People in Alabama may have noticed the media attention given to hernia mesh recalls over the past few years. In fact, according to the FDA, many defective mesh implants have been recalled by medical device manufacturers.
The FDA explains that when a manufacturer discovers that its product may fail unexpectedly, it should notify the doctors who have implanted the devices and distributors that have the product for sale. There are three classifications of medical device recalls:
- Class I: The product could reasonably be expected to cause serious health issues or fatality.
- Class II: The product could cause a health problem that is treatable or temporary, or it poses a slight risk of a serious health issue or fatality.
- Class III: No one is likely to be harmed by the product.
Depending on the classification, doctors may need to evaluate with each patient whether the risk is greater to remove the device or allow it to remain in place. For example, some patients may be in more danger from a second surgery than from a device that has only been the subject of a class II recall. Other actions that may come from a recall include inspection, repair, adjustment or new labels. The manufacturer may have to destroy the device.
While the manufacturer may recall its own product, the FDA has the authority to force the recall. This has rarely happened, as most companies initiate their own recalls when they discover that products are not in compliance with federal law. People can discover whether their hernia mesh or other medical device has been recalled by checking the FDA recall database.