Clients approach their defective product cases in different ways. Some call me with an injury caused by a medical device and say, essentially, “figure it out.” I have no problem with a client taking this position. Others keep detailed notes and meticulous records and send me a package of documents that can be several inches thick. I never require a client to do this initial “leg work,” but it can often jump start a case against the device manufacturer. If you are inclined to be more involved in the process, at least early on, I have noted some important tasks below you can accomplish to launch your hernia mesh case.

Let’s start with two assumptions: (1) you had hernia mesh implanted in your body in the past, and (2) you have suffered injury because of the hernia mesh. Where do you go from there?

Identify Your Product

It starts with this. The first and best place to go for this evidence is the product stickers page. These product stickers are found with the hospital’s medical records from the original implant surgery. It will look like a sheet of paper with a label or labels (“stickers”) attached to the page. These product stickers will identify (often in very small type) the manufacturer, the reference number, the catalog number, the lot number. It will likely mean very little to you when you see it, but trust me, it is an important document. I will say this: when a new client calls me with a mesh injury and promptly sends me the product stickers page, I know we are off to the races.

Caveat: the product stickers page is not always available. I’m not sure why, but occasionally a hospital will throw away the product stickers. It is an awful practice. In that case the hernia mesh must be identified through the implant surgery records (such as reference to the product in the operative note) and in a last resort through the billing records from the hospital. In some cases I have gotten the implant surgeon to sign an affidavit attesting to the specific product implanted. No matter how we get it done, we must identify the product implanted.

Gather Medical Records

This step is related to the step above, but involves more information and more documentation. You will need to contact all your medical care providers and ask for all medical records relating in any way to your hernia mesh surgery, as well post-surgery treatment. This would include implant and revision operative reports, discharge summaries, pathology reports, hospital notes, and other information gathered in the mesh implant surgery. These documents are the foundation of a strong hernia mesh lawsuit.

Identify Your Injury

Virtually all injury begins with the onset of pain or discomfort. But for a successful hernia mesh case, we will need to get specific. In most hernia mesh cases, there will have been a medically necessary revision surgery. The hernia mesh is implanted, it causes complications and pain, and it has to be removed. (That is, if it can be removed.) In normal medical procedures, revision surgeries should not be necessary; therefore, revision surgeries are inherently an injury to the patient. Beyond that, it will be important to identify the specific kind of injury the hernia mesh caused. Hernia mesh frequently causes adhesions, which are bands of scar tissue that bind organs or tissue together. Hernia mesh also causes inflammation, scarring, folding or curling, rejection, allergic reactions, and other serious complications. These injuries will likely be described in the medical records.

This step is important for a secondary reason: so we can identify whether the injury was caused by something other than the failure of the hernia mesh. In some cases after hernia mesh surgery, injury can occur because of surgical infection (that is, infection shortly after implant surgery), from other surgical complications, or even from an outside trauma (like a bad fall or a car crash).

Chart Your Hernia Mesh Timeline

You will need to confirm the dates of implantation, the identify the dates of onset of symptoms, the date of revision, and the dates of further revisions (if more revisions happened). Beyond that, you can use the product stickers to identify the hernia mesh implanted, and you will want to identify the hospital where you had the mesh implanted, the surgeon who performed the surgery, and the location and surgeon for any revision surgeries.

Maintain a Symptoms Journal

I always encourage this. It is simple enough: When you first begin to notice any sensations or pains which seem abnormal or unexpected, write down the date and a brief description of the pains on a piece of paper (or a notes app on your smart phone). The more detail the better—note the kind of pain you feel, the location, and any other descriptions. This journal may provide important information for your doctors but also for me as your attorney when I prepare a settlement package or a lawsuit. A pain/symptoms/well-being journal can provide valuable information to an attorney putting together the best case for you in the event you have a viable claim against a manufacturer for a failed hernia mesh product.

Contact a Good Product Liability Lawyer

Remember, you are not expected to do the work listed above. I have done this investigation often and I have gotten quite efficient at putting together strong cases. If you had hernia mesh revision surgery, you can contact me and ask me to sort it all out. So give me a call ((919) 830-5602) or use the contact form on this page to launch your hernia mesh case.

Note: A version of this article appeared on this site in July 2017.

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.