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Why Are So Many Hernia Mesh Products Defective?

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In the last two decades, over 250,000 hernia mesh devices were recalled from the market due to safety risks that could cause patients to develop major health issues after installation. Today, over 25,000 plaintiffs have sued leading hernia mesh manufacturers due to severe medical complications, including CR Bard, Atrium Medical Corp., Ethicon, and Covidien.

Common medical complications caused by defective hernia mesh

Some patients with defective hernia mesh implants experience health issues that could cause long-term discomfort if not quickly treated. A smaller number of patients may even experience life-threatening medical complications that require additional surgery to resolve. Though each patient’s exact symptoms are unique, these are some of the most reported complications from affected patients:

  • Chronic Pain
  • Bleeding
  • Hernia recurrence
  • Infection or inflammation
  • Bowel obstruction
  • Organ perforation
  • Mesh degeneration (tearing)
  • Mesh adhesion
  • Mesh shrinkage
  • Mesh relocation
  • Intestinal fistulas
  • Sepsis

Why do so many hernia mesh products cause complications?

Building material

According to the FDA, the majority of hernia mesh devices in the U.S. are made with synthetic materials. The most frequently used material used to make synthetic hernia mesh is polypropylene, a common plastic used in many applications around the world. Polypropylene is known for being inert, which means that it does not react chemically to other substances and should not decay. However, recent medical studies are finding that polypropylene may no longer be inert once it’s implanted in the body and could degrade over time.

Polypropylene mesh devices are sturdy and designed to stay intact for the rest of patients’ lives. However, even though polypropylene has been used to treat hernias for decades, medical researchers have discovered that it may be causing post-surgery complications due to its lack of flexibility, high adhesion risk, and its tendency to shrink once installed.

Design defects

In order to have the best selling product on the market, leading hernia mesh manufacturers will often release proprietary mesh designs to outperform their competitors. However, some unique mesh products sold in recent years have created lasting consequences for patients and manufacturers alike.

Between 2005-2007, the FDA recalled over 100,000 units of the CR Bard Composix Kugel Mesh Patch, including several models and sizes. The Kugel Patch was recalled because of its plastic coil ring a patented design feature that was meant to help the device unravel in the body once installed, but was unfortunately prone to breaking. This design defect caused some patients to suffer from serious medical complications like bowel perforation and intestinal fistulas.

Outer coating failure

Some hernia mesh devices are designed with an outer layer of protective coating meant to help reduce adhesion and scarring. Though this coating can be effective in helping the body adapt to a hernia mesh implant, it can also cause problems in certain conditions. C-QUR Hernia Mesh (made by Atrium Medical Corporation) and PROCEED Surgical Mesh (made by Ethicon) have both been recalled by the FDA because of complications caused by their coating layers.

In 2013, the FDA recalled over 145,000 C-QUR Hernia Mesh units due to their outer coatings adhering to their packaging liners when stored in high temperatures or humidity, making them unusable. Lawsuit plaintiffs also suggest that the coating layer on C-QUR devices, when they are handled properly and successfully installed in the body, could separate from the rest of the plastic mesh. This phenomenon is called delamination, and it can reportedly lead to infections or abnormal tissue development if it isn’t addressed quickly.

Around 18,500 units of Ethicon’s PROCEED Surgical Mesh were also recalled by the FDA due to packaging issues caused by a defective outer coating layer. Like with the C-QUR recall, the FDA warned that the coating on PROCEED units could delaminate and split apart from the rest of the plastic mesh.

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

The references used by our writers at FreeLegalReviews.com are deemed to be from credible and reputable sources, including peer-reviewed studies, court records, non-profit organizations, government agencies, highly regarded news media, and legal subject experts. Before making any medical or financial decisions, please seek the opinion of a qualified professional.
  1. U.S. Food and Drug Administration. (2023, July 13). Surgical Mesh Used for Hernia Repair. Retrieved from https://www.fda.gov/medical-devices/implants-and-prosthetics/surgical-mesh-used-hernia-repair
  2. Sternschuss, G., Ostergard, D., Patel, H. (2012, July 1). Post-Implantation Alterations of Polypropylene in the Human. The Journal of Urology, 188 (1), pp. 27–32. Retrieved from https://doi.org/10.1016/j.juro.2012.02.2559
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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
  9. 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
  10. 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
  11. 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.
  12. 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

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):
  1. You received a defective hernia mesh device in 2014 or later.
  2. Your hernia mesh implant caused serious medical complications.
  3. You had a follow-up surgery to resolve those complications.
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