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New research suggests that doctors are not getting enough information about the properties and potential risks with hernia mesh patches, indicating that standardized package labeling are needed.
The study was published online by the Journal of the American College of Surgeons last month, indicating that hernia mesh label information should provide uniform guidelines and greater scrutiny, in order to help doctors select the correct mesh for their patients.
Researchers from Washington University at the St. Louis School of Medicine looked at labeling guidelines and the requirements for the FDA’s 510(k) fast-track approval process, through which most hernia mesh products are approved. They also compared mesh packaging and Instructions For Use (IFUs) provided to doctors for commonly available hernia meshes.
According to the findings, medical devices overall, and hernia mesh products in particular, appear to lack the critical scrutiny and detailed specifications of things like food labels.
Researchers found that only 33% of the product labels investigated gave doctors information on composition of the hernia mesh. In addition, only 31% of IFUs provided doctors with information on the mechanics of the mesh, and only 11% indicated the mesh’s thickness. They also found that mechanics and pore size lacked consistent descriptive terms.
“While standardized terminology has been proposed in literature, property knowledge has not adequately permeated surgery, industry, or regulatory guidelines,” the researchers concluded. “There is an extreme underreporting and lack of consistency of clinically important mesh properties. Standardized packaging labels will provide accessibility of these properties and aim to bring standardized terminology into practice. With an increase in access to important properties, this can facilitate intraoperative decision making on a case-by-case basis.”
Hernia Mesh Litigation
The study comes at a time when medical device manufacturers face a growing number of hernia mesh lawsuits filed in courts nationwide over design defects associated with several different widely used products.
Most of the current cases filed in courts nationwide involve Atrium C-Qur lawsuits or Ethicon Physiomesh lawsuits, the latter of which involve a product that was removed from the market last year amid reports of problems.
The Atrium C-Qur, pronounced “Secure”, was approved by the FDA in March 2006, featuring a polypropylene mesh with an outer coating of gel made from 3 fatty acids. However, this design has been linked to reports of severe infections, allergic reactions and other problems.
Ethicon Physiomesh was introduced in March 2010, featuring a unique, multilayered design that was intended to improve performance. However, amid a high number of failures, an Ethicon Physiomesh recall was issued in May 2016, removing the product from the market worldwide. While the action was classified as a “market withdrawal” in the United States, the manufacturer has indicated that it will not be returning the product to the market.
As lawyers continue to review and evaluate claims for individuals who have experienced complications following hernia repair surgery, additional products have also been named in different complaints.