Hernia Mesh Injury Lawsuits: FDA Warnings

 

Hernia Mesh Injuries

Surprisingly, surgical mesh, particularly those used to repair hernias, have been in use since 1891. Since that time—and particularly over the past decade—the research has expanded, bringing to light some of the problems associated with hernia mesh. Although there are more than 50 different hernia mesh products to choose from, ranging from polypropylene to gels to animal skin, the most widely-used type of hernia mesh is the polypropylene type. After many people who had hernia mesh surgery developed serious problems with the mesh adhering to surrounding tissues and organs, some manufacturers added a variety of coatings to the mesh products, however this does not seem to have diminished the number of serious hernia mesh injuries. Some of the more common hernia mesh injuries include:

 

  • Serious infection, even sepsis in some cases. When hernia mesh is infected, it almost always requires revision surgery to remove the mesh (if possible) and replace it with sutures only, or a different type of mesh.
  • Bowel obstructions caused by hernia mesh adhesion can also be extremely serious; abdominal pain is one symptom of bowel obstruction, although it can also signify infection, adhesion formation and nerve damage.
  • Rashes have been seen among those with mesh implants, particularly those implanted with the C-QUR V-Patch and the Ventralex ST.
  • Pain is a common problem among those implanted with hernia mesh. The mesh can shrink, adhere to an organ or tissue or obstruct the bowel or intestines, all of which can cause debilitating pain.
  • Seromas—fluid capsules surrounding the mesh—can occur in those with hernia mesh implants and can be present with or without an accompanying infection.
  • Fistulas are abnormal tunnels between two structures, and in the case of hernia mesh, a fistula may attach to the bowel, causing pain and infection.

 

Hernia Mesh Injury FDA Warnings

More than 25 percent of all men will experience an abdominal hernia during their lifetime and some women will also experience this type of injury. More than 350,000 people undergo hernia repair procedures annually in the United States, which can be performed only with sutures, or with a combination of sutures and hernia mesh—a lightweight polypropylene mesh which is intended to bond—along with scar tissue—to the abdominal wall to add strength to the repair.

 

In October 2016, Vanderbilt University doctors released a study which concluded that out of 600 hernia mesh patients, more than 31 percent—almost a third—experienced complications from the hernia mesh within two years of the initial surgery. Based on this study, as well as others, as well as adverse event reports from hernia mesh patients and doctors, a hernia mesh injury FDA warning was issued in late 2016. The FDA warned that hernia mesh implants can lead to severe complications, including excessive scar tissue, chronic pain, organ perforation, organs adhering to one another, infection and intestinal or bowel blockage. 

 

Unfortunately, not all adverse events associated with hernia mesh are relayed to the FDA. When hernia mesh fails, if the same surgeon who implanted the mesh also removes the mesh, that surgeon may or may not report complications to the manufacturer. It then becomes the duty of the manufacturer to notify the FDA, and, as you can imagine, few manufacturers will do so. Surgeons and patients can directly file an adverse event report, but the process tends to be time-consuming and complex, putting off those who consider filing such a report. This means that only a very small percentage of hernia mesh injuries and complications actually get to the FDA, making it more difficult for the agency to issue hernia mesh injury safety communications.

 

Potential Hernia Mesh Recalls

In May 2016, Ethicon (a subsidiary of Johnson & Johnson) withdrew their Physiomesh Flexible Composite Mesh from the market after two independent research firms concluded there was a flaw in the design of the Physiomesh, leading to higher rates of failure, infection and pain. Ethicon claims they could not determine a cause of the flawed design, therefore voluntarily withdrew the mesh from the market.

 

A withdrawal from the market by the manufacturer of a drug or medical device is not the same as an FDA recall. A market withdrawal typically occurs when a firm removes a device for a violation which would not be subject to FDA legal action. In this case, although the FDA did not issue a medical alert or recall, victims are still allowed to file a claim for hernia mesh injuries caused by Physiomesh.

 

In July 2013, the FDA issued a Class II Recall on the C-QUR V-Pack mesh. A Class II recall is used when exposure to a specific product or device could cause temporary or medically reversible adverse health consequences. As a part of the Class II Recall, the government investigated the factory where the C-QUR V-Pack mesh was made and found a more serious issue—the humidity on in the manufacturing areas was excessively high, which could potentially damage other surgical devices.

 

A permanent injunction was filed against Atrium by the FDA, preventing them from manufacturing any medical devices which were not deemed medically necessary. Atrium paid the FDA $6 million, and were required to pass an inspection before they could continue operations.

On February 23rd, 2018, the FDA posted a Class II Recall for Atrium Medical Corporation’s ProLite Mesh, and the company voluntarily recalled certain improperly labeled mesh products as well.

 

Hernia Mesh Injury Lawsuits

While no hernia mesh injury FDA warnings or hernia mesh injury safety communications are necessary to file a hernia mesh injury lawsuit, if there are such warnings or communications, it can only help your case. It is expected, that in addition to the current state and federal hernia mesh injury lawsuits already filed, many more are to come. If you believe you were injured by a hernia mesh implant, it can be beneficial for you to speak to an experienced hernia mesh injury lawyer to ensure your rights and your future are properly protected. A knowledgeable Sullo & Sullo hernia mesh injury attorney can evaluate the specifics of your hernia mesh injury, helping you determine the best course of action.  
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