Mesh sAfety Platform for immediate implant based BReAst reconstruction
MAP-BRA 1 Fortiva is a IDEAL 2A/2B prospective cohort study designed to evaluate the safety and effectiveness of Fortiva porcine acellular dermal matrix in immediate implant based breast reconstruction.
ADM based implant reconstruction has been widely adopted in the UK. Many new Meshes are brought to market without data to support their safety and effectiveness. The aim of MAP BRA is to provide a platform study protocol to evaluate the safety of new mesh products whilst supporting the innovaltion and development of new techniques. MAPBRA1 is evaluating Fortiva porcine ADM.
The primary outcome measure of implant loss at 3 months. This is benchmarked against the national iBRA audit of over 2000 implant based breast reconstructions which showed an implant loss rate of 9%.
Fortiva is a novel porcine acellular dermal matrix which is currently used in abdominal wall repair. The mesh is fenestrated and available in a variety of sizes for use in both sub pectoral and pre pectoral breast reconstruction. It may be more cost-effective than other xenogenic ADMs.
The manufacturers RTI surgical have supported this study with an educational grant but have had no involvement in the study design and will not have access to data or control over publication.
This study has been awarded a research grant from the Association of Breast Surgery and is an NIHR portfolio study. We are currently seeking expressions of interest from units with experience in pre and sub pectoral implant based breast reconstruction. If you would be interested in recruiting please follow the link on the attached document.