While a majority of medical devices have revolutionized healthcare and helped to save thousands of lives, others have proved to be detrimental, causing patients to suffer serious side effects. One such medical device is a hernia mesh.
Hernia mesh is used for repairing hernias by strengthening the tissue repair and by minimizing the rate of recurrence. The issue with hernia mesh repair is that when it was brought to the market in 2000, there were design and manufacturing issues that caused them to be incompatible with the human immune system, wreaking havoc on the body by triggering immune system attacks, inflammation, and other complications.
This article goes over the history of problems and reasoning for a hernia mesh recall due to injuries and complications.
A Long History of Issues
From 2005 to March 2018, hernia mesh manufacturers recalled more than 211,000 units of mesh. These devices are alleged in numerous lawsuits to be defective. The timeline of recalled hernia mesh products dates back two decades:
- In 2000, new permanent hernia mesh devices from a variety of manufacturers came on the market.
- A decade later, in 2010, Ethicon’s Physiomesh product was approved for sale by the FDA.
- However, two years later the FDA issued a warning letter regarding Atrium’s C-Qur mesh product after conducting a series of investigations.
- In 2015, the FDA filed for a permanent injunction against Atrium for the C-Qur.
- In 2016, Ethicon issued a voluntary recall of its Physiomesh product following evidence indicating that the mesh was defective and causing major issues among certain patients.
- In 2017, the Physiomesh lawsuits that were pending in federal court were consolidated into multidistrict litigation (MDL).
- The FDA issued safety warnings in 2018, demanding that hernia mesh products be recalled and claiming that they were the main cause of obstruction complications as well as bowel perforation.
- Also in 2018, the FDA averaged more than 500 adverse event reports per month for all types of surgical mesh.
- In 2019, there were 6,168 lawsuits pending with trials set to begin in late 2019 and early 2020.
These defective products were manufactured by:
- R. Bard Kugel Hernia Mesh
- Ethicon Physiomesh
- Atrium Medical C-Qur Mesh/Patch
Injuries Associated with Hernia Mesh
The injuries a hernia mesh device can cause can be quite severe. The most common hernia mesh injuries include:
- Puncturing other tissue or organs
- Adhering to other tissue or organs from the formation of scar tissue
- Bowel obstruction
- Detachment and migration of the mesh
- Hernia recurrence
Dependent on the patient and the mesh they received, these complications can occur immediately after hernia mesh surgery or long after surgery takes place. Regardless, just about all of these common complications patients experience require additional surgery to fix.
The Personal Injury Attorneys at Carter Mario Law Firm Can Help
If you or a loved one has suffered harm caused by hernia mesh, you need experience on your side. Let Carter Mario Law Firm protect your rights and can help you with your hernia mesh lawsuit. Just call (203) 876-2711 today. You can also submit a FREE Initial Consultation Form. We know serious injury claims—and stand ready to help you receive the compensation you deserve.