Hernia Mesh Lawsuits [2020 Update]
Imagine that a medical device company creates a product that is used in millions of surgeries-without any meaningful approval by the FDA.
Unfortunately, this is exactly what happened with a product known as “hernia mesh.” And this didn’t happen with one company. It happened with seven companies that created dozens of hernia mesh products.
Fortunately, despite the FDA’s lack of action to protect patients, patients across the country are joining the effort to hold these companies accountable by filing lawsuits against them.
Below, you will find more information about your potential hernia mesh claim. If you think you might have a claim, we encourage you to call our hernia mesh lawyers immediately at (800) 248-6000.
Who is responsible for creating hernia mesh products?
The hernia mesh industry is a $48 billion industry. There are seven major companies that make hernia mesh products:
Each of these companies has a unique line of hernia mesh products. Bard has the largest market share, and Atrium has the smallest market share.
What is the difference between the mesh made by these companies?
The vast majority of hernia mesh products are “polypropylene” mesh. In other words, most hernia mesh is essentially made of plastic.
The problem is this: most medical authorities recognize that polypropylene should never be placed next to your organs.
This obviously is a problem when using hernia mesh in hernia repair surgeries.
To address this problem, each of the seve major manufacturers has created a unique coating to go over the polypropylene—creating a barrier between the plastic and the organ. For example, Atrium uses a fish oil coating on their hernia mesh products.
The problem? Each of these specialized coatings were never fully reviewed by the FDA before being used in surgeries.
How did these products bypass the FDA approval process?
Many people assume that the FDA reviews medical device products before they are released into the market. Unfortunately, that’s often not true.
The FDA has a little know “approval” process known as the 510(k) process.
What does this mean? In short, if a company claims that their product is like another product that’s already on the market, then they don’t need to undergo FDA review for their new product.
Here’s the problem: no one at the FDA verifies whether the two products are actually similar.
What’s worse is that the “predicate” device—the device that mesh manufacturers are using as a reason to bypass the FDA approval process—has been recalled by Bard.
Even so, isn’t hernia mesh generally considered safe?
Unfortunately, no. Even though hernia mesh is used in 9 out of every 10 hernia repair surgeries, there’s actually no data to support that any of these hernia mesh products are safe.
In fact, these products have an extremely high complication rate. In fact, the primary basis for a hernia mesh lawsuit is that the company failed to adequately warn of the serious risks posed by use of their product.
What are the potential complications from hernia mesh failure?
Almost one-third of people who undergo hernia mesh surgery experience complications. And these complications can be quite severe.
The primary complications from hernia mesh failure are pain and damage to the bowels and intestines. For example, hernia mesh can embed itself in a person’s organs and cause bowel perforation-a condition where fecal matter and bacteria gets into the abdominal cavity.
How can you know if you have a hernia mesh case?
The key criteria for a hernia mesh case are as follows:
- You received a hernia mesh implant between 2008 and present day.
- You have undergone a “revision” or removal surgery for the mesh.
- You do not currently have an attorney representing you for this claim.
How can I pursue a claim for my hernia mesh failure?
Given that the FDA is not studying hernia mesh products in depth, the last resort for injured patients is to pursue a claim against these companies.
Many injured hernia mesh patients have called our law firm to discuss their case. We can quickly tell you whether you have a hernia mesh claim and will help you get started.
If you believe you had a hernia mesh claim, we encourage you to call our law firm today at (800) 248-6000. We are here to help you now.