Atrium Medical C-Qur

Hernias occur when a section of muscle is weakened and a portion of an internal organ or other tissue is able to poke through a hole in that weakened muscle wall. They’re often caused by straining. While in many cases, hernias can heal on their own, sometimes they’re very large and need surgical intervention. Hernia mesh is supposed to help support the weakened muscle while it heals so that the hernia doesn’t return. C-Qur hernia mesh was supposed to help patients recover, but instead, many reported health complications, from severe pain and inflammation to organ perforation. Atrium, the manufacturer of C-Qur hernia mesh, was investigated numerous times by the FDA and was found to have violated federal regulations multiple times. The FDA even got an injunction from the courts against Atrium to temporarily suspend the production of C-Qur hernia mesh until the company could rectify those violations.

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What Is C-Qur Mesh?

C-Qur mesh is a polypropylene non-absorbable hernia mesh that is designed to repair hernias and soft tissue inside the body. The mesh, which was manufactured by Atrium, was coated in a layer of fish oil for its omega-3 fatty acids, which was intended to prevent tissue from adhering to the mesh.

Who Is Atrium?

Atrium Medical was acquired by Getinge, a Swedish medical device company that was founded in 1904. The acquisition occurred in 2011. Atrium produced a range of medical device technologies in particular to treat coronary diseases, vascular diseases, hernias, soft tissue injuries, chest trauma, and more. Getinge acquired Atrium because its medical products would complement Getinge’s existing available products and enhance their business, especially the innovation that they viewed to be at the core of Atrium’s product line.

What Is Hernia Mesh?

Hernia mesh is a surgical medical device that is used to treat hernias. Typically, it’s made of polypropylene, but can be made of other synthetic materials or even animal tissue from the intestines or skin of animals, usually a cow or a pig. Hernia mesh is an implantable mesh patch that doctors use to repair a hernia, supporting and reinforcing the hernia, and enabling it to heal. They can be absorbable or non-absorbable. Hernia mesh can also be coated, usually with a substance like fish oil that contains fatty acids that are supposed to prevent the tissue inside the body from adhering to the mesh.

What Is Absorbable Hernia Mesh?

Absorbable hernia mesh can be absorbed into the body. It’s designed to gradually degrade over time. This type of hernia mesh is designed to only provide temporary support for a hernia repair. The idea is that as the hernia mesh itself degrades, the tissue at the site of the hernia gradually becomes stronger so that the hernia mesh is needed less and less as the mesh degrades.

What Is Non-Absorbable Hernia Mesh?

Non-absorbable hernia mesh is a permanent addition to the body. It’s not meant to degrade over time and instead provides continued support to the location of the hernia. Non-absorbable hernia mesh is typically used to repair hernias that are more severe or require much more lasting support, such as if the hernia is a repeat in the same location.

What Is a Hernia?

A hernia occurs when a section of muscle weakens, allowing a portion of either tissue or an internal organ to poke through the weakened section. There are multiple different types of hernias, including:

  • Inguinal hernia
  • Incisional hernia
  • Hiatal hernia
  • Umbilical hernia
  • Congenital diaphragmatic hernia

Hernias are a very common medical condition and can affect anyone of all ages and genders. Some people are more at risk of getting hernias due to a genetic disposition, but they can occur because of strain from something like lifting heavy objects.

What Is an Inguinal Hernia?

An inguinal hernia is the most common type of hernia. It occurs when there is a weakened spot in the abdominal muscles through which tissue or even a part of the intestines can poke through the weakened spot. This type of hernia can be painful if you lift something heavy or if you bend over. Inguinal hernias aren’t typically dangerous but can become so if they don’t heal properly. In cases like these, surgery may be required to repair the hernia.

What Are the Symptoms of an Inguinal Hernia?

The symptoms of an inguinal hernia can include the following:

  • A bulge that is located in the pubic bone area
  • An aching feeling at the bulge
  • A burning feeling at the bulge
  • Discomfort or pain in the groin, especially when you:
    • Cough
    • Lift something
    • Bend over
  • A dragging feeling in the groin
  • A heavy feeling in the groin
  • Weakness in the groin
  • Pressure in the groin
  • Swelling or pain around the testicles if the intestines have descended into the scrotum

When Should You See a Doctor for an Inguinal Hernia?

