Bioactive Materials

Bioactive Materials

Volume 6, Issue 12, December 2021, Pages 4640-4653
Bioactive Materials

Titanium-coated polypropylene mesh as innovative bioactive material in conservatives mastectomies and pre-pectoral breast reconstruction

https://doi.org/10.1016/j.bioactmat.2021.05.002Get rights and content
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Highlights

  • This retrospective observational study, reports the results of pre-pectoral immediate breast reconstruction (IBR) using a prosthesis wrapped with Titanium-Coated Polypropylene Mesh (TCPM) vs. patients treated with tissue expander (TE) equally placed pre-pectorally (and wrapped with the same TCPM in 74% of the control group), with the aim to reduce the risk of reconstruction failure after conservative mastectomy.

  • The primary end-points of the study were the clinical outcomes. These outcomes were: the incidence of perioperative and postoperative complications (safety profile), quality of life (QoL) at 2 years after surgery, measured as the change between the pre- and post-op BREAST-Q scores, the aesthetic outcomes, and the capsular contracture grade. Two methods for the clinical analysis of the results have been used: Surgical-Team and patient self-evaluation. The Surgical-team evaluation was an objective evaluation based on clinical assessment, using a scale of six degrees (excellent, good, discreet, enough, poor, inadequate). The subjective patient-based self-evaluation applied the same six degrees. Moreover, secondary end-point of the study, was a histopathological capsule assessment to evaluate the integration of the TCPM in the mastectomy flap as a bioactive material.

  • Histological, and bio-molecular evaluation of TCPM samples were analyzed. In particular, Hematoxylin-eosin staining of post-operative biopsies of wrapping tissue TCPM mesh was performed focusing on the collagen presence and fibroblasts amount and specifically, on the complete healing and TCPM incorporation without side effects. Additionally, the immunofluorescence using specific markers CD 45 and Collagen 1, and immunohistochemistry using CD 45 on paraffin samples were performed. The endpoint was to evaluate the grade of inflammation represented by the number of lymphocytes in the treated site, and the eventual different collagen type expression (Collagen 1 and Collagen 3) in tissues underwent and not to radiotherapy and during the use of TCPM.

  • Analyzing the side effects with the use of t-test, the complication rate between SG and CG did not showed statistically significant differences (p=0,8472), although it was slightly higher in the SG. Despite the study group was bigger than the control group (+42%) the side effects' number did not statistically differ, confirming the safety and reliability of the TCPM procedure during DTI. Overall Satisfaction with Breasts, Psychosocial Well-being, and Sexual Well-being scores were all significantly increased after sub-cutaneous pre-pectoral DTI immediate reconstruction with TCPM mesh (p < 0.05) compared to CG. Mean satisfaction with the overall aesthetic result was high after breast reconstruction (8.72) in patients who underwent DTI pre-pectoral immediate reconstruction (SG) after 2 years from surgery.

  • The histological analysis of fragments of implant's wrapping tissue incorporating TCPM mesh displayed complete incorporation of the mesh with physiological aspects of healing. The immunochemistry concluded the Collagen 1, and 3 expressions did not differ, with statistical significance, between TCPM and NO TCPM samples, showing a process of physiological healing overlapping to perfect device incorporation, confirming that TCPM was a bioactive material. Conservative mastectomies with pre-pectoral IBR assisted by TCPM are resulted oncologically safe preserving breast appearance.

Abstract

Breast reconstruction is rapidly evolving, thanks to the growing acceptance of synthetic meshes as innovative biomaterials. 276 patients undergoing mastectomy (total of 328 mastectomies) were analyzed in a retrospective observational study to evaluate the pre-pectoral immediate breast reconstruction (IBR) using an implant wrapped with Titanium-Coated Polypropylene Mesh (TCPM) vs. patients treated with tissue expander (TE), equally placed pre-pectorally (and wrapped with the same TCPM in 74.3% of the control group’ breasts). 163 patients, of the study group (SG), underwent mastectomy and pre-pectoral IBR with implant wrapped with TCPM, in a one-step surgery, called direct-to-implant technique (DTI), while 113 patients control group (CG) underwent mastectomy and TE. DTI technique has been performed in 192 breasts of the SG while TE procedure in 136 breasts of the CG. The BREAST-Q questionnaire has been provided before the treatment and 2 years later. Baker scale has been used to evaluate capsular contracture. Oncologic, surgical, and aesthetic outcomes along with BREAST-Q scores were analyzed. Additionally, a histologic evaluation was conducted in 11 capsules' samples randomly chosen (6 derived from SG patients and 5 derived from CG). Complications were recorded in 43 cases (29SG-14CG): 8 skin-nipple necrosis (5SG-3CG), 8 wound dehiscence (6SG-2CG), 3 hematomas (1SG-2CG), and 24 infections (8SG-16CG). Grade IV capsular contracture was detected in 9 breasts (1SG-8CG), whereas 254 breasts were grade I (110SG-144CG), 33 (10SG-23CG) grade II, and 32 (4SG-28CG) grade III. Implant wrinkling was detected in 18 cases (10SG-8CG) after 30 months. The local tumor recurrence rate was 5.8%. Three recurrences were on the nipple-areola complex (1.9%). SG patients showed significantly higher rates in the BREAST-Q overall Satisfaction with Outcome (74.1), overall Satisfaction with Breasts (69.1), Psychosocial Well-being (81.9), and Sexual Well-being (63.1), versus CG's patients (p < 0.05). Histological analysis showed a process of normal tissue repair with a complete mesh integration and normal healing. Conservative mastectomies with pre-pectoral IBR assisted by TCPM proved themselves oncologically safe, biologically integrated into native tissues, and highly accepted in terms of quality of life guaranteeing a more natural and aesthetic breast appearance.

Core tip

This retrospective observational study provided clinical and histological outcomes of the pre-pectoral IBR using an implant wrapped with TCPM vs. patients treated with TE, equally placed pre-pectorally. The efficacy of IBR using an implant wrapped with TCPM was confirmed by the cosmetic results obtained and by a rate of side effects comparable to TE. All the histological analyses performed confirmed the TCPM mesh complete integration with the physiological aspects of healing: The Collagen 1 and 3 expressions did not differ, between TCPM and NO TCPM samples to confirm a process of healing overlapping to perfect device incorporation and normal healing.

Keywords

Mastectomy
Pre-pectoral breast reconstruction
Titanium-coated polypropylene mesh
Immediate breast reconstruction

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1

Top Italian Scientist (TIS) with H-index > 31 s. Scholar.