National Prospective Study on Quality of Life and Safety After Implant-Based Breast Reconstruction Using the Fully Resorbable TIGR4 Matrix

What this Trial Is About

Researchers are studying the quality of life and safety of the fully resorbable TIGRae Matrix in women who have undergone implant-based breast reconstruction surgery after mastectomy. This observational, national, multicenter, prospective study aims to collect data on patient-reported outcomes and complications related to this surgical mesh device. Participants will have had the TIGRae Matrix used during their breast reconstruction either as primary or secondary surgery. The study monitors quality of life using the BREAST-Q questionnaire at multiple time points after surgery, including 6, 12, 24, and 36 months. It also tracks complication rates, hospital stay duration, cosmetic outcomes, and any unplanned additional surgeries over three to five years. During the study, participants will complete questionnaires about their quality of life and undergo follow-up assessments to document complications and cosmetic results. Researchers will observe outcomes for up to five years after surgery. The primary focus is on quality of life measured 12 months post-surgery, with additional long-term monitoring to ensure safety and effectiveness of the device.

Post-market Surveillance Study to Evaluate the Quality of Life and the Safety and Effectiveness of the TIGR® Matrix After Reconstructive Breast Surgery