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ORIGINAL ARTICLE
Year : 2019  |  Volume : 22  |  Issue : 8  |  Page : 1115-1119

A short follow-up of prosthesis-based breast reconstruction using TiLOOP® Bra surgical mesh


Department of Breast Surgery, The Affiliated Changzhou No. 2 People's Hospital of Nanjing Medical University, Changzhou, China

Date of Acceptance10-Apr-2019
Date of Web Publication14-Aug-2019

Correspondence Address:
Prof. Y L Zhu
29 Xinglongxiang, Changzhou - 213 000, Jiangsu Province
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/njcp.njcp_487_18

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   Abstract 


Background: A new approach for prosthesis-based breast reconstruction is the use of a titanium-coated polypropylene mesh TiLOOP® Bra. However, the safety and outcomes are currently unclear in Chinese breast cancer patients. Methods: A retrospective study of patients undergoing prosthesis-based breast reconstruction using TiLOOP® Bra was carried out. Complications were divided into minor complications (require conservative treatment) and major complications (require surgical intervention). The influence of patient- and surgery-related characteristics on complications was analyzed. Results: Postoperative hematoma and seroma were respectively found in one and two breasts and could be treated conservatively. In three breasts skin infection occurred immediately after surgery resulting in skin necrosis of two breasts and wound dehiscence of one breast. These three breasts were treated with mesh removal, and revisionary surgery. Increased risk of mesh removal and implant explantation were observed in case of skin infection (P = 0.011) and skin necrosis (P = 0.033). Neither patient-related characteristics including age >50 years, BMI >25 kg/m2, and postoperative radiotherapy/chemotherapy, nor surgery-related characteristics including sentinel lymph node biopsy or axillary dissection alone, and curative/prophylactic surgery were significantly correlated with minor and major complications. Ultrasound evaluation showed a well-incorporated mesh into surrounding tissue. Conclusion: This titanium-coated polypropylene mesh showed acceptable complications and could be used safely in prosthesis-based breast reconstruction by stabilizing the implant pocket. Longer follow-up data and more randomized trials are necessary to determine the clinical use of this mesh.

Keywords: Breast cancer, mesh, prosthesis, reconstruction


How to cite this article:
Chen W X, Cheng L, Xu L Y, Zhu Y L. A short follow-up of prosthesis-based breast reconstruction using TiLOOP® Bra surgical mesh. Niger J Clin Pract 2019;22:1115-9

How to cite this URL:
Chen W X, Cheng L, Xu L Y, Zhu Y L. A short follow-up of prosthesis-based breast reconstruction using TiLOOP® Bra surgical mesh. Niger J Clin Pract [serial online] 2019 [cited 2019 Oct 15];22:1115-9. Available from: http://www.njcponline.com/text.asp?2019/22/8/1115/264415




   Introduction Top


As in many other countries, breast cancer is now the most common malignant tumor in Chinese women.[1] Skin- and nipple-sparing mastectomy and modified radical mastectomy are oncologically safe procedures and the offer of immediate breast reconstruction following mastectomy is currently standard practice at the time of diagnosis and therapy planning.[2]

Although autologous tissue breast reconstruction has emerged as a promising treatment option with excellent cosmetic results, it has become increasingly popular to use prosthesis-based breast reconstruction.[3],[4] Subpectoral implant placement is the generally accepted method. However, a full muscular pocket is not always feasible, especially for large prosthesis. While pectoralis major muscle provides good cover in the upper and lower medial quadrant between prosthesis and mastectomy flap, the lower lateral part of prosthesis is only covered by a skin-fat flap. This would result in a lack of support and increase implant extrusion, malposition, and palpability.

Many solutions have been generated in recent years to completely cover the implant's lower lateral part, spanning from mobilization of musculi serratus anterior or corial flaps to usage of biological acellular dermal matrix.[5],[6] A possible alternative is the application of a titanium-coated polypropylene mesh called TiLOOP ® Bra (pfm medical, Cologne, Germany). It is intended for extension of pectoralis major muscle, coverage the lower pole of prosthesis, and stabilization the implant pocket laterally without destroying further muscle tissue. Compared to simple polypropylene, this mesh displays a number of advantages including better cell growth, lower inflammation risk, and less scarring.[7],[8]

Several clinical trials regarding TiLOOP® Bra in prosthesis-based breast reconstruction have reported that the minor complication rates varied from 15.6% to 17%, major complication rates varied from 6.2% to 13.4%, and implant loss rates varied from 3.1% to 8.7%.[5],[9],[10] Nevertheless, there are no available clinical data on its safety and outcomes in Chinese breast cancer patients. In this retrospective study, we investigated a series of cases undergoing prosthesis-based breast reconstruction using TiLOOP ® Bra.


