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Recalls of the Atrium Prolite Mesh

Cooper University Hospital Medical Malpractice | Console & Associates P.C.

Companies selling surgical mesh have to make sure the product meets high standards. To test their product, they’ll use machines, computers, and case studies. But even the most thorough pre-market research studies cannot predict everything. Some problems could take years to appear, long after the window closes on most pre-market studies.

When it becomes clear that a medical device already on the market causes significant products, the company may recall the product, preventing surgeons from using it in the future.

But what about the patients in whose bodies these recalled, potentially dangerous medical devices have already been surgically implanted?

How Common Are Hernia Mesh Complications?

Man laying in pain

According to recent studies, up to 8% percent of hernia mesh surgeries result in infection. Doctors perform more than one million hernia repairs annually, most using mesh. This means that there are as many as 80,000 infections every year. Even though most patients won’t experience complications, thousands still do.

If they used a defective mesh, the number of infections could increase. The defective surgical mesh also can lead to chronic pain and reduced quality of life for patients.

When companies discover an issue with their mesh, they recall it. While this helps prevent new patients from being put at risk, it does nothing to help those already suffering. If you had a hernia repair procedure that used defective mesh, you could receive compensation.

Console and Associates has 25 years of experience handling personal injury claims. Over that time, we’ve worked with law firms across the country, including those that handle defective hernia mesh claims. If we cannot handle a claim, our goal is to connect you with an experienced attorney who can. If you suffered as a result of a defective mesh, call today. We’ll ask you a few questions so that we can put you in touch with the right attorney.

Why Are Hernia Mesh Products Recalled?

Before a product like surgical mesh gets approval for use, it has to pass minimum safety requirements. Unfortunately, some products have problems that are unknown until they appear after surgery. Some of the most common hernia mesh failures include:

  • Mesh Migration: The movement of surgical mesh to other parts of the body.
  • Mesh Contraction: The collapse of the surgical mesh, so it doesn’t cover the hernia location.
  • Adhesion: When scar-like tissues stick other tissues together.
  • Obstruction: A blockage in the large or small intestine.
  • Perforation: A hole forming in one of the neighboring organs.

The likelihood of experiencing any of these complications varies from patient to patient. For example, mesh shrinkage (contraction) occurs in roughly 8% of cases, according to the NCBI. Yet, when surgeons use defective mesh provided by the manufacturer, the risk increases.

If the mesh used in your surgery is defective, you may need surgery to get it replaced.

How To Check The Recall Status Of Your Hernia Mesh

If you think you have a defective mesh, the first thing you should do is speak with your doctor. If your doctor’s diagnosis is a mesh infection, having it treated quickly will help reduce your risk for complications.

After you get the medical attention you need, you should check to see if your mesh is under recall. The Food and Drug Administration (FDA) maintains a medical device recall database. The tool allows you to check the recall status of any device.

To check the status of your hernia mesh, you’ll want to make sure you have the following information:

  • Product Name
  • Product Code (Usually found on your medical documents)
  • Manufacturer Name (Who made it)

If you find your hernia mesh listed under recall, contact your doctor. After discussing your medical options with them, contact an attorney to discuss your legal options.

Recent Hernia Mesh Recalls

Product improvement and replacement is part of any device’s life cycle. As knowledge and technology improve, outdated designs give way to new ones. This doesn’t always mean that the old product is bad, only that it’s not quite perfect.

But, what if a product is bad? When a company discovers a flaw in their product after approving it for sale, one option is for them to recall it. In recent years, two popular hernia mesh products faced recalls due to alleged defects in design.

Johnson & Johnson Physiomesh Recalls

In 2016, Ethicon, a subsidiary of Johnson & Johnson, voluntarily recalled its Physiomesh, Flexible Composite Mesh. The market withdrawal included all product codes.

Ethicon reviewed two independent studies of their composite mesh that monitored the progress of patients. In both cases, the results showed a higher incidence of new surgery or hernia recurrence in patients using the composite mesh. According to the findings of these researchers, a design flaw caused the mesh to have a higher reopen rate and lead to higher rates of pain and infection.

Ethicon investigated these claims but could not determine a root cause. Their research provided no insight for doctors hoping to avoid these complications. Because of this, they decided to voluntarily withdrawal this product.

Market Withdrawal Vs Recall

Johnson and Johnson technically performed a market withdrawal on Ethicon Physiomesh, Flexible Composite Mesh. While it might look similar to an outside observer, this is not the same thing as an FDA recall.

According to the FDA, a market withdrawal occurs when:

“…a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.”

While the product is still removed similar to a recall, the process is voluntary. The FDA took no legal action against Johnson & Johnson, nor did they officially list the product as unsafe. It’s not clear why they didn’t issue a medical alert or recall, but victims can still seek justice in court.

C-QuR Hernia Mesh Recall

For Atrium Medical Corporation, part of the Maquet Getinge Group, problems related to hernia mesh have stretched on for several years.

