Hernia Mesh Surgery complications and lawsuits
c-Qur hernia mesh and ethicon physiomesh are causing many post surgery problems
November 22, 2017
If you are suffering complications from a hernia mesh surgery, you may be overwhelmed with information. Not only are you dealing with the pain but probably also trying to find a medical solution to it. You may also be thinking about hiring a lawyer.
If you do decide to sue, you will be involved in what is called a ‘mass tort’. Mass torts are product liability lawsuits against drug companies and device makers over dangerous drugs and devices. Frequently, there are thousands of plaintiffs, and their cases are ordinarily consolidated into a single court.
You may not know who made your hernia mesh, but here are some of the common brands that we believe are concerning. It is important to know that not all brands or makes of hernia mesh are problematic. There are an estimated one million hernia operations conducted each year, and statistically, they occur in a little under 2 percent of all men. Not all of these patients have problems of course.
The Problems With C-Qur Hernia Mesh
The C-Qur (pronounced “secure”) Hernia Mesh is made by Atrium. There are three main problems alleged.
The first problem with this mesh is that it’s made with polypropylene plastic that can cause a rejection response when placed in the body. This response can cause the mesh to bind beyond the muscle wall and bind to the intestines and other organs.
The second problem with this hernia mesh is that it contains a flexible metal ring that holds the mesh in a circle. This ring is prone to breaking.
The third problem with this hernia mesh is that it’s associated with a high rate of infections. The medical reason thought to be the cause is because the coating of the hernia mesh prevents fluid from escaping. It allows fluid to pool and remain dormant for months, becoming a breeding ground for bacteria.
Currently, these cases are consolidated into a multi-district litigation docket before US District Judge Landya McCafferty in New Hampshire. In this litigation, the plaintiffs allege that the C-Qur mesh was:
• Defectively designed or manufactured
• The defendants knew (or should have known) about the allergic or
• Defendants failed to provide adequate instructions and warnings.
Plaintiffs argue that the C-Qur Hernia Mesh was never tested for safety by the FDA. There were, however, a series of warnings and recalls. The first warning came in 2012 when the FDA issued a warning letter to Atrium, saying their sterilization process was defective. The FDA found 35 separate complaints of human hair being embedded into the mesh. There were multiple instances of C-Qur infections that the company failed to report.
There was a recall that took place on August 9, 2013. Atrium Medical recalled 95,286 units because the coated mesh could adhere to the inner packaging when exposed to high humidity. This ‘recall’ was in the form of a letter to doctors notifying them of the “stickiness” problem.
Finally, there was a FDA injunction against the company stopping them from producing the mesh, and that took place on Feb 4, 2015. It was followed up by more than 10 inspections by FDA investigators, who found major violations in the quality system regulation, the medical device reporting regulation, and the correction and removal regulation.
Finally, Plaintiffs point to scientific articles finding some hernia mesh causes an increase in adhesions. Additionally, these articles found that the C-Qur hernia mesh caused more infections than all the other brands combined.
Ethicon Physiomesh Recalls and Complications
Another hernia mesh to be aware of is the Ethicon Physiomesh flexible composite mesh. Ethicon is a division of Johnson & Johnson. Ethicon issued an urgent field safety notice and withdrew their product from the market in May 2016. The notice included a recall of all existing stock held by healthcare facilities for all variations of the Physiomesh product line. Health Canada issued a recall for Physiomesh products. It’s estimated that as many as 300,000 people have been implanted with Physiomesh in the United States since the product was approved in 2010. Approximately 30,000 patients in Canada also received the mesh.
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