Atrium C-QUR™ Mesh Recall Due to Safety Concerns
The C-QUR™ Mesh is a medical device that was manufactured and distributed by Atrium Medical Corporation starting in 2006. It has been used in hernia repair and other surgeries since then and has led to infections, injuries, and other complications in multiple patients.
If you or a family member has been injured by the C-QUR Mesh used in your surgery, you may be entitled to compensation. Ken Stern and the skilled personal injury attorneys at Stern Law, PLLC, have a long track record of successfully handling faulty medical device cases for injured patients and families nationwide. Defective medical device claims are complex and typically require taking action against large companies. You need a lawyer with extensive experience and the resources to pursue these challenging cases.
Schedule a free consultation with our legal team today. We provide personalized and strategically tailored advice for each of our clients.
FDA approval
The C-QUR Mesh received FDA clearance in 2006 through a legal provision intended to make it easier for useful and life-saving medical devices to get on the market. The process is called 510(k) or premarket notification.
The 510(k) is an option for manufacturers that produce a medical device that is “substantially equivalent” to another device that is legally on the market — usually one that has already gone through the rigorous FDA approval process.
A company requests 510(k) clearance by submitting paperwork showing its device and comparing with the device on the market that it considers substantially equivalent. The FDA will generally approve or deny clearance within 30 days, and FDA inspection of the manufacturing facilities will be done after the company starts manufacturing.
For manufacturers, the advantage of getting a medical device on the market through FDA 510(k) clearance is that it is easier and faster than going through the normal approval process.
Unfortunately, some products are given 510(k) even though the similar product on the market (called the “predicate”) has not been around long enough for potential dangers to be identified or established.
FDA warning letter
In 2012, the FDA sent Atrium Medical a warning letter. This letter indicated that the FDA had found that Atrium’s methods for manufacturing, packing, storage, or installation of the C-QUR Mesh and other devices were in violation of federal standards. The letter pointed out problems with Atrium’s sterilization procedures, warning that there were almost three dozen confirmed cases of human hair being found in sterilized meshes. It also found four complaints about infections associated with the C-QUR products. However, those complaints were closed without getting the results of culture tests or indicating the devices’ lot number.
Atrium’s product recall — without recalling the product
In 2013, Atrium Medical issued a Class II recall of its C-QUR Edge Mesh, but the recall did not result in the product being pulled from the market. Instead, Atrium sent out letters notifying doctors that the mesh’s coating could stick to the lining of the packaging when conditions were excessively humid.
Complaints and reports from doctors indicate that the Omega-3 fish oil coating was problematic under normal conditions, as well. Doctors have reported problems with the coating slipping as soon as the device was implanted, or within days after surgery.
The FDA injunction
On February 4, 2015, the FDA won an injunction against Atrium, preventing the company from producing the C-QUR mesh and other products until its procedures are brought into compliance with federal regulations.
Atrium Medical Corporation is a wholly owned subsidiary of Maquet Holding BV & Co. KG (Maquet). Maquet owns two other subsidiaries that manufacture medical devices, Maquet Cardiovascular, LLC (Maquet CV), in Wayne, New Jersey, and Maquet Cardiopulmonary AG in Germany.
Between 2009 and 2013, FDA investigators conducted 10 inspections at the three Maquet facilities, and major violations of the Quality System (QS) regulation, Medical Device Reporting (MDR) regulation, and Correction and Removal (CR) regulation were discovered.
Two warning letters were issued to Maquet during this time period: one to Atrium Medical, as mentioned earlier, and another to Maquet CV for selling a medical device without obtaining the necessary FDA approval or exemption.
After Atrium and Maquet failed to address or correct the issues raised in the warning letters and inspections, the FDA reached a consent decree for a permanent injunction with Maquet in February 2015, preventing Maquet from manufacturing from Atrium’s facility in Hudson, New Hampshire, until the issues are resolved, Maquet is in compliance, and the FDA has notified the company that it is allowed to resume production and distribution.
As part of the injunction, production and distribution for a number of Atrium hernia mesh products was put on hold, including ProLite Hernia Mesh; ProLoop Hernia Mesh; C-QUR Hernia Mesh (including Vpatch, Tacshield, FX, Mosaic, and Film); Flixene Vascular Graft; and Ivena Vascular Patch.
The FDA also noted in its announcement of the consent decree that it is aware of 45 recalls for devices manufactured by Maquet, five of which were Class I recalls. Class I recalls are done in situations where there is a reasonable probability that using a product will cause seriously adverse health concern or death.
Although the Hudson facility was shut down, the product is still available and being implanted at some hospitals.
Let Stern Law protect your rights after a hernia mesh injury
If you suspect that a faulty hernia mesh product is to blame for your injury or for a loved one’s death, Stern Law can help. Our firm can conduct an investigation into your case to determine whether the C-QUR Mesh is to blame for your injuries.
Our dedicated product liability lawyers can help you seek compensation for:
- Medical expenses
- Lost incomes
- Out-of-pocket costs
- Emotional trauma
- Pain and suffering
Let our network of skilled medical product liability lawyers and medical malpractice attorneys get to work on your case. Schedule a free and confidential consultation today, and our attorneys will go over your legal options and determine what full and fair compensation should be in your case.
