This medical device was so bad, that it was withdrawn from the market globally in May of 2016. Prior to this, a federal judge had to intervene to get the manufacturers into compliance after Food and Drug Administration (FDA) investigators uncovered major violations in Atrium and other two Maquet plants, between 2009 and 2013.
Additionally, between 2009 and 2014, the FDA was aware of 45 recalls of Maquet-manufactured devices, five of which were classified as Class 1 – representing the most significant risk to patients, according to a February 2015 agency news release.
A federal judge from the U.S. District Court for the District of New Hampshire entered a consent decree of permanent injunction against Atrium’s parent company and two of its officers for repeatedly failing to correct violations at Atrium in Hudson and other Maquet facilities in New Jersey and Germany.
ATRIUM C-QUR HERNIA MESH RECALLATRIUM C-QUR HERNIA MESH RECALL
Due to violations found by the FDA, parent company Maquet was ordered to stop manufacturing and distributing devices from Atrium’s Hudson facility until the company made appropriate corrections to ensure legal compliance, under the terms of the consent decree.
Atrium was allowed to distribute certain products that were deemed medically necessary, under certain regulatory supervisions, but the following products were described by the FDA as “unavailable”:
- C-QUR Hernia Mesh (including Vpatch, Tacshield, FX, Mosaic and Film)
- ProLite Hernia Mesh
- ProLoop Hernia Mesh
- Flixene Vascular Graft
- Ivena Vascular Patch
THE PROBLEM WITH ATRIUM’S MESH
A lot of surgical mesh have been faulty. There are studies about some of these medical devices that actually caused more recurrence and surgeries.
Atrium’s C-QUR in particular is a polypropylene mesh designed with an outer coating of gel made from triglycerides and omega-3 fatty acids, called the O3FA layer. Many patients complained the coating got stuck to their bowels and other parts of their inner body; causing pain, suffering, and required to redo the surgery.
In other words, you’re having pain from a hernia and go into surgery to get it repaired only to, sometime afterwards, get inflammation and more pain; probably loose time from work and then go back to the hospital to redo the repair and correct the complications caused by the mesh implant.
Atrium knew or should have known that their C-QUR hernia mesh was faulty and must have informed about the risks to doctors, hospitals and thus, patients.
If you or loved ones had hernia surgery, there’s a good chance that the doctor used a hernia mesh as support, to make the surgery better and less likely to return. If you were injured by a hernia mesh and suffered from its complication, you could have grounds for a claim against the manufacturer in an Atrium hernia mesh lawsuit .
DEFECTIVE HERNIA MESH INJURY CLAIMS
People shouldn’t have to suffer from a medical device that shouldn’t have been used in the first place. It’s usually not a doctor’s fault, but the responsibility of the manufacturer of these faulty hernia patches.
Greg Jones Law has been handling complex defective medical devices cases against big companies for 25 years. We know from experience that manufacturers can get their products to market too quickly, skipping proper testing.
Our firm works with attorneys across the country to represent people over companies, helping victims get compensated. These corporations have teams of lawyers protecting their interests, so patients injured by their devices need to have experienced and aggressive legal representation with the means to go against powerful companies.
Call 855-566-3752 or contact us online today to talk with our representatives about your Atrium Hernia Mesh Lawsuit. We do not charge for initial consultations. If there is no recovery, you owe no legal fees. We’re here to help you!