More than a million hernia repairs are performed annually in the United States. Unfortunately, debilitating or painful injuries can be caused by the medical devices designed to repair a patient’s defect, sometimes used in these repairs.
Hernia surgical mesh is a medical device used to provide support to weakened or damaged tissues and is composed of synthetic, or biological components. Recently, two such hernia surgical meshes, C-Qur Mesh and Physiomesh, were recalled or withdrawn by their manufacturer from the market. These meshes were found to have higher than average recurrence and reoperation rates. C-Qur, manufactured by Atrium, was part of an FDA class II recall, and Physiomesh was withdrawn by their manufacturer, Johnson and Johnson. The FDA has issued injunctions against Atrium C-Qur meshes and Physiomesh.
While symptoms can vary among patients, products like Physiomesh and C-Qur have been reported to the FDA for causing infection, pain, recurrence, adhesions, obstruction, and organ perforation.
While traditional hernia mesh is composed of polypropylene and has been on the market for years, advancement in surgical techniques with laparoscopic procedures have allowed surgeons to insert the mesh deeper within the abdominal cavity causing the polypropylene to come into contact with bowels and leading to severe complications. So, in a rush to corner the market, device manufactures created a new product – Barrier Mesh.
Barrier or Composite Hernia Mesh, like C-Qur and Physiomesh, are marketed with the idea that they provide a “barrier”. While the FDA requires medical device products to follow Pre-Market Approval and preclinical studies to ensure safety, these companies inform the FDA that they are taking two previously tested products and combining them into one. Thus, effectively bypassing the studies that ensure the safety of consumers. New isn’t always better.
Here at Carey, Danis & Lowe we have helped thousands of women in their pursuit of injury claims in regards to recent Transvaginal Mesh Litigation. We now want to take that expertise and help you, or your loved one, if injury has resulted from the use of a Composite Hernia mesh, like C-Qur or Physiomesh. Please call us at 314-725-7700 to speak with a trained hernia mesh team member.