Breast Reconstruction – TiLOOP Clinical Studies

 

Below you will find a list of clinical studies for the TiLOOP range of products.

Please contact us if you require any further information.

 

Implant-Based Breast Reconstruction Using a Titanium-Coated Polypropylene Mesh (TiLOOP Bra): A Multicenter Study of 231 Cases.

Dieterich, M. et al. 2013. Plastic and Reconstructive Surgery Journal 132(1): 8e – 19e

Abstract

Background – An alternative to implant-based breast reconstruction using acellular dermal matrix is the use of a titanium-coated polypropylene mesh. The mesh was approved for implant-based breast reconstruction in Europe in 2008, but only limited clinical data are available.

Methods – Two hundred seven patients (231 breasts) with skin-sparing/nipple-sparing or modified radical mastectomy and immediate or delayed implant-based breast reconstruction using titanium-coated polypropylene mesh were evaluated retrospectively. The primary endpoints were identification of patient-related and surgical factors that were predictive for an adverse outcome and the development of recommendations for patients eligible for implant-based breast reconstruction using the mesh. Complications were divided into major (need for additional surgery), minor (conservative treatment), and implant loss. Univariate and multivariate logistic regression analyses were performed to determine the influence of the patient- and procedure-related characteristics on postoperative complications and implant loss.

Results – No risk factors were observed for patient-associated complications. Major complications occurred in 13.4 percent, minor complications in 15.6 percent, and implant loss in 8.7 percent of patients. Univariate analysis revealed procedure-related risk factors for postoperative complications with a bilateral procedure (p = 0.013) or skin expansion before implant surgery (p = 0.043). Multivariate analysis confirmed these risk factors and revealed an increased risk for implant loss in patients with skin necrosis (p < 0.001) and capsule fibrosis (p < 0.001).

Conclusions – This titanium-coated polypropylene mesh shows acceptable complication rates and can be a helpful device in implant-based breast reconstruction. The mesh should only be used in primary cases and, when adhering to the proposed indications, is a safe and convenient option in implant-based breast reconstruction.

 

TiLoop® Bra Mesh Used for Immediate Breast Reconstruction: Comparison of Retropectoral and Subcutaneous Implant Placement in a Prospective Single-Institution Series.

Casella, D. et al. 2014. European Journal of Plastic Surgery 37(11): 599 – 604

Abstract

Background – Immediate implant reconstruction after a conservative mastectomy is an attractive option made easier by prosthetic devices. Titanized polypropylene meshes are used as a hammock to cover the lower lateral implant pole. We conducted a prospective nonrandomized single-institution study of reconstructions using titanium-coated meshes either in a standard muscular mesh pocket or in a complete subcutaneous approach. The complete subcutaneous approach means to wrap an implant with titanized mesh in order to position the implant subcutaneously and spare muscles.

Methods – Between November 2011 and January 2014, we performed immediate implant breast reconstructions after conservative mastectomies using TiLoop® Bra, either with the standard retropectoral or with a prepectoral approach. Selection criteria included only women with normal Body Mass Index (BMI), no large and very ptotic breasts, no history of smoking, no diabetes, and no previous radiotherapy. We analyzed short-term outcomes of such procedures and compared the outcomes to evaluate implant losses and surgical complications.

Results – A total of 73 mastectomies were performed. Group 1 comprised 29 women, 5 bilateral procedures, 34 reconstructions, using the standard muscular mesh pocket. Group 2 comprised 34 women, 5 bilateral procedures, 39 reconstructions with the prepectoral subcutaneous technique. Baseline and oncologic characteristics were homogeneous between the two groups. After a median follow-up period of 13 and 12 months, respectively, no implant losses were recorded in group 1, and one implant loss was recorded in group 2. We registered three surgical complications in group 1 and two surgical complications in group 2.

