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Hernia Mesh Manufacturers (And Products) Have A Documented History of Problems.
Over the last several years, the FDA has received numerous reports of adverse effects from hernia mesh patients. Despite this, hernia mesh continues to be used in the U.S.
In 2012, the FDA issued a warning letter to Atrium medical, stating that the company failed to address the reported infections associated with their mesh products. Additionally, the FDA stated that Atrium’s sterilization process for the mesh was not adequate.
Then, in 2015, the FDA filed an injection against Atrium that ordered the company to stop distribution and manufacturing of medical devices in the company’s New Hampshire plant. This shut down was in effect until Atrium proved to the FDA that the company was in compliance with certain federal Food, Drug, and Cosmetic Act provisions.
In 2016, two large European hernia mesh registries reported higher than average failure rates for Ethicon’s Physiomesh. Later that same year Ethicon ordered a full market withdrawal of all Physiomesh Flexible Composite Mesh products.
Problems commonly associated with hernia mesh failure include:
Despite the history of problems with hernia mesh products, numerous people are still implanted every year. Patients who needed to have additional surgeries to remove or “fix” the mesh may have the opportunity to take powerful legal action that can help protect others. Contact us to learn more.