Atrium Hernia Mesh Litigation, FDA Injunction

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Public Health Watchdog Breaking News
Public Health Watchdog Breaking News

Atrium C-Qur Hernia Mesh Multidistrict Litigation (MDL), Lawsuits

The Atrium C-Qur hernia mesh was introduced for hernia repair surgery in 2006 and has been used during hernia repair procedures nationwide over the past decade. The polypropylene mesh has a fish oil based Omega-3 gel coating designed to minimize scar tissue formation while promoting fixation of the mesh to the abdominal wall. According to patients the fish oil coating leads to serious complications due to an inflammatory response that causes bowel adhesion, blocks proper abdominal wall fixation, and leads to other serious health issues.

In one case, a woman from Arkansas filed a lawsuit in the U.S. District Court for the Western District of Arkansas, over allegations of severe pain and injury following implantation with Atrium C-Qur mesh during an open repair of her ventral (abdominal) hernia in 2011. According to the woman, she allegedly developed severe abdominal pain and hernia recurrence. During removal of the Atrium C-Qur mesh, the woman’s surgeons discovered that the mesh lodged inside of her body and was unable to be replaced with new mesh given significant scar tissue.

In another case, a woman from Ohio alleged to have developed severe and painful complications following a hernia repair with Atrium C-Qur mesh. The woman alleged the mesh became attached to her small bowels, causing an obstruction. She filed her personal injury and product liability complaint in the U.S. District Court for the Northern District of Ohio in November and alleged that she was implanted with an 11.4 x 11.4 cm piece of Atrium C-Qur Tacshield, which is made from polypropylene mesh and constructed with a unique fish oil Omega 3 gel coating not used in any other American hernia repair products. The woman required repair surgery two years later and had to stay in the hospital for five days.

A motion was filed on October 11, 2016 seeking to create a federal docket for all C-Qur hernia mesh lawsuits filed nationwide for consolidation in the District of New Hampshire. At that time, 13 C-Qur lawsuits were pending in federal courts; six were filed in the District of New Hampshire and the first C-Qur lawsuit filed in federal court was assigned to Judge Landya Boyer McCafferty in the United States District of New Hampshire. The multidistrict (MDL) hearing for the C-Qur hernia mesh occurred on December 1, 2016. Judge McCafferty was appointed to preside over the C-Qur MDL on December 8, 2016. The MDL is currently comprised of 24 lawsuits.

A number of surgeons and hospitals have stopped implanting the C-Qur hernia mesh over a variety of adverse events, which have been alleged in the litigation and include, in part:

  • Abnormal liver function test results.
  • Additional surgeries to remove the C-Qur mesh.
  • Allergic reactions to the fish oil coating on the device.
  • Bowel Obstruction involving dense adhesions connecting the mesh to the bowel.
  • Chronic Pain described as intense once the mesh is implanted, remaining until explanted.
  • Dental problems, including complete tooth loss.
  • Infections that may remain dormant for months.
  • Neurological changes that include poor memory and concentration.
  • Organ perforation in which a hole may form in an organ, such as the intestines, when in contact with parts of the C-Qur mesh.
  • Rash covering the abdomen and other parts of the body that disappears when the C-Qur mesh removed.
  • Rejection at abnormally high rates, including foreign body responses, including inflammation and encapsulation of the mesh with scar tissue.

Surgeons use a variety of Atrium C-Qur mesh devices for various abdominal procedures. The litigation involves all types of Atrium C-Qur hernia mesh, including:

  • C-Qur: Original Omega 3 fatty acid hernia mesh for open and laparoscopic hernia repair.
  • C-Qur Edge: The only C-Qur hernia mesh to be recalled.
  • C-Qur V-Patch: Small hernia repair such as umbilical, epigastric, and trocar site defects.
  • C-Qur Tacshield: Repair of medium to large open ventral hernia repairs.
  • C-Qur FX: Open and laparoscopic hernia repair.
  • C-Qur CentriFX: See-thru clarity mesh for lateral and medial hernia defects.
  • C-Qur Mosaic: See-thru clarity mesh for open and laparoscopic hernia repair.
  • C-Qur Film: An adjunct in abdominal and pelvic surgery to minimize incidence, extent, and severity of post-operative adhesions.

