What is C-Qur Mesh?
C-Qur Mesh (pronounced like “Secure”) is manufactured by Atrium Medical Corporation. It is used to repair hernias and other wounds including chest wall reconstruction, traumatic or surgical wounds, and other fascial surgical intervention procedures. Atrium C-Qur is a polypropylene mesh coated with what Atrium advertises as a “natural Omega gel coating,” a coating “derived from highly purified pharmaceutical grade fish oil consisting of a unique blend of triglycerides and Omega 3 fatty acids.”
C-Qur, C-Qur FX, C-Qur TacShield, C-Qur V-Patch, C-Qur CentriFX, and C-Qur Mosaic were all approved by the FDA in 2005 using the controversial 510(k) approval process, in which Atrium claimed C-Qur was “substantially similar” to mesh products already on the market. However, Atrium C-Qur Mesh was the first mesh product to utilize the Omega 3 fatty acid coating. 510(k) approval allowed Atrium to avoid doing pre-market research and studies to prove the product safe and effective before the devices were marketed.
Complications of C-Qur Hernia Mesh
On October 11, 2012 the FDA issued a Warning Letter to Atrium Medical Corporation following an inspection of their plant in Hudson, New Hampshire. The warning letter said Atrium had failed to validate their sterilization process for C-Qur mesh, and that it had failed to investigate and report multiple instances of C-Qur hernia mesh infections. On July 19, 2013 Atrium initiated a Class 2 recall on C-Qur Edge Mesh, notifying doctors that C-Qur mesh could stick to the packaging, which could peel the coating off the polypropylene.
Complications have been reported to the FDA including multiple reports of infections; that the coating on C-Qur mesh stuck to the packaging, resulting in the packaging sleeve going into the patient (removed before surgery completed); and also that the C-Qur mesh coating peeled off the polypropylene shortly after implantation and was found resting below the surgical site.
Some of the injuries which patients have experienced after implantation with C-Qur hernia mesh include:
- Chronic pain
- Internal injuries
- Mesh adhesion
- Mesh failure
- Allergic reactions
- Organ perforation
- Revision surgery
What can you do?
If you or a loved one has been injured after being implanted with C-Qur hernia mesh, you may have a claim for damages. Contact the defective medical device lawyers at Thornton Law Firm for a free, confidential evaluation of your legal rights at 1-888-341-1405. Or tell us your story here for a free and thorough evaluation of your legal rights.
Trust our Massachusetts defective drug attorneys to help
Contact Attorney Marilyn McGoldrick online or at 1-888-341-1405 for a free consultation with a recognized leader in Massachusetts defective drug and medical device litigation. You have nothing to risk. We offer a fair and accurate assessment of your case.