The C-Qur hernia mesh is a surgical mesh medical device developed by Atrium Medical Corporation for use in hernia repair surgeries. Designed to reinforce weakened or damaged tissue, the C-Qur hernia mesh aims to lower the risk of hernia recurrence by providing additional support at the surgical site. Despite its intended benefits, the C-Qur hernia mesh has become the subject of numerous hernia mesh lawsuits. Plaintiffs allege that the mesh can cause serious complications, such as mesh migration, adhesion to internal organs, infection, and chronic pain.
Many of these lawsuits claim that Atrium Medical failed to properly warn patients and healthcare providers about the potential risks associated with the C-Qur hernia mesh. As a result, the safety and effectiveness of this medical device have come under intense scrutiny, raising concerns about the use of surgical mesh products in hernia repair.
FDA injunction filed against Atrium due to repeated failure to comply with FDA standards
In 2015, the Food and Drug Administration (FDA) took decisive action against Atrium Medical Corporation and its parent company, Maquet, by filing for a permanent injunction. This move came after Atrium Medical repeatedly failed to correct safety violations identified during FDA inspections.
The violations included inadequate sterilization procedures, insufficient follow-up on product complaints, and lapses in safety trials for their medical devices, including the C-Qur hernia mesh.
Despite receiving multiple warning letters from the FDA, Atrium Medical and Maquet did not address these critical issues. The FDA’s injunction was intended to halt the manufacture and sale of medical devices that could pose risks to patient safety, particularly the C-Qur hernia mesh, which had been linked to serious complications such as mesh migration, infection, and chronic pain.
The FDA’s actions underscore the importance of strict compliance with safety standards in the production of surgical mesh and other medical devices.
FDA injunction filed against Atrium due to repeated failure to comply with FDA standards
In 2015, the US Food and Drug Administration (FDA) filed for a permanent injunction against Maquet Holding B.V. & Co. KG (Maquet). The FDA injunction included Maquet subsidiary Atrium Medical Corporation, the maker of the C-Qur hernia mesh. The FDA’s scrutiny was particularly focused on Atrium’s c qur mesh products. The FDA cited Atrium and Maquet for repeatedly failing to correct safety violations. Deficiencies in the manufacturing process contributed to the FDA’s decision to file for an injunction.
The FDA issued multiple fda warnings to Atrium Medical Corporation regarding the safety of its mesh products. A class ii recall was issued for certain Atrium mesh products due to manufacturing defects.
The FDA recall of C-Qur mesh products was prompted by safety concerns and manufacturing violations. Excessive humidity during storage or production can compromise the integrity of mesh products. High humidity was identified as a factor in some of the product’s packaging and coating issues. Problems with the mesh coating were cited in FDA investigations and contributed to the regulatory action.
The FDA injunction noted three Maquet manufacturing locations in violation of FDA standards. Atrium Medical Corporation manufacturers the C-Qur hernia mesh in Hudson, New Hampshire. Maquet and Atrium manufacturer a wide variety of medical devices, including surgical mesh and cardiovascular devices. Maquet Cardiovascular, LLC manufacturers cardiac devices in Wayne, New Jersey. The FDA injunction proposed forbidding both facilities from creating and selling medical devices.
FDA injunction against Atrium approved
A federal judge for the District of New Hampshire quickly approved the permanent injunction the following day. The District Court for the District of New Hampshire oversaw the approval of the injunction, which was a significant step in the ongoing legal proceedings.
A permanent FDA injunction is a serious matter. The FDA requested a permanent injunction after multiple warnings were given. The court approved FDA injunction prevents Atrium from manufacturing or selling the C-Qur hernia mesh from its Hudson, New Hampshire facility. Multi district litigation has been established to handle the numerous lawsuits related to C-Qur mesh products. C Qur lawsuits have been filed by patients alleging harm from the mesh. C Qur cases are being consolidated in the District of New Hampshire for coordinated pretrial proceedings.
