Atrium C-Qur Injuries
Atrium C-Qur™ Hernia Mesh Side Effects Lawsuit
If you or someone you know was injured by Atrium C-Qur™Hernia Mesh, then you might be entitled to compensation. Atrium's C-Qur™ mesh is used for hernia repair and chest wall reconstruction. It is also used in traumatic or surgical wounds, and other surgical situations requiring a reinforcing, non-absorbable material. However, the U.S. Food and Drug Administration (FDA) has received a number of serious injuries linked to the Atrium C-Qur™ mesh. The agency has also cited Atrium Medical Corporation for poor manufacturing practices.
Atrium C-Qur™Hernia Mesh Injuries
When it was first approved in 2006, this device was marketed as an innovative method for hernia repair. More recently, however, the Atrium C-Qur™ Mesh has been linked to serious injuries, including:
- Mesh erosion (mesh moves through body tissues)
- Pain, infection, bleeding
- Sepsis (life-threatening complication of infection that leads to inflammation throughout the whole body)
- Organ Perforation
- Mesh Migration and Adhesion
- Neuromuscular problems
- Scarring/shrinkage caused by mesh contraction
- Revision surgery and ongoing illness
- Emotional distress
- Decreased quality of life
The C-Qur™ was approved through 510(k), meaning that it was not clinically tested before being released onto the market. The 510(k) review process allows devices to be sold and used without testing, as long as manufacturers can argue that it is similar enough, or "substantially equivalent" to a previously approved device.
FDA Warning Letter
In a warning letter dated October 11, 2012 the FDA said that four of Atrium's medical devices, including the C-Qur™, were adulterated because of poor manufacturing practices. The other devices were the V12 and iCast Covered Stents, and Express Pre-Filled Chest Drains. Based on an inspection made between July 21st and September 7th 2012, the agency cited the company for a number of concerning findings.
The FDA letter cited Atrium for "Failure to review, evaluate and investigate any complaint involving the possible failure of a device, labeling or packaging to meet any of its specification." For instance, the FDA said that the company failed to follow-up on four complaints of infection associated with the C-Qur™ mesh. Sample culture results were pending for these complaints, but all four were closed without any further investigation. The agency also took issue with the Atrium’s procedure for reviewing complaints. For example, 6 out of 14 C-Qur™ mesh infection complaints had no lot number and documents show no effort to obtain this information. All 6 were closed without further investigation, the FDA stated.
The FDA said, among other things, that Atrium had failed to provide proof of a sterile environment for the devices. Specifically, the letter stated that Atrium failed to "adequately validate" the process used to sterilize all 39 devices.
FDA investigators also noted 35 instances where human hair was found in what was supposed to be sterile medical devices. Atrium failed to investigate this through a Corrective and Preventative Action process. "The presence of foreign material in sterile packaging constitutes a significant concern." the letter stated. In August 14, 2012 an FDA investigator saw Atrium employees working in the facility with hair exposed.
Atrium C-Qur™Hernia Mesh Injury Lawsuits
Atrium is facing litigation over injuries related to its C-Qur™ mesh. One such lawsuit was filed on March 15, 2013 in the U.S. District Court for the District of Massachusetts. The woman suing Atrium had the mesh inserted into her body on July 24, 2008 to repair a ventral hernia. Following her surgery, she suffered from a variety of complications that nearly took her life, allegedly due to the mesh. After the mesh was first implanted, she had difficulty breathing and developed a fever of 102 degrees. The patient alleges she was in such pain that even morphine did not help. About a week after her hernia mesh operation, her doctor discovered that she had an infection and needed an immediate life-saving surgery. The doctor removed three sections of the Plaintiff’s small intestines during the surgery. She also learned that she had flat-lined six times during the second operation. Afterwards, she had multiple infections that led to her being placed in isolation. She came out of the second surgery on full life support.
The mesh patient underwent a third surgery on August 8, 2008, after which she ripped her incision due to restlessness. The wound was left open since there was not enough skin to close it, and she was placed in a medical coma until September 4, 2008. After spending eight weeks in the hospital, whe went to rehabilitation to learn how to walk, stand and use her hands again. Eventually, she was able to transition from a wheelchair to a walker. During her time at rehab, she suffered a bladder infection and developed a new hernia. A final surgery was performed on March 11, 2009 to repair the two hernias created during the previous surgery and to close the hole left open in her abdomen. In May 2009, the Plaintiff’s doctor said that the C-Qur™ mesh had a metal piece that detached and cut through her small intestines. brain damage because of the numerous times she flat-lined during her second surgery.
Legal Help for Victims of Atrium C-Qur™ Hernia Mesh Injuries
If you or someone you know was injured by the Atrium C-Qur™ Hernia Mesh, you may have valuable legal rights. For more information, please fill out our online form to the right or call 1(800) YOURLAWYER (1-800-968-7529).