Hernias are a common health problem for adults. How they’re treated often depends on an individual’s overall health and how the hernia affects their daily life. When medical treatment is needed, surgery making use of a special mesh is the common recommendation. But some of these meshes have caused problems for some patients. One such surgical mesh in particular has been the Strattice Reconstructive Tissue Matrix (Strattice mesh). To understand the issue with the Strattice mesh, let’s first get some background information.

What Is a Hernia and How Is it Treated?

A hernia is a medical condition where there’s a hole or weakness in a wall of tissue, such as fascia or muscle. Because of this hole or weakness, an internal organ or fatty tissue will protrude or push through and into a part of the body where it shouldn’t be. This can cause pain, organ dysfunction (through a loss of blood supply or obstruction in the organ), swelling and/or a visible bulge at the site of the hernia.

Depending on the severity and location of the hernia, as well as the condition of the patient, surgery is often recommended. Until somewhat recently, this typically involved cutting into the body, then pulling existing tissue surrounding the hernia together to close the hole.

The benefit of this approach was that it used the patient’s own tissue to repair the hernia. A disadvantage was that it could lead to the hernia coming back. To address this issue of hernia recurrence, hernias started being repaired with meshes. These were screen-like sheets that were used to strengthen and support the tissue weakness causing the hernia.

The earlier surgical meshes were made out of synthetic materials, such as polypropylene. These weren’t ideal because they sometimes led to problems, including:

• Inflammation
• Adhesions (fibrous bands of tissue that connect organs and other parts of the body)
• Patient discomfort, including severe pain
• Perforated organs
• Infection
• Bowel blockages
• Internal bleeding
• Nerve damage
• Fistulas (a connection between tissues or organs in the human body that are not normally connected)

Many of these issues stemmed from the patient’s body treating the synthetic mesh as a foreign body. Because of the problems linked to synthetic meshes, many lawsuits have been filed against their makers.

Due to the problems associated with synthetic meshes, medical device companies tried surgical meshes made from biological materials. By using human or animal tissues to create a surgical mesh, the hope was that the patient would produce a lower foreign body response, have a lower risk of infection and eventually replace or supplement the biological mesh with the patient’s own tissue. One such product was the Strattice mesh, although this product had its problems.

What’s Wrong With the Strattice Biologic Hernia Mesh?

The Strattice mesh was made from pig skin, which was supposed to make it far more compatible with the human body compared to meshes using synthetic materials. Yet according to some of the patients who received the Strattice mesh, they suffered many problems that were common with synthetic meshes. These problems potentially stemmed from the biological mesh coming apart or breaking down inside the body.

According to the allegations in one Strattice mesh lawsuit, the extent of the problem with the Strattice mesh includes 450 adverse medical event reports. Of these 450 reports, there have been six deaths, at least 340 injuries and at least 107 product malfunctions.

The Strattice mesh has a history of FDA recalls, including a Class 3 Device Recall in 2010 for a mislabeling error and a Class 2 Device Recall in 2011 because it was being used in a way that hadn’t been properly approved.

Because of the problems some patients have had with the Strattice mesh, they filed suit against the maker of the Strattice mesh, including LifeCell Corporation and related business entities like Allergan, Inc. and Allergan USA, Inc.

Lawsuits Stemming From Alleged Problems with the Strattice Hernia Mesh

So far, the bulk of the Strattice-related lawsuits have been filed in New Jersey, both in federal and state court. At least 50 of the state court cases have been consolidated into multi-county litigation, or MCL. Some of the causes of action made by Strattice mesh plaintiffs include:

• Design defect
• Failure to warn
• Negligence
• Negligent misrepresentation
• Fraud
• Breach of express warranty
• Breach of implied warranties
• Violation of consumer protection laws

MCL in New Jersey is similar to multi-district litigation in federal court. But instead of individual cases from U.S. district courts getting consolidated into a single federal district court, the individual state cases from New Jersey county courts get consolidated into a single New Jersey county court. The Strattice mesh MDL has been sent to Atlantic County.

What Happens Next?

According to a September 15, 2022 Amended Case Management Order, the first trial has been scheduled for January 29, 2024. Until then, the parties will finish up handling pre-trial matters, such as discovery, deciding the order the cases will go to trial and filing any necessary motions.

If you received a hernia mesh, you should talk to your doctor about what you need to do to address any potential medical concerns. If it turns out something went wrong with the mesh, give me a call at (919) 830-5602 and we’ll see if there’s something I can do to help.

Treating Hernias with Surgical Mesh

First off, let’s briefly explain what a hernia is. A hernia appears when an internal organ protrudes through a wall of tissue (often a muscle) into another area of the body where it doesn’t belong. Depending on how bad the hernia is, surgery may be required to fix it.

