The Story of Hernia Mesh Recalls
Hernia mesh has produced large profits for medical device companies. Since its introduction and widespread use, many manufacturers have entered the market with goal of taking their own share of the profit [Hernia Mesh History]. Because of the massive revenue potential many manufacturers rush products to market which has led to recent surge in hernia mesh recalls.
The problem is that many of these manufacturers used the 501(k) approval process to quickly push their products to market. What does this mean exactly?
The 501(k) exemption basically allows devices which are considered "low-risk" easy entry to the market. With this exemption, mesh manufacturers are not subject to clinical trials and bypass a number of safety checks. The traditional FDA approval process is extremely rigorous. Not to mention, it's also very costly and time consuming. Because of this, manufacturers take the path of least resistance and unfortunately the FDA has opened a loophole for them to pass right through.
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Let's review the list above of current hernia mesh recalls and manufacturers. Note: Not all products below are under FDA or manufacture recall however, they are all facing litigation in some form.
Atrium Medical began manufacturing a line of hernia mesh products back in 2006. The company was acquired by Maquet which is now a subsidiary of the Gentige Group. Their C-Qur product line is still used today despite countless lawsuits warning from the FDA. The C-Qur mesh product is a composite mesh with an Omega-3 fatty acid coating. This coating has proven to be extremely problematic for patients causing severe allergic reactions, infections and bowel obstruction.
In 2013 The FDA issued a Class 2 Recall of the product because of a packing issue. Essentially humid conditions were peeling off the fatty acid coating before implantation. That recall has since ended but the real risk remains. The C-Qur line is notorious for producing infections in patients at the surgery site. most of these being chronic. The Omega-3 fish-oil coating has also been problematic with triggering undesired immune responses such as inflammation.
C-Qur product line
C-Qur has produced several different products since 2006.
- C-Qur V-Patch
- C-Qur OVT
- C-Qur RPM
- C-Qur Mosaic
- C-Qur FX
- C-Qur TacShield
C-Qur products have been known to cause chronic infection, abdominal pain, bowel obstruction, fistulas, internal bleeding and number of other symptoms. If you think you may be affected contact us today. Our news blog contains updated information on Atrium related hernia mesh recalls.
Ethicon, a division of Johnson & Johnson, produces a large number of hernia mesh products including patches, flat mesh, biologics and fixation devices. The subsidiary also manufacturers transvaginal mesh products which have also seen a fair amount of complications and negative attention. Their Physiomesh and Proceed Ventral Patch products are the two that are considered harmful (at least that we're aware of).
The Physiomesh product is polypropylene patch used in hernia repair that has a double-sided coating. This coating protects the patient from contact with the polypropylene core, which can adhere to organs and create fistulas. Other symptoms include infection, bowel instruction and general mesh failure (breaks or tears inside the patient). The product was released in 2010 using the 501(k) approval process mentioned above and was pulled of the market in 2016 after a voluntary recall. Ethicon issued an Urgent: Field Safety Notice notifying all surgeons and operating room supervisors to immediately stop using the product.
Ethicon Proceed Mesh
The "Proceed" mesh patch originally debuted in 2005 and featured a multilayer design featuring ORC. The soft outer layer is made up of mesh while the inside layer is made of polypropylene. The product has been plagued by defects since its introduction. The design had the intent of reducing permanent tissue attachment (a serious issue that many mesh products are known to cause) by protecting against direct exposure to the polypropylene. Issues arose when it was discovered that the layers were separating inside of patient leading to tissue/polypropylene contact. In 2010, the FDA forced Ethicon to recall these devices. Patients have reported symptoms such as tenderness or complications at the surgery site, fever, abdominal pain and a myriad of other issues. Read more information on our Proceed Mesh page to learn more about this and other hernia mesh recalls.
