Atrium C-Qur Mesh Lawsuits Allege Fish Oil Coating Caused Adhesion
According to court records, a number of C-Qur lawsuits allege injuries from the omega-3 fatty acid coating designed to be an anti-inflammatory “adhesion barrier”. The coating is placed to prevent organs from adhering to one another as the patient heals. One recent lawsuit was filed on Oct. 31 in the U.S. District Court for the Northern District of Georgia. The plaintiff is a Georgia woman who was implanted with the C-Qur hernia mesh in 2008. According to the complaint, her hernia returned and doctors placed another C-Qur patch. The plaintiff suffered from chronic pain, nausea, vomiting, infections and other problems, allegedly due to the mesh. Her lawsuit states that in 2014 and 2015, the mesh had “bunched up in layers” or “folded up”, leading to pain and other complications.
Parker Waichman LLP is closely monitoring the Atrium C-Qur hernia mesh litigation. The firm continues to offer free legal consultations to individuals with questions about filing a hernia mesh lawsuit.
Lawsuits allege that Atrium failed to warn patients or the medical community about the risks of the C-Qur hernia mesh.
In February, the journal BMC Surgery published a case report of a 61-year-old woman who was implanted with a fish oil coated hernia mesh. Three months later, she complained of dyspepsia (discomfort in the upper abdomen or chest) and pain. Ten months after the procedure, her symptoms were worse. Doctors noted a hard mass, which turned out to be “dense adhesive disease around the mesh”. Authors noted a lack of studies on this issue and called for more research.
In addition to the C-Qur, Atrium is facing hernia mesh lawsuits over the C-QUR TacShield, and the C-QUR V-Patch.
C-Qur Hernia Mesh Plaintiffs File Motion for MDL
Plaintiffs filed a motion to consolidate hernia mesh lawsuits into a federal multidistrict litigation in the U.S. District Court, District of New Hampshire. The motion, which was filed Oct. 10, seeks to centralize C-Qur lawsuits to one court in order to streamline legal proceedings. The goal of an MDL is to make complex litigation more efficient and eliminate duplicate discovery. The U.S. Judicial Panel on Multidistrict Litigation (JPML) was scheduled to hear Oral Arguments regarding consolidation on Dec. 1 in Charlotte, North Carolina.
Court records show that at least 15 lawsuits have been filed against Atrium Medical alleging injuries from the C-Qur hernia mesh. Plaintiffs allege that the hernia mesh can cause injuries such as infection, rejection, organ perforation, inflammation, chronic pain, additional surgery, rash, neurological changes, dental problems, bowel obstruction and abnormal liver function.
Lawsuits state that the hernia mesh was not tested for safety or efficacy before it was approved. Plaintiffs point out that the C-Qur was approved through 510(k), which circumvents the need for clinical testing if manufacturers prove that the devices are “substantially equivalent” to a previously approved product (called a predicate). Devices can be approved through 510(k) even if the predicate had safety issues of its own. Several controversial medical devices, including metal-on-metal hip implants and transvaginal mesh devices, were cleared through 510(k). This has caused the route to come under criticism for certain medical devices.
Atrium Medical C-Qur Recall, FDA Warning Letter
Atrium Medical received a warning letter from the U.S. Food and Drug Administration (FDA) in 2012 involving violations at its facility. Regulators said Atrium products, including the C-Qur, were considered adulterated due to manufacturing violations. The agency said Atrium failed to test whether its new manufacturing and sterilization processes were effective, for instance. The FDA also criticized the company for failing to address issues and complaints. For example, FDA said the company did not implement corrective actions regarding reports of human hair and other foreign materials in the sterile mesh.
The Atrium C-Qur Edge mesh was recalled in 2013 because the coating on the mesh could stick to the inner lining of the handling sleeve when exposed to humidity. “The notification identifies the problem, product, and risk factors. If the Product is exposed to excessive humidity for an extended period of time, then the increased humidity occurring inside the pouch can potentially cause the coating on the mesh to strongly adhere to the inner handling sleeve.” the recall letter states. The devices were recalled; however, the products were not removed from the market. Atrium addressed the issue by sending a letter to physicians.
The FDA designated the recall as Class 2, indicating a situation where exposure to a recalled product can cause temporary or medically reversible adverse events or the probability of serious adverse events is remote.
Other Hernia Mesh Recalls and Litigation
Parker Waichman comments that Ethicon is also facing litigation regarding its hernia mesh products, specifically the Physiomesh Flexible Composite Mesh. The device is used for minimally invasive abdominal and groin hernia repair. Ethicon recalled the Physiomesh because data from two large hernia registries showed a higher rate of recurrence and reoperation compared to other mesh devices.
“Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors” Ethicon said in its Urgent Field Safety Notice. “Consequently, Ethicon [has] not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and [has] decided to recall Ethicon Physiomesh composite mesh from the global market,”
Physiomesh lawsuits have been filed alleging the device caused injury. Ethicon is accused of failing to disclose the risks. According to court documents, a Physiomesh lawsuit filed in Illinois is slated for trial on Jan. 22, 2018. Another lawsuit was filed over the hernia mesh device in Florida on Sept. 22.
Filing a Hernia Mesh Lawsuit
If you or someone you know suffered injuries related to the use of a hernia mesh product, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).