Because hernias involve a hole in a muscle or other tissue, additional reinforcement is usually needed to close the opening and keep it from reopening. This is where surgical mesh comes in. The mesh often takes the form of a plug or sheet of biological or synthetic mesh and is surgically implanted over the hole.

Clinical studies have shown that using surgical mesh to treat hernias reduces the chances of the hernia returning. Each year hundreds of thousands of hernia surgeries are performed. Given their proven effectiveness, it’s no wonder that many of these surgeries use a surgical mesh. Unfortunately, a significant number of the meshes have serious flaws.

more Problems in Patients with Hernia Surgical Mesh

Many patients who undergo surgery to have surgical mesh implanted for hernia treatment recover quickly and go on with their lives. However, some patients suffer from the following problems with their surgically implanted mesh:

– Allergic reactions – Adhesions (scar tissue that sticks together) – Perforation of organs – Return of the hernia – Severe pain – Bowel blockages – Uncomfortable or painful sex – Internal bleeding – Infection – Damage to nerves – Movement of the mesh within the body – Fluid buildup – Rejection of the implant (the body’s immune system attacks the mesh) – Fistulas (an abnormal connection between two hollow areas of the body, like the intestines)

Removal of the surgical mesh is often required, but by the time the mesh is removed, the damage has been done and long-term problems remain. As a result, many patients have sued the manufacturers of these surgical meshes.

Hernia Surgical Mesh Lawsuits

A few years ago, Bard Davol faced numerous lawsuits concerning its Kugel hernia mesh. These lawsuits have been mostly resolved by now, but they appear to represent just the tip of the iceberg.

Patients who have surgical meshes made by other companies are having problems too, and they are starting to line up at the courthouse steps for their day in court. Two major hernia mesh lawsuits involve the following products.

C-Qur

Atrium Medical Corporation manufactured the C-Qur hernia mesh, which is made of polypropylene and coated with Omega-3 fatty acid fish oil. The use of fish oil was intended to reduce the chance of adhesions occurring, but instead has caused many complications. These include allergic reactions to the fish oil, life threatening infections and the fish oil coating separating from the mesh once it is implanted inside the body.

In July of 2013, the Atrium Medical Corporation recalled the C-Qur mesh, with over 30,000 meshes taken off the market. There are currently about two dozen C-Qur mesh lawsuits pending in MDL. However, it’s expected the number of C-Qur lawsuits will grow.

Physiomesh

Ethicon is another company that manufactured a hernia mesh made out of polypropylene called Physiomesh. This mesh had a special coating which was also designed to prevent adhesions. However, the coating led to a complication: It also prevented the mesh from properly integrating into body tissue.

The Physiomesh implant had a larger number of problems that Ethicon did not anticipate, including fluid buildup, scar tissue formation and hemorrhaging. These have led to serious symptoms, such as chronic pain, bowel blockages and infections.

In May of 2016, Physiomesh was withdrawn from the market, although not officially recalled. Currently only a few lawsuits have commenced, although many more lawsuits are anticipated.

Why Did These Hernia Mesh Products Have Problems?

As you might expect, there is no simple answer to this question, but there are two major factors that likely contributed to the problems.

First, the hernia mesh was made out of polypropylene, which was originally considered to be completely inert within the human body. However, studies have shown the polypropylene degrades over time and can damage surrounding tissue.

In order to deal with the problems of polypropylene, medical device manufacturers covered the mesh in special coatings, like Omega-3 fish oil. But these coatings didn’t work very well. So why didn’t companies like Ethicon or Atrium Medical Corporation find a material other than polypropylene?

The answer to this question brings us to factor number two: getting FDA approval as quickly as possible. If a medical device company decided to use a completely different surgical mesh material, it would have taken longer and cost more money to get the product to market. This is because the mesh would have been considered a brand new medical device and therefore full clinical and safety studies and trials and would have been needed. By simply using a new coating, the device would be considered “substantially equivalent” to a medical device already approved by the FDA and therefore would be cheaper and much more readily available to use in patients.

One of the procedures medical device companies used to get their products to market faster was the 510(k) expedited approval process. I’ve written about the 510(k) procedure often on this site. Using this process, Physiomesh and C-Qur didn’t need to be tested in humans; animal tests were considered sufficient.

While there can be advantages of getting medical products to market sooner rather than later, hernia surgical mesh serves as another example of the dangers of not conducting proper tests to ensure a medical product’s safety and effectiveness. Unfortunately, it doesn’t appear these fast-track approval procedures are going anywhere anytime soon given the passage of the 21^st Century Cures Act.

Now What?

The hernia surgical mesh lawsuits are in their early stages with at least one trial set to start in early 2018. It shouldn’t be surprising that more plaintiffs will step forward before then, alleging problems with their hernia surgical mesh.

If you have had a surgical mesh implanted into your body to treat a hernia, especially a product from one of the above mentioned companies, you should speak with your doctor as soon as possible. This is important, even if you aren’t aware of any problems with the mesh.