The FDA sent its first warning letter to Maquet back in 2010. The FDA sent its final warning letter to Maquet two months before filing for the injunction. The FDA also sent Atrium Medical Corporation’s Hudson, New Hampshire facility a warning letter in 2012.
The FDA issued the 2012 Atrium warning letter after a series of investigations. The FDA investigations revealed problems with sterilization, complaint follow-ups, safety trials and general noncompliance. The warning letter admonished Atrium for changing the conveyor speed and temperature during the process of the C-Qur mesh. Atrium did not conduct any studies related to the manufacturing changes according to the FDA. The FDA warning letter also named other Atrium products, including the iCast. The ongoing litigation involving Atrium C Qur highlights the legal challenges faced by the manufacturer. Atrium C Qur hernia mesh is at the center of many product liability claims. Hernia mesh lawyers are representing clients in these lawsuits against Atrium Medical Corporation. Hernia mesh manufacturers have a responsibility to ensure product safety, and failure to do so can result in significant legal consequences.
The iCast is a stent with an expandable balloon. Atrium again utilized the FDA 510(k) program for approval of the iCast. The FDA warned of at least 35 complaints received regarding balloon detachment of the iCast. Finally, the FDA observed Atrium employees not wearing adequate sterilization attire, including hair nets and disposable hats. Unsurprisingly, over 30 complaints on Atrium products allege human hair within the “sterile” medical devices.
As a result of the FDA injunction, many dangerous medical devices won’t make it into the stream of commerce. Hernia mesh devices like C-Qur are subject to strict regulatory oversight. The C-Qur mesh has been cited as a faulty medical device in several lawsuits. Withdrawn C Qur products have impacted the availability of certain mesh devices in the market. There are broader legal and regulatory issues surrounding C Qur products and their safety profile.
FDA injunction does not recall the C-Qur hernia mesh
It is important to note that the FDA’s permanent injunction against Atrium Medical Corporation does not constitute a recall of the C-Qur hernia mesh already distributed to hospitals. Many healthcare facilities that purchased C-Qur mesh products in bulk at discounted prices may still be using these mesh devices in hernia repair surgeries.
The FDA injunction only restricts the manufacture and sale of new C-Qur hernia mesh products, leaving previously sold mesh in circulation. Only a Class I recall would require hospitals to stop using or return existing C-Qur mesh. Patients who have been implanted with C-Qur hernia mesh should be vigilant for symptoms of complications and seek medical attention if they experience issues.
Those affected may also be eligible to seek compensation through a hernia mesh lawsuit, as legal action continues against Atrium Medical for alleged harm caused by their mesh products.
FDA injunction does not recall the C-Qur hernia mesh
Unfortunately, the permanent FDA injunction does not prevent hospitals from implanting C-Qur mesh that they previously bought. Many hospitals purchased the C-Qur hernia mesh in bulk at cheap prices. As a result, many hospitals are still implanting the C-Qur hernia mesh. The FDA injunction only prevents the manufacture and sale of the C-Qur mesh. Only a class I recall will prevent hospitals from using old C-Qur mesh.
C-Qur mesh has also been used in chest wall reconstruction and the repair of surgical wounds. The mesh was marketed as causing minimal inflammatory response, but some patients have experienced significant inflammation. It is designed to prevent touching internal organs, but failures in this design can lead to complications such as adhesions and inflammation. Bowel obstruction is a serious complication that can result from mesh implantation.
Have you been implanted with a hernia mesh? If so, call 1-800-701-3672 for a free C-Qur hernia mesh lawsuit free consultation. We review cases on an individual basis, all investigations into your claim are risk-free. All of our services are on a contingency basis, you owe no money unless we win your case. Compensation may cover medical expenses incurred due to mesh complications. All of the information shared is confidential and protected by attorney/client privilege. Visit our general hernia mesh lawsuit page for more information on dangerous hernia meshes.
