Hernia Mesh Recall

Adverse events relating to mesh hernia repair have occurred. Many of the hernia repair complications reported to the U.S. Food and Drug Administration have been associated with recalled mesh products.

The FDA reported in its analysis of medically adverse events that recalled mesh products were “the main cause of bowel perforation and obstruction complications.” A bowel obstruction is a blockage in the small or large intestine. Both perforation and obstruction can lead to abdominal cramping, fever and chills or more serious consequences such as sepsis and peritonitis.

Some manufacturers have initiated their own voluntary hernia mesh recalls. Classed from 1 to 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. Chronic enteric fistula is an abnormal connection between two organs, at least one of which is part of the gastrointestinal tract.

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

Most of the Class 2 recalls cover a variety of issues. Some of these include packing, nonsterility, delamination concerns and the requirement for repair surgery because of hernia recurrence.

Manufacturer ACell recalled its products on March 21, 2019. Sofradim followed, issuing Class 2 recalls of its products on April 26, 2018.

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

Manufacturer Atrium Medical Corporation issued Class 2 recalls for its ProLite Mesh product on November 22, 2017. The company then recalled multiple types of its C-QUR 2013 product on July 19, 2013.

The ProLite Mesh was distributed to Spain only. Atrium products shipped around the world, making them one of the most high-profile hernia mesh recalls.

Bard Inc., which Davol now owns, manufactures several polypropylene hernia mesh products for hernia repair. Several have undergone Class 2 recalls over the years.

There was also one Class 3 recall, which means the use of or exposure to a product in violation is not likely to cause adverse health consequences. The distribution of the products in all classes of recalls ranged from nationwide to global distribution.

Covidien made several Class 2 recalls of its hernia mesh products over the years. The company is a subsidiary of Medtronic.

At the time of its voluntary recall of the Parietex Composite Parastomal Mesh, the company indicated it had received reports of injury. Globally there were 10 reports of mesh failure following the use of the product in the previous five years.

From 2005 to 2014, Ethicon made Class 2 recalls of more than 18,000 units of its Proceed hernia mesh. Many of the recalls were related to issues of compromised sterility.

Delamination of mesh could potentially lead to complications. According to the company, the risk associated with its 2006 recall was that the “exposure of the polypropylene layer to the bowel prior to reperitonealization could increase the risk of adhesions and bowel fistulization.”

Because of extensive recalls during many years, the FDA has commissioned safety reports, issued warnings and involved the Department of Justice in an extreme case. Recalls occurred because patients experienced hernia mesh injuries, the mesh products had a high failure rate or the packaging was inadequate or incorrect in some way 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, seroma and other responses after using several 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 present challenges for medical researchers and regulators, which they continue to attempt to resolve through traditional and new evidence-based research methods, such as big data platforms.

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.

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 important to consult with a legal professional who can provide personalized advice based on your circumstances and injuries.