breast size: 2 (almost identical), 1 (minor difference), and 0 (considerable difference) 2. Breast shape: 2 (almost identical), 1 (minor difference), and 0 (considerable difference) 3. Scar: 2 (unnoticeable) and 1 (slightly noticeable) 4. Breast softness: 2 (soft), 1 (somewhat firm), and 0 (fairly firm)

Please cite this article in press as: Tsuji W, Yotsumoto F, Pros and cons of immediate Vicryl mesh insertion after lumpectomy, Asian Journal of Surgery (2017), http://dx.doi.org/10.1016/j.asjsur.2017.08.001

+

MODEL

Immediate Vicryl mesh insertion after lumpectomy Table 1

Cosmetic assessment score sheet.

Breast size Breast shape Scar Breast softness Nipple and areola size/shape

2

1

0

Almost identical Almost identical Unnoticeable Soft

Minor difference Minor difference Slightly noticeable Somewhat firm No difference between left and right No difference between left and right Less than 2 cm

Considerable difference Considerable difference Noticeable Fairly firm Difference between left and right

Less than 2 cm

More than 2 cm

Nipple and areola color tone Nipple position (difference between left and right) with regard to distance from sternal incidures Position of the maximum descent point of the breast (difference in height between left and right)

5. Nipple and areola size/shape: 1 (no difference between left and right) and 0 (difference between left and right) 6. Nipple and areola color tone: 1 (no difference between left and right) and 0 (difference between left and right) 7. Nipple position (difference between left and right with regard to distance from sternal incisures): 1 (<2 cm) and 0 (2 cm) 8. Position of the maximum descent point of the breast (difference in height between left and right): 1 (<2 cm) and 0 (2 cm) Comprehensive evaluation: 11e12 points, excellent; 8e10 points, good; 5e7 points, fair; and 0e4 points, poor. For the control arm, patients with breast cancer who underwent lumpectomy without immediate Vicryl mesh insertion were randomly recruited when they visited for annual postsurgical examinations in 2015. Ultrasonography examinations were performed using HI VISION Preirus (Hitachi Co., Ltd., Tokyo, Japan). Additionally, adverse events were assessed retrospectively. Statistical differences were determined using Wilcoxon test. A statistical significance was assigned as *P < 0.05.

Table 2

3

Difference between left and right More than 2 cm

JMP version 9 software (SAS Institute Inc., Cary, NC, USA) was used for statistical analysis.

3. Results From April 2008 to October 2014, 24 female breast cancer patients received immediate Vicryl mesh insertion after lumpectomy at Shiga Medical Center for Adults, Shiga, Japan. All patients were followed up at the same institution, and received postsurgical annual examinations as mammography and ultrasonography. Cosmetic outcomes were assessed when patients visited outpatient clinic for postsurgical examinations in 2015. As a control arm, 24 patients who underwent lumpectomy from 2003 to 2014 were collected (Table 2). The median age at the time of surgery was 47 years (range: 26e74) and 50 years (range: 42e65), for the Vicryl mesh group and lumpectomy only group, respectively (P Z 0.38) (Table 2). The mean body mass index was 22.35 (17.44e29.84) and 21.6 (17.6e30.2) for the Vicryl mesh group and lumpectomy only group, respectively (P Z 0.77).

Patient demographics and cosmetic outcomes.

