However, hernia mesh products such as Ethicon’s Physiomesh Flexible Composite Mesh and C-QUR Mesh manufactured by Atrium Medical Corporation have been associated with dangerous side-effects such as infection, severe abdominal pain, intestinal blockage, migration, and perforation, as well as hernia reoccurrence and the need for reoperation or surgical removal of the product. Lawsuits have been filed against the manufacturers of these products.
Manufactured by the Johnson & Johnson subsidiary Ethicon, Physiomesh Flexible Composite Mesh was originally approved for use by the FDA in 2010. Just six years later, the product was recalled due to its high rate of hernia recurrence or reoperation. On May 25, 2016, Ethicon sent an
Urgent Field Safety Notice to hospital operating room supervisors and management voluntarily recalling a dozen of its Physiomesh Flexible Composite Mesh products. The product has been found to lead to higher hernia recurrence or reoperation rates after laparoscopic ventral (abdominal) hernia repair when compared to similar products. The recall requires facilities to remove all affected products and return them to Ethicon.
Certain Atrium Medical’s C-QUR Mesh products have also been the subject of a recall—specifically, the C-QUR TacShield Mesh product—categorized as a
Class II recall by the FDA in 2013. Prolonged exposure to high humidity may cause the coating on the mesh, which is derived from Omega 3 fatty acid (“O3FA”) fish oil, to stick to the packaging, rendering it ineffective. Should the product fail, patients may require revision surgery. First introduced to the market in 2006, with a number of variations produced from 2008-2015, many of Atrium’s C-QUR Mesh line of products are still being sold today.