How much data has been used to support the clearance of the Menaflex device compared to that provided in submissions for other cleared surgical meshes?
More than 400 surgical meshes have been cleared through the 510(k) program and most have been cleared with little or no clinical data. ReGen provided more clinical data, with longer follow-up to ensure the safety and effectiveness of the Menaflex, than has been provided for any other surgical mesh. ReGen provided data on 162 patients with almost five years of follow-up to support a 510(k) for a new indication in the meniscus. In contrast, a surgical mesh with a new indication to seal air leaks in the lungs was supported by clinical data from 26 patients through discharge. A 510(k) submission for use of a mesh in the shoulder rotator cuff was cleared with data from five patients with three months follow-up and two surgeon letters of support. And use of a mesh in the vertebral body of the spine was cleared with no clinical data.
