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Hernia Mesh Recalls

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.

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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.

Common Complications from Hernia Mesh
  1. Pain
  2. Infection
  3. Hernia recurrence (hernia comes back)
  4. Adhesion (sticking to organs)
  5. Bowel perforation (cutting or poking holes in the intestine)
Did you or a loved one suffer complications from recalled hernia mesh? Get a Free Case Review

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.

Hernia Mesh Recall List
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”

Source: FDA Statement on Hernia Mesh

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 Hernia Mesh Timeline
  • 2006

    FDA approved Atrium’s first C-QUR mesh products

  • 2010

    FDA approved Ethicon’s Physiomesh Flexible Composite Mesh

  • 2012

    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.

  • 2015

    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.

  • 2016

    Two, large European hernia registries reported higher than average failure rates for Physiomesh Flexible Composite Mesh.

  • 2016

    Ethicon issued a “market withdrawal” of Physiomesh Flexible Composite Mesh products.

  • 2016

    FDA analysis found that recalled mesh is responsible for some of the most serious complications.

  • 2018

    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.

As of March 2018, there were 30 lawsuits pending against Atrium over its C-QUR mesh. There were 680 lawsuits over Ethicon’s Physiomesh.

2011 Settlement
In 2011, Bard Davol settled 2,600 lawsuits over its Kugel patch for $184 million.

Please seek the advice of a medical professional before making health care decisions.

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16 Cited Research Articles

  1. U.S. Food and Drug Administration. (2012, October 11). Warning Letter CMS # 363780. Retrieved from http://wayback.archive-it.org/7993/20161023095443/http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm325084.htm
  2. U.S. District Court, District of New Hampshire. (2015, February 3). United States v. Atrium Medical Corp., et al. Consent Decree of Permanent Injunction. U.S. Department of Justice. Retrieved from https://www.justice.gov/file/338871/download
  3. Ethicon. (2016, May 27). Urgent: Medical Device Removal Ethicon Physiomesh Flexible Composite Mesh (All Product Codes). http://www.hsa.gov.sg/content/dam/HSA/HPRG/Medical_Devices/Updates_and_Safety_reporting/Field_Safety_Corrective_Action/FSN/2016/May/HSA%206004101-002-16-22_35%20FSN.pdf
  4. U.S. Judicial Panel on Multidistrict Litigation. (2016, December 8). IN RE: Atrium Medical Corp. C-QUR Mesh Products Liability Litigation. Transfer Order, MDL No. 2753. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2753-Initial_Transfer-12-16.pdf
  5. U.S. Judicial Panel on Multidistrict Litigation. (2017, June 2). IN RE: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation.Transfer Order, MDL No. 2782. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2782-Initial_Transfer-05-17.pdf
  6. U.S. Judicial Panel on Multidistrict Litigation. (2016, December 8). IN RE: Atrium Medical Corp. C-QUR Mesh Products Liability Litigation; MDL No. 2753. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2753-Initial_Transfer-12-16.pdf
  7. U.S. Department of Justice. (2015, February 3). District Court Enters Permanent Injunction Against New Hampshire Company and Senior Executives to Stop Distribution of Adulterated and Misbranded Products. Retrieved from https://www.justice.gov/opa/pr/district-court-enters-permanent-injunction-against-new-hampshire-company-and-senior
  8. Schreinemacher, M.H. et al. (2009, March). Degradation of mesh coatings and intraperitoneal adhesion formation in an experimental model. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/19224521
  9. U.S. Food and Drug Administration. (2010, April 9). 510(k) Premarket Notification; Physiomesh. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K093932
  10. U.S. Food and Drug Administration. (2006, March 31). 510(k) Premarket Notification; Atrium C-QUR. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K050311
  11. Perriello, B. (2016, June 20). J&J’s Ethicon recalls Physiomesh flexible composite hernia mesh. Retrieved from http://www.massdevice.com/jjs-ethicon-recalls-physiomesh-flexible-composite-hernia-mesh/
  12. U.S. Food and Drug Administration. (2018, March 21). Class 2 Device Recall CQUR Edge Mesh. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=119924
  13. U.S. Food and Drug Administration. (2018, March 21). Class 2 Device Recall. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43417
  14. U.S. Food and Drug Administration. (2018, March 21). Class 2 Device Recall CQUR VPatch Mesh. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119925
  15. U.S. Food and Drug Administration. (2018, February 4). Hernia Surgical Mesh Implants. Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/default.htm
  16. U.S. Food and Drug Administration. (2018, March 23). MAUDE – Manufacturer and User Facility Device Experience. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
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