   Patients and Methods Top


Study design

Between November 2016 and October 2017, we performed a retrospective study of 10 patients who underwent skin- and nipple-sparing mastectomy or modified radical mastectomy with immediate definitive prosthesis reconstruction using titanium-coated polypropylene mesh TiLOOP ® Bra. The study protocol was conducted in accordance with the Declaration of Helsinki and approved by the ethics committee of Changzhou No. 2 People's Hospital.[11] Informed consents were obtained from all patients.

Patient selection

Patients were included if the following selection criteria were met: Age < 80 years and small-medium breast size. Exclusion criteria were T4 or inflammatory breast cancer, distant metastasis, comorbidities including diabetes, hypertension, renal failure, chronic hepatic diseases, and congestive heart failure, smoking, and previous breast surgery or radiotherapy on chest wall.

Material description

TiLOOP® Bra consists of a lightweight, large-pore, non-absorbable prosthetic mesh made from monofilament polypropylene with titanium coating. According to the manufacturer's instructions, such soft and flexible mesh structure serves as matrix for the growth of muscle and stromal cells. Adsorption of a thin fibrous tissue layer appears whose cells grow through the pores of mesh fabric. Thereby, TiLOOP® Bra supports, reinforces, and bridges the body's own tissue in prosthesis-based breast reconstruction.

Surgical technique

The mastectomy incision was chose according to tumor location, and surgical technique using titanium-coated polypropylene mesh was carried out as previously reported.[12] In short, after mastectomy completion and skin flap preparation, pectoralis major muscle was elevated from chest wall by blunt dissection and electrocautery to create a subpectoral pocket. An adequate prosthesis was put under the muscle, and a TiLOOP ® Bra mesh was sutured to the edge of pectoralis major muscle to cover the lower pole and wrapped around the implant without attaching it to the chest wall [Figure 1]. Drains were placed in subpectoral space and removed when drainage was less than 30 ml per day. Prophylactic antibiotics were given to all patients during and 3 days after surgery.
Figure 1: TiLOOP® Bra mesh was sutured to the edge of pectoralis major muscle to cover the lower implant pole

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Complication definition

Complications were divided into minor and major complications as previously described.[13] Minor complications were those events that could be treated conservatively without surgical intervention. They included hematoma, seroma, skin infection, skin necrosis, wound dehiscence, nipple necrosis, and capsule fibrosis. Major complications were the above mentioned events that required additional surgical intervention after compression, puncture, debridement, dressing change, and antibiotic therapy. They resulted in mesh removal, implant loss, and revisionary surgery.

Statistical analysis

Statistical analysis was performed using the SPSS 20.0 package. A value of P < 0.05 was considered to be statistically significant.


   Results Top


Patient characteristics

Between November 2016 and October 2017, a total of 10 patients (14 breasts) underwent prosthesis-based breast reconstruction using titanium-coated polypropylene mesh TiLOOP ® Bra was evaluated. Patients had a mean age of 44.4 ± 5.9 years (range: 34-54 years), mean body mass index (BMI) of 22.5 ± 2.4 kg/m 2 (range: 19.5-27.3 kg/m 2), and mean follow-up was 13.2 ± 3.1 months (range: 8.1-19.8 months).

Surgical characteristics

Of the 14 mastectomies, 10 were of curative intent and 4 were prophylactic because of patient desire. A bilateral procedure was performed in four patients, and the remaining six patients had unilateral mastectomy [Figure 2]. In all patients, implants from the same manufacture were used (Mentor, USA). Mean prosthesis size was 255 ± 26 cc (range: 200-280 cc), and mean days of used drains were 7.6 ± 2.6 days (range: 3-11 days).
Figure 2: Two patients with invasive breast cancer before and after bilateral mastectomy with prosthesis-based breast reconstruction using TiLOOP® Bra mesh. The right nipple looked necrosis after surgery in case 1, but it turned to be normal after surgical dressing with alcohol-dipped gauze

