Atrium C-Qur Mesh is supposed to help those with hernias. It is designed to help support the weak or damaged tissue after a hernia surgery repair. It went into use in 2006—but the Food and Drug Administration stopped production of the mesh in 2015. They did this in response to serious medical complications that arose because of side effects from the mesh.
Most of these dangerous products have been recalled. Victims have had to have the mesh surgically removed to combat severe health issues that it may have caused. In these situations, an Atrium C-Qur Mesh lawsuit lawyer may be able to help you recover medical expenses and other damages associated with this type of surgery.
Having a hernia is painful on its own. But, when you combine it with use of a medical device that does not work as it intended, the situation can get much worse. In fact, it can cause problems for the rest of your life—and you deserve to recover money.
At John Foy & Associates, we understand just how unfair this situation is, and we want to fight back with you. We have the skill and experience you need to get money for your case. Let us give you a FREE consultation. Call us at 404-400-4000 and get your free consultation today.
What Kind of Damage Can Atrium C-Qur Mesh Cause?
Damage for those who use Atrium C-Qur Mesh after hernia surgery will vary. Those experiencing very few side effects just reported minor or infrequent pain. Others had issues with a long list of complications, including:
- Severe and/or chronic pain
- Infection
- Bowel obstruction
- The mesh embedding itself into the tissue
- Rejection
- Inflammation due to the body creating a foreign body response (where the body attempts to project itself by surrounding the device with scar tissue)
- Rash
- Dental problems associated with infection
- Abnormal liver function
- Neurological changes
- Organ perforation (a hole or tear in an organ)
- Nerve damage
- Seroma (buildup of fluids in the body)
- Mesh migration and shrinkage
The mesh can actually become almost a part of the tissue involved. When the mesh embeds itself into your tissue, that can cause long-term damage to the tissue and organs in the surrounding area.
In addition, Atrium C-Qur mesh is coated with Omega 3 (essentially fish oil). This gel coating can make the device curl and deform over time. When the device moves like this, it can cause other injuries, such as going through other organs and intense pain. The gel coating can also create responses that are similar to allergic reactions, such as swelling, irritation, and pain.
In 2013, the FDA issued a Class II recall when they realized that the gel coating would peel off and stick to the inside of the mesh’s packaging in high humidity.
Why did the FDA Approve This Dangerous Product?
Atrium C-Qur Mesh was approved by the FDA for use in hernia surgeries in 2006. While you may think that FDA approval automatically makes a product safe, that’s not always the case. In this situation, Atrium used a process to get FDA approval that claims that its product is substantially similar to a product that already has FDA approval.
This procedure is known as the 510(k) Premarket Notification process. By using this workaround, Atrium did not have to through the intense testing and research normally required to get FDA approval.
Although Atrium C-Qur Mesh is most-often used in hernia surgeries, it has also been used for:
- Chest wall reconstruction
- Traumatic wound repair
- Surgical wounds
- Other fascial surgical intervention procedures
The FDA visited the Atrium manufacturing plant in New Hampshire in 2013. In that inspection, the FDA discovered that Atrium was not following proper practices for medical device production. Specifically, Atrium didn’t have a good way to correct and prevent problems in the manufacturing process. By the time the FDA inspected the plant in 2013, they had already been there three other times and noted similar violations. It is unclear why the FDA did not react sooner to these troubling issues.
The FDA noted that the 2013 inspection also found that Atrium wasn’t reporting incidents that they knew led to death or serious injury as the law required. The manufacturing plant in New Jersey was shut down in 2014 until it began following all FDA requirements.
Who Can Sue for an Atrium C-Qur Mesh Injury?
Many patients do not know what kind of hernia mesh was used on them. Your doctor may have provided this information to you, but from a patient’s perspective, that information may not be very useful—until you have problems. You should be able to ask your doctor what kind of mesh was used in your surgery. A lawyer can also help you determine the exact mesh used.
You may need to undergo revision surgery—talk to your doctor about this possibility. Then, speak with an Atrium C-Qur Mesh lawsuit lawyer about your options. You may qualify for a hernia mesh lawsuit if:
- You had a hernia repair surgery that used hernia mesh
- Your surgery was during or after 2008
- You have undergone or have scheduled hernia revision surgery
Any adverse side effects that you experience may be important in your lawsuit. Keep in mind that you may not associate specific symptoms with your hernia mesh surgery right away. You may be surprised just how wide-ranging the symptoms can be.
If this mesh was used for any other purpose and caused problems, you may be able to file a lawsuit for those situations too. Mesh lawsuits are not limited to hernia procedures.
Talk to an Atrium C-Qur Mesh Lawsuit Lawyer for Free
Atrium C-Qur Mesh can cause serious, life-altering injuries. In many situations, you can get money to account for the often-severe damage and pain that this defective medical device can cause. John Foy & Associates is here for you. We can help you get in touch with right medical experts to bring your case effectively. We also offer a listening ear and a shoulder you can lean on in this confusing and challenging time—and we know how to win cases. Let us give you a FREE consultation. Call us at 404-400-4000 or fill out the form to your right and get your FREE consultation today.