A new study suggests that most hernia mesh products currently on the market lack key information that could help doctors make better and more informed treatment decisions.
The authors of the study, which was recently published in the Journal of the American College of Surgeons, are now calling for all hernia mesh products to include standardized external labels similar to nutritional information labels found on most food products.
“Nutritional labels have very specific guidelines as to what you report and how. But here are things, meshes, that we implant into people, and there are no guidelines on what to report,” Jeff Blatnik, MD, an assistant professor of surgery at Washington University School of Medicine in St. Louis and co-author of the paper, recently told General Surgery News.
The standardized hernia mesh labels proposed by Dr. Blatnik and his co-author, former research assistant Lindsey G. Kahan, would include information on a device’s size, weight, pore size, base material, presence of a barrier and biomechanical properties.
For their study, Dr. Blatnik and Ms. Kahan analyzed the labels and “Information for Use” (IFU) inserts for 36 types of hernia mesh, including 30 synthetic and six biologic mesh types.
They found that the external package labels for all types of mesh was extremely limited. While more information was included on the IFU, physicians would be unable to access it without opening the package.
Among other things, Dr. Blatnik and Ms. Kahan noted that:
The publication of the study comes as several medical device manufacturers, including Atrium Medical Corp., C.R. Bard, Inc. and Ethicon, Inc., face a growing number of hernia mesh lawsuits involving synthetic, composite (multi-layer) implants constructed of polypropylene fibers.
Atrium Medical is currently facing more than two dozen lawsuits filed on behalf of individuals who allegedly suffered serious hernia mesh complications due to the company’s C-Qur patch. Federally-filed C-Qur hernia mesh lawsuits have been centralized in a multidistrict litigation now underway in the U.S. District Court, District of New Hampshire.
Ethicon, Inc., a subsidiary of Johnson & Johnson, is named a defendant in hundreds of lawsuits filed on behalf of individuals who experienced hernia recurrence and other complications allegedly related to its Physiomesh Flexible Composite mesh products, which were withdrawn from the global market in May 2016 because of higher rates of complications compared to other hernia implants. All federally-filed Ethicon Physiomesh lawsuits have been centralized in a multidistrict litigation currently underway in the U.S. District Court, Northern District of Georgia.
C.R. Bard faces around 50 product liability claims involving its polypropylene hernia mesh implants, including the Ventralex and Perfix devices. On April 10th, plaintiffs pursuing those lawsuits in various federal courts throughout the country filed a motion with the U.S. Judicial Panel on Multidistrict Litigation seeking centralization of the docket in a single U.S. District Court, preferably the Southern District of Ohio or the Western District of Missouri.