Table Of Contents
- Update: FDA Provides Safety Update on Hernia Repair Mesh as Medtech Companies Face Lawsuits
- Hernia Patch Complications
- C-Qur Mesh Approved via FDA Loophole
- Atrium Hernia Mesh Products
- C-Qur Hernia Patch Recall
- Atrium C-Qur MDL Established in New Hampshire
- Lawsuit Allegations
- Atrium C-Qur Mesh Lawsuit Filed in Pennsylvania
- C-Qur Mesh Patch Lawsuits Consolidated in New Hampshire
- Get a Free Atrium C-Qur Hernia Mesh Lawsuit Evaluation With Our Lawyers
Update: FDA Provides Safety Update on Hernia Repair Mesh as Medtech Companies Face Lawsuits
In 2019, the FDA halted the sale of mesh products for transvaginal repair of pelvic organ prolapse. Mesh devices, however, have a more established track record in abdominal hernia repair with a generally favorable safety profile.
Nevertheless, concerns persist regarding hernia devices. A recent court ruling mandated Becton Dickinson subsidiary C.R. Bard to compensate $4.8 million to an individual treated with its Ventralex hernia mesh. BD is currently grappling with over 33,000 product liability claims related to its hernia repair devices, with additional trials slated for the upcoming fall.
In this context, the FDA has shared its current insights into the safety of surgical mesh in hernia repairs. The agency presented data from two facets of its safety monitoring program, outlining prevalent adverse events from its 55,000 reports and disclosing findings from its analysis of academic literature.
Commonly cited adverse events in FDA reports encompass pain, injury, disability, infection, inflammation, and nausea. Some of these findings align with the academic literature, where the FDA observed incidence ranges of 0% to 21% for surgical site infection and 0.3% to 68% for pain. Instances of pain significantly impacting quality of life had an incidence rate of up to 3.8%.
Atrium C-Qur is a polypropylene mesh designed with an outer coating of a gel made from triglycerides and omega-3 fatty acids, called the O3FA layer.
According to this 2017 study by the National Center for Biotechnology and Information patients who received the hernia patch have reported problems, complaining that the mesh gets stuck to their bowels and other parts of the body, increasing the risk of life-threatening complications .
Hernia Patch Complications
Based on the FDA’s analysis of medical device adverse event reports from 2022  and of peer-reviewed, scientific literature, the most common adverse events for all surgical repair of hernias — with or without mesh — include:
- Chronic Infections
- Allergic Reactions
- Abdominal Pain
- Bowel Adhesion
- Bowel Obstruction
- Organ Perforation
- Mesh Erosion
- Mesh Failure
- Hernia recurrence
- Revision Surgery
- Seroma (fluid buildup under the skin)
C-Qur Mesh Approved via FDA Loophole
According to the FDA, Atrium C-Qur hernia mesh entered the U.S. market in March 2006 via the FDA’s 510(k) approval program , which allows companies to skip rigorous pre-market research and studies. The C-Qur hernia mesh was cleared because it was “substantially equivalent” to another product that was approved in the 1990s.
However, the C-Qur patch is the first mesh to ever utilize an omega-3 fatty acid coating. Devices approved through 510(k) are susceptible to lawsuits, unlike products that undergo extensive testing for Pre-Market Approval (PMA).
Atrium Hernia Mesh Products
Despite problems with the design of C-Qur hernia mesh, Atrium has introduced a variety of similar products that may increase the risk of the above complications/injuries:
- Atrium C-Qur Mesh
- Atrium C-Qur Mosaic
- Atrium C-Qur TacShield
- Atrium C-Qur V-Patch
- Atrium C-Qur Centrifx
- Atrium C-Qur FX Mesh (formerly C-Qur Lite)
C-Qur Hernia Patch Recall
In August 2013, the FDA stated that Atrium recalled about 1,500 C-QUR Edge mesh patches after it was found that coating on the devices could adhere to the inner packaging sleeve because of high humidity .
If the Product is exposed to excessive humidity for an extended period of time, then the increased humidity occurring inside the pouch can potentially cause the coating on the mesh to strongly adhere to the inner handling sleeve, the FDA said.
Atrium C-Qur MDL Established in New Hampshire
According to the United States District Court, all federal lawsuits alleging injury from hernia mesh patches manufactured by Atrium Medical Corp. have been centralized in multidistrict litigation (MDL No. 2753) in the U.S. District Court of New Hampshire .
Plaintiffs allege that Atrium C-Qur mesh has a fish oil coating that produces an allergic reaction which can lead to severe health complications. Additionally, if the hernia patch adheres to the bowel, it could lead to the bowel becoming twisted or perforated, causing gastric ulcers or other adverse intestinal problems, according to the lawsuits.
C-Qur hernia patch lawsuits allege that Atrium Medical Corporation:
- Failed to adequately research its hernia mesh products;
- Failed to properly investigate reports of hernia patch complications;
- Failed to recall C-Qur mesh after problems were discovered;
- Failed to warn about the risk of injury with the products, and
- Designed and sold a defective and unreasonably dangerous medical device.
Atrium C-Qur Mesh Lawsuit Filed in Pennsylvania
January 23, 2017 – Justia stated that an Ohio woman who allegedly suffered damage to her internal organs after receiving a C-Qur hernia patch has filed a product liability lawsuit against Atrium Medical in Pennsylvania federal court .
Plaintiff Willie Calloway was implanted with Atrium C-Qur mesh in 2010 while undergoing surgery to repair a hernia in her belly button. Five years later, Calloway claims she needed another hernia repair surgery after developing a painful lump where the mesh patch had been inserted.
When doctors went in to repair her recurrent hernia, they found large adhesions between the Atrium mesh and her small bowel. Surgeons had to remove 2 feet of her bowel because the damage was so extensive, according to the lawsuit.
C-Qur Mesh Patch Lawsuits Consolidated in New Hampshire
December 13, 2016 – Nearly two dozen federal lawsuits alleging injuries from Atrium C-Qur hernia mesh have been consolidated as part of a multidistrict litigation lawsuit (MDL No. 2753) in the District of New Hampshire before Judge Landya B. McCafferty. All of the suits contain similar allegations that C-Qur mesh causes an allergic or inflammatory response that can lead to severe health complications.
- Hernia Mesh Patch Lawsuit
- Hernia Mesh Lawsuit Settlements
- Atrium ProLite and ProLoop Hernia Mesh Lawsuits
See all related medical device lawsuits our lawyers covered so far.
Get a Free Atrium C-Qur Hernia Mesh Lawsuit Evaluation With Our Lawyers
The Medical Device Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in hernia patch lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Case Evaluation: Again, if you have an infection, gastric ulcer, or other hernia mesh complications, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.