What Is The Problem With Physiomesh, C-QUR, and other Polypropeline Meshes?
Manufactured by Ethicon, the Physiomesh product was cleared through the FDA 510(K) approval process in 2010. The FDA 510(K) approval process is used when a product is modeled after a device that has been fully approved by the FDA, and it requires less testing than the FDA requires for new medical devices on the market. Using the FDA 510(K), Ethicon conducted minimal testing on mesh devices. In tests that were conducted, most patients experienced some type of issue with the product. Furthermore, Ethicon may have concealed unfavorable results and failed to conduct any clinical trials on the product, ensuring the product entered the market as quickly as possible. In May 2016, Ethicon voluntarily withdrew the device from the market.
Similarly, the C-QUR product (manufactured by Atrium) has a history of defective design and deceptive marketing tactics. In fact, the FDA issued several warnings to Atrium, yet the company failed to improve the design and cease its deceptive marketing promises. Evidence also suggests that general surgeons who conduct mesh surgeries were promised impossible results and given false or misleading information about the device. At least one clinical trial is known to have been terminated due to concerns with the product.