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 cited Atrium and Maquet for repeatedly failing to correct safety violations. 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.
A federal judge for the District of New Hampshire quickly approved the permanent injunction the following day. 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. 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 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.
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. Have you been implanted with a hernia mesh? If so, call 1-800-701-3672 for a free C-Qur hernia mesh lawsuit evaluation. 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. 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.