The Atrium C-Qur mesh is a line of implantable hernia mesh products. They are made and sold by the Atrium Medical Corporation. While the Atrium C-Qur implants use different materials and coatings than many other hernia mesh devices, they are still plagued by many of the same defects. These defects can cause chronic pain and severe medical complications in patients. Thousands of hernia mesh lawsuits have been filed against Atrium for injuries suffered by patients after being implanted with a C-Qur mesh. The U.S. Food and Drug Administration (FDA) even forced Atrium to shut down one of its facilities after it found that the company was making and packaging medical devices in non-sterile environments.
- 1. What are Atrium C-Qur mesh products?
- 2. How to identify a product from the Atrium C-Qur line of meshes
- 3. Defects in Atrium C-Qur meshes
- 4. Only limited recalls for Atrium C-Qur mesh devices
1. What are Atrium C-Qur mesh products?
The Atrium C-Qur (pronounced “secure”) line of hernia mesh products spans several models, each of which is designed for a different type of hernia procedure. The models in the C-Qur line of hernia mesh products include:
- C-Qur,
- C-Qur FX,
- C-Qur CentriFX,
- C-Qur Edge,
- C-Qur V-Patch,
- C-Qur Mosaic,
- C-Qur Film, and the
- C-Qur Tacshield.
Each product is specifically tailored for use in different hernia procedures. All of them, however, are designed to create scar tissue on the location of the implant. This scar tissue grows into the mesh’s pores, effectively making the implanted mesh a part of the muscle. With the additional scar tissue and the mesh to support it, the muscle is supposed to become stronger and prevent future and recurrent hernias.
2. How to identify a product from the Atrium C-Qur line of meshes
While there are a handful of hernia mesh implants in the Atrium C-Qur line, all of them have two things in common: They use a polypropylene mesh and a lining of Omega 3 fatty acid.
While polypropylene mesh has become industry standard, the original Atrium C-Qur model, which was approved by the FDA in March, 2006, was the first hernia mesh implant to use an Omega 3 lining.1 This Omega 3 lining gives the implant a brownish color that other implants do not have.
3. Defects in Atrium C-Qur meshes
Both the polypropylene mesh and the Omega 3 coating have caused serious medical complications and chronic pain in people who have had Atrium C-Qur mesh devices implanted. Additionally, problems in Atrium’s manufacturing and packaging process have put non-sterile devices into the market to hurt patients.
3.1 Plastic mesh erodes after being implanted
The polypropylene mesh used in the Atrium C-Qur devices is known to erode after being implanted, causing chronic pain and other medical complications.
Polypropylene is a cheap type of plastic that oxidizes, or erodes when it comes into contact with oxygen. The tissues and blood that surround a hernia mesh implant contain oxygen. Even when a hernia mesh implant is treated with an antioxidant, this erosion is bound to happen, eventually.
When the polypropylene implant erodes, it shrinks. This shrinkage poses a serious problem when scar tissue has grown into the mesh – an ingrowth that the mesh is designed to trigger. Especially when nerves have developed in the ingrowth, the shrinking mesh can create significant discomfort and chronic pain.
3.2 Defects in the Omega 3 coating on Atrium C-Qur implants
While the Omega 3 coating on Atrium’s C-Qur implants is supposed to prevent the mesh in the implant from adhering to other tissues and organs, it frequently fails to do this. Additionally, the Omega 3 coating has been known to cause infections and allergic reactions in patients.
Because polypropylene mesh is designed to create scar tissue that binds the mesh to the underlying tissue, hernia mesh manufacturers often coat the backside of the mesh with another material to keep the tissues behind the implant from sticking to the device. Atrium tried doing this by coating its C-Qur line of mesh products with Omega 3, a fatty acid derived from fish oil. The results, however, were no better than other protective materials, leaving patients at risk of other tissues combining with the mesh and causing serious medical problems.2
In addition to failing to prevent the implant from creating unwanted adhesions with other tissues, the Omega 3 lining in Atrium’s C-Qur implants has also been linked to an increased rate of infection. One study found that the infection rate of C-Qur V-Patch implants, when placed intra-peritoneally, was 19%.3
3.3 Atrium’s manufacturing and packing practices put patients at risk
Atrium has also put patients at risk by failing to abide by federal regulations at its manufacturing and packing facilities. Inspections by the FDA revealed repeated violations at Atrium’s facilities, leading to a federal lawsuit against Atrium for putting adulterated and misbranded medical devices into the market.4 The lawsuit was settled in a consent decree that involved the near-total closure of Atrium’s manufacturing facility in Hudson, New Hampshire.5
4. Only limited recalls for Atrium C-Qur mesh devices
Despite the injuries that Atrium’s C-Qur hernia mesh implants have caused, the company has refused to issue a Class 1 recall that would have pulled the defective devices out of hospitals. Instead, the only recall affecting Atrium C-Qur implants has been a Class 2 recall that merely warned surgeons about the possibility for the Omega 3 coating on C-Qur implants to stick to the inside of the packaging materials.6
Without a general recall, people who have been hurt by their Atrium C-Qur implant have been forced to join the Atrium C-Qur multidistrict litigation (MDL) to recover compensation for their losses.
Legal References:
- FDA Approval of Atrium C-Qur hernia mesh
. - See Schreinemacher MH, van Barneveld KW, Dikmans RE, Gijbels MJ, Greve JW, Bouvy ND, “Coated meshes for hernia repair provide comparable intraperitoneal adhesion prevention,” Surgical Endoscopy 27(11):4202-9 (November 2013).
- Cheng D, Bonato L, Leinkram C, “Infection and recurrence rates of the C-QUR V-Patch™ in ventral hernia repairs,” Hernia 22(5): 767-772 (October 2018).
- U.S.A. v. Atrium Medical Corporation, No. 15-00041 (D. N.H. filed Feb. 3, 2015).
- U.S.A. v. Atrium Medical Corporation, (D. N.H. Feb 3, 2015) (consent decree of permanent injunction); Department of Justice, “District Court Enters Permanent Injunction Against New Hampshire Company and Senior Executives to Stop Distribution of Adulterated and Misbranded Products,” (February 3, 2015).
- FDA Class 2 Device Recall Z-1938-2013 – CQUR VPatch Mesh.