By Valerie Keene (with some editing by KBA)
A Guide to Hernia Mesh Lawsuits and Settlements
Plaintiffs continue filing lawsuits alleging defective hernia meshes caused serious complications requiring revision surgery or mesh removal. As noted by our friends at drugwatch, the Plaintiffs allege that mesh Bard Davol, Ethicon, Atrium, and others manufactured eventually failed and injured them seriously. There are several pending litigations.
Although some of these products have been recalled or voluntarily withdrawn from the market (like Physiomesh for which there is an MDL), no full recall has been issued yet. Plaintiffs filed a storm of cases against Ethicon’s Physiomesh, Atrium’s C-QUR mesh, and Bard/Davol. These lawsuits cite studies associating hernia mesh products with severe injuries and high recurrence rates.
If you or a member of your family suffered injuries after a mesh implant, you might want to seek financial compensation. Here is some information to guide you through the complexities of the current hernia mesh mass tort.
Why is a defective hernia mesh dangerous?
Surgeons use hernia mesh products routinely in the U.S. FDA provides some helpful detail about hernias and the use of mesh products. By and large, they work without incident. Patients should discuss concerns with physicians because sometimes problems do arise. Common complications include infection, pain, adhesions, mesh extrusion and hernia recurrence. Pain may be caused by mesh erosion,
Hernias are difficult to repair in the long-term and have a high rate of recurrence. When the failure involves a mesh, the adverse consequences may be even worse. The reopened hernia may be much larger than it was before, and potential organ adhesions may force the surgeon to remove additional chunks of abdominal tissues, intestines, and muscles together with the patch. The scar tissue that grows inside the patch may shrivel causing the device to shrink together with it. The fibrous mass formed is associated with many long-term or chronic adverse reactions.
Specific hernia meshes, however, are associated with different side effects, depending on their unique characteristics. For example, many of them such as Atrium’s C-Qur, Bard Davol’s Ventralex ST, and Composix Kugel consist of a coated polypropylene ring. The coating consists of polyglycolic acid (PGA), monocyte or allegedly Omega-3 fatty acids (fish oil), which are designed to be absorbed into the patient’s body after a certain amount of time, exposing bare polypropylene to the internal organs. The consequences may be dire and could require multiple additional surgeries to remove entire sections of the bowel, long hospitalization times, and systemic infections.
On the other hand, if the plug’s coating gel is not porous enough, as may happen with C-Qur, the ability of the mesh to ingrow into the abdominal wall may be substantially reduced causing detachment and reopening of the hernia. A nonporous mesh can also result in an intense inflammatory response, which may lead to pain, infection, or require revision surgery to replace the device entirely. Lastly, defective meshes can shrink and change shape immediately after the surgical procedure, forming creases and folds inside which tissues may grow, leading to adhesions and inflammation.
Why some people have filed hernia mesh lawsuits
In 2016 the U.S. Food and Drug Administration (FDA) acknowledged that mesh products were associated with a troubling high occurrence of complications. The agency’s investigation of the many medical adverse event reports found the surgical patches to be the leading cause of obstruction and a bowel perforation. FDA cleared the devices through the infamous 510(k) Premarket Notification Process. Lawyers allege that the products are dangerous and poorly tested. Some of the studies that suggested safety and effectiveness involved a short period of time only. By comparison, complications could manifest 10 to 15 years after implant.
Eventually, the manufacturers recalled some of these mesh, but for those who had them already, it was too late. Thousands of patients now seek monetary compensation. Plaintiffs and their lawyers accuse medical device companies of designing defective products and failing to warn patients and doctors about the failure rates and nature of the risks.
What are your chances of receiving compensation?
Currently, there may be as many as 70,000 cases pending in courts across the United States. A lot of manufacturers prefer to settle claims with the victims by paying them a settlement rather than face trial. Every case is different. Past results do not predict future outcomes. With that in mind, there have been some hernia mesh related trials in the past decade. For example, a Rhode Island jury provided Plaintiff Christopher Thorpe with $1.5 million in 2010. It found Davol Inc. and C.R. Bard Inc. liable for injuries he suffered after a surgeon implanted a Kugel patch to repair his hernia. The device later broke, folded, and adhered to his abdomen.
Although Kugel cases are still viable, most patients settled or filed lawsuits by now. The current cases pending have not gone to trial yet, to the best of our knowledge. Many trials start this or next year. It is impossible to predict the outcome generally or for any specific case right now. Sometimes people wait a long time to go through the process only to learn they do not have a compensable case. Other times the amount offered is small considering all one has been through.
Generally, cases where the medical records document that the mesh was the cause of an injury would have the best chance of recovery. In other cases, there has been a subsequent surgery or the doctor removed the mesh, but there is no indication of a mesh-related failure. Therefore, one’s chances of recovery turn on their individual medical history and experience with the mesh, as well as the unique aspects of the product itself. These are things that doctors and attorneys can discuss with people interested in learning more.
What can people with hernia mesh do?
First, they should speak with their medical providers. Second, if they believe the mesh caused an injury, they can speak with a law firm. The law firm will usually obtain medical records and review them. Then they will decide if they can file a claim.
About KBA’s guest author (Valerie Keene, Esq.)
Valerie Keene is an experienced lawyer and legal writer, editor, and content manager. She has provided educational legal content for over a decade, focusing on various practice areas, including personal injury and toxic torts. Her litigation successes have included wins for cases involving contract disputes, real property disputes, and consumer issues. She provides clients with solid legal advice and representation.