An advisory panel on general and plastic surgery voted against recommending FDA approval of Integra LifeSciences’ SurgiMend mesh for the specific indication of breast reconstruction, even though the device has been used in breast reconstruction for more than a decade under a 510(k) clearance.
A specific indication for breast reconstruction — which no device currently has — would have positioned Integra in a $500 million market that is expected to grow to $900 million by fiscal year 2025. The SurgiMend device is currently indicated for use as a reinforcement for soft tissue where weakness exists, including within plastic and reconstructive surgery.
FDA Advisory Panel Red Lights Integra’s Breast Reconstruction Mesh