The Kugel patch is one of Bard's earliest and well know defective mesh products. The Kugel is a circular patch featuring an innovative spring loaded ring. The ring allows the product to spring open once implanted adding structural support and stability. This product is manufactured by Davol, a subsidiary of Bard
When Davol first warned consumers of the threatening side effects and patch recall, patients implanted with the Composix Kugel Mesh patch were not surprised. Since December 2005, Davol Inc. Has recalled the hernia patch a total of three separate times. Health tests have shown the Kugel's "memory recoil ring" to be faulty. This is the piece that surrounds and keeps the patch in place which reportedly can break after implantation.
When the implanted patch breaks, significant side effects can occur including bowel problems and chronic enteric fistulas. These complications result in extraordinary abdominal damage, extra surgery, and in some cases death.These situations should not be taken lightly and if you are experiencing pain, get checked by a physician immediately. Patients are urged to join the hernia patch lawsuits against Davol and C.R. Bard ( the makers of the patch ). Class action suits against
the company have alleged that the makers were entirely conscious of the design and manufacturing issues and did not give proper notice to medical professionals and patients. Victims are urged to come forward and file suit by contacting a legal professional. Click here to let us help with that and receive compensation for your pain.
To summarize, the issue here was with the polypropylene material inside which lead to reported defects and, eventually, FDA recall in 2005. Punctured bowels are a common complaint and continue to be reported from affected patients. More info on Bard and their hernia mesh recalls can be found in our product subpages.
The Bard 3DMax is mesh product used to treat inguinal hernias. This type of hernia originates in the groin area and is more common in males. [Types of Hernias] Unlike most other patches and mesh products, the 3D Max features a curved concave design to fit in the groin area (inguinal canal). The product contains Polypropylene that has been known to shrink and degrade over time. The 3D Max can also cause serious tissue damage over time as the product erodes. There have even been cases where the mesh attaches to the spermatic chord in males. When this occurs, surgical removal is required and can result in testicular removal.
Bard released the Ventralex patch using the 501(k) approval process in 2002. They claimed the product was similar to their already approved Kugel mesh which allowed them to expedite time to market. They were right, is was similar. Like the Kugel ,the Ventralex also contains polypropylene, which as we know by now, causes serious issues over time. Bard pulled a select lot of Ventralex patches from the market via a 2006 and 2011 recall. If you you think you might be infected, contact us now.
The Sepramesh was originally manufactured by a company called Genzyme Biological in 2005. Eventually Bard acquired the rights to manufacture the mesh patch and incorporated it into their product line. Sepramesh has a natural fatty outer coating and polypropylene core. Surgical site complications have been known to occur including inflammation and sever chronic infection. As of today, the Sepramesh is not currently under FDA recall. However, lawsuits continue to mount against the product.
Other Bard products known to cause complications include:
Contact us today if you have one of these devices and are experiencing any type of pain or discomfort.
Coviden, Which has now been acquired by Medtronic, issued a class 2 recall on this product in 2010. The sterile coating was being compromised because of a packing issues. The patch is made of polypropylene and can cause complications at the surgical site.
In addition to Sergipro, Medtronic also produces the Parietex Composite and the Parietex Plug & Patch system. Medtronic is also known for producing faulty vaginal mesh produces and has faced litigation for the past several years. Product specific information regarding hernia mesh recalls can be found in the following subpages:
You can also read about some of the record mesh settlements that have been paid to victims.
Medical Malpractice Cases
Many people don't understand this sort of a situation may also be classified as medical malpractice, particularly if a surgeon utilized a hernia patch that was in a lot that was recalled. We've actually seen this in an alarming number of cases. Sometime operating room keep stock of recalled devices by mistake. The manufacturer has the responsibility to distribute these notices to hospitals and surgeons but sometimes mistakes are made. This is why it's important to check our individual product pages and get the specifics on the recalled product codes. If you're unsure, just ask. You'll want to contact us and gain professional counsel to have your options evaluated. If we determine that you were implanted with a recalled, device, we can potentially file a defective medical device action. Be sure you have your medical records and the lot number of the hernia patch used. You can often contact the hospital for this detail if you don't already have it.
Have you been injured in this type of operation?
Contact us today and let's discuss your case.
Published By: The Mesh Attorney
Author, creator and expert on hernia mesh related injuries, case and settlements.