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

Man laying in painAccording to recent studies, 7.3 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 73,000 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?

Video Transcript

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 there is an 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

Ethicon, a subsidiary of Johnson & Johnson, withdrew their Physiomesh, Flexible Composite Mesh in May of 2016. The market withdrawal included all product codes.

Two independent hernia mesh research firms discovered a substantial flaw in the design. Their studies found that patients with flexible composite mesh had a higher reopen rate. The surgical mesh was ineffective and led 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, this is not the same thing as an FDA recall. To an outside observer, the result might look the same, but they’re not.

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

Atrium Medical Corporation is part of the Maquet Getinge Group. The company manufactures a variety of medical devices, including its C-QuR surgical mesh.

Made of Polyethylene, the C-QuR device came packaged in fish oil. The Omega-3 fatty acids found in the oil helped reduce scarring and inflammation. Unfortunately, the oil also made the product stickier than expected. Originally, Atrium recalled the C-QuR mesh because the fish oil caused the surgical mesh to stick to its packaging. When a surgeon attempted to remove the device, it would tear.

FDA Lawsuits

In July of 2013, the FDA issued a Class II Recall on the C-QuR V-pack Mesh. According to the FDA, a Class II Recall is a situation in which:

“…use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

When the government investigated the factory as part of the recall, they discovered a more serious issue. The humidity on the manufacturing floor was too high. This could lead to damage of other surgical devices. Because of this, the government filed a permanent injunction against Atrium Medical Corporation. A permanent injunction prevents them from making any devices that are not deemed “medically necessary.” In addition, they agreed to pay the government $6 million. Before resuming normal operations, they must pass an FDA inspection.

Civilian 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 caused higher inflammation. In addition, they claim that fish oil helped contribute to a higher risk of infection. A majority of these claims are still pending in 2018.

2018 Hernia Mesh Recalls

Class 2 Recall - ProLite Mesh

On February 23rd, 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 26th, 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.

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 they 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 surgery. This type of claim is also known as a medical malpractice lawsuit. If your pain was preventable, you deserve compensation.

Surgery room

Speak With An Attorney

No 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. When made incorrectly, these companies are putting thousands of patients at risk of 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. If they take your case you won’t have to worry about legal fees or expenses. Every law firm within our network operates on a contingency fee model. Your lawyer won’t get a dime until they win your case.




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