Hernia Mesh Recall

There haven’t been any major recalls of hernia mesh products since 2021. However, the U.S. Food and Drug Administration (FDA) has reported that over 211,000 packages of hernia mesh have been recalled since 2005.

The FDA labeled most of these recalls as Class 2, meaning they could cause temporary, treatable health issues. One notable exception was C.R. Bard’s Kugel patch, which the FDA classified as a Class 1 recall due to serious health risks, including the potential for death.

Johnson & Johnson’s Ethicon, Bard Davol and Atrium are the three companies with the most recalls.

As of March 2025, these companies, along with Covidien, were involved in approximately 26,243 hernia mesh lawsuits across four different federal court cases.

The FDA has recorded numerous adverse events related to hernia repairs using mesh. Many hernia repair complications reported to the FDA are associated with recalled mesh products.

A bowel obstruction is a blockage in the small or large intestine, while adhesion refers to the development of scar-like tissue. Perforation is the appearance of holes in nearby organs or tissues. Both perforation and obstruction can lead to abdominal cramping, nausea and vomiting, or more severe consequences such as sepsis (a system-wide infection) and peritonitis (an abdominal infection).

Some manufacturers have initiated their own voluntary hernia mesh recalls. The FDA classifies recalls from 1–3 depending on the seriousness of the potential consequences. Class 1 recalls are the most serious.

Several Class 1 recalls occurred because the hernia mesh’s “memory recoil ring could break and potentially lead to bowel perforation and/or chronic enteric fistula,” according to the manufacturer. Bowel perforation from hernia mesh can cause feces to leak into the abdomen. A chronic enteric fistula is an abnormal attachment between the gastrointestinal tract and another organ.

A Class 2 recall means a person may suffer temporary or medically reversible adverse health consequences from the recalled product. The FDA classified most hernia mesh recalls from 2005 to 2019 as Class 2.

Class 2 recalls cover a variety of issues. Some of these include improper packaging, nonsterile components, delamination (mesh breaking into layers) and the need for repair surgery because of hernia recurrence.

Manufacturer Sofradim issued Class 2 recalls of its Versatex products on April 26, 2018. ACell followed, recalling its Gentrix products on March 21, 2019.

Gentrix Surgical Matrix meshes are made from biological products designed to dissolve over time. Sofradim’s product, however, is made from polyester textiles.

Manufacturer Atrium Medical Corporation recalled several types of its C-QUR product on August 9, 2013. The company then issued Class 2 recalls for its ProLite Mesh product on February 23, 2018.

The ProLite Mesh was only distributed in Spain. However, Atrium C-QUR products shipped worldwide, making this one of the most high-profile hernia mesh recalls.

Bard, Inc. — which Beckton Dickinson now owns — manufactures polypropylene hernia mesh products. Over the years, several have undergone Class 2 recalls.

There was also one Class 3 recall (the Bard 3D Max Mesh), which means the use of or exposure to a product in violation is not likely to cause adverse health consequences. Bard distributed these products in all classes of recalls either nationwide or globally.

Over the years, Covidien — a subsidiary of Medtronic — has issued several Class 2 recalls of its hernia mesh products.

At the time of its voluntary recall of the Parietex Composite Parastomal Mesh, the company indicated it had received injury reports. Globally, there were 10 reports of mesh failure following the use of this product from 2013 to 2018.

From 2006 to 2020, Ethicon issued Class 2 recalls of more than 18,000 units of its Proceed hernia mesh. Most of the recalls were due to delamination, a process in which the mesh material breaks down into several layers. A few others were due to various other sterility issues.

Delamination of mesh could lead to complications. According to the company, the risk associated with its 2006 recall was that exposing the polypropylene layer to the bowel before regenerating the peritoneum (a membrane separating the abdomen’s contents from its walls) carried increased risks of scar tissue formation and abnormal openings in the intestines or stomach.

Because of extensive recalls over many years, the FDA has commissioned safety reports and issued warnings about various hernia mesh products. Recalls occurred because patients experienced hernia mesh injuries, the mesh products had a high failure rate or the packaging was inadequate and posed a threat or risk of injury.

Studies show that patients continue to report significant issues. These include chronic and acute pain, hernia recurrence, hematoma (blood pooling outside of blood vessels), seroma (clear fluid trapped under the skin) and other responses after using various brands and models of hernia meshes.

Regulatory science evaluates the safety and performance of medical devices throughout their life cycle. Hernia mesh materials are complex and can present challenges for medical researchers and regulators.

If you discover that your hernia mesh has been recalled, consult your surgeon for additional information so they can evaluate your situation and provide guidance on medical interventions or monitoring. Keep all documentation related to your hernia mesh, including records and communications with health care providers.

You may want to contact a medical device litigation attorney for a free consultation and an evaluation of your case. An experienced attorney will inform you of your legal rights and guide you through the process if you decide to pursue a claim.

Hernia mesh lawsuits for related complications are ongoing. Remember, each case is unique, and it’s essential to consult with a legal professional who can provide personalized advice based on your circumstances and injuries.