Hernia Mesh Lawsuit

For years, patients have trusted hernia mesh devices to repair their injuries, only to experience serious complications after surgeries involving these implants. 

If you’ve had a hernia mesh implanted since 2006 and later experienced infection, bowel obstruction, organ damage, or chronic pain, or needed additional surgeries, you may be entitled to compensation from the manufacturers. 

What is a hernia?

A hernia occurs when an internal organ or tissue pushes through a weak spot or opening in the muscle or connective tissue that normally holds it in place. Most hernias involve an abdominal organ pushing through one of the walls of the abdominal cavity.

Not all hernias cause symptoms, but depending on the type, they may lead to a noticeable lump in the abdomen or groin. Some people may also experience pressure, discomfort, or a dull, pinching pain when the hernia protrudes.

Because hernias often recur or worsen without surgical intervention, many surgeons use hernia mesh implants to strengthen the affected area and reduce the risk of recurrence. 

However, in recent years, the U.S. Food and Drug Administration (FDA) has issued multiple warnings and recalls related to hernia mesh products after reports of severe complications and injuries linked to certain mesh devices.

What is hernia mesh?

Hernia repair is among the most common surgical procedures worldwide, with an estimated 20 million operations performed each year. In the United States, more than 80% of hernia repairs involve the use of hernia mesh implants, a widely accepted method for reinforcing weakened tissue. 

Doctors use hernia mesh, also called surgical mesh, to strengthen weakened or damaged tissue. Manufacturers make these medical devices from either synthetic materials or animal tissue.

Surgeons often use surgical mesh to repair conditions like hernias, which have a higher risk of recurring without reinforcement.

One of the major risks of hernia strangulation occurs when the condition cuts off blood flow to the affected organ. To prevent this and reduce the risk of recurrence, surgeons often use hernia mesh to strengthen the affected area and support proper healing.

FDA recalls of hernia mesh

Since 2005, the FDA has recalled thousands of hernia mesh products from the market.

Several of Bard’s devices have been subject to Class I recalls, the FDA’s most serious recall category. These recalls are due to risks of bowel perforation and chronic enteric fistulas, an abnormal connection that can form between the gastrointestinal tract and another organ. When the FDA issues a Class I recall, it typically removes the affected devices from the market.

The FDA’s Medical Device Recalls database lists several Bard hernia mesh products as Class I recalls, including:

• Bard Mesh Monofilament Knitted Polypropylene
• Bard Composix® Kugel™ Hernia Patch

Other manufacturers have hernia mesh devices classified as Class II recalls, such as:

• BG Medical (SURGIMESH®)
• Gore Medical (SEAMGUARD®)
• Bard (Ventralight™) 
• Covidien (Parietex™)

Class II recalls often involve issues like improper packaging, non-sterile materials, mesh delamination (splitting into layers), or the need for revision surgery due to hernia recurrence. These recalls account for the majority of hernia mesh removals from the market.

Reports of hernia mesh injury

According to the FDA’s Manufacturer and User Facility Device Experience (MAUDE), there have been numerous reports of complications, side effects, and injuries associated with hernia mesh. 

Some of the most common issues include:

• Mesh failure: The mesh does not function as intended and may need to be surgically removed
• Bowel obstruction: The mesh can migrate or adhere to surrounding tissue, causing a blockage in the intestines
• Erosion: Over time, the mesh can wear away, leading to symptoms such as fever, infection, pain, and nausea
• Migration: The mesh may move from its original placement, potentially causing complications
• Chronic pain: Long-lasting pain can occur throughout the body, often resulting from mesh failure or related complications
• Adhesion: Particularly with coated mesh devices, the mesh can stick to internal tissues, causing discomfort and other issues
• Infection: Infections may develop at any time after surgery, even more than 30 days post-operation, resulting in symptoms like fever, severe headaches, sweating, and, in severe cases, sepsis
• Perforation of organs or tissue: The mesh can puncture or tear organs or surrounding tissue, sometimes requiring partial bowel removal
• Seromas: Fluid accumulation under the skin can occur, which may lead to infection
• Recurrence of the hernia: In some cases, the hernia may return, often necessitating additional surgery

What is the hernia mesh lawsuit?

Over the years, many patients who underwent hernia repair surgery have reported serious complications, including:

• Infections
• Bowel obstruction
• Organ damage
• Chronic pain
• The need for additional surgeries

Hernia mesh devices made from certain materials can shrink, harden, migrate, or fail over time, causing further injuries such as organ or bowel damage and requiring additional corrective procedures.

In an effort to stay competitive, some hernia mesh manufacturers released “new and improved” products without sufficient long-term testing. The FDA fast-tracked many of these devices through its Premarket Notification 510(k) process, which allows products to reach the market quickly if they are substantially similar to existing devices. This process often requires less rigorous premarket testing and relies on collecting additional safety data after the product is already on the market.

Court documents have also revealed that some manufacturers marketed these devices for unnecessary or inappropriate uses, such as repairing small hernias that could have been treated with less invasive procedures like laparoscopic surgery or simple suturing.

The hernia mesh lawsuits allege that these complications stem from defective designs, unsafe materials, and deceptive marketing practices. Patients who suffered injuries linked to hernia mesh implants may be eligible to pursue legal action and seek compensation for medical expenses, pain and suffering, and revision surgeries required to address complications.

Joining the hernia mesh lawsuit

You may qualify for the hernia mesh lawsuit against hernia mesh manufacturers if you or a loved one has had a hernia mesh device implanted after 2006, and later experienced:

• Revision surgery to repair failures or address complications, or you have one scheduled
• Additional injuries from defective hernia mesh

If you or a loved one experienced a failed hernia mesh device and suffered injuries or death, you may have a case. 

SURGIMESH®, Covidien®, Parietex™, Bard®, Kugel™, SEAMGUARD®, and Gore Medical are registered trademarks of BG Medical, Medtronic, Becton Dickinson and Co., Blanc & Fisher, and W.L. Gore & Associates. Their names are used here only for the purpose of identifying the products in question. Woods & Woods, LLC is not affiliated with, sponsored by, or associated with BG Medical, Medtronic, Becton Dickinson and Co., Blanc & Fisher, W.L. Gore & Associates, the FDA, Cleveland Health Clinic, or the National Library of Medicine. Never stop taking medication without first talking to your doctor.