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 recurrence (hernia comes back)
- Adhesion (sticking to organs)
- Bowel perforation (cutting or poking holes in the intestine)
Hernia Mesh Brands Recalled
|Manufacturer, Dates & Units||Products||Reason|
|Atrium Medical Aug. 9, 2013 (145,251 units recalled)||C-QUR Edge Mesh C-QUR TacShield C-QUR V-Patch Mesh C-QUR Mesh (all sizes)||Improper packaging|
|Bard Davol Dec. 22, 2005 Expanded on Jan. 5 and Mar. 24, 2006 (31,761 units)||Bard Composix Kugel Mesh X-Large Patch Oval (various sizes) Bard Composix Kugel Large Oval, 5.4” x 7” Bard Composix Kugel Oval, 6.3” x 12.3” Bard Composix Kugel Large Circle, 4.5”||Potential of ring breaking and causing bowel perforation or fistula|
|Bard Davol Jan. 10, 2007(16,603 units)||Bard Composix Kugel Hernia Patch Large Oval with EPTFE, 5.4” x 7” Bard Composix Kugel Hernia Patch Large Circle with EPTFE, 4.5”||Potential of ring breaking and causing bowel perforation or fistula|
|Ethicon Dec. 21, 2005 (18,000 units) Oct. 18, 2010 (87 units from one lot)||Proceed Surgical Mesh||Potential to lose laminate coating. This can expose mesh to bowels and causing adhesions or bowel fistulization|
|Ethicon Feb. 19, 2014 (223 units from specific lots)||Proceed Surgical Mesh||Packaging defect cause delamination leading to potential adhesions|
|Ethicon May 27, 2016 (Market withdrawal: all units removed from global market)||Physiomesh Flexible Composite Mesh||High failure rates reported|
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.
Federal court granted FDA an injunction against Atrium. It ordered Atrium to stop distribution and manufacturing of medical devices from the company’s Hudson, New Hampshire, plant. The shutdown was in effect until Atrium complied with certain Federal Food, Drug, and Cosmetic Act provisions.
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.