ReGen to FDA: 'Thanks, But No Thanks'
WASHINGTON, March 22, 2011 /PRNewswire/ -- ReGen Biologics, Inc. (ReGen), manufacturer of the popular and successful Menaflex Collagen Meniscus implant, today declined the U.S. Food and Drug Administration's (FDA) offer of a hearing under 21 CFR Part 16 before the agency formalizes its decision to rescind clearance of the device.
According to ReGen Chair and CEO Gerald E. Bisbee, Jr., Ph.D., the company's experience with the FDA over the past six years makes it clear that any such hearing would be futile. "The safety and effectiveness issues surrounding the clearance of our device were settled years ago at a November 14, 2008 Advisory Panel meeting. The independent experts on that Panel were completely in Menaflex's favor," he said. "The only issues that require remediation are the blatantly arbitrary and unfair processes of the FDA, and those aren't on the table in a Part 16 review. Enough is enough."
ReGen's Menaflex device is a resorbable surgical mesh used in meniscus surgeries to reinforce damaged or weakened meniscal soft tissues, which provides a scaffold for replacement by a patient's own soft tissue. It was approved in Europe in 2000 under the most stringent review classification for use in medial meniscus injuries, and in 2006 for lateral meniscus injuries. To date, the device has been used successfully in over 3000 European surgeries, with no safety issues. In fact, a recent independent publication from a prestigious European academic center shows that 10 years after surgery, Menaflex patients show superiority to patients receiving the standard of care, partial meniscectomy.
In December 2008, following 3 years of review under the 510(k) process including input from an Advisory Panel of independent experts, the FDA ruled that the product is as safe and effective as other surgical meshes and cleared it for use by surgeons in the U.S. Two years later, following a change in top management at FD