Over the past couple of years Maquet Holding B.V. & Co. and its subsidiary, Atrium Medical Corporation, have come under fire for failing to meet FDA safety standards when it comes to the design and manufacturing of their C-Qur hernia mesh product. Between 2009 and 2013 the FDA conducted ten inspections across three of the Maquet manufacturing facilities. Those inspections uncovered major Quality System, Medical Device Reporting, and Correction and Removal violations that resulted in the FDA halting the manufacturing of C-Qur mesh implants.
The FDA first sent a warning letter to Maquet in 2010, which detailed the identified violations and required that they be corrected to avoid further action. Maquet failed to make the required changes and in 2012, the FDA sent another warning letter to the corporation. In this letter, they detailed the problems with sterilization, complaint follow-up, safety trials and general non-compliance, which were found during their investigations. The FDA sent a final warning letter in December 2014, which again detailed the company’s violations and their obligation to address these issues.
Maquet and Atrium failed to adequately respond to the FDA’s multiple warning letters. This led the FDA to file for a permanent injunction against Atrium Medical in February 2015. A federal judge form the U.S. District Court for the District of New Hampshire agreed with the FDA and entered a consent decree of permanent injunction against Maquet and three of its subsidiaries, including Atrium Medical Corporation, which manufactured and distributed C-Qur hernia mesh.
The consent decree orders that Maquet cease manufacturing and distributing devices from Atrium’s Hudson facility until that facility is in compliance with all regulations. The consent decree bans Maquet from making and selling the following Atrium products:
- C-QUR Hernia Mesh (including Vpatch, Tacshield, FX, Mosaic and Film)
- ProLite Hernia Mesh
- ProLoop Hernia Mesh
- Flixene Vascular Graft
- Ivena Vascular Patch
Although the injunction prevents Maquet from manufacturing and selling these products, unlike a recall it does not require the return of previously sold products and does not prevent healthcare facilities from using product that they already have in stock. For instance, several hospitals, who were able to purchase C-Qur mesh at cheap bulk prices before the injunction was entered, are still implanting this mesh in patient’s today, which is technically not a violation of the injunction order.
Cases against Atrium in connection to injuries allegedly sustained by C-Qur mesh, have been consolidated in a Multi-District Litigation (“MDL”) in the United States District Court of New Hampshire. Click here to visit the Atrium C-Qur Official MDL website and learn more about the status of this litigation.
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