Age at the operation (median) Year of operation BMI Quadrant

Tumor size

Patients who received radiation therapy Cosmetic assessment (average) Adverse event

Upper inner Lower inner Upper outer Lower outer is (DCIS) T1 (2 cm,
Yes No

Lumpectomy with Vicryl mesh insertion (n Z 24)

Lumpectomy only (n Z 24)

P-value

26e74 (47) 2008e2014 17.44e29.84 (22.35) 8 2 11 3 6 7 11 24 (100%) 3e12 (8.0) 16 8

43e75 (53) 2003e2014 17.8e29.7 (21.9) 2 4 16 2 3 18 5 24 (100%) 4e12 (9.1) 2 22

0.38 e 0.77 0.17

0.86

e 0.17 <0.001

Please cite this article in press as: Tsuji W, Yotsumoto F, Pros and cons of immediate Vicryl mesh insertion after lumpectomy, Asian Journal of Surgery (2017), http://dx.doi.org/10.1016/j.asjsur.2017.08.001

+

MODEL

4

W. Tsuji, F. Yotsumoto

There were no significant differences regarding tumor location (P Z 0.17) and tumor size (P Z 0.86). All patients underwent radiotherapy after the surgery. The average score for cosmetic assessment was 8.0 and 9.1 for the Vicryl mesh group and lumpectomy only group, respectively (P Z 0.17). Adverse events were significantly higher in Vicryl mesh group (P < 0.001). In Vicryl mesh group, 10 patients started radiotherapy more than 8 weeks after surgery because of adverse events. In lumpectomy only group, 2 patients received delayed radiotherapy due to adverse events. Sixteen patients had adverse events such as erythema (Table 3). The time until the adverse events occurred ranged from 7 days to 7 months, 28 days in vicryl mesh group. Here, we show one typical case with erythema experienced. The erythema occurred at approximately 2 weeks after the operation (Fig. 4). Ultrasonography showed that the skin was edematous and the Vicryl mesh remained in the fluid (Fig. 4). The fluid from the cavity was collected. The fluid was serous, and a culture test revealed no bacteria in the fluid. The patient was observed closely, and the erythema disappeared at approximately 6 weeks after the operation. Then, radiation therapy for the conserved breast was administered. The appearance of the breast at 8 months after the operation is depicted in Fig. 5. An irregular, low-echoic area was observed by ultrasonography. Postsurgical mammography findings showed architectural distortion is noted in the tumor bed in the upper quadrant of right breast. Clips were placed within the tumor bed to assist with radiotherapy planning. Neither calcifications nor foreign body reactions were found (Figs. 5 and 6). The cosmetic assessment score was evaluated at 21 months after the operation and was 6 out of 12 (Fig. 6). The irregular, hypoechoic area became smaller at 21 months after the operation. When we first began to apply immediate Vicryl mesh insertion, we considered that the erythema was due to infection. However, the fluid from every patient was serous. One patient examined bacterial culture test and revealed no pathogenic bacteria. Rest of patients were not examined culture test. Fifteen patients were administered prophylactic antibiotics and underwent close observation. One patient underwent incision and drainage; she is the only patient who underwent reoperation. Rest of 14 patients were treated conservatively. In the lumpectomy only group,

Table 3

Summary of adverse events.

Adverse event

Lumpectomy with Vicryl mesh insertion (n Z 24)

Lumpectomy only (n Z 24)

None Erythema Discharge from the wound Burn

8 (33.3%) 11 (45.8%) 5 (20.8%)

22 (91.6%) 1 (4.2%) 0 (0%)

0 (0%)

1 (4.2%)

Time until adverse event occurs (median)

7 d to 7 m 28 d (1 m 5 d)

13 d to 1 m 7 d (25 d)

Figure 4 Two weeks after the surgery. Erythema has developed over the entire breast. Ultrasonography shows edematous skin. The Vicryl mesh remains in the fluid.

no patients underwent reoperation. Erythema disappeared with time. Later, patients who intended to receive immediate Vicryl mesh insertion were informed prior to surgery that they might experience erythema of the breast. None of the patients has had local recurrence thus far.