You should see a doctor no matter what if you notice a bulge in your groin or abdominal area. However, it’s not an emergency unless you notice signs that the hernia has become strangulated.

When Is an Inguinal Hernia Dangerous?

An inguinal hernia can become dangerous if it becomes incarcerated. This means that the tissue that is bulging through the weakened muscle is trapped there and can’t be pushed back to where it belongs. When this occurs, the tissue can become strangulated, which means that blood can’t flow to it. Strangulated hernias can be dangerous.

What Are the Symptoms of a Strangulated Hernia?

If you notice any of the following symptoms of a strangulated hernia, it’s important to visit a doctor as quickly as possible:

  • Nausea
  • Vomiting
  • Nausea and vomiting together
  • Fever
  • A sudden pain that intensifies quickly
  • Difficulty passing gas
  • Inability to make a bowel movement
  • The bulge turns purple, red, or otherwise dark-colored

What Causes an Inguinal Hernia?

An inguinal hernia doesn’t always have an obvious cause. In some people, they occur for no discernible reason. However, sometimes inguinal hernias can be caused by:

  • Pregnancy
  • Strenuous activity
  • Chronic sneezing
  • Chronic coughing
  • Straining during bowel movements
  • Straining during urination
  • Increased abdominal pressure
  • An already existing weakened spot in the wall of the abdomen

What Can Increase the Risk of Developing an Inguinal Hernia?

The risk factors that can increase the chances of developing an inguinal hernia include the following:

  • Genetics
  • Having a chronic cough
  • Being a man
  • Being an older person
  • Being caucasian
  • Having chronic constipation
  • Being pregnant
  • Having had a previous inguinal hernia
  • Premature birth
  • Low birth weight

What Is an Incisional Hernia?

An incisional hernia is a hernia that occurs at the location of a surgical scar. If you have undergone surgery and the incision is still healing, then it’s possible to develop a hernia as tissue or an internal organ pushes through the location of the weakened muscle. Typically, surgery is required in order to return the protruding tissue to its normal position.

What Is a Hiatal Hernia?

A hiatal hernia happens when the upper part of the stomach protrudes through the diaphragm, which is the muscle that connects the abdomen to the chest. There is an opening in the diaphragm for the esophagus to pass through so that it can connect to the stomach. In a hiatal hernia, the stomach pushes through this opening, which is called the hiatus. In some cases, a hiatal hernia is often not serious if it’s small. Large hiatal hernias can result in acid reflux and heartburn because stomach acid is able to travel back up into the esophagus. Surgical intervention may be required to repair a very large hiatal hernia.

What Are the Symptoms of a Hiatal Hernia?

Smaller hiatal hernias may not have any symptoms, but larger hernias can present the following symptoms:

  • Shortness of breath
  • Heartburn
  • Trouble swallowing
  • Chest pain
  • Abdominal pain
  • Acid reflux
  • Vomiting blood
  • Black stools
  • Regurgitating liquids or food back into the mouth
  • A full feeling soon after eating

What Can Cause a Hiatal Hernia?

A hiatal hernia happens when the upper part of the stomach protrudes through a weakened portion of the diaphragm. Why this occurs isn’t always known, but the possible causes can include the following:

  • Injury
  • Trauma from surgery
  • Having a large hiatus
  • Changes in the diaphragm caused by age
  • Pressure on the diaphragm and surrounding muscles, often caused by:
    • Exercising
    • Lifting a heavy weight
    • Straining
    • Vomiting
    • Coughing

What Can Increase the Risk of a Hiatal Hernia?

People who are older than the age of 50 or who are obese are at greater risk of developing a hiatal hernia.

What Is an Umbilical Hernia?

An umbilical hernia occurs at the abdominal muscles that are located near the navel and is when a portion of the intestines bulges through a weakened portion of that part of the abdomen. Umbilical hernias can occur in both adults and infants, but they more commonly occur in infants. You can see that an infant has an umbilical hernia because there’s a protrusion at the baby’s belly button whenever they cry. In children, umbilical hernias often heal on their own. In adults, however, they may require surgery to repair.

