Post-Marketing Study to Confirm Safety and Performance of Motiva Flora Tissue Expander in Breast Reconstruction Surgery

What this Trial Is About

Researchers are evaluating the safety and performance of the Motiva Flora4 Tissue Expander in women undergoing staged breast reconstruction surgery after mastectomy. This post-marketing clinical study is open-label, prospective, and multicenter, involving 136 women across six countries. The goal is to confirm how well the tissue expander works and its safety over a 6-month period. Participants will receive a two-stage breast reconstruction using devices from the Motiva Flora4 Tissue Expander catalogue. The process includes breast tissue expansion followed by placement of the final breast implant. The study focuses on the tissue expanders performance during the reconstruction stages. Women in the study will attend follow-up visits for up to 6 months after surgery. Researchers will monitor device- and procedure-related adverse events, success and completion of tissue expansion, and patient satisfaction using a 5-point Likert scale. Additional evaluations include MRI and CT scans to assess device integrity and interaction with imaging. Participants will also be observed for any complications or device issues during and after the reconstruction process.

Motiva Flora Tissue Expander PMCF