Surgical Meshes in Inguinal Hernia Repair

There are roughly 90 different surgical meshes for inguinal hernia repairs, with costs ranging from $100 to more than $1000. Very little exists to guide surgeons in the choosing of mesh beyond aggressive marketing by companies touting their product’s quality and justifying its cost. To complicate matters, surgical meshes on the market are cleared by the US Food and Drug Administration through the 510(k) process, which requires “substantial equivalence” to existing devices. Clinical trials are rarely required, and postmarket surveillance is conducted by the same companies that market the product. Occasionally surgeons and health systems report adverse events that may lead to product recalls. However, even recalled meshes can be used as “existing” devices, thereby serving as the standard for the introduction of new meshes. This underscores the importance of better assessment and more robust postmarket surveillance of surgical meshes.