C-QUR Hernia Mesh
C-QUR Mesh products made by Atrium Medical Corporation have come under scrutiny as hernia repair patients increasingly report complications due to use of this medical product.
Increasingly, new product liability lawsuits allege Atrium produced and sold a defectively-designed medical device and failed to warn doctors and patients of the known serious health risks.
In many instances, patients have reported suffering complications such as:
- Infections (including chronic infections)
- Bowel obstructions
- Severe and lasting pain
- Recurrence of a hernia
These issues often necessitate corrective surgery, which doesn’t always solve the issue.
Plaintiffs in C-QUR hernia mesh lawsuits assert Atrium knowingly produced dangerous or defective hernia devices. For this, the company should be held to account and required to compensate unsuspecting consumers for their medical bills, lost wages and pain and suffering.What is a Hernia?
Hernia repair is one of the most commonly performed surgeries in the U.S.
As the U.S. Food & Drug Administration notes, a hernia occurs when an organ, fatty tissue or intestine squeezes its way through a weak spot or hole in surrounding connective tissue or muscle, usually at the site of an abdominal wall. Sometimes, these hernias are visible, especially when a person is bearing down or straining.
There are six main types of hernias (inguinal, femoral, incisional, ventral, umbilical and hiatal), and most are the result of some combination of weakness in connective tissue and ongoing pressure.
Mesh devices have been used for years to treat these conditions. However, outcomes in recent years with devices like C-QUR made by Atrium and Physiomesh made by Ethicon (a Johnson & Johnson subsidiary) are often adverse.What Is C-QUR?
Manufacturer Atrium describes its product C-QUR as a product used for:
- Hernia repair
- Chest wall reconstruction
- Traumatic wounds
- Surgical wounds
- Facial surgical intervention procedures requiring reinforcement with non-absorbable supportive material
Atrium makes C-QUR mesh with polypropylene with an Omega 3 gel coating. The company’s website describes the coating as “natural,” but it’s proven problematic for numerous patients.510k Approval of C-QUR
Normally, medical devices like this one would need to undergo rigorous testing that could span many years before receiving approval to hit the market and be implanted in patients. But like so many medical devices currently used in these surgeries, C-QUR sidestepped this process through the 510(k) Clearance program of the U.S. Food & Drug Administration.
The program involves a pre-market submission made to the FDA by the drug company attesting that the device is at least as safe and effective and substantially equivalent to a legally marketed device already on the market.
For a product to be deemed “substantially similar” to another legally marketed device, the device must be as safe and effective as the device to which it is being compared. It must also:
- Have the same intended use;
- Have the same technological characteristics; OR
- Have the same intended use;
- Have different technological standards that do not raise new questions of effectiveness and safety and demonstrate the device is at least as effective and safe as the one already on the market.
C-QUR obtained its 510(k) approval in 2005, asserting it was substantially similar to a mesh produce that had been tested and approved in the 1990s. This was despite the fact C-QUR was the first ever mesh device to use the Omega 3 fatty acid coating.
The C-QUR hernia mesh devices include the:
- C-QUR V-Patch
- C-QUR FX Mesh
- C-QUR TacShield
- C-QUR Centrifix
It should be noted that products approved via this 510(k) process may be more likely to face litigation because the product wasn’t thoroughly tested before it hit the market. It’s up to the company to ensure their products are safe and that they warn consumers of the risks involved.Problems with C-QUR
Mesh manufacturers Atrium and Ethicon have been cited time and again by the FDA for problems with these devices.
In 2012, the FDA issued a warning letter to the company, pointing out it was not properly addressing the complaints that the firm was receiving regarding infections. The company was also not reportedly attentive to concerns about sterility. In dozens of cases, doctors reported finding human hair in the devices, despite the marketing material promising the devices to be sterile.
In 2013, the company issued a recall asserting the coated mesh could adhere to the inner packaging liner if exposed to high humidity conditions for extended periods of time. The Class 2 recall, which affected some 33,000 C-QUR mesh devices of all shapes and sizes, does not reference any potential health consequences and was terminated in 2016.
Some patients say the company has been prioritizing profits over people by not revealing important information about the high risk illustrated by high rates of complications.
In 2015, the FDA took a rare step in issuing a permanent injunction that blocks Atrium from manufacturing and selling C-CUR Hernia mesh, finding these devices were not safe and effective as promised.Winning a C-QUR Lawsuit
When Atrium refused patient demands to compensate patients for losses connected to C-QUR, a flood of lawsuits followed.
These included federal cases in Massachusetts, Florida, and Illinois. It’s expected thousands more will be filed against C-QUR. Because of the sheer volume of cases, courts have established a Multi-District Litigation, wherein early legal issues will be handled at once and only a few “bellwether” cases will proceed. This process does not strip individual plaintiffs of the right to control their claim (unlike a class action) but typically helps these cases move more quickly through the pipeline.
Most larger companies will not settle MDL cases until those bellwether lawsuits are decided at trial. The bellwether cases have chosen to go first usually are indicative of the variation within the claims. The outcomes in those matters will a precedent that gives all parties involved an idea of how future C-QUR cases will turn out. If plaintiffs are successful in those first few cases, the company may choose to settle most others moving forward.
If you suffered complications from Atrium C-Qur hernia mesh, an experienced product liability lawyer can help you determine your legal options.
C-CUR Hernia Mesh Attorney – (617) 367-2900 – Free Consultation