Implant Based Breast Reconstruction Using a Titanium-Coated Polypropylene Mesh (TiLOOP® Bra): A Systematic Review and Meta-analysis.

BACKGROUND: Implant-based breast reconstruction (IBBR) can be performed using a variety of biological and synthetic meshes. However, there has yet to be a consensus on the optimal mesh. This study investigates the safety and patient satisfaction of using TiLOOP® Bra in IBBR and compares its postoperative complication risk with that of porcine acellular dermal matrix (ADM) and SERAGYN® BR. METHODS: The literature review was performed via PRISMA criteria, 23 studies met the inclusion criteria for the TiLOOP® Bra review, and 5 studies met the inclusion criteria for the meta-analysis. Patient characteristics and per-breast complications were collected. Data were analyzed using Cochrane RevMan and IBM SPSS. RESULTS: In 3175 breasts of 2685 patients that underwent IBBR using TiLOOP® Bra, rippling was observed as the most common complication, followed by seroma and capsular contracture. No significant difference in the overall complication rate between pre- and sub-pectoral IBBR using TiLOOP® Bra. However, the meta-analysis showed that the TiLOOP® Bra group had significantly lower odds of implant loss, seroma, wound dehiscence, and the need for reoperation or hospitalization than the ADM group. Additionally, the TiLOOP® Bra group had a significantly lower seroma rate compared to the SERAGYN® BR group, while the other outcome indicators were similar between the two groups. CONCLUSION: TiLOOP® Bra has become increasingly popular in IBBR in recent years. This review and meta-analysis support the favorable safety profile of TiLOOP® Bra reported in the current literature. The meta-analysis revealed that TiLOOP® Bra has better safety than ADM and a comparable risk of complications compared to SERAGYN® BR. However, as most studies had low levels of evidence, further investigations are necessary. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Is a soft tissue reinforcing mesh necessary in immediate prosthetic breast reconstruction for early breast cancer in patients with low-volume breast? A single-center, retrospective Chinese clinical study.

It is controversial as to whether soft tissue reinforcement mesh should be used for immediate prosthetic breast reconstruction after nipple-sparing mastectomy for low-volume breast early breast cancer (LVBEBC) in Chinese adult women. We collected data on 89 patients with LVBEBC who underwent such a surgery and divided them into two groups: 39 patients in the totally subpectoral prosthesis-only breast reconstruction group (simple group) and 50 patients in the prosthesis-combined titanium-coated polypropylene mesh (TCPM) group (or the so-called "dual plane" or "mesh-assisted partially subpectoral breast reconstruction group") (combined group). The results demonstrated no difference in operative time, intraoperative bleeding, and postoperative complications between the two groups; however, total drainage volume and extubation time were less and shorter, respectively, in the combined group. The median follow-up time was 18.6 months without local recurrence or distant metastasis in both groups. At 24 months after surgery, the excellent and good rates of breast reconstruction were higher in the combined group. However, patients' BMI, breast morphology, and breast volume of 300 mL or more had an effect on the shape of the reconstructed breast; in addition, in patients with higher BMI, conical breast morphology, and breast volume over 300 mL, the shape of the breast was more perfect with the prosthesis combined with TCPM reconstruction.Trial registration: This retrospective study was "retrospectively registered" in the Sixth Affiliated Hospital of South China University of Technology of China on March 15, 2022 (No. 2022018) and in the National Medical Research Registry filing system of China ( https://www.medicalresearch.org.cn ) (No. MR-44-22-003618).

Pre-pectoral Breast Reconstruction Does Not Affect Early Immunological Response: A BIAL 2.20 Study Subanalysis.

