Safety and Efficacy of a Synthetic Mesh in Two-Stage Surgical Breast Reconstruction

Breast cancer (mammary carcinoma) is the most common cancer among women worldwide. After breast surgery to remove the tumor (mastectomy), patients often wish to have breast reconstruction. This reconstruction is usually performed in two stages: First, a tissue expander is inserted and gradually filled with fluid to stretch the skin. The expander is then replaced with a permanent implant. Complications can arise during this process, such as capsular contracture (a painful hardening around the implant) or infections. The use of a special plastic mesh (TiLOOP® Bra Mesh) could potentially improve treatment outcomes in this context. The mesh is intended to provide better support for the expander, facilitate stretching, and improve the aesthetic outcome.

The aim of this study is to examine whether the use of TiLOOP® Bra Mesh offers advantages over standard therapy and whether complications associated with breast reconstruction can be reduced. The study is randomized, controlled, and blinded, meaning that patients are randomly assigned to one of two groups. In one group, breast reconstruction is performed using TiLOOP® Bra Mesh; in the other, it is performed without this mesh. Neither the patients nor the physicians evaluating the results know which method was used. The study primarily examines the complication rate (e.g., infections, implant displacement, capsular contracture) as well as the efficiency of tissue expansion. In addition, the aesthetic outcomes, patient satisfaction, psychological effects, and potential follow-up costs will be analyzed.

Eligible participants are women between the ages of 18 and 70 with newly diagnosed breast cancer without metastases who opt for a skin- or nipple-sparing mastectomy followed by reconstruction. They must be physically fit (Karnofsky Index > 80) and must not have any serious comorbidities. A body mass index (BMI) over 35 kg/m², previous radiation therapy to the breast, advanced or inflammatory breast cancer, pregnancy, breastfeeding, severe allergies, alcohol or drug abuse, and severe mental health disorders exclude participation.