A woman recently filed a lawsuit against Atrium Medical, the manufacturers of the Atrium C-Qur hernia mesh, alleging severe pain and injury after the mesh was used during an open repair of her ventral (abdominal) hernia in 2011.
According to the plaintiff, she began to experience severe abdominal pain as well as a recurrence (return) of the hernia. At the time of the removal of the Atrium C-Qur (pronounced “secure”) mesh, doctors found that the hernia mesh had lodged up inside the woman’s body and they were unable to implant a new mesh due to significant scar tissue.
What is Hernia Surgical Mesh?
Surgical mesh is a medical device made to provide support for tissue and organs that have been damaged or weakened. Mesh is designed to reinforce a hernia repair or strengthen abdominal wall tissue. Unfortunately, there has been an increase in surgical mesh lawsuits due to allegations that the various meshes do not work as they were intended and are associated with serious complications.
Atrium C-Qur Hernia Mesh Issues
The Atrium C-Qur hernia mesh was available for hernia repair surgery in 2006 and has been used nationwide during hernia repair procedures for the last ten years. The C-Qur hernia mesh contains a fish oil coating. The polypropylene mesh (plastic) has a fish oil based Omega-3 gel coating, and was designed as an anti-adhesion barrier. Adhesions are a post-surgical complication where the tissues and organs stick to each other due to the presence of scar tissue.
Plaintiffs in C-Qur lawsuits allege that the device is defective and presents a risk of infection, rejection, organ perforation, inflammation, chronic pain, additional surgery, rash, neurological changes, dental problems, bowel obstruction, and abnormal liver function.
The allegedly defective hernia mesh devices are the Atrium C-Qur mesh, C-Qur TacShield, and C-Qur V-Patch.
The national law firm Parker Waichman LLP has extensive experience in medical device lawsuits and is closely monitoring the Atrium C-Qur hernia mesh litigation.
Atrium C-Qur Lawsuits
The C-Qur multidistrict litigation (MDL) was established in December 2016. There were 21 lawsuits transferred into the MDL as of January 17, 2017, according to court records. An MDL is a process where similar lawsuits are gathered together in one court to make the legal process more efficient. By consolidating lawsuits with similar complaints to one court before one judge, MDLs eliminate duplicate discovery and streamline legal proceedings with the goal of faster resolution.
The U.S. Judicial Panel on Multidistrict Litigation (JPMDL) consolidated all Atrium C-Qur hernia mesh lawsuits pending in the federal court system, centralizing the claims in the District of New Hampshire under Judge Lanya McCafferty.
It is alleged that Atrium Medical neglected to warn patients and physicians about the risks associated with the C-Qur hernia mesh.
The C-Qur was approved by the U.S. Food and Drug Administration (FDA) fast-track review process known as 510(k). Manufacturers are only required to prove “substantial equivalence” to a device already approved by the FDA and means that the new product is at least as safe as the older device. This eliminates the requirement for rigorous clinical testing and allows the new product to come to market faster.
A plaintiff from Ohio alleged she developed severe and painful complications following a hernia repair where Atrium C-Qur mesh was used. The plaintiff claimed the hernia mesh became stuck to her small bowels and caused an obstruction. The woman filed a personal injury and product liability complaint in November 2016 in the U.S. District court for the Northern District of Ohio.
The plaintiff reported her surgeons implanted a piece of Atrium C-Qur TacShield which is also made from polypropylene mesh and has a unique fish oil Omega-3 coating that is not used in any other American hernia repair products. The plaintiff was diagnosed with an incarcerated hernia some two years later and required repair surgery and a five-day hospital stay.
JAMA (Journal of the American Medical Association) published a study in October 2016 of a finding that the benefits of hernia mesh are partially offset by the risks. Study authors commented that hernia mesh was approved through 510(k) remarking on the lack of clinical trial data. The authors wrote, “The complete spectrum for the risks and benefits of mesh used to reinforce hernia repair is not known because there are very few clinical trial data reporting hernia outcomes as they pertain to mesh utilization. This highlights the need for more long-term studies of mesh repair using high-quality registries such as the one in Denmark.”
Legal Advice and Information Regarding Mesh Implants
If you or someone you know suffered injuries associated with a hernia repair mesh implant, you may have valuable legal rights. Parker Waichman LLP offers free, no-obligation case evaluations. We urge you to contact our personal injury attorneys at 1-800-YOURLAWYER (1-800-968-7529).