4. Discussion Lumpectomy does not always result in a satisfactory outcome. Patients with breast cancer rarely complain of their cosmetic outcome because their concerns tend to focus on preventing breast cancer recurrence. Cosmetic outcomes are often their secondary issue. Immediate Vicryl mesh insertion was first reported by Sanuki et al6 We applied their surgical method after lumpectomy because the technique is quite simple, and the cosmetic outcome seemed to be excellent. Vicryl mesh is reported to be a less costly alternative to acellular dermal matrix.7 Unlike in western countries, an acellular dermal matrix is not available in Japan. Vicryl mesh is one of the several implantable biomaterials used after lumpectomy. Here, we demonstrated that there was no significant difference in the cosmetic outcome between the Vicryl mesh group and lumpectomy only group. Additionally, adverse events such as erythema were observed in a high percentage of patients. Vicryl mesh is a copolymer made from 90% poly-glycolic acid and 10% L-lactic acid, and is absorbed by hydrolysis in vivo. Vicryl mesh is typically resorbed at 3e4 weeks,7 and results in a loss of mechanical

Please cite this article in press as: Tsuji W, Yotsumoto F, Pros and cons of immediate Vicryl mesh insertion after lumpectomy, Asian Journal of Surgery (2017), http://dx.doi.org/10.1016/j.asjsur.2017.08.001

+ Immediate Vicryl mesh insertion after lumpectomy

MODEL

5

Figure 5 Appearance and ultrasonographic image at eight months after the operation. Mammography findings 1 year after the operation. The erythema has resolved, but the left breast is smaller than right breast. Ultrasonography shows irregular low-echoic area. Vicryl mesh is not observed. Postsurgical mammography findings showed architectural distortion is noted in the tumor bed in the upper quadrant of right breast.

Figure 6 Twenty-one months after surgery. The right breast size is markedly different from the left. The patient’s cosmetic assessment score is 6 out of 12. The ultrasonography image shows that the size of the irregular, low-echoic area is smaller than it was at 8 months after surgery. Mammogram findings show architectural distortion as chronic postsurgical change.

Please cite this article in press as: Tsuji W, Yotsumoto F, Pros and cons of immediate Vicryl mesh insertion after lumpectomy, Asian Journal of Surgery (2017), http://dx.doi.org/10.1016/j.asjsur.2017.08.001

+

MODEL

6 strength. Nyame et al performed bacterial adhesion assays to demonstrate that Vicryl mesh produce decreased rates of bacteria-mediated biofilm formation in comparison with an acellular dermal matrix such as AlloDerm (Lifecell, Branchburg, NJ, USA) and FlexHD (Johnson & Johnson).8 A systematic review article reported that the infection rate was 2.6% (confidence interval: 0.7e6.6%).5 Eleven patients had erythema at our hospital, but not all patients who had erythema had infection. Actually, fluid was serous and culture tests revealed no bacteria from the wound. Erythema is considered to be due to hydrolysis of the Vicryl mesh. The patients who had erythema underwent radiation therapy for the conserved breast after the erythema resolved. Radiotherapy should start within 20 weeks after breast-conserving surgery because delays are associated with higher local recurrence rates and shorter breast cancer-specific survival.9 Otherwise, there was a statistically significant increase in the local recurrence rate at 5 years with a delay in starting postoperative radiotherapy, and the authors concluded radiotherapy should start within 8 weeks of surgery.10 In Vicryl mesh group, 10 patients commenced radiotherapy after 8 weeks of surgery because of adverse events but no later than 20 weeks. From this point, adverse events after breast-conserving surgery should be avoided. Vicryl mesh has also been extensively used in many surgical specialties such as thoracic surgery, abdominal surgery, gynecology, and nephrology.11 Compared to such operations, the surgical site of breast conserving surgery is relatively close to the surface of the body, and erythema is notable.

5. Conclusion Immediate Vicryl mesh insertion is a simple method. However, it leads to significantly increased incidence of postoperative complications and delay in commencement of adjuvant radiotherapy. Furthermore, the cosmetic outcomes are not superior to that of no reconstruction. The development of superior biomaterials is anticipated for breast reconstruction after lumpectomy.