What Are the Symptoms of an Umbilical Hernia?

The most common symptom of an umbilical hernia is a bulge appearing near the navel.

What Causes an Umbilical Hernia?

An umbilical hernia in an infant is usually caused by the opening in the abdomen for the umbilical cord not fully closing as it typically does after birth. In an adult, an umbilical hernia is usually caused by something putting pressure on the abdomen, which weakens the muscles and allows the intestines to poke through. For example, an umbilical hernia in an adult can be caused by:

  • A prior abdominal surgery
  • Fluid buildup in the abdominal cavity
  • Having been pregnant multiple times
  • Obesity
  • Dialysis to treat diabetes over a long term

What Is a Congenital Diaphragmatic Hernia?

A congenital diaphragmatic hernia is a birth defect that occurs when the diaphragm doesn’t fully develop in the womb and a baby is therefore born with a hole in the muscle. When this occurs, it’s possible for an internal organ or other tissue to move into the hole in the diaphragm while the baby is still developing in the womb. The internal organs that can move into this space could be the bowels, the liver, or the stomach, for example.

If this occurs, other aspects of a baby’s development can be negatively affected because the organs aren’t in the right place. For example, the development of the lungs could be hampered because there isn’t as much room in the chest cavity as there normally would be for them to develop properly, which can lead to breathing problems later on, although it’s possible for the development to happen correctly after the baby is born.

How Is a Hernia Repaired?

A hernia is typically repaired via surgery. Surgery can either be an open surgery or a laparoscopic, which means that a small incision is made and the hernia repair is done through that small incision. Which type of surgery is needed to repair a hernia depends on the hernia’s location and size, as well as the age and overall health of the patient.

A hernia repair surgery often does two things. First, it repairs the hernia, but the surgeon may also implant hernia mesh to help support the weakened tissue. In a first-time hernia repair surgery, absorbable hernia mesh may be used. If the hernia has occurred before or is particularly weak, or depending on the type of hernia, then a non-absorbable hernia mesh may be used instead to provide more permanent support for the weakened muscle.

Why Was the C-Qur Hernia Mesh Recalled?

Beginning in 2013, there was a packaging issue that resulted in Atrium recalling almost 150,000 units of the C-QUR hernia mesh. The products that Atrium recalled due to the packaging problem, which caused excessive humidity over a long period of time, included C-Qur V Patch, C-Qur Edge, C-Qur Tacshield, and standard C-Qur hernia mesh. This humidity resulted in the hernia mesh products’ coating sticking to the packaging.

What C-Qur Hernia Mesh Complications Were There?

Prior to the 2013 recall of C-Qur hernia mesh with packaging problems, the FDA received reports of complications due to the usage of C-Qur hernia mesh in hernia repair. Many of the complaints were regarding negative health effects from the fish oil coating on the hernia mesh, which caused a negative immune response, with the following side effects:

  • Infection
  • Sepsis
  • Mesh rejection
  • Mesh migration
  • Damage to organs
  • Fistula
  • Complex seroma
  • Formation of a sinus tract
  • Delays in the closure of the wound
  • Severe pain
  • Gastric ulcers
  • Organ perforation
  • Inflammation
  • Death

Has the FDA Warned About C-Qur Hernia Mesh?

The FDA has investigated Atrium multiple times between 2008 and 2013 and during those inspections, failures to follow federal regulations were found. The problems that the FDA found ranged from reporting issues to monitoring and manufacturing problems. This resulted in the FDA sending a warning letter to Atrium in 2012. Because Atrium was found to have changed the manufacturing process for its C-Qur mesh without first testing the new procedures, the FDA sought an injunction from the courts against Atrium to prevent them from manufacturing C-Qur hernia mesh until the company was able to rectify the problems.

C-Qur hernia mesh was then cleared for production again by the FDA in 2016 through the FDA’s 501(k) fast-track program, which enables companies to gain approval from the FDA without having to undergo the usual research requirements due to the fact that similar products were already being sold on the market. Although the C-Qur hernia mesh was cleared by the FDA, many patients have reported complications as a result of having had C-Qur hernia mesh implanted and Atrium is facing lawsuits because of it.


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