Conclusions – Titanium-coated polypropylene meshes, as a tool for immediate definitive implant breast reconstruction, resulted as safe and effective in a short-term analysis, both for a retropectoral and a totally subcutaneous implant placement. Long-term results are forthcoming. A strict selection is mandatory to achieve optimal results.

 

Subcutaneous Direct-to-Implant Breast Reconstruction: Surgical, Functional, and Aesthetic Results after Long-Term Follow-Up.

Bernini, M, et al. 2015. Plastic Reconstruction Surgery Global Open 3(12): e574

Abstract

Background – Direct-to-implant breast reconstruction can be achieved more easily by means of soft-tissue replacement devices such as dermal matrices and synthetic meshes. The feasibility of a subcutaneous approach has been recently investigated by some studies with different devices functioning as implant support. Aim of this study is to analyze the long-term results, both objective and subjective, of a previous nonrandomized trial comparing prepectoral (subcutaneous) and retropectoral breast reconstructions.

Methods – Patients enrolled in a nonrandomized prospective trial, comparing the standard retropectoral reconstruction and the prepectoral subcutaneous approach, using a titanium-coated mesh in both techniques, were followed up and evaluated for long-term results. Cases were compared in terms of the causes and rate of reinterventions, of the postoperative BREAST-Q questionnaire results, and of an objective surgical evaluation.

Results – The subcutaneous group had a rate of implant failure and removal of 5.1% when compared with 0% in the retropectoral group. Aesthetic outcome was significantly better for the subcutaneous group both at a subjective and at an objective evaluation. Capsular contracture rate was 0% in the subcutaneous group.

Conclusions – A higher rate of implant failure and removal, although not significant, always because of skin flaps and wound problems, should be taken into account for a careful patients selection. The subcutaneous breast reconstruction shows good long-term results. A coherent subjective and objective cosmetic advantage of this approach emerges. Moreover, no capsular contracture is evident, albeit in a relatively limited number of cases.

 

Subcutaneous Tissue Expander Placement with Synthetic Titanium-Coated Mesh in Breast Reconstruction: Long-term Results.

Casella, D, et al. 2016. Plastic Reconstruction Surgery Global Open 3(12):e577

Abstract

A subcutaneous, prepectoral, muscle-sparing approach has been recently described for implant-based breast reconstruction. This is a preliminary series of 2-stage breast reconstructions by means of tissue expander placed subcutaneously with the support of a titanium-coated polypropylene mesh. A pilot series of cases was started in 2012. Inclusion criteria were informed consent, age less than 80 years, normal body mass index (range, 18.5-24.9), no T4 and metastatic cancers, no comorbidities, and nonsmoking patients.

Expander losses, infections, seromas, skin/nipple necrosis, wound dehiscence, and reinterventions were registered in follow-up visits. Furthermore, patients were followed up in second-stage procedures and for at least 1 year from implant positioning to collect any surgical complication, reinterventions, cosmetic outcome, and oncological data. Between June 2012 and March 2014, 25 cases were enrolled in the study. Expander/implant loss rate was 0%. Skin/nipple necrosis rate was 4%. Infections rate was 12% after first-stage and 4% after second-stage procedure. Seromas rate was 0%. Five (20%) fat graft procedures were performed over the expander before second-stage reconstruction, and no reinterventions were required after second stage. Patients mean score was 99 for cosmetic outcome satisfaction, in a 0-100 scale. Subcutaneous 2-stage reconstruction with synthetic mesh proved safe and feasible. Patients satisfaction is very good after 14 months median follow-up form definitive implant placement.

Although the present study involved only a small number of cases, a tissue-expander subcutaneous reconstruction seems to have promising results. Whenever pectoralis major muscle can be spared, a conservative reconstruction might be an option.

 

Risk-Reducing, Conservative Mastectomy-Analysis of Surgical Outcome and Quality of Life in 272 Implant-Based Reconstructions Using TiLoop(®) Bra Versus Autologous Corial Flaps.

