Juries Across the Nation Expected to Issue Multi-Million Dollar Verdicts for a Product Used in Millions of Hernia Repairs – Here’s What You Need to Know

Surgical Mesh Defective Product Lawsuits Gain Momentum

In March, we reported on medical complications associated with certain kinds of surgical mesh in hernia surgeries. We mentioned that, in the past few years, hernia mesh failure complications resulted in major tort cases in the U.S., and that a failed hernia surgery may provide reason to pursue a personal injury lawsuit for medical malpractice. Since March, we have seen some major developments to this story. As of November 2017, there were more than 300 lawsuits pending in federal courts against two major hernia mesh manufacturers – Atrium and Ethicon. The lawsuits have been combined into two large multidistrict litigations (MDLS) in New Hampshire and Georgia. No trial dates have been set yet and lawyers expect that hundreds of additional lawsuits may be added to the MDLS before they reach the trial stage.

It is estimated that, in the U.S., doctors perform around 1 million hernia repair surgeries a year. The use of patches, plugs or sheets made of surgical mesh is currently an established standard used during such surgeries to strengthen the tissue damaged by the hernia. As there is no indication that the practice will be abandoned or revised anytime soon, thousands of hernia failure cases are bound to surface in the months and years to come. Hughes & Coleman personal injury attorneys are committed to offering legal representation for anyone who may have been affected by this issue. This week’s blog is dedicated to an in-depth analysis of the problem and legal options available for those who might have been affected by it. If you or a loved one have undergone hernia repair surgery and are now suffering adverse medical events, we hope that you will find this information helpful. If you feel that you have basis for a claim against one of the hernia mesh manufacturers mentioned here or for a medical malpractice lawsuit, please contact us immediately to obtain a free consultation on your case.

Hernia Mesh Primer

A hernia is a fairly common medical condition that occurs when an abdomen organ breaks through the surrounding tissue causing a protrusion, or a bulge. Hernias most often occur in the abdominal wall or in the inner groin but can also affect the outer groin, belly button, scar tissue and even diaphragm. Hernias are painful and can cause dangerous complications. Currently, surgery is the only treatment that can repair a hernia. Unfortunately, hernias have a high rate of recurrence – which means they tend to pop up again in the same place because the previously affected tissue is already weakened. And that’s where surgical mesh comes into play.

Surgical mesh is a sterile woven fabric used to cover or fill up the damage done by a hernia. This is done to strengthen and provide support for the weakened muscle tissue affected. The biggest brands and manufacturers of surgical mesh include Bard Davol, Atrium Medical, and Ethicon. Hernia mesh use is not strictly indispensable in hernia repair surgeries – the damaged tissue may also be sewn together with stitches. Nevertheless, it is standard procedure to apply it as some studies have suggested that the use of hernia mesh is associated with lower rates of recurrence. In other words, the consensus seems to be that surgical mesh does a relatively good job at strengthening the tissue weakened by the hernia – at least better than suture repairs, or stitches^[1].

Various types of hernia mesh are currently produced and widely used and they can be grouped into the following categories: absorbable, non-absorbable, coated, synthetic and animal derived. Absorbable mesh loses its strength and degrades over time, to be finally absorbed by the body. Its purpose is to provide support until the affected tissue regenerates. Non-absorbable mesh, on the other hand, is considered a permanent implant as it will stay in a patient’s body indefinitely, providing lasting support to the affected tissue.

As its name suggests, synthetic hernia mesh is made of synthetic materials, mostly of a plastic called propylene. If this material comes into the direct contact with the intestine, it can adhere, or stick, to it and cause severe complications. That’s why synthetic mesh is often coated with absorbable fatty acids, cellulose or collagen to prevent sticking. Animal-based mesh is derived from processed and disinfected animal tissue such as intestine or skin.

What Are The Risks?

