Between 2005 and 2019, more than 211,000 pieces of hernia mesh have been recalled. These include hernia recurrence as well as mesh failure, injured organs, and more. Some mesh recalls sparked lawsuits from patients who had been damaged by the product.
The majority of hernia mesh recalls that occurred between 2005 and February 2019 were categorized by the FDA as “Class 2”. If the recalled product causes temporary or reversible adverse health effects, it’s classified as a Class 2 recall.
C.R. Bard’s Kugel Patch was recalled in a Class 1 recall for a problem with the product. This signifies that the recalled product has the potential to cause significant or even fatal health effects. Also, the bulk of recalls came from three companies: Johnson & Johnson’s Ethicon division (which gave a market withdrawal rather than a recall), C.R. Bard, and Atrium.
Hernia Mesh Brands Recalled
As a result of the issues arising from the mesh, hernia mesh recalls were issued voluntarily. Although recalls of FDA-mandated products are rare, mesh products from Atrium Medical, Bard Davos, Ethicon, and ACell have all been recalled.
For some brands, the product packaging faults caused the recalls. In contrast, several patients were admitted for more significant issues such as adhesion and intestine fistulas and injured organs, device migration, and bowel blockage. Several others have been pulled from the market due to much higher than average failure rates.
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List of Recalled Hernia Mesh
The hernia mesh that were recalled includes:
- Atrium Medical C-QUR Mesh
- Ethicon Physiomesh Flexible Composite Mesh (was issued a market withdrawal, not recall)
- Bard Composix Kugel Hernia Patch
- Ethicon Proceed Surgical Mesh
- Gentrix Surgical Matrix
- Parietex Composite Parastomal Mesh
FDA Issues a Serious Health Advisory Regarding Recalled Mesh
The Food and Drug Administration (FDA) issued a warning about hernia mesh in 2014. A public health alert was issued concerning the risks of hernia mesh use. Mesh recalls have been linked to six common issues, according to the Food and Drug Administration. These include:
Persistent hernia (hernia comes back), Adhesion (sticking to organs), Obstruction in the intestine (blocked bowels), Bowel abrasion (cutting or poking holes in the intestine), Infection, and Pain.
Recalled Mesh Lawsuits and Settlements
Hernia mesh victims are suing the companies that made the mesh for damages. The lawsuit asserts that the mesh was defective and badly manufactured. In the complaints, it is alleged that manufacturers have hidden the risks of using the product.
Bard’s polypropylene hernia mesh, Ethicon’s Physiomesh, and Atrium’s C-QUR are the three most often used hernia mesh brands. A Multidistrict lawsuit has been filed against each of them (MDLs). Multiple comparable lawsuits are consolidated into a single MDL for the sake of the economy. For the Kugel patch, Bard Davol faced more than 3,000 lawsuits in MDL. The MDL ended in 2017 following a $184 million settlement of 2,600 cases following a trial defeat.
In October 2020 alone, here are some of the lawsuits:
- A federal MDL has 3,128 Physiomesh litigation against Ethicon.
- In federal court, 2,378 C-QUR mesh cases have been filed against Atrium.
- MDL lawsuits have been filed against Bard for 9,394 different polypropylene hernia mesh products.
- For Atrium, Bard, and Ethicon, bellwether trials are planned for 2021 in federal MDLs.
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What to Do If Your Hernia Mesh Is Recalled
There is no need for you to have the mesh removed if you are not having any issues with it. Your doctor should be the first to know if you’ve had problems with your mesh if it’s been recalled. Some mesh-related issues might be life-threatening and require immediate attention. Your doctor can help you determine whether or not your mesh is developing issues and whether or not you require further surgical intervention.
Recalled hernia mesh patients who have undergone surgery to remove it, or have been advised they need surgery but can’t because it’s too unsafe, may be eligible to file a hernia mesh lawsuit. Also, after the surgery, be sure to save the hernia mesh for proof if you intend to file a hernia mesh lawsuit.
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