Atrium Medical C-Qur Hernia Mesh Lawsuits Moving Forward

//Atrium Medical C-Qur Hernia Mesh Lawsuits Moving Forward

Atrium Medical C-Qur Hernia Mesh Lawsuits Moving Forward

atrium buildingMesh Medical Device News Desk, July 10, 2016 ~ This article is Sponsored Content written by Brett Vaughn, RN, BSN, and JD of the Hollis Law firm, of Overland Park, Kansas, about Atrium Medical Hernia Mesh and specifically its C-Qur hernia mesh.  

As many of you readers know, unlike transvaginal mesh, there are few law firms in the US that are willing to take on hernia mesh cases and with one million hernia surgeries a year, there are many patients experiencing complications who are looking answers.  

If you have hernia mesh and are experiencing complications, please obtain your medical records so you can manage your health care and complications.  

 

by Brett Vaughn, ~ Mesh Medical Device News Desk reports among all of the different mesh manufacturers,  there is a growing number of lawsuits filed against Atrium Medical Corporation. The lawsuits allege severe personal injuries resulting from the failure of the Atrium C-Qur hernia mesh.

Lawsuits against Atrium and their C-Qur hernia mesh are currently pending in federal courts in Texas, Florida and New Hampshire, with more lawsuits likely to be filed in the near future.

Atrium C-Qur mesh from website

Atrium C-Qur mesh from website

 

C-Qur shapes

C-Qur shapes

These suits open another chapter for Atrium Medical, operating out of Hudson, New Hampshire, with its parent company, Maquet, based in Germany.

What’s emerging is a long, tangled story of legal and regulatory problems surrounding the C-Qur line of hernia mesh products.

The C-Qur hernia mesh gained FDA approval through the FDA 510(k) program in 2006, which allowed Atrium to skip thorough pre-market studies. In order to gain 510(k) approval, Atrium had to prove that its mesh was substantially similar to a previously approved mesh.

Just like most transvaginal meshes, Atrium’s C-Qur hernia mesh is made from polypropylene, the polymer plastic that’s known to shrink, cause a foreign body reaction, become infected and erode.

Atrium’s hernia mesh began being implanted at a much higher rate nationwide after Atrium signed a three-year national contract with Premier Inc. in 2010.  Premier is a group purchasing organization (GPO), which supplies over one-thousand hospitals. GPOs are the only type of company in which kickbacks are actually legal.

Legislation was passed a few decades ago with the intent of allowing smaller hospitals to join together in order to increase their purchasing power, thus driving down prices (similar to how insurance works). It has evolved into companies like Premier.

The agreement was for Atrium to provide its hernia mesh in bulk at cheap prices. Premier would then supply its member hospitals with Atrium’s hernia mesh. The member hospitals would typically have to agree to only use Atrium’s hernia mesh. After Atrium was one year into its contract with Premier, Maquet Cardiovascular bought Atrium for over one-half billion dollars.

C-Qur hernia mesh

C-Qur hernia mesh

Shortly after Atrium was acquired by Maquet, the FDA issued a warning letter to Atrium Medical in 2012. The warning letter noted that the manufacturing and sterilization process for the C-Qur hernia mesh was altered without proper test being conducted. The FDA also cited multiple instances of C-Qur hernia mesh infections that the company failed to investigate and report.

The most disturbing revelation was that the FDA found numerous instances of human hair being embedded into Atrium’s sterile medical devices.

In 2013, Atrium issued a class II recall on the C-Qur mesh. Even though there was a recall, none of Atrium’s hernia mesh products were actually pulled from the market. Atrium simply wrote a letter notifying doctors to be aware that the mesh’s coating could stick to the packaging and peel off the mesh itself. The purpose of the the coating is to prevent the polypropylene portion of the mesh from coming into direct contact with a patient’s organs.

Unfortunately, physicians have reported to the FDA experiences of the coating peeling off upon implantation or within days after implantation

Several studies have investigated the complications associated with Atrium’s C-Qur hernia mesh. A study conducted in Belgium had to be stopped early because of an unacceptably high rate of C-Qur hernia mesh infections.

A separate study also experienced infections in nearly every C-Qur hernia mesh that was implanted.

C. Brett Vaughn, Hollis Law

C. Brett Vaughn, Hollis Law

Recently, the FDA sued Atrium and Maquet for introducing adulterated medical devices into interstate commerce.

The FDA was granted a permanent injunction against the facility that manufacturers the C-Qur hernia mesh. Atrium’s hernia mesh was not pulled off the market though.

Many providers have discontinued using the C-Qur hernia mesh; however, it is still being implanted at some hospitals.

Injuries related to Atrium’s hernia mesh can take years to manifest. These injuries include infection, bowel perforation, bowel resection, additional surgeries, severe pain, rejection of the mesh and abdominal rashes. 

Mesh Medical Device News Desk will continue to follow this story and provide updates as this litigation progresses. There is also additional information about the Atrium C-Qur hernia mesh available at the Hollis Law Firm. #

 

By | 2016-07-10T21:03:49+00:00 July 10th, 2016|Legal News|17 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.

17 Comments

  1. Raymond Gore July 14, 2016 at 6:50 am - Reply

    Hernia mesh

  2. Jennifer Dowell July 30, 2016 at 4:47 pm - Reply

    It states Atrium sent letters to hospital and doctors? Well I checked with my hospital and they never received a letter of recall and she went back to 2008, the head of nursing there said she was going to talk to the doctor that did my surgery and ask him about this, because they have a lot of Atriums products…hmmm, so how many more have been implanted? This crap isn’t right!

