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Hernia Mesh Devices Recalled by the FDA
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The hernia mesh lawsuit includes many different types of hernia mesh and, the U.S. Food and Drug Administration (FDA) has recalled three hernia mesh implant devices in the past two decades. Since 2005, the FDA has issued one Class I hernia mesh recall and two Class II recalls.
The FDA’s recall classification system
The FDA uses three recall categories to determine the risk of danger presented by an unsafe product or medical device.
Items under a Class II recall could either cause “medically reversible adverse health consequences,” or the low possibility of developing “serious adverse health consequences.”
Products and devices under a Class III recall are “not likely to cause adverse health consequences.”
Composix Kugel Mesh Patch (Bard)
Class I Recall, 2005
In the most serious recall to date, the FDA recalled over 100,000 CR Bard Composix Kugel Mesh Patch units from 2005-2007, including multiple shapes and sizes.
According to the FDA, the plastic coil ring designed to help the Kugel Patch unfurl after being inserted into the body was prone to breaking. This defect made it more likely for patients to develop intestinal fistulas, suffer from bowel perforation— which could lead to sepsis— or experience another severe medical complication requiring urgent treatment.
C-QUR Hernia Mesh (Atrium Medical Corp)
Class II Recall, 2013
In 2013, the FDA recalled around 145,000 units of Atrium’s C-QUR hernia mesh. The recall involved multiple C-QUR models, including C-QUR Edge, C-QUR TacShield, and C-QUR VPatch.
Atrium’s C-QUR hernia mesh products were covered with an omega-3 fish oil coating, which caused multiple safety issues leading up to the FDA recall. In humid conditions, the coating could adhere to the mesh’s packaging liner, making it unusable. Furthermore, lawsuit plaintiffs claim that the fish oil coating in Atrium’s C-QUR mesh had a tendency to separate once installed, leading to increased cases of infection and abnormal tissue development.
PROCEED Surgical Mesh (Ethicon)
Class II Recall, 2006-2014
Though it took nearly an entire decade, the FDA recalled around 18,500 units of Ethicon’s PROCEED Surgical Mesh due to packaging issues. According to the FDA, the affected mesh devices were likely to lose their adhesive coating and split apart in a process called “delamination.”
Join the hernia mesh lawsuit
If you or a family member received a defective hernia mesh implant and had to receive a follow-up surgery to resolve severe medical complications, you may be eligible for a hernia mesh settlement.
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See if you qualify for the hernia mesh lawsuit.
Referenced Articles
- U.S. Food and Drug Administration. (2020, September 29). Recalls, Corrections and Removals (Devices). Retrieved from https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices
- U.S. Food and Drug Administration. (2006, February 22). Class 1 Device Recall Bard. (Recall no. Z-0524-06). Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43767
View more sources
- U.S. Food and Drug Administration. (2006, February 22). Class 1 Device Recall Bard. (Recall no. Z-0525-06). Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=43768
- U.S. Food and Drug Administration. (2006, February 22). Class 1 Device Recall Bard. (Recall no. Z-0762-06). Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=44997
- U.S. Food and Drug Administration. (2006, February 22).Class 1 Device Recall Bard. (Recall no. Z-0760-06). Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=44995
- U.S. Food and Drug Administration. (2006, February 22). Class 1 Device Recall Bard. (Recall no. Z-0761-06). Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=44996
- U.S. Food and Drug Administration. (2006, February 22). Class 1 Device Recall Bard. (Recall no. Z-0526-06). Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=43769
- U.S. Food and Drug Administration. (2007, January 30). Class 1 Device Recall Bard Davol Composix Kugel Hernia Patch. (Recall no. Z-0360-2007). Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49722
- U.S. Food and Drug Administration. (2013, August 9). Class 2 Device Recall CQUR Mesh. (Recall no. Z-1936-2013). Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119923
- U.S. Food and Drug Administration. (2013, August 9). Class 2 Device Recall CQUR TacShield Mesh. (Recall no. Z-1939-2013). Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119926
- U.S. Food and Drug Administration. (2013, August 9). Class 2 Device Recall CQUR VPatch Mesh. (Recall no. Z-1938-2013). Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119925
- U.S. Food and Drug Administration. (2013, August 9). Class 2 Device Recall CQUR Edge Mesh. (Recall no. Z-1937-2013). Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=119924
- U.S. Food and Drug Administration. (2006, January 26). Class 2 Device Recall. (Recall no. Z-0449-06). Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43417#:~:text=Ethicon%2C%20Inc.&text=Lots%20of%20Proceed%20Surgical%20Mesh,of%20adhesions%20and%20bowel%20fistulization.&text=The%20recall%20was%20initiated%20on%2012%2F21%2F2005.
- U.S. Food and Drug Administration. (2011, January 14). Class 2 Device Recall PROCEED Surgical Mesh. (Recall no. Z-0903-2011). Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95190
- U.S. Food and Drug Administration. (2014, April 3). Class 2 Device Recall Ethicon Inc. (Recall no. Z-1329-2014). Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126188
About the Hernia Mesh Lawsuit
Products at-risk
Synthetic hernia mesh devices made with polypropylene, a sturdy plastic.
Who's being sued?
- CR Bard, owned by Becton, Dickinson and Company
- Atrium Medical Corporation, owned by Marquet Cardiovascular, LLC
- Ethicon, Inc., owned by Johnson & Johnson
- Covidien, owned by Medtronic
How to qualify for the hernia mesh lawsuit (all of the following):
- You received a defective hernia mesh device in 2014 or later.
- Your hernia mesh implant caused serious medical complications.
- You had a follow-up surgery to resolve those complications.