BACKGROUND/AIM: Reduction of postoperative stress is a modern tenet in surgical oncology with the aim of reducing early postoperative lymphopenia. Our prospective study evaluated post-operative immune response at baseline and postoperative day (POD) 1 and 2 after direct-to-implant pre-pectoral (PP) breast reconstruction with titanium-coated polypropylene mesh versus subpectoral (SP) breast reconstruction. PATIENTS AND METHODS: Between January and December 2020, 37 patients were randomized between PP (n=17) or SP (n=16) reconstruction. Baseline and operative data were analyzed. Postoperative pain assessment using numeric pain rating scale (NPRS), and a full blood count with lymphocyte subsets were collected before surgery, and on POD1 and POD2. Data were evaluated by two-way analysis of variance test. RESULTS: Baseline data did not demonstrate any statistical difference. Inter-group analysis did not provide any statistically significant difference in leukocytes, total lymphocytes, and lymphocytes subsets among SP and PP reconstruction groups (p>0.05). However, compared to specificity, the PP group experienced shorter operative time, with a mean difference 30.19 min, lower blood loss (p=0.017), lower rate of postoperative anemia (p=0.039), and a more favorable profile in inter-group pain analysis (p<0.001). CONCLUSION: PP reconstruction with titanium-coated polypropylene mesh does not increase immunological impairment in the early postoperative period when compared with SP reconstruction and provides lower postoperative pain, reduction of operative time, and lower rate of postoperative anemia.

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

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.

Titanized polypropylene mesh in laparoscopic sacral colpopexy.

INTRODUCTION: This study investigated perioperative and mid-term clinical outcomes after laparoscopic sacrocolpopexy (LSCP) with light titanium-coated polypropylene (TCP) mesh in a large group of patients affected by International Continence Society stage II-IV pelvic organ prolapse (POP). METHODS: This multicenter retrospective study included 217 patients treated with LSCP using TCP mesh. We aimed to (1) analyze the intra- and postoperative complication rates according to the ICS/IUGA Complication Classification Code guidelines, (2) evaluate the anatomical results and (3) assess postoperative patient satisfaction with the Patient Global Impression Improvement questionnaire. Nonparametric Wilcoxon signed-rank tests, χ2 test and Fisher's exact test were used where appropriate. RESULTS: The intraoperative complications were two (0.9%) cases of hemorrhage, two (0.9%) cases of incidental cystotomy and four (1.8%) cases of incidental colpotomy. During the postoperative follow-up, we recorded mesh exposure in 3 (1.4%) out of 217 patients. These 3 patients were from a group of 22 women who underwent vaginal opening during surgery, while in the remaining 195 patients without incidental colpotomy, no mesh exposure was observed (13.6% vs. 0.0%, p < 0.001). No failure of the apical compartment was observed, while 3 (1.4%) out of 217 patients experienced isolated anterior recurrence, and 1 (0.4%) patient had isolated posterior recurrence. All patients reported PGI-I scores ≥ 3, and 209 patients (96.3%) had a PGI-I score ≥ 2. CONCLUSIONS: The use of light TCP mesh is safe and effective during LSCP for POP repair from both an anatomical and a functional point of view, posing a very low postoperative mesh-related complication risk.

Simple prosthesis versus prosthesis plus titanium-coated polypropylene mesh for implant-based immediate breast reconstruction after total mastectomy for breast cancer.

BACKGROUND: Our study compares the cosmetic effects, postoperative complications, and quality of life of immediate breast reconstruction with simple prosthesis or prosthesis plus titanium-coated polypropylene mesh (TCPM) after total mastectomy for breast cancer. METHODS: In total, 69 patients who underwent total mastectomy, sentinel lymph node biopsy, and immediate prosthetic breast reconstruction from January 2015 to December 2018 in our hospital were selected, and their cosmetic effects, complications, and quality of life after reconstruction were recorded immediately after surgery and 6 months after surgery. RESULTS: Of these 69 patients, 29 were in the simple prosthesis group and 40 in the prosthesis + TCPM group. The incidence of surgical complications was 17.2% in the simple prosthesis group (5/29; including 4 cases of capsular contracture and 1 case of infection) 15.0% in the prosthesis + TCPM group (6/40; 1 case of flap necrosis, 2 cases of poor wound healing, 2 cases of hematomas, and 1 case of inadequate blood supply to nipple). The complications were successfully managed after symptomatic treatment in both groups. No prosthesis loss was noted. The incidence of postoperative complications showed there to be no significant differences between these two groups (P=0.06, χ2=0.80). The satisfaction rate of patients on cosmetic effects was 95.0% (38/40) in the prosthesis + TCPM group, significantly higher than that in the simple prosthesis group (75.90%, 22/29) (P=0.05, χ2=3.87). The quality of life in the simple prosthesis group at 2 weeks and six months after the operation was significantly lower than that in the prosthesis + TCPM group. The incidence rate of arm pain and fatigue at 2 weeks after operation was significantly higher than that in the prosthesis + TCPM group (P=0.04, χ2=4.42). The satisfaction of family life and sexual interest 6 months after the operation was also significantly lower in the simple prosthesis group than in the prosthesis + TCPM group (P=0.03, χ2=4.95). CONCLUSIONS: Breast reconstruction with prosthesis combined with TCPM does not increase surgical complications and has a good cosmetic effect and high patient satisfaction. Thus, it is a safe and reconstruction method.

