Guidance for Hernia Mesh Package Labeling Recommendations, FDA-2025- D-1150
August 5, 2025
The National Center for Health Research (NCHR) appreciates the opportunity to submit these comments regarding the U.S. Food and Drug Administration’s (FDA’s) Draft Guidance for Industry and FDA Staff: Hernia Mesh Package Labeling Recommendations. NCHR is a nonprofit public health think tank dedicated to bridging the gap between scientific evidence and public policies that affect the health and safety of adults and children. We focus on the safety and effectiveness of medical and consumer products, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers.
We agree with the stated goals of the draft guidance to “help promote the safe and effective use of hernia mesh.” We also agree that labeling changes are needed “because suboptimal device selection associated with these devices has resulted in serious adverse events, including deaths.“ We share the FDA’s concerns that “Since January 1, 2019, FDA has received over 86,000 adverse event reports related to hernia mesh, of which the most common reported adverse events include adhesions, recurrence, pain, and infection.”
However, we conclude that the guidance and the proposed labeling changes are inadequate because they do not provide essential warnings or other important information such as specific examples indicating which types of mesh used for which purpose are most likely to cause which kinds of adverse events. While the FDA may be correct that “concise, consistent, and easily understandable package labeling of hernia meshes that contains certain clinically relevant information may facilitate the safe and effective use of these devices,” the FDA has provided no clear evidence to support that claim. Moreover, without additional information, healthcare professionals should not expect their patients to avoid the very common complications that the research literature has documented.
Labeling for these mesh products should provide warnings that patients and healthcare professionals can consider as they make decisions about repairing a hernia. And yet, the FDA website includes an article entitled “Surgical Mesh Used for Hernia Repair” that includes more information about risks than the proposed guidance’s changes to labeling. The FDA web article states, “Based on the FDA’s analysis of medical device adverse event reports and of peer-reviewed, scientific literature, the most common adverse events for all surgical repair of hernias—with or without mesh—are pain, infection, hernia recurrence, scar-like tissue that sticks tissues together (adhesion), blockage of the large or small intestine (obstruction), bleeding, abnormal connection between organs, vessels, or intestines (fistula), fluid build-up at the surgical site (seroma), and a hole in neighboring tissues or organs (perforation). For hernia repair with mesh, additional adverse events include migration or shrinkage (contraction) of the mesh itself, which may more likely be associated with the previously mentioned complications of hernia repair.” This level of detail should be included in the labeling for mesh products for hernia repair unless a specific product has provided clinical trial evidence to the FDA indicating it does not cause any of these risks.
Even more important than the inadequate description of possible adverse events in the guidance, the current labeling and proposed new labeling do not provide any information about the frequency of any of the common adverse events that the FDA lists (adhesions, recurrence, pain, and infection) and fails to mention the frequency or types of very serious adverse events that have been reported in the research literature or the adverse events on FDA’s website. These serious adverse events as reported on the FDA website are not specific to any specific company’s mesh products, and that is one of the reasons why labels with concise and easily understandable descriptions of the different mesh products are unlikely to substantially reduce the incidence of adverse events.
In reviewing numerous hernia mesh adverse events reported on the FDA’s website, we noted two terms used for the causes of some of the more catastrophic complications:
- “Meshoma” is the word used since at least an Archives in Surgery article in 2004 to describe a hernia mesh that has balled up. This is a painful complication that can harm nerves and other organs, but the removal is so difficult that it often causes additional harm;
- “Clam-shelling” refers to the mesh folding in on itself and trapping nerves. This also makes the mesh very difficult to remove and can cause serious harm.
In addition to the above concerns, we note that it is almost impossible to find labeling for any 510k hernia mesh products online. Labeling for each hernia mesh product should be easily accessible on the FDA website and the websites promoting these mesh products.
In conclusion, the use of mesh in hernia repair is widespread, the potential harm of hernia mesh is well documented, and FDA has not required companies to provide any meaningful data on the potential risks of most of these mesh products. On the contrary, the 510(k) process allows recalled and discontinued hernia mesh products to be used as predicates for new mesh products, and the FDA provides no evidence that the proposed labeling changes will substantially improve patients’ ability to make decisions based on informed consent or physicians’ ability to make informed surgical decisions about whether to use hernia mesh under what circumstances, and which mesh products may be less likely to cause harmful complications.