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C-QUR Hernia Mesh

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Surgeons use Atrium C-QUR hernia mesh to repair hernias, weak spots or tears in the abdominal muscle wall where organs or tissue can poke through. C-QUR surgical mesh is coated with Omega 3 fatty acids from fish oil and is supposed to prevent inflammation and scarring from tissues adhering to the mesh. But studies show it has higher adhesion and infection rates than many other hernia mesh brands.

C-QUR hernia mesh is a surgical mesh made of polypropylene plastic and coated in an Omega 3 fatty acid (O3FA) fish-oil coating. Atrium Medical Corporation, now a part of the Maquet Getinge Group, manufactures C-QUR mesh products.

The FDA originally cleared the Atrium C-QUR mesh through the 510(k) process in 2006. This process does not require clinical trials or detailed case studies to prove safety or effectiveness. These meshes are intended to be permanent implants.

The C-QUR mesh is a tissue designed to repair hernias — a condition that occurs when an internal organ or tissue bulges through a weak area of muscle. Surgeons may also use the mesh for chest wall reconstruction, reinforcing fascia — a thin sheet of fibrous tissue enclosing muscle or organs — and traumatic and surgical wounds.

This type of mesh is called a tissue-separating mesh because it is coated with a bioabsorbable film that is meant to keep mesh from touching internal organs and prevent mesh adhesions (scarring). In its marketing materials, Atrium claims the O3FA coating “has been shown to minimize tissue attachment to mesh.”

However, a number of case studies link the C-QUR hernia mesh to several side effects and complications including  chronic infection, pain and bowel adhesion that require more surgery for mesh removal.

Have you experienced serious complications from a hernia mesh device or related surgery?

C-Qur Hernia Mesh Surgery

Surgeons can use Atrium’s C-QUR surgical mesh products to treat all types of hernias. But, Atrium intended C-QUR for surgical repair of inguinal hernias in a procedure called intraperitoneal onlay mesh technique (IPOM). In this technique, doctors place the mesh in the abdomen inside the peritoneum — the thin sheath of tissue covering the abdominal organs. The piece of mesh overlaps the hernia weak spot and patches it. Surgeons then suture the mesh into place.

This means the mesh has direct contact with internal organs. In theory, the C-QUR O3FA coating prevents the mesh from creating scar tissue and inflammation when it touches internal organs.

The IPOM technique began in the 1990s and grew in popularity because it was much easier and faster to perform, despite higher complication rates. After the introduction of this surgical technique, more companies developed coated hernia meshes.

Atrium C-QUR Mesh Brands

After the original C-QUR mesh hit the market in 2006, Atrium produced a number of other product variations from 2008 to 2015. All these brands are still available on the market.

  • C-QUR Lite Mesh V-Patch – April 2008, for pre-peritoneal repair
  • C-QUR Edge Mesh V-Patch – April 2008, for intra-abdominal placement
  • C-QUR V-Patch Mesh – June 2009, for small hernia defects
  • C-QUR OVT Mesh – January 2010, for open ventral/incisional hernia repair
  • C-QUR RPM Mesh – April 2012, mesh with reduced coating for open and laparoscopic repair (later changed to Mosaic)
  • C-QUR Mosaic – October 2015, for open and laparoscopic repair
  • C-QUR FX – October 2015, mesh without tissue separating layer for open and laparoscopic repair
  • C-QUR TacShield – October 2015, for fixation guidance with large ventral hernias
  • C-QUR CentriFX – October 2015, for laparoscopic inguinal hernia repair

C-QUR Mesh Complications

Hernia surgery, just like any other surgery, has its share of complications. Surgery with hernia mesh, including C-QUR, has additional complications.

The most common complications include:

  • Pain
  • Chronic infection
  • Scar tissue that causes tissues and organs to stick together (adhesions)
  • Blockage of small or large intestine
  • Bleeding
  • Fistulas, abnormal connections between organs, vessels of tissues
  • Seroma, fluid buildup at the site
  • Perforation of organs
  • Mesh migration
  • Mesh shrinkage
  • Skin rash

In animal studies, researchers found the infection rate was higher with C-QUR mesh than with other meshes. One animal died less than two weeks after implantation because of bowel obstruction caused by mesh adhesions.

In order for mesh to be stable, tissue has to grow into it. Studies also show the coating interferes with tissue ingrowth into the mesh.

FDA Recalls

On August 9, 2013, the FDA announced a Class II recall of more than 95,000 units of C-QUR V Patch Meshes and 1,501 units of C-QUR Edge Mesh. The recalls ended on March 18, 2016. Atrium Medical Corporation recalled the mesh because humidity could cause the O2FA coating to stick to the bag.

Clinical Studies

There are a handful of studies that question the safety and effectiveness of Atrium C-QUR hernia mesh.

The most recent case study published in February 2016 by C.Y. Kong and colleagues related the case of a 61-year-old woman implanted with C-QUR mesh for an incisional hernia. After 10 months, she complained of pain and upper abdomen discomfort. During surgery, study authors found thick, oozing adhesions around the mesh. Doctors removed the mesh and part of her stomach. They determined the mesh and fish-oil coating created an inflammatory response and caused the adhesions.

One of the first studies on C-QUR mesh by Dr. M.H. Schreinemacher and colleagues appeared in a 2009 issue of the British Journal of Surgery.  Authors found after 30 days, there was a significant increase in adhesions and immune response around the mesh implants.

C-QUR Mesh Lawsuits

A number of patients who say they suffered serious complications because of C-QUR mesh filed lawsuits against Atrium and the Maquet Getinge Group. Lawsuits claim the mesh caused serious injuries such as such as chronic infections, nerve damage and fluid buildup in the abdomen that required additional surgery to remove the mesh.

Plaintiffs allege that Atrium’s C-QUR mesh is unreasonably dangerous and defective, according to court filings. They also claim the mesh makers failed to warn them about the risks.

Terry and Gary McLain filed a hernia mesh lawsuit in 2016 against Atrium and Maquet Getinge Group after Terry had surgery with C-QUR mesh in 2011. In 2013, McLain experienced abdominal pain and recurrence of her incisional hernia, according to court documents.

After two years, the surgery site was still open and draining. Doctors diagnosed McLain with mesh rejection and had to have the mesh removed. The surgeon believed the fish oil in the C-QUR design caused the need for revision surgery.