Efficacy comparison of immediate breast reconstruction after breast cancer surgery and modified radical mastectomy / 肿瘤研究与临床

Objective To investigate the clinical efficacy and cosmetic outcome of two methods of immediate breast reconstruction and modified radical mastectomy for the patients with breast cancer after breast cancer surgery. Methods The clinical data of 95 patients with early breast cancer in the First Affiliated Hospital of Jinzhou Medical University from October 2014 to September 2018 were retrospectively analyzed. The patients were divided into latissimus dorsi combined with implants group (27 cases), titanium-coated polypropylene mesh combined with implants group (18 cases) and modified radical group (50 cases). The differences of surgical data, postoperative complications and quality of life were compared in the three groups. The postoperative cosmetic effect of two immediate reconstruction groups was observed. Results The differences of drainage duration and intraoperative blood loss in the three groups were not statistically significant (both P > 0.05). There were statistical differences in the hospital stay and the postoperative quality of life score (both P < 0.01). The incidence of postoperative complications in latissimus dorsi combined with implants group, the titanium-coated polypropylene mesh combined with implants group and the modified radical group was 48.1％ (13/27), 22.2％ (4/18) and 12.0％ (6/50), respectively. And the difference between latissimus dorsi combined with implants group and the modified radical surgery group was statistically significant (χ 2 = 12.33, P < 0.01). The good rate of cosmetic effect in titanium-coated polypropylene mesh group was higher than that in latissimus dorsi combined with implants group, and there was no statistically significant difference [83.3％ (15/18) vs. 81.5％ (22/27), χ 2 = 0.025, P > 0.05]. Conclusions Immediate breast reconstruction including latissimus dorsi combined with implants or titanium-coated polypropylene mesh combined with implants after radical mastectomy on the basis of indications can improve the quality of life and the cosmetic results of patients, but postoperative treatment is necessary for the increased complications after the two reconstruction methods.

Can titanium mesh influence local recurrence management after implant-based breast reconstruction?

INTRODUCTION: TiLOOP(®) Bra is a permanent titanium-coated polypropylene mesh currently used in post-mastectomy breast reconstruction with implants. This mesh is generally presented as inducing low-grade inflammatory reactions, but only few reports focused on its possible side effects. In the case described here, the use of the mesh led to minor clinical problems that needed to be clinically and surgically managed at the same time as a local relapse. CASE DESCRIPTION: A patient with high-grade ductal carcinoma in situ underwent primary surgery (nipple-sparing mastectomy and one-stage reconstruction using the TiLOOP(®) Bra mesh) and was subsequently referred for radiological and clinical investigation when various nodules became apparent during a follow-up physical examination. Prior to the histopathological proof, the diagnosis of local recurrence was complicated by the occurrence of an extensive granulomatous reaction in the fixation areas along with mild inflammatory changes scattered on the surface of the mesh. DISCUSSION AND EVALUATION: This case illustrates a side effect of titanium-coated permanent mesh in immediate implant-based reconstruction, i.e. the formation of granulomas in the inframammary fold, probably in the area where the mesh had been folded or fixed. We propose a safer technical approach to avoid the problem and a clinical management strategy for patients at high risk of local recurrence who develop granuloma-like nodules. CONCLUSIONS: A surgical technique is suggested to prevent granuloma formation. If, however, subcutaneous nodules that may be local recurrences do appear, they should not be interpreted by default as a granulomatous reaction, but should be fully investigated and possibly excised.