A hernia is an injury that occurs when soft tissue bulges through a weak spot in a person’s abdominal muscles. Hernias are extremely common, with more than 3 million new cases in the United States each year, and if they don’t cause problems or complications, or if they don’t get bigger, no treatment may be necessary.
But in many cases, surgical repair in recommended. When hernia surgery is performed, surgeons usually use mesh implants to help support the weakened or damaged tissue.
How Do Hernia Mesh Implants Work?
During hernia surgery, the bulging tissue is pushed back in, and the hole in the abdominal wall is closed up with sutures or stitches. In more than half of all cases, the surgeon will also use a flexible sheet of woven mesh as a kind of patch to reinforce the weakened area.
The mesh is believed to lower the rate of hernia recurrence, but it is also associated with a whole host of complications. A study published earlier this year found that the rate of complications was significantly higher in hernia surgery patients with mesh implants than for those without mesh implants.
Why Do Hernia Mesh Implants Fail?
In recent years, the U.S. Food & Drug Administration (FDA) has issued warnings for several types of surgical hernia mesh, including:
- Atrium C-Qur Edge
- Bard Ventralex™ ST
- Bard Ventralight™ ST
- Johnson & Johnson Ethicon PhysioMesh™
All of these devices were approved through the FDA’s 510(k) premarket notification clearance process, which allows companies to skip the rigorous premarket safety testing required for many other types of medical devices.
There are many potential causes of hernia mesh device failure, depending on the specific design of the device used. Breakage of the mesh is often to blame. Hernia mesh has also been known to shrink or migrate over time.
In some cases, it is believed that the material used to manufacture the mesh is rejected by the patient’s body, which in turn causes inflammation and potentially serious infection. Sometimes surgical error is to blame, as in when a surgeon uses a piece of mesh that is too big or too small.
Often, more than one factor is the cause of a hernia mesh patient’s problems. But that should never be used as an excuse to let a medical device company off the hook for its role in aggressively marketing an unsafe product. If you had a problem with hernia mesh, please contact an attorney in Sommers Schwartz’s Complex Litigation Group to review your case.