In the past fifteen years, surgical mesh produced by different manufacturers and brands has been subject to various recalls by the U.S. Food and Drug Administration (FDA) after it was discovered that their products were associated with some adverse effects and complications. The recalls affected some products of all of the major brands – including Kugel Mesh by Bard Davol, C-QUR mesh by Atrium, and Proceed Surgical Mesh by Ethicon. FDA warns that the following complications caused by hernia mesh failure have been reported:

• pain
• infection
• hernia recurrence
• adhesion
• bowel obstruction

In addition, a 2016 study published in the journal Hernia showed that 31% of patients who had a hernia repaired using mesh experienced surgical site infections within two years of surgery and almost 10% required additional medical intervention. Animal studies have additionally shown that infection rates were higher where the coated C-QUR hernia mesh, manufactured by the Atrium company, was used.

Moreover, in May of last year, Ethicon withdrew its Physiomesh Composite Mesh and Laparoscopic Hernia Kits from the market. Even though the company does not consider the move a product recall – as this would suggest that the products mentioned were defective in some way and that would open the way for lawsuits – Ethicon issued a special Urgent Field Safety Notice that explained the reasons behind the withdrawal. The notice contained the following statement:

“The recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ETHICON PHYSIOMESH™ Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries”

Current and Past Lawsuits Against Hernia Mesh Manufacturers

As mentioned, the individual lawsuits related to hernia mesh failure have recently been consolidated into multidistrict litigations or MDLS. Multidistrict litigation is a special legal procedure where lawsuits of many individuals – sometimes as many as hundreds or thousands – are combined together to speed the pre-trial proceedings and preparations. Current MDLS related to hernia mesh are being handled by federal courts in Georgia and Rhode Island and involve Ethicon’s Physiomesh Flexible Composite Mesh and various types of Atrium’s C-QUR Mesh. The plaintiffs accuse the manufacturers of acting negligently in that they knew or should have known that their products were defective but failed to warn the public accordingly. The specific counts of negligence state that:

• the mesh in question is a defective product
• the mesh in question has not been adequately tested
• the public has not been warned against the potential dangers
• the information about the defective mesh has been intentionally, knowingly, and recklessly, concealed from the public by the manufacturers
• the manufacturers intentionally misrepresented the quality and safety of hernia mesh
• the hernia mesh in question has been negligently designed and marketed in spite of safety concerns

The injuries listed in the lawsuits include:

• Adherence (becoming stuck to internal tissue)
• Bowel obstruction
• Infection
• Mesh failure
• Migration (moving from where it was implanted)
• Perforation of organs or tissues
• Seromas (pockets of fluid) that require surgery

In addition to these multidistrict litigations against Ethicon and Atrium, individual lawsuits have also been brought against two other manufacturers – Bard and Covidien.

Bard Davol, a subsidiary of C.R.Bard medical manufacturing giant, has already been involved in litigation connected with hernia mesh failure. As it is the case with the current lawsuits, about 150 individual cases against Bard Davol were consolidated into MDL and brought before a federal court in Rhode Island in 2007. The final number of cases surpassed 3,000. The lawsuits concerned various models of the Kugel Patch hernia mesh that were first recalled in 2005. In 2011, Bard offered $184 million to settle 2,600 lawsuits.

If You Are Suffering From A Mesh Failure

Since complications resulting from hernia mesh failure can be not only painful but also pose a serious risk, you should speak to your doctor as soon as possible about your symptoms. He or she will be able to detect the underlying causes of your complications and advise as to the best course of actions in your situation.

If your adverse reactions are determined to be caused by a defective hernia mesh product, and especially if one of the mesh products of the brands and manufacturers mentioned above was used in your hernia repair surgery, you may have a defective product claim.

^[1] For example, one of the most recent studies from 2014 published in the Journal of the American Medical Association showed that “using mesh leads to a lower chance of hernia recurrence than just stitching the torn tissue closed”. However, it must be noted that, according to the abstract provided by JAMA, the study concerned only one specific type of hernia (primary ventral hernia) and noted that the use of surgical mesh resulted in only “a small reduction in recurrence rates compared with suture repairs”, or stitches. In addition, the study observed “an increased risk of seroma and SSI”, or surgical site infection, related to mesh repair.