Physiomesh, a now-recalled hernia repair mesh, is not substantially equivalent to prior devices despite FDA 510(k) approval, according to lawsuits filed that claim the device is linked to injuries and high revision rates. Physiomesh is a polypropylene mesh that is designed to assist in the repairing of a hernia. The mesh was approved by the U.S. Food and Drug Administration (FDA) using a 510(k) approval, which is a fast-track approval method that allows a product to be marketed as long as it is “substantially equivalent” to a device already approved. Ethicon, a subsidiary of Johnson & Johnson and the maker ... Read More
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