Ethical standards and informed consent All patients gave informed consent for inclusion in this study. This study meets the 1964 Declaration of Helsinki in protecting human subjects.

Conflict of interest All authors have no conflicts of interest.

Acknowledgments

W. Tsuji, F. Yotsumoto

References 1. Coates AS, Winer EP, Goldhirsch A, et al. Tailoring therapies e improving the management of early breast cancer: St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2015. Ann Oncol. 2015 Aug;26(8): 1533e1546. PubMed PMID: 25939896. Pubmed Central PMCID: PMC4511219. 2. Tsuji W, Teramukai S, Ueno M, Toi M, Inamoto T. Prognostic factors for survival after first recurrence in breast cancer: a retrospective analysis of 252 recurrent cases at a single institution. Breast Cancer. 2014 Jan;21(1):86e95. PubMed PMID: 22477265. 3. Clarke M, Collins R, Darby S, et al. Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087e2106. PubMed PMID: 16360786. Epub 2005/12/20.eng. 4. Morrow M, Van Zee KJ, Solin LJ, et al. Society of Surgical OncologyeAmerican Society for Radiation OncologyeAmerican Society of Clinical Oncology Consensus Guideline on Margins for Breast-Conserving Surgery with Whole-Breast Irradiation in Ductal Carcinoma in situ. Pract Radiat Oncol. 2016 SepeOct; 6(5):287e295. PubMed PMID: 27538810. Pubmed Central PMCID: PMC5070537. 5. Rodriguez-Unda N, Leiva S, Cheng HT, Seal SM, Cooney CM, Rosson GD. Low incidence of complications using polyglactin 910 (Vicryl) mesh in breast reconstruction: a systematic review. J Plast Reconstr Aesthet Surg. 2015 Nov;68(11): 1543e1549. PubMed PMID: 26275493. 6. Sanuki J, Fukuma E, Wadamori K, Higa K, Sakamoto N, Tsunoda Y. Volume replacement with polyglycolic acid mesh for correcting breast deformity after endoscopic conservative surgery. Clin Breast Cancer. 2005 Jun;6(2):175. PubMed PMID: 16001998. 7. Tessler O, Reish RG, Maman DY, Smith BL, Austen Jr WG. Beyond biologics: absorbable mesh as a low-cost, low-complication sling for implant-based breast reconstruction. Plast Reconstr Surg. 2014 Feb;133(2):90ee99e. PubMed PMID: 24469217. 8. Nyame TT, Lemon KP, Kolter R, Liao EC. High-throughput assay for bacterial adhesion on acellular dermal matrices and synthetic surgical materials. Plast Reconstr Surg. 2011 Nov;128(5): 1061e1068. PubMed PMID: 22030489. Pubmed Central PMCID: PMC3766523. 9. Olivotto IA, Lesperance ML, Truong PT, et al. Intervals longer than 20 weeks from breast-conserving surgery to radiation therapy are associated with inferior outcome for women with early-stage breast cancer who are not receiving chemotherapy. J Clin Oncol. 2009 Jan 01;27(1):16e23. PubMed PMID: 19018080. 10. Huang J, Barbera L, Brouwers M, Browman G, Mackillop WJ. Does delay in starting treatment affect the outcomes of radiotherapy? A systematic review. J Clin Oncol. 2003 Feb 01; 21(3):555e563. PubMed PMID: 12560449. 11. Tobias AM, Low DW. The use of a subfascial vicryl mesh buttress to aid in the closure of massive ventral hernias following damage-control laparotomy. Plast Reconstr Surg. 2003 Sep;112(3):766e776. PubMed PMID: 12960857.

We appreciate all patients who participated this study.

Please cite this article in press as: Tsuji W, Yotsumoto F, Pros and cons of immediate Vicryl mesh insertion after lumpectomy, Asian Journal of Surgery (2017), http://dx.doi.org/10.1016/j.asjsur.2017.08.001