A lawsuit has been filed against the company behind a surgical mesh implant for causing severe complications, including chronic pain and permanent injuries. The plaintiff alleges that he was not provided with adequate information about safety before surgery or given proper guidance after it occurred, which led to further problems.
The “fda hernia mesh recall list” is a lawsuit that was filed in 2015. The plaintiffs are suing the FDA for their decision to approve a certain type of hernia mesh.
(As of February 20, 2018)
Hernia mesh is used to support injured tissue and speed up healing following hernia surgery. However, some patients who have hernia repair surgery have serious issues that they feel are caused by the surgical mesh that was put.
Physiomesh and C-Qur mesh, for example, may cause harm to the intestines, bowels, and abdomen. Additional (or revision) surgery may be required to address these adverse effects.
Patients who needed hernia revision surgery are now suing Ethicon and Atrium, the makers. They claim that the corporations created harmful and faulty goods and neglected to notify customers about the risks.
Contact us immediately for a free, no-obligation legal consultation if you or a loved one needed revision surgery due to hernia mesh side effects.
What Are Some Hernia Mesh Complications?
Hernia mesh may cause the following negative effects in patients:
- intestines or bowels that have been perforated
- Puncture of various organs in the abdomen
- Fistulas in the intestine
- Obstruction or excision of the bowel
- Tears in the abdominal wall
- Mesh ingrowth isn’t happening.
- Mesh material’s adhesions to the bowel
Which Hernia Meshes Have Been Recalled by the FDA?
The FDA issued a warning letter to Atrium in October 2012 for failing to address C-Qur mesh infection and sterility problems. Human hair was discovered in the gadget, prompting 35 complaints.
Atrium was sued by the FDA for insufficient quality control at its manufacturing site in New Hampshire.
C-Qur mesh was recalled by Atrium in July 2013 due to a Class 2 FDA recall because the coating might attach to the packaging liner if exposed to high humidity. The risk of infection may be increased as a result of this separation.
The FDA sued Atrium for insufficient quality control at its manufacturing site in New Hampshire, ordering the business to halt manufacture and distribution of the C-Qur mesh.
Ethicon’s Physiomesh was also recalled in July of 2016. Ethicon, a Johnson & Johnson subsidiary, voluntarily issued the recall, citing a higher risk of recurrence and revision surgery compared to other brands.
Why Are Some Patients Unsuitable for Hernia Mesh?
Ethicon’s Physiomesh and Atrium’s C-Qur mesh are both constructed of materials that are incompatible with the bodies of many patients.
Polypropylene plastic is used in both Physiomesh and C-Qur mesh. The bulk of transvaginal mesh devices are made of the same material, which has resulted in over 100,000 personal injury cases.
Monocryl, an absorbable substance meant to avoid irritation and adhesion, is also coated on Physiomesh, which patients claim is not suited for implantation.
Atrium, a Maquet subsidiary, manufactures C-Qur mesh. It is coated with Omega-3 fatty acid fish oil, unlike Physiomesh. Some people may have adverse responses to this oil.
The FDA’s fast-track 510(k) Clearance program cleared both Physiomesh and C-Qur mesh. If firms can show their goods are comparable enough to other products on the market, the 510(k) Clearance procedure does not need clinical studies involving human patients.
What Are Some Well-Known Hernia Mesh Cases?
The first Ethicon Physiomesh litigation is set to begin in Illinois’ Southern District in January 2018.
An infection, two abdominal abscesses, and intestinal fistulas were purportedly induced by the Physiomesh.
Matthew Huff, who was implanted with Physiomesh in 2013 for an abdominal wall hernia, filed the claim. Mr. Huff had corrective surgery two years later. An infection, two abdominal abscesses, and intestinal fistulas were purportedly induced by the Physiomesh.
Personal injury cases have also been filed against Atrium, which have been combined in a multidistrict litigation (MDL) in the United States District Court for the District of New Hampshire.
Check out our infographic about hernia mesh.
In January 2017, James Brown and his wife filed an Atrium lawsuit for the C-Qur mesh. Mr. Brown had the gadget inserted during a hernia repair procedure in December 2013, but he still had stomach discomfort. In January 2016, he had another surgery to remove the mesh. He had a “foreign body large cell response” and scarring of the surrounding tissue, according to doctors.
According to the complaint, Atrium misled medical experts into believing the medication was safe despite knowing it was physiologically incompatible with surgery patients. According to the lawsuit, Atrium neglected to properly notify the FDA of adverse occurrences and conducted “stealth recalls” of the product without informing the FDA or the medical community.
What Are Some of the Most Popular Hernia Mesh Brands?
The following are some of the most often utilized hernia mesh manufacturers and brands.
