Yes. In 2013, the FDA issued a Class II recall on one of Atrium’s C-QUR hernia mesh products, after finding that the product’s fish oil coating could peel off and stick to the inside of its package when exposed to excessive humidity. This is the same fish oil coating that is alleged to cause the mesh to curl and deform in the body.
Ethicon voluntarily recalled certain models of the Physiomesh in 2016 after studies revealed high hernia recurrence rates in patients with that particular hernia mesh implanted, according to medical device business journal MassDevice.