In a new study, surgeons from Washington University in St. Louis have found that many hernia mesh products fail to disclose crucial device information on their outer packaging, according to a report published in the Journal of the American College of Surgeons.
Surgeons Say Hernia Mesh Should Be Labeled Like Food
Dr. Jeff Blatnik, assistant professor of surgery, who conducted the study along with Lindsey Kahan, a medical student at Brown University, thinks it may be a good idea to standardize the labeling on hernia mesh products, in a style that would be similar to the labels we currently find on foods.
“Nutritional labels have very specific guidelines as to what you report and how,” Blatnik told General Surgery News. “But here are things, meshes, that we implant into people, and there are no guidelines on what to report.”
“Nutritional Information” For A Medical Device
Blatnik and Kahan believe that mesh device manufacturers should be required to label their product packaging with something akin to a nutritional information section, a prominent panel that would provide surgeons with a quick reference for the mesh product’s key features, including pore size, material composition and weight.
Despite their importance in clinical practice, many of these details aren’t even listed in the detailed Instructions for Use pamphlets that you can find inside the box. And, even if they were, relying on the internal pamphlets is “impractical,” Blatnik and Kahan say, since surgeons have to tear open the mesh packaging to read them.
Far better, the authors argue, if surgeons “can have access that information simply by looking at a label on a package.” Clear labeling, they claim, would “help [physicians] make a better decision and an informed decision.”
Hernia Mesh Labeling Often Incomplete, Experts Say
After reviewing the labels for 36 different hernia mesh offerings, Blatnik and Kahan say pore size is the least-publicized mesh feature. According to the European Hernia Society, the pore size of a mesh is one of the most critical device characteristics in predicting patient outcomes, yet you won’t learn those details from the packaging of many actual mesh products.
And, for those mesh products in which pore size was reported, few listed the feature in accordance with the European Hernia Society’s guidelines. One product even advertised an incorrect pore size, Blatnik and Kahan report.
None of the 36 mesh products were labeled with information on their resorption time, the amount of time it takes for their foreign materials to be absorbed by body tissues.
Few Mesh Manufacturers Report FDA-Required Data Points
You might wonder why we would be relying on the opinions of a European non-profit organization in crafting regulations for the US market, but experts in America agree that mesh labeling is insufficient. In fact, Dr. Blatnik, the study’s lead author, is currently heading up an initiative at the Americas Hernia Society to work with the FDA and medical device manufacturers in creating a standardized mesh labeling format.
To buttress their analysis, Blatnik and Kahan also compared the information reported on hernia mesh products to the data collected by FDA reviewers.
Most mesh products find their way onto the American market through the FDA’s 510(k) clearance process. Manufacturers are required to report their product’s thickness, pore size and density, along with the results of biocompatibility tests and other biomechanical qualities. Only 13% of the analyzed mesh patches included all of these details on their external packages. The full details could only be found in Information for Use pamphlets for 30% of the products.
Mesh Knowledge On-The-Ground Is Woefully Inadequate
Dr. Ajita Prabhu, an assistant professor of surgery at the Cleveland Clinic, isn’t convinced that better labeling will actually change things in the real world.
While she’s heartened by the effort to standardize mesh labels, calling the current labels “disappointing and inaccessible,” Dr. Prabhu thinks that true clinical breakthroughs will only come when surgeons know how to interpret the information properly.
Better Labeling Might Not Improve Clinical Decisions
“I have always found it interesting that despite hernia surgery being arguably the most often performed general surgery operation,” Dr. Prabhu told General Surgery News, “we do a remarkably poor job of educating our residents about the properties of mesh materials and their indication for use.”
Without that basic groundwork, Prabhu argues, a more-detailed writeup on the characteristics of a mesh product might not be enough to sway surgical decisions.
Surgeons “should be aware of the basic properties of what they are putting into a patient, if nothing else, for their own knowledge,” she says, but without a medical consensus on the best materials or features for specific conditions, practicing surgeons could still be groping in the dark.
Industry Could Oppose Standardization
The push for standardization in the hernia mesh industry is growing, represented most-prominently by the efforts of the European Hernia Society. Manufacturers, though, could stand in the way of progress, Dr. Prabhu adds.
“The claim of most mesh industries,” Dr. Prabhu says, “is that they want to provide the very best material for repair of hernias. However, if all of these properties end up being standardized and reported, doesn’t it stand to reason that there will eventually be some clear winners and some clear losers?”
Without standardization, manufacturers will be free to continue making claims of their own product’s superiority, with or without evidence in support of their contention. That’s a marketing boost few major companies would be willing to forego of their own accord.