Rezai, M, et al. 2016. Gland Surgery 5(1):1 – 8

Abstract

Background – Different approaches have evolved for conservative mastectomies, mostly according to surgeon’s preference. Patients’ perspective was not always in the primary focus. BRCA status has drawn much attention and therapeutic as well as prophylactic mastectomies are rising. However, knowledge on quality of life (QoL) thereafter is limited. We investigated the surgical and patient reported outcome of conservative mastectomies with implants and TiLoop(®) Bra vs. corial flaps.

Methods – Conservative mastectomies were analyzed from a prospectively maintained database in a unicentric study of consecutive 272 reconstructions from 2000-2014. We used four validated QoL questionnaires: FACT-G, EORTC C-30, EORTC B-23 and Breast Cancer Treatment Outcome Scale (BCTOS). The use of TiLoop(®) Bra, a titanized polypropylene mesh, for lower breast pole coverage was compared to autologous corial flaps.

Results – A total of 217 patients with 272 conservative mastectomies (55 bilateral) were included. Median follow-up was 3.5 years (range, 0-14 years). Skin-sparing mastectomy (SSM) was performed in 131 patients and subcutaneous mastectomy (SCM) in 86 patients. Invasive breast-cancer was the indication for surgery in 106 patients, non-invasive breast cancer (DCIS) in 80 patients, prophylactic indication (BRCA1/2-mutation) in 30 patients and contralateral alignment in 1 patient. TiLoop(®) Bra was used in 78 and corial flap in 79 patients. Response to questionnaires was 70%. TiLoop(®) Bra improved aesthetic results (P=0.049) and prevented implant dislocation (P=0.009). All patients expressed their adherence to the decision for surgery. Patients with SCM expressed their satisfaction even to a higher extent than those with SSM, particulary with regard to symmetry (P=0.018) and scars (P=0.037).

Conclusions – QoL after conservative mastectomies is demonstrated as excellent in several validated QoL-instruments. Double-plane technique for coverage of the implant yields good results with autologous corial flaps and Tiloop(®) Bra, favouring the latter in terms of aesthetics and prevention of implant dislocation.

 

Mesh Versus Acellular Dermal Matrix in Immediate Implant-Based breast reconstruction – A Prospective Randomized Trial.

Gschwantler-Kaulich D, et al, 2016. European Journal of Surgical Oncology 42(5):665 – 71

Abstract

Background – Comparative studies on the use of meshes and acellular dermal matrices (ADM) in implant-based breast reconstruction (IBBR) have not yet been performed.

Methods – This prospective, randomized, controlled, multicenter pilot study was performed at four Austrian breast cancer centers. Fifty patients with oncologic or prophylactic indication for mastectomy and IBBR were randomized to immediate IBBR with either an ADM (Protexa(®)) or a titanized mesh (TiLOOP(®) Bra). Complications, failed reconstruction, cosmetic outcome, patients’ quality of life and the thickness of the overlying tissue were recorded immediately postoperatively and 3 and 6 months after surgery.

Result – 48 patients participated in the study (Protexa(®) group: 23; TiLOOP(®) Bra group: 25 patients). The overall complication rate was 31.25% with similar rates in both groups (Protexa(®) group: 9 versus TiLOOP(®) Bra group: 6; p = 0.188). There was a higher incidence of severe complications leading to failed reconstructions with implant loss in the Protexa(®) group than in the TiLOOP(®) Bra group (7 versus 2; p < 0.0001). An inverted T-incision technique led to significantly more complications and reconstructive failure with Protexa(®) (p = 0.037, p = 0.012, respectively). There were no significant differences in patients’ satisfaction with cosmetic results (p = 0.632), but surgeons and external specialists graded significantly better outcomes with TiLOOP(®) Bra (p = 0.034, p = 0.032).

Conclusion – This pilot study showed use of TiLOOP(®) Bra or Protexa(®) in IBBR is feasible leading to good cosmetic outcomes and high patient satisfaction. To validate the higher failure rates in the Protexa(®) group, data from a larger trial are required.