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Complication description

No patient was lost to follow-up. Both minor and major complications occurred in six breasts. Postoperative hematoma and seroma were respectively found in one and two breasts and could be treated conservatively. Capsule fibrosis was seen in one breast, whereas no nipple necrosis happened. In three breasts, skin infection occurred immediately after surgery resulting in skin necrosis of two breasts. In another breast, skin infection and wound dehiscence were observed 2 month after surgery. These three breasts were treated with antibiotics, debridement, mesh removal, and revisionary surgery namely latissimus dorsi flap transfer.[14] Increased risk of mesh removal and implant explantation were observed in case of skin infection (P = 0.011) and skin necrosis (P = 0.033) [Table 1].
Table 1: Overall complications and subgroup analysis according to minor and major complications in 14 breasts

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Patient- and surgery-related characteristics on complications

None of the patient-related characteristics including age >50 years, BMI >25 kg/m 2, postoperative radiotherapy, and postoperative chemotherapy was a significant risk factor for minor and major complications. No surgery-related characteristics including sentinel lymph node biopsy alone, axillary lymph node dissection alone, curative surgery, and prophylactic surgery were correlated with minor and major complications [Table 2].
Table 2: Analysis of patient- and surgery-related characteristics as risk factors for major and minor complications

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Ultrasound evaluation

Ultrasound image of a patient14 months after immediate prosthesis-based breast reconstruction using titanium-coated polypropylene mesh showed a series of punctiform signals above the implant [Figure 3].
Figure 3: Ultrasound image of a patient 14 months after prosthesis-based breast reconstruction using TiLOOP® Bra mesh showed a series of punctiform signals next to pectoralis major muscle (a) and above the implant (b)

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   Discussion Top


In course of immediate breast reconstruction after mastectomy the gland could be replaced by autologous tissue or prosthesis. Although excellent esthetic results could be obtained using autologous tissue, not all women desire autologous reconstruction or have enough tissue. Prosthesis-based breast reconstruction is the most commonly performed procedure worldwide, and prosthesis coverage by a whole muscular pocket to avoid implant exposure has been the preferred choice.[3] With the introduction of biological mesh in recent years, a combined muscular-mesh pocket has become a novel approach.

In the present work, a series of patients underwent prosthesis-based breast reconstruction using titanium-coated polypropylene mesh TiLOOP ® Bra wase evaluated. The most common minor complications were hematoma and seroma, while the major complications after skin infection were mesh removal, implant loss, and revisionary surgery. They were due to skin necrosis in two breasts and wound dehiscence in another breast. Previous studies have reported that the minor complication rates varied from 15.6% to 17%, major complication rates varied from 6.2% to 13.4%, and implant loss rates varied from 3.1% to 8.7%. A difference of our data to publications with mesh in prosthesis-based breast reconstruction is a higher mesh removal rate and implant explantation rate of 21.4% (3/14). This might be explained by the new procedure and learning curve.

The current work revealed that neither patient-related characteristics including age >50 years, BMI >25 kg/m 2, and postoperative radiotherapy/chemotherapy, nor surgery-related characteristics including sentinel lymph node biopsy or axillary dissection alone, and curative/prophylactic surgery were significantly correlated with minor and major complications. These results were consistent with recent studies of risk factors for complications after prosthesis-based breast reconstruction using surgical mesh.[9],[12],[15] Nonetheless, it is noteworthy that three breasts treated with postoperative chemotherapy, a factor known to affect outcome in breast reconstruction, experienced complications, mesh removal, and revisionary surgery.

During the ultrasound follow-up, images of reconstruction surgery using TiLOOP ® Bra mesh displayed a series of punctiform signals above the implant. Histological examination also showed a well incorporated mesh into surrounding tissue, as recently reported.[12] In clinical practice, the mesh was barely palpable, and the breast maintained its softness with a minimal prosthesis palpability. When asked, patients did not mention any discomfort.

A limitation to this study is the small sample size. On one hand, a number of patients were excluded because of comorbidities including diabetes and hypertension, and smoking; on the other hand, the mesh was relatively expensive and not affordable for all selected patients. A further limitation is the short follow-up. It is important to determine the degree to which complications influenced patient satisfaction and long-term outcomes. Therefore, more prospective cohort studies are needed in future.


   Conclusion Top


Titanium-coated polypropylene mesh TiLOOP ® Bra could be used safely in prosthesis-based breast reconstruction by stabilizing the implant pocket. None of the patient- and surgery-related characteristics was a significant risk factor for minor and major complications. Longer follow-up data and more randomized trials are necessary to determine the clinical use of this mesh.

