FDA 510(k) medical device approval leaves room for error

physiomesh FDA 510(k) medical device approval leaves room for errorThe FDA frequently uses a medical device approval method called the 510(k) process, used to hasten a new product to market, but a growing list of reported injuries and complaints indicates the process may not be thorough enough.

The 510(k) approval is a fast-track method of gaining permission from the FDA to market and sell a new medical device as long as the product is “substantially equivalent” to a product previously sold on the market. No additional clinical tests are required as long as the manufacturer can prove the new device’s similarities to another product.

On May 11, an approval letter was issued for Gore Synecor Preperitoneal Biomaterial, a new surgical mesh device used to repair hernias. Its approval, however, claims it is “substantially equivalent” to Physiomesh, a questionable hernia mesh device that was voluntarily recalled by its manufacturer, Ethicon, a subsidiary of Johnson & Johnson. The reason for the Physiomesh recall was due to a high rate of failure.

Physiomesh is a polypropylene mesh designed to assist in hernia repair. It was also approved by the FDA’s 510(k) process, based on claims that the device is similar to Proceed Mesh, UltraPro Hernia System, and UltraPro Mesh.

Physiomesh was marketed, however, as being unlike any other hernia mesh product sold in the U.S. due to its unique multi-layer design. The device is made up of two layers of polyglecaprone-25 (“Monocryl”) film, which covers to underlying layers of polydioxanone (“PDS”) film, which coats the middle layer of polypropylene mesh.

The Gore Synecor Preperitoneal Biomaterial has been animal tested on rats and rabbits for periods of 30 days, then 90 days. A 180-day study was done on rabbits to compare the device’s function and reaction against that of Physiomesh. According to the FDA, this is more than enough proof that the device is safe for humans.

The letter concludes, “No clinical evaluations were required to support this submission.”

Considering the extremely high rate of failure in Physiomesh, Gore Synecor Preperitoneal Biomaterial will, hopefully, have better success.