C-Qur is a polypropylene mesh coated with fish (Omega-3) oil from Atrium. The oil is meant to prevent the mesh from adhering to tissue, however based on the number of lawsuits filed over this line of meshes, this isn’t always the case.
The FDA authorized the C-Qur mesh in 2006 under the 510(k) protocol, which meant that no pre-market studies were required.
In July 2013, Atrium announced a Class 2 FDA recall of C-Qur mesh because the coating might attach to the packaging liner if exposed to high humidity, posing a risk of infection. More than 95,000 meshes were recalled as part of this recall.
3DMax by C.R. Bard
C.R. Bard’s 3D Max hernia mesh is a polypropylene mesh that was authorized under the 510(k) protocol, which means it didn’t have to go through pre-market research like C-Qur. In October of 2008, 3DMax received approval. Bard withdrew the mesh only two months later due to product mislabeling.
The 3DMax, like many other polypropylene meshes, has been linked to migration, discomfort, and revision surgery.
Ventralex ST by C.R. Bard
“Self-expanding polypropylene… patch that may be utilized to treat tiny ventral abnormalities such as umbilical hernias and trocar site deficits,” according to the Ventralex hernia patch. Ventralex patches were initially authorized in 2002, and the most current one was approved in 2013. It was authorized under the 510(k) protocol, much as many other mesh devices.
The Ventralex ST Medium Circle with Strap Hernia Patch was recalled by Bard in a “urgent” Class 2 FDA recall in October 2011.
Composix Kugel Mesh by C.R. Bard
At least three recalls (in 2005, 2006, and 2007) followed, as well as hundreds of lawsuits and millions of dollars in settlements and jury judgments.
After suffering excruciating consequences from his Kugel mesh, Christopher Thorpe was granted $1.3 million by a jury in 2010. This was a watershed moment for Bard, who settled 3,000 additional Kugel cases for a whopping $184 million in 2011.
Ethicon/Johnson & Johnson’s Physiomesh
Ethicon’s Physiomesh was recalled in July of 2016. Ethicon (a Johnson & Johnson subsidiary) issued the recall, citing a higher risk of recurrence and revision surgery compared to other brands.
What are the Claims in Hernia Mesh Lawsuits?
Manufacturers of hernia mesh, such as Ethicon and Atrium, have been accused of a variety of things in personal injury lawsuits:
- Creating a “unreasonably risky and faulty product” with a high chance of serious side effects
- Selling a product that did not function as expected and was directly responsible for the need for surgical removal
- Failure to alert defendants and medical professionals about the mesh devices’ dangers
Who Can File a Lawsuit Over a Hernia Mesh?
If you match the following conditions, you may be eligible for a hernia mesh lawsuit:
- Hernia surgical mesh was utilized during your laparoscopic hernia repair operation.
- On or after January 1, 2008, the procedure was performed.
- You’ve had or are about to undergo hernia revision surgery.
What kind of remuneration might they expect?
Compensation for the following may be obtained via a hernia mesh lawsuit:
- Medical expenses
- Wages that have been lost (past and future)
- Suffering and pain
Though no settlements for Physiomesh or C-Qur mesh have been reached yet, C.R. Bard’s lawsuit history for its Composix Kugel Mesh provides some insight into potential compensation.
More than 3,000 lawsuits have been filed over the Composix Kugel Mesh. It included memory recoil rings that might break or bend, leading to abscesses and fistulas.
C.R. Bard offered $184 million in 2011 to resolve 2,600 complaints brought in a multidistrict action in Rhode Island.
What Is the Process for Filing a Hernia Mesh Lawsuit?
Contact us for a free, no-obligation legal consultation if you or a loved one had hernia repair surgery and had issues from the surgical mesh.
Our lawyers have helped clients collect more than $5 billion from irresponsible firms, including Big Pharma, and we will fight to help you hold mesh makers accountable as well. Best of all, there is no fee unless we get a jury award or a settlement on your behalf.
The “hernia mesh lawsuit timeline” is a timeline of the events that have occurred in the Hernia Mesh Lawsuit. The timeline includes injuries, complications, and recalls.
Frequently Asked Questions
How do I know if my hernia mesh has been recalled?
A: If your hernia mesh is from a company that has been subject to an FDA recall, you should immediately check the product label for information on whether or not its been recalled by looking at the D and S symbols. The D symbol indicates that there are no known issues with this product, while the S symbol signifies that there have been some reports of adverse reactions associated with use of this particular piece of hardware.
What is the name of the hernia mesh that was recalled?
A: The name of the mesh that was recalled is Cordis.
What is the average payout for a hernia mesh lawsuit?
A: The average payout for a hernia mesh lawsuit is $1.7 million dollars, the highest being $10 million.
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