Author contributions

Conceived and designed the experiments: WC LC. Analyzed the data: WC LX YZ. Wrote the paper: WC.

Financial support and sponsorship

This work was supported by grants from the Natural Science Foundation of China (81702591 and 81502294), the Natural Science Foundation of Jiangsu Province (BK20170294), and Science Foundation of Changzhou (CJ20159044).

Conflicts of interest

There are no conflicts of interest.



 
   References Top

1.
Fan L, Strasser-Weippl K, Li JJ, St Louis J, Finkelstein DM, Yu KD, et al. Breast cancer in China. Lancet Oncol2014;15:e279-89.  Back to cited text no. 1
    
2.
Gerber B, Krause A, Dieterich M, Kundt G, Reimer T. The oncological safety of skin sparing mastectomy with conservation of the nipple-areola complex and autologous reconstruction: An extended follow-up study. Ann Surg2009;249:461-8.  Back to cited text no. 2
    
3.
Jagsi R, Jiang J, Momoh AO, Alderman A, Giordano SH, Buchholz TA, et al. Trends and variation in use of breast reconstruction in patients with breast cancer undergoing mastectomy in the United States. J Clin Oncol2014;32:919-26.  Back to cited text no. 3
    
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Macadam SA, Ho AL, Lennox PA, Pusic AL. Patient-reported satisfaction and health-related quality of life following breast reconstruction: A comparison of shaped cohesive gel and round cohesive gel implant recipients. Plast Reconstr Surg2013;131:431-41.  Back to cited text no. 4
    
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Gschwantler-Kaulich D, Schrenk P, Bjelic-Radisic V, Unterrieder K, Leser C, Fink-Retter A, et al. Mesh versus acellular dermal matrix in immediate implant-based breast reconstruction-A prospective randomized trial. Eur J Surg Oncol2016;42:665-71.  Back to cited text no. 5
    
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Scheidbach H, Tamme C, Tannapfel A, Lippert H, Kockerling F. In vivo studies comparing the biocompatibility of various polypropylene meshes and their handling properties during endoscopic total extraperitoneal (TEP) patchplasty: An experimental study in pigs. Surg Endosc2004;18:211-20.  Back to cited text no. 7
    
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Scheidbach H, Tannapfel A, Schmidt U, Lippert H, Kockerling F. Influence of titanium coating on the biocompatibility of a heavyweight polypropylene mesh. An animal experimental model. Eur Surg Res2004;36:313-7.  Back to cited text no. 8
    
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Dieterich M, Paepke S, Zwiefel K, Dieterich H, Blohmer J, Faridi A, et al. Implant-based breast reconstruction using a titanium-coated polypropylene mesh (TiLOOP ® Bra): A multicenter study of 231 cases. Plast Reconstr Surg2013;132:8e-19e.  Back to cited text no. 9
    
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Hallberg H, Lewin R, Elander A, Hansson E. TIGR((R)) matrix surgical mesh-a two-year follow-up study and complication analysis in 65 immediate breast reconstructions. J Plast Surg Hand Surg2018;52:253-8.  Back to cited text no. 10
    
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World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA2013;310:2191-4.  Back to cited text no. 11
    
12.
Dieterich M, Reimer T, Dieterich H, Stubert J, Gerber, B. A short-term follow-up of implant based breast reconstruction using a titanium-coated polypropylene mesh (TiLoop ® Bra). Eur J Surg Oncol2012;38:1225-30.  Back to cited text no. 12
    
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Lin KY, Blechman AB, Brenin DR. Implant-based, two-stage breast reconstruction in the setting of radiation injury: An outcome study. Plast Reconstr Surg2012;129:817-23.  Back to cited text no. 13
    
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Tomita K, Yano K, Nishibayashi A, Fukai M, Miyasaka M, Hosokawa K. The role of latissimus dorsi myocutaneous flaps in secondary breast reconstruction after breast-conserving surgery. Eplasty2013;13:e28.  Back to cited text no. 14
    
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Kobraei EM, Nimtz J, Wong L, Buseman J, Kemper P, Wright H, et al. Risk factors for adverse outcome following skin-sparing mastectomy and immediate prosthetic reconstruction. Plast Reconstr Surg2012;129:234e-41e.  Back to cited text no. 15
    


    Figures

  [Figure 1], [Figure 2], [Figure 3]
 
 
    Tables

  [Table 1], [Table 2]



 

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