By Joe Fantini June 4, 2019

Is hernia mesh dangerous? How did defective hernia mesh devices get to patients so quickly? Can the medical device be fixed? These were the key issues at the Americas Hernia Society’s (AHS) annual meeting. Over the course of three hours, doctors and scientists discussed the controversial medical device. In theory, they believe hernia mesh is a fantastic idea. It should improve lives around the world. Unfortunately, it’s clear that the execution of that fantastic idea fell short.

How Defective Hernia Mesh Devices Made it Past the FDA

There are problems with hernia mesh medical devices. That much is clear. How were manufacturers able to get those devices past the FDA and into patients around the globe? Panelists at the AHS meeting pointed out that hernia mesh is a class II device. Class II devices aren’t subject to strict approval procedures. In fact, class II devices don’t have to be put through clinical trials before they’re implanted in patients.

Hernia mesh manufacturers were able to take advantage of vague rules under the FDA’s 510(k) process. To gain 510(k) clearance, a hernia mesh company simply has to explain that their new device was “substantially similar” to a device that had already been cleared by the FDA.

The FDA’s 510(k) clearance process was initially intended to be interpreted narrowly. Its purpose was to protect innovation. Scientists wouldn’t have to conduct lengthy and expensive tests if their product was similar to one that already existed. However, over time, companies exploited the rule. They began to rely on devices that had gained the FDA’s stamp of approval before 1976 when rules were much more relaxed. Some even relied on devices that had been pulled from the market due to complications and risks.

Hernia mesh hasn’t been approved by the FDA. It’s been cleared. Those are two very different things. Approval requires testing. Clearance doesn’t necessarily demand any tests, at all.

Mesh Registry Would Help Scientists Understand How Mesh Works

Since most hernia mesh devices haven’t been tested, patients are essentially the test subjects. Issues with hernia mesh aren’t discovered until long after the devices are implanted in hernia patients. The damage has been done by the time a defect is identified. Those patients have been subject to painful injuries and significant emotional trauma.

Panelists at the AHS meeting lamented that there’s still not enough data about specific mesh devices. Companies don’t test the devices before they’re sold. While the FDA has received hundreds of thousands of adverse event reports regarding mesh, it’s believed that only a fraction of patients actually speak up about their injuries. The precise threat posed by hernia mesh – as it is currently manufactured – is unknown.

Doctors like the idea of a hernia mesh registry. The registry “would collect relevant, long-term data on specific hernia meshes.” This would accelerate the rate at which mesh-related complications are discovered. Only once problems with the mesh are identified can they be fixed.

Hernia Mesh Manufacturers Named in Thousands of Injury Lawsuits

More than 10,000 hernia mesh lawsuits have been filed against device manufacturers. There haven’t been any settlements yet. However, if hernia mesh litigation is anything like vaginal mesh litigation, injured hernia patients should be well compensated. Hernia mesh device companies may be interested in settling claims privately, rather than taking their chances in front of a jury. Juries appear to be getting increasingly upset with medical device companies. They’re siding with injured consumers more and more.

If you’ve been injured because of a defective hernia mesh implant you might be entitled to compensation. Speak with an experienced hernia mesh injury lawyer to learn about your rights today.