How Are Hernia Mesh Products Regulated?
Who Is Regulating the Manufacturing of Hernia Mesh Products?
Products that are used in the medical field on patients in the American population are monitored by the United States Food and Drug Administration or FDA. The FDA reviews all Group II medical devices for safety and clears the regulations to ensure that the product is indeed safe for use by the medical practitioners and healthcare workers. The problem with these clearances is that many medical products are “cleared” by the FDA with only a general demonstration of being equal to a similar medical product already on the market.1 This process is called Premarket Notification or 510(k), and the FDA’s minimal requirements in this area can cause problems for consumers who are patients who receive a hernia mesh product later on that is defective or damaged.1