The company manufactures a variety of medical devices, including its C-QUR V-Patch surgical mesh. Made of Polyethylene, the C-QuR device once came packaged in fish oil. This seemed like a good idea at the time because the Omega-3 fatty acids found in the oil were thought to help reduce scarring and inflammation once implanted in a patient, but it turned out to be a serious flaw. The oil made the product stickier than expected – so much so that it stuck to the packaging and made the mesh implant unusable. When surgeons attempted to remove the device, it would stick to the inside lining and tear.

In 2013, the FDA issued a recall of C-Qur Mesh implants, not for safety reasons but because of this design flaw. Unfortunately, this was only one of the problems discovered at Atrium Medical Corporation. When the government investigated the factory as part of the recall, it discovered a more serious issue. The humidity on the manufacturing floor was too high, which could lead to damage of other surgical devices.

After uncovering this problem during a multi-year investigation and reporting that the company had failed to address multiple safety violations, the government filed a permanent injunction against Atrium Medical Corporation in 2015. This permanent injunction prevented Atrium from making any devices not deemed “medically necessary” until such time as the company passed an FDA inspection and was approved to resume normal activities.  In addition, Atrium agreed to pay the government $6 million.

In 2017, Atrium was one of several companies facing class-action lawsuits over the defective surgical mesh.

Civil Lawsuits

Some C-QuR Hernia Mesh lawsuits allege that one of the perceived benefits of the device is actually a cause for pain. Instead of reducing inflammation, the claims allege that fish oil contributes to higher risks of inflammation and infection. A majority of these claims were still pending in 2018, when more mesh recalls were announced.

2018 Hernia Mesh Recalls

The recall for Physiomesh and C-Qur might be in the news thanks to recent lawsuits, but they are not the only examples of defective or potentially dangerous mesh. In 2018, the FDA issued additional recall notifications involving surgical mesh products.

Class 2 Recall – ProLite Mesh

On February 23, 2018, the FDA posted a class 2 recall for Atrium Medical Corporation’s “ProLite Mesh.” According to the official notice, Atrium Medical Corporation voluntarily recalls some mesh products that are improperly labeled.

“An incorrect ProLite Mesh configuration was packaged as product code 1010306-06, with lot number 412298. ProLite Mesh manufactured as product code 1010306-04 was inadvertently placed inside the pouch of packages labeled with product code 1010306-06 and lot number 412298.”

– Official Recall Notice

This is a limited recall, affecting an estimated 60 units.

Class 2 Recall – Versatex Monofilament Mesh

On April 26, 2018, the FDA posted a recall notice for the Versatex Monofilament Mesh manufactured by Sofradim Production. The official product name is Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M. According to the recall:

There have been patient reports of abdominal hernia recurrence following hernia repair. The recalling firm has added a statement to the device’s Instructions for Use to make surgeons aware of risks in using the device in Transversus Abdominis Muscle Release (TAR) procedures.

– Official Recall Notice

This recall impacts an estimated 699 units. If your doctor used this product to treat a hernia, you should contact them immediately to see if you require revision surgery. If you had a Versatex Monofilament Mesh and already had a revision surgery performed, speak with an attorney. You may be entitled to compensation.

What should I do if my hernia mesh is recalled?

If you discover that the mesh used in your surgery is under recall, speak with your doctor. In some cases, the recall could be for something other than a medical flaw – and not something that you need to worry about.

If there is a medical concern, it’s important that you speak with your doctor as soon as possible. Your health always comes first.

After consulting your doctor, contact an attorney. If you don’t know of an attorney who is handling these claims, call us at (866) 778-5500, and we will connect you with one.

A Recall Is Not Required For A Claim

Recalls are a strong indicator of manufacturer responsibility. Companies spend a lot of money bringing a new product to market, and recalling one is expensive. To stop selling a product means that manufacturers might not make that money back, so they only recall products if they have to.

But just because your hernia mesh isn’t currently under recall doesn’t mean you don’t have a claim.

One of the ways a company learns that their product might be defective is through consumer claims. Ethical companies listen to the feedback given by surgeons for how patients respond to their devices. If they notice a pattern, such as chronic pain, it could lead to the study that forces them to recall the product. By pursuing a claim, you may help prevent others from suffering as you have in the future.

Medical Malpractice

Even without a defective device, surgery makes your body vulnerable. Infection and chronic pain can also result from errors made during the hernia surgery. This type of claim is also known as a medical malpractice lawsuit. If your pain was preventable, you deserve compensation.

Speak With An Attorney

No Fee PromiseNo one should live in pain because a manufacturer made a defective product. The use of surgical mesh has very real consequences to the patients who undergo this surgery. These companies and their defective mesh products are putting thousands of patients at risk of preventable infections or chronic pain.

If doctors used a surgical mesh that was later recalled, or if you experienced complications after surgery, call us. You won’t have to pay to speak to an attorney about your claim. Every law firm within our network operates on a contingency fee model, which means you won’t have to worry about any out of pocket legal fees or expenses. Your lawyer won’t get a dime until they win your case.


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