The personal injury attorneys at Parker Waichman LLP have decades of experience representing clients in lawsuits over injuries allegedly caused by defective medical devices. The firm continues to offer free legal consultations to individuals with questions about filing a hernia mesh lawsuit.

Federal Regulators’ Activities Surrounding the Atrium’s C-Qur Hernia Mesh

The U.S. Food and Drug Administration (FDA) approved Atrium’s C-Qur hernia mesh in March 2006 using the agency’s 510(k) approval route, which enables medical device makers to bypass rigorous Pre-Market Approval (PMA) research and testing if they can be shown to be substantially similar to a previously approved device. The C-Qur polypropylene hernia mesh was found to be similar to a mesh approved in the 1990s; however, Atrium’s C-Qur hernia mesh is the first mesh to utilize an omega 3 fatty acid coating.

The C-Qur hernia mesh is also used for chest wall reconstruction and traumatic and surgical wounds. Atrium advertises the C-Qur as having an all-natural Omega 3 fatty acid (O3FA) gel coating. In actuality, a highly purified pharmaceutical grade fish oil consisting of a unique blend of triglycerides, O3FA, and an array of other substances coat the mesh. Atrium C-Qur hernia mesh lawsuits have alleged problems with the O3FA coating.

The FDA issued a warning to Atrium on October 11, 2012, indicating that Atrium neglected to sufficiently address various complaints associated with infections tied to its C-Qur hernia mesh and that Atrium appeared ignore various sterility complaints, including at least 35 separate complaints of human hair discovered in medical devices meant to be sterile. The FDA noted that Atrium added additional products to their sterilization load, including the C-Qur V-Patch, without gauging challenges the device may have presented to sterilization processes. The FDA also advised Atrium about how it modified the temperature during manufacturing of the C-Qur mesh. Atrium’s defense was that its manufacturing process burned the C-Qur hernia mesh, but never answered as to why Atrium’s C-Qur mesh began to burn during manufacturing.

On August 9, 2013, the FDA announced that an Atrium C-Qur Edge hernia mesh recall was deemed a Class 2 because the Omega 3 fatty acid coating on the mesh could adhere to the inner packaging liner due to exposure to high humidity. The recall impacted 1,501 C-Qur hernia mesh devices. Atrium warned physicians to inspect the C-Qur mesh to ensure the device was intact prior to implantation; however, Atrium did not pull any C-Qur mesh devices.

On February 3, 2015, the United States of America, on behalf of the FDA, filed USA v Atrium Medical Corporation in the U.S. District Court of New Hampshire. The FDA lawsuit alleged that Atrium introduced adulterated medical devices into interstate commerce, noting that Atrium’s methods of manufacturing, packing, storing, and installing the medical device did not conform with current good manufacturing practice requirements for medical devices.

On February 4, 2015, the FDA issued a permanent injunction, ceasing manufacture and distribution of the C-Qur hernia mesh at Atrium’s Hudson facility. The FDA Office of Compliance indicated that, “Patients must be assured that medical devices are safe, effective, and high quality.” Production will not be permitted to resume until the FDA finds Atrium in compliance. Unfortunately, the permanent FDA injunction does not stop hospitals from implanting C-Qur mesh that was previously purchased. In fact, many hospitals purchased the C-Qur hernia mesh in bulk at reduced prices and many hospitals still implant the C-Qur hernia mesh. The FDA injunction prevents the manufacture and sale of the C-Qur mesh; a recall designated a Class I recall will prevent hospitals from using old C-Qur mesh.

Hernia Mesh Lawsuit Questions?

If you or someone you know suffered injuries related to the use of hernia mesh implants, you may have valuable legal rights. Our hernia mesh lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).