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.

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.

Hernia mesh is causing problems. People who have been implanted with hernia mesh have suffered adhesions (scar tissue that sticks together), inflammation, pain, allergic reactions, internal bleeding, infections, and many other injuries.

One of the hernia mesh products sold for years, Ethicon’s Physiomesh, has caused many of these health problems in patients. In revision or removal surgeries, the Physiomesh has been discovered to have shrunk, folded, or curled. Surgeons have found scar tissue surrounding the mesh. This scar tissue can cause severe pain and discomfort. In many cases, by the time the mesh is removed, the damage has been done and long-term problems remain.

What Is Hernia Mesh?

A hernia appears when an internal organ protrudes through a wall of tissue (often a muscle) into another area of the body where it does not 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 thought to be needed to close the opening and keep it from reopening. This is where hernia 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.

But not all hernia mesh is effective. And some don’t work.

Some Key Facts About Physiomesh

Physiomesh is a multi-layer mesh with layers of polypropylene and film. Ethicon hoped that the film layers would resist adhesions (scarring), permit mesh ingrowth into the abdominal wall, and maintain separation between the mesh and internal organs.

Physiomesh is a product intended to be used in laparoscopic surgeries. This is the less-invasive surgical technique using fiber-optic instruments and tubes. A laparoscopic surgical procedure is illustrated in the photograph to the left. In hernia repair operations, the tubes enter the abdominal wall and, using small cameras and other medical instruments, the surgeon is able to repair the hernia surgically, including in some cases implanting hernia mesh. Obviously laparoscopic procedures are less traumatic to the patient and easier from which to recover. That is, if the implanted devices are not defective.

Unfortunately, Physiomesh has been shown to cause scarring around the mesh, inflammation, implant folding and curling, and other serious complications. Physiomesh causes adhesions but does not permit adequate ingrowth into the abdominal wall.

Sadly, these results would have been available to Ethicon if it had done adequate premarket testing on the Physiomesh instead of rushing it to the market.

In April 2010 Physiomesh was approved to treat hernias in patients. It was approved by the FDA through the 510(k) process, which I have written about often on this site. The 510(k) process is a way around the more complex (and safer) premarket approval process. Under 510(k), the manufacturer notifies the FDA of its intent to market a device like hernia mesh and explains the device’s “substantial equivalence” to a device already on the market. The FDA may then approve the medical device for sale in the United States without extensive premarket testing. This is how Physiomesh made it to the market, in October 2010.

Physiomesh was on the market from October 2010 until the product was withdrawn in May 2016. This means that if you had surgery for hernia mesh repair between October 2010 and May 2016, and mesh was implanted, it could possibly be Ethicon’s Physiomesh.

Want to Learn More About Physiomesh?

There are studies you can access online which drills down on the subject of hernia meshes and the causes of hernia mesh failure:

Long-term evaluation of adhesion formation and foreign body response to three new meshes. Authors: Vogels RR, van Barneveld KW, Bosmans JW, Beets G, Gijbels MJ, Schreinemacher MH, Bouvy ND. Published in Surgical Endoscopy, 2015 August 29 (8):2251-9. Among other findings, this study concluded that “[f]ractioning of the Physiomesh(®) coating over time led to an increase in interfilamentary granuloma formation, leading to scar plate formation, but with only minimal to no abdominal wall adherence” and that Physiomesh is not “superior in all aspects required for effective and safe incisional hernia repair.”

Comparison of two different concepts of mesh and fixation technique in laparoscopic ventral hernia repair: a randomized controlled trial. Authors: Pawlak M, Hilgers RD, Bury K, Lehmann A, Owczuk R, Smietananski M. Published in Surgical Endoscopy, 2016 Mar 30 (3):1188-97. This study was stopped due to safety reasons, which is alarming. Conclusion: ” . . . the obtained results from the enrolled patients indicate that the [Physiomesh] system associated with significantly greater hernia recurrences and postoperative pain compared with the [Ventralight ST/SorbaFix] system.”

There are other studies out there, and plenty of other information on Physiomesh and the problems it has caused.

So What’s Next?

One estimate indicates that as many as 160,000 patients received the Physiomesh hernia mesh in the United States between October 2010 and May 2016. It is expected that hundreds of people will eventually file suit against Ethicon for injuries caused by Physiomesh.

On May 25, 2017, the Judicial Panel on Multidistrict Litigation (JPML) conducted a hearing on a motion brought by Physiomesh plaintiffs, who asked the JPML to create a new multidistrict litigation specifically for Physiomesh cases. I will let you know when a decision has been reached on that motion, though I suspect we will see a Physiomesh MDL.

In the meantime, if you have had any surgical mesh implanted in your body to treat a hernia, and particularly if you know you received a Physiomesh hernia repair product, 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. You may be fine, but you should monitor your situation carefully.

