Atrium C-QUR, Ethicon Physiomesh, Hernia Mesh Allegedly Cause Severe Intestinal Complications
In 2013, Atrium Medical manufacturers recalled 145,000 C-QUR units citing “packaging problems”. However, studies have shown that C-QUR mesh, which is lined with an uncommon fish-oil-derived coating, may be prone to higher rates of infection than other hernia meshes.
After receiving complications reports as early as 2008, the U.S. Food and Drug Administration (FDA) visited the C-QUR manufacturing plant four times between 2009 and 2013. During these inspections, the manufacturers were reported to be in violation of federal regulations. In 2012, the FDA presented Atrium with a warning letter, which is one of the most serious actions the FDA can take against a manufacturer.
In the letter, it was reported that there were manufacturing and sterilization issues present at the time of the inspections and that human hair and other foreign materials were found in supposedly sterilized C-QUR. Further, the FDA accused the manufacturer of changing their manufacturing process without proper testing.
Ethicon’s Physiomesh, a similar mesh product was pulled off the shelves in 2016 after a class 2 device recall letter was issued by the FDA. Patients were reporting hernia recurrences and other complications after surgeries where the mesh was implanted in their bodies. The complications reported to the FDA included: hernia recurrence, bunching of the mesh, adhesions, failure to assimilate into the body, pain, and inflammatory reactions.
Both companies are at the center of thousands of lawsuits involving their mesh products.
What is a Hernia Mesh and Why Are People Reporting Problems with It?
A hernia occurs when an organ, intestine, or fatty tissue presses through a whole or weakened area in the surrounding muscle or connective tissue. As they more often occur at the abdominal wall, hernias may be seen as an external bulge in that area. In hernias that are surgically repaired, a doctor may use a medical device known as a surgical mesh to provide additional support to the weakened or damaged tissue.
The most common reported adverse reactions to hernia mesh are pain, infection, hernia recurrence, adhesion, and bowel obstruction. In the case of Atrium C-QUR, many patients are reporting severe intestinal complications.
Ethicon’s Physiomesh Lawsuits Allege the Product Caused Permanent Injuries
A Johnson & Johnson subsidiary, Ethicon, is also in the spotlight due to the alleged defective design of its Physiomesh® transvaginal mesh product. Over 3,000 lawsuits have been brought against the manufacturer for the supposed serious complications and injuries sustained by surgery patients who had the product implanted in them.
In contrast to the C-QUR mesh, Ethicon’s Physiomesh is made of a type of plastic known as polyethylene. Its special coating was intended to make the mesh adaptable once in the body and prevent tissue attachment.
The FDA issued a recall of Physiomesh in May 2016 and classified the action as a market withdrawal in the United States, while foreign regulatory agencies have named it a recall. In 2016, Ethicon reached a $120 million deal to settle the multidistrict litigation.
Atrium C-QUR Mesh Lawsuits Allege the Mesh’s Gel Coating Is Defective
In one case brought against Atrium before the U.S. District Court of New Hampshire, C-QUR mesh was described as creating a perfect breeding ground for bacteria to proliferate. Furthermore, it describes the defendant’s C-QUR mesh as “cytotoxic, immunogenic, and not biocompatible, which causes or contributes to complications, such as delayed wound healing, inflammation, foreign body response, rejection, infection, and other complications”.
Complications Associated with Defective Hernia Mesh
Some of the complications reported after hernia mesh surgery are hematoma, surgical site infection, bladder injury, vascular injury, and bowel injury. The most common complications are serious and always require surgical intervention to repair the damage.
According to Drug Watch, hernia mesh complications may also include:
- Adhesion
- Bowel obstruction
- Bowel perforation
- Infection
- Rejection
- Migration
- Recurrence
- Chronic Pain
Do I have a Hernia Mesh Lawsuit Claim?
An individual may have a hernia lawsuit claim if it can be proven that a manufacturer’s negligence led to severe injuries requiring surgery to correct. Manufacturers can be held responsible for defective, dangerous, and improperly labeled products. Hernia mesh lawsuit claims may involve:
- Defective product design
- Improper labeling that does not warn about possible failures and complications
- Defective product manufacturing
A patient’s doctor may also be held accountable if it is found that malpractice was committed when the doctor implanted the defective mesh. Medical negligence litigation requires a trial attorney to prove that accepted standards of care were violated and that those violations led to injury or death.
How Long Does a Hernia Mesh Lawsuit Take?
As each case is different and varies greatly whether a plaintiff is suing a manufacturer for a faulty product or a doctor for medical malpractice, there is no average duration for a hernia mesh lawsuit. Further, a hernia mesh lawsuit may settle out of court at any time.
What is the Average Settlement for a Hernia Mesh Lawsuit?
Although there have been no public announcements of settlement amounts for current active lawsuits against Atrium or Ethicon, the largest hernia mesh lawsuit settlement amount to date is $184 million, which was paid by C.R. Bard to settle approximately 3,000 cases in 2011. According to the Legal Reader, settlement amounts awarded to an individual often fall between $50,000 to $200,000, with the average settlement being around $105,000.
The settlement amount depends on several factors, including:
- The extent of injuries
- Medical costs associated with repairing damage due to the hernia mesh
- Pain and suffering
- Impact on an individual’s work and family
Looking to File a Hernia Mesh Lawsuit – 4 Things to Know When Contacting Our Law Firm
1. Who manufactured your hernia mesh surgical implant?
2. What were the dates of your hernia mesh implant and revision surgeries?
3. Contact Panter, Panter & Sampedro to help assess your hernia mesh lawsuit claim
4. Act quickly to meet hernia mesh lawsuit deadlines
Contact An Experienced Product Liability Attorney
Hernia mesh lawsuits are notoriously complex. That’s why you need a product liability attorney at your side every step of the way. The legal team at Panter, Panter & Sampedro has earned the trust of clients by achieving excellent results. Having tried many multi-million dollar cases leading to favorable verdicts and settlements totaling over $100 million, we are prepared to handle your product liability case from beginning to end.
Sources:
https://www.drugwatch.com/hernia-mesh/c-qur/
https://www.fda.gov/medical-devices/implants-and-prosthetics/hernia-surgical-mesh-implants
https://www.nhd.uscourts.gov/pdf/Atrium_LongForm_122719.pdf
https://eclassactions.com/hernia-mesh-lawsuits/
https://www.nolo.com/legal-encyclopedia/how-long-will-my-hernia-mesh-lawsuit-take.html
https://www.legalreader.com/what-is-the-average-settlement-for-a-hernia-mesh-lawsuit/