    • James Carlton August 5, 2016 at 2:43 am - Reply

      The article is not entirely correct, there was never a recall letter needed. What was sent was a ‘field safety notice’, which is something different; every hospital received it as and they had to confirm it back to the company.
      This was the letter that was sent:
      https://www.swissmedic.ch/recalllists_dl/08335/Vk_20130904_20-e1.pdf

      • jen August 15, 2016 at 5:47 pm - Reply

        So every hospital they sold to would have a field safety document on file at these hospitals correct? What about the doctors would they have one also? I will be checking on this

      • C. Brett Vaughn August 16, 2016 at 8:33 am - Reply

        James, a recall letter was needed. Your are correct that a “field safety notice” was allegedly sent to every facility. I’m not sure where you got the information that every hospital received it, but you are in error. Manufacturing processes were then changed and the C-Qur Edge was discontinued. This constitutes a recall per FDA standards and the public is to be notified.

  3. JoAnn September 15, 2017 at 3:52 pm - Reply

    I have had many problems with c qur mesh since 2009. I’ve lost most of my teeth, brittle and break. Ive had a ruptured viscus and perferated ulcer in2010. Chronic infections in my internal organs and sepsis 2016.

    • Jane Akre September 15, 2017 at 5:52 pm - Reply

      I certainly hope you have a lawyer JoAnn because it is one being litigated.!

      • JoAnn September 17, 2017 at 2:21 pm - Reply

        I do have a lawyer I hope they ha.ndle C Qur mesh. I know they handle J°]&J phisomesh.

        • Jane Akre September 17, 2017 at 9:28 pm - Reply

          Those are the two meshes that ARE being litigated. Please be careful and go with a big reputable firm that will fight for you.

    • Patty September 16, 2017 at 9:50 pm - Reply

      Joann- don’t give up! I know what you are going through, I nursed my husband back from the brink of death, 3 times. Keep fighting with all you have. Get a good lawyer. Reply to me on here if you want the name of the lawfirm. I know of one several people who, like us, lost everything, and one who lost his life due to the complications , his wife divorced him before he died and so he died alone. Just fight the good fight and know you are not alone.

  4. JoAnn September 15, 2017 at 3:53 pm - Reply

    This c qur mesh needs to be recalled by the fda..

  5. Patty September 16, 2017 at 9:45 pm - Reply

    My husband had his implanted in 2011, and taken out 30 days later due to its omega 3 fish oil coming off and tye mesh hardened, way before any lawyer would touch a lawsuit on the CQUR . We found a lawyer FINALLY in 2012 that took the case. The mesh was replaced by an ethicon physio mesh which almost killed him. Just received notice that lawyer is suing them too. It’s been 5 years and still waiting in court. Most people give up, but we have stuck with it. These meshes ruin lives. The aftermath can destroy marriages. Cause monatary losses in the hundreds of thousands ( we lost home, business, everything we owned. But , I stuck with the one I married in sickness and in health. My opinion- don’t give up or give in, that’s what these crooks want. Get a good lawyer who cares. And over all, pray.

  6. Carie October 4, 2017 at 9:51 pm - Reply

    I had a hernia repair in 2011 I was implanted with c-qur v-patch. About 2 weeks after surgery my feet began to swell and got cellulitis for the first time my feet swell so bad I can’t put shoes on. Since then I have been plaged with bouts of pneumonia where I had to have bigger doses of antibiotics than normal. Migraines, extreme abdominal pain, fibromyalgia, reoccuring cellulitis, rotting teeth, high liver enzymes, and much more. For the past 6 years my family and I have been racking our brains trying to figure out why I’m getting sick. Went back to surgeon complaining of pain in same area n it turns out that I have 3 more hernias in the same place as my mesh. I’m suppose to have another surgery next Friday. Scared is an understatement!

    • Jane Akre October 4, 2017 at 11:25 pm - Reply

      Carrie, please reconsider another mesh repair until you determine whats happening with your body….

      • Carie October 5, 2017 at 8:17 pm - Reply

        They are suppose to be 3 small hernias. I asked what mesh he would be using he said he won’t know for sure until he gets in there. I’m hoping if they are small maybe he can just stitch them up like they use to. I won’t let them put any c-qur meshes in me I will walk out! Going to talk to my lawyers and see what they think and what my rights are as a patient. Plus I need to know for sure if he is repairing in the same spot.

        • Jane Akre October 5, 2017 at 11:48 pm - Reply

          Carie- Is your doctor able to do a non mesh repair? Does he ever do them? some have not been trained that way. If you haven’t had mesh before Shouldice Clinic in Toronto probably offers a cheaper repair, definitely no mesh. When Ralph Nader needed a hernia repair, he did his homework and chose Shouldice. Ralph is a pretty smart guy!!!!

  7. D Marie November 14, 2017 at 6:12 pm - Reply

    Shouldice Clinic in Toronto is by far the BEST place in the world to have a hernia repaired because it is ALL they DO EVERYDAY. They have seen it all! They have the lowest complication rate and definitely know what they are doing. They do not do any other surgeries– just hernias. Be smart and refuse to go anywhere else. Hernias are difficult and complicated. Why risk it? Unless your doc does hernias all day everyday, he/she is likely to make a mistake and the cost to you and your family will be too great. If I can’t go to Shouldice, I won’t get surgery.

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