Hernia Mesh Recall
Hernia mesh manufacturers have recalled more than 211,000 units of hernia mesh from 2005 to March 2018. Manufacturers recalled the hernia mesh after people reported failures and organ injuries following surgery. The U.S. Food and Drug Administration blamed recalled mesh for some of the worst complications.
Hernia mesh manufacturers recall their products if they discover a problem. Hernia mesh manufacturers recalled more than 211,000 units of hernia mesh from 2005 to March 2018.
At least one manufacturer pulled a brand off the market after high failure rates. Companies also recalled hernia mesh after doctors and patients reported other serious complications.
The U.S. Food and Drug Administration tracks reported hernia mesh complications. The FDA said that recalled mesh was “the main cause” of bowel perforation and obstruction seen in those patients. Bowel perforation and obstruction are some of the worst complications of hernia mesh.
Reasons for Hernia Mesh Recalls
The FDA has announced several manufacturer recalls in recent years.
Some recalls were for packaging errors. But others were for serious complications. These included organ perforation and adhesion.
The agency issued a safety communication on hernia mesh in 2014. It warned the public about hernia mesh complications.
The agency identified five of the most common complications from recalled mesh.
Hernia Mesh Brands Recalled
Companies that issued hernia mesh recalls include Atrium Medical, Bard Davol and Ethicon. The three companies have recalled more than 211,000 hernia mesh units since 2005. Reasons for the recalls include improper packaging, high failure rates and potential for defects that could cause bowel perforation, adhesions or fistulas.
- Atrium Medical C-QUR Mesh
- Bard Composix Kugel Hernia Patch
- Ethicon Proceed Surgical Mesh
- Ethicon Physiomesh Flexible Composite Mesh
Hernia Mesh FDA Warnings
In 2015, the FDA asked a court for an injunction against mesh manufacturer Atrium Medical. Atrium manufactures C-QUR hernia mesh.
The agency said Atrium ignored repeated warnings about problems at its C-QUR factory. The injunction blocked C-QUR manufacturing and sales until Atrium fixed the problems.
The FDA blamed recalled mesh for complications people reported to the agency.
“Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market”
C-QUR has been one of the most high-profile hernia mesh recalls in recent years. Ethicon’s Physiomesh Flexible Composite Mesh has been the other.
FDA approved Atrium’s first C-QUR mesh products
FDA approved Ethicon’s Physiomesh Flexible Composite Mesh
FDA issued a warning letter to Atrium Medical. It said Atrium failed to address reported infections. The FDA also said that Atrium’s sterilization process was inadequate.
Two, large European hernia registries reported higher than average failure rates for Physiomesh Flexible Composite Mesh.
Ethicon issued a “market withdrawal” of Physiomesh Flexible Composite Mesh products.
FDA analysis found that recalled mesh is responsible for some of the most serious complications.
FDA averaged more than 500 adverse event reports per month for all types of surgical mesh. This included almost 300 reports for Physiomesh and 200 for C-QUR in the first three months of the year.
The FDA has different definitions for recalls and market withdrawals. Market withdrawals happen when the violation is not subject to legal action. Companies can take the product off the market or fix its violation. This way, manufacturers avoid a recall.
Hernia Mesh Lawsuits and Settlements Following Recalls
Patients who suffered hernia mesh injuries are suing mesh manufacturers. They claim that the mesh was faulty and poorly designed. The lawsuits accuse manufacturers of hiding the risks.
Most current hernia mesh lawsuits target Ethicon’s Physiomesh and Atrium’s C-QUR brands. Both are the subject of separate multidistrict litigations (MDLs). MDLs combine several similar lawsuits for efficiency.
Please seek the advice of a medical professional before making health care decisions.