When a device or drug maker pays money to an injured person for a defective product, several costs must be repaid from these funds. There will likely be medical liens, expenses of litigation, attorney’s fees, and health insurance liens. You can get an overview of these cost repayments in a post I wrote last year. In today’s post I want to take a closer look at health insurance liens (and the related concept of health insurance “subrogation”), mainly because health insurance companies can take a big bite out of your product liability settlement funds. Best to understand this unpleasant news upfront.

How Do Health Insurance Liens Work?

If you have health insurance, much of the cost of your medical care will be paid by your health insurance plan. Let’s say you need revision surgery to remove defective hernia mesh. The total cost of the surgery is $36,000.00, but under contracted payment rates between the hospital and your health insurance company, the cost is reduced to $24,000.00. Under your agreement with your insurance company, it pays $20,000.00 for this surgery and you pay a total of $4,000.00 in “co-pays” (that is, the amount you must pay “out of pocket” under your health insurance plan). So far so good.

A week after the surgery, while you recover from the operation (and watch afternoon commercials asking if you have been injured by defective hernia mesh), you receive a letter from your health insurance provider asking specific questions about how you were injured. The health insurance company is trying to figure out if a third-party is ultimately responsible for your injuries and thus for the costs of your revision surgery. The insurance company may want to know if you are pursuing a product liability claim against the manufacturer of the hernia mesh. It is no secret that the health insurance company is looking to be reimbursed for the payments it made for your mesh revision surgery. The moment you file a lawsuit against the product manufacturer, your health insurance company will submit a “lien” identifying its claim to some of the settlement funds. And trust me, these companies will not let this claim go lightly; they will pursue reimbursement aggressively, and you will most likely have a contractual responsibility to pay the health insurance company from your settlement funds. In fact, if possible the insurance company will expect to be repaid 100% of the costs it paid for your health care caused by the negligence of others.more

Health insurance subrogation is the closely-related concept whereby your health insurance carrier pays for your health care and then directly pursues reimbursement of those payments against the negligent third party or the third party’s insurance provider. Subrogation is the substitution of one person or entity for another with respect to an insurance claim or debt, and the entity substituted will obtain all the rights associated with the insurance claim or debt. What this means is that if your health insurance company pays money for your medical care, and it turns out your injuries were caused by a negligent third-party (such as a distracted driver or the manufacturer of hernia mesh) then the health insurance provider can step forward and demand to be repaid for the costs it incurred in your treatment. Essentially, it can pursue a lawsuit against the negligent third-party on its own, without you.

But Isn’t My Health Insurance Company Supposed to Pay for My Health Care?

In a word, yes. And these companies will pay for your health care related to injuries you sustain from a failed medical device, a problem prescription, or a car crash. At least, they will pay what they are required to pay based on the health insurance contract (and not a penny more). However, if a third party is at fault, they will want to be repaid from the third party for payments made.

This repayment can sting because it will naturally lower your overall net award from your product liability settlement. It also stings because you have paid health insurance premiums for years to provide medical care when you are injured, and the moment you receive compensation for an injury caused by someone else, your health insurance company will expect to be repaid for the medical care it paid on your behalf.

Let me put it another way, in any given year you may not receive any health care, but you paid monthly health insurance premiums every month. The insurance company does not give you that money back, and there is no mechanism for you to recover these premiums in a year when you did not need health care. What can I say? The health insurance industry has a more robust lobby in Washington D.C. than do individuals injured by defective products.

How Much Can the Health Insurance Company Take of my Product Settlement?

This can be the shocking part: in some cases the health insurance lien can be larger than the third-party is willing to pay in settlement. This means that you as the injured person may receive nothing from pursuing an injury claim against a negligent person or company. Quick example: you are hurt by the failure of a metal-on-metal artificial hip, but in the revision surgery you suffer a mild heart attack. Your health care related to your recovery from the heart attack eventually costs the health insurance company $225,000.00, but the hip manufacturer will only offer $300,000.00 to settle your case. In that situation, after other costs are paid there would be no money left over for your pain and suffering.

Some good news is that many states recognize the “Made Whole Doctrine.” This doctrine is a defense to a health insurance provider’s lien or subrogation rights. It goes like this: the insured (or injured person) must be “made whole” before an insurance company may step in and assert its rights to be repaid. But a word of caution: often the subrogation rights of insurance companies is stronger than the defense of the made whole doctrine.

If the “Made Whole Doctrine” does not protect you in your state, the other modest good news is that health insurance companies will occasionally work with a competent lawyer to lower the overall health insurance lien. For example, in the above example the health insurance company may agree to take two-thirds of the total cost for the health care “to get the deal done.” In that case, there would be money left over for you.

Finally, in many multidistrict litigation settlement agreements, the parties negotiate an arrangement for the product manufacturer to pay the health insurance liens and other liens as part of the overall settlement package. This can be one of the more attractive features of a multidistrict litigation settlement.

If you have more questions, call me: (919) 830-5602.

Note: this is not legal advice.

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.